HK1141217B - Resposable biosensor assembly and method - Google Patents

Description

Partially reusable biosensor assembly and method

CROSS-REFERENCE TO RELATED APPLICATIONS

Priority of this application to U.S. non-provisional patent application No.11/966,685 filed on 28/12/2007 and U.S. provisional patent application No.60/883,121 filed on 2/1/2007, both entitled "partially reusable biosensor assembly and method", the entire disclosures of which are incorporated herein by reference in their entirety.

Technical Field

The present invention relates generally to devices for delivering mechanically elongated devices through the skin into the body to perform various medical or physiological functions. More particularly, the present invention relates to a device for safely and automatically percutaneously placing a soft cannula biosensor or a flexible biosensor using a partially reusable biosensor assembly having reusable and disposable portions.

Background

Many elongate and flexible medical devices are designed for insertion through the skin. For example, sensors facilitate sensing certain conditions within a patient. Electrochemical sensors are commonly used in the management of diabetes to monitor blood glucose levels. In one version, the electrochemical sensor comprising the enzyme is fabricated on a small diameter wire. A second reference electrode is also fabricated around the wire in the vicinity of the sense electrode. The sensor assembly is inserted through the skin such that it is surrounded by interstitial fluid. A portion of the sensor remains outside the body where electrical connections to the sensing and reference electrodes can be made. Suitable electrical measuring means external to the body may be used to measure the current from the sensor for recording and displaying glucose values or other measurements. These types of devices are described, for example, in U.S. Pat. No.5,965,380 to Heller et al and U.S. Pat. No.5,165,407 to Wilson et al.

In addition to electrochemical glucose sensors, many other electrochemical sensors measure the chemistry of blood or other body fluids or substances. Electrochemical sensors typically measure parameters using one or more electrochemical processes and electrical signals. Other sensors perform measurements using optical techniques.

Biosensors are sometimes housed in devices that are located on the skin during operation. To prevent infection and for other reasons, the device may be discarded after each use.

Disclosure of Invention

The invention provides the following technical scheme:

according to a first aspect of the invention, a Reusable Sensor Assembly (RSA) comprises:

a housing for the reusable sensor assembly;

a transmitter disposed within the housing of the reusable sensor assembly; and

a microcontroller coupled to the transmitter, the microcontroller configured to be communicatively coupled to a Disposable Sensor Assembly (DSA) having an analyte sensor, the microcontroller further configured to receive measurement signals from the disposable sensor assembly and cause the transmitter to transmit telemetry signals in response to the received measurement signals.

According to a second aspect of the invention, a Disposable Sensor Assembly (DSA) comprises:

a housing of a disposable sensor assembly having an opening;

a sensor insertion guide structure disposed within the housing and adapted to provide axial support for an analyte sensor and allow the analyte sensor to pass at least partially through the guide structure and out the opening when motive force is applied to the analyte sensor, thereby disposing the analyte sensor to an insertion position; and

a coupling device positioned on or in the sensor insertion guide structure and adapted to facilitate communicative coupling of the analyte sensor to a microcontroller of a Reusable Sensor Assembly (RSA) when the analyte sensor is in an insertion position, the analyte sensor configured to generate a measurement signal upon partial insertion into animal skin.

According to a third aspect of the present invention, a partially reusable sensor assembly comprising a Reusable Sensor Assembly (RSA), the reusable sensor assembly comprising: a housing for the reusable sensor assembly; a transmitter disposed within the housing of the reusable sensor assembly; a microcontroller coupled to the transmitter and configured to receive a measurement signal from a Disposable Sensor Assembly (DSA) and cause the transmitter to transmit a telemetry signal in response to the measurement signal;

the disposable sensor assembly includes: a housing of a disposable sensor assembly having an opening; a sensor insertion guide structure disposed within said housing and adapted to provide axial support for an analyte sensor when motive force is applied to the analyte sensor and to allow the analyte sensor to pass at least partially through said guide structure and out of said opening, thereby placing the analyte sensor in an insertion position; and a coupling device positioned on or in the sensor insertion guide structure and adapted to facilitate communicative coupling of the analyte sensor to the microcontroller when the analyte sensor is in an inserted position.

Drawings

Embodiments of the present invention will be readily understood by the following detailed description in conjunction with the accompanying drawings. To facilitate this description, like reference numerals designate like components. Embodiments of the invention are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings.

FIG. 1 shows a block diagram of a partially reusable sensor assembly according to an embodiment of the invention;

FIG. 2A illustrates one embodiment of an electrochemical glucose sensor fabricated on a length of thin and flexible wire in accordance with embodiments of the present invention;

FIG. 2B shows a cross-section of an electrochemical sensor that can be seen when inserted into skin according to an embodiment of the present invention;

FIG. 3 illustrates a partially reusable sensor assembly and insertion tool prior to insertion of a biosensor according to an embodiment of the present invention;

FIG. 4 illustrates a partially reusable sensor assembly and insertion tool being placed on the skin in accordance with an embodiment of the present invention;

FIG. 5 shows a partially reusable sensor assembly according to an embodiment of the present invention placed onto the skin and a biosensor inserted into the skin;

FIG. 6 shows a biosensor with guide tabs according to an embodiment of the invention;

FIG. 7 illustrates a disposable sensor assembly portion of a partially reusable sensor assembly according to an embodiment of the present invention;

FIG. 8 illustrates a partially reusable sensor assembly with a reusable sensor assembly placed directly on the skin and a disposable sensor assembly also placed directly on the skin in accordance with an embodiment of the present invention;

FIG. 9 shows a block diagram of the interaction of various electronic components and functions of a partially reusable sensor assembly, according to an embodiment of the present invention;

FIG. 10 illustrates a partially reusable sensor assembly with a mechanism for retracting an inserted biosensor into the disposable sensor assembly according to an embodiment of the present invention; and

11A, 11B, and 11C illustrate a partially reusable sensor assembly with a hinged RSA structure according to embodiments of the present invention.

Detailed Description

In the following detailed description, reference is made to the accompanying drawings which form a part hereof wherein like numerals designate like parts throughout, and in which is shown by way of illustration embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of embodiments in accordance with the present invention is defined by the appended claims and their equivalents.

Various operations may be described as multiple discrete operations in turn, in a manner that is helpful in understanding embodiments of the present invention; however, the order of description should be understood to imply that these operations are order dependent. Moreover, not all operations are necessary; the inclusion of an operation in the description should not be understood to imply that it is essential, unless so stated.

The description (including the claims) may use perspective-based descriptions such as up/down, back/front, and top/bottom. Such descriptions are merely used to facilitate explanation and are not intended to limit application of embodiments of the present invention.

The terms "coupled" and "connected," along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Rather, in particular embodiments, "connected" may be used to indicate that two or more elements are in direct physical or electrical contact with each other. "coupled" may mean that two or more elements are in direct physical or electrical contact with each other. However, "coupled" may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other.

