WO2025162797A1

WO2025162797A1 - Sensor device for determining at least one physiological property of a subject and method for determining at least one physiological property

Info

Publication number: WO2025162797A1
Application number: PCT/EP2025/051578
Authority: WO
Inventors: Thomas KUENSTING
Original assignee: Roche Diabetes Care GmbH
Current assignee: Roche Diabetes Care GmbH
Priority date: 2024-02-02
Filing date: 2025-01-22
Publication date: 2025-08-07
Anticipated expiration: 2026-08-02

Abstract

A sensor device (110) for determining at least one physiological property of a subject (112), such as at least one analyte in a bodily fluid (114) of the subject (112) and/or at least one information on a body condition of the subject (112), is disclosed. The sensor device (110) comprises a housing (124) comprising an external housing part (126) configured to be positioned outside the subject's body (128), an internal housing part (130) configured to be positioned at least partially within a rectal cavity (132) of the subject (112), and an intermediate part (134) configured for connecting the internal housing part (130) and the external housing part (126). The intermediate part (134) tapers from the external housing part (126) to the internal housing part (130). The sensor device (110) comprises at least one sensing element (118) configured for determining the physiological property, wherein the sensing element (118) is positioned at least partially within the internal housing part (130). The sensor device further comprises at least one power source (144) configured for operating the sensing element (118) and at least one wireless communication interface (150) configured for providing measurement data obtained by the sensing element (118) to at least one further device (152).

Description

Sensor device for determining at least one physiological property of a subject and method for determining at least one physiological property

Technical Field

The present invention relates to a sensor device for determining at least one physiological property of a subject and to a method for determining at least one physiological property of a subject. The physiological property may be at least one analyte in a bodily fluid of the subject and/or at least one information on a body condition of the subject. However, further applications may also be feasible.

Background art

Sensor devices and corresponding methods for continuous monitoring of physiological parameters may be performed for a wide range of purposes. Non-invasive means may generally be preferred by patients compared to invasive approaches, e.g. due to their ease of use.

For measuring body temperature placing a sensor in the rectal cavity is generally known, e.g. Esophageal/Rectal Temperature Probe 21090 A, Ml 837 A by Philips®.

Further, “Sensors Selection for Continuous Monitoring of Bowel State and Activity” by Aref Smiley et al., Conf Proc IEEE Eng Med Biol Soc. 2018 July; 2997-3000, doi: 10.1109/EMBC.2018.8512948, describes different methods and sensors to measure bowel state and activity in vivo. Furthermore, US11375959B2 discloses attaching measuring devices e.g. in the form of a patch to a subject at different sites such as the anal sphincter or the inferior rectal nerves to measure physiologic parameters, such as water load distribution, heat flux and cardiac state.

Furthermore, CN215424540U describes a multi-sensing fusion rectal analysis device including a detector body with a detection and sensing component such as a camera and pressure sensor, a connecting wire and an external controller.

WO 2017/070787 Al discloses a pressure-sensing device comprising an insertable member configured to be placed within an orifice selected from a vagina or anus of a user. At least one pressure sensor is disposed in the insertable member and in fluid communication with a partially compressible airflow channel to detect changes in air pressure due to pressures applied to the insertable member.

CN 205163071 U describes a wireless biofeedback monitor for pelvic floor training with an acceleration sensor, a data processing unit and a power module within a casing configured to be placed in a vagina or a rectum.

Problem to be solved

It is therefore desirable to provide a sensor device for determining at least one physiological property of a subject and a method for determining at least one physiological property of a subject, which at least partially avoid the shortcomings of known devices and methods of this kind. As an example, devices and respective methods shall be disclosed, which allow for a non-invasive and reliable continuous monitoring of at least one physiological property of a subject. The disclosed devices and methods may allow for a facilitated non-stationary monitoring of the at least one physiological property of the subject, specifically for a monitoring that allows for a mobility of the subject.

Summary

This problem is addressed by a sensor device for determining at least one physiological property of a subject and a method for determining the at least one physiological property of the subject with the features of the independent claims. Advantageous embodiments, which might be realized in an isolated fashion or in any arbitrary combinations, are listed in the dependent claims as well as throughout the specification. As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

In a first aspect of the present invention, a sensor device for determining at least one physiological property of a subject is disclosed. The physiological property of the subject may be at least one analyte in a bodily fluid of the subject and/or at least one information on a body condition of the subject. The sensor device comprises: a housing comprising an external housing part configured to be positioned outside the subject’s body, an internal housing part configured to be positioned at least partially within a rectal cavity of a the subject, and an intermediate part configured for connecting the internal housing part and the external housing part, wherein the intermediate part tapers from the external housing part to the internal housing part; at least one sensing element configured for determining the physiological property, wherein the sensing element is positioned at least partially within the internal housing part; at least one power source configured for operating the sensing element; and at least one wireless communication interface configured for providing measurement data obtained by the sensing element to at least one further device.

The term “sensor device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element or device configured for detecting at least one condition or for measuring at least one measurement variable. The sensor device is configured for determining the physiological property of the subject.

The term “subject” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a human being or an animal, independent from the fact that the human being or animal, respectively, may be in a healthy condition or may suffer from one or more diseases. The subject may be a patient and/or a user. As an example, the subject may be a human being or an animal suffering from at least one illness such as diabetes or the Parkinson’s disease. As an example, the subject may be a patient whose physiological property may be determined as part of a healthcare measure taken at a point of care or at the patient’s home environment. For example, the subject may be a user, e.g. a patient, intending to monitor an analyte value, such as a glucose value, in the user’s body tissue. For example, the subject may be a user, e.g. a patient, intending to monitor a kinetic status such as a muscle tone. However, in an embodiment, the user may be different from the subject. Additionally or alternatively, the invention may be applied to other types of users or patients.

The term “physiological property” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a bodily and/or physical quality, state or condition of the subject. The physiological property may be or comprise the presence, absence or concentration of at least one analyte in the bodily fluid of the subject, e.g. glucose, and/or the physiological property may be or comprise the at least one information on a body condition of the subject, such as the muscle tone of the subject, e.g. the muscle tone of the sphincter of the subject. Further physiological properties are feasible. Further examples of the at least one information on a body condition of the subject are given in more detail below.

The term “determining at least one physiological property” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a process of detecting and/or measuring the physiological property in a qualitative and/or quantitative manner. The process of determining the physiological property may comprise generating and/or acquiring at least one measurement signal according to the physiological property to be determined. In the case that the physiological property is an analyte in a bodily fluid of the subject, the presence, absence and/or concentration of the analyte in the bodily fluid may be deduced from the measurement signal. In the case that the physiological property is the muscle tone of the subject, the muscle tone may be deduced from the measurement signal. The sensor device may be configured for monitoring volatile and/ or non-volatile compounds present in the rectal cavity and/or determinable from the rectal cavity, e.g. for monitoring microbiome drifts by analyzing the chemical footprint or for monitoring blood glucose indirectly via volatile compounds, e.g. indole.

