HK1228240A1 - Apparatus and method for measuring biologic parameters - Google Patents

Description

Apparatus and method for measuring biological parameters

The present application is a divisional application of the chinese patent application entitled "apparatus and method for measuring biological parameters" filed as invention No. 201310097177.3 on 26/2/2004.

Technical Field

The present invention includes a support and sensing structure disposed in a physiologic tunnel for measuring body function and controlling abnormal conditions indicated by the measurements.

Background

Interference factors and variables can introduce significant sources of error that render the measured biological parameter clinically insignificant. Invasive and semi-invasive methods have been employed in order to avoid the interference factors and to obtain undisturbed signals. These methods suffer from a number of disadvantages including the difficulty of continuous monitoring over an extended period of time. Non-invasive methods also do not bring the desired clinical usefulness. The sensor is placed on the skin in the presence of interfering factors that make it impossible to obtain a clinically useful and accurate signal and background signals that far exceed the signal associated with the measured physiological parameter.

The most accurate, accurate and clinically useful way to assess the caloric state in humans and animals is to measure brain temperature. Brain temperature measurements are a key and general indicator of disease and health conditions, and are the only vital signs that are not artificially altered by emotional states. Other vital signs (heart rate, blood pressure and respiration rate) are affected and artificially changed by emotional states or voluntary actions.

The body temperature is determined by the blood temperature, which releases heat by far infrared radiation. Adipose tissues absorb far infrared rays, and actually, the body is completely protected by a layer of adipose tissues attached to the skin. As such, since the prior art uses a sensor placed on the skin in the presence of adipose tissue, the temperature measurement using the skin is not accurate and correct.

Since it seems impossible to measure brain temperature non-invasively with the prior art, attempts have been made to determine intra-muscular temperature, also known as core temperature (core temperature). Currently, an invasive, artificial, cumbersome and costly method is used to measure the internal (core) temperature, which involves inserting a catheter with a temperature sensor into the ureter, rectum or esophagus. However, this method is not suitable for routine measurements, which is painful and has potential, fatal complications.

Semi-invasive methods have also been attempted. Abreu discloses in U.S. patent 6,120,460 an instrument and method for continuously measuring core temperature using a contact lens in an eye pocket (eyelid pocket), but the contact lens is a semi-invasive device that should be prescribed by a physician and sometimes is not easy to place in the eyes of infants or even adults, many people fear touching their eyes.

There are several drawbacks and limitations in the prior art for making continuous temperature and/or core temperature measurements.

Today, temperature measurements are non-continuous, non-core, and caregiver dependent. The caregiver must insert the thermometer into the patient's mouth, rectum, or ear. To obtain the core temperature, the caregiver invasively inserts the tube into the body, which can lead to infection and serious complications.

Measuring the core temperature in a hospital and/or continuously by conventional methods requires an invasive procedure, inserting the tube into the body or by ingesting a thermometer pill, which is very difficult and dangerous. Thermometer pills can cause diarrhea, measuring the temperature of the ingested fluid/food rather than body temperature, and can cause fatal complications if the pill obstructs the ducts of the pancreas or liver. Due to the presence of many interfering factors, including adipose tissue, placing the sensor on the skin does not produce clinically useful measurements.

It is not possible to obtain accurate and clinically useful measurements by simply placing the sensor on the skin, not only of the brain temperature, but also of metabolic parameters, physical parameters, chemical parameters, etc. One key factor is the presence of adipose tissue. Fat varies from person to person, changes with age, fat content changes with time in the same person, fat attenuates signals from blood vessels, fat absorbs heat, fat prevents transmission of undisturbed far infrared radiation, fat increases the distance spanned by the element being measured in the body and an external sensor placed on the skin surface.

There is a need for a method and apparatus for non-invasive, convenient and continuous monitoring of brain temperature with sensors placed on the skin in a painless, simple, extracorporeal and safe manner.

There is also a need to identify a method and apparatus that allows convenient, non-invasive, safe and accurate monitoring of biological parameters, including metabolic parameters, physical parameters, chemical parameters, and the like.

There is a need to identify an apparatus and method capable of measuring biological parameters by positioning a sensor on a physiological channel to obtain an undisturbed and continuous biological signal.

Summary of The Invention

The present invention provides methods, apparatus and systems that effectively address the needs of the prior art.

In general, the present invention provides a set of sensing systems and reporting devices, which may be used alone or in combination, designed to access physiological pathways to measure biological, physical and chemical parameters. Anatomically and physiologically, the channel discovered by the present invention is an anatomic path that carries undisturbed physiological signals outside the body. The channel consists of a direct and undisturbed connection between a functional (signal) source within the body and an external site located on the channel end of the skin. The physiological channels convey continuous and complete data related to the physiology of the body. Undisturbed signals from within the body are presented to external sites on the channel ends. A sensor placed on the skin at the end of the channel can obtain an optimal signal without disturbing factors and sources of error.

Included in the invention is a support structure for positioning the sensor on the skin at the end of the channel. Devices are disclosed that are directed to measuring brain temperature, brain function, metabolic function, hydrodynamic function, hydration status, hemodynamic function, body chemistry function, and the like. The present invention includes devices and methods for evaluating biological parameters using patches, clips, eyeglasses (eyeglasses), head-worn gear (gear), etc. with sensing systems modified to access physiological channels to produce accurate and clinically useful information about the physiological state of the wearer, and to improve the safety and performance of the wearer and to help enhance and preserve the life of the wearer by providing adequate reporting devices and alarm devices associated with the monitored biological parameters. The other component produces a direct or indirect effect on the other device or modulates another device or product based on the measured biological parameter.

In an effort to better measure biological parameters, long-term and careful studies have been conducted, including the discovery of Brain Temperature channels (BTTs) and other biological channels in humans and animals. The present invention identifies physiological channels in the body for the first time. The present invention also identifies for the first time the end of the channel at the skin surface where the best signal is available and the measurement can be made without disturbing factors and background noise exceeding the signal being measured. The present invention also identifies and accurately maps for the first time the specific geometry and location of the passageways that comprise the primary entry site. The present invention also identifies for the first time the precise location of the sensing system on the primary entry site to optimally acquire the signal. Intensive research has been carried out, including the development of software to characterize the infrared radiation to accurately determine different aspects of the channel. The present study has determined that measurements of brain (core) temperature and other body parameters can be achieved in humans and animals in a non-invasive and continuous manner with sensors placed on a defined area of skin at the end of a physiological channel.

An important role and key factor in life preservation and human functioning is brain temperature. Brain tissue is the tissue in the body most vulnerable to heat damage caused by high and low temperatures. Brain temperature is the most clinically relevant parameter for determining the caloric status of the body, the brain being responsible for producing 18-20% of the body's calories, a very particular fact given that the brain only accounts for 2% of body weight. The large amount of heat energy generated in the brain is maintained in a confined space, while the scalp, skull, and CSF (cerebrospinal fluid) form a heat insulating layer. By identifying BTTs by the present invention, the adiabatic barrier is overcome and a direct link to the internal brain physiology and physics is provided.

Anatomically and physiologically, brain temperature channels consist of a continuous, direct and undisturbed connection between a source of heat in the brain and an external point at the end of the channel. Physical and physiological events at one end of a channel within the brain are reproduced at the other end on the skin. BTT allows heat to be transferred directly through the channel integrity without interference from heat absorbing elements that are capable of absorbing far infrared radiation transmitted as heat in the brain by blood. There are six features required to define the BTT. These features are:

1) the region without the heat absorbing element, i.e. the region, must be free of adipose tissue. This is a key and necessary feature to define the temperature channel,

2) this area must have a terminal branch of the blood vessel, to transfer the full amount of heat,

3) the terminal branch must be a direct branch of the blood vessels from the brain,

4) the terminal branches must be positioned superficially, to avoid heat absorption by deep structures such as muscles,

5) this region must have a thin and negligible interface between the sensor and the thermal energy source to generate high heat flow, an

6) This area must be free of arteriovenous circuits that regulate body temperature.

All six features are present on the skin at the medial canthal area (medial canthal area) adjacent to the medial corner of the eye, which is located above the medial canthal ligament (medial canthal tendon) and within the medial side 1/3 of the upper eyelid. In detail, the terminal end of the BTT area on the skin, measured from the medial canthus at the medial canthal ligament, is about 11mm in diameter and extends upward about 6mm and then angularly protrudes above the upper eyelid for a further 22 mm.

The BTT region is the only fat-free region in the body that is otherwise fed by the terminal branches, has shallow vessels from the cerebrovascular system, and has a thin interface without a thermoregulatory circuit. The BTT region is fed by the terminal branch of the superficial supraocular vein, which is a direct connection to the cavernous sinus, an endothelial-lining system of venous access in the brain that collects and stores thermal energy. The blood vessels supplying nutrition to the BTT area have no arteriovenous circuits regulating body temperature and terminate on the skin adjacent to the medial canthus, just above the canthal area, at the beginning of the upper eyelid. This blood vessel transmits undisturbed heat to the inner canthus area and the skin of the upper eyelid, as can be seen on the color and black and white photographs of the infrared images shown in fig. 1 and 2. Undisturbed thermal radiation from the brain is transferred to the skin surface at the end of the tunnel. This heat is transferred to the fat-free skin area at the end of the tunnel. The blood vessels that transmit heat are located just below the skin, so that infrared radiation is not absorbed by the deep structures.

If the blood vessel is located deep, other tissues and chemicals may absorb heat, which may lose clinical effectiveness of the measurement. Direct heat transfer occurs, and in the body, the skin in the BTT area is thinnest and there is no arteriovenous loop that regulates body temperature. A very important aspect for optimal temperature measurement is that it is not disturbed by adipose tissue and directly transfers heat.

In the body, at this specific and distinct region of the end of the channel, no adipose tissue is present and the signal can be obtained without interference. The combination of those six factors makes it possible to emit the infrared radiation from the brain undisturbed and intact in the form of direct heat transfer at the BTT area location, which can be seen in the infrared image photographs (fig. 1-8). In this specification, BTT and physiologic channels are also referred to as "Target areas" (Target areas).

From a physical perspective, BTT is the equivalent of a brain thermal energy tunnel with high total radiant energy and high heat flux. The temperature of the brain is determined by the balance of the thermal energy due to metabolic rate plus the thermal energy presented to the brain by the arterial supply minus the heat removed by the cerebral blood flow. The heat transferred between the tissue and the capillaries is high and the temperature of the cerebral venous blood is in equilibrium with the brain tissue. Therefore, the true temperature and thermal energy of the brain can be estimated by measuring the temperature and thermal energy of the cerebral venous blood. The superior ocular vein has a direct and undisturbed connection with the cavernous sinus at 3.6J.ml^-1.(℃)^-1The heat capacity of (b), 45% of the hematocrit, carries cerebral venous blood. The brain thermodynamic response, thermal energy and brain temperature were evaluated by placing a sensor to capture the thermal energy carried by the cerebral venous blood at the end of the BTT.

Studies involving BTT and physiologic pathways include various activities and studies, including: 1) in vitro tissue analysis of mucosal and superficial body regions; 2) in vivo tests for temperature assessment of the outer regions of humans and animals; 3) functional in vivo angiographic evaluation of a heat source; 4) morphological study of tissue morphological features of the BTT region; 5) the method comprises the following steps: thermocouple, thermistor and far infrared ray, in vivo to evaluate the temperature of BTT area; 6) comparing the BTT measurement to the intraocular anatomy and current standards (oral cavity) most commonly used for temperature measurement; 7) cold and hot attacks to determine the temperature stability of the BTT; and 8) infrared imaging and determining isotherms. Software for evaluating channel geometry has also been developed and used. The reference temperature and the temperature of the BTT area are measured simultaneously with a thermistor that is similarly calibrated in advance. A specific circuit with multiple paths is designed to perform the test and collect the data.

Temperature measurements of the BTT region showed almost identical temperature signals between the BTT region and the inner conjunctival anatomy of the eye, which is an extension of the central nervous system. Temperature measurements of the intraocular conjunctival anatomy were used in experiments, which have been described by Abreu in U.S. patent nos. 6,120,460 and 6,312,393. The average temperature difference between BTT and the eye is within 0.1 deg.C (0.18F.), the average normal body temperature value of BTT is 37.1 deg.C (98.8F.), and the average normal body temperature value in the eye is 37 deg.C (98.6F.). Preferably compared to the standard oral temperatures most commonly used. The temperature voltage signal in the BTT zone shows that the BTT zone temperature level is 0.3 ℃ (0.5 ° f) higher on average when compared to the oral temperature.

The subject was subjected to cold and hot attacks by exercise and a greenhouse. The temperature in the BTT region decreases and increases in proportion to the temperature decrease and increase in the oral cavity. However, the rate of temperature change in the BTT zone is about 1.2 minutes faster than in the mouth, and in some cases, the temperature of the BTT site is 0.5 ℃ (0.9 ° f) higher. Subjects of different race, gender and age were evaluated, the precise location of the BTT was determined in different populations, and any anatomical variation was determined. In all subjects, the BTT was present at the same location with no significant anatomical changes, as can be seen from ir imaging samples of different subjects.

The tunnel is located in a crowded anatomical area, and therefore, the placement of the sensors requires specific geometry to optimally align with the tunnel ends. Clinical usefulness of the tunnel can only be achieved if the sensors are specifically positioned relative to the anatomical landmarks and the support structure. The channel is located at a specific location with unique anatomical landmarks that help define the exterior geometry and locate the channel ends. The main entry point of the channel is the preferred location for placement of the sensor, requiring that the sensor be preferably placed on the outer edge of the support structure. A preferred embodiment of measuring a biological parameter by accessing a physiological channel includes positioning a sensor at a specific geometric location on a support structure.

The support structure includes a patch containing a sensor. For the purposes of this description, any structure containing a means of adhesive to secure the structure to the skin at the end of the tunnel is referred to as a patch, including strips with an adhesive surface, such as "BAND-AID" adhesive bandages. It should be understood that a variety of attachment means may be used, including adhesives, designs incorporating spring pressure attachment, designs based on other attachment methods, such as resilient, rubber pads, and the like.

The patch is tailored to position the sensor at the end of the channel for optimal signal acquisition. Preferably, the patch has an adhesive backing in contact with the skin to secure the patch to the area, although adhesives may be used in combination with other means, such as fastening or pressure, to stably position the sensor over the channel.

The support structure also comprises clips or structures with or without adhesive placed at the ends of the channels, fixed to this area by pressure means. Any structure that uses pressure to hold the structure against the skin at the end of the channel is referred to as a clip.

The head-worn structure is a structure worn on the head or neck to position the sensor at the end of the tunnel, including a headband with an attachment near the tunnel, a visor, a helmet, earphones, a structure around the ears, and the like. For descriptive purposes, TempAlert is referred to herein as a system that measures the temperature of a BTT area, has a means to report the measurement, and may incorporate an alarm means that is activated when the temperature reaches a certain level. The support structure also includes any item having a sensing device, wherein the sensing device is positioned at an end of the channel.

The support structure also includes the medial canthal patch of the eye. The medial canthal patch, also referred to herein as the medial canthal pad, includes a pad or patch that places the sensing device on the skin at the medial canthal area above the channel, which is permanently attached or fitted into the eye. Any sensing device incorporated into the glasses (fixed or movable) to access the channels is referred to herein as EyEXT, for sensing physical and chemical parameters. Any product having a visual function, protecting the eyes or face, and having a portion in contact with the channel, referred to herein as eyeglasses, includes conventional eyeglasses, optometry glasses (prescription eye glasses), reading glasses (reading glasses), sunglasses, goggles of any type, safety glasses for masks (including gas masks, surgical masks, cloth masks, diving masks, sleeping goggles, etc.), and the like.

For brain temperature evaluation, the channel region consisted of the medial and superior canthus regions. For brain function assessment, the channeling area is composed primarily of the upper eyelid area. For metabolic function evaluation, the passage area consisted of an area adjacent to the medial canthus and the upper and lower eyelids.

Measurements of metabolic function, brain function, immune function, physical parameters, physicochemical parameters, etc. include various support structures having sensors proximate to physiological pathways. The sensor is placed in apposition to the skin in close proximity to the medial canthus, preferably over the medial canthus area. The sensor is also positioned within the inner portion 1/3 of the upper eyelid. Most preferably, the sensor is positioned at the primary entry point of the channel, which is located on the skin 2.5mm inside the canthus and 3mm above the inside canthus. The diameter of the main entry point is about 6-7 mm. Positioning the sensor at the primary entry point of the channel provides an optimal site for measuring physical and chemical parameters of the body.

In addition to a sensor that is in contact with the skin at the target area, it should be understood that a sensor that is not in contact with the skin may be employed as well. For example, an infrared temperature measurement system may be used. This measurement is based on the Stefan-Boltzman principle of physics, in which the total radiation is proportional to 1/4 absolute temperature, whereas in the Wien Displacement principle, the generation of the peak wavelength is constant with temperature. The field of view of the non-contact infrared instrument of the present invention is altered to match the size and geometry of the BTT area on the skin.

Various lenses known in the art are used to obtain the field of view required by the application. For example, but not by way of limitation, thermopiles are adapted and placed on the skin in a manner that has a field of view aimed at the primary entry site of the BTT region. The signal is then amplified and converted to a voltage output value, which is digitally processed by an MCU (micro-processor).

The infrared system is integrated into a support structure in contact with the body, such as any of the support structures of the present invention. Furthermore, it should be understood that the infrared system of the present invention may be integrated into a portable or handheld unit that is completely separate from the body. The instrument of the present invention may also be held by an operator to align the instrument with the BTT area for measurement. The instrument also includes an extension shaped to comfortably fit over the BTT site to measure the biological parameter without discomfort to the subject. The extended portion that contacts the skin at the BTT is shaped according to anatomical landmarks and the geometry and size of the BTT site. An infrared radiation sensor is disposed in the extension, in contact with the skin, to receive radiation emitted from the BTT site.

The present invention provides a method for measuring a biological parameter comprising placing a sensing device on the skin at the end of a channel, generating a signal corresponding to the measured biological parameter and reporting the value of the measured parameter.

The invention also includes a method of measuring a biological parameter by non-contact infrared thermometry comprising positioning an infrared detector over a BTT site, having a field of view that includes the BTT site, and generating a signal corresponding to the measured infrared radiation. Biological parameters include temperature, blood chemistry, metabolic function, etc.

Temperature and the ability to perform chemical analysis of blood components are proportional to blood perfusion. The present invention demonstrates that the access region, also referred to herein as the target region, has the shallowest perfusion of the head, communicating directly with the brain, and that the vessel is a direct branch of the cerebrovascular system, without an arteriovenous loop that regulates temperature. It is generally believed that the target area has the highest temperature at the surface of the body, as can be seen in photographs from experiments measuring infrared emissions from the body and the eye.

The target area found not only had the thinnest and most uniform skin throughout the body, but was the only skin area without a fat layer. The signal drops significantly as fat absorbs a large amount of radiation. Moreover, other skin areas can only provide inaccurate and inaccurate signals due to the large variation of adipose tissue from person to person and due to the large variation of adipose tissue with aging. In the target area, such interference by the fat layer does not occur. Furthermore, the combined characteristics of the target area, as opposed to the skin in other parts of the body, make it possible to obtain an accurate signal and a high signal-to-noise ratio far exceeding the background signal. In addition, body temperature, such as the temperature present at the skin surface in other parts of the body, varies with the environment.

Other main findings of the present invention are that the target area was proven to be unaffected by environmental changes (including cold and hot challenge experiments). The target area provides an optimal location for temperature measurement, which has a stable temperature and is not affected by the surrounding environment. The target area found is in direct contact with the brain, is not affected by the environment, and provides a natural, completely heat-sealed and stable core temperature. The apparatus and method of the present invention non-invasively places the temperature sensor on the skin in direct contact with the heat source from the brain without interference from the heat sink element, achieving the desired accuracy and clinical usefulness.

This target area is highly vascularized and is the only epidermal area in which the direct branches of the cerebrovascular system are located superficially and covered by a thin skin without a fat layer. The terminal branch trunk of the ocular vein (main trunk) is located just above the BTT region, just above the angular ligament, which is fed by the internal tarsal artery and the orbital vein. The BTT area of the skin is fed by distal and superficial blood vessels that terminate in specific fat-free areas, without arteriovenous shunts that regulate body temperature, providing a superficial source of undisturbed biological signals including brain temperature, metabolic function, physical signals, and body chemistry such as glucose content.

Infrared spectroscopy is a method based on the absorption of infrared radiation by a substance, which is identified by its unique molecular vibrational modes, which are characterized by specific resonance absorption peaks in the infrared range of the electromagnetic spectrum. Each chemical species absorbs infrared radiation in its own unique way, with its own unique absorption spectrum, depending on its atomic and molecular arrangement and modes of vibrational and rotational vibration. This unique absorption spectrum allows various chemical substances to have their own infrared spectra on a basis, also known as fingerprints or signatures, which can be used to identify each of these substances. Radiation containing various infrared wavelengths is emitted towards the substance to be measured, the amount of absorption of which depends on the concentration of said chemical substance to be measured, according to the Beer-Lambert law.

Interference factors and variables such as fat, bone, muscle, ligament and cartilage introduce important sources of error, which are particularly critical since background noise greatly exceeds the signal of the substance of interest. Since the skin of the BTT area is free of these interference factors, placing the sensing system in the BTT area enables the best signal, including spectral measurements, to be obtained with minimal noise.

The spectroscopic assembly integrated into a support structure disclosed in the present invention is capable of accurately and non-invasively measuring blood constituents since there is no major source of variability and error in the target region, such as adipose tissue. In addition, the target area is also free of other critical factors that interfere with the emission of electromagnetic energy, such as muscle, cartilage, and bone. The vessels that transmit infrared radiation are positioned shallowly and infrared radiation is transmitted to the ends of the channels without interacting with other structures. The only structure that infrared radiation is to span is a very thin skin that does not absorb infrared wavelengths. The present invention includes an infrared spectroscopy device to obtain clinically useful measurements to accurately and precisely determine the concentration of blood constituents at the end of a channel.

In addition to spectroscopy, which delivers electromagnetic energy to a target region, the present invention also discloses an apparatus and method for measuring a substance of interest from a target region by far infrared thermal emission. However, in addition to near infrared spectroscopy and thermal emission, other means of measuring the substance of interest at the target area are disclosed, including electroosmosis, such as melt enhancement by iontophoresis, or reverse iontophoresis, where electrical energy is applied to augment the passage of liquid through the skin. Also, percutaneous optical devices are integrated into the support structure, including medial canthal patches (medial nasal patches), modified nasal cushions (nose pads), and frames of eyeglasses, which are positioned to access the tunnel.

It is understood that the application of electric current, ultrasound, and flowing chemical enhancers, electroporation, and other devices may be used to increase permeability at the channel site, such as increasing glucose flow with a basic salt. In addition, micro-holes are created in the target area with a laser or other means of penetrating the skin, followed by placement of a sensing device on the BTT site, which is capable of measuring chemical substances.

Furthermore, a reservoir (reservoir) fitted or disposed in a support structure, such as the frame and pads of eyeglasses, is capable of transdermally delivering a substance at the BTT site through a variety of strategies including iontophoresis, sonar electroosmosis, electrostriction, electroporation, chemical or physical penetration enhancers, hydrostatic pressure, and the like.

In addition to measuring the actual oxygen content of the blood, the present invention also discloses a device for measuring the oxygen saturation and oxygen complex hemoglobin content. In this embodiment, the medial canthal patch of the support structure or the modified nasal cushion of the spectacles contains LEDs that emit at both wavelengths of approximately 940nm and 660 nm. When the blood oxygen changes, the ratio between the light emitted at the two frequencies changes, indicating oxygen saturation. Since blood content is measured at the end of the physiological brain channel, the amount of oxygenated hemoglobin in the cerebral arterial blood is measured, which is the most valuable and critical parameter for motor effects (athletic purpures) and health status monitoring.

The present invention also provides a method for measuring a biological parameter, the method comprising the steps of directing electromagnetic radiation at a BTT area on the skin, producing a signal corresponding to the generated radiation and converting the signal into a value of the measured biological parameter.

In addition to using passive radio propagation and communication through cables; active radio propagation can also be performed using active transmitters containing micro-batteries mounted in a support structure. A passive radiator functions by means of energy supplied to it from an external source. The sensor transmits signals to a remote location using different frequencies indicative of the level of the biological parameter. The ultrasonic microcircuit can also be mounted in a support structure and modulated by a sensor capable of detecting chemical and physical changes in the target area. The signal can be transmitted with a modulated sound signal, especially underwater, because water attenuates sound less than radio waves.

A preferred embodiment comprises a support structure comprising a patch adapted to be worn or attached to a channel with an adhesive, comprising a structural support, a sensor for measuring a biological parameter, a power source, a microcontroller and a transmitter. These parts may be combined into one system or operated as separate units. The sensor is preferably positioned within 7mm of the outer edge of the patch. The apparatus of the present invention includes a temperature sensor positioned in the outer edge of the patch for sensing temperature. The emitter, power source, and other components may be of any size, may be placed in any portion of the patch, or may be connected to the patch, as long as the sensing portion is positioned at the edge of the patch in accordance with the principles of the present invention. The sensor in the patch is placed on the skin adjacent to the medial angular region (medial canthus) approximately 2mm from the medial angular ligament. The sensor preferably comprises an electrical sensor, but non-electrical sensors, such as chemicals that respond to temperature changes, including mylar, may also be used.

In addition to patches, another preferred embodiment for measuring biological parameters on physiological channels includes the medial canthal pad. The medial canthal patch is a specialized structure containing a sensor for access to the channel, adapted to be worn or attached to the eye juxtaposed to the channel, including a structural support, a sensor for measuring a biological parameter, a power source, a microprocessor and a transmitter. These parts may be combined into one system or operated as separate units. The sensor is placed in the BTT area. The emitter, power source and other components may be placed in the medial canthal pad or other parts of the spectacles. An angular patch or an extension of the nasal cushion of the spectacles may bring the sensing device juxtaposed to the BTT close to the physiologic tunnel.

The instrument of the invention comprises a temperature sensor positioned in the medial canthal pad. Temperature measurements were taken and the sensing system was positioned on the skin area including the angular inner corner of the eye and the upper eyelid. The sensor in the medial canthus pad is preferably placed on the skin adjacent to the medial canthus area (medial canthus). Although one of the preferred embodiments for measuring brain temperature consists of the medial canthal pad, it is understood that within the scope of the present invention, a geometric and dimensioned nasal pad is also included, accessible to the channel, preferably equipped with a temperature sensor at the outer edge of said nasal pad, for measuring brain temperature and other functions. The invention also includes enlarged and improved sensor-containing nose pads that employ specific geometries to adequately seat on the BTT area.

In accordance with the present disclosure, and by utilizing the anatomical landmarks according to the present invention, the sensors can be precisely positioned on the skin at the end of the tunnel. However, since there is no externally visible indication on the skin regarding the size and geometry of the channel, additional means may be employed to visualize, map or measure the channel ends on the skin. These attachments are particularly useful for fitting the medial canthal pad or the nasal pad of the modified spectacles.

Thus, an infrared detector employing a thermocouple or thermopile may be used as an additional means of determining the point of maximum heat emission and mapping the region. In this case, the optical shop selling the glasses has a thermal imaging system. Opticians, technicians, etc. take infrared images or record the area and locate the channel of a particular user in real time. Then, based on the thermal infrared image, the medial canthal pad or modified nasal pad is adjusted to fit the particular user. The glasses are formulated according to the thermal images generated. This allows for custom formulation according to the individual needs of the user. Any system that records temperature may be used for three-dimensional color thermal wave imaging, including those with maximum visual effect and resolution.

It is a further feature of the present invention to provide a method for locating an aisle, such as in an eyeglass store, including the steps of measuring thermal infrared emissions, generating an image from the infrared emissions, and detecting the area with the highest amount of infrared emissions. Yet another step included is adjusting the sensors in the support structure to match the area of maximum infrared emission.

One of the support structures includes the medial canthal patch or the nasal cushion of the spectacles. The patch may be formulated for thermography, but may be placed over the tunnel by including an external indicator on the patch, which indicator is arranged on a permanent anatomical landmark, such as the medial corner of the eye. Although the medial canthal patch of the eye has a external indicator for precise placement, the thermography approach is more suitable for the eye than the medial canthal patch or the external indicator on the nasal cushion of the modified eye, since the optician prepares the eye to follow the user's anatomy.

The source of the signal is critical to the clinical usefulness of the measurement. The brain is a key and universal indicator of the health status of the body. Signals from the brain or brain regions provide the most clinically useful data. According to another embodiment, the measurement of a biological parameter will be described. The content of sodium and other elements in sweat is a critical factor for safety and function, as well as health monitoring of athletes and soldiers.

For example, hyponatremia (reduced sodium content) can lead to reduced function and even death. Hyponatremia occurs due to excessive water intake, often during strenuous physical activity and military training. Sweat can be seen as an ultrafiltrate of blood. The blood vessels supplying the skin of the head are branches of the central nervous system vasculature. The amount of chemicals present in sweat from these vessels is indicative of the amount of chemicals present in the cerebrovascular system. For example, the sodium content in sweat from blood vessels of the head varies with respect to the rate of sweating. When the sodium level in sweat reaches a particular threshold, the apparatus and method of the present invention will provide a reminder to the particular wearer to prevent death or injury due to water poisoning. The presence of various chemical elements, gases, electrolytes, as well as the pH of sweat and skin surfaces can be determined with suitable electrodes and sensors integrated in eyeglasses and other support structures worn on the head or fixed on the head or face. These electrodes are preferably microelectrodes that can be activated by a variety of reactive chemicals present in sweat or skin surfaces, and different chemicals and substances can diffuse through appropriate permeable membranes to sensitize appropriate sensors.

