Physiological characteristic sensor system

Abstract

A physiological characteristic sensor system includes a physiological characteristic sensor. The physiological characteristic sensor includes a housing having a first housing portion coupled to a second housing portion, and an antenna coupled to the first housing portion. The physiological characteristic sensor system includes a sensor inserter configured to be coupled to the physiological characteristic sensor. The sensor inserter includes a sensor holder configured to be coupled to the second housing portion in a second state to couple the physiological characteristic sensor to the sensor inserter.

Description

Technical Field

[0001] Embodiments of the subject matter described herein generally relate to medical devices, such as physiological characteristic sensor systems. More specifically, embodiments of the present subject matter relate to a system for a physiological characteristic sensor and a sensor inserter for coupling the physiological characteristic sensor to a user. Background Art

[0002] Sensors can be used to treat or monitor various medical conditions. In one example, thin-film electrochemical sensors are used to test analyte levels in a patient or user. More specifically, thin-film sensors have been designed to obtain an indication of blood glucose (BG) levels and monitor BG levels in diabetic patients, wherein the distal segment of the sensor is located subcutaneously in direct contact with the extracellular fluid. Such readings can be particularly useful in adjusting treatment regimens that typically include regular administration of insulin to the user.

[0003] Glucose sensors of the type described above can be packaged and sold as products, such as continuous glucose monitors, that adhere to the patient via an adhesive skin patch during use. In some cases, the continuous glucose monitor can be packaged with a sensor inserter tool, which enables subcutaneous / percutaneous implantation of the glucose sensor. The sensor inserter tool includes a needle for piercing the user's skin while introducing the sensor. The needle is then withdrawn, leaving the sensor in the user's skin.

[0004] In cases where a continuous glucose monitor is packaged with a sensor inserter tool, the sensor introducer tool may be accidentally mishandled, which may affect the performance of the continuous glucose monitor and / or the sensor inserter tool. Additionally, because the sensor introducer tool includes a needle, it is desirable to properly dispose of the sensor inserter tool once the continuous glucose monitor has been deployed.

[0005] Therefore, it is desirable to provide a physiological characteristic sensor system, such as a continuous glucose monitor, comprising a glucose sensor and a sensor inserter tool that mitigates accidental misoperation and enables proper disposal of the sensor inserter tool. Further desirable features and characteristics will become apparent from the following detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background. Summary of the Invention

[0006] The technology of the present disclosure generally relates to a physiological characteristic sensor system including a physiological characteristic sensor and a sensor inserter for coupling the physiological characteristic sensor to a user.

[0007] According to various embodiments, a physiological characteristic sensor system is provided. The physiological characteristic sensor system includes a physiological characteristic sensor. The physiological characteristic sensor includes a housing having a first housing portion coupled to a second housing portion, and an antenna coupled to the first housing portion. The physiological characteristic sensor system includes a sensor inserter configured to be coupled to the physiological characteristic sensor. The sensor inserter includes a sensor holder configured to be coupled to the second housing portion in a second state to couple the physiological characteristic sensor to the sensor inserter.

[0008] A physiological characteristic sensor system is also provided. The physiological characteristic sensor system includes a physiological characteristic sensor having a housing. The physiological characteristic sensor system includes a sensor inserter configured to couple to the physiological characteristic sensor. The sensor inserter includes a frame, a sensor carrier, and a sensor holder. The sensor holder is coupled to the sensor carrier, and the sensor carrier is coupled to the frame. The frame has at least one rib, and the sensor holder has at least one holder arm configured to couple to the physiological characteristic sensor in a second state. The at least one rib holds the at least one holder arm in the second state.

[0009] A physiological characteristic sensor system is also provided. The physiological characteristic sensor system includes a physiological characteristic sensor. The physiological characteristic sensor includes a housing having a first housing portion coupled to a second housing portion. An antenna and a first contact are coupled to the first housing portion, and a printed circuit board assembly and a battery are coupled to the second housing portion. The antenna and the battery communicate with the printed circuit board assembly. The first contact includes a pair of spring arms interconnected by a body, and the body is coupled to the first housing portion such that the pair of spring arms are movable relative to the body portion. The physiological characteristic sensor system includes a sensor inserter configured to couple to the physiological characteristic sensor.

[0010] This summary is provided to introduce a series of concepts that are further described below in the detailed description in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The details of one or more aspects of the present disclosure are set forth in the following figures and description. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the description and drawings, as well as from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following drawings, wherein like reference numerals refer to like elements throughout.