The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an arbitrary element, such as a chemical substance, component or compound that may be detected or measured in the bodily fluid of the subject. As an example, the at least one analyte may be a chemical compound which takes part in metabolism, such as one or more of glucose, cholesterol or triglycerides.

The term “bodily fluid” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a liquid or substance, such as a pulp or paste-like substance, produced by and/or present in the body of a human or animal. As an example, the bodily fluid may be or may comprise blood. The bodily fluid may be blood comprised by a blood vessel, such as a blood-bearing vein or artery, e.g. blood carried by the internal rectal venous plexus. As an example, the bodily fluid may comprise an intestinal content of the subject, such as feces or an intestinal content of other kind. For monitoring the microbiome and/or a microbiome drift the intestinal content of the subject may be monitored using the sensor device, wherein the sensing element may be at least partially located within the rectal cavity of the subject.

The term “information on a body condition of the subject” is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to at least one item of information characterizing, describing and/or relating to a state of the sub- j ecf s body. As an example, the information on a body condition of the subj ect may comprise at least one measured physical quality, property or parameter of the subject’s body. The information on a body condition of the subject may comprise at least one change in the measured physical quality, property or parameter of the subject’s body. The measured physical quality and/or the change of the measured physical quality may be measured within the subject’s body by the sensing element of the sensor device. As an example, the information on a body condition of the subject may comprise at least one of a force; a pressure; a temperature; a position, e.g. a location of the subject in space; gravity; a speed; an acceleration; and/or a measured change of at least one of the listed measurands.

As an example, the information on a body condition of the subject may comprise at least one muscle tone, e.g. the muscle tone of the sphincter of the subject. The muscle tone may be determined by measuring a pressure of the sphincter of the subject using the sensing element. The measured pressure may be generated by the sphincter on the sensing element. The sphincter may surround the internal housing part, when it is at least partially positioned in the rectal cavity of the subject.

The term “muscle tone” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a contraction state of a muscle and/or to a state of partial contraction of the muscle. The muscle tone may be a continuous and passive partial contraction of the muscle while the subject is in a resting state. The physiological property of the subject may be the muscle tone of the sphincter.

The sensor device may be configured for continuously monitoring the physiological property and/or for quasi-continuous monitoring of the physiological property. For example, the sensor device may be configured for continuous glucose monitoring. For example, the sensor device may be configured for continuous monitoring of a muscle tone. The sensor device may be configured for determining the physiological property in the rectal cavity of the subject. As an example, the sensing element, which may be encased by the housing, e.g. by the internal housing part, may be positioned at least partially within the rectal cavity of the subject. The sensing element is configured for determining the physiological property. As an example, for determining the physiological property, the sensing element may be configured for measuring at least one parameter measurable and/or accessible from the rectal cavity, e.g. in adjacent and/or neighboring structures such as the internal rectal venous plexus, the sphincter and/or the intestines.

The sensor device comprises at least one sensing element. The term “sensing element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an arbitrary element capable of generating at least one signal, such as a measurement signal, e.g. an electrical signal, which is a qualitative or quantitative indicator of the physiological property. The measurement signals generated by the sensing element may be or may be part of the measurement data provided by the sensing element to the further device. For example, the sensing element may comprise at least one spectrometer, e.g. a near infrared spectrometer. For example, the sensing element may comprise at least one pressure sensor.

For example, the determining of the physiological property may relate to determining at least one analyte in the bodily fluid of the subject, such as glucose. The sensing element may be configured for detecting quantitatively or qualitative the analyte in the bodily fluid, e.g. a glucose concentration. The sensing element may be configured for detecting quantitatively or qualitative the analyte in the internal rectal venous plexus. The sensing element may be configured for performing at least one optical detection method. The optical detection method may comprise spectroscopy, such as near infrared spectroscopy. The term “near infrared spectroscopy” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an arbitrary spectroscopic method using near infrared light. Near infrared light may refer to a partition of electromagnetic radiation having a wavelength in the range from 750 nm to 1000 pm. The sensing element may comprise at least one spectrometer, e.g. a near infrared spectrometer. Reference may be made to EP1311189A2, which relates to the field of near infrared spectrometry for predicting patient blood glucose levels. Further reference may be made to Molecular and Laser Spectroscopy, Advances and Applications, 2018, Pages 11-38, Chapter 2 - Near-IR Spectroscopy and Its Applications; doi.org/10.1016/B978-0-12-849883-5.00002-4. For example, the sensing element may be configured for optical detection of blood glucose. Using optical detection methods can allow determining the analyte without invasive means such that no breach of and/or no incision in the skin is created.

Additionally or alternatively, the physiological property determined by the sensor device may be at least one muscle tone of the subject. The sensing element may comprise at least one pressure sensor configured for determining a surrounding pressure. The surrounding pressure may correspond to a sphincter tension or may be influenced and/or affected by the sphincter tension, when the sensor device is positioned at least partially in the rectal cavity of the subject. As an example, the sensor device may be configured for determining the muscle tone of the subject by determining the muscle tone of the sphincter using the pressure sensor of the sensing element. The sensor device may be configured for monitoring of the kinetic status of people with Parkinson’s disease. Monitored parameters may be body movement patterns via a movement sensor and general tonus via surrounding pressure, e.g. sphincter tension. Results may be displayed to the patient, a caregiver or health care professional or may be transferred to an effector device like a deep brain stimulator.

The sensor device may be configured for additionally monitoring one or more of temperature; spatial movement; spatial position, e.g. vertical or horizontal position; vibrations, e.g. tremble; sound and/or noise; pulse, e.g. via pulse oximetry, e.g. via near infrared spectroscopy; electrical heart signals, e.g. via electrocardiogram, also referred to as ECG; pressure of the portal venous system; microbiome and/or microbiome drift. The sensing element may comprise one or more of at least one temperature sensor; at least one GPS sensor; at least one movement sensor; at least one microphone; at least one near infrared spectrometer; at least one electrode, e.g. at least one set of electrodes configured for measuring the ECG; at least one pressure sensor; at least one chemical sensor, e.g. for determining the microbiome and/or a microbiome shift. As an example, further techniques using measuring principles based on antibodies, aptameres, antisense DNA and antisense RNA may be used, e.g. for measuring the microbiome and/or microbiome drift. Due to the convenience of the approach and the rather large possible form factors, also additional and/or alternative monitored parameters may be implemented easily.