For the purposes of the present invention, the phrase in the form "A/B" or in the form "A and/or B" means "(A), (B), or (A and B)". For the purposes of the present invention, a phrase in the form of "at least one of A, B and C" means "(A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C)". For the purposes of the present invention, a phrase in the form of "(a) B" means "(B) or (AB)", that is to say that a is an optional element.

The description may use the phrases "in one embodiment" or "in an embodiment," which may each refer to one or more of the same or different embodiments. Furthermore, the terms "comprising," "including," "having," and the like, when used with respect to embodiments of the present invention, are synonymous.

The term "actuator" means any of a variety of electrical, hydraulic, magnetic, pneumatic, or other devices by which something is moved or controlled.

The phrase "sensor insertion guide structure" refers to a physical structure that either guides an analyte sensor in a predetermined direction when motive force is applied to the sensor, or provides axial support for the sensor, or both. Additional details regarding suitable guide structures may be found in U.S. patent application No.11/558,394, filed on 9.11.2006, which is incorporated herein by reference in its entirety.

The term "axial support" means supporting or cradling a relatively straight, elongated object when motive force is applied thereto in such a way as to oppose a force vector acting perpendicular to an imaginary line drawn through the length of the device; such support or rest is sufficient to prevent or reduce curling, creasing, folding or bending of straight, elongated objects; or such support or rest may be sufficient to allow the object to return to a relatively straight configuration after the motive force ceases to be applied, such that the object substantially retains its original shape with minimal curling, creasing, folding, or bending.

For the purposes of describing embodiments of the present invention and in the following claims, the term "electrical network" means an electronic circuit and components in any desired structural relationship that are adapted to partially receive an electrical signal from an associated sensor and optionally transmit another signal to, for example, an external electronic monitoring unit that is responsive to the sensor signal. The circuitry and other components may or may not include printed circuit boards, cabling or cabling systems, and the like. The signal transmission may occur wirelessly using electromagnetic waves for RF communication, for example, or the data may be read using inductive coupling. In other embodiments, the transmission may be over a wired or otherwise direct connection.

Embodiments may provide a partially reusable sensor assembly that includes both Reusable Sensor Assemblies (RSAs) and Disposable Sensor Assemblies (DSAs). In one embodiment, the RSA may include, for example, a transmitter, a microcontroller, and a battery. In one embodiment, the microcontroller may be configured to receive measurement signals from an analyte sensor disposed within a DSA, the DSA being partially inserted into the animal's skin; such as the skin of a human patient. The microcontroller may also be configured to cause the transmitter to transmit a telemetry signal via RF or other means in response to the received measurement signal. The independent monitoring device may monitor the received telemetry signal and provide useful information to a user, such as a physician, nurse, or patient, regarding the biological or physiological condition measured by the analyte sensor. For example, a diabetic patient may wear a partially reusable sensor assembly to monitor their blood glucose levels in real time to better treat their condition.

In one embodiment, the battery of the RSA may be configured to power the transmitter and the microcontroller. The battery may also be configured to power an analyte sensor of or associated with the DSA. In one embodiment, the DSA and RSA may be adapted to be removably secured to each other. That is, the RSA may be affixed to the DSA in a manner that facilitates communicative coupling between the microcontroller and the analyte sensor, but may also be detached by the user after a period of time, such as when the analyte sensor reaches the end of its useful life or some other period of time. At that point, the RSA may be attached to another DSA to form another partially reusable sensor assembly that may be attached to the same or a different patient. In this way, the relatively expensive components of the RSA, the microcontroller, transmitter, and battery, may be reused multiple times or indefinitely, while the analyte sensor, which may have a much shorter lifetime, may be discarded after each use. This may make it less expensive in embodiments to monitor biological or physiological conditions with a partially reusable sensor assembly for extended periods of time than if components of the RSA were discarded with the DSA and analyte sensor after each use. Further, allowing RSA to be reused may result in a reduction in the amount of waste generated over time.

As shown in fig. 1, one embodiment of a partially reusable biosensor insertion device (partially reusable sensor assembly) may include a Reusable Sensor Assembly (RSA)101 and a Disposable Sensor Assembly (DSA) 103. The components of RSA101 that may be enclosed in RSA housing 115 may include battery 107 and electrical network 105 electrically coupled to each other. The components of the DSA103 that may be enclosed within the DSA housing 117 may include the sensor 111 and the support tube 113, both of which are at least partially disposed within the DSA housing 117. In embodiments, RSA housing 115 and DSA housing 117 may be fabricated from, for example, molded plastic or other suitable material. The guide tabs 123 may be connected to the support tube 113 and the electrical connector 119. Electrical connection 119 may connect sensor 111 to RSA101 through an intermediate electrical connection within guide tab 123 and support tube 113. In an embodiment, battery 107 may be a lithium ion battery capable of operating the device for a maximum time period of, for example, between 3 days and 30 days or more. In an embodiment, the battery 107 may be rechargeable and configured to be repeatedly reused. In embodiments the battery 107 may be configured to be disposable. In an embodiment, battery 107 may be configured to deliver power to DSA103 in addition to powering electrical network 105 within RSA 101. In an embodiment, battery 107 may be adapted to deliver approximately 50mA-hr to 70mA-hr or more, thus allowing electrical network 105 to continuously transmit Radio Frequency (RF) or other electromagnetic signals to a separate monitoring unit for a period of time of approximately 3-7 days or more.

In embodiments, the DSA103 may be configured to be attached to the skin using various mechanisms, including an adhesive or patch 121, affixed to the bottom side of the DSA 103. In embodiments utilizing patch 121, patch 121 may be secured to DSA103 using an adhesive or suitable mechanical mechanism (clips, snaps, rails, etc.), and patch 121 may be configured to be further secured to the skin using adhesive(s), bioresorbable tack(s), or the like. In other embodiments, the partially reusable sensor assembly may be configured to be attached to a patient with a bandage.

In an embodiment, patch 121 may be a breathable patch. In embodiments, some or all of the patches, DSAs, and/or RSAs may include an antimicrobial/coating. In an embodiment, patch 121 may have a site-centered hole with a pattern of antimicrobial polymer coating that is patterned around an area immediately adjacent to the biosensor insertion site. In an embodiment, the coating may be, for example, silver ions, metallic silver, colloidal silver, silver salt, silver sulfadiazine, or another form of silver. Silver is known to have antibacterial properties. In an embodiment, the coating may be silver combined with chlorine to form silver chloride. In an embodiment, the coating may be silver/silver chloride. In an embodiment, the antimicrobial coating may take the form of a thin film that completely covers the site of the central aperture and may be pierced by the sensor 111 when inserted into the skin.