For example, but not limited to, electrochemical sensors are used to measure various analytes such as glucose, and electrolytes in sweat are measured using pilocarpine iontophoresis, either alone or in conjunction with microfluidic systems, using glucose oxidase sensors. It will be appreciated that in addition to the support structure of the present invention, other articles such as watches, clothing, shoes, etc. may be modified to be suitable for measuring the concentration of substances, such as electrolytes present in sweat, but with reduced clinical relevance for assessing the metabolic status of individuals outside the central nervous system.

Body abnormalities can result in changes in the pH, permeability, and temperature of sweat from brain and neck vessels, as well as changes in substance concentrations, such as lactic acid, glucose, lipids, hormones, gases, markers, infectious agents, antigens, antibodies, enzymes, electrolytes such as sodium, potassium, and chloride, and the like. The eyewear and any headwear may be modified to suit the measurement of substance concentration in sweat. Micro-glass electrodes are fitted in the ends of the temples behind the ears, or alternatively on the edge of the lens proximate the forehead, for detecting divalent cations, such as calcium, as well as sodium and potassium ions and pH. Chloride-ion detectors are used to detect the salt concentration in sweat and on the skin surface.

Many agents, including biological warfare agents and HIV viruses, are present in sweat, can be detected using glasses or support structures on the head and face, employ sensors covered with antibodies against the agents, produce photochemical reactions, manifest as colorimetric reactions and/or potential shifts, then change in voltage or temperature, are detected and transmitted to a monitoring station, or are reported locally by audio or visual means. When an antigen-antibody reaction occurs, the electrocatalytic reaction antibody also generates an electrical signal. It is also understood that other items such as watches, clothes, shoes, etc. or any sweat absorbing item may be adapted to identify antigens, antibodies, infectious agents, markers (cancerous, cardiac, genetic, metabolic, pharmaceutical, etc.) in accordance with the present invention. However, identification of these elements remote from the central nervous system has reduced clinical relevance.

It is easy to quantify the different amounts of fluid in sweat, as well as the concentration of substances calibrated to the fluid content in sweat. The relationship between the concentration of chemicals and molecules in blood and the concentration of the chemical in sweat can be described mathematically in a computer and programmed.

The invention also includes eyeglasses and a support structure in which a radiofrequency sensor capable of measuring the negative resistance (negative resistance) of the nerve fibres is fitted in the eyeglasses or the support structure. By measuring the resistance, the effects of microorganisms, drugs and poisons can be detected. The system further comprises eyewear, wherein the miniature radiation-sensitive sensors are mounted in the eyewear or the support structure.

The brain has an abundant vascular system and receives approximately 15% of quiescent cardiac output, and since there is no fat, this channel provides an optimal acquisition signal to assess the hemodynamic area. Thus, the change in blood viscosity can be evaluated from the change in damping of vibrating quartz crystallites mounted in spectacles or support structures, and the present invention can be adapted to measure blood pressure, with instantaneous and continuous monitoring of blood pressure through intact vessel walls from the brain to evaluate hemodynamics and hydrodynamics. In addition, a contact microphone is provided for measuring arterial pressure with an acoustic device.

The pressure is applied to the blood vessels by micro cuffs (micro cuff) fitted in the medial canthal pads, or alternatively with the temples. Pressure may also be applied through the rigid structure to reach a preferred endpoint when generating sounds associated with blood disorders. The characteristic sounds of systole (contraction of the heart) and diastole (relaxation of the heart) are captured with loudspeakers. The microphone integrated into the medial canthal pad was adapted to identify the heart sounds. Pressure transducers such as capacitive pressure transducers with integrated electronics for signal processing and microphones can be combined in the same silicon structure and assembled into the medial canthal pad. A motion sensor and/or a pressure sensor is fitted in the medial canthal pad to measure the pulse.

Reversible mechanical expansion methods, photometric or electrochemical methods, and electrodes are installed in the glasses or support structures of the present invention for detecting acidity, gas, analyte concentration, and the like. Oxygen can also be evaluated on the basis of its magnetic properties or analyzed by micro-polarographic sensors mounted in glasses or other support structures. Miniature microphones mounted in eyeglasses or other support structures are modified to be suitable for detecting sounds from the heart, breath, fluid, vocal (vocal) and environment, which are sensed and transmitted to a remote receiver or reported by local audio and visual means. The sensor is adapted and installed to monitor biological parameters at the end of the channel.

The glasses or other support structure also have elements that generate and transmit identifiable signals, a process used to locate and track individuals, particularly in military operations. Permanent magnetic beads can also be assembled in glasses for tracking as described above. Fixed frequency transmitters are mounted in the glasses and serve as tracking devices that transmit the frequencies received from the fixed frequency transmitters to passing satellites using a satellite tracking system or with the aid of a global positioning system. An accelerometer is mounted in the glasses to detect movement and deceleration. Since eyeglasses are generally an unsuspecting item, using eyeglasses as a tracking device is useful for locating kidnapped individuals or rescue operations in the military.

The use of integrated circuits and advances in converter, power supply and signal processing technologies have enabled extreme miniaturization of various components, which has enabled the assembly of several sensors in one unit.

The present invention provides continuous, automatic monitoring of brain temperature without the need for a caregiver. The present invention is capable of identifying a peak in temperature. Thereby making a correct diagnosis and initiating treatment in time. Time is important for identifying temperature peaks and infection-causing organisms. Delaying peak identification and initiating treatment of the infection can lead to death of the patient. The invention can identify the temperature peak value timely and automatically, and prevent the occurrence of complications.

The present invention also alerts the user to hyperthermia or hypothermia so that:

1. proper hydration;

2. performance is improved;

3. the safety is improved; and

4. feedback control is performed during treadmill and other activities to maintain proper hydration and performance.

Every year, many athletes, construction workers, college students, and the general public end up dying of heat stroke. Once the brain reaches a certain temperature level, e.g. 40 ℃, an almost irreversible process ensues. Heatstroke has one of the highest mortality rates, as there are no special symptoms, and after a certain time point, the brain temperature rises rapidly. If the situation is more severe and is held off for a longer period of time, the expected results will be worse, especially when cooling is held off. When the outside temperature falls below a safe level without measuring the core temperature and lacking an early warning system, excessive heat and heat stroke cannot be prevented. The present invention provides a device for continuous temperature monitoring with a warning system to prevent dangerous levels from being reached and cooling measures that can be used when required. The instrument is adapted for unobtrusive use by athletes, soldiers, workers and the general public.

All chemical reactions in the body are temperature dependent. High temperatures cause enzymatic changes and protein denaturation, while low temperatures slow down important chemical reactions. Hydration is dependent on brain temperature, and loss of body fluids can lead to increased brain temperatures. Minimal fluctuations in body temperature can adversely affect body performance, increasing the risk of disease and life threatening events. It is therefore important for athletes, sport participants, military personnel, police, firefighters, forest guards, factory workers, farmers, construction workers and other professionals to have accurate means of knowing their brain temperature.

When the core temperature rises, other blood utilized by the muscle is cooled by breathing and perspiration. The body will automatically perform these activities when the temperature is outside the preferred narrow range. It is this blood change that ultimately impairs physical function, and heat-induced damage to brain tissue interferes with normal cognitive function. Intense exercise increases heat production in the muscles by a factor of 20. Athletes drink water in order to prevent hyperthermia and death due to heat stroke. Because water is taken ad libitum, water poisoning that can lead to death occurs in many cases, and this occurs among many healthy people, including marathon runners and military personnel. In addition to reduced function, excessive water (over-hydration) or water deficiency (dehydration) can also cause death events. It is therefore important that individuals have accurate means of knowing exactly when and how much water they drink. Proper hydration can be achieved by monitoring the brain temperature with the present invention, and athletes and soldiers will know precisely when and how much water to drink.

The fluid is taken in time according to the core temperature, so that the cardiovascular function can be optimized and the thermal injury can be avoided. Because there is a delay between ingestion of the fluid and absorption of the fluid by the body, the method of the present invention includes signaling the need to ingest the fluid at a lower core temperature, e.g., 38.5C, to compensate for the delay and thereby avoid the onset of wasting. The temperature threshold may be adjusted according to the individual, the physical activity and the ambient temperature.

In addition, software can be created based on the data obtained from the BTT site to optimize fitness (fitness), motor function, and safety. An upper temperature limit for a particular athlete to maintain optimal performance may be determined and this data used to tailor the software to guide that athlete through the competition. For example, an athlete is prompted to drink cold liquid to prevent reaching a particular temperature level that is determined to reduce the athlete's performance. The determined brain temperature level for optimal functioning is used to guide the athlete's effort (effort) in competitions and training. Hyperthermia also affects intellectual performance, making software based on data from BTT, optimizing firefighters' intellectual and physical functions in an individual fashion. People have different thresholds for the detrimental effects of hyperthermia, and therefore, setting a level to all users can result in underutilizing one's ability while leaving others at risk of reduced functioning. Similarly, a drop in body temperature can also significantly reduce exercise endurance and mental performance, and the same settings apply to cold conditions. The brain temperature, oxygen and lactic acid content are determined for endurance training, fitness training of athletes, and for monitoring the effect of training. The systems, methods and apparatus of the present invention provide mechanisms for providing increased safety and optimization of fitness activities to athletes and recreational sports participants.

It is a feature of the present invention to provide a method for accurate and timely intake of fluid comprising the steps of measuring brain temperature, reporting the measured signal and ingesting an amount of fluid based on the measured signal. Other steps may be included such as using an audible reproduced reporting device or a visual device to indicate what beverage to drink and how much to drink to lower the core temperature. It should be understood that the method of the present invention combines temperature measurement with sodium ion measurement in sweat or blood in accordance with the principles of the present invention.

Children do not tolerate heat to the same extent as adults, and the body of a child produces a higher amount of heat relative to its individual size than an adult. Children adjust to body temperature less rapidly than adults. Furthermore, children have a larger skin surface area relative to their individual size, which means that they lose more water by evaporation from the skin. It is understood that different sizes, shapes and designs of medial canthal pads can be used in the present invention, including pediatric sizes. Sensor-equipped children's glasses have an enhanced radio transmitter that allows signals to be transmitted to a remote receiver that alerts parents at dangerous temperature levels. A sensing system is incorporated into the eyewear that emits a signal when the eyewear is removed or when the temperature sensor does not capture the signal in the correct manner. By way of illustration and not limitation, a pressure sensing device is incorporated into the end of the temple to detect whether the sunglasses are being worn, a sudden drop in pressure signal indicates that the eyeglasses are removed, or the incorrect placement of the sensor also produces an identifiable signal. Adhesive, double sided tape, or other means for reinforcing fixation is used in the medial canthal pad to ensure a more stable placement. It will be appreciated that the glasses may be equipped with sensors to detect ambient temperature and humidity so that the wearer may be accurately alerted to any aspect affecting thermal regulation.

In current industrial, nuclear and military environments, individuals are required to wear protective clothing. While the protective garment prevents damage caused by hazardous materials, the garment improves the rate of heat storage. It should be understood that the present invention can be combined with a garment having adjustable permeability to automatically maintain the core temperature within safe limits.

In addition, the present invention alerts individuals to the risk of thermal injury (risk of wrinkles and cancer) at the beach or during outdoor activities. When viewing the game at the beach, in open stadiums, camping or exposure to the sun, the radiant energy of the sun is absorbed and converted to heat. The combination of different ways of heat transfer to the body results in an increase in body temperature, reflected in brain temperature. In the absence of sunlight, body temperature can also be elevated by heat transfer, convection and conduction. The absorption of heat from the environment results in an increase in the average kinetic energy of the molecules, followed by an increase in the core temperature.

The core temperature level is associated with thermal damage to the skin. After a certain level of heat is reached, the risk of protein denaturation and collagen destruction in the skin increases. This can be compared to the changes that occur in a omelette. After a certain amount of thermal radiation is transferred, the protein changes from a liquid and transparent state to a hard and white structure. When a protein reaches a certain temperature level, the structural change becomes permanent. During exposure to the sun, thermal damage ensues after the core temperature has risen to a certain extent, for example to a level of 37.7-37.9 ℃ at rest (e.g. sunbathing), and the risk of wrinkle formation increases as protein and collagen are destroyed. The increase in brain temperature is related to the amount of heat radiation absorbed by the body, and the duration of exposure at a temperature level multiplied by the temperature level is an indicator of thermal injury, wrinkle formation, and skin cancer.

The present invention provides an early warning system that can be set up to alert in real time when exposure to sunlight should be avoided to prevent further absorption of thermal radiation and to reduce the risk of skin changes that can occur during outdoor activities or at the shore. Furthermore, thermal damage to the skin prevents the skin from cooling sufficiently, which may lead to an increased risk of dehydration, thereby further raising the temperature. The present invention helps people exposed to sunlight and maintain beauty and health during outdoor sports, while fully enjoying the benefits of the sun and sunlight.

By the present invention, a method for timing exposure to sunlight includes the steps of measuring body temperature, reporting the measured value and avoiding exposure to the sun for more than a certain period of time based on the measured level.

Hypothermia is the first killer of outdoor activities in the united states and europe. Hypothermia also reduces the performance of athletes and can lead to injury. It is difficult to detect hypothermia because its complications are not well known, such as disorientation and clumsy hands and feet, which are difficult to distinguish from the usual behavior. Without measurement of core temperature and the absence of a warning system, it is not possible to prevent hypothermia when body temperature falls below safe levels because symptoms are unclear. The present invention alerts individuals to hypothermia during skating, diving, mountain climbing, and hiking. The invention provides means for accurately informing that the temperature is too high or too low when a certain temperature threshold is reached.

The present invention continuously monitors the brain temperature and, upon the occurrence of a temperature spike or fever, activates a diagnostic system to detect the presence of the infectious agent, which may be localized to the BTT site, or may identify the infectious agent on other parts of the body, such as in the bloodstream or in the eye bags. The present invention may be incorporated into a drug dispensing device that automatically delivers a drug in accordance with a signal generated at a BTT site, including transdermal devices, iontophoresis, or by injection with a pump.

The invention also includes a tool for family planning. The system detects peaks and changes in baseline temperature and determines ovulation time and the phase of the menstrual cycle. Enabling women to plan or avoid pregnancy. This eliminates the need for invasive means for monitoring the timing of artificial insemination in humans and animals. The invention also allows for the detection of the onset of uterine contractions (delivery) so that the animal can be safely produced, as well as the use of the support structure on the BTT of the animal.

The invention also includes automatic climate control based on the values measured at the BTT. The temperature of the user controls the temperature within the vehicle. The signal from the apparatus of the invention automatically turns on the air conditioner according to the user's settings when the body starts to warm up, alternatively, the heating is activated when the body is cold. This automatic operation allows the driver to focus on the road and thus reduces the risk of a crash. It is understood that other items capable of affecting body temperature may be controlled by the present invention, including vehicle seats.

Current vehicle climate control systems are overly powerful because they are designed to heat/cool air masses within the vehicle's cabin over a period of time, from an extreme starting temperature to a standard temperature. Since people have different heat requirements to achieve comfort, the temperature setting is always changed manually, which further increases energy consumption. For example, the temperature within the vehicle is set to be maintained at 73 ° f. After 15 minutes, some people feel too cold and some people feel too hot. The passenger then changes the setting to 77 ° f and then, after another 10 minutes, feels too hot and needs to manually change the set point again, and the process continues. In addition to the different needs of people of different ages, the needs of people with diabetes and other diseases, as well as men and women, are different.

Frequent manual adjustments to climate control in the vehicle cabin can increase fuel consumption by 20% and increase emissions of pollutants such as carbon monoxide and nitrogen oxides.

The present invention provides an automatic climate control in which the brain temperature controls the air conditioner and the seat of the vehicle, maximizing comfort and minimizing fuel consumption. The invention improves the fuel saving, discharges less pollutants which affect the ozone layer and protects the environment; by reducing the emission of toxic smoke, the public health is improved, the distraction is reduced to manually control the regulation and control of the climate in the vehicle, and the comfort and the safety of drivers are improved.

The warm environment within the transport vehicle cabin may be regulated according to the temperature of the BTT site, including by contact sensor measurements and non-contact sensor measurements, such as infrared sensors or thermal imaging. The temperature of the BTT adjusts any item or device within the vehicle, changing the temperature within the passenger compartment, including air conditioners and heaters, vehicle seats, doors, windows, steering wheels, carpet on the floor, and the like. Illustratively, the temperature of the BTT adjusts the amount of heat radiation passing through the vehicle's window, which if signaled by the BTT that heat is being sensed, will immediately darken to prevent more heat from entering the vehicle, and vice versa, if cold is being sensed, will change its light permeability, allowing more heat waves to penetrate into the vehicle. Any item that contacts or is near the body is conditioned to change its temperature, allowing the vehicle owner to achieve a warm comfort level.

In addition to the support structure and thermal imaging system described in this disclosure for monitoring and regulating temperature within a transport vehicle compartment, it should be understood that a pocket-mounted contact lens with a temperature sensor may also be modified to regulate temperature within a vehicle compartment. Exemplary transport vehicles include cars, trucks, trains, planes, boats, ships, boats, and the like.

It should also be understood that the sensing system may include sensors at other locations in the body, working in conjunction with temperature sensors that measure the temperature and/or thermal radiation at the BTT site. The transfer of thermal energy from the article to the vehicle owner may occur by any of radiation, convection, etc., and any mechanism for transferring the presentation or removal of thermal energy may be adjusted based on the temperature signal measured at the BTT.

With any type of sensor alone at the BTT site or in combination with sensors of other parts of the body, the present invention provides a more efficient energy system for achieving warm comfort for the passengers in any type of existing or developing transport vehicle.

Also, automatic climate control in a home, office or any defined area can be achieved by activating the thermostat, either directly or by means of BlueTooth (BlueTooth) technology, depending on the temperature measured at the BTT according to the invention. In addition to convenience and comfort, such automation may save energy because of the significant energy consumption resulting from gross manual changes made in the thermostat.

It should be understood that any body temperature measurement system can provide automatic climate control or regulate the temperature of an item in accordance with the principles of the present invention.

The invention also includes methods for reducing body weight. The method includes monitoring temperature during weight loss based on increasing body heat to reduce said body weight. The system alerts athletes to weight loss programs to prevent injury or death caused by overheating. The system is capable of monitoring body temperature in saunas, steam rooms, spas, etc. as part of a weight loss program to prevent injury and improve results.

Also, this method achieves enhanced memory and improved functioning by providing an automatic mechanism to control the ambient temperature and the temperature around the body, in addition to maintaining health, based on the brain temperature measured by the present invention. Humans spend 1/3 hours near their lives for sleep. Many changes in body temperature occur during sleep. All metabolic and enzymatic reactions in the body depend on sufficiently high temperature levels. The proper control of ambient temperature to meet the needs of body temperature, for example during sleep, has an important role in metabolism. The proper environmental temperature and ambient temperature are matched with the body temperature, so that the sleeping of people is better, the efficiency of enzymatic reaction can be improved, and the intelligence ability and the immune reaction ability are improved. Various devices, such as blankets, clothing, hats, mattresses, pillows, or any item that contacts or is adjacent to a body is altered, automatically raising or lowering the temperature of the item in accordance with the temperature signal from the present invention.

The body naturally gets colder during the night and many people have insufficient rest and constantly roll over the side in bed due to temperature effects. Since the return to and fro takes place with involuntary movements and the person does not wake up without changing the stimulus, for example raising the temperature in the room or raising the temperature of the electric blanket. The present invention automatically changes the ambient temperature or the temperature of the item to meet the temperature needs of the person. This is particularly useful for infants, elderly, diabetic patients, neurological disorders, heart disease and various other symptomatic patients, as this population has a low neurological responsiveness to changes in body temperature, and is more compromised during the night, increasing the risk of complications in addition to reduced productivity due to loss of sleep. Thus, the temperature of the electric blanket or the ambient temperature is automatically adjusted according to the BTT temperature. When a low temperature of the BTT is detected by the apparatus of the present invention, a wireless or wired signal is transmitted to the item to raise its temperature, in the case of an electric blanket or heating system, automatically adjusting the thermostat to present more heat.

The present invention also provides devices and methods for use with biofeedback activities. The brain temperature signal from the sensor at the BTT site produces a feedback signal such as a tone or visual display indicating the temperature, and if the brain temperature increases (higher frequency and red) or decreases (lower frequency and blue), a series of tones or colors are identified. The display device may be connected by wires to a support structure that holds the sensor at the BTT site.

Cooling the head does not change the brain temperature. Athletes, soldiers, firefighters, construction workers, etc. are at risk of heat stroke despite being watered with cold water or using a fan. Medically, this is a dangerous situation, since the physical activity is still being performed when the head feels that cooling is considered internal cooling, while the brain is still in fact at risk of heat-induced damage and heat stroke. Other medical attacks related to temperature perturbations involve reaction times. The brain's restorative response to temperature changes is slower than the core temperature (measured in the rectum, bladder, esophagus, and other in vivo mechanisms). Thus, in vivo measurements may show a steady temperature, while the brain temperature is still above safe levels, with the risk of damage to brain tissue due to hypothermia or hyperthermia. The only medically acceptable way to prevent temperature induced damage to brain tissue is the continuous monitoring of brain temperature provided by the present invention.

The present invention utilizes a large number of active or passive sensors incorporated in the support structure to access the physiologic tunnel to measure biological parameters. The invention preferably includes all functional parts (functions) in a miniature semiconductor chip as one integrated circuit, combining sensors, processing and transmission units and control circuits.

Other embodiments include temperature measurement and mass screening of fever and temperature disturbances (hyperthermia and hypothermia), including body radiation detectors, referred to herein as BTT thermoscans, including thermal imaging systems that acquire thermal images of BTT tips. The BTT ThermoScan of the present invention has a sufficiently high temperature and isotherm discrimination to monitor temperature at any time that it is not possible to have the measurement manipulated by human influence.

BTT ThermoScan detects brain temperature and provides an image corresponding to or including a BTT region.

BTT ThermoScan includes a camera that converts thermal radiation into video images that can be on a display screen, such as the images seen in fig. lA, 1B, 3A, 4A, 5C, 7A, 7B, 8A, 8B, 9A, and 9B (for animals), most preferably the image seen in fig. 1B. In the visible range, the radiant energy emitted from the body and the BTT area can be detected and captured.

In the infrared range, the skin at the site of human BTT has a very high emissivity (e in the Stefan-Boltzman equation), almost equal to that of a black body. A video image was captured through and looking at the BTT ThermoScan lens, customized software was changed to show a color isotherm graph, and software was used to obtain the image of fig. 1B, where any 99 ° f point was yellow. For detection of SARS, the software was changed to show in yellow any point in the BTT region above 100 ° f. The software is altered to provide an automatic warning system when yellow appears on the display screen. Thus, the early warning device is activated when the brain temperature tunnel region appears yellow on the display screen. It should be appreciated that any color scheme may be employed. For example, the threshold temperature is displayed in red.

As shown in fig. 7A and 7B, cold challenge experiments were performed and the thermal emission stability of the BTT region was demonstrated. Cold attacks consist of continuously capturing hot infrared images when the subject is exposed to cold, including facing cold air generators (e.g., air conditioners and fans), drinking cold beverages, soaking the body in cold water, and spraying alcohol on the skin. Despite artificially altering the body temperature by human means, the radiation from the BTT area is still intact and appears as bright white spots on the BTT area. In contrast, during cold exposure, the face becomes progressively darker, indicating a decrease in facial temperature. Fig. 7B shows a darker face than fig. 7A, without any change in the thermal radiation from the BTT region.

In addition to cold attacks, thermal attacks are performed to artificially raise body temperature, including physical exercise, sun exposure, facing heaters, drinking, smoking, and body immersion in hot water. In all of these tests, the BTT region remained stable and the temperature of the rest of the face changed, which reflected the temperature of the skin rather than the internal brain. As shown in fig. 2A-2C, the brain is completely isolated from the environment except for the end of the BTT. The prior art technique produces too many false positives and in airports and customs, some people fail to pass the inspection because they drink some wine or smoke. Accordingly, the present invention provides a system and method that can eliminate and reduce false negatives and false positives when using a thermographic detection system.

Many useful applications can be implemented, including extensive scanning screening for fever, screening of hyperthermia in athletes after sporting events (e.g., marathons), screening of hypothermic and hyperthermia in soldiers to select individuals that are physiologically most suitable for combat, and any other temperature perturber in any condition where a BTT ThermoScan is installed.

One particular application includes the prevention of terrorist attacks, the infection of certain diseases by terrorists (e.g., SARS-severe acute respiratory syndrome), and the avoidance of thermometers to avoid fever examinations when entering countries where terrorist attacks are performed.

SARS, because it cannot be eliminated, can be a serious terrorist threat. Through natural reproduction, SARS becomes a weapons of mass destruction that cannot be destroyed by either force or outcrossing. Terrorists may catch the infection for the purpose of spreading the infection in the target country. With the prior art, any device would be concealed, and when there is real heating, the prior device would measure a normal temperature. Terrorists have taken simple measures, such as washing their face with cold water or ice or soaking in cold water, to cope with any of the prior art devices for measuring fever, including existing infrared imaging systems and thermometers. When the thermophysiology of the body is measured and evaluated by the prior art, it is taken care of in the past that the measurement performed will produce false negatives of fever.

Terrorists with SARS are readily able to spread the disease by any means, including large-scale, individual handshaking with staff on a daily basis, spending time in confined environments such as movie theaters, department stores, government buildings and other facilities, or contaminating water and drinking water sources. All those infected are unaware that they have become ill and begin to spread SARS to family members, colleagues, friends and others who in turn can infect others, resulting in an epidemic of the disease.

Medically, the deliberate spread of SARS has an immeasurable destructive effect. A person who is not aware of the self-infection may go to a hospital for a routine examination, or a person who feels uncomfortable may go to a hospital for a routine examination. Patients and others who come to the hospital may be infected with the disease. The diagnosed patient is very weak and is easily infected with SARS. The spread of SARS in a hospital is devastating and requires the hospital to be shut down. Thus, a person with SARS may cause the entire hospital to be shut down. Since a person infected with the disease may go to different hospitals, several hospitals may be contaminated and have to be partially or completely shut down. This can lead to paralysis of the healthcare system throughout the region, and the patient must be transferred to another hospital. These patients may be infected with SARS and the circulation of transmission continues. If such terrorist attacks are performed in multiple regions organized, multiple healthcare systems in one country may be paralyzed and, in addition, countless doctors and nurses may become infected with SARS, which may further weaken the healthcare systems due to shortage of personnel.

Prevention of the catastrophic consequences of a terrorist attack is critical. The instrument and method of the present invention can detect SARS and is not amenable to human means. The placement of the BTTThermoScan of the present invention at the borders of a country, in ports and at airports prevents the artificial control of temperature measurements and possible terrorist attacks. The system of the present invention is capable of identifying the presence of SARS and other fever-related disorders at any time and under any circumstances.

In addition, athletes can be screened in a number of scans using a BTT ThermoScan mounted on the finish line. For any athlete who crosses the finish line at the highest level of hyperthermia, the alarm will be activated. Thus, since any delay in identifying hyperthermia can lead to heat stroke, and even death, care can be taken immediately to achieve the best clinical results. The BTT ThermoScan was modified to view at least part of the BTT area. BTT ThermoScan detects brain temperature and provides images corresponding to or including BTT regions. Although the athlete waters up, BTTThermoScan accurately detect the thermal condition of the body by detecting the temperature at BTT.

Body temperature disturbances, such as hyperthermia or hypothermia, can impair the mental and physical functioning of any worker. Drivers and pilots are particularly prone to functional degradation when affected by temperature disturbances and have a risk of accidents. The body temperature can be monitored by mounting the btthermoscan on the dashboard of a vehicle or airplane, capturing a thermal image of the BTT of the driver or pilot with a camera of the BTT ThermoScan, and providing a reminder once the disturbance is detected. It should be understood that any thermal imaging system may be mounted on a vehicle or aircraft to monitor body temperature and alert drivers and pilots.

BTT ThermoScan also includes scanning screens for dangerous children and adults monitored during the flu season. Due to the shortage of care givers, automated screening can greatly enhance the provision of healthcare to those in need. When a student walking past an infrared camera is identified as having a temperature disturbance (e.g., fever), a conventional digital camera is activated to photograph the student. The photo is sent via e-mail to a caregiver at school who determines that the student needs care and can also automatically use the stored digital photo.

A hospital, factory, home, or any location that would benefit from automatically scanning and screening or individually screening temperature perturbators, may employ a thermal imaging camera in accordance with the present invention.

It will be appreciated that the concentration of hemoglobin can be determined using an instrument containing a radiation source emitting at the BTT site at a wavelength of about 556 nm. The hemoglobin present in the red blood cells at the end of the BTT absorbs a substantial amount of the 556nm wavelength and the reflected radiation received by the photodetector determines the hemoglobin content. Blood flow is assessed by the known content of thermal radiation, a higher thermal radiation indicating a greater blood flow according to a mathematical model.

The contact sensor, the non-contact sensor and the thermal imaging camera can be conveniently placed by the anatomical shape presented to be externally visible. Cerebral venous blood is seen under the skin at the angular region adjacent to the medial canthus. Thus, a method for measuring temperature includes visually detecting a blue or bluish skin of a BTT area and positioning a sensor at or adjacent to the blue or bluish area. For subjects with darker skin, the characteristic features of the different skin structures in the BTT region adjacent to the medial canthus serve as a baseline for measurement.