For example, the sensing element may comprise at least one thermometer for continuous temperature monitoring. The wireless communication interface may be configured for providing temperature data to a further device such as to a display device or a device of a medical personal, in particular without need for cables. This may be advantageous for use on intensive care units. The continuous monitoring can enable more reliable determination of basal body temperature and thus can provide a method of contraception with improved Pearl index or good prediction of fertile windows.

The term “housing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an arbitrary element encasing the sensing element. The housing may separate and/or delineating the sensing element from the environment surrounding the housing. The housing may comprise several parts, wherein the different parts may together form the housing in its entirety. The parts may be separate components. Additionally or alternatively, a single component may comprise two or more parts, at least partially. As an example, the parts of the housing may differ in their function and/or position.

The housing comprises an external housing part configured to be positioned outside the subject’s body. The term “external housing part” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a part or area of the housing configured to be positioned outside the subject’s body, e.g. outside the rectal cavity. The external housing part may be positioned completely outside the subject’s body or may be positioned at least partially inside the subject’s body, e.g. the rectal cavity. The external housing part may be a protruding part of the sensor device protruding outside the subject’s body. The external housing part may also be used for the convenient removal of the sensor device.

The housing comprises an internal housing part configured to be positioned at least partially within the rectal cavity of the subject. The term “internal housing part” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a part or area of the housing configured to be positioned inside the rectal cavity such as permanently or for a defined time. A circumference of the internal housing part may vary. As an example, starting from the intermediate part the circumference of the internal housing part may first increase and then decrease again towards a tip of the sensor device. A varying circumference of the internal housing part may contribute to keeping the sensor device in position, e.g. in conjunction with the sphincter. The sensor device further comprises an intermediate part configured for connecting the internal and the external housing part. The term “intermediate part” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a part or area of the housing between the external and the internal housing part. The intermediate part may be configured for connecting the external and the internal housing part. The intermediate part tapers from the external housing part to the internal housing part. For example, the intermediate part tapers from the external housing part to the internal housing part, wherein the internal housing part may comprise a diameter equal to or even smaller than the diameter of the intermediate part. For example, the diameter of the internal housing part is greater than the diameter of the intermediate part, such that the intermediate part tapers from the internal housing part to the external housing part. A circumference of the external housing part may exceed a circumference of the internal housing part. The intermediate part may be a tapered part separating the internal housing part and the external housing part, which may keep the sensor device in conjunction with the sphincter in position. Some region of the intermediate part may extend outside the subject’s body.

The sensor device may comprise at least one handle configured for supporting placement and removal within the rectal cavity of the subject. The term “handle” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an element designed especially to be grasped by the hand. The handle may form part of the housing, e.g. of the external housing part. As an example, the external housing part may serve as the handle, e.g. by being formed as a cone. Additionally or alternatively, the handle may be formed by at least one of: a grip, a knob or a loop. Other types of handles are feasible. For example, the handle may be an integral part of the housing. For example, the handle may be connected and/or connectable to the housing. The handle may be separable from the housing. As an example, the handle may facilitate placement of the internal housing part within the rectal cavity of the subject. The handle may remain connected to the sensor device during measurement or may subsequently to the positioning within the rectal cavity be removed from the sensor device leaving the sensor device within the rectal cavity.

The term “positioned at least partially within” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a situation where a first element is fully or partially located within a second element such that the second element may fully or partially surround and/or enclose the first element.

The term “power source” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an arbitrary element supplying the sensor device, with electrical energy. The power source may be rechargeable, e.g. by inductive charging. The power source may be an electrical energy reservoir such as at least one battery. The battery may be an arbitrary source of electric power comprising one or more electrochemical cells with external connections for powering an electrical device. When a battery supplies power, its positive terminal may be referred to as cathode and its negative terminal may be referred to as anode. The sensor device may comprise at least one connector element configured for establishing an electrical contact between the power source and electronic components of the sensor device. For example, the battery may specifically be a primary battery. The primary battery may be configured for being used once. The primary battery may also be referred to as single-use or disposable battery. For example, the battery may be a 3V or 1.5V battery. For example, the power source may be a standard battery. As the rectal cavity is rather large, the form factor of the sensor device may be chosen to allow the use of standard batteries (e.g. AAA). For example, the power source may be a rechargeable battery, such as a rechargeable battery configured for inductive charging. In case of a rechargeable battery, convenient inductive charging may be implemented by placing the sending part in a (soft) mat, cushion of special furniture. The sending part may be an induction coil with a very low frequency, such as 50-60 Hz. The use or induction coils with higher frequencies may also be feasible and may also be advantageous. Higher frequencies can also have advantages Another option for convenient wireless charging may be specialized bath furniture to fast charge when the device needs to be removed to allow for physiological use of the orifice. For example, wireless charging may be performed by means implemented invisibly in an office chair.

The term “wireless communication interface” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to an item or element forming a boundary configured for transferring information in a wireless fashion. The wireless communication interface may provide means for transferring measurement data obtained by the sensing element to at least one further device, e.g. for further evaluation. The communication interface may provide a data transfer connection, e.g. Bluetooth, NFC, inductive coupling or the like. As an example, the measurement data obtained by the sensing element may be transferred wirelessly, such as via Bluetooth. The wireless communication interface may be at least partially positioned within the external housing part. As an example, an antenna of the sensor device may be positioned within the external housing part. This may allow to improve the wireless communication.

The term “continuous monitoring” as used herein, is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to the process of determining the at least one physiological property at a plurality of time points within a predetermined period of time, e.g. in a time period in the range from 1 minute to 48 hours, e.g. in the range from 5 minutes to 24 hours, e.g. in the range form 15 minutes to 2 hours. Within the predetermined period of time the physiological property may be determined at a predetermined frequency, e.g. at a frequency in the range from 10 Hz to once per 8 hours, e.g. in the range from once per 2 minutes to once per 6 hours, e.g. in the range from once per 5 minutes to once per 2 hours.