In one embodiment, the sensor 111 may be configured to be inserted into the skin of the animal through the opening 109 by a suitable device (not shown) configured to insert the sensor into the skin of the animalMotive force is supplied to the sensor 111. In an embodiment, DSA103 may contain a sensor insertion guide structure configured to assist passage of sensor 111 through opening 109 and provide axial support for sensor 111 during insertion. In embodiments, the sensor 111 may be configured to be inserted into the skin using the support tube 113 through any one of a variety of electrical, hydraulic, magnetic, pneumatic, or manual actuation means, including, for example, a linear solenoid actuator, a rotary solenoid actuator, CO₂A cartridge actuator, a spring actuator, an air pump actuator, etc. In embodiments, an actuator may be included that is configured to deliver a high-speed motive force sufficient to drive a thin, flexible sensor into the skin of an animal without the aid of a sharpening introducer or similar device. Additional details regarding such suitable actuators and sensor insertion guide structures suitable for providing suitable axial support may be found in U.S. patent application No.11/558,394, filed 2006, 11, 9, which is incorporated herein by reference in its entirety and which describes a method and apparatus for inserting an analyte sensor without the use of a sharpening introducer.

In embodiments, sensor 111 may be configured to be inserted using an actuation device not located within DSA103, such as an actuator included within an inserter device that may be adapted to provide sufficient motive force to the actuator when docked at DSA103 or RSA101 in a certain orientation or placed in close proximity to DSA103 or RSA101 and actuated by a user or other actuation mechanism.

In other embodiments, the partially reusable assembly may include a sharpening guide configured to aid in inserting the sensor 111 into the skin. The introducer may be configured to be inserted manually by the patient or using the same or a different actuation device as used for inserting the sensor 111. In embodiments, the sensor 111 may be configured to be inserted simultaneously with or after the insertion of the sharpening guide. Additional details regarding suitable sharpening guides and associated insertion devices may be found in U.S. patent application No.11/468,673, filed on 30/8/2006, which is incorporated herein by reference in its entirety and describes a device and method for inserting a sensor using a sharpening guide inserted using human-provided motive force. Additional details may also be found in U.S. patent application No.11/952,033, filed on 6.12.2007, which is incorporated herein by reference in its entirety, and which describes the insertion of a sensor using a sharpening introducer that is inserted into the skin using an actuation means prior to or during sensor insertion.

In an embodiment, DSA103 and sensor 111 may be configured to use a maximum time of, for example, 5 to 15 days. In other embodiments, the sensor 111 may be used for a period of less than 5 days or greater than 15 days. When sensor 111 is no longer usable, DSA103 may be configured to be discarded. In embodiments, RSA101 may be configured to be detached from DSA103 and reused with another DSA or similar device.

In embodiments, DSA103 and RSA101 may be configured to be connected prior to attaching the combined device to the skin. In an embodiment, if the device is to be attached to the patient's skin in an area of their body that is difficult to see, for example in the lower part of the patient's body in the case of a patient with a large skirt of abdominal fat, the connection before the skin attachment may allow for easier connection. In other embodiments, DSA103 and RSA101 may be configured to be connected after RSA101 or DSA103 is attached to the patient's skin. In embodiments, sensor 111 may be configured to be inserted prior to attaching RSA101 to DSA 103.

In an embodiment, both RSA101 and DSA103 may be configured to be directly secured to battery 107. The fixation to battery 107 may in embodiments be a physical connection between RSA101 and DSA 103. In other embodiments, RSA101 and DSA103 may be configured to be attached together using plastic snaps, sliders, rails, adhesives, or other mechanisms. In embodiments, a circular catch on RSA101 and/or DSA103 may be configured to allow battery 107 to snap into RSA101 and/or DSA 103.

In an embodiment, electrical connection 119 may be a flexible cable configured to provide a high reliability, waterproof interconnection to sensor 111 without requiring a movable contact on sensor 111 to remain in contact with sensor 111. In an embodiment, the electrical connection 119 may include slack and thus be configured to allow it to remain connected to the guide tab 123 during and after both the movement sensor 111 and the guide tab 123 during the insertion process. Thus, in embodiments, sensor 111 may be configured to be connected to RSA101 after attaching RSA101 to DSA103 but before inserting sensor 111. Thus, the sensor 111 may be configured to be polarized prior to sensor insertion.

In embodiments, DSA103 and RSA101 may be configured to transmit signals using inductive coupling, allowing signals to pass without direct electrical interconnection (e.g., electrical connection 119). In such embodiments, DSA103 may be configured to use the electrical signals from sensor 111 to generate magnetic effects or field variations that may bridge the insulation gap between RSA101 and DSA 103. RSA101 may be configured to generate electrical signals using magnetic effects or field variations and propagate them within the circuitry of RSA 101. The electrical network 105 may be configured to receive such signals. In an embodiment, DSA103 may be configured to receive power from RSA101 through inductive coupling.

In an embodiment, electrical connection 119 may include an intermediate circuit (not shown) configured to assist in feeding signals from sensor 111 into electrical network 105.

In an embodiment, the electrical network 105 may include a transmitter configured to transmit signals to an electronic monitoring unit (not shown). Such signals may be conditioned or unconditioned measurement signals originating from the sensor 111 and/or the DSA 103. Such a monitoring unit may be configured to perform various calculations, analyses and displays of data. In addition, the electronic monitoring unit may be configured to provide an indication of an action to be taken using various prompt buttons or lights based on the received data. Additional details regarding such display means may be found in U.S. patent application No.11/558,399, filed on 9.11.2006, which is incorporated herein by reference in its entirety and which describes the use of shape recognition methods, devices and systems to classify the shape of one or more recent glucose trends during continuous glucose monitoring and alert a user when a particular shape or trend is identified. The sensor 111 may be configured to sense biological and/or physiological conditions other than those related to blood glucose levels and trends. Likewise, display methods other than those taught by U.S. patent application No.11/558,399 may also be utilized. Thus, U.S. application No.11/558,399 is representative of data and display methods that may be implemented in accordance with the present invention.

In an embodiment, the electrical network 105 may be configured to receive electrical signals from the sensors 111 and transmit further signals to an external electronic monitoring unit or other device. In embodiments, electrical network 105 may include various components in any desired structural relationship, whether the network has a printed circuit board, signal conditioner, microcontroller, analog-to-digital converter, wireless telemetry device, transmitter, receiver, power controller, antenna, etc., and whether it is a cabled or wired system, etc. In an embodiment, such signal transmission may be performed wirelessly with electromagnetic waves, such as RF communication. In an embodiment, an apparatus may be configured to read data using inductive coupling. In other embodiments, the device may be configured to transmit over a wire or other direct connection. In embodiments, circuitry may be placed within RSA101 to minimize or at least reduce the cost of DSA 103.

In an embodiment, electrical network 105 may include a display with digital logic configured to perform various calculations, analyses, and displays of data received from sensors 111. In embodiments, circuitry may be provided that is configured to generate an alarm that is viewable on a display or through a light emitting diode or the like. In an embodiment, such circuitry may be configured to generate an audible alarm. Typical alarms include: an out-of-range alarm in the event that the partially reusable biosensor plug-in device is moved outside the transmission range of the external electronic monitoring unit; threshold alarms in the event that the device detects that the alarm from sensor 111 corresponds to a dangerous or critical clinical state; low battery condition, etc.