The present invention includes means for collecting thermal radiation from a BTT site, means for positioning a temperature sensitive device to receive thermal radiation from the BTT site, and means for converting the thermal radiation to a brain temperature. The present invention also provides a method for determining brain temperature, the method comprising collecting thermal emissions from a BTT site, generating a signal corresponding to the collected thermal emissions, processing the signal and reporting the temperature level. The present invention also includes an apparatus and method for properly positioning a temperature sensor in a stable position at a BTT site.

It is another object of the present invention to provide a support structure that is improved for positioning a sensor on the skin at the end of a channel for measuring a biological parameter.

It is an object of the present invention to provide an apparatus and method for measuring brain temperature, including patches, tapes, elastic devices, clips, etc. that include sensors placed over physiological pathways.

It is an object of the present invention to provide an apparatus and method for measuring brain temperature, including a thermal imaging system including an infrared sensor that senses infrared radiation from a BTT.

It is an object of the present invention to provide a multipurpose spectacles equipped with a medial canthal pad containing a sensor placed on a physiologic channel to measure a biological parameter.

It is another object of the present invention to provide new methods and apparatus for measuring at least one of brain temperature, chemical function and physical function.

It is a further object of the present invention to provide an apparatus that is worn on adults and children.

It is another object of the present invention to provide an apparatus that reports signals generated at a channel by at least one of wired connection to a reporting device, wireless transmission to a reporting device, and local reporting by audio, visual, or tactile means, such as by a vibrator assembled in a support structure.

It is yet another object of the present invention to provide an apparatus that avoids dehydration or over hydration (water poisoning) for the wearer.

It is a further object of the present invention to provide methods and apparatus for improving the performance and safety of athletes and sport participants.

It is a further object of the present invention to provide a support structure for positioning sensors on a pathway that can be worn by at least one of athletes in training and competition, soldiers in training and combat, workers in work, and the general public in normal activities.

It is another object of the present invention to provide climate automation and control of the vehicle's seats based on the core temperature of the vehicle owner to improve safety and comfort within the vehicle.

It is an object of the present invention to provide a method and apparatus for acting on a second device in dependence on the level of a measured biological parameter.

It is another object of the present invention to provide methods and apparatus for maintaining skin health, reducing the risk of skin wrinkling and reducing the risk of skin cancer by preventing solar damage from thermal radiation and alerting the wearer when the temperature reaches a certain threshold.

It is another object of the present invention to provide a method and apparatus for managing weight loss by a calorie-based weight loss method.

It is another object of the present invention to provide a method and apparatus for alerting an athlete to prevent injuries or deaths due to overheating in a program for reducing body weight based on increasing body temperature.

It is a further object of the present invention to provide a method and apparatus that can monitor heating and temperature spikes.

It is a further object of the present invention to provide a device for family planning by detecting ovulation time.

It is another object of the present invention to provide methods and apparatus for presenting a drug based on a signal generated by a channel.

It is a further object of the present invention to provide a method and apparatus for improving occupational safety by continuously monitoring biological parameters.

It is yet another object of the present invention to provide an article of manufacture having a sensing instrument positioned on a pathway to monitor a biological parameter that can be secured or fitted in at least one of the structure of a spectacle frame, a nose pad of spectacles, a headgear, and an article of clothing.

The invention also features transmitting a signal from the support structure to act on at least one of a training apparatus, a bicycle, a sporting device, a protective garment, footwear, and a medical device.

It is a further object of the present invention to provide for the transmission of signals generated by the channels to the treadmill and other exercise machinery to maintain proper hydration and prevent temperature disturbances of the user.

It is yet another object of the present invention to provide an apparatus and method for monitoring a biological parameter by accessing a physiological channel with an active or passive device.

The invention also features transmitting signals from the support structure to a watch, pager, mobile telephone, computer, or the like.

These and other objects of the present invention, as well as many of the attendant advantages thereof, will become more readily apparent upon reference to the following description, taken in conjunction with the accompanying drawings.

Drawings

Fig. 1A is a thermal infrared image of a human face showing brain temperature channels.

Fig. 1B is a computer-generated thermal infrared color image of a human face showing brain temperature channels.

Fig. 2A shows a schematic diagram of a physiologic tunnel.

Fig. 2B is a schematic cross-sectional view of a human head showing the tunnel.

FIG. 2C is a schematic view showing the coronal section (coronal section) of the cavernous sinus of FIG. 2B.

FIG. 3A thermal infrared image of a human face showing the channel.

Fig. 3B is a schematic illustration of the image in fig. 3A showing the geometry of the channel ends.

Fig. 4A is a thermal infrared image of the side of a human face showing a full view of the primary entry site for the brain temperature tunnel.

Fig. 4B is a schematic diagram of the image in fig. 4A.

Fig. 5A is a thermal infrared image of the front of a human face showing the primary entry site for the brain temperature tunnel.

Fig. 5B is a schematic diagram of the image in fig. 5A.

Fig. 5C is a thermal infrared image of the side of the face of fig. 5A showing the primary entry site for the brain temperature tunnel.

Fig. 5D is a schematic diagram of the image in the attached view 5C.

Fig. 6 is a schematic view of a human face showing the total area of the main entry point and the edge portion of the tunnel.

Fig. 6A is a schematic diagram showing brain temperature channels and metabolic channels.

Fig. 7A and 7B are thermal infrared images of a human face before and after a cold attack.

Fig. 8A and 8B are thermal infrared images of the faces of different subjects showing the tunnel.

Fig. 9A and 9B are thermal infrared images of animals showing the tunnel.

Figure 10 is a perspective view showing a preferred embodiment of a personal wear support structure comprised of a patch having an active sensor positioned on the skin at the end of a tunnel in accordance with the present invention.

Figure 11 is a perspective view showing another preferred embodiment of a support structure worn by a person in accordance with the present invention, the support structure being comprised of a patch having an active sensor positioned on the skin at the end of a channel.

Figure 12A is a front view showing a preferred embodiment of a support structure worn by a person in accordance with the present invention, the support structure being comprised of a patch having passive sensors positioned on the skin at the ends of a tunnel.

Fig. 12B is a side view showing the flexibility of the support structure shown in fig. 12A.

FIG. 13 is a schematic structural view of a preferred embodiment.

Fig. 14 is a schematic diagram of a preferred embodiment of the present invention in relation to a processing device and product.

Fig. 15A-15E are schematic diagrams showing a preferred embodiment of the use indicator of the present invention.

Figures 16A-16C are perspective views of the preferred embodiment showing a person wearing the assembled support structure, such as a patch.

FIG. 17 is a perspective view showing another preferred embodiment of a person wearing a support structure assembled with clips, a sensor being placed on the skin at the end of a tunnel according to the present invention.

Figure 18 is a perspective view of another preferred embodiment showing a person wearing the support structure and the sensors being placed on the skin at the end of the tunnel and connected by wires.

Fig. 19a1, 19a2, 19B, 19C, and 19D are schematic diagrams of preferred geometries and dimensions of the support structure and sensing device.

FIGS. 20A-20C are schematic illustrations of preferred support structure perimeter dimensions relative to the perimeter of the sensing device.

Fig. 21A and 21B are schematic views of preferred locations of the sensing device.

Fig. 22A-22C are perspective views of a preferred embodiment showing a person wearing a support structure assembled as a medial canthal pad with sensors placed on the skin distal to a tunnel according to the present invention.

Fig. 23A and 23B are perspective views of an alternative embodiment in accordance with the present invention showing a support structure consisting of an improved nose pad with sensors placed on the skin at the ends of the channels.

Figure 24 is a perspective view of another preferred embodiment of a support structure according to the present invention.

FIG. 25 is a perspective view of a preferred embodiment of a support structure showing other structures including sensors.

Fig. 26A is a rear view of a preferred embodiment of a support structure with a display device.

Figure 26B is a front view of a preferred embodiment of a support structure with a display device.

FIG. 27 is an exploded view of another preferred embodiment showing a three-piece support structure.

Fig. 28A is an exploded view of a preferred embodiment of the support structure showing detachable medial canthal patches.

Fig. 28B is a posterior view of the detachable medial canthal patch of fig. 28A.

Fig. 28C is a front view of the detachable medial canthal patch of fig. 28A.

Fig. 29 is a rear view of a preferred embodiment of the support structure assembled into a clip for use on eyeglasses.

Fig. 30 is a perspective view of an alternative embodiment of a support structure with the medial canthal pad affixed to another structure using an adhesive backing.

Fig. 31A is a top view of an alternative embodiment of a support structure with a hole for fixation of the medial canthal pad.

Fig. 31B is an enlarged perspective view of a component of the support structure of fig. 31A.

Fig. 31C is a side view of components of the support structure of fig. 31B.

Fig. 31D is a side view of the medial canthal patch fixed to the support structure.

Fig. 32A is a perspective view of a person wearing a support structure consisting of an angular cap that is fixed over the nasal cushion of regular spectacles.

Fig. 32B is a perspective view of the angular cap of fig. 32A.

Fig. 33A is an exploded view of an angular cap fixed on the nasal cushion.

Fig. 33B is a perspective view of the final result of the fixation of the angular cap to the nasal cushion.

FIG. 34 is a perspective view of a modified rotatable nose pad for placement of a sensor on the skin at the end of a channel in accordance with the present invention.

FIG. 35 is a schematic representation of another preferred embodiment of the present invention, using spectral reflectance.

Fig. 36 is a schematic diagram showing a person according to another preferred embodiment of the present invention, using spectral transmission.

Fig. 37 is a cross-sectional view of another preferred embodiment of the present invention, employing thermal emission.

Figure 38 is a side view of an alternative embodiment employing a headgear as a support structure.

FIG. 39 is a schematic diagram of a preferred embodiment for generating thermoelectric energy to supply a sensing system.

FIG. 40 is a perspective view of a preferred embodiment used by an animal.

Fig. 41A and 41B are perspective views of an alternative embodiment of a portable support structure with sensors positioned on the channels.

Fig. 42A and 42B are schematic views showing a noncontact sensor according to the present invention.

Fig. 43A-43C are graphs showing a preferred embodiment of the cone protrusion (cone extension) diameter.

Fig. 44A and 44B show alternative epitaxial tip geometries and shapes.

Fig. 45A and 45B show the geometry and profile of an exemplary support structure, including a touch sensor.

Fig. 46A-46D show exemplary medial canthal pad or modified nasal pad geometries and shapes.

FIG. 47 is an exemplary block diagram illustrating a preferred embodiment of an infrared imaging system of the present invention.

Fig. 48-51 are schematic diagrams showing infrared imaging systems of the present invention mounted in various locations on a support structure to reflect changes in a person's body temperature.

Fig. 52A is a schematic view showing an infrared imaging system of the present invention mounted on a vehicle.

Fig. 52B is a representation of an illustrative image generated with the infrared imaging system of fig. 52A.

FIG. 53 shows a flow chart illustrating a method for use in the present invention.

Fig. 54A and 54B are perspective views of a preferred embodiment incorporated onto a head gear.

Fig. 55 is a perspective view of a preferred embodiment consisting of a mask and an air bag (air pack).

Fig. 56A and 56B show schematic diagrams of BTT entry point detection systems in accordance with the present invention.

FIG. 57 is a diagram showing an automatic detection system for entry points in BTTs.

Fig. 58A-58C are schematic diagrams illustrating alternative support structures according to the present invention.

FIG. 59 shows a schematic of bi-directional thermal energy flow in BTTs.

FIGS. 60A-60C show sketches of preferred BTT heat packs (thermal packs).

Figure 61 is a schematic front view showing a preferred BTT heat pack according to the present invention.

Fig. 62 is a schematic cross-sectional view of a BTT heat pack.

Fig. 63A is a schematic cross-sectional view of a BTT heat pack in a relaxed state.

Fig. 63B is a schematic cross-sectional view of the BTT heat pack of fig. 63A in a compacted state to conform to a BTT area.

Fig. 64A is a schematic side cross-sectional view of a human head with a BTT heat pack.

Fig. 64B is a schematic front view of an eye region having the BTT thermal pack of fig. 64A.

Fig. 65 shows a perspective view of a BTT heat pack containing a rod 866.

Figure 66 shows a schematic of another embodiment of a dual pouch BTT heat pack.

Fig. 67A shows a schematic front view of a BTT thermal mask.

FIG. 67B shows a side cross-sectional view of the BTT thermal mask of FIG. 67A.

Fig. 67C shows a front view of the BTT thermal mask of fig. 67A on the face and on the BTT.

Fig. 68A shows a front view of a support structure comprised of an eyewear (eyewear) holding a BTT heat pack.

Fig. 68B shows a front view of a support structure comprised of clips holding a BTT heat pack.

Figure 69A shows a perspective view of a preferred BTT heat pack.

Fig. 69B is a rear view of the BTT hot/cold pack 910 and the expansion lobe 906.

Fig. 69C is a plan perspective view of the BTT hot/cold pack 910 and the substantially flat portion 912.

Fig. 69D shows a perspective view of the BTT heat pack of fig. 69A disposed on a BTT.

Fig. 70 shows a schematic diagram of a handheld contactless BTT measurement device.

FIGS. 71A-71C show schematic diagrams of a touch sensitive measuring device that is hand held.

FIG. 72 is a schematic image showing a hand-held touch sensor measurement device.

Fig. 73 shows a schematic of a heat transfer device coupled to a BTT measurement device.

Figure 74 shows a perspective view of a preferred measuring device for animals.

FIGS. 75A-75E show graphs of thermal signals.

Fig. 76A and 76B show schematic diagrams of antenna arrangements.

Fig. 77A-77C show schematic views of a support structure comprised of hook and loop fasteners.

FIG. 78 shows a schematic view of a support structure comprised of hook and loop fasteners with a lens mounted.

Fig. 79A and 79B are perspective views of alternative support structures.

FIG. 80 shows a schematic view of the support structure of FIG. 79A.

Fig. 81A and 81D are schematic views of a preferred support structure.

Figure 81B is a side perspective view of the boomerang patch 1760 of figure 81A.

Fig. 81C and 81D show perspective views of the support structure of fig. 81A.

Fig. 82 shows the electrical distribution of a support structure consisting of eyewear.

Fig. 83 shows a perspective view of an automatic climate control system.

Fig. 84 is a front view showing a nasal airway dilator as an extension of the patch of the present invention.

FIGS. 85A-85C are schematic diagrams showing kits according to the invention.

Description of The Preferred Embodiment

The accompanying drawings, which are set forth in certain terms, illustrate preferred embodiments of the invention and are therefore considered to be illustrative for the purpose of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.

Fig. 1A shows a thermal infrared image of a human face showing physiological channels. This image shows an image of the terminal brain temperature channel (BTT) as represented by the bright white dots in the medial canthal area and the medial half of the upper eyelid. The BTT end on the skin has a specific geometry, boundary and internal area, with the main entry point located in the upper medial part of the angular area, directly in the lower part of the upper eyelid, and 4mm medial to the angular area. The border is located in the medial canthus area, thus directly down the medial canthus, 5mm down from the medial canthus, and then travels to the upper eyelid, where the border begins in the middle of the upper eyelid as a defined area, extending laterally in a fan shape, and the upper border begins at the middle half of the upper eyelid.

The color scale indicates the temperature range present on the human face. The hottest spot is indicated with a bright white dot and the coldest area is indicated with black. The temperature between the hottest and the coldest region is displayed in different shades in the brightness scale. The nose, which is composed mainly of cartilage and bone, has a low blood content and is cold (black in appearance). This is the most common cause of frostbite in the nose.

The periocular region of the upper and lower eyelids (shown in grey) is highly vascularized and has a low content of adipose tissue and is relatively hot. The skin under the eyelids is very thin and free of adipose tissue. However, there are no other conditions in this region that are required to define a brain temperature channel.

The requirements of BTT also include the presence of terminal branches to present total heat, which are direct branches from the brain, which are positioned superficially, to avoid the absorption of far infrared radiation by other structures, and the absence of arteriovenous loops that regulate body temperature. Thus, BTT is an area of skin in the medial canthus and upper eyelid that is a unique location that can access the brain's temperature pathways. The skin surrounding the eyelids presents undisturbed signals for chemical measurement by spectroscopy, known as metabolic pathways, that can best result in a chemically evaluated signal that is not used to evaluate the total radiant energy of the brain.

FIG. 1B is a computer generated thermal infrared color schematic image of a human face showing in detail the geometry and different regions of the brain temperature channels and surrounding regions. This type of radiation is visible to only a few organisms, such as some beetles and snakes, but not to humans. The infrared image makes invisible to visible. Thus, the geometry and dimensions of the channels can be better quantified. The color scheme of the isotherm shows a red peripheral region of the channel and a yellowish white central region, with the main entry point at the end of the BTT located in the upper medial portion of the medial canthal area above the canthal ligament.

The main entry point is the region where the signal is best obtained. The image also shows that the thermal energy is uniform across the two BTT sites. Since the other areas, including the forehead, do not have the six features previously described as required to define the BTT, the areas have a lower total radiant energy, showing a light green color and a dark green color. Therefore, the forehead is not suitable for measuring the total radiant energy. The entire nose has very low radiant energy, shown as blue and purple areas, while the tip of the nose is shown as brown, with the lowest temperature of the face. Therefore, the nose region is not suitable for measuring biological parameters.

Fig. 2A is a schematic diagram of physiological channels, particularly brain temperature channels. Physiologically, BTT is a brain thermal energy pathway that exhibits high total radiant energy and high heat flux, and can be characterized as a brain thermal energy pathway. The channel stores thermal energy, provides an undisturbed path for transporting thermal energy from one end of the channel in the cavernous sinus inside the brain to the other end on the skin, and transfers the thermal energy in the form of far infrared radiation to the skin surface at the end of the channel. High heat flow exists at the channel ends, which are characterized by a thin interface, with heat flow being inversely proportional to the thickness of the interface.

The total radiant energy (P) at the channel ends is defined as P ═ σ · e ═ a · T⁴Where σ is the Stefan-Boltzman constant, σ equals 5.67x 10^-8W.m^-2.K^-4And e is the emissivity of the region. Since the channel ends provide the best radiation area, due to T in the equation⁴In the meantime, when the brain temperature increases, the total radiant energy rapidly increases. As demonstrated in the experiments mentioned in this invention, the radiant energy of BTT occurs at a faster rate than the radiant energy in the tongue and mouth.

The site of BTT on the skin is a very small area, less than 0.5% of the body surface area. However, this extremely small area in the body provides the best signal-acquisition area for measuring physiological and chemical parameters.

Fig. 2A shows a brain 10 having thermal energy 12 stored therein. The BTT 20 includes a brain 10, thermal energy 12 stored in the brain 10, thermal energy stored in a channel 14, and thermal energy 16 transferred to the end of an external channel. The thermal energy 12, 14, 16 is represented by black arrows of the same size and shape. The arrows have the same size and represent undisturbed thermal energy from one end of the channel to the other, characterized by the same temperature within the channel.

Thermal energy from the cavernous sinus of the brain 10 is transferred to the end of the channel 16, through the unobstructed cerebral venous blood path, with rapid heat transfer. The channel also has a wall 18 representing the wall of the blood vessel, which stores thermal energy at the same temperature and acts as a conduit from the inside of the body 10 to the outside (skin surface) 19, ending with the terminal blood vessel 17, transferring the total amount of thermal energy to said skin 19.

The skin 19 is very thin and can generate a high heat flow. The thickness of the skin 19 can be neglected in comparison to the skin 39, 49 on the non-channel areas 30 and 40, respectively. Due to the nature of skin 19, high heat flux is generated, and heat balance can be reached quickly when the sensor is placed on skin 19 at the end of BTT 20.

In other skin areas of the face and the entire body, as well as in the exemplary non-tunnel regions 30 and 40 of fig. 2, several interference phenomena occur, including self-absorption and thermal gradients, in addition to the lack of direct vascular connection to the brain. 1. Self-absorption: this is related to the phenomenon that deep tissues selectively absorb wavelengths of infrared energy before emitting to the body surface. The self-absorption content and type of infrared energy is unknown. Those preferred emissions are weak at the body surface due to self-absorption by other layers resulting in chaotic thermal emissions and meaningless spectral characteristics of the analyte, illustratively represented by the various sizes, shapes and orientations of arrows 34a-36g and 44a-46g of FIG. 2. Thus, self-absorption of the non-channel region naturally prevents the emission of heat useful for the measurement from being presented to the body surface. 2. Thermal gradient: there is a thermal gradient, with deeper layers being at a higher temperature than shallower layers, illustratively represented by thicker arrows 36d and 46d at deeper layers as compared to the positioning of the shallower, thinner arrows 36e and 46 e. When traversing various layers such as fat and other tissue ex vivo muscle, excessive and highly variable scattering of photons occurs, resulting in energy loss.

Thus, in contrast, the channeling areas 20 coincide with no infrared energy absorption, and the blood vessels are located on the body surface. This allows for an undisturbed transfer of infrared energy to the skin surface 19 and to a temperature detector, for example an infrared detector placed side by side on the skin 19. The BTT region has only a very thin layer of skin 19, while the terminal blood vessels 17 are just below the thin interface skin 19, and there is no thermal gradient in the BTT region. The thermal energy 16 generated by the terminal blood vessels 17 extending to the epidermis 19 corresponds to the undisturbed brain (true core) temperature of the body. The preferred route to achieve thermal equilibrium with brain tissue temperature is through the central venous system, which exits the brain and enters the orbit as an supraocular vein. Arterial blood, which is 0.2-0.3 ℃ lower than central venous blood, does not reach a true equilibrium with brain temperature. Although, in some cases, arterial blood is important, the venous system is the preferred heat transporter for measuring brain temperature. In some cases, arterial blood temperature is important to determine whether it is possible to cool the brain through arterial blood.

The non-channel regions 30 and 40 are characterized by the presence of heat absorbing elements. The non-channel regions 30 and 40 are depicted with dashed lines and are characterized by the presence of heat absorbing constituents and the defect of disturbed heat transfer within said non-channel regions 30 and 40. The various tissue layers and other components of the non-channel regions 30 and 40 selectively absorb infrared energy emitted by deeper tissue layers before the energy reaches the skin surface, with different thermal energies and different regions represented by arrows and arrows of different shapes and sizes.

The non-channel region 30 represents the measurement of temperature with a sensor on the skin, which is anatomically located above the heart 32. White arrows 34 represent the thermal energy in heart 32. The non-channel region 30 includes a heart 32 and various blood vessels that store thermal energy and branches 36a, 36b, 36c, 36d thereof.

Different amounts of heat are transferred and the different temperatures determined depend on the location and anatomy of the blood vessels 36a, 36b, 36 c. The blood vessel branches extensively from the trunk 34 a. The non-channel region 30 also includes heat absorbing structures 37, such as bone and muscle, across which thermal energy 34 from the heart 32 must pass to reach the skin 39. The non-channel region 30 also includes an infinite number of layers of adipose tissue 38 that further absorbs thermal energy. Due to the presence of fat 38, the amount of thermal energy reaching the skin surface 39 is reduced, which is indicated by arrows 36d and 36e, wherein arrow 36d has a higher temperature than arrow 36 e. The non-channel region 30 also includes a thick skin 39 with low heat flow indicated by arrows 36 f.

The thick skin 39 corresponds to the skin of the chest, while the fat layer 38 corresponds to the various contents of fat present in the chest. Arrows 36g represent the turbulent and reduced total radiant energy that is transferred after the thermal energy crosses the interfering components of the non-channel region, including the thick interfaces and heat absorbing structures. Furthermore, BTT 20 does not have the fat layer present in the non-channel regions 30 and 40. Lack of thick interfaces such as thick skin and fat, lack of thermal barriers such as fat, and lack of thermal absorbing elements such as muscles so that radiation can be emitted undisturbed at the BTT tip. Lack of thick interfaces such as thick skin and fat, lack of thermal barriers such as fat, and lack of thermal absorbing elements such as muscles so that radiation can be emitted undisturbed at the BTT tip.

Referring also to fig. 2, non-channel region 40 represents a sensor on the skin of arm 42 to measure temperature. The heat transfer in the non-channel region 40 is somewhat similar to that of the non-channel region 30, with the end result being turbulence and reduced total radiant energy that is not representative of the temperature at the other end of the interior. The blood vessel branches widely from the trunk 44 a. The thermal energy and temperature in the blood vessels 46a, 46b, 46c is different from the regions 36a, 36b, 36 c. The structure across which the thermal energy 44 must travel to reach the skin is also different from the non-channel region 30. The amount of heat absorbing structure 47 is different and therefore the final temperature of the non-channel region 40 is also different when compared to the non-channel region 30. The amount of fat 48 is also different, with the fat changing temperature in regions 46d and 46e, with region 46d being deeper than region 46 e. Thick skin 49 also reduces heat flow and temperature in region 46 f. The reduction in radiant energy, represented by arrows 46g, is typically quite different when compared to radiant energy 36g, and thus different skin temperatures are measured for different body regions. This is applied to the entire body skin surface except the skin at the end of the BTT.

The clinical relevance of measurements of internal temperature, such as rectal temperature, differs from brain measurements. Selective cooling of the brain has been demonstrated in a number of mammalian species under laboratory conditions, and some methods are applicable to humans. For example, the temperature in the bladder and rectum is quite different from the temperature of the brain. High and low temperatures in the brain are not reflected in the temperatures measured for other internal organs.

Fig. 2B is a schematic cross-sectional view of a human head 9 showing a brain 10, a spinal cord 10a, a channel 20 represented by an supraocular vein, a cavernous sinus 1, and various thermal barriers 2, 2a, 3, 4a, 4B, 5, the cavernous sinus 1 being a thermal energy storage compartment of the brain, while the thermal barriers maintain the brain in a completely insulated structure. The adiabatic barrier includes skin 2 corresponding to the scalp, skin 2a corresponding to the covering face, fat 3 covering the skull and the entire surface of the face, skull 4, spine 4a surrounding spinal cord 10a, facial bone 4b covering the face, and cerebrospinal fluid (CSF) 5. The combined thickness of the brain-insulating barriers 2, 3, 4, 5 amounts to 1.5cm-2.0cm, which has a comparable thickness, being the largest single barrier to the insulating environment throughout the body. Due to this completely confined environment, the brain cannot effectively remove heat, and heat loss occurs at an extremely low rate. The skin 2 corresponds to the scalp, which is the skin and related structures covering the skull, is poorly thermally conductive and is a thermal insulator. The adipose tissue 3 absorbs most of the far infrared wavelengths and is a thermal buffer. The skull 4 has poor thermal conductivity, and CSF serves as a physiological buffer and does not generate heat.

The heat generated in the brain at metabolic rate corresponds to 20% of the total heat produced by the body, this enormous amount of heat being kept in a confined and heat-sealed space. Brain tissue is the tissue most susceptible to heat-induced damage, including damage induced by high and low levels of heat energy. Due to thermal insulation of the brain, and the physiological inability or loss of heat from the brain, states of hypothermia (cold) and hyperthermia (hot) cause brain damage and rapid secondary death, which occur in thousands of healthy individuals every year, in addition to onset and death due to excessive fever in patients. Unless proper and timely reminders are provided by continuously monitoring brain temperature, any person affected by cold or hot disturbances is at risk of heat-induced brain damage.

FIG. 2B also shows a very small entry point 20a, less than 0.5% of the body surface, corresponding to the end of the passageway 20 of the skin 2B. The skin 2b is very thin, 1mm thick or thinner than the skins 2 and 2a, and the skins 2 and 2a are five times thicker or thicker than the skin 2 b.

The passage 20 begins at the cavernous sinus 1 and is a conduit for the cerebral venous drainage and the transfer of heat with radiant energy at the end 20 of the passage. The channel 20 provides an unobstructed path to the cavernous sinus 1, which is located in the middle of the brain and directly connects two heat sources to the brain: 1) thermal energy generated due to the rate of brain metabolism and transported by the venous system; and 2) thermal energy supplied by the arteries and transferred from other parts of the body to the brain. The direct contact distribution is shown in detail in fig. 2C, which is the coronal plane of fig. 2B corresponding to the line labeled "a".

Fig. 2C is a coronal plane through the cavernous sinus 1, which is a luminal-like structure with multiple spaces 1a filled with venous blood from the vein 9 and from the superior ocular vein 6. The cavernous sinus 1 collects thermal energy from the brain tissue 7, from the left and right internal carotid arteries 8a, 8b and from venous blood from the vein 9. The structures 7, 8a, 8b, 9 are all arranged along and in intimate contact with the cavernous sinus 1. A particular feature that makes the cavernous sinus 1 of the passageway the standard of a very useful temperature perturbation is the close association with the carotid arteries 8a, 8 b. The carotid artery carries blood from the body and the amount of heat energy transferred through the blood vessels to the brain can produce hypothermic or hyperthermic conditions. For example, when exposed to cold, the body becomes cold, and cold blood from the body is carried through the internal carotid arteries 8a, 8b into the brain, with the cavernous sinus 1 being the entry point of these blood vessels 8a, 8b into the brain.

As soon as the cold blood reaches the cavernous sinus 1, the corresponding thermal state is transferred to the channel and the skin surface at the end of the channel, thus providing an alarm immediately before the cold blood is distributed throughout the brain. This also applies, for example, to the case of hot blood during exercise, which results in the generation of 20 times more heat than the baseline. The heat carried by the blood vessels 8a, 8b is transferred to the cavernous sinus 1 and can be detected at the end of the passage. In addition, the heat energy generated by the brain is carried by the cerebral venous blood, and the cavernous sinus 1 is a structure filled with venous blood.