The sensor device may comprise at least one processing unit and/or may be connectable, e.g. by the wireless communication interface, with the processing unit. The term “processing unit”, also denoted as “processing device” or “processor”, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary logic circuitry configured for performing basic operations of a computer or system, and/or, generally, to a device which is configured for performing calculations or logic operations. The processing unit may be configured for processing basic instructions that drive the computer or system. As an example, the processing device may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math co-processor or a numeric co-processor, a plurality of registers, specifically registers configured for supplying operands to the ALU and storing results of operations, and a memory, such as an LI and L2 cache memory. The processing unit may be a multicore processor. The processing unit may be or may comprise a central processing unit (CPU). Additionally or alternatively, the processing device may be or may comprise a microprocessor, thus specifically the processor’s elements may be contained in one single integrated circuitry (IC) chip. Additionally or alternatively, the processing device may be or may comprise one or more application-specific integrated circuits (ASICs) and/or one or more field- programmable gate arrays (FPGAs) and/or one or more tensor processing unit (TPU) and/or one or more chip, such as a dedicated machine learning optimized chip, or the like. The processing unit may be configured, such as by software programming, for performing one or more evaluation operations. The processing unit may be configured for performing the named step(s). Thus, as an example, the processing unit may comprise a software code stored thereon comprising a number of computer instructions. The processing unit may provide one or more hardware elements for performing one or more of the indicated operations and/or may provide one or more processors with software running thereon for performing one or more of steps. For example, the processing unit may be a processor of a mobile device such as of a smart phone, smart watch or tablet and the like. For example, the processing unit may be embodied at least partially cloud based, e.g. as a cloud-based infrastructure. The cloudbased infrastructure may provide a computing infrastructure which is separated from the sensor device but which may be configured for exchanging data between the cloud-based infrastructure and the sensor device via the at least one network. The cloud-based infrastructure may refer to a common infrastructure deployed in a cloud which serves as the foundation to build other applications or services on top of it.

The processing unit may be configured for evaluating the measurement data generated by the sensing element thereby determining measurement values and/or information on the physiological property. For example, the processing unit may be configured for determining concentration values from the measurement signals. The processing unit may be configured for comparing the measurement values to at least one predefined limit, e.g. a range.

The sensor device may comprises at least one user interface. The term "user interface" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a feature of the sensor device configured for interacting with its environment, such as for the purpose of unidirectionally or bidirectionally exchanging information. For example, the user interface of the sensor device may be configured to share information with the user, e.g. the subject whose physiological property is determined, and/or medical personal attending to the subject, such as in a point of care environment. For example, the sensor device may comprise at least one user interface configured for vibrational and/or acoustic signaling. For signaling the user, e.g. the subject and/or medical personal, a vibrational “alarm” may be implemented. For example, the user interface may comprise at least one loudspeaker and/or at least one acoustic signal device. The user interface may comprise at least one buzzer for acoustic signaling, e.g. in the external housing part of the sensor device. For example, the buzzer may be capable to produce several frequencies and/or frequency patterns. This may allow mimicking natural sounds for more discrete signaling. For example, the sensor device may be configured for playing the sound of a male or female voice clearing his/ her throat to indicate high or low blood glucose levels, respectively.

The user interface may be configured for giving a vibrational and/or acoustic signal when the determined physiological property exceeds and/or falls below at least one predetermined value. As an example, the at least one predetermined value may be a blood glucose concentration and the user interface may be configured for signaling the determined blood glucose concentration exceeding and/or falling below the at least one predetermined value e.g. by giving different acoustic and/or vibrational signals. As an example, the user interface may be configured for signaling hyperglycemia and/or hypoglycemia. For example, upon reaching low or high blood glucose levels, a warning may be communicated e.g. via long (hyperglycemia) or short (hypoglycemia) vibration.

For example, the further device to which the measurement data obtained by the sensing element are transferred by using the wireless communication interface may be or may comprise least one display device. The display device may be configured for displaying an analyte concentration by using at least one display device, e.g. of a mobile device. As an example, the determined glucose concentration may be transferred to the mobile device as the further device by using the wireless communication interface, where the determined glucose concentration is displayed on the display device.

For example, the further device to which the measurement data obtained by the sensing element are transferred by using the wireless communication interface may be or may comprise at least one effector device. The term “effector device” as used herein, is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term may refer, without limitation, to a device configured for initiating and/or triggering and/or performing an action depending on the obtained measurement data and/or evaluated measurement data. For example, the effector device may be an insulin pump. For example, the effector device may be a deep brain stimulator. For example, the effector device may be one or more of: an analgesic pump; a pump with muscle relaxant, e.g. Baclofen; a ventilator, e.g. a ventilator supplying a patient with a variable oxygen percentage; a vaporiser for anaesthetic gas.

In addition to unvoluntary reactions, voluntary activities may also be measured, e.g. as in the area of brain computer interfaces, such as mouse pointer and voice output. The sensing element is positioned at least partially within the internal housing part. The arteries feeding the internal rectal venous plexus may have a 120° symmetry. As an example, the sensing element may cover an angular section corresponding to a region comprising arteries feeding the internal rectal venous plexus. A surface of the sensing element may be reduced to cover less than 360°, e.g. (120+x)° or (240+x)°, where x is the minimum angular width for a sensing element. The sensing element may cover at least a third of the inner circumference of the internal housing part, e.g. such as an angular section in the range from (120+x)° or (240+x)°. The remaining angular section of the inner circumference of the internal housing part may be devoid of the sensing element, such as an angular section in the range from (120+x)° or (240+x)°. As an example, the sensing element may cover at least 25 percent of an inner circumference of the internal housing part. As an example, the sensing element may cover at least 50 percent of an inner circumference of the internal housing part. As an example, the sensing element may cover a continuous angular segment, e.g. an angular segment of at least 90° and/or an angular segment of at least 180°. Additionally or alternatively, the sensing element may cover at least two separate angular segments, e.g. at least two angular segments that are disconnected from one another by at least one angular segment that is not covered by the sensing element. As an example, the sensing element may cover two separate angular segments that are arranged in a symmetric manner such that the sensing device may have a two-count rotary axis. This may allow the sensor device to be robust against erroneous placements such as being placed in the rectal cavity in a twisted manner. As an example, the sensing device may cover the angular segment from half past one to half past past four and the angular segment from half past seven to half past ten.

In the case where the sensing element does not cover the entire inner circumference of the internal housing part, a stable positioning of the sensor device within the rectal cavity of the subject may ensure that the angular section covered by the sensing element corresponds to the symmetry and/or position of the internal rectal venous plexus.

As an example, the external housing part may be non-circular. For example, the external housing part of the sensor device may have an elongated shape, e.g. a long-oval shape. A rotation of the sensor device, and therefore of the sensing element, may be prevented by the elongated shape of the external housing part in conjunction with the surrounding anatomy, e.g. the leg anatomy. A correct angular position of the internal housing part and the sensing element can be ensured. For example, the external housing part may be non-circular (e.g. long-oval) to prevent rotation in conjunction with the surrounding (leg) anatomy, if rotation along the main axis is not desired, e.g. to ensure the angular positioning of the internal housing part, e.g. the internal housing part at least partially comprising the sensing element. The sensor device may comprise at least one adapter. To comply with customer needs for more decorative devices, an adapter, e.g. a nut, may be added to the external housing part, e.g. for connecting jewellery or other decorations like tails etc.. Alternatively, the adapter may be used to device accessories that may allow more user-friendly interaction, e.g. placement and removal.