In an embodiment, the user may take the following steps using the partially reusable biosensor insertion device shown in fig. 1. The user can remove DSA103 from the sterile package. The user may then place RSA101 with a fully charged battery 107 on top of DSA 103. The user may then attach the partially reusable sensor assembly to their skin. This may include, in embodiments, the user removing a thin covering (e.g., a release liner) from the bottom of the patch 121. The user may then insert the sensor 111 using the integrated actuation device and/or a separate insertion tool. The user may then be alerted by the partially reusable biosensor plug-in device or a separate electronic monitoring unit that the sensor 111 needs to be calibrated. Calibration may be accomplished by a user using a finger prick test or other known calibration methods. The patient may then wear the device for a period of, for example, 5 to 15 days or more. After the time to wear the partially reusable sensor assembly, the user may remove the device from their skin, decouple RSA101 from DSA103, and remove DSA 103. The user may then place RSA101 onto a new DSA103 or other DSA removed from the sterile package and repeat the process. In embodiments, battery 107 may be recharged while RSA101 is decoupled from DSA103, during which recharging battery 107 is either separate from RSA101 or integral with RSA 101. Thus, in embodiments, a user may remove battery 107 from RSA101 and recharge it independently. In an embodiment, the recharging unit may include a stress test circuit configured to test the battery 107 and determine that it has sufficient remaining power to operate the partially reusable sensor assembly for a particular length of time, e.g., 1 to 15 days or more.

In various embodiments, the entire unit including the electronic circuitry may be configured to be disposable. In one embodiment, the rechargeable battery may be configured to be reused applied over one skin of the partially reusable sensor assembly to another. In embodiments, DSA103 and/or RSA101 may house separate disposable batteries. In an embodiment, RSA101 may not have a battery. In embodiments, RSA101 may be configured to be powered by a battery in DSA103 through a direct wired connection, inductive coupling, or other mechanism.

Fig. 2A shows an analyte sensor 200 configured to be inserted into skin/tissue according to various embodiments of the invention. In fig. 2A, the analyte sensor 200 may be an electrochemical glucose sensor fabricated on a length of thin, flexible wire. A reference or ground electrode 205 and a sensing electrode 207 may be incorporated into the analyte sensor 200. The small diameter tip 201 (proximal end) of the sensor 200 may be inserted through the skin. In one embodiment, the diameter may be about 0.25mm or less. In one embodiment, the larger diameter end (distal end) of sensor 200 may include a sleeve 203 of tubing, such as steel tubing or silver coiled wire, which may be configured to increase its rigidity and/or facilitate electrical connection. In some embodiments, the diameter of the larger cross section is, for example, about 0.5 mm. In an embodiment, the larger diameter portion of the sensor may be configured to remain outside of the body when inserted. Fig. 2B shows a cross-section of sensor 200 inserted into skin 209. In an embodiment, the sensor 200 may be configured such that a portion of the length of the sensor 200 may be implanted under the skin 209, for example 10-20 mm.

In embodiments, the sensor may be rigid or flexible. In some embodiments, the flexible sensor is a sensor that can be repeatedly flexed, such as a type in which a subcutaneously implanted sensor in a human body is flexed without breaking during normal movement over a period of time (e.g., 3-7 days or more). In embodiments, the flexible sensor may be configured to flex hundreds or thousands of times without breaking.

In an embodiment, the sensor 200 may have an enlarged portion at its distal end, with an integrated power source (e.g., a battery) and an inner coil of conductive wire disposed within the enlarged portion. An imaginary axis of the inner coil of conductive filaments may extend parallel or collinear with an imaginary line segment extending through the length of the sensor 200. A corresponding outer coil of conductive wire having a larger diameter than the inner coil may be disposed within a DSA and/or RSA included as part of the partially reusable sensor assembly. The outer coil may be positioned within the partially reusable device such that when the sensor 200 is inserted into the skin, the sensor 200 may be positioned within the circumference of the outer coil and the imaginary axis of the outer coil may extend parallel or collinear with the imaginary axis of the inner coil. In such an arrangement, electrical signals generated from the sensor may propagate through the inner coil, which may be configured to correspondingly generate a magnetic response in the outer coil, which in turn may correspondingly generate electrical signals in a circuit to which the outer coil may be connected. The partially reusable device may be configured to carry these respective signals to other electronic components of the partially reusable device. In this way, the sensor may be configured to communicate with the partially reusable device through inductive coupling without the need to include physical wiring to directly connect the sensor 200 to the partially reusable device.

Fig. 3 shows a partially reusable sensor assembly with an articulating support plate 305 and a separate insertion tool 313, according to an embodiment. Reusable Sensor Assembly (RSA)301 may be configured to be electrically coupled to Disposable Sensor Assembly (DSA)303 through electrical connector 307. In one embodiment, RSA 301 and DSA 303 may be configured to be physically connected. Battery 309 may be configured to power both an electrical network (not shown) within RSA 301 and sensor 315. In an embodiment, a stand-alone battery (not shown) may be configured to provide power to the DSA 303 and be contained within the DSA 303.

The support tube 311 may be attached to the distal end of the sensor 315 and may extend beyond the rear of the DSA 303 in one embodiment.

The support plate 305 may be configured to attach to the bottom of the DSA 303 through a hinge 317. The support plate 305 is shown in an open position in fig. 3 with the elongated corner end of the insertion tool 313 placed between the support plate 305 and the DSA 303. The support plate 305 may be configured to be placed on or attached to the skin of a patient. The attachment may be by adhesive, bioresorbable staples, or other mechanisms. An actuator (not shown) within the insertion tool 313 may be configured to apply a motive force to the distal end of the support tube 311, which in turn may cause the sensor 315 to pass through an opening in the DSA 303 and be inserted into the patient's skin. The corners of the insertion tool 313 may provide a suitable angle of entry of the sensor 315 into the patient's skin.

Fig. 4 shows the partially reusable sensor assembly placed onto the skin 419 of a patient with the sensor 415 inserted into the skin 419, according to an embodiment. The partially reusable sensor assembly may be comprised of a Reusable Sensor Assembly (RSA)401 and a Disposable Sensor Assembly (DSA)403 connected by electrical connections 407. The partially reusable component may be configured to be powered by a battery 409. The sensor 415 may be configured to be at least partially supported by the support tube 411. The hinge plate 405 may be attached to the DSA 403 by a hinge 417 and configured to be placed directly onto the skin 419, and the insertion tool 414 may be configured to be placed between the bottom of the DSA 403 and the hinge plate 405.

The edge of DSA 403 may be configured to create a skin indent 421 when the elongated corner end of insertion tool 414 is placed between DSA 403 and hinge plate 405. Skin indentation 421 may temporarily increase the natural tension in skin 419 to more easily allow piercing of skin 419 with sensor 415. The relatively downwardly sloping surfaces of skin indentation 421 may also create a skin region that exhibits a deeper insertion angle relative to the direction of the insertion path of sensor 415 than would be present in the absence of skin indentation 421. This increased insertion angle and skin tension when inserted may allow sensor 415 to pierce skin 419 with less motive force and/or with less chance of sensor 415 deflecting or bending. In addition, tilting of the sensor assembly, which may be partially reused during insertion, may achieve an appropriate insertion angle without increasing the height of the DSA 403.