Fig. 3A is a thermal infrared image of a human face in which the geometry of the channel ends on the skin are visualized. The bright white dots depict the central region of the channel. Fig. 3B is a schematic illustration of an exemplary geometry of the skin surface at the end of a channel. The inner portion 52 of the channel 50 is circular. The side 54 is proximate the upper eyelid margin 58 and the caruncle 56 of the eye 60. The channel extends from the medial canthal area 52 into the upper eyelid 62 as a horn-like projection.

The interior region of the channel 50 includes a general area of the primary entry points and the primary entry points, as shown in fig. 4A-5D. Fig. 4A is a thermal ir image of the lateral face showing an overview of the major entry points of the brain temperature channels, appearing as bright white dots located at the medial and superior angular medial and medial canthus. Fig. 4B is a diagram showing the general area 70 of the primary entry point and its relationship to the eye 60, angular inner corner 61, eyebrow 64, and nose 66. The general area 70 of the primary entry point has fewer interfering elements than the peripheral area of the tunnel, providing an area that more reliably reproduces brain temperature.

Fig. 5A is a thermal infrared image of the front of a face with the right eye closed, showing the major entry points of the brain temperature channels, appearing as bright white dots above and in the middle of the angular inner canthus. The eye is closed and it is easy to observe that the radiant energy comes only from the skin at the end of the BTT.

Fig. 5B is a graph showing primary entry point 80 and its relationship to angular canthus 61 and eyelid 62 of eye 60 at the upper closure. Since region 80 has the least amount of interfering elements and is widely present in the same anatomical location of all people, the primary entry point 80 of the tunnel provides the region that most reliably reproduces brain temperature. The main entry point 80 has the greatest total radiant energy and has the highest emissivity surface. The primary entry point 80 is located on the skin in the upper part of the medial angular region 63, in the upper medial part of the medial angular region 61.

Fig. 5C is a thermal infrared image of the side of the face of fig. 5A, with the left eye closed, showing a side view of the main entry points of the brain temperature channels, appearing as bright white dots. The eye is closed and it can be observed that the radiant energy comes only from the skin at the end of the BTT.

Fig. 5D shows the primary entry point 80 in the upper part of the angular region above the angular medial corner 61, and also shows the location of the primary entry point 80 relative to the eye 60, eyebrow 64 and nose 66. The support structure may accurately position the sensing device over the primary access point of the passageway because the primary access point is completely delineated by anatomical landmarks. In summary, the sensor is placed over the angular medial aspect and adjacent to the angular cutaneous region of the eye. While indicators may be placed on the support structure to better guide placement of the sensors, the ubiquitous presence of various persistent anatomical landmarks allows for precise placement by non-skilled personnel.

The primary entry point is the preferred location for placement of the sensor through the support structure, but placement of the sensor at any location at the end of the tunnel, including the general entry point area and the surrounding area, provides an application-dependent, clinically useful measurement. The accuracy required for the measurement will determine the placement of the sensor. In the case of neurosurgery, cardiovascular surgery, or other surgical procedures where the patient is at high risk of hypothermia or malignant hyperthermia, the preferred location of the sensor is the primary entry point. For amateur or professional sports, military, worker, home heating detection, sun wrinkle resistance, etc., placement of the sensor on any portion of the access area can provide the accuracy required for clinical effectiveness.

Fig. 6 is a schematic view of the face showing the general area of the primary entry point of channel 90 and the entire area of the channel end and its relationship to the canthal ligament 67, in accordance with the present invention. The channel ends include a generally main entry point region 90 and an upper eyelid area 94. Region 90 has a peripheral portion 92. The two angular regions have angular ligaments and the left eye is used for ease of illustration. Canthal ligament 67 appears in the angular canthus 61 of eye 60. The left canthal ligament 67 is directly opposite the right canthal ligament, indicated by dashed line 61a, starting from medial canthus 61. Although the primary entry point is above the canthal ligament 67, a portion of the peripheral region 92 of the tunnel is below the ligament 67.

Fig. 6A is a schematic diagram showing two physiological channels. The upper panel shows the region corresponding to BTT 10. The lower panel shows the area corresponding to the metabolic pathway 13, including the upper eyelid region 13a and the lower eyelid region 13B, shown as a light blue area in fig. 1B. For measuring the concentration of chemical substances, the total radiation energy is not mandatory. A key aspect of clinically useful spectroscopic measurements is the signal from the brain region, reducing or eliminating the interfering components, the main interfering component being adipose tissue. Accurate clinical measurements can be obtained by removing adipose tissue and receiving spectral signals from the brain carried by blood vessels. The sensor, which is fixed by a support structure, can be modified to have a field of view that matches, completely or partially, the metabolic pathway 13, capturing the thermal radiation from said pathway 13.

To determine the thermal stability of the channel region with respect to environmental changes, cold and hot challenge tests were performed. Fig. 7A and 7B are thermal infrared images of an exemplary experiment showing a human face before and after a cold attack. In FIG. 7A, the face has a brighter appearance than FIG. 7B, and the face of FIG. 7B is darker in color, indicating a lower temperature. Compared to the nose of fig. 7B, the nose of fig. 7A has a completely whitish appearance, whereas the nose of fig. 7B has a completely blackened appearance. Since the region outside the tunnel has an arteriovenous loop that regulates body temperature and interfering components, including fat, changes in ambient temperature are reflected in the region. Thus, the measurements of those non-channel regions of the face reflect the ambient temperature rather than the true body temperature. The non-channel areas of the face and body skin change with changes in ambient temperature. The radiant energy in the channel region remained stable with no change in thermal energy content, demonstrating the stability of thermal emission in the BTT region. Only when the brain temperature changes does the thermal radiation of the channeling areas change, which provides the most reliable measure of the thermal state of the body.

Fig. 8A and 8B are thermal infrared images of the faces of different subjects showing the channel visualized as bright white dots at the inner canthal area. Physiological pathways are commonly present in all individuals, although there are anatomical variations and ethnic differences. Fig. 9A and 9B are thermal infrared images showing channels, indicating that channels appearing as bright white dots are also present in animals, here illustrated by cats (fig. 9A) and dogs (fig. 9B).

A preferred embodiment comprises a temperature sensor with measurement processing electronics mounted in a patch-like support structure that brings the active sensor directly into contact with the skin over the site of the brain's temperature tunnel. Thus, fig. 10 shows a perspective view of a preferred embodiment of a person 100 wearing a support structure consisting of a patch with active sensors 74 placed on the skin at the ends of the tunnel. A person 100 lies on a mattress 76 containing an antenna 78. A wire 82 extends from the antenna 78 to a controller unit 84, and the controller 84 communicates with a device 88 via a communication line 86. The exemplary device 88 includes a decoding and display unit in the bedside or nursing station. It should be understood that the controller unit 84, in addition to communicating via the cable 86, may also include wireless transmission means for wirelessly transmitting the acquired signal to a remote station (remote station). The inductive radio frequency active telemetry system may use the same antenna 78 for transferring energy and receiving signals.

The antenna 78 is mounted in a removable or permanent manner into a mattress, pillow, bed frame, or the like. The preferred embodiment includes a thin flat antenna encapsulated with an elastic polymer that fits into the mattress without being visible to the user. Alternatively, the antenna may be placed in any area around the patient, for example on a night stand.

The antenna 78 and the controller unit 84 function as a receiver/interrogator. The receiver/interrogator antenna 78 transmits RF energy into the microcircuit of the patch 72. This energy is stored and converted for processing of the temperature measurements and for transmission of data from the patch 72 to the antenna 78. Once sufficient energy is transmitted, the microcircuit generates measurements and transmits this data to the receiver/interrogator antenna 78, which is processed in the controller 84 and further transmitted to the device 88 for display or further transmission. The elements involved in obtaining the sensing data (energy measurements) are switched in a sequence such that the quantized results are obtained and stored before the noise-rich transmission signal is activated. Thus, two inherently incompatible processes are successfully co-present, as they are not activated simultaneously.

Enabling RF connection to a communication device by "spreading" the spectrum of transmitted energy in a manner that inherently adds redundancy to the transmission in the presence of noise, while reducing the likelihood that the transmission will be translated by receiver/interrogator 78 into another transmission or noise that could cause receiver/interrogator 78 to transmit and display erroneous information. Such a wireless transmission scheme can be implemented with few active elements. The modulation purposefully spreads the transmitted energy in the spectrum, creating immunity, and ultimately the system can be produced by batch processing and therefore is extremely low cost.

Since the energy to operate the sensor 74 in the patch 72 comes from the antenna 78, the microcircuit in the patch 72 is very weak and extremely weak. The size of the patch 72 is further minimized to extremely small dimensions by a design method that places all of the processing elements of the RF connection in the controller unit 84 as a receiver. The RF communication scheme and control of the sensor 74 resides in a receiver/interrogator controller 84 which is powered by commercially available batteries or by AC current. Thus, the RF communication scheme and control of the sensor 74 is directly controlled by the MCU of the controller 84. The current present in the patch 72 is preferably completely independent (self-contained). The sensing system 74 in the patch 72 is preferably a silicon chip microcircuit that contains, in addition to power conditioning circuitry and digital state control, the circuitry required to support the sensors, quantify data from the sensors, encode data from radio frequency transmissions, and transmit data. The sensors, support circuitry, RF power and communications are all stored on a microchip die, allowing large scale and low cost circuit building. This solution is preferably used for passive and active devices.

The operation process consists of two modes, manual and automatic. In the manual mode, an operator such as a caregiver activates the system, RF energy radiated onto the microcircuit of the patch 72 is stored and converted for use in the temperature measurement process, and data from the BTT tip is transmitted to the antenna 78. Once sufficient energy has been transferred (within 1 second), the microcircuit will take measurements and transmit data to the antenna 78 receiver and controller 84 to be displayed, for example, on a back-lit LCD display screen at the nursing station. An audible "beep" will indicate that the data has been received and can be viewed. In the automatic mode, the process is automatically and continuously performed by interrogation at a previously adjusted frequency, and an alarm is activated when the reading is outside a specified range. Also with a stereo antenna, the controller 84 is configured to search the antenna for three dimensions to ensure a continuous and proper connection between the antenna 78 and the sensing device 74. It should be appreciated that the sensor is capable of modulating the reflected RF energy. Thus, the energy will trigger the sensor to obtain a temperature measurement, and the sensor will then modulate the reflected energy. The reflected energy and signal will be received by the interrogator and displayed as described above.

The present invention also provides a method for monitoring a biological parameter, the method comprising the steps of: fixing an active sensor on a human body; generating electromagnetic radiation by a device secured to at least one of a mattress, a pillow, and a frame; generating a signal from the active sensor; receiving the signal by a device affixed to at least one of a mattress, a pillow, and a bed frame; and determining a value of the biological parameter from the signal.

It should be understood that various external energy sources may be used, such as electromagnetic coupling, including supercapacitors that are externally charged by electromagnetic induction coupling (electromagnetic induction coupling) and batteries that may be recharged with an external oscillator. It should also be understood that the sensing system may be activated from a distance by ultrasound.

Fig. 11 is a perspective view of another preferred embodiment showing in more detail a person 100 wearing a support structure, placed on the skin at the end of the tunnel, consisting of a patch 72 with sensors 74, an emitter 71 and a digital converter and controller 73. The person 100 wears a necklace as the antenna 78 and a pendant of the necklace as the control unit and the transmission unit 79. Solar cells and/or specialized battery power units 79. Patients are accustomed to carrying the Holter monitor card and hanging it around their neck with a string, so patients who are compliant with the systems currently employed will be quite compliant with this embodiment. It will be appreciated that in addition to necklaces, a variety of items including clothing and electrical devices may be used as receivers/interrogators, such capabilities being readily incorporated into mobile phones, laptop computers, palmtop computers, network appliances connected to the internet, etc., so that a patient may use his mobile phone/computer appliance to monitor his own brain temperature.

The preferred embodiment shown in figures 10 and 11 preferably provides continuous monitoring of fever or temperature spikes for any surgery, any patient received at a hospital, a patient at a nursing home, and at an ambulance to prevent death and injury from nosocomial infections (Hospitalinfection). Nosocomial infections are infections that are encountered during hospitalization. Nosocomial infections are the fourth leading cause of death in the united states, causing over 100,000 deaths each year, primarily due to the failure to determine fever or temperature spikes early. The present invention enables infection to be determined and treated in a timely manner due to the automatic 24 hour temperature monitoring. If a peak in temperature occurs, an alarm is activated. This allows the infection to be identified and treated in a timely manner, thereby preventing death or serious complications, such as septic shock, which occurs as a result of delayed treatment of the infectious process. In addition, the preferred embodiment provides a means of continuously monitoring fever at home, including during sleep in children and adults.

Fig. 12A is a front view showing a preferred embodiment of a person 100 wearing a support structure consisting of a patch 109 with indicator lines 111 containing active sensors 102 placed on the skin at the ends of the channels. The preferred embodiment shown in fig. 12 provides a transmission means 104, a processing means 106, an AD converter 107 and a sensing means 102, which are connected to a power supply 108 via a flexible circuit 110. For example, the transmission module includes RF, sound, or light. Fig. 12B is a side view showing the elastic nature of the support structure of fig. 12A, with a flexible circuit 110 connecting the microelectronic package (microelectronic package)103 on the right side of the patch 109 to the power supply 108 on the left side of the patch 109, the microelectronic package containing the transmission means, the processing means and the sensing means. Exemplary embodiments will be described in detail.

According to this exemplary embodiment for temperature measurement, the thermal energy emitted by the BTT is sensed by a temperature sensor 102, such as a micro-thermistor, which generates a signal representative of the sensed thermal energy. The signal is then converted to digital information and processed by the processor 106 using standard processing for detecting temperature. An exemplary acoustic wave system for brain temperature measurement includes a temperature sensor, input coupling circuitry, signal processing circuitry, output coupling circuitry, and output display circuitry. A temperature sensor 102 (e.g., a thermistor) in a patch 109 placed on the skin surface at the medial canthal region responds to changes in brain temperature, which appear as a DC voltage signal.

The signal is coupled via an input coupling circuit into a signal processing circuit for modulating the output value of an oscillator, for example a multivibrator circuit, a piezoelectric system operating in the audio frequency range or slightly above, an oscillator being the main component of the signal processing circuit. The output value of the oscillator is input to an amplifier, which is the second main component of the signal processor.

The amplifier increases the output level from the oscillator so that the output value of the signal processor is sufficient to drive the output display circuit. Depending on the nature of the output display circuitry, such as an audio speaker, a visual LED display, or other possible display means, the output coupling circuitry is used to match the signal from the signal processing circuitry to the output display circuitry. For output display circuits that require digital input signals, the output coupling circuit includes an analog of digital (a/D) conversion circuitry. The DC power circuit is an important component retained in the signal processing module. In signal processing circuits, DC power supply circuits are required to support the operation of the oscillator and amplifier. Embodiments of the DC power circuit include ultra-miniature DC batteries, photosensitive DC power sources, or a combination of the two, and the like. The miniature converters (transducers), signal processing electronics, transmitters (transmitters) and power supply are preferably assembled as an Application Specific Integrated Circuit (Application Specific Integrated Circuit) either alone as a hybrid Circuit or in combination with MEMS (micro electro mechanical systems) technology.

The thermistor voltage is input into a microcontroller unit, i.e., a signal chip microprocessor, which is pre-programmed to process the thermistor voltage into a digital signal corresponding to the measured patient temperature at the BTT site in degrees celsius (or fahrenheit). It should be understood that different programming schemes may be used. For example, the sensor voltage is directly input into the microcontroller, converted to a temperature value, and then displayed on a display screen at the temperature value, e.g., 98.6 ° f. On the other hand, the voltage is processed by a digital converter Analog (ADC) before being input into the microcontroller.

After additional signal conditioning, the microcontroller outputs values to drive a piezoelectric audio (ultrasonic) transmitter. The piezoelectric transmitter wirelessly transmits digital pulses which can be identified by software in a receiver module of the size of a radio alarm clock, the receiver module being comprised of a microphone, a low pass audio filter, an amplifier, a microcontroller unit, a local temperature display and a pre-selected temperature level pre-warning device. The signal processing software is preprogrammed into the microcontroller unit of the receiver. Although the present invention provides for an RF transmission device in the presence of noise, the particular embodiment with a loudspeaker as a receiver has the additional advantage in a hospital environment that does not generate RF interference to many other RF devices that are typically present in the environment. The microcontroller unit drives a temperature display for each patient being monitored. Each transmitter is tagged with its own ID. Thus, one receiver module may be used for different patients. Watches, mobile phones, etc. modified to have a microphone may be used as the receiver module.

In another embodiment, the output value of the microprocessor is used to drive a piezoelectric buzzer. The output value of the microcontroller drives the buzzer to remind a user of being in a state that the health of the user is threatened. In this design, the output value of the microprocessor is input into a digital-to-analog converter (DAC) that converts the digital data from the microprocessor into a comparable analog signal for driving the buzzer.

In yet another embodiment, the output from the (DAC) is used to drive a speech synthesizer chip that is programmed to output appropriate audio to alert the user to the risk of heatstroke, such as athletes. For a perceived temperature above 39 ℃, the message is "your body temperature is high. And searching shade places. It can be drunk after drinking cold drink. Rest ". For temperatures below 36 ℃, the information is: "your body temperature is low. Shelter was sought to avoid cold. The hot beverage is drunk. Warming up ".

In another embodiment, the output value is used to drive an optical transmitter that is programmed to output the appropriate optical signal. The emitter has infrared rays that are activated when the temperature reaches a certain level. The light signal acts as a remote control unit that activates the remote unit that emits the alarm sound. This embodiment may alert parents, for example, when a child sleeps overnight with a temperature spike.

An exemplary embodiment of a station for local reporting consists of three electronic modules, such as patches 109, that contain sensors 102 placed on the skin of the BTT site, mechanically loaded in a fabric or plastic holder (holder). In addition to the battery, these modules are: the temperature sensor module, the microcontroller module and the output display module. Electronic interfaces are employed between the various modules of all devices to function properly. The structure of the system consists of a strip, e.g. a patch 109 attached to the BTT area by a self-adhesive pad (self-adhesive pad). A thermistor coupled to the microcontroller drives an audio piezoelectric transmitter or LED. The system reports the temperature locally without the need for a receiver. A tone or light alerts the user when a particular threshold is encountered. The tone acts as a harmonic or reproduces a human voice.

Another exemplary embodiment for remote reporting consists of four electronic modules: a sensor module, a microprocessor module, an output transmitter module, and a receiver/monitor module. From a mechanical point of view, the first three modules are practically identical to the first embodiment. From an electronic point of view, the temperature sensor and the microprocessor module are identical to the previous embodiments. In this embodiment, the output transmitter module replaces the previous local output display module. The output transmitter module is designed to wirelessly transmit the temperature results determined by the microprocessor module to a remote receiver/monitor module. Electronic interfaces are used between the various modules to function properly. The device can be used by patients in hospitals or at home. By reading the data provided by the receiver/monitor module, a continuous base temperature level can be obtained.

Various temperature sensing elements may be used as temperature sensors, including thermistors, thermocouples or RTDs (resistance temperature detectors), platinum wires, surface mounted sensors (surface mounted sensors), semiconductors, thermoelectric systems for measuring surface temperature, fluorescent fibers, bi-metallic devices, liquid expansion devices and state change devices (change-of-state devices), heat flux sensors, crystal temperature measurements and reversible temperature indicators including liquid crystal Mylar sheets. A preferred temperature sensor comprises a 104JT type thermistor available from Shibaura, japan.

Fig. 13 shows a block diagram of a preferred embodiment of the present invention connecting a transmitter 120 to a receiver 130. The transmitter 120 preferably includes a chip 112 that, in addition to a power supply 122, amplifier (a)124, sensor 126 and antenna 128, incorporates a Microprocessor (MCU)114, radio frequency transmitter (RF)116 and a/D converter 118, preferably fixed within the chip. An exemplary chip includes: (1) rfPIC12F675F, (available from Microchip Corporation, Arizona, USA), which is a MCU + ADC +433Mhz emitter (2) CC1010, available from Chipcon Corporation, Norway.

In addition to a power supply 150 and input/output unit (I/O)148 and associated modem 152, optical transceiver 154, and communications portion 156, the receiver 130 preferably includes a chip RF transceiver 132 (e.g., CC1000 available from chipcon corporation), a microprocessor unit (MCU)134, an amplifier and filter unit (a/F)136, a display 138, a clock 140, a keypad 142, LEDs 144, a speaker 146.

In addition to the aforementioned commercially available RF transmitter chips, various devices may be used in the transmission scheme. A simple transmission device consists of an instrument with a single channel transmitter of 916.48MHz b and sends temperature readings to a receiver at the bedside at a frequency proportional to the readings. The thermistor will control the frequency of the oscillator, inputting a data input value to the RF transmitter. If the duty cycle is below 1%, the 318MHz band may be used. In addition to frequency, periodic measurement techniques may be employed. The model uses a single radio frequency carrier as a signal transmitter, modulating the carrier signal with brain temperature information from a conversion means (e.g. a thermistor) capable of changing its electrical characteristics as a function of temperature. The frequency or amplitude of the carrier signal may be modulated with the temperature information so that a receiver tuned to that frequency can demodulate the changing carrier signal, recovering the slowly changing temperature data.

Another transmission technique suitable for transmitting signals from sensors in the support structure is a chirp device. When such a device is activated, the transmitter outputs a carrier signal that starts at the lower frequency in the ISM band and slowly increases the frequency over time until the maximum frequency is reached. The brain temperature information is used to modify the rate of change of the frequency of the chirp. The receiver is designed to measure the chirp input very accurately by looking for two or more specific frequencies. When the first frequency is detected, the clock measures the common time until the second frequency is received. Therefore, a third frequency, a fourth frequency, etc. may be added to help reject noise. Since virtually all direct frequency spread spectrum transmitters and frequency hopping transmitters (frequency hopping transmitters) are randomly dispersed throughout the ISM band, the likelihood that they will actually generate the "correct" sequence of frequencies at the correct time is low.

Once the receiver determines the elapsed time between target frequencies, this time is a value that can represent the brain temperature. If the expected second, third or fourth frequency is not received by the receiver in the "known" time window, the receiver will reject the original input value as noise. This provides a spread spectrum system that transmits information over a broad spectrum, but encodes the information differently than the expected noise from other users of the ISM band. The chirp transmitter is inexpensive and easy to assemble, and the brain temperature transducer is one of the active elements that control the rate of change of frequency.

Other preferred embodiments for local reporting include sensors, operational amplifiers (LM 358 available from National semiconductor Corporation) and LEDs, in addition to a power supply. It should be understood that the operational amplifier (Op Amp) may be replaced with an MCU and the LED with a piezoelectric element.

Fig. 14 is a schematic diagram showing a support structure 160, a sensor 158 and a MCU164 control and/or adjustment unit 162. Communication between the MCU164 and the unit 162 is achieved via a wire 168 or wirelessly 166. By way of example, and not limitation, exemplary units 162 include climate control units in automobiles, thermostats, vehicle seats, furniture, sporting equipment, clothing, footwear, medical devices, drug pumps, and the like. For example, in an exercise machine, the MCU164 is programmed to transmit the temperature level to the receiver unit 162. The MCU in the exercise equipment unit 162 is programmed to adjust speed and other settings in accordance with signals generated by the MCU 164.

Preferred embodiments allow for precise placement of the sensing instrument by the support structure on the BTT site. The support structure is designed to conform to anatomical landmarks of the BTT region to ensure that the sensor is correctly positioned at all times. The corner of the eye is considered a permanent anatomical landmark, i.e. it is present in the same location in all people. The BTT region is also a permanent anatomical landmark, as demonstrated by the present invention. To facilitate consistent placement over the BTT site, indicators in the support structure can be used as shown in fig. 15A-15E.

Fig. 15A shows a guide wire 170 placed on the outer surface of a support structure 172. The guide wire 170 is aligned with the medial corner of the eye 174. The sensor 176 is located above the guide wire 170, on the outer edge of the support structure 172, and once the guide wire 170 of the support structure 172 is aligned with the medial canthus 174, the sensor 176 is positioned at the primary entry point of the channel. Thus, the support structure can be accurately and consistently applied in a manner such that the sensor 176 always overlies the BTT area.

Figure 15B shows a different design of the patch 172 with the same guide wire 170 aligned with the medial corner of the eye 174, so that the sensor 176 can be consistently placed in the BTT area despite the differences in design.

Figure 15C is another preferred embodiment showing the sensor 176 aligned with the interior corner 174. Thus, in this embodiment, no guide wires are required and the sensor 176 itself guides placement.

In fig. 15D, the MCU 175 and the battery 177 of the patch 172 are located outside of the BTT site, while the sensor 176 is precisely located on the BTT site. It should be understood that any type of indicator on the support structure may be utilized to properly seat in the BTT zone, including external markings, leaf-like structures, cuts on the support structure, different geometries for alignment of the medial canthus, and the like.

Figure 15E shows another preferred embodiment, showing upper edge 176a of sensor 176 aligned with medial angle 174 below the medial canthal area and microchip controller 175 located above the medial canthal area. Support structure 172 has a geometric indicator 179 comprised of a small depression in support structure 172. It will be appreciated that a strip functioning as a support structure, such as an adhesive bandage, has the other side opposite the sensor and the hardware made of a tear-off piece. One side of the sensor is first attached to the skin and any excess tape is easily torn off. Two sizes, adult and child, including all possible users.

The material of the support structure functioning as a patch may be flexible and have insulating properties as polyethylene does. Depending on the application, the skin from the outside to the inside of the patch of the multilayer structure includes the following: a thin insulating layer; a two-layer foam adhesive (polyethylene); a sensor (thermistor) and a Mylar sheet. The sensor surface may be covered with a Mylar sheet, then wrapped with the adhesive side of the foam. Any flexible thin material having high thermal resistance and low thermal conductivity is preferably used as an interface between the sensor and the outside, such as urethane foam (K ═ 0.02W/m). Any support structure may be combined with the preferred insulating material.

The preferred power source for the patch includes the natural thermoelectric elements disclosed herein. In addition, standard thin and light plastic batteries using plastic combinations such as fluorothiophenes (fluorothiophenes) as electrodes can be used, which are flexible so that they can be better constructed to the anatomy of the BTT site. Another exemplary suitable power source includes a lightweight, ultra-thin solid-state lithium battery, which is composed of a semi-solid plastic electrolyte (plastic electrolyte) that is about 300 microns thick.

The system has two modes: at room temperature, the system is quiescent and at body temperature, the system is activated. The system also has an on/off switch that uses the skin resistance to create a circuit so that the system is activated only when the sensor is placed on the skin. The patch also has a built-in switch where the conductive backing (backing) is peeled off, the circuit (pad) is opened, and the system is activated. Further, when removed from the body, the patch is placed in a container (case) containing a magnet. A magnet in the container acts as a switch that is closed and the transfer is terminated when the patch is in the container.

Figures 16A-16C are schematic views of a preferred embodiment showing a person 100 wearing a support structure 180 assembled as a patch. In the preferred embodiment shown in fig. 16A, the support structure 180 contains LEDs 184, batteries 186, and sensors 182. Sensor 182 is positioned at the primary entry point over the medial angular region adjacent medial canthus 25. In accordance with the principles of the present invention, the LED184 is activated when the signal reaches a certain threshold. Figure 16B is another preferred embodiment showing the person 100 wearing the support structure 180, the sensor 180 being positioned over a substantial area of the main entry point of the tunnel, the upper edge 181 of the support structure 180 being aligned with the medial canthus 25. The support structure 180 comprises an extension, resting on the cheek region 189, equipped with transmission means 183 for wireless transmission, processing means 185 and a power source 187. Fig. 16C is an exemplary preferred embodiment showing a person 100 wearing two sheet structures 180a, consisting of a support structure 180b and a loading structure 180C, connected by wires 192, preferably a flexible circuit. Support structure 180b contains sensor 182 positioned at the BTT location. The mounting structure 180c comprises an adhesive tape on the forehead 21, carrying the processing means 183a, the transmitting means 183b and the power source 187, for transmitting signals to a unit 194, such as a mobile phone.

Fig. 17 is a schematic diagram showing another preferred embodiment of a support structure 180 having a sensor 182 secured to a nose 191 by a clip 196. The support structure 180 extends up to the forehead 193. The loading structure 195 of the support structure 180 contains a pressure attachment device, such as a clamp 196. The mounting structure 197 on the forehead contains a transmitting device and a power source. The clip 196 employs a spring-based structure 196a that applies gentle pressure to hold the support structure 180 and sensor 182 in a stable position. The mounting structure 197 may also contain an LCD display 19. The LCD 19 has an inverted image that the user observes in a mirror, and further, the LCD 19 has a hinge or can be folded to be properly positioned so that the user can easily observe the displayed numerical value.

Fig. 18 is a perspective view of another preferred embodiment showing a person 100 wearing a support structure 180 consisting of patches, with sensors 182 placed on the skin at the ends of the tunnel, connected to a decoding and display unit 200 by wires 199. The support structure 180 has a visual indicator 170 aligned with the medial corner of the eye 174. Wire 199 includes tape 201 over its first 20cm, most preferably the tape attached to wire 199 is over the first 10cm of the wire from sensor 182.

Fig. 19a1-19D are schematic views of preferred geometries and dimensions of the support structure 180 and the sensing device 182. A specific geometry and dimensions of the sensor and support structure are necessary for the best functioning of the invention. The support structure 180 is sized and designed to optimize function and to conform to the geometry and dimensions of the various portions of the channel.