In a further aspect of the present invention, a method for determining at least one physiological property of a subject, such as at least one analyte in a bodily fluid of the subject and/or at least one information on a body condition of the subject, is disclosed.

The method uses a sensor device as described above or as described in further detail below.

The method comprises the following steps, which may be performed in the given order. However, a different order may also be possible. The method may further comprise additional method steps, which are not listed. Further, one or more or even all of the method steps may be performed only once or repeatedly. The method steps may be performed in a manner, wherein two or more steps may fully or at least partially be overlapping in time.

The method comprising the steps of: i) inserting the sensor device into the rectal cavity of the subject; ii) determining the physiological property, by using the sensing element; and iii) providing the at least one measurement of the physiological property measured by the sensing element to the at least one further device by using the wireless communication interface.

Regarding details of the sensor device as well as regarding terms and definitions, reference may be made to the description of the sensor device as given above and/or as further given below.

The physiological property determined by the method may as an example be the at least one analyte in the bodily fluid of the subject, such as the presence, absence and/or concentration of the analyte in the bodily fluid. The analyte may be glucose. The method may further comprise displaying the glucose concentration by using at least one display device, e.g. of a mobile device. As an example, the determined glucose concentration may be transferred to the mobile device as the further device by using the wireless communication interface, where the determined glucose concentration is displayed on the display device. Additionally or alternatively, the physiological property determined the by the method may be the at least one information on a body condition of the subject. As an example, the physiological property determined the by the method may be at least one muscle tone of the subject.

The method may be a method for continuously monitoring the physiological property. As an example, the determining of the physiological property in step ii) may comprise continuously monitoring and/or continuously measuring the physiological property.

The sensor device and the method provide numerous advantages over sensor devices and methods as known in the art.

Generally, several monitoring methods like continuous glucose monitoring, also referred to as CGM, may currently depend on invasive technologies. Minimally invasive (e.g. contact lenses) and non-invasive approaches (e.g optical technologies) may have been proposed. So far, minimally or non-invasive approaches may have generally not been successful due to several limitations, amongst them skin properties as barriers to detection, movement, respectively the need to fix the device, and (in case of optical methods) ambient light.

Generally, the rectal cavity has been used for a long time for non-physiological purposes as it can be easily accessed, e.g. for measuring temperature and/or applying medication via suppositories. By placing the sensor device from aborally into the rectal cavity via the respective natural orifice, the sensors device may have a well-defined position, may be sheltered from many external influences like ambient light and the implemented sensor device may be able to access the internal rectal venous plexus, which is located in the submucous space. Apart from the direct accessibility, the venous plexus may be directly fed by blood form arteries; accordingly, the contained blood may reflect capillary blood more closely than interstitial fluid usually monitored by CGM devices and may be also better than venous or arterial blood alone.

Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

Embodiment 1 : A sensor device for determining at least one physiological property of a subject, such as at least one analyte in a bodily fluid of the subject and/or at least one information on a body condition of the subject, the sensor device comprising a housing comprising an external housing part configured to be positioned outside the subject’s body, an internal housing part configured to be positioned at least partially within a rectal cavity of the subject, and an intermediate part configured for connecting the internal housing part and the external housing part, wherein the intermediate part tapers from the external housing part to the internal housing part; at least one sensing element configured for determining the physiological property, wherein the sensing element is positioned at least partially within the internal housing part; at least one power source configured for operating the sensing element; and at least one wireless communication interface configured for providing measurement data obtained by the sensing element to at least one further device.

Embodiment 2: The sensor device according to the preceding embodiment, wherein the physiological property determined is at least one analyte in the bodily fluid of the subject, such as glucose.

Embodiment 3 : The sensor device according to any one of the preceding embodiments, wherein the physiological property determined is at least one muscle tone of the subject.

Embodiment 4: The sensor device according to any one of the preceding embodiments, wherein the physiological property is determined in a continuous monitoring.

Embodiment s: The sensor device according to any one of the preceding embodiments, wherein the wireless communication interface is at least partially positioned within the external housing part.

Embodiment 6: The sensor device according to any one of the preceding embodiments, wherein the sensor device comprises at least one user interface configured for vibrational and/or acoustic signaling.

Embodiment ?: The sensor device according to any one of the preceding embodiments, wherein the power source is rechargeable, wherein the power source is rechargeable by inductive charging. Embodiment 8: The sensor device according to any one of the preceding embodiments, wherein the sensor device comprises at least one handle configured for supporting placement and removal within the rectal cavity of the subject.

Embodiment 9: The sensor device according to any one of the preceding embodiments, wherein the sensing element covers at least an angular section corresponding to a region comprising arteries feeding the internal rectal venous plexus.

Embodiment 10: The sensor device according to any one of the preceding embodiments, wherein the sensing element covers an angular section of 360° or at least n angular sections of at least (360/(n+l))°.

Embodiment 11 : The sensor device according to any one of the preceding embodiments, wheren the sensing element covers at least 25 percent, e.g. at least 50 percent, of an inner circumference of the internal housing part.

Embodiment 12: The sensor device according to any one of the preceding embodiments, wherein the external housing part has an elongated shape.

Embodiment 13: The sensor device according to any one of the preceding embodiments, wherein the sensor device is configured for additionally monitoring one or more of temperature; movement; spatial position, e.g. vertical or horizontal position; vibrations, e.g. tremble; sound; pulse, e.g. via pulse oximetry, e.g. via near infrared spectroscopy; electrical heart signals, via electrocardiogram; pressure of the portal venous system; microbiome.

Embodiment 14: The sensor device according to any one of the preceding embodiments, wherein sensing element is configured for optical detection of blood glucose, wherein the optical detection comprises near infrared spectroscopy.

Embodiment 15 : The sensor device according to any one of the preceding emeobiments wherein the external housing part has an elongated shape in an plane perpendicular to a longitudinal axis housing, the longitudinal axis of the housing extending through the external housing part, the intermediate part and the internal housing part.

Embodiment 16: The sensor device according to any one of the preceding embodiments wherein the elongated shape is an oval shape. Embodiment 17: A method for determining at least one physiological property of a sub- ject, such as at least one analyte in a bodily fluid of the subject and/or at least one information on a body condition of the subject, using a sensor device according to any one of the preceding embodiments, wherein the method comprises the following steps: i) inserting the sensor device into the rectal cavity of the subject; ii) determining the physiological property, by using the sensing element; and iii) providing the at least one measurement of the physiological property measured by the sensing element to the at least one further device by using the wireless communication interface.