FIG. 5 shows the partially reusable sensor assembly after insertion of the sensor 515 and removal of the insertion tool, in accordance with various embodiments of the present invention. After removal of the insertion tool, the plate 505 may be configured to rotate about hinge 517 and, in embodiments, may be configured to contact the bottom end of a Disposable Sensor Assembly (DSA) 503. Once the partially reusable sensor assembly is folded down, any previous localized skin indentation may disappear, leaving sensor 515 inserted into the skin at an angle. In embodiments, the plate 505 may be secured to the bottom end of the DSA 503 using any of a variety of means including adhesives, snaps, sliders, rails, pins, or other mechanisms. The fixation may prevent unnecessary movement of the partially reusable sensor assembly and sensor 515.

FIG. 6 shows a sensor assembly according to an embodiment of the invention. Sensor 601 is shown connected to support tube 603. The support tube 603 may be connected to a small guide tab 605, which may be connected to a flexible cable 607. The flexible cable 607 may be configured to electrically couple the guide tabs 605 to the waterproof electrical connector 609. The guide tab 605 may include an electrical connection (not shown) configured to electrically couple it to the sensor 601 through the support tube 603. In an embodiment, the guide tab 605 may be electrically coupled directly to the sensor 601. The electrical connector 609 may be attached to the reusable portion of the partially reusable sensor assembly at a fixed location that may facilitate a water seal of the partially reusable sensor assembly. Slack in the configuration of the flex cable 607 may allow movement of the sensor 601 and guide tabs 605 during the insertion process while maintaining electrical connectivity of those components to a Reusable Sensor Assembly (RSA). In an embodiment, the flex cable 607 may be constructed of a conductive material, such as copper or other conductive metal(s) surrounded by a dielectric material, such as a flexible plastic material. The conductive material may extend along the length of the flex cable 607 to electrically couple the guide tabs 605 to the electrical connector 609.

In an embodiment, the wires in the flexible cable 607 may be configured to extend the range of radio frequency transmissions between the RSA and the electronic monitoring unit, thereby allowing the partially reusable sensor assembly to operate at greater distances from the electronic monitoring unit.

Fig. 7 shows an open top view of a Disposable Sensor Assembly (DSA)701 according to an embodiment. DSA 701 may include DSA housing 703 with opening 705 connecting to guide structure 709. The sensor 707 may be located inside the guide structure 709 prior to insertion. Support tube 711 and guide tabs 713 may be connected to sensor 707 and electrically coupled to electrical connector 715 by flexible cable 717. Electrical connector 715 may electrically couple a Reusable Sensor Assembly (RSA) to DSA 701.

Additionally, housing 703 may include a battery 719, which may be configured to supplement the battery included in the RSA. In an embodiment, the battery 719 may be configured to keep the sensor 707 polarized prior to attachment of the RSA. In one embodiment, the battery 719 may have a battery life that matches or exceeds the maximum service life of the sensor 707, e.g., 1 to 15 days or more. In an embodiment, the battery 719 may be disposable. The battery 719 may be rechargeable in other embodiments. In an embodiment, DSA 701 may be attached to an RSA that does not include a battery itself. In an alternative embodiment, DSA 701 may not contain a battery.

FIG. 8 illustrates a partially reusable sensor assembly according to an embodiment of the present invention. A Disposable Sensor Assembly (DSA)803 may be placed on top of DSA patch 805 and a Reusable Sensor Assembly (RSA)801 may be placed on top of RSA patch 809. RSA patch 809 and DSA patch 805 may be attached to the patient's skin. In embodiments, RSA patch 809 and DSA patch 805 may have various shapes, including square, rectangular, circular, etc., and may be independent or connected in various ways. Although shown as separate, RSA patch 809 and DSA patch 805 may be formed as a single patch with separate regions for RSA801 and DSA 803. Although patches are described above, in other embodiments, other securing mechanisms, such as adhesives, may be used in place of one or more patches.

In an embodiment, RSA patch 809 and DSA patch 805 may be breathable patches. In an embodiment, RSA patch 809 and/or DSA patch 805 may have site-centered holes with an antimicrobial polymer pattern, with the coating dispersed around the area immediately adjacent to the biosensor insertion site. In an embodiment, the coating may be, for example, silver ions, metallic silver, colloidal silver, silver salt, silver sulfadiazine, or another form of silver. Silver is known to have antibacterial properties. In an embodiment, the coating may include silver combined with chlorine to form silver chloride. In an embodiment, the coating may comprise silver/silver chloride.

DSA 803 may include a DSA casing 807 that may house various components of DSA 803. The sensor 811 may be configured to be positioned with a guide structure (not shown) proximate the insertion actuator 813. Insertion actuator 803 may be configured to apply a motive force to sensor 811 causing sensor 811 to enter the patient's skin through opening 815 located on the bottom of DSA housing 807. In an embodiment, DSA patch 805 may include a hole that corresponds to opening 815 and is thus configured to allow sensor 811 to pass through opening 815, through a hole in DSA patch 805, and into the skin. In one embodiment, female electrical connector 817 may be included on DSA casing 807. DSA 803 may be positioned on DSA patch 805 such that female connector 817 faces the direction of RSA 801.

In embodiments, other electrical connectors may be used, such as a male electrical connector. In embodiments, suitable electrical connectors may be configured and/or positioned to help align the DSA and RSA with each other and/or on the associated patch.

RSA801 may be housed in RSA casing 827. Surface mounted electronics 819 may be internal to RSA housing 827. In an embodiment, the electronics 819 may be disposed on a printed circuit board. In an embodiment, the electronics 819 may be disposed on a flexible printed circuit board. In an embodiment, the electronics 819 may include a microcontroller, analog-to-digital converter, signal conditioner, power controller, wireless telemetry device, and the like. In an embodiment, some or all of those electronic components may be housed in DSA 803. The antenna 821 may be electrically coupled to the electronics 819 and configured to facilitate radio frequency transmissions to the stand-alone electronic monitoring unit. In embodiments, the partially reusable sensor assembly may be configured to communicate wirelessly with a separate electronic monitoring unit using electromagnetic waves, such as RF communication, or may be configured to transmit data using inductive coupling. In other embodiments, the partially reusable sensor assembly may be configured to transmit via a wired or other direct connection.