Fig. 19a1 shows support structure 180 as a patch. The patch 180 contains a sensor 182. The patch 180 may contain other hardware or just the sensor 182. Exemplary sensors 182 are flat thermistors or electro-thermal sensors placed on the body surface. The preferred maximum dimension of the patch is referred to as "z" and is equal to or less than 12mm, preferably equal to or less than 8mm, and most preferably equal to or less than 5 mm. The minimum distance from the outer edge of the sensor 182 to the outer edge of the patch 180 is referred to as "x". "x" is equal to or less than 11m, preferably equal to or less than 6mm, and most preferably equal to or less than 2.5 mm. For illustrative purposes, the sensors 182 have different sides, and the distance "y" corresponds to the maximum distance from the outer edge of the sensor to the outer edge of the patch 180. The minimum distance "x" is a determining factor of the preferred embodiment, albeit with different sides. It should be understood that the entire surface of the sensor 182 may be covered with adhesive so that there is no spacing between the sensor and the outer edge of the support structure.

An exemplary embodiment of skin that includes a surface of the sensor that contacts the BTT site is made with Mylar. The Mylar surface comprises the sensor itself with an adhesive on its skin-contacting surface. In this case, the support structure comprises a piece of glue or adhesive, which can be built flush with respect to the sensor itself. Thus, in fig. 19A, the support structure 171 is comprised of a piece of glue secured sensor 182 juxtaposed on the BTT area. The sensors 182 comprise Mylar, thermistors, thermocouples, etc., the sensors 182 are preferably on the edge of a support structure 171 such as a sheet of glue or any support structure, and the sensors 182 are preferably further insulated on their outer surface with a sheet of insulating material 173, such as polyethylene.

As shown in fig. 19a2, the sensor 182 has an adhesive on its surface to be secured to the skin 11. The sensor is then applied to the BTT site in accordance with the principles of the present invention. Preferably, the distance "x" is equal to or less than 2.5mm so that the sensor 182 is optimally positioned precisely at the primary entry point of the channel so that the signal can be optimally obtained, which is used in applications requiring the most accurate measurements, such as in monitoring a surgical procedure. While the patch may be used as the support structure described with preferred dimensions, it should be understood that the same dimensions may be applied to any support structure, including clips, medial canthal pads, head mounted accessories, etc., in accordance with the principles of the present invention.

Fig. 19B is an exemplary embodiment of a circular patch 180 with a flat sensor 182. The preferred dimensions "x" and "z" apply equally to FIG. 19A 1. Fig. 19C is an exemplary embodiment of a patch with a bead sensor 182. The preferred dimensions "x" and "z" apply equally to FIG. 19A 1. Fig. 19D is an exemplary embodiment with a sensor-chip 15. The sensor chip 15 includes a sensor integrated as part of a chip, such as an Application Specific Integrated Circuit (ASIC). For example, the sensor chip 15 includes a sensor 15a, a processor 15b, and a transmitter 15 c. The preferred dimension "x" applies equally to fig. 19a 1. Other hardware, such as power supply 27, may be loaded into support structure 180 having a large dimension referred to as "d" as long as dimension "x" is maintained, which does not affect its performance.

The support structure and sensors are modified to match the geometry and dimensions of the channel for contact or non-contact measurements, wherein the sensors do not contact the skin at the site of the BTT.

FIGS. 20A-20C show a preferred dimension "x" according to the present invention. As shown in fig. 20A, the distance from the outer edge 180A of the support structure to the outer edge of the sensor 182a is 11 mm. Preferably, as shown in FIG. 20B, the distance from the outer edge 180a of the support structure to the outer edge of the sensor 182a is 6 mm. Most preferably, as shown in FIG. 20C, the distance from the outer edge 180a of the support structure to the outer edge of the sensor 182a is 2.5 mm.

The preferred location of the sensor 182 relative to the medial corner 184 is shown in fig. 21A and 21B. The support structure 180 houses a sensor 182, aimed at the medial corner 184 (fig. 21B). Preferably, as shown in fig. 21A, the support structure 180 positions the sensor 182 above the medial corner of the eye 184.

Preferred embodiments of the support structure assembled into patches and clips are preferably used in hospital environments and in health care settings, including continuous monitoring of heat generation or temperature spikes. The support structure assembled as a medial canthal pad or headgear is preferably used to monitor hydration status, occupational safety, and to monitor hyperthermia, hypothermia, and amateur athletes, professional athletes, soldiers, firefighters, construction workers, and other high intensity occupations, and to prevent wrinkle formation due to thermal damage from sunlight.

Fig. 22A-22C are perspective views showing a preferred embodiment of person 100 wearing a support structure assembled as the medial canthal pad 204 of eye lens 206. In the preferred embodiment shown in fig. 22A, medial canthal pad 204 contains sensor 202. A connecting arm (connecting arm)208 connects the medial canthal pad 204 to the spectacle frame 206, adjacent to a conventional nasal pad 212. Sensor 202 is positioned over the medial canthus area adjacent medial canthus 210.

Fig. 22B shows an exemplary preferred embodiment of the person 100 wearing a support structure assembled into medial canthal pads 204, with sensors 202 integrated into specially constructed eyeglass frames 216, containing LEDs 228, 230. A connecting piece 220 connecting the left lens edge 222 and the right lens edge 224 is constructed and positioned higher than the lens edges 222,224 of the conventional eyeglass structure. Due to the high position of the attachment tab 220 and the particular configuration of the frame 216, the upper edge of the left lens edge 222 is positioned slightly above the eyebrows 226. This configuration allows the medial canthal pad 204 to be positioned over the BTT site with the LEDs 228, 230 aligned on the visual axis. The arms 232 of the medial canthal pad 204 may be flexible and adjustable for proper placement of the sensor 202 on the skin at the BTT site for removal from the BTT site when no measurement is needed. The LED228 is green and the LED 230 is red, and when the signal reaches a certain threshold, the LEDs 228, 230 are activated.

Fig. 22C is a schematic preferred embodiment showing person 100 wearing a support structure assembled into medial canthal pad 204 with sensor 202. The signals 202 from the sensors are transmitted wirelessly by a transmitter 234 carried in the temple 236. The receiving unit 238 receives signals from the transmitter 234 for processing and display. Exemplary receiving units 238 include watches, mobile phones, pagers, palm computers, and the like.

Fig. 23A-23B show perspective views of alternative embodiments of support structures assembled into the nose pads 242 of the improved eyeglasses 244. Fig. 23A shows a perspective view of eyewear 244 containing a modified nose pad 242, with sensor 240 and processor 241, sweat sensor 246 and power supply 248 held by temple 250, and emitter 252 held by temple 254, all electrically connected. The modified nose pad 242 consists of an oversized nose pad with an angle-like extension 243 above it, placing the sensor 240 onto the end of the channel.

Fig. 23B is a schematic showing eyeglasses 256 incorporating oversized modified nose pads 258, with sensor 240 held by temples 262, sweat sensor 260, and emitter 264 held by temples 266. In accordance with the size and principles of the present invention, the modified oversized nose pad 258 preferably measures 12mm or more of its upper portion 258a, containing the sensor 240 at its outer edge.

As shown in fig. 24, another preferred embodiment of the present invention, a visor 268 providing a fixed medial canthal pad 260 is adapted to position the sensors 262, 264 on the tunnel site of the skin. As shown, the goggles 268 also secure a transmission device 261, a power source 263, a local reporting device 265 such as an LED and an antenna 267 for remote reporting. The antenna 267 is preferably integrated as part of the lens rim 269 of the goggles 268.

As shown in fig. 25, in the medial canthal pad 272, other devices related to the signal generated by the sensor 270 include a power switch 274, a setting switch 276 representing a mode selector, a transmitter 278 for wireless transmission of the signal, a speaker 282, a piezoelectric device 283, an input device 284 and a processing device 286. Devices 274, 276, 278, 282, 284, and 286 are preferably secured by any portion of eyeglass frame 280. It should be understood that various devices, switches, and control devices that can store data, time, and other multi-function switches may be incorporated into the instrument in addition to wires for wired transmission of signals.

Fig. 26A shows a rear view of a preferred embodiment of sensors 299, 300 secured by the medial canthal pads 290, 289 of an eyewear 292, comprising a lens edge 297 and a display 298, in addition to an emitter 288, a sweat sensor 294 and a lead 296 disposed in the temple 295 and the lens edge 293 of said eyewear 292, connected to a display device 296.

Fig. 26B is a front view of eyewear 292, which includes sweat sensor 294, emitter 288, and lead 296 disposed in temple 295 and lens edge 293 of eyewear 292, connected to a display device. In this embodiment, sweat sensor 294 generates a signal indicative of the concentration of the substance in sweat (e.g., 9mmol/L sodium ions) shown on display 296 on the left, sensor 300 fixed by the medial canthal pad 290 generates a signal indicative of the brain temperature, e.g., 98 ° f, shown on display 298 on the right. Sweat sensors may be porous or microporous, such that the passage of liquid through the sensor is optimized when measuring chemical constituents.

Various display devices and associated lenses for proper focusing may be employed, including liquid crystal displays, LEDs, fiber optics, micro projectors, plasmapheresis devices, and the like. It will be appreciated that the display device may be attached directly to the lens or be an integral part of the lens. It will also be appreciated that the display device may comprise a separate portion included in or outside the edge of the lens. In addition, the two lenses and the displays 296, 298 held in the lens edges 293, 297 may be replaced with a single unit that may be attached directly to the frame of the glasses 292 with or without the use of the lens edges 293, 297.

Fig. 27 is a perspective view of another preferred embodiment showing three pieces of support structure 304, preferably provided with medial canthal pad tabs modified to serve as interchangeable tabs. This embodiment includes three sheets. The sheet 301 includes a left lens edge 301a and a left temple 301 b. The sheet 302 includes a right lens edge 302a and a right temple 302 b. Plate 303 is referred to as the medial canthal plate connection and comprises a bridge connecting lens 303a and lens pad structure 303 b. The pad 303 is specifically adapted to provide a medial canthal pad 306, with the sensor 308 positioned at the BTT site. Referring to this embodiment, the user can purchase three glasses according to the present invention in which the connector 303 has a sensing function, and thus, the cost is low. However, the three-piece glasses 304 provide a connector 303 having a sensing function instead of the connector 303 having no sensing function. As shown in fig. 27, the connector 303 with the medial canthal pad 306 and sensor 308 also includes a radio frequency transmitter 301 and a battery 312. Thus, connector 303 provides all the necessary hardware, including means for sensing, transmitting and reporting signals. Any attachment means known in the art may be used, including pressure means, sliding means, pins, etc.

Another preferred embodiment provides a movable medial canthal patch 314 to which sensor 316 is mounted, as shown in fig. 28A. As shown, connecting bridge 320 of lens 318 is removably connected to medial canthal plate 314. Eyewear 318 also includes sweat sensors 322, 324 secured by front portion 311 and emitter 326 secured by temple 313. Front portion 311 of eyewear 318 defines a forehead portion and extends across the wearer's forehead, containing sweat sensors 322, 324. Sweat flows through the membranes of the sensors 322, 324 to the electrodes, producing a current proportional to the amount of analyte present in the sweat.

Fig. 28B is a posterior view of the mobile medial canthal patch 314 showing visual reporting means 323, 325, such as green and red LEDs in the left arm, and a sensor 316 adapted to be placed on the end of the tunnel, and leads 326 for electrically connecting the left arm 329 and right arm 328 of the medial canthal patch 314. Fig. 28C is a front view of the movable medial canthal blade 314 showing the power source 330, emitter 332 and sensor 316 in the left arm 329, and the lead 326 for electrically connecting the left arm 329 and the right arm 328 of the medial canthal blade 314. The medial canthal patch 314 can be replaced with a non-sensing conventional nasal cushion of the same size and dimensions as the medial canthal patch 314 to substantially conform to the connecting bridge 320 of the lens 318 of fig. 28A. The mobile angular plate has, in addition to the LED, a built-in LCD display and/or RF transmitter for displaying the value. Thus, the mobile canthal patch or patches, one or more reporting devices, are integrated into a single sensing and reporting unit.

Fig. 29 is a rear view of a preferred embodiment of the support structure assembled into a clip-on structure 340 of the eyeglasses, including attachment means 338 such as hooks or magnets, transmission means 342, processing means 344, power source 346, medial canthal pad 348 mounted on a tri-axial rotatable structure 349 to be properly positioned over the BTT site, and sensor 350. Clip-on structure 340 is modified to fit over conventional spectacles, securing medial canthal pad 348 over the nasal pad of conventional spectacles.

The sensing medial canthal pad is preferably attached to an attachment structure, such as an eye-glass, independent of the presence of a special attachment or attachment device, such as a notch, pin, etc., fitted to the eye-glass. This embodiment provides a means of widespread use of the sensory medial canthal pad in various types or brands of attachment structures. Fig. 30 shows a front view of the medial canthal pad 352, including an adhesive backing 354, securing the pad 352 to an attachment structure such as an eyeglass or another support structure. The adhesive surface 354 is modified to match the area of the lens to which the medial canthal pad 352 is affixed, as corresponds to the area of a conventional nasal pad of the lens. The medial canthal pad 352 functions as a completely independent unit, containing sensor 356, power source 358 and reporting device 360, electrically connected by leads 361, 362. The reporting means 360 includes local reporting by visual means (e.g., LEDs), audio means (e.g., piezoelectric sound chips or speakers), and remote reporting by wireless transmission.

Fig. 31A is a top view of an alternative embodiment of the support structure assembled into an eyeglass 380 having holes 364, 365 in the conventional nasal pads 366, 376 for securing the specialized medial canthal pads. The eyeglasses 380 include a wire 368 disposed in the right lens edge 371 of the frame of the eyeglasses 380, with the wire 368 connecting the emitter 370 carried in the right temple 369 to the nose pad 366. The eyeglasses 380 also include a lead 363 that is mounted to the left lens edge 365, with the lead 363 connecting the emitter 372 mounted to the left temple 374 to the nose pad 376. Fig. 31B is an enlarged perspective view of a portion of the support structure 380 having a hole 365 in the conventional nose pad 376. Fig. 31C is a side view of a conventional nose pad 366 having an aperture 364. Fig. 31D is a side view of the medial canthal patch 382 fitted into the hole 364 of the conventional nasal cushion 366.

Fig. 32A is a perspective view of a person 100 wearing a support structure containing an angular cap 390 that is secured over a nose pad 392 of a conventional spectacle 394. Fig. 32B is a perspective rear view of the canthal cap 390 showing the sensor 396, transmitter chip 398 and opening (opening)397 for securing the cap 390 on the nasal cushion.

Fig. 33A is a perspective view of an angular cap 390 secured over a nasal cushion 392. The canthal cap 390 contains a sensor 396, an emitter chip 398 and an opening 397. Fig. 33B is a perspective view showing the final result of the fixation of the angular cap 390 to the nasal cushion 392

The present invention provides a specific nasal cushion to properly position the sensor on the BTT site. Fig. 34 is a perspective view of a modified left rotatable nose pad 400 modified to place sensors on the skin at the ends of a tunnel, comprising a nose pad 402 with sensors 401, an arm 404 and a cartridge (house)406 carrying an actuator (gear) that makes it possible to rotate the nose pad like a turntable to place the sensors 401 on different tunnel regions identified as 1 and 2. Position 1 places the sensor at the angular medial corner, in the general area near the major entry point of the channel, and position 2 places the sensor just above the angular medial corner at the major entry point of the channel. This embodiment makes it possible to activate the sensing system automatically and to exploit the fact that the temperature of the bridge of the nose is low as seen in fig. 1 (nose is black) and fig. 2 (nose is purple and blue). When the cushion is in its rest position ("zero"), the sensor is maintained in a low temperature position at a temperature of 35.7 ℃, corresponding to the normal position of the nasal cushion on the nose. At position "zero", the sensor is in sleep mode (35.8 or lower temperature). Moving the sensor to a hot area, such as the general area (location 1) or the main entry point (location 2), automatically activates the sensor, enters the activation mode and initiates the sensing function.

It should be understood that numerous specific nasal and medial canthal pads may be used in accordance with the principles of the present invention, including pivot hinges that allow the pads to fold fully or partially, self-adjusting pads using springs, pivots, skateboards, etc. in the sulcus, and self-adjusting devices that can accommodate anatomical changes of different ethnicities. It will be appreciated that the improved nose pad is preferably positioned elevationally on the frame, most preferably by attachment to the upper portion of the lens rim or within 6mm from the upper edge of the lens rim.

A variety of materials may be used, including materials with super-viscosity, to closely appose the sensing devices to the BTT site. Various metal wires with super-elastic properties are used as hinge means to properly position the sensing device over the BTT site. The medial canthal pad can be made of soft synthetic resin material, such as silicone rubber, conductive plastic, conductive elastomer material, metal, flexible material, etc., to be properly positioned on the BTT site of the medial canthal area for proper function. It is also understood that the medial canthal pad has elastic properties suitable for compression, including a material that remains in a stressed shape when decompressed when stressed. Any type of rubber, silicone, etc. with shape memory may also be used in the medial canthal pad and the modified nasal pad.

By substantially reducing or eliminating interfering components, providing a high signal-to-noise ratio, and improving the sensor to capture thermal radiation from the BTT, the present invention provides the means required to accurately and precisely measure biological parameters, including measuring chemical components in the body with optical means such as infrared spectroscopy (infra-red spectroscopy). Furthermore, the apparatus and method of the present invention by enhancing the signal allows clinically useful readings to be obtained using a variety of techniques and using different types of electromagnetic radiation. In addition to near infrared spectroscopy, the present invention achieves good results and high signal to noise ratios when using other forms of electromagnetic radiation such as mid infrared radiation, radio wave impedance, photoacoustic spectroscopy, Raman spectroscopy, visible spectroscopy, ultraviolet spectroscopy, fluorescence spectroscopy, scattering spectroscopy, and polarized light polarization, as well as other techniques such as fluorescence (including Maillard reactions, light induced fluorescence, and ultraviolet induced glucose fluorescence), colorimetry, refractive index, light reflection, thermal gradients, frustrated total internal reflection, molecular inscription, and the like. Sensors modified to capture thermal energy at BTE (brain thermal energy) channel sites provide the best means of measuring biological parameters using electromagnetic means. BTE channels are physical equivalents of physiological BTTs and are used herein to characterize the physical properties of the channel. The geometry and dimensions of the BTT and BTE pathways on the skin are identical.

The following features of the BTE channel allow the signal to be optimally obtained. The skin at the end of the BTE channel is thin. If the skin is thick, the radiation cannot penetrate and reach the substance being measured. The skin of the BTE channel has a constant thickness consistently over its entire surface. Any thickness of skin present on other skin areas makes it impossible to obtain the required accuracy. The BTE channel is free of fat. The intensity of the reflected and transmitted signals varies greatly from patient to patient, depending on the physical characteristics of the individual, such as fat content. The blood vessels at the end of the BTEs are shallow, are terminal vessels and have no arteriovenous circuits. On other parts of the skin, deep blood vessels are located deep, varying widely in both location and depth from person to person. The BTE channel is covered at its ends by a non-light scattering element, such as bone, cartilage, etc. The thermal radiation does not have to pass through cartilage or bone to reach the substance being measured. The end of the BTE channel on the skin has a specific but fixed geometry, well delineated by permanent anatomical landmarks. On other skin surfaces of the body, inconsistencies between the positions of the heat source and the detector are a significant source of error and variability.

After the emissions interact and are absorbed by the measured substance, the natural heat emission is measured by a far infrared radiation spectroscope. The present invention provides a thermally stable medium with negligible amounts of interfering components and thin skin being the only structure to be traversed before the thermal emission from the BTE channel reaches the detector. Therefore, when the thermal energy emitted from the BTE channel is converted into the concentration of the substance to be measured, its accuracy and precision are high.

The natural spectral emission of BTE channels varies depending on the presence and concentration of chemicals. According to Planck's rule, the emitted far infrared thermal radiation and a predetermined amount of thermal radiation can be calculated. By measuring the absorption of thermal energy outside the band of the substance of interest, a baseline intensity can be calculated. By comparing the measured and predicted values for the BTE channel site, the thermal energy absorption in the material band of interest can be determined by spectroscopic means. This signal is then converted to a concentration of the substance based on the amount of thermal energy absorbed.

Sensors modified to probe BTE channels provide a means for measuring a substance of interest, take advantage of the natural brain far infrared radiation emitted by BTE channels, and apply the Beer-Lambert law in vivo. The spectral radiation of infrared energy from the surface of the BTE channel site corresponds to the spectral information of the chemical species. These thermal emissions under 38 ℃ illumination comprise a wavelength range of 4,000-14,000 nm. For example, glucose strongly absorbs light in the band of about 9,400 nm. When far infrared thermal radiation is emitted at the BTE channel site, glucose will absorb the radiation portion corresponding to its absorption band. In a thermally closed and thermally stable environment in the BTE channel, the absorption of thermal energy by glucose is linearly related to the blood glucose concentration.

The support structure comprises at least one radiation source from infrared to visible light that interacts with the substance to be measured in the BTE channel and a detector for collecting the generated radiation.

The present invention provides a method for measuring a biological parameter comprising measuring infrared thermal radiation at a BTE channel site, generating an output electrical signal representative of the radiation intensity, converting the generated input value, and transmitting the converted input value to a processor. The processor is modified to provide the necessary analysis of the signals to determine the concentration of the measured substance and to display the results.

The invention includes means for directing preferably near infrared energy onto the skin surface at the end of the BTE channel, means for analyzing the reflectance or backscatter spectrum and converting it to the concentration of the substance being measured, and a support structure for positioning the light source and detector or means on the skin surface adjacent to the BTE channel site.

The present invention also provides a method for determining the concentration of a substance, the method comprising directing electromagnetic radiation, such as near infrared, onto skin at a BTE channel site, detecting near infrared energy from the skin at the BTE channel site, obtaining a generated spectrum, generating an electrical signal of the detection, processing the signal, and reporting the concentration of the substance of interest from the signal. The invention also includes apparatus and methods for positioning a light source and detector in a stable position with a stable pressure and temperature of the surface to which radiation is directed and from which radiation is received.

The invention also includes means for directing infrared energy through the nose using the medial canthal pad, means for placing the radiation source and detector directly opposite each other, and means for analyzing the transmitted generated spectrum and converting the transmitted generated spectrum into a measured concentration of the substance. The invention also provides a method for measuring a biological parameter, said method comprising directing electromagnetic radiation, such as near infrared, through the nose using the angular pad, collecting the near infrared energy radiated from said nose, obtaining the resulting spectrum, generating an electrical signal of the detection, processing the signal, and reporting the concentration of the substance of interest from said signal. The invention also includes apparatus and methods for positioning a radiation source and detector in stable positions with a stable pressure and temperature of the surface through which the radiation is directed.

The invention also includes means for collecting natural far infrared thermal radiation from the BTE passage, means for positioning a radiation collector to receive the radiation, means for converting the collected radiation from the BTE passage into a measured concentration of a substance. The present invention also provides a method for measuring a biological parameter, the method comprising using natural far infrared thermal emission from a BTE channel as the generated radiation for measuring a substance of interest, collecting the generated radiation spectrum, producing a detected electrical signal, processing the signal and reporting the concentration of the measured substance from the signal.

Depending on the amount of substance measured at the BTE channel, a drug dispensing system including a perfusion pump is activated, for example, insulin is automatically injected when it is desired to normalize the glucose level of the artificial pancreas.

Any substance present in the blood that can be analyzed by electromagnetic means can be measured in the BTE channel. For example, but not by way of limitation, such substances may include exogenous chemicals such as drugs and alcohols as well as endogenous chemicals such as glucose, oxygen, lactic acid, cholesterol, bicarbonate, hormones, glutamate, urea, fatty acids, triglycerides, proteins, creatinine, amino acids, and the like. Values such as pH, which correlates with light absorption, can also be calculated using reflectance spectroscopy.

Referring to FIG. 35, there is shown a perspective view of a preferred reflection measurement instrument of the present invention. Fig. 35 shows a light source 420, such as an infrared LED, juxtaposed with a light detector 422, disposed in a support structure 426, such as a medial canthal pad or a modified nose pad of eyeglasses, the light source 420 being juxtaposed with the skin 428 of the BTE channel 430 to direct radiation 424 to the BTE channel 430. The light source 420 delivers radiation 424 onto the skin 428 of the BTE channel, which is partially absorbed due to interaction with the substance 432 being measured, resulting in attenuated radiation 425. Then, part of the radiation 424 is absorbed by the substance 432, and the resulting radiation 425 emitted from the BTE channel 430 is collected by the photodetector 422 and converted by the processor into a blood concentration of the substance 432. The thin skin 428 is the only tissue between the radiation 424,425 and the substance 432 to be measured. The concentration of substance 432 is determined by measuring the collected light attenuation factor resulting from the absorption of the signal from the substance to be measured.

Since the infrared LED can emit light of a known intensity and wavelength, is small in size and low in cost, and light can be precisely delivered to a site, the infrared LED (wavelength-specific LED) is a preferred light source of this embodiment. The light source 420 preferably emits at least one near infrared wavelength, but alternatively a number of different wavelengths may be employed. The light source emits radiation 424, preferably between 750 and 3000nm, including wavelengths that are indicative of the absorption spectrum of the measured substance 432. Preferred photodetectors include a semiconductor or photodiode having a 400 micron diameter photosurface coupled to an amplifier to form an integrated circuit.

Fig. 36 shows a schematic of a person 100 wearing a support structure 434 and a light source 436 and a detector 438 modified to measure a biological parameter using a spectral transmission device. The light source 436 and the light detector 438 are positioned diametrically opposite such that the output of the radiation source 436 passes through a nasal interface 442 containing the substance 440 being measured before being received by the detector 438. The light detector 438 collects the resulting penetrating radiation that is directed through the nasal interface 442. Various LEDs and optical fibers are arranged in a support structure 434 such as the medial canthal pad, the nasal pad and frame of the glasses, preferably used as light transmission and light detector 438 for the light source 436.

The support structure 434, such as the arm of the medial canthal pad, is movable, adjusted to different positions, creating a fixed or variable optical path (optical path). Preferred substances to be measured include oxygen and glucose. The brain maintains a constant blood flow, while the terminal blood flow varies according to cardiac output and the surrounding environment. The oxygen content present in physiological channels reflects the central oxidative status. Oxygen monitoring in physiological channels represents the global hemodynamic status of the body. Many of the vaccinium uliginosum states such as sepsis (disseminated infection) or heart problems that alter the perfusion of large portions of the body can be monitored. Oxygen in the BTE channel enables continuous monitoring of blood perfusion, early detection of hemodynamic changes.

Fig. 37 is a cross-sectional perspective view of another preferred embodiment of the present invention, utilizing thermal radiation from the BTE. Figure 37 shows a support structure 450 for a heat carrying infrared detector 444 having a filter 446 and a sensing element 448, preferably a thermopile, responsive to thermal infrared radiation 452 naturally emitted by a BTE channel 454. The support structure 450 is modified with a sensing device 448 having a field of view corresponding to the geometry and dimensions of the skin 462 at the end of the BTE channel 454. The support structure 450 provides walls 456, 458 that are in contact with the skin 462, which walls form a cavity 460 that contains thermal radiation 453 that has passed through the thin skin 462.

For example, spectral radiation at 38 ℃ emitted in a 9,400nm band in the heat-sealed and heat-stable environment of the BTE channel 454 is absorbed by glucose in a linear fashion according to glucose concentration content due to the carbon-oxygen-carbon bonds of the pyran ring in the glucose molecule. The final radiation 453 is the thermal emission 452 minus the radiation absorbed by the substance 464. The resulting radiation 453 enters an infrared detector 444, generating an electrical signal corresponding to the spectral characteristics and intensity of the resulting radiation 453. The resulting radiation 453 is then converted to a concentration of the substance 464 based on the absorption of the absorbed thermal energy relative to a reference intensity outside the band of the substance 464.

The same principles disclosed in the present invention can be used for near infrared transmission measurements, as well as for continuous wave tissue oximetry, evaluation of hematocrit, blood cells, and other blood components. The substance to be measured may be endogenous, such as glucose, or exogenous, such as ethanol and drugs including photosensitizing drugs.

A number of support structures enable the placement of sensors at the BTT site to measure biological parameters. Thus, FIG. 38 is a side view showing an alternative embodiment of person 100, employing a head-worn ornamental article 470 as a support structure, placed on the skin at the BTT site, having leads 478 and sensors 476. The microelectronic package 472 contains the transmission device, processing device and power source and is arranged or mounted on a headband 470, the headband 470 providing leads 478 from the microelectronic package 472 for connection with a sensing device 476 on the skin of the BTT site.

It will be appreciated that the sensing device is an integral part of the support structure or is attached to any support structure, for example using conventional fasteners including screws, pins, clips, tongue-and-groove fasteners, interlocking pieces (interlocking pieces), direct attachments, adhesives, mechanical connections, etc.; the support structure includes patches, clips, glasses, headwear, and the like.

Various means of providing electrical power to the sensing system have been disclosed. The BTE channel also provides a new approach for naturally generating electrical energy. Thus, FIG. 39 is a schematic illustration of a preferred embodiment for generating thermoelectric energy from a BTE channel to power a sensing system. The generator of the present invention converts heat from the channels into the electrical power required to power the system. The thermoelectric module is integrated into the support structure to power the sensing system. The thermoelectric module preferably comprises a thermopile or thermocouple, comprising different metal wires, forming the contacts. As heat is dissipated from the channels through the thermoelectric modules, an electrical current is generated. Since the BTE channel is surrounded by a region of low temperature, charge is distributed on the surface and interface of the thermal current generated by the temperature of the BTE channel, the Seebeck effect provides a means of generating power, and electromotive force (emf) is induced in the presence of a temperature gradient.