Embodiment 18: The method according to the preceding embodiment, wherein the physiological property determined is the at least one analyte in the bodily fluid of the subject, such as glucose.

Embodiment 19: The method according to the preceding embodiment, further comprising displaying the glucose concentration by using at least one display device, e.g. of a mobile device.

Embodiment 20: The method according to any one of the preceding embodiments, wherein the physiological property determined is the at least one muscle tone of the subject.

Embodiment 21 : The method according to any one of the preceding embodiments, wherein determining the physiological property in step ii) of the method comprises continuously monitoring the physiological property.

Short description of the Figures

Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

In the Figures: Figure 1 shows a side view of an embodiment of the sensor device;

Figure 2A, 2B and 2C shows an embodiment of the sensor device positioned in the rectal cavity of a subject (2 A) and two alternative schematic views of a cross-section of the sensor device (2B and 2C)

Figure 3 shows a further embodiment of the sensor device positioned in the rectal cavity of a subject

Figure 4 shows a flow chart of a method for determining at least one physiological property of a subject

Detailed description of the embodiments

Figure 1 shows a side view of a sensor device 110 for determining at least one physiological property of a subject 112, such as at least one analyte in a bodily fluid 114 of the subject 112 and/or at least one information on a body condition of the subject 112. The physiological property may be or may comprise the presence, absence or concentration of at least one analyte in the bodily fluid 114 of the subject 112, e.g. glucose, and/or the muscle tone of the subject 112, e.g. the muscle tone of the sphincter 116 of the subject 112. Further physiological properties are feasible.

As illustrated in Figure 1, sensor device 110 comprises at least one sensing element 118 configured for determining the physiological property. The sensing element 118 may be capable of generating at least one measurement signal, e.g. an electrical signal, which is a qualitative or quantitative indicator of the physiological property. Depending on the physiological property determined by the sensor device 110, the sensing element 118 may comprise at least one spectrometer 120 and/or at least one pressure sensor 122. An embodiment of the sensor device 110, wherein the physiological property determined is an analyte in the bodily fluid 114 of the subject 112, e.g. glucose, is illustrated in Figure 2A and is described in further detail below. An embodiment of the sensor device 110, wherein the physiological property determined is a muscle tone of the subject 112, is illustrated in Figure 3 and is described in further detail below.

As depicted in Figure 1, the sensor device 110 comprises a housing 124. The housing 124 comprises an external housing part 126 configured to be positioned outside the subject’s body 128, an internal housing part 130 configured to be positioned at least partially within a rectal cavity 132 of the subject 112, and an intermediate part 134 configured for connecting the internal housing part 130 and the external housing part 126. As shown in Figure 1, the intermediate part 134 tapers from the external housing part 126 to the internal housing part 130.

The external housing part 126 may be positioned completely outside the subject’s body 128 or it may be positioned at least partially inside the subject’s body 128, e.g. the rectal cavity 132. The external housing part 126 may be a protruding part of the sensor device 110 protruding outside the subject’s body 128. The external housing part 126 may also be used for the convenient removal of the sensor device 110. As an example, the sensor device 110 may comprise at least one handle 136 configured for supporting placement and removal within the rectal cavity 132 of the subject 112, which may form part of the housing 124. As an example, the external housing part 126 may serve as the handle 136, e.g. by being formed as a cone 138, as illustrated in Figure 1. Additionally or alternatively, the handle 136 may be formed by at least one of a grip, a knob or a loop (not shown in the Figures). Other types of handles 136 are feasible.

As illustrated in Figure 1, the intermediate part 134 may refer to a part or area of the housing 124 between the external housing part 126 and the internal housing part 130. The intermediate part 134 tapers from the external housing part 126 to the internal housing part 130. Thus, a circumference of the external housing part 126 may exceed a circumference of the internal housing part 130. Thus, the intermediate part 134 may be a tapered part separating the internal housing part 130 and the external housing part 126 Some region of the intermediate part 134 may extend outside the subject’s body 128 as shown in Figure 1. As an example, a diameter 140 of the external housing part 126 may exceed a diameter 142 of the internal housing part 130, which may keep the senor device 110 in conjunction with the sphincter 116 in position, e.g. by preventing that the sensor device 110 may slide into the rectal cavity 132. The diameters 140, 142 are indicated in Figure 1 by dotted double-sided arrows. Further, as apparent from Figure 1, the diameter 142 of the internal housing part 130 may vary. Thus, the diameter 142 of the internal housing part 130 may increase and then decrease again towards a tip of the sensor device 110. The varying diameter of the internal housing part 130 may keep the senor device 110 in conjunction with the sphincter 116 in position, e.g. by preventing that the sensor device 110 may slip out of the rectal cavity 132.

As depicted in Figure 1, the sensor device 110 further comprises at least one power source 144 configured for operating the sensing element 118. The power source may supply the sensor device 110 with electrical energy. The power source 144 may be rechargeable, e.g. by inductive charging. The power source 144 may be an electrical energy reservoir such as at least one battery 146 as indicated in Figure 1. The battery may specifically be a primary battery 146 configured for being used once. Additionally or alternatively, the power source 144 may be a rechargeable battery 146. The sensor device 110 may comprise at least one connector element 148 configured for establishing an electrical contact between the power source 144 and electronic components of the sensor device 110.

The sensor device 110 comprises at least one wireless communication interface 150 configured for providing measurement data obtained by the sensing element 118 to at least one further device 152. The wireless communication interface may provide means for transferring the measurement data to at least one further device 152, e.g. for further evaluation. The communication interface 150 may provide a data transfer connection, e.g. Bluetooth, NFC, inductive coupling or the like. As an example, the measurement data obtained by the sensing element 118 may be transferred wirelessly, such as via Bluetooth as indicated by the radiowaves 154 in Figure 1. The wireless communication interface 150 may be at least partially positioned within the external housing part 126, as also shown in Figure 1. As an example, an antenna of the sensor device 110 may be positioned within the external housing part 126. This may allow to improve the wireless communication.

As shown in Figure 1, the sensor device 110 may comprise at least one processing unit 155 and/or may be connectable, e.g. by the wireless communication interface 150, with the processingunit 155. The processing unit 155 may be configured for evaluating the measurement data generated by the sensing element 118 thereby determining measurement values and/or information on the physiological property. For example, the processing unit 155 may be configured for determining concentration values from the measurement signals. The processing unit 155 may be configured for comparing the measurement values to at least one predefined limit, e.g. a range.