In one embodiment, battery 823 may be integrated into the top side of RSA housing 827 for easy installation onto a recharging unit, or for easy removal. In an embodiment, the battery 823 may be a lithium ion flat pack battery. In other embodiments, other types of batteries may be utilized. Male connector 825 may be configured to connect to female connector 817 to electrically couple RSA801 to DSA 803. In an embodiment, battery 823 may be configured to power components of DSA 803 including sensor 811. In an embodiment, electronics 819 may be configured to receive signals from sensor 811 that are sent as electrical signals to RSA801 through female connector 817 and male connector 825. In embodiments, RSA801 may be configured to receive signals from sensor 811 through inductive coupling or infrared signaling. In an embodiment, DSA 803 may contain a battery (not shown) to maintain polarization on sensor 811 prior to attachment and to power sensor 811 after insertion.

In an embodiment, the male connector 825 may be or may include a flexible cable. In an embodiment, the wires inside the flex cable may be configured to extend the range of radio frequency transmissions from RSA801 to an electronic monitoring unit (not shown). This may allow RSA801, and thus the patient to which it is attached, to move to a greater distance from the electronic monitoring unit without interrupting the transmission in embodiments.

In embodiments, RSA801 may be designed to be reused, for example, up to 3 months 12 times or 1 year 50 times. In embodiments, RSA801 may be configured to be used more or less frequently. RSA801 may be configured to be sterilized between uses with a medical autoclave (a sterilization system from Sterrad Systems), sterilization techniques using ethylene oxide gas, gamma radiation sterilization, and the like. In an embodiment, the partially reusable sensor assembly shown in fig. 8 may be configured for use with multiple patients with an appropriate sterilization procedure.

In an embodiment, RSA patch 809 may include rails (not shown) that may be configured to slidably engage with corresponding sliders (not shown) on RSA801 to facilitate easy removal of RSA801 without removing patch 809 so that after power to battery 823 is depleted, a new RSA with a fully charged battery may be easily placed onto the patient and coupled to DSA 803 by male connector 825. In an embodiment, DSA patches 805 and DSA 803 may include similar rail and slider structures.

FIG. 9 illustrates a block diagram of electrical functions and components within a partially reusable sensor assembly, in accordance with various embodiments. A Reusable Sensor Assembly (RSA)901 and a Disposable Sensor Assembly (DSA)903 are shown in a side-by-side configuration. Other configurations are possible, such as stacking RSA 901 on top of DSA903 and vice versa.

RSA 901 may be configured to utilize wireless telemetry 905 connected to antenna 907 for transmitting signals received from sensors (not shown) to an Automatic Calibration and Monitoring Unit (ACMU) 921. In an embodiment, wireless telemetry 905 may utilize the Institute of Electrical and Electronics Engineers (IEEE)802.15.4 low speed Wireless Personal Area Network (WPAN) standard. In other embodiments, the wireless telemetry 905 may utilize other IEEE 802.15WPAN standards. In embodiments, the wireless telemetry 905 may utilize other wireless standards and/or protocols such as bluetooth, ZigBee suite of protocols.

RSA 901 may also include RSA microcontroller 925 which may contain digital logic configured to, among other things, execute wireless telemetry 905. RSA microcontroller 925 may be configured to receive digital signals from receiver 909 (e.g., an infrared receiver) and may be configured to utilize a selected wireless telemetry protocol and/or standard in preparation for wireless transmission of the received digital signals to an Automatic Calibration and Monitoring Unit (ACMU)921 in accordance with the selected wireless telemetry protocol.

DSA903 may contain a transmitter 911 (e.g., an infrared transmitter) configured to send signals received from the sensor to a receiver 909. In an embodiment, the transmitter 911 may be configured to transmit using a wired connection, infrared transmission, inductive coupling, Radio Frequency (RF) transmission, or the like to transmit a signal to the receiver 909.

A sensor bias circuit (sensor bias)915 may be coupled to the sensor signal conditioning 917 and configured to provide a reference voltage to the sensor. The sensor bias circuit 915 may be configured to polarize the sensor to condition it for use. The signal conditioning 917 can be configured to amplify, smooth, convert, etc., the received sensor signal. In an embodiment, the DSA microcontroller 919 may be configured to perform analog-to-digital conversion of the conditioning signal it receives. The DSA microcontroller 919 can be configured to send the digitized signal to the transmitter 911.

DSA903 may also contain a disposable power source 913 (e.g., a disposable battery). In an embodiment, the disposable power supply 913 may be configured to keep the sensor powered for as long as the sensor is intended to be inserted into the patient's skin or for a longer period of time. In an embodiment, the disposable power supply 913 may be configured to be discarded along with the DSA903 once its useful life expires or once another specified time elapses. In other embodiments, the disposable power source 913 may be a rechargeable battery, which may be configured to be removed from the DSA903 and placed back into the DSA903 or another DSA after recharging.

RSA 901 may contain reusable battery 923. In an embodiment, the reusable battery 923 may be configured to remain powered for as long as the sensor is intended to be inserted into the patient's skin or for longer periods of time. In an embodiment, reusable battery 923 may be configured to be disposed of after a single use. In other embodiments, reusable battery 923 may be a rechargeable battery.

Embodiments may not include a disposable power supply 913. In such embodiments, reusable battery 923 may be configured to provide power to DSA903 over a wired connection, which may be the same or different from the wired connection that connects receiver 909 to transmitter 911. In an embodiment, DSA903 may be configured to receive power through inductive coupling. Embodiments may not include reusable battery 923. In such embodiments, RSA 901 may be configured to receive power from disposable power supply 913 through a wired connection or inductive coupling. Such a wired connection may be the same or different from the wired connection connecting the receiver 909 to the transmitter 911. In embodiments where the transmitter 911 and receiver 909 are configured to utilize infrared or other wireless technologies, DSA903 and RSA 901 may be configured to provide/receive power between each other using separate wired connections. In other wireless or infrared embodiments, DSA903 and RSA 901 may be configured to provide/receive power using inductive coupling. In an embodiment, both a disposable power source 913 and a reusable battery 923 can be included.

FIG. 10 illustrates a stackable partially reusable sensor assembly, according to various embodiments. The circular DSA1001 may be configured to couple with a recess 1019 disposed within a Reusable Sensor Assembly (RSA) 1003. The through opening 1013 in DSA1001 may be configured to correspond to the axis 1015 of the center of RSA 1003. DSA1001 may be configured to snap into place, for example, using an interference fit. In an embodiment, plastic rails (not shown) on the sides of DSA1001 may be configured to slide into corresponding grooves (not shown) on the edges of recess 1019 and secure DSA1001 and RSA1003 using an interference fit. In embodiments, DSA1001 may be configured to be secured into recess 1019 using other mechanisms.

RSA1003 may be configured to be placed on the skin prior to attaching DSA1001, or in an embodiment DSA1001 may be configured to be coupled to RSA1003 prior to placement on the skin. In an embodiment, RSA1003 may be configured to be attached to skin using an adhesive. In an embodiment, a patch with adhesive on both sides may be used on the bottom of RSA1003 and configured to attach RSA1003 to the skin. In one embodiment utilizing a patch, a cutout of the patch may be positioned to allow the sensor 1009 to pass through the plane occupied by the patch, such that the sensor 1009 does not need to pass through the patch material when inserted.