Thus, FIG. 39 shows the connection T of metal line A470 and metal line B472 maintained at different temperatures₁And T₂To be connected with T₁Placed at the main entry point of the channel, and connected to T₂Placed in a low temperature region such as the nasal bridge (labeled blue or purple in fig. 1B, referred to herein as blue-violet nose). Metal lines a470 and B472 are made of different metals and the current flows from the hot region to the cold region due to the thermal gradient, the magnitude of the current being the ratio of the thermoelectric potential. Potential U is U ═ Q_a-Q_b)*(T₁-T₂) Wherein Q is_aAnd Q_bRepresents a metal A and a metal B₂Thermoelectric coefficient (thermoelectric energy), and T₁Temperature, T, representing entry point of BTE channel₂Indicating the temperature of the blue-violet nose. The generated thermoelectric energy can power the sensing system, capacitors 474 inserted into the system for controlling and storing energy, and the MCU 476 is modified to control the energy transfer required for measurement, processing and signal transmission.

It should be understood that other means of converting thermal energy from the BTE channels to electricity may be employed. It will also be appreciated that the ocular surface and the caruncle of the eye have a thermal gradient and Seebeck effect, but are less desirable than the skin using the end of the BTE channel because the fitting and lead contact and/or extend from the ocular surface, causing discomfort and infection. It should also be understood that the cold end includes any relatively cold items, including the eyeglass frame and air.

A number of the support structures disclosed in the present invention, including eyeglasses, are easily modified to provide the power generation system of the present invention unobtrusively, for example, using a support structure such as eyeglasses with the hot junction placed at the BTE using the medial canthal pad and the cold junction placed over the nose using the nasal pad of conventional eyeglasses. It should also be understood that any other electrical device may be modified to supply energy derived from the brain thermal energy pathway, with the power generation system using brain thermal energy being designed to power the sensing system of the present invention.

Other embodiments include positioning the sensor at a BTT site of the animal with a support structure. Any useful application may be implemented, including improving artificial insemination by monitoring the ovulation phase, monitoring the health of the herd by continuously monitoring the brain temperature, parturition detection, etc.

Thus, fig. 40 is a perspective view showing a preferred embodiment of the animal 101, with the sensor 480 positioned at the BTT site and the wires 482 connecting the sensor 480 with the microelectronic package 484 containing the transmission means, processing means and power source in the animal 101's pocket 486. The signal from the microelectronic package 484 is preferably transmitted on radio waves 489. The signal from the transmitter in the package 484 is transmitted to the GPS collar so that the hot animal with the animal in place can be determined by the GPS device. Once the brain temperature is determined to be elevated by the sensing device 480, the high temperature signal activates the GPS collar to locate the affected animal. Alternatively, when an abnormal signal is received, the remote radio station that receives the electric wave 489 activates the GPS system. In this case, the transmitter in packet 484 transmits only the signal to the remote station, and not to the GPS collar.

Fig. 41A is a perspective view of a portable support structure 490 with a sensor 492 positioned to contact the skin 494 of the BTT site to measure a biological parameter. The support structure 490, which is assembled as a thermometer with a contact sensor 492, is held by a second person 17 to place the sensor 492 on the skin 494 for measurement. Fig. 41B is a perspective view of a portable support structure 496 having a wall 500 housing a non-contact sensor 498, such as a thermopile, with a field of view that matches, in whole or in part, the geometry and dimensions of the skin area at the end of the BTT. A support structure 496, assembled as an infrared thermometer, is held by the second person 105 to position the sensor 498 and measure the biological parameter. It should be appreciated that although an infrared detector may be aimed at the BTT site in accordance with the present invention, the measured temperature is not clinically useful due to the effects of ambient temperature. Thus, the support structure 496 contains walls 500 that create a defined space for thermal radiation from the tunnel skin to reach the sensor 498. The walls 500 of the support structure are modified to match the geometry of the channel, providing a cavity 499 bounded by a sensor surface 492, a skin region 493 being probed by the sensor 498 in a similar manner as described in fig. 37.

Referring now to fig. 42A and 42B, fig. 42A is a schematic diagram showing a support structure 496, also referred to herein as a cartridge (housing), the cartridge 496 containing a window 502 and a radiation sensor 504, an extension 510 being secured to the cartridge to be suitable for temperature measurement in the BTT area. In a preferred embodiment, extension 510 has a wall 500 and is substantially conical and is secured to cassette 496 to fit into hand 105 as shown in fig. 41B. To measure the temperature, the user 105 positions the extension 510 adjacent the BTT site so that the wall 500 of the extension 510 abuts the BTT area and the radiation sensor 504 probes the BTT area. Figure 42B is a schematic diagram showing walls 500 forming an extension 510 of the cavity 499 in which thermal radiation 506 emitted from the skin 508 of the BTT area 518 is received by the radiation sensor 504. The BTT region 506 is surrounded by thin skin and fat of the non-BTT region 512. BTT temperature measurements are obtained from the output of the radiation sensor 504 contained in the cassette 496. The electronics 514 in the box 496 convert the received radiation to a temperature level that is displayed on a mounted display 516 as exemplarily illustrated in fig. 41B.

The radiation sensor 504 detects infrared radiation 506 from the BTT skin surface 508 by probing at least a portion of the BTT surface skin area 508 through the infrared radiation transparent viewing window 502. Radiation sensor 504 is preferably a thermopile, but other radiation sensors may be employed, such as pyroelectric detectors or any other radiation sensor that detects heat flux from the surface being evaluated. Exemplary window 502 materials include silicon and germanium. The sensor 504 is preferably mounted on an extension 510 that is sized and geometrically matched to the BTT area 508. The extension 510 is easily positioned such that only a skin region 508 at the end of the BTT 518 is probed by the radiation sensor 504, wherein the skin region 508 is at substantially the same temperature as the brain. Once in position where the sensor 504 probes the BTT skin area 508, the button 522 is pressed to begin the measurement, the processor 514 in the box 496 determines the brain temperature and displays the value on the liquid crystal display 516 connected to the voice device 524 that emits the audio signal. Any portion of the instrument that is in contact with the skin is covered with a disposable lid.

Although the temperature at the end of the BTT tunnel is substantially equal to the brain temperature, depending on the temperature of the cavernous sinus and the brain blood, different mathematical calculations and means can be used to determine the temperature of the BTT region, including arterial, venous and ambient temperature. It should be understood that BTT probes contain sensors that measure the ambient temperature, and that the measured ambient temperature is used to calculate the temperature of the subject.

The temperature of the BTT zone is used as a reference value for calibrating measurements obtained on other muscle parts outside the BTT zone. The electrical equivalent of a BTT channel is a region of high voltage, low current, where the voltage representative of temperature is virtually equal at both ends of the channel. High perfusion of the BTT tip maintains high temperature on the skin at the tip of the BTT tip.

The present invention also provides a method for detecting body temperature comprising the steps of providing a temperature detector positioned adjacent to a BTT during a temperature detection process, and determining the temperature based on radiation sensed at the BTT area. It should be appreciated that the probe may remain in one position or move around the BTT area, determining the surface with the highest temperature.

Another method of detecting body temperature includes the steps of scanning the BTT region and other regions of the head or contralateral BTT region with a temperature probe, selecting a maximum temperature, preferably by mounting a processor in the BTT probe, scanning the right and left BTT regions, determining and selecting the maximum temperature.

Another method of determining the highest temperature point in the BTT region may be by scanning the BTT region with a radiation detector, modifying the processor to select the highest reading, and indicating the reading with an acoustic signal. The temperature probe 20 provides an audible beep for each peak reading.

Fig. 43A-43C are graphs showing a preferred embodiment of the diameter of the tapered projections 510 at the end of the cassette 496 that contact the skin 508 at the BTT site 518. It will be appreciated that although the extension may take any shape, the extension is preferably conical in shape and the radiation sensor is positioned to probe the BTT region. The cup 520 has an outer diameter at its end that is equal to or less than the BTT area. In fig. 43A, the distal end 524 of the cup 520 preferably has an outer diameter equal to or less than 13mm in order for the radiation sensor 504 to probe the general area of the BTT site 508. In fig. 43B, the distal end 524 of the cup preferably has an outer diameter equal to or less than 8mm in order for the radiation sensor 504 to probe the generally major entry point of the BTT site 508. In fig. 43C, the tip 524 of the cup 520 preferably has an outer diameter equal to or less than 5mm in order for the radiation sensor 504 to probe the primary entry point. It will be appreciated that although the preferred geometry of the radiation sensor and extension is circular, having a substantially conical shape, any other shape of radiation sensor and/or extension may be employed, including oval, square, rectangular, etc. It will be appreciated that the diameter and geometry are preferably chosen to match the BTT region. It should also be appreciated that the size of the sensor 504 is modified to match the size of the cup 520 to probe the area of skin 508.

According to another aspect of the invention, the extension portion is modified to be secured to the eyelid. The portion of the extension 510 of the cassette 496 that contacts the skin 508 has an internal concave surface that matches the contours of the eyelid. Alternatively, the portion of the conical extension 510 that contacts the skin 508 has a convex surface that matches the medial canthus area and the upper eyelid above the medial canthus.

It is also understood that children use 2/3 about the size of an adult size, and children use even half or less of an adult size. Thus, the preferred size of the outer diameter of the extension for use by children is: for the radiation sensor to probe the general area, the extension portion preferably has an outer diameter equal to or less than 9mm for probing the general area of the BTT, equal to or less than 6mm for probing the general main entry point of the BTT, and equal to or less than 4mm for probing BTt.

Fig. 44A and 44B show an alternative geometry and shape for the tip 524 of the extension 510 of the non-contact sensor that probes at least the portion of the BTT region adjacent to the canthus 528 of the eye 526, except that the tip 524 of the extension 510 is preferably rounded. In fig. 44A, the profile of the distal end 524 of the extension 510 is shown as being oval. Fig. 44B shows the tip 524 of the oval, banana-shaped or half-moon shaped extension 510 for probing the inner canthus area and the upper eyelid area.

Fig. 45A and 45B show exemplary geometries and shapes of support structures containing contact sensors that are placed on the skin in the BTT area. Fig. 45 shows a schematic front view of a rod-shaped temperature sensor 530 contained in a patch 532, positioned vertically on a BTT region 534 near the medial corner of the eye 538 and nose 537, with a flexible cord 536 extending from the distal end (digital end) of the sensor 530. Figure 45B is a side view of figure 45A showing sensor 530 with cord 536 contained in patch 532 adjacent eye 539. The sensor is placed in the center of the patch, where an area of less than 11mm in diameter is measured.

Fig. 46A-46D exemplarily show the geometry and shape of the medial canthal pad or modified nasal pad, and their relationship to the medial canthus. Fig. 46A shows a front view of an improved nose pad 540 with a sensor 542 located in the center of the nose pad 540, where the sensor 542 is positioned on the skin proximate to the medial canthus 544 and the BTT area of the nose 546. Fig. 46B is a side view of the eye 545 and nose 546 and modified nasal cushion 540 with sensor 542 positioned over the BTT site. Fig. 46C shows a front view of a modified nose pad 550 with sensors 552 located at the outer edge of the nose pad, which is placed on the skin area near the BTT site of the medial canthus 554 and nose 556. Fig. 46D is a side view showing the eye 555 and nose 556 and the modified nasal cushion 550 with the sensor 552 positioned over the BTT site.

It should be understood that although an extension is the preferred embodiment for the sensor not to be in contact with the skin, an infrared sensor probe modified to contact the skin in the BTT area may also be used.

Now, for the thermal imaging system of the present invention, FIG. 47 is a schematic block diagram showing a preferred embodiment of the infrared imaging system of the present invention. Fig. 47 shows a BTT ThermoScan 560, including a camera 562, a microprocessor 564, a display 566, and a power source 568. The system also includes bearer software (proprietary software) and software that is customized to accurately measure and map BTT areas. The BTT ThermoScan 560 includes a camera 562 with a lens 574, an optical system 572 containing mirrors, filters and lenses for optimizing image acquisition, and a light detector 570, also referred to herein as a radiation sensor or radiation detector, for quantifying and recording energy flux in the far infrared range. The display unit 566 displays a thermal image of the BTT probed through the lens 574 in the camera. Radiation detector materials known in the art are used in photodetector 570, including alloyed indium-antimonides, mercury-cadmium-tellurides, copper-doped germanium, platinum silicide, barium strontium Titanate (barumstrontium Titanate), and the like.

An infrared radiation detector converts incident radiation including the BTT region into amplified electrical energy. The detector 570 is responsive to the infrared radiation to provide an output signal and discrete points related to the intensity of the thermal energy received from the BTT region and the surrounding areas of the BTT region.

Discrete points are photographed and the individual point sources (point sources) must have sufficient energy to stimulate the radiation detector material to release electrons. Any dot size (point size) may be used, preferably with dimensions of 1 and 2mm in diameter. When an angle of 1.3mrad is used, the BTT ThermoScan is able to capture instantaneous images from a spot size of about 1mm in diameter at a distance of 1m from the detector. It should be understood that any spatial resolution that best captures BTT images may be employed, but is preferably between 1.0 and 1.6 mrad. The camera 562 of the BTT ThermoScan 560 has a field of view suitable for probing BTT areas. The discrete points are further converted into an image of the face, including the BTT region at the medial corner of the eye and the upper eyelid. The screening function of BTT ThermoScan is based on the temperature of the BTT region, the absolute temperature, or the differential temperature of the BTT region relative to a reference value.

The electrical reflection of the thermal radiation is displayed on a monitor in intensity, with the intense signal producing a bright (white) spot as shown in fig. 1A, the white spot representing the maximum radiant energy from the source. In fig. 1A, the source is a human face, and the maximum radiation intensity exists within the BTT region. Calibration is performed for the display screen, resulting in a continuous gray scale gradient from dark (isotherm 0) to bright (isotherm 1). The individual points are stored digitally for further processing and analysis.

It should be understood that various lenses, prisms, filters, Fresnel lenses, etc. known in the art may be employed to change the viewing angle or optimize signal acquisition, as well as capture the thermal energy flux from the face and BTT area. The lens of the BTT ThermoScan 560 is preferably perpendicular to the plane of the face or BTT area being probed.

The radiation detector material in the BTT ThermoScan 560 is preferably sensitive to radiation having a wavelength of 8-12 μm, the BTT ThermoScan 560 having a temperature span (span set) of 2-5 ℃, being very sensitive, being modified to discriminate temperatures within 0.008-0.02 ℃ in the range of 1 m. The temperature measurement is based on a radiation device with built-in electronics or the difference is made using a reference such as a black body. Although the system may be uncooled, solid state devices, liquid nitrogen, compressed argon, evaporation of piezoelectric components, etc., may be employed in order to maximize detector efficiency and obtain the best signal-to-noise ratio.

Many radiation detectors capable of detecting infrared waves are being developed, including silicon, solid state systems and microbolometers (microbolometers), and all new or yet to be developed such systems are used in the apparatus of the present invention to detect thermal radiation from the BTT and display a corresponding BTT image on a monitor.

Exemplary infrared detector systems include microbolometers fabricated from silicon materials or integrated circuits containing temperature sensitive refractory materials that absorb infrared radiation, such as vanadium oxide. Incident infrared radiation from the BTT region is absorbed by the microbolometer, producing corresponding changes in impedance and temperature. The various microbolometers act as pixels, and the change in resistance produces an electrical signal corresponding to the thermal radiation from the BTT region, which is displayed on the screen of a computer.

The display of BTT images is a preferred embodiment of the present invention, but the present invention is also practiced in a manner that does not display images. Radiation from the BTT can be obtained by the aforementioned radiation sensor, and the temperature of the BTT area can be calculated from the electrical signal generated by the radiation sensor using the reference value. Any means of detecting thermal radiation and/or temperature from the BTT region may be used in accordance with the principles of the present invention.

In addition to easily handling the temperature of the skin surface outside the BTT area, as shown in the images on the screen depicted in the photographs of fig. 1A and 1B, significantly lower temperatures exist in the BTT-outside area. When the region outside the BTT is used to sense thermal radiation and/or measure temperature, lower and more unstable temperatures outside the BTT region result in the generation of clinically insignificant temperature levels or thermal imaging.

It should be understood that various signal conditioning and processing methods for matching temperature zones outside the BTT zone to values corresponding to the BTT zone are also within the scope of the present invention. During temperature measurement, a higher level of accuracy may also be obtained using images outside the BTT region that appear more like a blob (blu) and a superimposition of the images that comprise the BTT region than the BTT region. In accordance with the principles of the present invention, it is also possible to compare radiation patterns outside the BTT region to the BTT region without the need to generate images of the BTT region for accurate and precise temperature measurement and evaluation of the thermal state of the body. Any method or apparatus for temperature evaluation or thermal state evaluation, with or without generating an image based on the temperature level and thermal radiation present in the BTT region, falls within the scope of the present invention.

Fig. 48 is a schematic diagram showing a thermal imaging system 560 of the present invention modified for use at an airport 580, including an infrared camera 582, a processor 584 and a display 586, mounted in a support structure 588 at the airport 580. The camera 582 scans the BTT region present in the inner canthus 590 of the human face 591 and provides an output signal to the processor 584. When a passing person 592, 593 looks at the lens or is photographed by the camera 582, the output signal is an electrical signal related to the thermal radiation energy characteristics of the BTT 590 in the face 591. The processor 584 processes the output signal so that an image of the BTT area 594 is produced by the display 586, e.g., the monitor of a computer.

Illustratively, the passenger 592 is looking at the camera 582, sensing thermal radiation from the BTT region 590, and the passenger 582 wearing the eyewear must remove the eyewear in order for the camera 582 to accurately capture the BTT region 590. If someone passes the camera 582 and does not obtain thermal images of the BTT 590, an alarm will be activated. Likewise, if one's temperature is disturbed, an alarm indicating the temperature disturbance will be activated.

Fig. 49 is a schematic diagram showing a thermal imaging system 560 of the present invention modified for use in any venue populated with people such as movie theaters, meetings, stadiums, concerts, interior previews, schools, etc. In fig. 49, the infrared camera 596 of BTT ThermoScan 560 is located at the entrance of the above-mentioned site, and person 598 presents their certificate or ticket to administrator (agent)602, and BTT ThermoScan 560 scans the face of person 598, captures the thermal image 600 and the temperature of the BTT tunnel, displayed on remote computer display 604. The camera 596 has an adjustable height and a tracking system that tracks the head, so the camera 596 can position itself to sense thermal radiation from people 598 at different distances and at different heights. It should also be understood that the BTT Thermoscan 560 can be used in any location, including an eyeglass store, to adjust the placement of sensors in the eyeglasses.

Strategic locations such as government buildings, military bases, courts, certain factories, etc. will also benefit from screening for temperature disturbances. As shown in fig. 50, guard 606 stands alongside infrared detector camera 608, which senses thermal radiation from the BTT area and preferably includes a card slot 610 in its housing 612. Although a guard 606 is shown, the BTT ThermoScan of the present invention may operate at an unprepared entrance. In this embodiment, BTT thermal imaging 560 serves as a key to automatically open a door 614. Accordingly, staff member 616 scans his Company Identification card (Company Identification card) at socket 610, and the instrument prompts the user to look at camera 608 to capture a thermal image of the BTT area. If the temperature of the BTT is within acceptable limits, the processor of the Thermoscan 608 may be changed to open the door 614. If the BTT temperature shows fever indicating possible infection, the staff member is instructed to find a caregiver. This greatly facilitates safety procedures in locations where food products are handled, where a staff member with contagious diseases may contaminate an entire batch of food products.

Fig. 51 is a schematic diagram of another embodiment of the present invention for monitoring body temperature disturbances during athletic activities such as athletic meet, military training, etc., showing an infrared heat detector 620 sensing thermal radiation 622 from an athlete 624. The thermal radiation detector 620 includes a detector head 626 containing an infrared sensor 628, a digital camera 630 and a set of lights, red 632, yellow 634 and green 636 indicating the thermal status of the athlete with the red 632 indicating a temperature that would reduce the safety or performance of the athlete, the red 632 flashing indicating a temperature above a safe level, the yellow 634 indicating a boundary temperature, the green 636 indicating a safe temperature level, the green 636 flashing indicating an optimal thermal status or performance enhancement. Infrared sensor 628 detects thermal radiation 622 and if red light 632 is activated, digital camera 626 will take a picture of the scene and determine the number of athletes at risk for heat stroke or thermal illness (heat illness). The infrared detector 620 further includes a processor 638 that processes signals, and a transmitter 640 that transmits signals by wire or wirelessly. It should be appreciated that a wider field of view may be used to obtain multiple BTT signals simultaneously, such as BTT radiation from the second athlete 642 being sensed by the infrared detector head 626.

Referring now to fig. 52A, the BTT ThermoScan of this embodiment preferably includes a miniature solid state infrared detector 650 mounted on a bezel 652 of a vehicle 654 to sense thermal radiation from the BTT of the driver 656, and ambient radiation is monitored by a processor 658 mounted in the vehicle dashboard to determine whether the driver 656 is in danger of a temperature disturbance (hyperthermia or hypothermia) that interferes with mental and physical functioning and can cause an accident. The temperature of the BTT location other than the driver 656 may be used for climate control and control of the seat temperature of the vehicle 654. The air conditioner is automatically activated when the image of the BTT site indicates a high body temperature.

Fig. 52B is a representation of the image produced by the detector 650, showing the BTT area 660 on the display 662. Fig. 48 is a representation of an exemplary image produced by the infrared imaging system of the present invention. Fig. 52B is a front view showing the face of a person and the BTT area 660 displayed on the display 662, as well as other areas present outside the BTT area of the face, such as the forehead 664, the nose 666, and the cheeks 668. Note that fig. 1B shows a realistic picture of the geometry of the general entry point of the BTT displayed on the screen, and fig. 4A shows a side view of the face and the BTT area displayed on the screen.

FIG. 53 illustrates an exemplary method of the present invention, represented by a flow chart. It should be understood that the method may be implemented using various signal processing and conditioning in various hardware, firmware, and software configurations, and therefore, the steps described herein are for illustration only and are not limiting upon the scope of the invention. A preferred embodiment includes detecting thermal radiation from a source that includes at least a portion of the BTT region (step 670). In step 672, an image is generated from a radiation source, the radiation source comprising at least a portion of the BTT region. In step 674, the image generated in step 672 is displayed. Step 676 determines a temperature level from the image displayed in step 674. Step 678 determines if the temperature identified in step 676 matches a temperature target. The temperature target is indicative of a temperature disturbance or a need to change the climate control level of the vehicle. In view of the temperature disturbance, if a temperature occurs and is detected at the BTT that matches the stored target temperature, an alarm is activated in step 680, prompting the subject for the temperature disturbance (e.g., fever, hyperthermia, and hypothermia), and processing continues in step 670. If there is no match, step 678 proceeds to the operation in the next step 670.

To enhance the image generated by the BTT ThermoScan, the method further includes aligning a field of view of the infrared detector with the BTT region and removing the eyewear during thermal inspection of the BTT region.

Fig. 54A is a perspective view of another preferred embodiment showing a person 100 wearing a support structure 680 comprised of patches, the sensors 680 being positioned on the skin at the ends of the tunnel, connected by leads 684 to a helmet 686 containing decoding and processing hardware 688, transmitter 702 and display unit 704. Exemplary helmets include those known in the art for training in sports, military, fire fighting, and the like. Alternatively, as shown in fig. 54B, the support structure includes eyewear 700 having warning lights 702, with sensors 710 of the eyewear 700 connected by wires 704 to a headgear such as helmet 706. The sensor 710 has an arm 708 with a spring means 709 for positioning and pressing the sensor 710 against the skin in the BTT area.

Referring now to fig. 55, a temperature sensor 710 is worn on a nose portion (nonsemiece) 712 of a mask 714, such as a fire mask. Leads 716 from mask 714 are arranged in an insulated manner, such as being positioned in the structure of mask 714 and in snorkel 718 which connects mask 714 to air bag 722. A wire 716 connects the sensor 710 to a radio transmitter 720 located in an air bag 722. Alternatively, the wire 716 is disposed outside of the vent tube 718. An alarm light 724 in the mask 714 alerts the firefighter of high or low temperatures.

Fig. 56A is a diagram showing a BTT entry point detection system responsive to an area of a body surface having a highest temperature, including a temperature sensor 730, an amplifier 732, a processor 734, and a pager 736. Processor 734 is modified to drive pager 736 to emit a high frequency tone at high temperatures and a low frequency tone at low temperatures. Scanning the BTT area with the sensor 730 allows for the precise location of the BTT's primary entry point, which corresponds to the highest frequency tone generated during the scan. Another preferred embodiment for detecting the primary entry point of a BTT includes replacing the beeper or pager that sounds or vibrates with a light warning system. Illustratively, FIG. 56B shows a pen 740, an LED 738 mounted on a faceplate (board)746, and an LED 739, a sensor 750, and a processor 742 mounted on the pen 740. A lead 744 connects the pen 740 to the faceplate 746. The processor 742 is modified to activate the lights 738, 739 to find the highest temperature during the scan of the BTT area. For example, as shown in fig. 56B, a pen 740 may be mounted on a faceplate 746 adjacent to a shelf (shelf)748 selling TempAlert thermometers 752 so that the consumer can precisely locate the primary entry point for the BTT. The sensor 750 of the pen 740 may be, for example, a non-contact sensor (e.g., a thermopile) or a contact sensor (e.g., a thermistor).

Detection of the primary entry point of the BTT may also be done automatically. Thus, fig. 57 shows a 4x 4 sensor array 760 placed on a BTT. The sensor array 760 contains 16 temperature sensors that measure the temperature at the BTT site. Each sensor T1-T16 in array 760 provides a temperature output value. The sensor array 760 is connected to a microprocessor 754 which is modified to identify the sensor in the sensor array 760 having the largest temperature output value, the highest temperature corresponding to the primary entry point of the channel. For example, the temperature sensor T6761 is determined to provide the maximum temperature output value, and then the temperature of the sensor T6 is displayed. The processor 754 continuously searches for a maximum temperature output value in the sensor array 760 in an automated manner, continuously displaying the maximum temperature.

Figure 58A is an alternative embodiment showing a support structure 758 comprised of a piece of silicone molded to conform to the BTT area, with leads 769 and sensors 770 contained therein. Fig. 58B shows a support structure 758 with a sensor 770 positioned on a BTT region 775, with leads 769 extending from the molded piece of silicone structure 758 to the forehead 773. Referring now to fig. 58C, the support structure 758 may alternatively include a multi-layer structure of Mylar surfaces 762, a sensor 770 with wires 769, and a cup-shaped silicone sheet 774 that encapsulates the sensor 770 so that the sensor 770 may be properly and stably positioned in the BTT area.

It is a further object of the present invention to provide a method and apparatus for treating and/or preventing temperature disturbances. As shown in fig. 2B, the brain is completely insulated in all sides except for the inlet of the BTT. BTTs are thermal energy channels in which thermal energy flows in both directions, and thus, heat can be removed from or presented to the brain by placing a device that presents or removes heat outside the body at the entrance to the BTT. Thus, fig. 59 shows a bi-directional flow of thermal energy represented by arrows 780 carrying heat to the brain and 782 removing heat from the brain, with a distribution of heat to and from the brain 784 occurring through a heat storage region 786, shown in fig. 2B in the center of the brain. Thermal energy from blood, which may be cold or hot, from thermal storage area 786 is distributed throughout brain tissue 784 through blood vessels 788 for treatment and/or prevention of hyperthermia (heatstroke) or hypothermia.

It is therefore another object of the present invention to provide a new and novel BTT thermal pad (thermal pad) for applying cold or heat to a BTT area to cool and heat the brain.

It is yet another object of the present invention to provide a new and novel BTT thermal pad for covering the entrance to the BTT area, which may extend to other areas of the face. However, since the brain is insulated on all sides except the BTT inlet, cooling is merely extracorporeal and fails to reach the brain, which is still at the "frying" temperature despite the cool feeling of the outside. In view of this, a preferred embodiment includes an extended BTT thermal pad that covers the face, where only the BTT area is exposed to cold, while the remainder of the extended BTT thermal pad that covers the face is insulated, preventing the gel or ice placed in the pocket from warming. The BTT thermal pad container includes a radiant heat reflective film overlying various portions thereof, and thermal insulation overlying the same or other portions, together to promote directional cooling. Thus, when the BTT is cooled, only the heat directed by the BTT is absorbed.

BTT thermal devices applied to BTT areas facilitate selective brain cooling or selective brain heating for treating hyperthermia and hypothermia, respectively. The brain is the most sensitive organ to heat-induced damage and can be protected by applying heat through the BTT during hypothermia or removing heat during hyperthermia. Cooling and heating are selective, since the temperature of other body parts does not have to be changed, which is particularly important when cooling the brain to treat patients suffering from stroke or any brain disease. The majority of the brain tissue is water, and the heat removal or application required to cool or heat the brain can be accurately calculated using well-known BTU (british thermal unit) based formulas. BTU is the amount of thermal energy required to raise 1 pound of water by 1 ° f, and 1BTU is released when 1 pound of water is lowered by 1 ° f.

BTT thermal pads for therapeutic treatment of excessive heating or excessive cooling in the brain preferably comprise a bag having a substantially comma-like, banana-like or boomerang shape in a fully covering relationship with the entire BTT inlet, the bag comprising an outer wall and an inner wall forming a closed chamber filled with ice cubes, gel-like material, solid material or the like for cooling or heating the BTT skin area covering the BTT inlet.