The further device 152 to which the measurement data obtained by the sensing element 118 are transferred by using the wireless communication interface 150 may be or may comprise least one display device 156. For example, the physiological property determined by the sensor device 110 may be a glucose concentration in the bodily fluid of the subject 112. As an example, the determined glucose concentration may be transferred to a mobile device 158 as the further device 152 by using the wireless communication interface 150, where the determined glucose concentration is displayed on the display device 156. The sensor device 110 may comprises at least one user interface 160. The user interface 160 may be configured for interacting with the environment, such as for the purpose of unidirectionally or bidirectionally exchanging information. For example, the user interface of the sensor device 110 may be configured to share information with the user, e.g. the subject 112 whose physiological property is determined, and/or medical personal attending to the subject 112, such as in a point of care environment. The sensor device 110 may, for example, comprise at least one user interface 160 configured for vibrational and/or acoustic signaling. For signaling the user, e.g. the subject and/or medical personal, a vibrational “alarm” may be implemented. For example, the user interface 160 may comprise at least one loudspeaker and/or at least one acoustic signal device. As shown in Figure 1, the user interface 160 may comprise at least one buzzer 162 for acoustic signaling, e.g. in the external housing part 126 of the sensor device 110.

The further device 152 to which the measurement data obtained by the sensing element 118 are transferred by using the wireless communication interface 150 may be or may comprise or control at least one effector device (not shown in the Figures). The effector device may be configured for initiating and/or triggering and/or performing an action depending on the obtained measurement data and/or evaluated measurement data. As an example, the physiological property determined may be a glucose concentration in a bodily fluid 114 and the effector device may be an insulin pump. For example, the physiological property determined may be a muscle tone and the effector device may be a deep brain stimulator. For example the effector device may be one or more of: an analgesic pump; a pump with muscle relaxant, e.g. Baclofen; a ventilator, e.g. a ventilator supplying a patient with a variable oxygen percentage; a vaporiser for anaesthetic gas.

Figure 2 A shows an embodiment of the sensor device 110, wherein the physiological property determined is an analyte in the bodily fluid 114 of the subject 112, such as glucose. The sensing element 118 may be configured for detecting quantitatively or qualitative the analyte in the bodily fluid, e.g. a glucose concentration. As illustrated in Figure 2A, the sensing element 118 may be configured for the quantitative or qualitative detection of glucose in the internal rectal venous plexus 164. In this case, the bodily fluid comprising the analyte may be blood 166, e.g. the blood 166 carried by the blood vessels 168 of the internal rectal venous plexus 164. The sensing element 118 may be configured for performing at least one optical detection method. The optical detection method may comprise at least one spectroscopic method using near infrared light. Near infrared light may refer to a partition of electromagnetic radiation having a wavelength in the range from 750 nm to 1000 pm. Thus, the sensing element 118 may comprise at least one spectrometer 120, e.g. a near infrared spectrometer 170 as shown in Figure 2A. For example, the sensing element 118 may be configured for optical detection of blood glucose in the internal rectal venous plexus 164 using near infrared spectroscopy. Using optical detection methods can allow determining the analyte without invasive means such that no break in the skin is created.

The sensing element 118 is positioned at least partially within the internal housing part 130. The sensing element 118 may cover at least 50 percent of an inner circumference 172 of the internal housing part 130. The arteries 174 feeding the internal rectal venous plexus 164 may have a 120° symmetry. Such a symmetry is illustrated in a schematic fashion in Figures 2B and 2C. As an example, the sensing element 118 may cover an angular section 176 corresponding to a region comprising arteries feeding the internal rectal venous plexus 164. A surface of the sensing element 118 may be reduced to cover less than 360°, e.g. (120+x)° or (240+x)°, where x is the minimum angular width for a sensing element 118. The sensing element 118 may cover at least a third of the inner circumference 172 of the internal housing part 130, e.g. such as an angular section 176 in the range from (120+x)° or (240+x)°. The remaining angular section of the inner circumference 172 of the internal housing part 130 may be devoid of the sensing element 118, such as an angular section in the range from (120+x)° or (240+x)°. Figure 2B illustrates a sensing element 118 covering an angular section 176 of about 180°. Figure 2C illustrates a sensing element 118 covering an angular section 176 of about 90°. In the case, where the sensing element 118 does not cover the entire inner circumference 172 of the internal housing part 130, a stable positioning of the sensor device 110 within the rectal cavity 132 of the subject 112 may ensure that the angular section 176 covered by the sensing element 118 corresponds to the symmetry and/or position of the internal rectal venous plexus 164. A rotation of the sensor device 110 in the rectal cavity 132, and therefore of the sensing element 118, may be prevented by a non-circular shape of the external housing part 126 in conjunction with the surrounding anatomy, e.g. the leg anatomy. As an example, the external housing part 126 of the sensor device 110 may have an elongated shape 178, e.g. a long-oval shape, as shown in Figure 2C.

In a further embodiment shown in Figure 3, the physiological property determined by the sensor device 110 may be at least one muscle tone of the subject 112. The sensing element 118 may comprise at least one pressure sensor 122 configured for determining a surrounding pressure. The surrounding pressure may correspond to a sphincter tension or may be influenced and/or affected by the sphincter tension, when the sensor device 110 is positioned at least partially in the rectal cavity 132 of the subject 112 as illustrated in Figure 3. As an example, the sensor device 110 may be configured for determining the muscle tone of the subject 112 by determining the muscle tone of the sphincter 116 using the pressure sensor 122 of the sensing element 118. The sensor device 110 may be configured for monitoring of the kinetic status of people with Parkinson’s disease. Monitored parameters may be body movement patterns via a movement sensor 180 and general tonus via surrounding pressure, e.g. sphincter tension. Results may be displayed to the patient, a caregiver or health care professional or may be transferred to an effector device like a deep brain stimulator (not shown in the Figures).

The sensor device 110 may comprise more than one sensing element 118, e.g. two, three or even more than three sensing elements 118. As an example , the sensor device 110 may comprise at least one pressure sensor 122 as the sensing element 118 and at least one further sensing element 118, e.g. at least one chemical sensor. Further sensors are feasible.

The sensor device 110 may be configured for additionally monitoring one or more of temperature; spatial movement; spatial position, e.g. vertical or horizontal position; vibrations, e.g. tremble; sound and/or noise; pulse, e.g. via pulse oximetry, e.g. via near infrared spectroscopy; electrocardiogram, also referred to as ECG; pressure of the portal venous system; microbiome. The sensing element 118 may comprise one or more of: at least one temperature sensor; at least one GPS sensor at least one movement sensor; at least one microphone; at least one near infrared spectrometer; at least one electrode, e.g. at least one set of electrodes configured for measuring the ECG; at least one pressure sensor; at least one chemical sensor, (not shown in the Figures). Due to the convenience of the approach and the rather large possible form factors, also additional and/or alternative monitored parameters may be implemented easily.