In one embodiment, DSA1001 may include a top plate 1005 and a bottom plate 1007 both configured to rotate relative to each other. The sensor 1009 may be configured to be placed inside a DSA guide structure 1011 within the base plate 1007. The sensor 1009 may be attached to the top plate 1005 at its distal end and configured to be fully contained within the DSA guide structure 1011. The through opening 1013 may be shaped to correspond to the shape of the shaft 1015 such that a particular orientation of the DSA1001 will be required to slide the shaft 1015 into the top of the RSA 1003. This may ensure that DSA steering structure 1011 will line up with RSA steering structure 1016 if DSA1001 and RSA1003 are so attached. RSA guide 1016 may be arcuate and oriented to exit through RSA1003 at bottom opening 1017. The top opening 1021 may be located within the recess 1019. When DSA1001 is properly coupled with recess 1019, DSA guide structure 1011 may be configured to align with RSA guide structure 1016 to form one continuous guide structure through which sensor 1009 may be configured to pass during insertion.

In an embodiment, an actuator (not shown) may be configured to be actuated when DSA1001 is coupled with recess 1019 and a motive force is applied to sensor 1009, causing it to move through the composite guide structure for insertion into the skin through bottom opening 1017. In an embodiment, the trigger mechanism may be configured to be pushed and pulled by the patient or another person after the DSA1001 is coupled to the RSA1003 in order to actuate the actuator for sensor 1009 insertion.

In an embodiment, the sensor 1009 may be configured to retract from and then exit the patient's skin by rotation of the top plate 1005 relative to the bottom plate 1007, through the RSA guide structure 1016, and fully tuck into the DSA 1001. DSA1001 may be configured to be subsequently decoupled from recess 1019 with sensor 1009 fully retracted and out of view, thereby contributing to the patient's psychological comfort.

In embodiments, circuitry including a microcontroller, antenna, battery, transmitter, signal conditioner, electrical coupler, infrared transmitter, receiver, etc., may be contained within DSA1001, RSA1003, or both. In an embodiment, another device with circuitry may be attached to the top of the DSA 1001.

11A, 11B, and 11C illustrate cross-sectional views of a partially reusable sensor assembly with a pivoting RSA arrangement, according to an embodiment of the present invention. In fig. 11A, RSA1101 is shown pivoted upward relative to DSA1103 located on and/or attached to skin 1151. The DSA may in embodiments be shaped as a flat plate with an adhesive patch on the bottom side. The sensor cartridge 1105 may be a detachable component of the DSA1103 and may include a sensor 1107 prior to insertion. Sensor cartridge 1105 may be configured to fit over DSA docking socket 1109. It may be configured to hold sensor 1107 and maintain it in a sterile state prior to insertion. It may also include all or part of guide structure 1111 to provide guidance and/or axial support for sensor 1107 during insertion. DSA docking socket 1109 may be configured to provide placement and/or orientation for sensor cartridge 1105 prior to insertion of sensor 1107. RSA1101 may be configured to tilt using a hinge mechanism or other mechanism, for example, at a compliant point of the material comprising RSA1101 or at a junction between RSA1101 and DS 1103.

The guide structures 1111 may extend from the bottom of the DSA1103 to the top of the docking receptacle 1109. Guide structure 1111 may be configured to provide axial support for sensor 1107 during insertion. In an embodiment, guide 1111 may be tilted to allow sensor 1107 to be inserted into skin 1151 at an angle suitable for insertion. Through opening 1113 may be located on the bottom of DSA1103 and at the terminal end of guide structure 1111 to allow sensor 1107 to pass through the bottom of DSA1103 during insertion. The guide 1111 may be tubular or may have another geometry depending on the embodiment. In an embodiment, the guide 1111 may be flat and may be configured to receive the molded portion at the proximal end. The docking receptacle 1109 may be configured to provide guidance and/or axial support for the sensor 1107 as well during insertion.

Figure 11B shows a cross-sectional view of a partially reusable sensor assembly coupled with an interposer 1121 located over a sensor cartridge 1107, according to an embodiment. In an embodiment, inserter 1121 can include an actuator (not shown) that is configured to be actuated by a user and causes insertion of sensor 1107 into skin 1151. Sensor 1107 is shown inserted into skin 1151. The interposer 1121 can be shaped in various ways to accommodate human factors and/or to accommodate actuators. Interposer 1121 can be placed by a user on top of DSA 1103. The docking receptacle 1109 may be configured to grip the proximal end of the sensor 1107 after insertion and provide a waterproof or water-resistant electrical connection between the partially reusable sensor assembly and the sensor 1107 using a direct electrical connection, inductive coupling, or other mechanism.

Fig. 11C shows a cross-sectional view of a partially reusable sensor assembly with a downward sloping RSA 1101. After insertion, inserter 1121 can be removed by the user. When removed, inserter 1121 can be configured to withdraw sensor cartridge 1105 and discard it. In an embodiment, RSA1101 may be configured to be removably secured in place on DSA 1103. RSA1101 may include a removable or permanent cover. RSA1101 may be configured to provide waterproof or water-resistant electrical contacts or electrical couplings for sensor 1107 through docking socket 1109 when RSA1101 is tilted downward and secured in place on top of DSA 1103.

As described elsewhere in this specification, RSA1101 may be configured to receive electrical measurement signals originating from sensor 1107 and transmit them to a separate monitoring unit. RSA1101 may also contain reusable electronics such as an RF or other transmitter, a microcontroller as described elsewhere in this specification, and a reusable/rechargeable battery. The embodiments shown in fig. 11A, 11B, and 11C may be used to limit the height and size of DSA1103 by fitting a portion of DSA1103, e.g., docking receptacle 1109 including a portion of steering structure 1111, into the volume occupied by RSA1101 when RSA1101 is tilted downward onto DSA 1103. RSA1101 may have various sizes and shapes. In an embodiment, RSA1101 may fit over the entire top side of DSA 1103. Such a configuration may balance the available volume of RSA1101 internal components without increasing the footprint of DSA 1103.

Although certain embodiments have been illustrated and described herein for purposes of description of the preferred embodiment, it will be appreciated by those of ordinary skill in the art that a wide variety of alternate and/or equivalent embodiments or implementations calculated to achieve the same purposes may be substituted for the embodiments shown and described without departing from the scope of the present invention. Those with skill in the art will readily appreciate that embodiments in accordance with the present invention may be implemented in a very wide variety of ways. This application is intended to cover any adaptations or variations of the embodiments discussed herein. Therefore, it is manifestly intended that embodiments in accordance with the present invention be limited only by the claims and the equivalents thereof.

Claims (22)

1. A Reusable Sensor Assembly (RSA), comprising:

a housing for the reusable sensor assembly;

a transmitter disposed within the housing of the reusable sensor assembly; and

a microcontroller coupled to the transmitter, the microcontroller configured to be communicatively coupled to a Disposable Sensor Assembly (DSA) having an analyte sensor, the microcontroller further configured to receive measurement signals from the disposable sensor assembly and cause the transmitter to transmit telemetry signals in response to the received measurement signals.