An exemplary brain cooling or heating device includes a hot and cold pad or bag modified to fit and match the specific geometry of the BTT inlet, including a preferably resilient and sealed pad having a gel therein comprised of a mixture of water, a cryoprotectant selected from the group consisting of propylene glycol, glycerin, and mixtures thereof in combination with other compounds such as sodium polyacrylate, benzoate salts of soda, hydroxide salts of benzoate (hydroxibenzoate), and mixtures thereof. Any other cooling or heating means comprising a combination of ammonium nitrate and water or a combination of chemical mixtures and gels is used as a coolant, as well as a combination of heating agents such as iron powder, water, activated carbon, vermiculite, salt and Purge natural mineral powder. Those compounds are available from a number of commercial suppliers (e.g., Becton-Dickson under the trade name ACE).

Fig. 60A shows a diagrammatic view of a preferred dual BTT thermal pad, also referred to herein as a BTT cold/hot pack 790, adjacent to the eyes 798, 802, including right and left dual pocket systems 792, 794, connected by a connector 796. Figure 60B shows in more detail a perspective view of a single-pouch BTT cold/hot pack device 810, represented by the device applied to the left, preferably comprising a generally comma-shaped, boomerang or banana-shaped pad sealed at its end 812 in a conventional manner to enclose a quantity of gel-like material 800 that substantially fills the pad 814 such that the pad 814 closely conforms to the specific topography of the BTT region in the crypt between the eye and nose. Fig. 60C is a reverse view showing extensions 816 that fit into the recesses of the BTT region of the pad 814 containing the gel 800. This device is referred to herein as a BTT cold/hot pad or BTT cold/hot pack. Referring also to fig. 60C, a perspective view of the BTT cold/hot pack device is shown as being machined into a pillow-like configuration so that the BTT cold/hot pack can be molded (molding) into the BTT area.

In use, the BTT thermal pad can be placed in a refrigerator or other cooling device for cold compress (coldcompress), or in hot water for hot compress. The BTT thermal pad preferably comprises a flexible, resilient plastic envelope (envelope). The material in the BTT thermal pad is preferably a gel that maintains its gel-like consistency over a large temperature range. There are many gels that can be cooled to freezing and absorb heat when warmed. There are a number of different types of such gels. Some of them frozen into a solid, and some were still soft at 0 ° f. Ice packs (Cold packs) such as frozen water-ethanol mixtures may also be used. Alternatively, BTT heat packs comprise a bag having an inner wall and an outer wall, internally lined with plastic, defining a chamber that is filled with ice through an opening in the bag. In this case, the bag is preferably sealed with a rubber material.

While an elastomeric material is described as the preferred material for containing the gel, it should be understood that any material or fabric may be used, including vinyl, cotton, rayon, thermoplastics, synthetic polymers, mixtures of these materials, and the like. The size and shape of the BTT pad structure is modified to conform to the particular anatomy of the depression between the eye and nose to match the particular geometry of the BTT inlet.

Any cooling or heating device known in the art may be used in the BTT pad treatment device, including hot or cold water flowing through a conduit modified to carry or present heat to the BTT zone. The conduit may be fitted in any headwear or eyeglass frame in which the extraction means is fitted, providing a continuous flow of water through the conduit. The BTT pad is connected to a conduit having a connector to a water temperature control and circulation unit of the headwear or eyeglasses. Hot and cold water is circulated through pipes that communicate to present or remove heat from the BTT.

Elastic straps (Elastic bands) or hook and loop fasteners are used to secure the BTT pad in place. Any of the support structures mentioned herein for securing the BTT pad in place includes a piece of glue. For example, BTT pads include clip-like devices, or BTT heat pads are secured to the frame of the eyeglasses. The nose pads of the eyeglasses or modified eyeglasses include cooling or heating means for transferring heat to or from the BTT. BTT thermal pads include a handle mounted on the pad that can be held by hand or placed by hand in the BTT area, for example, to be held by a competitor to lower the temperature of the brain during rest of a race, or to warm the brain of a skier during a winter race.

An alternative embodiment includes a BTT heat pad attached to the headwear that supplies moisture to cool the BTT area by evaporation. In this case, cold water is produced by evaporative cooling of the hood and forehead and the upper part of the wearer's head.

Any cooling or heating device is used to cool or heat the BTT zone, optionally the brain, preferably a moldable device that conforms to the anatomy of the BTT inlet zone, with directional temperature control characteristics to cool or heat the skin at the BTT inlet. Any of the devices for heating or superheating or for cooling, including those known in the art and those described by Abreu in U.S. patent nos. 6,120,460; 6,312,393 and 6,544,193 and other pending patents to Abreu, are modified for use in support structures for placement at the BTT inlet and for cooling or heating the brain, U.S. patent nos. 6,120,460; 6,312,393 and 6,544,193 are incorporated herein by reference in their entirety.

The present invention provides a moldable BTT heat pad or BTT heat pack in a packaging device (packaging arrangement) having different thermal conductivity and heat reflection characteristics to extend its effective cooling/heating time. The structure and material of the BTT heat pad or BTT heat pack allows shaping and holding it on the BTT site of the skin between the eyes and nose. The materials disclosed herein are capable of retaining their elastic plasticity at temperatures in the range of-10 ℃ to 140 ℃.

Referring to fig. 61, a front view of an alternative embodiment of a BTT heat pack 820 is shown, comprising a pack 822 having a gel 800, the pack having two portions, a first portion 824 positioned in a major portion of the BTT 824 containing a maximum amount of the gel 800, and a second portion 826 positioned in a peripheral portion of the BTT containing a lesser amount of the gel.

Fig. 62 shows a cross-sectional view of a BTT heat pack containing gel 800, the pack being closed at its ends 832, 834.

It should be understood that a ring shape around the eyes or other shape including the face/forehead may also be used, as long as portions of the BTT heat pack are constructed and juxtaposed onto the BTT area. The preferred shape and size match the particular geometry of the BTT region described herein.

Figure 63A shows a preferred embodiment of a BTT thermal pack 830 in a relaxed state comprising a hard upper portion 836, preferably made of hard rubber or plastic, attached to a pack 838 made of soft plastic, containing a gel 800, deformable under external pressure. As shown in fig. 63B, upon compression, BTT heat pack 830 has a centrally formed convex shape 842, indicated by arrows 844, at the opposite end of hard upper portion 836 to conform to the BTT anatomy between the eye 852 and nose 854 of person 100.

The BTT heat pack is preferably moldable, with the container or pack being constructed of a material that is deformable and pliable over the temperature range of use to conform to the anatomy of the BTT area. The central raised area in the bale allows for close interaction and thermal energy transfer with the BTT inlet, but it should also be recognized that the particular shape of the raised portion of the BTT cold/hot bale may itself vary somewhat according to ethnic groups.

Fig. 64A shows a side cross-sectional view of a head 856 of a person 100 with a BTT heat pack 850 in a pillow-like configuration located at a BTT site 858. BTT heat packs were constructed, held in close apposition to the BTT site. Fig. 64B is a front view of the BTT hot/cold pack 850 shown in fig. 64A, on a BTT site 858 adjacent to the left eye 862.

Fig. 65 shows a perspective view of a BTT heat pack 860, including a pack 864 containing a gel 800 and a wand 866 for holding the BTT pack 860 in place at the BTT site. Figure 66 shows a front view of a dual pouch BTT heat pack 870 having pouches 872, 874 connected to a wand 880 by flexible leads 876, 878.

Fig. 67A shows a BTT thermal mask 880 having an eye opening 844 and a nose opening 886, comprised of a pouch (pouch) containing gel 800, including pockets 888, 890 matching the anatomy of the BTT area. The remainder of mask 880 includes planar region 892. The planar region 892 is preferably thermally insulating, allowing for directed thermal energy flow such that the gel 800 contacts only the skin in the BTT region. Figure 67B is a cross-sectional side view of mask 880 showing pouch 894 with pockets 888, 890 and remaining planar area 892.

Fig. 67C is a perspective view of BTT thermal mask 898 having pouches 895, 896 that allow user 897 to be worn in close apposition to the BTT area.

Fig. 68A shows a perspective view of a BTT thermal pack 900 applied to the BTT area via a support structure consisting of eyewear 902 worn by a user 903. Fig. 68B is a front view of a BTT hot/cold pack 930 with dual pockets 932, 934, for right and left BTTs, connected by an arm 936, the arm 936 acting as a clip to secure the hot/cold pack to the BTT of a user 938.

A brain cooling or brain heating apparatus according to the principles of the present invention comprises a hot and cold pad or bag, modified to conform and match the specific geometry of the BTT inlet, consisting of a preferably soft and sealed pad and a gel in said pad, the skin contacting surface having a substantially convex shape. Thus, fig. 69A is a side view of a BTT heat pack 910 and an expansion lobe 906 that rests on the skin and conforms to the BTT anatomy. Figure 69B is a rear view of the BTT hot/cold pack 910 and expansion lobe 906 resting on the skin conforming to the BTT anatomy. Fig. 69C is a plan perspective view of BTT hot/cold pack 910 and substantially flat portion 912, with flat portion 912 facing outward and not contacting the skin. Figure 69D is a perspective view of a hot/cold pack 910 with gel 909 applied to the BTT area of a user 911.

Tubing adapted to match the specific geometry of the BTT site and the anatomy of the area with circulating water is used to selectively cool or heat the brain.

Depending on the chemical compound used, e.g. heating agent, the BTT heat pack may comprise a pouch to avoid direct contact with the skin, preventing any thermal damage to the skin.

It should be understood that the combined temperature sensor and BTT cold/hot pack may be implemented and placed in position using the support structures described herein, such as eyeglasses and any headgear. The nose pads of the glasses incorporate a heat flow sensor for determining how fast the heat is reduced. For example, a gradient across a sheet of Mylar indicates the direction of heat flow. It will also be appreciated that the right side of the nose pad of the glasses has a temperature sensor and the left side has a cooling/heating device, applying or removing heat in dependence on the temperature measured on the right side.

It should also be understood that many variations will be apparent to those skilled in the art, which are within the scope of the invention. For example, the sensor may be placed on the BTT site and then an adhesive tape placed over the sensor to secure the sensor in place on the BTT site. Thus, in this embodiment, the sensor need not have an adhesive surface, nor a support structure permanently attached to the sensor.

A number of hand-held devices with non-contact or contact sensors capable of measuring Brain temperature at BTTs, making single or continuous measurements, are referred to herein as Brain Thermometers (Brain Thermometers) or Brain temp devices. Thus, fig. 70 shows an array 1000 of infrared sensors 1002 interrogating BTT portal 1004, mounted in a cassette 1006 that contains a lens 1008 that focuses radiation 1010 on the sensor array 1000 in a manner such that the sensor array 1000 only probes the skin of BTT portal 1004, while a microprocessor 1012 is modified to select the maximum temperature value read by infrared sensors 1002 in array 1000, which is displayed on a display 1014. Exemplary infrared sensors of array 1000 include thermopiles, thermocouples, pyroelectric sensors, and the like. The processor 1012 processes the signals and displays the maximum temperature values measured by the sensors 1002 in the array 1000 in the display 1014. Fig. 71A shows another embodiment comprising a non-contact measurement system comprising, in addition to a lead 1015 connected to an external module 1017, a housing 1022 containing a single infrared sensor 1018 (e.g., a thermopile), a lens 1016 for focusing radiation 1010 of the BTT region 1004 onto the sensor 1018, an emitter 1019 and an ambient temperature sensor 1020 for adjusting temperature readings based on ambient temperature, and processing means 1012 for processing signals and displaying temperature values and a display means 1014, the external module comprising a processor 1013 modified to further process signals, such as processing spectroscopic, chemical and temperature measurements, said module 1017 further modified to display and transmit values calculated by the processor 1013, including wireless transmission and transmission over a distributed computer network (distributed computer network) such as the internet. As shown in FIG. 71B, an alternative pen-like system in accordance with the invention and FIG. 71A includes an expanded portion 1024 having a substantially convex shape at a distal end 1030 for contacting the skin 1026 and matching the concave anatomy of the skin 1026 of the BTT inlet 1028. The expanding convex tip 1024, which contacts the skin 1026, helps stretch the skin 1026 so that it has a higher emissivity of radiation under certain skin conditions, allowing the system to measure the temperature of the skin in the BTT area under optimal conditions on any type of skin.

An exemplary lens system for probing thermal radiation from a BTT includes an exemplary 25-lens for reading at a sensor tip 1 inch from the skin at the BTT entrance, and a 100-sensor array for reading radiation from a 3-inch distance between the BTT skin and the sensor tip. Preferably a 5 degree field of view, most preferably a 2-3 degree field of view, and even a 1 degree field of view is used to view the primary entry point of the BTT. The spot diameter (viewing area) of the infrared sensor is preferably between 1-20mm in diameter, most preferably between 3-15mm in diameter, so that when the sensor is aimed at the BTT inlet area, which corresponds to the bright spot of fig. 1A and the red-yellow area of fig. 1B, the infrared sensor receives radiation from the BTT inlet area. It should be understood that the infrared device (thermopile) is placed at any distance to read the temperature at the BTT inlet area, as long as the sensor is positioned in a manner to probe the BTT inlet area, with the lens focusing the radiation onto the temperature sensor.

The array is modified to capture the temperature of the BTT region. The acquired temperature signal is less than the entire face, not the temperature of the face, nor the temperature of the forehead. The temperature signal comes from the BTT, which is a particular area of a particular geometry surrounding the medial portion of the upper eyelid under the medial canthus and eyebrows. This temperature signal from the BTT can be obtained by contact sensors (e.g., thermistors), non-contact sensors (e.g., thermopiles), and infrared thermal imaging. This temperature signal can be input to a processor acting on the product to remove or transfer heat as described in fig. 73. The product is activated by a measured temperature level, which is measured at the BTT by any of a hand-held single measuring device, a continuous temperature measuring device and the device of the invention. Furthermore, the temperature level signal can activate another device, and activate a function of the device. The temperature level measured by the handheld device may be automatically transmitted to the receiver by wireless or wired transmission means.

Fig. 71C shows another embodiment comprising a non-contact measurement system comprising, in addition to an amplifier 1040 for processing signals and displaying temperature values, a processing device 1042, and a display device 1044, a box 1032 containing a single infrared sensor 1034 (e.g., a thermopile), a loading window 1039, and a cylindrical extension of the cavity 1038 for focusing radiation 1010 of the BTT region 1004 onto the sensor 1034, the sensor 1034 being located about 3cm outside the window 1039 of the cylindrical extension 1036. The cylindrical extension has a transverse dimension of less than 3mm, preferably less than 2.5mm, most preferably less than 2.0mm, and is optionally cylindrical, rectangular or square.

A retractable scale 1046 is fitted in the case 1032, the tip of which rests on the face for ensuring that the case is at the correct distance and orientation relative to the BTT for optimal exploration of the BTT area. It should be understood that any measuring and positioning device for optimal probing of the BTT by the sensor may be used and is within the scope of the present invention. It should be understood that any positioning means for establishing a fixed relationship between the sensor and the BTT is within the scope of the present invention.

FIG. 72 is a perspective view of another embodiment that is preferably used as a single measurement of skin by contacting the BTT with a contact temperature sensor. Thus, FIG. 72 shows a pen housing 1050 having a sensor 1052 (e.g., a thermistor) encased by a thermally insulated tip 1054 having a sufficiently convex outer shape to conform to the BTT area, and a wire 1055 connecting the sensor 1052 to a processor 1056 which is in electrical communication with an LCD display 1058, an LED 1060 and a piezoelectric device 1062. In use, the sensor 1052 contacts the skin of the BTT access area 1004, producing a voltage corresponding to the temperature, which is input to the processor 1056, then when the maximum temperature is obtained during the measurement period, the LED 1060 and device 1062 are activated, which is then displayed in the display. The sensor 1052 and wrap tip 1054 are covered with a disposable cap having a convex outer surface that conforms to the convex tip 1054.

The temperature signal from sensor 1052 is converted to an audio signal, emitted by piezoelectric device 1062, which is proportional to the measured temperature level. In addition, the processor 1056 in the cartridge 1050 is modified to block the maximum audio signal (representing the highest temperature) when the user scans the BTT region. Also, when the maximum temperature level is reached, the LED 1060 in the cartridge body 1050 is activated and the value is then displayed on the display 1058.

It should be understood that any product that transfers heat or removes heat from the body in a direct or indirect manner may be used in accordance with the principles of the present invention. Thus, fig. 73 shows other exemplary embodiments including sensing means in the form of a non-contact sensing means 1070, such as a thermopile carried in a hand held device, or a contact sensing means 1072, such as a thermistor carried in a patch, which measures the temperature of the BTT area, connected by wired or wireless transmission means as previously shown to a product, such as a mattress 1078 or collar 1080, said products 1078 and 1080 being capable of changing their own temperature or the temperature in the vicinity of the product. The exemplary embodiment includes a mattress 1078 modified by electrical means to change its temperature in accordance with signals received from temperature sensors 1070 and 1072, the temperature sensors 1070 and 1072 measuring the temperature of the BTT area and the product surrounding the neck, such as collar 1080. Products 1078 and 1080 have curved conduits 1074 and 1076, respectively, through which cold or hot water flows for removing heat from or delivering heat to the body by mattress 1078 or to the neck and head by collar 1080, the water system of mattress 1078 having valve 1082 and the water system of collar 1080 having valve 1083 controlled by processors 1084 and 1085, respectively. The processor 1084 of the mattress 1078 and the processor 1085 of the collar 1080 are modified to open or close the valves 1082 or 1083 depending on the temperature level of the BTT as measured by the sensors 1070 and 1072. Signals from temperature sensors 1070 and 1072 control valves 1082 and 1083, which open to allow cold water to fill the mattress when the signal from sensor 1070 or 1072 indicates a high body temperature (e.g., a temperature at or above 100.5 ° f). Similarly, when the signal from sensor 1070 or 1072 indicates hypothermia (e.g., a temperature below 96.8 ° f), the signal from the sensor 1070 and 1072 opens valves 1082 and 1083, allowing warm water to fill mattress 1078 and collar 1080. It should be understood that any garment, makeup, clothing, helmet, headwear, eyewear, hat, etc., may be used as a product in which heat is removed or transferred to achieve thermal comfort for the wearer, depending on the temperature of the BTT region. It should also be understood that any sensor, contact (e.g., thermistor) or non-contact (thermopile or thermal imaging sensing system), that measures the temperature of the BTT is used to control the product removal or transfer of heat to the body or body part (physical matter). It should also be understood that the product includes an infusion line capable of presenting hot or cold liquid into the patient's blood vessels depending on the skin temperature surrounding the medial canthus and eyelid corresponding to the BTT inlet. Other exemplary products include footwear, floors with heating or cooling systems, electrical absorbing materials (electrical drawing), in-line warmers, and the like.

In embodiments using a skin-contacting touch sensor, the head of the probe is covered with a disposable cap, such as a sheet of polymer, preferably having good thermal conductivity, the shape of which matches the shape of the various probes in accordance with the principles and disclosure of the present invention.

In addition to measuring, storing and transmitting biological parameters, various instruments of the invention such as patches, eyewear, rings, contact lenses, and the like include identification and history acquisition and storage means for storing user identification and history data, preferably using a programmable, erasable electronic module, wherein the data can be changed, added or deleted from the module. The identity and historical data are transmitted to the monitoring station, either alone or together with biological data (e.g. brain temperature and chemical measurements such as glucose levels and the presence of antibodies), preferably by wireless transmission. Thus, fig. 74 shows a schematic of the instruments and systems used by animals for biological monitoring, identity and historical data. It should be understood that the disclosed system is applicable to humans as well as animals.

FIG. 74 is a schematic diagram of a preferred embodiment for a quadruped creature, showing an exemplary integrated system comprising: an eye-ring (eye ring) emitting device 1501, said eye-ring (eye loop) or eye-ring (eye ring)1501 preferably comprising an antenna 1500, a sensor 1502, a microprocessor, transmission and memory module 1504 and a power source 1503, said ring being placed in the eye, preferably at the eye periphery of an eye-bag (eye pocket) 1516; a collar 1520, said collar 1520 preferably containing a power supply 1506, a microprocessor, transmission and memory module 1508 and a GPS transmission system 1510, in communication with an orbiting satellite 1514 via radio waves 1512, the module 1508 in bi-directional communication with the module 1504 of the ring 1501 via radio waves 1522 to power the ring 1501 and collect data from the ring 1501, said module 1508 in communication with an external radio receiving station 1509 and receiving antenna 1513 via radio waves 1511; an externally placed receiver 1518 and antenna 1519 that receives signals from module 1504 of loop 1501; and an external antenna 1524 positioned, for example, in a feeding room (feed lots) connected to computer 1526, said antenna 1524 being in communication with modules 1504 of loop 1501 in two-way communication.

Each eye loop 1501 has a unique serial number and is permanently or temporarily implanted in a remote animal. In each transmission, a 24 hour temperature record is sent, most preferably 6-12 times per day. The unique one-factor statistical broadcast network architecture allows all herds to share one frequency and one set of data receivers. The receiver is designed to receive remote temperature sensing data from the network of remote sensing units of the animal's eye and transmit it to the collection computer for storage, display and monitoring.

While various communication and power systems are shown in fig. 74, it should be understood that the system may operate with only one instrument, such as the ring 1501 sending signals to the receiver 1518 and antenna 1519 for further processing and display, or preferably the ring 1501 transmitting data to the module 1508 of the collar 1520, the module 1508 acting as an enhanced radio transmitter transmitting signals to the antenna 1513 and remote station 1509 for processing, monitoring and displaying the data.

It should be understood that instead of an active system having a battery as a power source, a passive system may be used, where the loop 1501 is powered by an external power source, such as electromagnetic induction provided by the collar 1520 or antenna 1524. It should also be understood that a hybrid system comprising a power source consisting of a battery 1503 and a passive system of a module 1504 containing an antenna for receiving electromagnetic energy from module 1508 of collar 1520 may be used. In this embodiment, the active portion of the system utilizes memory in module 1504 powered by battery 1503, collects data from sensor 1502 (e.g., a thermistor), and stores the data in a memory chip of module 1504. The passive system containing the antenna in module 1504 may also be activated when a quadruped creature is placed, for example, in a breeding room via a connecting antenna 1524. When the passive system 1504 in the loop 1501 is connected to an external antenna 1524 in the farm, the data stored in the memory chip of the module 1504 of the loop 1501 is received by the external antenna 1524 and transmitted to a second memory chip 1523, the chip 1523 being part of the module external antenna 1524. The processor of module 1504 in ring 1501 is modified to transfer stored data when connected to an external antenna 1524. Various previously mentioned inductive coupling schemes are used to power and collect data from the eye ring 1501 via the antennas 1523 and 1509.

Data from a large number of animals (e.g., cattle) is transmitted to a receiving system. It is preferred that only one animal transmit data at a particular time (corresponding to only one animal being in the system) to avoid data collisions that interfere with each other, which interference prevents successful wireless transmission of the biological parameters. Two exemplary schemes may be employed, polling (polling) and broadcasting (broadcasting). The alternate detection method requires each animal to be equipped with a receiver that receives the individual serial number required for the data from the central location and activates the animal's transmitter to send a data log. Another method is a broadcast system, where each animal broadcasts its data log independently. The problem is to avoid collisions, i.e. more than one animal is transmitting data for a certain period of time, which prevents successful transmission of data. The transmitter of each animal preferably transmits data for a particular period of time, while the receiver is modified to receive signals from each animal for a certain period of time.

The loop 1501 may also include solar cells arranged to capture sunlight, a digital transmission 16 bit ID # for authenticating animals and tracking animals for life. The preferred size of the outer diameter of the ring 1501 for livestock is between 40mm and 45mm, preferably between 35mm and 40mm, and most preferably between 30mm and 35mm or less than 30 mm. For large animals, such as elephants, for testing ovulation and pregnancy for artificial insemination, the outer diameter is preferably between 90mm and 100mm, preferably between 75mm and 90mm, most preferably between 50mm and 75mm or less than 50 mm. The preferred maximum size of the loop for the animal, including the circuit board and battery, is between 15mm and 20mm, preferably between 10mm and 15mm, most preferably less than 10mm, for large animals 10-15mm is added to obtain the optimum size. The preferred height of the loop 1501 for livestock is between 9mm and 12mm, preferably between 6mm and 9mm, most preferably less than 5mm, for large animals 5mm is added to achieve the optimum size. The preferred embodiment includes hardware assembled in one quarter of a ring containing the sensor, located in the lower pouch.

When a preset temperature limit is reached, an alarm is activated. The system of the invention can be used with real-time transmission of temperature to detect the moment of fever in the animal, which begins with the animal's body temperature beginning to rise. The method includes detection of fever and then inseminating the animal preferably between 6 and 12 hours after the onset of detection of fever, most preferably between 4 and 8 hours after detection of fever.

Preferably, temperature data stored by the module 1504 or 1508 for a duration (e.g., 24 hours) is downloaded into a computer system, such as the computer 1526 modified to determine a thermal signature (Thermalsignature). The caloric signature represents a continuously occurring temperature change, reflecting a particular biological state. Exemplary thermal mass signatures are depicted in FIGS. 75A-75E. FIG. 75A is a representation of a viral infection in which the temperature rises relatively rapidly, in this example, high temperatures corresponding to poxvirus infections such as foot and mouth disease are present. On the other hand, as shown in FIG. 75B, a slow temperature rise over 6-8 hours represents a kind of heat indication of a rise in body temperature due to hot climate. Fig. 75C shows a rapid rise in temperature, with a peak, followed by sustained high temperatures, reflecting bacterial infection. Fig. 75D shows a caloric signature reflecting mastitis with two peaks, an initial temperature rise followed by a greater rise after the first instance (epsode). Fig. 75E shows caloric indicia indicating animal calories (arrow 1544) with gradually increasing baseline temperatures. About 8-12 hours after the onset of fever, the temperature rises further, indicating the ovulatory phase (arrow 1546), after which the temperature rises constantly. It will be appreciated that for humans and animals, a digital library of caloric identifiers is stored and used to determine the type of biological condition present from signals received from the ring or any other sensor that measures the temperature of the BTT. The thermal indicia required by the temperature measurement system is matched to the processing system and stored in the memory of the computer and associated software for matching and identifying the thermal indicia. It should be understood that the thermal identification system of the present invention includes any temperature measurement system for an animal or human in which a temperature disturbance, low temperature or high temperature is present.

A number of antenna reception schemes are employed. Fig. 76A shows an exemplary antenna configuration 1538, which includes 8 antennas numbered 1-8 in a pen (pen) that can be used to cover a herd of 1000- & 2000 animals. At a particular time T1, animal 1530 transmits data that is captured by the nearest antenna, such as antenna 1532. For animal use and for conserving power, the data is stored for 24 hours and downloaded when the animal passes one of the antennas at time T1. The transmission loop continuously transmits data when heat is generated or a biological parameter changes. In addition, the ring only transmits data once per day. The antenna arrangement is also used for positioning of animals. The fence and antenna configuration is drawn on the computer screen and depicted on the screen, and by identifying the antenna receiving the signal, the highlighted location in the computer screen can be used to locate the animal. In fig. 76A, antennas 1534 and 1532 receive signals, and since antenna 1536 is far from the animal, no signal is received. Thus, animal 1530 is located in an area covered by antennas 1532 and 1534. Fig. 76B shows fine positioning with a radio receiver orientation probe, where a radio receiver 1540 is carried by the farmer or positioned near the area covered by antennas 1532 and 1534, which contains a warm animal 1530 and healthy animals 1542a, 1542B, 1542 c. Since animal 1530 is the only one that continuously transmits signals, radio receiver 1540 is able to accurately determine diseased animal 1530 in a healthy animal. The ID of animal 1530 is transmitted along with the biological data for further identification of animal 1530. Alternatively, the farmer uses an electromagnetic hand-held external power switch in proximity to the animal to activate the circuit in eye 1501 to manually initiate data transmission to the receiver for further processing. With the present invention it is also possible to locate any missing animals, an animal running out of the pen can be determined as not emitting a signal in the pen.

Although multiple antenna configurations are shown in fig. 76A, a preferred embodiment includes an antenna 1513 or an alternative antenna 1519, and a weatherproof metal encased receiver unit, such as receiver 1509 or an alternative receiver 1518, with a radio receiving module, a computer interface, and a power supply.

When using erasable or programmable numbers, the eye 1501 is used again, writing and recording a new serial number to the eye or eye 1501.

Although a loop in the eye pouch is shown, it should be understood that other methods and devices include temperature signals from the BTT of a bovine animal, with the BTT outside the eye, within the anterior horn of the eye (the animal's canthus is located in the foremost part of the eye), which are captured by contact or non-contact temperature sensors and thermal imaging systems.

The signal from the eye loop 1501 preferably automatically activates the other device. Illustratively, an automatic water spray system is modified to be activated by a radio signal from eye 1501, which sprays cold water when eye 1501 transmits a high body temperature signal, cooling the animal.

Various diseases can be monitored and detected by the apparatus of the present invention. By way of illustration, characteristic increases in brain temperature can detect foot and mouth disease, babesiosis, botulism, rabies, praelukast, and any other disorder characterized by a change in temperature, as well as disorders detected by chemical and physical evaluation, such as detection of prions infecting the eyelid or eyeball surface of an animal with antibodies against prions, producing an identifiable marker such as fluorescence or producing a mechanical or electrical signal upon antigen-antibody interaction. Prions cause bovine spongiform encephalopathy, also known as "mad cow disease," and are present in the eye and can be detected by immobilized antibodies against such prions contained in the eye loop or by products of such prions. For detecting mastitis (or a febrile animal) that is scheduled for milking, the present invention provides a method of preventing contamination of other animals being milked by generating a milking sequence in which the febrile animal is milked last. This will prevent the diseased animal from contaminating the device which is then used by other healthy animals.