The sensor device 110 may be configured for continuously monitoring the physiological property. For example, the sensor device 110 as illustrated in Figure 2 A may be configured for continuous glucose monitoring. For example, the sensor device 110 as illustrated in Figure 3 may be configured for continuous monitoring of a muscle tone. As an example, the sensor device 110 may be configured for determining the at least one physiological property at a plurality of time points within a predetermined period of time in the range from 5 min to 5 h. The sensor device 110 may be configured for determining the at least one physiological property at a predetermined frequency.

In a further aspect of the present invention, a method for determining at least one physiological property of a subject 112, such as at least one analyte in a bodily fluid 114 of the subject 112 and/or at least one information on a body condition of the subject 112, is disclosed. The method uses a sensor device 110 as described above. The method is illustrated in the flow chart 181 shown in Figure 4. The method comprises the following method steps, which may specifically be performed in the given order. However, a different order may also be possible. The method may further comprise additional method steps, which are not listed. Further, one or more or even all of the method steps may be performed only once or repeatedly. The method steps may be performed in a manner, wherein two or more steps may fully or at least partially be overlapping in time. As shown in Figure 4, the method comprises the steps of: i) inserting the sensor device 110 into the rectal cavity 132 of the subject 112; ii) determining the physiological property, by using the sensing element 118; and iii) providing the at least one measurement of the physiological property measured by the sensing element 118 to the at least one further device 152 by using the wireless communication interface 150.

In the flow chart 181 of Figure 4, method step i) is denoted by reference number 182, method step ii) is denoted by reference number 184 and method step iii) is denoted by reference number 186.

The physiological property determined by the method may be the at least one analyte in the bodily fluid 114 of the subject 112, such as the presence, absence and/or concentration of the analyte in the bodily fluid 114. The analyte may be glucose. The method may further comprise displaying the glucose concentration by using the at least one display device 156, e.g. of the mobile device 158. As an example, the determined glucose concentration may be transferred to the mobile device 158 as the further device 152 by using the wireless communication interface 150, where the determined glucose concentration is displayed on the display device 156.

Additionally or alternatively, the physiological property determined by the method may be the at least one information on a body condition of the subject 112. As an example, the at least one information on a body condition of the subject 112 may be or may comprise at least one muscle tone of the subject 112.

The method may be a method for continuously monitoring the physiological property. As an example, the determining of the physiological property in step ii) may comprise continuously measuring the physiological property. List of reference numbers sensor device subject bodily fluid sphincter sensing element spectrometer pressure sensor housing external housing part body of the subject internal housing part rectal cavity intermediate part handle cone diameter of the external housing part diameter of the internal housing part power source battery electrical connector wireless communication interface further device radiowaves processing unit display device mobile device user interface buzzer internal rectal venous plexus blood blood vessel near infrared spectrometer inner circumference arteries angular section elongated shape movement sensor flowchart

Claims

1. A sensor device (110) for determining at least one physiological property of a subj ect (112), such as at least one analyte in a bodily fluid (114) of the subject (112) and/or at least one information on a body condition of the subject (112), the sensor device (110) comprising a housing (124) comprising an external housing part (126) configured to be positioned outside the subject’s body (128), an internal housing part (130) configured to be positioned at least partially within a rectal cavity (132) of the subject (112), and an intermediate part (134) configured for connecting the internal housing part (130) and the external housing part (126), wherein the intermediate part (134) tapers from the external housing part (126) to the internal housing part (130); at least one sensing element (118) configured for determining the physiological property, wherein the sensing element (118) is positioned at least partially within the internal housing part (130); at least one power source (144) configured for operating the sensing element (118); at least one wireless communication interface (150) configured for providing measurement data obtained by the sensing element (118) to at least one further device (152);

- the sensing element is configured for performing at least one optical detection method;

- the bodily fluid is blood comprised by the internal rectal venous plexus, and

- the sensing element covers at least an angular section corresponding to a region comprising arteries feeding the internal rectal venous plexus.

2. The sensor device (110) according to the preceding claim, wherein the physiological property determined is at least one analyte in the bodily fluid of the subject (112), such as glucose.

3. The sensor device (110) according to any one of the preceding claims, wherein the physiological property determined is at least one muscle tone of the subject (112).

4. The sensor device (110) according to any one of the preceding claims, wherein the physiological property is determined in a continuous monitoring.

5. The sensor device (110) according to any one of the preceding claims, wherein the wireless communication interface (150) is at least partially positioned within the external housing part (126).

6. The sensor device (110) according to any one of the preceding claims, wherein the sensor device (110) comprises at least one user interface (160) configured for vibrational and/or acoustic signaling.

7. The sensor device (110) according to any one of the preceding claims, wherein the power source (144) is rechargeable, wherein the power source (144) is rechargeable by inductive charging.

8. The sensor device (110) according to any one of the preceding claims, wherein the sensor device (110) comprises at least one handle (136) configured for supporting placement and removal within the rectal cavity (132) of the subject (112).

9. The sensor device (110) according to any one of the preceding claims, wherein the sensing element (118) covers at least 25 percent of an inner circumference (172) of the internal housing part (130).

10. The sensor device (110) according to any one of the preceding claims, wherein the external housing part (126) has an elongated shape (178).

11. The sensor device (110) according to any one of the preceding claims, wherein the sensor device (110) is configured for additionally monitoring one or more of temperature; spatial movement; spatial position; vibration; sound; pulse, e.g. via pulse oximetry; electrical heart signals, e.g. via electrocardiogram; pressure of the portal venous system; microbiome.

12. The sensor device (110) according to any one of the preceding claims, wherein sensing element (118) is configured for optical detection of blood glucose, wherein the optical detection comprises near infrared spectroscopy.

13. A method for determining at least one physiological property of a subject (112), such as at least one analyte in a bodily fluid (114) of the subject (112) and/or at least one information on a body condition of the subject (112), using a sensor device (110) according to any one of the preceding claims, wherein the method comprises the following steps: i) inserting the sensor device (110) into the rectal cavity of the subject (112); ii) determining the physiological property, by using the sensing element (118); and iii) providing the at least one measurement of the physiological property measured by the sensing element (118) to the at least one further device (152) by using the wireless communication interface (150).

14. The method according to the preceding claim, wherein the physiological property determined is the at least one analyte in the bodily fluid (114) of the subject (112), such as glucose.

15. The method according to the preceding claim, further comprising displaying the glucose concentration by using at least one display device (156), e.g. of a mobile device (158).