2. The reusable sensor assembly of claim 1, further comprising a battery disposed within a housing of the reusable sensor assembly and configured to supply power to the disposable sensor assembly.

3. The reusable sensor assembly of claim 1, further comprising an electrical connector of the reusable sensor assembly disposed within the housing of the reusable sensor assembly and coupled to the microcontroller, and the housing of the reusable sensor assembly is configured to be removably secured to the housing of the disposable sensor assembly in an orientation that facilitates communicatively coupling the microcontroller to the disposable sensor assembly through the electrical connector of the reusable sensor assembly.

4. The reusable sensor assembly of claim 3, wherein the electrical connector of the reusable sensor assembly is configured to communicatively couple the microcontroller to the disposable sensor assembly through a direct electrical connection with the electrical connector of the disposable sensor assembly or through an inductive coupling with the electrical connector of the disposable sensor assembly.

5. The reusable sensor assembly of claim 1, wherein the housing of the reusable sensor assembly is configured to be removably secured to the housing of the disposable sensor assembly in an orientation in which at least a portion of a bottom surface of the reusable sensor assembly is flush with a top surface of the housing of the disposable sensor assembly, the bottom surface of the housing of the disposable sensor assembly being adapted to be secured to the skin of an animal.

6. The reusable sensor assembly of claim 1, wherein the housing of the reusable sensor assembly is configured to be removably secured to the housing of the disposable sensor assembly in an orientation in which a bottom surface of the housing of the reusable sensor assembly is configured to be tilted away from a top surface of the housing of the disposable sensor assembly while the housing of the reusable sensor assembly remains removably secured to the housing of the disposable sensor assembly.

7. The reusable sensor assembly of claim 5, wherein a bottom surface of the housing of the reusable sensor assembly includes a cavity adapted to fit a docking receptacle disposed on a top surface of the disposable sensor assembly, the docking receptacle configured to communicatively couple to an electrical connector of a reusable sensor assembly disposed within the reusable sensor assembly when the housing of the reusable sensor assembly is removably secured to the housing of the disposable sensor assembly.

8. The reusable sensor assembly of claim 1, wherein the measurement signal originates from the analyte sensor and the telemetry signal comprises the measurement signal.

9. The reusable sensor assembly of claim 1, wherein the housing of the reusable sensor assembly is adapted to be removably secured to the housing of the disposable sensor assembly to form a partially reusable sensor assembly and to be removed from the housing of the disposable sensor assembly and removably secured to the housing of another disposable sensor assembly to form another partially reusable sensor assembly.

10. A Disposable Sensor Assembly (DSA) comprising:

a housing of a disposable sensor assembly having an opening;

a sensor insertion guide structure disposed within the housing and adapted to provide axial support for an analyte sensor and allow the analyte sensor to pass at least partially through the guide structure and out the opening when motive force is applied to the analyte sensor, thereby disposing the analyte sensor to an insertion position; and

a coupling device positioned on or in the sensor insertion guide structure and adapted to facilitate communicative coupling of the analyte sensor to a microcontroller of a Reusable Sensor Assembly (RSA) when the analyte sensor is in an insertion position, the analyte sensor configured to generate a measurement signal upon partial insertion into animal skin.

11. The disposable sensor assembly of claim 10 wherein the housing of the disposable sensor assembly is adapted to be removably secured to the housing of the reusable sensor assembly, and the positioning of the coupling device on or in the sensor insertion guide structure is adapted to facilitate communicative coupling of the analyte sensor to the microcontroller when the disposable sensor assembly is removably secured to the housing of the reusable sensor assembly.

12. The disposable sensor assembly of claim 11 wherein the coupling device is an electrical connector of a disposable sensor assembly adapted to communicatively couple to an electrical connector of a reusable sensor assembly disposed within the reusable sensor assembly housing.

13. The disposable sensor assembly of claim 12 wherein the electrical connector of the disposable sensor assembly is part of a docking receptacle disposed on a top surface of the housing of the disposable sensor assembly, the docking receptacle adapted to fit into a cavity disposed on a bottom surface of the housing of the reusable sensor assembly when the housing of the disposable sensor assembly is removably secured to the housing of the reusable sensor assembly, the cavity including the electrical connector of the reusable sensor assembly.

14. The disposable sensor assembly of claim 12 wherein the disposable sensor assembly is adapted to receive power from the battery of the reusable sensor assembly through the electrical connector of the disposable sensor assembly.

15. The disposable sensor assembly of claim 10, further comprising a signal transmission device configured to communicate with the microcontroller via the signal transmission device of the reusable sensor assembly by infrared, direct electrical connection, Personal Area Network (PAN) transmission, or inductive coupling.

16. The disposable sensor assembly of claim 10, further comprising a docking receptacle disposed on a top surface of a housing of the disposable sensor assembly, the sensor insertion guide extending into the docking receptacle.

17. The disposable sensor assembly of claim 16, wherein the docking receptacle is configured to receive a detachable sensor cartridge having an analyte sensor disposed within a cartridge guide structure of the detachable sensor cartridge, the detachable sensor cartridge adapted to receive an insertion device containing an actuator configured to apply a motive force to a distal end of the analyte sensor.

18. The disposable sensor assembly of claim 17, wherein the insertion device is configured to withdraw the removable sensor cartridge from the docking receptacle after sensor insertion.

19. The disposable sensor assembly of claim 10, further comprising a user-actuated actuator disposed within a housing of the disposable sensor assembly and configured to apply a motive force to a distal end of the analyte sensor.

20. The disposable sensor assembly of claim 10, further comprising an adhesive patch disposed on an outer surface of the housing of the disposable sensor assembly and adapted to adhere to the skin of an animal.

21. A partially reusable sensor assembly comprising a Reusable Sensor Assembly (RSA), the reusable sensor assembly comprising: a housing for the reusable sensor assembly; a transmitter disposed within the housing of the reusable sensor assembly; a microcontroller coupled to the transmitter and configured to receive a measurement signal from a Disposable Sensor Assembly (DSA) and cause the transmitter to transmit a telemetry signal in response to the measurement signal;

the disposable sensor assembly includes: a housing of a disposable sensor assembly having an opening; a sensor insertion guide structure disposed within said housing and adapted to provide axial support for an analyte sensor when motive force is applied to the analyte sensor and to allow the analyte sensor to pass at least partially through said guide structure and out of said opening, thereby placing the analyte sensor in an insertion position; and a coupling device positioned on or in the sensor insertion guide structure and adapted to facilitate communicative coupling of the analyte sensor to the microcontroller when the analyte sensor is in an inserted position.

22. The partially reusable sensor assembly of claim 21, wherein the housing of the reusable sensor assembly is configured to be removably secured to the housing of the disposable sensor assembly, and the coupling device is positioned and adapted to facilitate communicative coupling of the analyte sensor to the microcontroller when the housing of the reusable sensor assembly is removably secured to the housing of the disposable sensor assembly.