The present invention provides continuous monitoring of animals 24 hours a day from birth to slaughter, and in addition to identifying and locating diseased animals, automatically analyzes and detects any disease that may pose a threat to human health or animal health. Therefore, with the present invention, the sick animals do not appear on the consumer's table. Thus, the present invention includes a method for improving food safety and increasing the value of the meat being ingested. A continuous disease monitoring system called DM24/7 (disease monitoring 24/7) involves monitoring biological variables from birth to slaughter, 7 days per week for 24 hours, inputting the information into a computer system, and recording the information. Any Meat from an animal Monitored with DM24/7 is stamped with a stamp called "Monitored Meat" (Monitored Meat). The stamp means that the animal is monitored for the presence of infectious disease for life. Any user purchasing "monitor meat" may log onto the internet and, upon entering the meat's number (ID), the number may be found on the purchased meat packaging. The user has access to thermal life (thermal life) and biological monitoring of the animal from which the meat is derived, and whether the animal is hot or diseased. The method and apparatus include a video stream associated with the ID of the animal, which video or picture displays information about the farm from which the animal originated or the meat packaging plant in which the animal was processed, thereby providing a complete set of information about the animal and the environment in which the animal was raised. In addition to viewing on the internet, the system also provides point of sale information in private locations such as homes. Thus, whenever a user purchases a product, the bar code of which is scanned, for example, a video or picture about the farm or the company packaging the meat appears on the screen at the point of sale. This method may also be used when purchasing any other product, preferably so that the consumer can use leisure time to visit a store to become more familiar with the product being purchased.

Preferably, one end of the ring has a temperature sensor covered with a thermally insulating material (e.g., with an imide ester) while the surface of the other end is exposed. The preferred measurement method employs an anatomically outer portion of the measurement surface facing the pouch and an inner portion of the insulation facing the pouch.

The eye ring contains a memory device for permanent or temporary storage of a unique identification number for identifying the animal being monitored. This ID code in the processor of the ring is transmitted as an individual number to the receiver for identification and tracking purposes only, or is related to a temperature value or other biological variable value. The memory chip in the loop also contains the life history and historical data of the animal, including body weight, vaccine immunity, birth date, birth place, sex, disease history, genetic constitution, etc.

The BTT area has an entrance in the range of about 30 square centimeters with a major entrance point of about 25 square centimeters generally including the medial corner of the eye and the eyelid area adjacent to the eyelid margin. The correlation coefficient between the temperature of the BTT region and the core temperature reflecting the brain thermal state was 0.9. Instead of using the entire face, methods for infrared or thermal imaging sensing and contact sensors involve explicitly deriving temperature signals from the BTT region, and then locating the hottest point of the BTT region, which is used as a source signal to activate another device or perform an action.

It should be understood that an infrared thermal imaging camera may also be used, with a processor in the camera selecting the point source that emits the greatest radiation from the BTT inlet, and the temperature level with the greatest thermal energy corresponding to the point source being displayed in the display. An exemplary infrared camera includes a BTT Thermoscan of the present invention.

The BTT Thermoscan of the present invention is modified to probe the BTT entrance around the medial canthus and the field of view of the sensor matching the BTT area entrance by means of the lens is shown in fig. 1A and 1B and fig. 3A-9. An exemplary operational flow for measuring the temperature of a BTT with a thermal imaging system includes, in a first step, probing a BTT portal with a radiation detector in a camera, after which a processor is modified to search for a point source in a thermal image of the BTT having maximum thermal radiation. In a later step, the temperature of the point source with the greatest amount of radiation in BTT thermal imaging is calculated, which is preferably displayed. In a subsequent step, the calculated temperature value is transmitted by wired or wireless means to a product which will remove heat from or transfer heat to the body in a direct or indirect manner. In a later step, the temperature of the product is adjusted based on the received signal. Exemplary products that transfer or remove heat from the body in an indirect manner include air conditioning/heating systems of vehicles. Exemplary products that transfer or remove heat from the body in a direct manner include vehicle seats. The measurement system according to the invention is modified to find the hottest area around the inner canthus and eyelid. Once the hottest point around the medial corner of the eye and the eyelid is found, the second step involves finding the hottest point in the area determined in the first step, which means finding the hottest point of the BTT entry as shown in fig. 1A and 1B.

According now to another preferred embodiment of the invention shown in fig. 77A-77C, the instrument comprising a patch for biological monitoring according to the invention comprises two parts: the durable portion, which contains the sensors, electronics and power source, and the disposable portion, which is free of any hardware, are releasably attached together, preferably by hook and loop fastener material (available under the trade name VELCRO). Thus, fig. 77A is a schematic diagram showing a patch consisting of two parts interconnected by hook and loop means, referred to herein as VELCRO, the VELCRO 1591 comprising a disposable sheet 1730 and a durable sheet 1596, the durable sheet 1596 carrying and electrically connecting the sensor 1590, power supply 1594 and emitter and processor module 1592, the VELCRO surface 1598 of the durable sheet 1596 being detachably connected to the VELCRO surface of the disposable sheet 1730, the outer surface of the disposable sheet 1730 being covered with a liner 1732 which, when peeled away, exposes the adhesive surface which is applied to the skin. In use, the two portions 1730 and 1596 are attached and held in place by hook and loop material, the liner 1732 is peeled away, the adhesive covering the outer surface of the disposable 1730 is exposed, the adhesive surface is applied to the skin, the VELCRO Patch 1591 is secured to the skin, the sensor 1590 is stopped adjacent to the inlet of the BTT, and a signal indicative of the brain temperature is generated. While VELCRO hook and loop fasteners are described as the preferred attachment between the disposable portion and the durable portion, it should be understood that any other attachment means may be used to attach the disposable sheet to the durable sheet, such as by glue, pins, etc., or any other conventional fastening means.

Fig. 77B shows two parts of a VELCRO Patch, comprising a disposable part 1600 containing only VELCRO material and a module 1592 containing sensors 1590, a power supply 1594, including a transmitter, a processor, a piezoelectric Patch, a buzzer and a speaker, a transmitter and processor module 1592, and LEDs 1602 electrically connected to the VELCRO surface of a durable Patch 1596 by wires contained in the VELCRO material, the durable Patch 1596 being detachably connected to the VELCRO surface 1601 of the disposable Patch 1600, the outer surface of the disposable Patch 1600 covered with a liner 1604 being located on the opposite side of the annular surface 1601 of the disposable Patch 1600, which adhesive surface is exposed for application to the skin when the liner is peeled off. Since the hardware carried on the durable portion 1596 is relatively expensive, the durable portion 1596 with the hardware can be reused, whereas the disposable portion 1600, which comprises only a VELCRO ring, can be manufactured relatively inexpensively, and since the portion is a skin-contacting portion, the portion 1600 is removed after contact with the skin or when contaminated with body fluids. It will be appreciated that the durable portion may include a resilient plastic case containing hardware, and a disposable portion composed of double-sided adhesive tape. It is within the scope of the invention to include a support structure, such as a two-part patch, where the disposable part is in contact with the skin and the durable part carries the hardware and the circuit is not in contact with the skin. It is also within the scope of the invention to include a support structure comprised of hook and loop material such as VELCRO comprising two parts, a disposable part and a durable part, wherein the disposable part is in contact with the skin and the durable part comprises a sheet in addition to the VELCRO material, which is durable and not in contact with the skin. By way of illustration and not limitation, the durable portion of VELCRO may comprise a spring loaded rod plate such as that used in airway expanders (Breathe Right for humans and Flair for animals), while the disposable portion comprises a release liner and an adhesive surface that contacts the skin of a human or animal. Another example includes a durable portion carrying a container with a liquid or chemical substance to be applied to the skin, and a disposable portion in contact with the skin via an adhesive surface or a mechanical fastener such as an elastic strip. Yet another example includes a watch attached to VELCRO material as a durable portion containing a sensing portion, e.g., for measuring glucose, and a disposable portion. Preferably, the VELCRO portion contains hooks as a durable portion, the sheet is loaded in addition to the VELCRO material, and the VELCRO portion containing hooks as a disposable portion, which is preferably in contact with a body part such as the skin.

When applied to the skin, VELCRO Patch is a Patch having a durable portion and a disposable portion connected by hook and loop material, with no hardware visible on the surface of the durable portion except for a reporting device such as an LED to alert the user when the biological parameter is out of range. Thus, fig. 77C shows a perspective view of the VELCRO Patch of fig. 77B, the VELCRO Patch 1724 being applied to the skin surrounding the eye 1726, the outer surface of the durable portion 1722 containing the LEDs 1720, the LEDs 1720 being activated by a processor and drive module (not shown) loaded in the durable portion 1722 of the VELCRO Patch 1724.

The VELCRO Patch of the present invention may also include a coupling structure for coupling a lens to the VELCRO Patch, referred to herein as VELCRO Eyewear. Thus, FIG. 78 is a schematic illustration of a VELCROEeyewear 1710 comprised of a durable portion 1712 carrying a sensor 1700, a power supply 1706 and an emitter-processing module 1704 in addition to a channel modified to receive a lens 1702, the lens 1702 being able to slide into the channel 1708 and be secured therein. The trench structure of the present invention allows any type of lens to be used and replaced as desired. However, it should be understood that the lens 1702 may be permanently attached to the VELCRO durable portion 1712. It will also be appreciated that the VELCRO material may be prepared in a manner that conforms to the facial anatomy and that the various fixation devices previously described for attachment of the lens may be used. VELCROEyewear also has a bracket (temple) attached to its side for further securing it to the face of the user. It should also be understood that any sensor may be used, including temperature, pressure, piezoelectric sensors for detecting the pulse of a blood vessel, glucose sensors, and the like.

Fig. 79A is a perspective view showing another exemplary embodiment of a support structure 1740 comprising a bowl-like structure having an outer surface 1742 sufficiently raised to conform to the anatomy of a BTT portal, the support structure 1740 carrying a sensor 1744 and electrical connections. Figure 79B shows another embodiment of a support structure 1748 with an outer surface 1750 that is sufficiently raised to conform to the anatomy of a BTT, the structure 1748 also being sufficiently elongated to match the BTT portal geometry, and also carrying a sensor 1752 and an electrical connection 1754.

Fig. 80 is a cross-sectional view of the bowl shown in fig. 79A, including a bowl-shaped support 1756 having a convex outer surface 1757 and a sensor 1758 protruding from the surface of the bowl-shaped support 1756 that is closely juxtaposed with the skin 1759 of the BTT and the terminal blood vessel 1755 of the BTT.

Figure 81A is a top perspective view of another preferred embodiment of a support structure comprised of a boomerang or banana shaped patch 1760 containing a thin insulating polyurethane layer 1766 carrying a support structure 1762 with a sensor 1764 carried therein, the sensor 1762 having a different height than the layer 1764, which causes the sensor 1764 to protrude at a higher elevation than the layer 1766. The surface of layer 1766 contains a pressure sensitive acrylic adhesive for securing the patch to the skin. Figure 81B is a side perspective view of the boomerang patch 1760 of figure 81A showing different heights between the structure 1762 carrying the sensor 1764 and the wire 1765 and the adhesive polyurethane layer 1766. The preferred height difference between the structures 1766 and 1762 is 5mm, preferably between 3mm and 4mm, and most preferably between 1mm and 3 mm. Figure 81C is a schematic view of a patch 1760 with a release liner on the sensor area 1768, the release liner 1773 being comprised of two pieces, an upper piece 1769 and a lower piece 1771. Fig. 81C shows the upper plate 1769 peeled away, exposing the adhesive surface 1770. The release liner 1773 comprises a single portion or a multi-portion liner having a single slit or a plurality of slits. Suitable release liners for use with the adhesive layer are known in the art. According to this embodiment, when applying the patch 1760 to a BTT area, the sensor liner 1768 may be removed first, and the patch 1760 then positioned with the sensor area juxtaposed to the BTT inlet. Once the correct final placement of the patch 1760 is determined, the lower liner 1771 is removed and the patch 1760 is applied to the nasal area, and then the upper liner 1769 is removed and applied to the skin over the margin of the eyelids. Figure 81D is a perspective view showing a patch 1760 being applied to the skin of a user 1770 with external indicia on the patch 1760 indicating sensor locations 1768 and a line 1772 aligned with the medial corner of the eye. It will be appreciated that the present invention includes an arrangement of sensors in a support structure, wherein the sensors are located at a different height than a larger base support structure containing the patch.

Fig. 82 is a top view of the eyewear showing an exemplary electrical arrangement of the support structure consisting of the improved nose pad and the frame of the eyewear 1880 including an electromagnetic switch 1774 on the left lens edge 1776 and a magnetic bar 1778 on the left leg 1882 for electrically activating the system when electrically contacted, a transmitter and power module 1884 on the nose bridge 1886 electrically connected to the switch 1774 by wires 1888 in the lens edge 1776, and an antenna 1890 in the left lens edge 1892 connected to the module 1884. When the legging uses the eyewear, an electrical connection is made between the switch 1774 and the magnetic bar 1778, automatically activating the system. It should be appreciated that various spring mechanisms may be integrated into the shaft (craft) to secure the sensor to better juxtapose the sensor to the BTT area.

The present invention provides methods for optimizing fluid intake to achieve ideal hydration (euhydration) and avoid dehydration and over hydration. The present invention provides continuous non-invasive core temperature monitoring, when the temperature reaches a certain preset level, such as a temperature rise reflecting an increase in heat stored in the body, and then lowering the body temperature by ingesting a fluid: brain temperature reflects the state of hydration, while dehydration leads to elevated core (brain) temperatures. The method according to the invention comprises a method of operation for dehydration situations, sedentary persons exposed to inflammatory heat (as illustrated by high mortality in heat waves), persons in physical activity. The present invention shows that when body temperature reaches 100.4 ° f, ingesting 4 ounces of water per hour will lower body temperature to 98.6 ° f and will maintain body temperature at temperatures below 99.5 ° f, thereby preventing the risk of a hot stroke. In the case of athletes engaged in athletic activities such as pedaling, the present invention shows that ingestion of a carbohydrate and mineral containing liquid (e.g., the trade name PowerAde by Coca-Cola company) maintains optimal functioning when BTT temperatures reach 99.3F, with ingestion of 6-8 ounces and functioning every 1-2 hours. In accordance with the principles of the present invention, various algorithms may be established for situations where the athlete is in danger of overheating. Athletes who are reminded of the need to ingest liquid during a competition use a particular size of container containing liquid or water.

Methods and algorithms can be established to relate temperature (hypothermia) to nutritional status (malnutrition) in the elderly and in those with anorexia nervosa, the temperature level being indicative of malnutrition and also of what food to ingest to maintain sufficient temperature. It should also be understood that foods can also be developed based on body temperature to achieve optimal nutritional value-fresh and frozen or processed foods. It will also be appreciated that temperature changes indicative of ovulation can be used as a means of producing fertility enhancing food by determining which food product enhances ovulation.

The invention also provides methods and devices for assessing diets, such as caloric restriction, where temperature is indicative of metabolism, such that lower baseline temperatures are indicative of decreased metabolism and metabolic waste production, including monitoring carbohydrate intake and metabolism. The invention also provides a method for monitoring hypoglycemia in a diabetic patient, wherein a decrease in temperature is a sign of hypoglycemia. The invention also provides methods for detecting pulmonary gas infarctions and cardiac events associated with specific temperature increases. Any symptom associated with a temperature change can be predicted and detected by the method of the present invention, ranging from a pregnancy abnormality associated with a drop in body temperature to hyperthermia of a head injury.

The present invention provides various other advantages. Other exemplary advantages include: 1. monitoring multiple sclerosis, since an increase in brain temperature can lead to worsening of symptoms, when the method of the invention determines that such an increase in temperature, corresponding measurements can be taken, e.g. drinking cold liquid at the appropriate time or cooling the brain as described previously, 2. a significant difference between BTTs on the left and right sides is indicative of pathological central nervous system symptoms, 3. detection of an increase in brain temperature enhances the diagnosis of meningitis or encephalitis, thereby avoiding excessive lumbar puncture (lumbar tap) in non-infected persons, and 4. young infants cannot regulate body temperature in the same way as adults, and are prone to becoming overheated. Sudden Infant Death Syndrome (SIDS) is most common in overheated infants. By monitoring the body temperature of the infant, the infant body temperature monitoring system can remind parents of the infant body temperature rising condition.

The receiver that receives the signal from the sensing system of the present invention may be external or implantable. When implanted in the body, the receiver may be powered by external magnetic induction or by externally recharging the battery. The receiver receives signals from a temperature sensor, a glucose sensor, etc., and forwards the signals for further display.

Any transmitter of the present invention may be integrated with bluetooth, GRPS data transmission, etc. The signal from the transmitter is then captured by any bluetooth enabled device, such as a mobile phone, electronic organizer (electronic organizer), computer, etc. The software of the mobile phone is modified to receive the encoded signal from the transmitter. The algorithm in the receiver will map the signal and display the value. The mobile phone has an automatic dialing to call the doctor, for example when the indication is hot. It will be appreciated that signals from a mobile telephone or signals directly from a transmitter of the support structure are transmitted to a computer connected to the internet for transmission in a distributed computer network.

The prior art uses facial skin temperature as a detection means to monitor body temperature. As shown in fig. 1A and 1B, the temperature of the facial skin varies significantly among different regions and does not represent the core temperature. Furthermore, the temperature of the facial skin does not present thermal energy in a stable manner. Any device or method that uses facial skin temperature to activate another device or monitor body temperature does not provide an accurate or precise response. In addition, the facial skin temperature does not reflect the thermal state of the body, and the correlation between the core temperature and the brain temperature is poor. The only body surface that communicates directly and undisturbed with the interior of the body is a specialized region of a particular geometry located at the entrance of the BTT. Any temperature sensing device placed at or near the BTT inlet can measure the core temperature in an accurate and correct manner. It should be understood that any sensor including a colorimetric adhesive label, such as a liquid crystal colorimetric thermometer, placed on the skin in the BTT area may be used and is within the scope of the present invention.

Referring now to the previously described climate automatic control system, exemplary embodiments will be described in more detail. While the preferred embodiment will be described for use in a cabin of a transport vehicle (e.g., a cart), it should be understood that the method, apparatus and system may be applied in any defined context, such as a home, a workplace, a hotel, etc., where the temperature in a defined environment is adjusted according to the temperature of the BTT such that the subject in the defined environment feels thermal comfort.

The temperature measurement of BTT is indicative of the thermal comfort of the body. Studies of the present invention have shown that as body temperature increases or decreases, the thermal comfort of the body decreases as the brain temperature, reflected as BTT, changes. Thermal comfort in humans is reflected by BTT skin temperature, with higher BTT skin temperatures producing hot body sensations and lower BTT skin temperatures producing cold body sensations. In order to obtain thermal comfort for the cabin owner, the system of the invention controls the thermal comfort of the cabin based on the temperature signal generated by the BTT. The present invention preferably employs specific specialized regions of the face, rather than the entire face, to control the temperature of the cabin and the thermal comfort of the cabin. The system of the present invention preferably monitors the temperature over less than the entire face, with optimal control over the heating and cooling of the cabin for thermal comfort to the cabin owner.

Since thermal comfort is reflected in the brain temperature, cabin climate is adjusted according to the BTT temperature, providing a comfortable environment for the cabin owner. The BTT temperature is set to control HVAC (heater-air conditioner) and other parts of the vehicle previously described, such as seats, carpet, etc., which are adjusted to maintain the occupant's heat sensation in a comfortable state. In particular, items in contact with or adjacent to the body are used to automatically remove or apply heat to the owner's body based on the BTT signal. To further improve the thermal comfort, the system comprises a temperature sensor in the cabin for detecting the cabin temperature. Thus, fig. 83 shows an exemplary climate automatic control system comprising a temperature sensing device 1894 (e.g., eyewear) for contact measurement of BTT and a temperature sensing device 1895 (e.g., infrared detector) for non-contact measurement of BTT for monitoring the temperature of BTT, the control device 1896 being adapted to automatically adjust the items 1898 in the cabin 1900 to remove or present heat based on a signal generated by the BTT sensing device 1894, to detect the temperature of the cabin 1900 with the cabin temperature sensor 1902, the items 1898 in the cabin being adapted to remove heat when the signal from the BTT sensor 1894 indicates a high temperature and to present a temperature when the BTT sensor 1894 indicates a low temperature. Although for illustrative purposes, the vehicle's seat is used as the item that removes/presents heat, it should be understood that other items such as HVAC, carpet, steering wheel, and other previously mentioned items may also be used. Whenever the vehicle is started, the cabin sensor 1902 detects a cabin temperature and conditions the item 1898 to remove or present heat based on a temperature signal from the cabin sensor 1902. The cabin temperature is then or simultaneously measured by the sensor 1902 and the output of the BTT sensor 1894 is input to the control device 1896, which activates the article 1898 to remove or present heat in response to a signal from the BTT sensor 1894. If the BTT sensor 1894 indicates a high temperature (>98.8 ° f), then the item 1898 will remove heat, and if the BTT sensor 1894 detects a low temperature (<97.5 ° f), then the item 1898 will present heat for thermal comfort of the cabin. An exemplary embodiment for cooling includes a control means 1896 connected to the air conditioning control system for controlling the amount of cold air generated and blown in proportion to the temperature level output by the BTT sensor 1894. For exemplary heating, a control device 1896 is connected to the control system 1906, and the heat delivery is gradually adjusted by the electric vehicle seat 1898 according to the output level of the BTT sensor 1894. When the BTT temperature is in the range of 97.5 ° f to 98.8 ° f, control 1896 is modified to remain neutral, without adjusting article 1898. Since each person's thermal comfort is different, the system is modified to remove or present heat according to the owner's individual needs, according to a particular temperature threshold, rather than having to follow a default setting of 97.5F to 98.8F. It should be appreciated that combinations of skin sensors placed in other parts of the body may be used with BTT sensor 1894. It will also be appreciated that the rate of change of skin temperature is taken into account and input into the microprocessor which is modified to adjust the article to large changes in skin temperature at the BTT site, for example sudden body reductions above 0.6 ℃, resulting in a corresponding reduction in the level of cold generated or even shutting down the air conditioning system. It is also understood that BTT sensing devices include contact devices (e.g., patches and eyewear of the present invention), non-contact devices (e.g., infrared devices of the present invention, thermal imaging (e.g., BTT thermosecan of the present invention), and the like.

Yet another embodiment according to the present invention includes a support structure comprising a sensor for measuring a biological parameter, attached to a nasal strip (strip) to dilate a human airway, such as breath right (commercially available under the trade name breath right), for dilating an animal airway (commercially available under the trade name Flair). Exemplary airway dilator nasal strips are described in U.S. Pat. nos. 5,533,503 and 5,913,873. The present invention incorporates airway expanders into patches for biological monitoring. The present invention may be an integral part of the airway dilator. The airway dilator is an expanding part of the present invention. Attaching a patch for measuring biological parameters and an airway dilator is convenient and beneficial since they are useful in the same activity. Nasal dilator is beneficial during sleep, physical activity or when catching a cold or respiratory infection, monitoring changes in body temperature during sleep, physical activity and monitoring fever during respiratory infection, using the patch of the present invention. The nasal passage dilator and patch of the present invention, which use adhesive on their backing to secure to the skin, are both secured to the skin of the nasal bridge, with the BTT patch above the nasal bridge and the airway dilator preferably below the nasal bridge. The nasal Dilator extension of the patch of the present invention is referred to herein as a biomeitor Dilator (BMD). Thus, fig. 84 is a front view of a preferred embodiment of a person 100 wearing a BMD 1908 comprising a patch 109 connected by a connecting arm 1907 to an airway dilator nasal strip 1909, the BMD being placed over a nose 1911, the patch 109 containing an indicator wire 111 and an active sensor 102 containing the skin of the end of a channel positioned over the upper portion of the nose 1911 and the airway dilator nasal strip 1909 positioned over the skin of the lower portion of the nose 1911 of the user 100. The embodiment of BMD 1908 shown in fig. 84 provides that the emitting means 104, the processing means 106, the AD converter 107 and the sensing means 102, connected to the power supply 108 by the elastic circuit 110, are loaded in a patch 109. Although a connecting arm is shown, it should be understood that the BMD may be prepared as a single piece with the upper portion carrying the sensors and circuitry and the lower portion located in the nose including spring-loaded strips that function as nasal airway dilators. Methods of simultaneously monitoring biological parameters while dilating a nasal airway are disclosed.

Another embodiment includes a plurality of kits shown in FIGS. 85A-85C. Thus, FIG. 85A is a perspective view of a kit 1910, with an adhesive tape 1912 and an activity sensor 1914 attached 1916. The activity sensor 1914 is not attached to the support structure and, in use, is preferably placed in contact with the adhesive tape 1912 to secure the sensor 1914 to the skin via the adhesive surface of the adhesive tape 1912. Another embodiment shown in fig. 85B includes a kit 1918 that includes a support structure 1920, such as a patch, clip, eyewear (e.g., glasses, sunglasses, goggles, and goggles), etc., and a receiver 1922, such as a watch, but also a mobile phone, electronic organizer, etc., that may be used as a receiver, forming a portion of the kit. The reagent cartridge 1918 also has a magnet 1923 loaded in its structure as described previously as a switch. It should be understood that the reagent cartridge 1918 may include only a patch with the magnet 1923 adjacent to the patch 1922. The watch 1922 preferably has a sloped surface for better viewing during athletic activities such as pedaling, and the view of the watch 1926 is angled toward the rider's face so that the user can see the temperature level displayed on the watch 1926 as long as looking toward, without turning the head. Another embodiment shown in fig. 85C includes a kit 1932 containing a specialized BMD patch 1928 and a receiver 1930, exemplified as a watch.

Another embodiment includes footwear having a temperature sensor for detecting cold and a radio transmitter for transmitting a signal to a receiver (e.g., a watch). The signal from the footwear in combination with the signal from TempAlert of BTT provides a combination of preventive means against frostbite and hypothermia.

It will be appreciated that a support structure such as a patch may be loaded with steam, and when the outer surface of the patch is scratched, the steam containing menthol is released to smooth the surface and alleviate nasal blockage, which is convenient when the patch is used to monitor heat generation.

It should also be understood that steel or copper may be placed on top of the sensor to improve thermal conductivity, as well as any other conventional means to increase heat transfer to the sensor.

It should be understood that any electrochemical sensor, pyroelectric sensor, acoustic sensor, piezoelectric sensor, optical sensor, etc. may be secured to the support structure for measuring a biological parameter in accordance with the principles of the present invention. It will be appreciated that sensors employing amperometric, potentiometric, conductometric, impedance and fluorometric systems and the like may be used in the instrument of the invention for measuring biological parameters. It should also be understood that other forms of biosensing may be employed, such as changes in ionic conductivity, enthalpy and mass, and immunobiological interactions. It should also be understood that new materials and thermally conductive liquid crystal polymers that react according to temperature can be used in the present invention, placed on the BTT site.

The foregoing description should be considered as merely illustrative of the principles of the present invention. Since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims (8)

1. A climate control apparatus, comprising: including as a sensor a probe comprising: a radiant energy probe for placement on the skin of the brain passageway and shaped to receive infrared radiant energy from the skin at the brain passageway, the brain channel is located on the skin at the medial canthal region adjacent the medial canthus, above the medial canthal ligament and within the medial side 1/3 of the upper eyelid, wherein the probe comprises a column that receives the infrared radiant energy through a 5 degree, 2-3 degree, or 1 degree field of view, the column having a maximum transverse dimension of less than 3.0mm, or wherein the probe comprises a lens for collimating radiant energy received from the brain channels to a field of view of 5 degrees, 2-3 degrees or 1 degree, wherein the brain temperature channel is located at the terminal end of the BTT region on the skin measured from the medial canthus at the medial canthal ligament at about 11mm in diameter, and extended upward about 6mm and then over 22mm in angular protrusion over the upper eyelid area; and control means for controlling the climate in dependence of the skin temperature measured at the brain channels.

2. A climate control instrument comprising a detector as a sensor, wherein the sensor comprises at least one of an infrared sensor and a thermal imaging system.

3. A climate control instrument comprising a detector as a sensor, wherein the sensor comprises at least one of an optical fiber, a fluorescence sensor, a pyroelectric sensor and a heat flux sensor.

4. A climate control apparatus comprising a control device, wherein the control device controls at least one of a cabin, a confined area and a residence of a transport vehicle.

5. A climate control apparatus comprising control means, wherein the control means comprises processing means for conditioning an article to provide thermal comfort to a mammal.

6. A climate control apparatus comprising a control device, wherein the control device controls at least one of a heater, an air conditioner, a seat of a vehicle, a carpet, a steering wheel, a window, a floor, furniture, clothing, footwear, a blanket, an infusion circuit, and a medical device.

7. A radiation detector, comprising: a thermal imaging system shaped to receive infrared radiant energy from the skin at a brain passageway on the skin adjacent to the medial canthus area located within the medial canthal ligament and medial side 1/3 of the upper eyelid; and a sensor for converting the infrared radiant energy to an electrical signal, the sensor having a field of view of 5 degrees, 2-3 degrees, or 1 degree, wherein the thermal brain channel is located at the terminal end of the BTT region on the skin measured from the medial canthus at the medial canthus ligament approximately 11mm in diameter and extends upward approximately 6mm and then angularly protrudes above the upper eyelid region for a further 22 mm.

8. A thermal imaging system, wherein the thermal imaging system comprises an infrared camera, a processor and a display, the camera scanning a BTT region present in the medial corner of the eye of a human face and providing an output signal to the processor.