[0012] Figure 1 is a perspective view of an exemplary physiological property sensor system including a sensor inserter and a physiological property sensor according to various teachings of the present disclosure;

[0013] Figure 2 It is along Figure 1 The line 2-2 intercepts Figure 1 A cross-sectional view of a physiological characteristic sensor system;

[0014] Figure 3 yes Figure 1 Exploded view of the physiological characteristic sensor;

[0015] Figure 4 It is along Figure 2 The line 4-4 is intercepted Figure 1 A cross-sectional view of a physiological characteristic sensor;

[0016] Figure 5 is surrounded by at least one sealing member Figure 1 a detailed view of a seal formed by a distal end portion of a glucose sensor associated with a physiological property sensor;

[0017] Figure 6 is a partially exploded bottom perspective view of a physiological characteristic sensor illustrating an exemplary coupling of an antenna to a first housing portion of the housing of the physiological characteristic sensor;

[0018] Figure 7 is a partially exploded top perspective view of a physiological characteristic sensor illustrating an exemplary coupling of spring contacts associated with a printed circuit board assembly with a second housing portion of the housing of the physiological characteristic sensor;

[0019] Figure 7A is a side view of a physiological characteristic sensor showing the electrical connection to the printed circuit board assembly Figure 6 and Figure 7 Antenna;

[0020] Figure 8 Is used with Figure 1 Another exemplary antenna for use with a physiological characteristic sensor;

[0021] Figure 9 is electrically connected to the printed circuit board assembly of the physiological characteristic sensor Figure 8 A perspective view of the antenna;

[0022] Figure 10is a bottom view of a first housing portion of the physiological characteristic sensor illustrating a first contact coupled to the first housing portion;

[0023] Figure 11 is a schematic cross-sectional view showing a battery coupled to a first contact;

[0024] Figure 12 is with Figure 1 a detailed view of a base portion of a glucose sensor associated with a physiological characteristic sensor coupled to a printed circuit board assembly;

[0025] Figure 13 is Figure 12 Detailed view of a coupling post engaged with a coupling aperture associated with a base of a glucose sensor, taken at 13;

[0026] Figure 14 yes Figure 1 Exploded view of the sensor inserter;

[0027] Figure 15 is connected to Figure 1 a perspective view of a needle inserter of a sensor inserter for a physiological characteristic sensor;

[0028] Figure 16 is connected to Figure 1 Detailed view of the needle inserter of the needle retractor of the sensor inserter;

[0029] Figure 17 is a cross-sectional view through a sensor carrier associated with a sensor inserter illustrating at least one holder arm of the sensor holder separated from the physiological characteristic sensor in a first state;

[0030] Figure 18 yes Figure 17 a bottom view of the sensor carrier illustrating at least one holder arm of the sensor holder coupled to the physiological characteristic sensor in a second state;

[0031] Figure 19 is connected to Figure 1 a perspective view of a sensor holder of a frame associated with a sensor inserter illustrating at least one rib of the frame biasing the at least one holder arm in a second state;

[0032] Figure 20 is connected to Figure 1 a perspective view of a sensor holder of a frame associated with a sensor inserter illustrating at least one rib of the frame releasing the at least one holder arm such that the at least one holder arm is in a first state;

[0033] Figure 21 yes Figure 17 a bottom view of the sensor carrier illustrating the at least one holder arm of the sensor holder separated from the physiological characteristic sensor in a first state;

[0034] Figure 22 is connected to Figure 1 A cross-sectional view of a sensor carrier and a sensor holder of a physiological property sensor;

[0035] Figure 23 is a detail view of an insertion catch of the sensor carrier spaced apart from a surface of the frame when the sensor inserter is in a first position;

[0036] Figure 24 is a detail view of a physiological property sensor supported by a protrusion of a cap of a sensor inserter in a first position;

[0037] Figure 25 is a cross-sectional view taken through the sensor carrier looking down at the sensor holder illustrating the sensor holder coupled to the sensor carrier;

[0038] Figure 26 is a bottom view of the sensor carrier, wherein the physiological characteristic sensor is coupled to the sensor carrier via the sensor holder, and the at least one holder arm of the sensor holder is in a second state;

[0039] Figure 27 is a schematic top view of a physiological property sensor supported by a cap illustrating magnetic field lines associated with a magnet coupled to the cap;

[0040] Figure 28 is a detail view of an end portion of the plunger coupled to the cap by an interference fit to form a seal between the cap and the plunger;

[0041] Figure 29 is a detail view of a tamper-evident strip coupled to the cap and plunger;

[0042] Figure 30 is a perspective view of a sensor inserter in a first position with a cap removed prior to coupling a physiological characteristic sensor to an insertion site on a portion of an anatomical structure;

[0043] Figure 31 is a perspective view of the sensor inserter in a second position, wherein the sensor inserter is positioned over an insertion site and a user depresses a plunger to deploy the physiological property sensor onto and into the anatomical structure;

[0044] Figure 31A It is along Figure 31 31A-31A is a cross-sectional view of the sensor inserter in the second position;

[0045] Figure 31B It is from Figure 31 a cross-sectional view of the sensor inserter in a third position, taken from the perspective of line 31A-31A, wherein the physiological characteristic sensor is deployed at the insertion site and coupled to the anatomical structure;

[0046] Figure 32 is a perspective view of the sensor inserter in a third position, wherein the sensor inserter is removed from the physiological characteristic sensor at the insertion site; and

[0047] Figure 32A It is along Figure 32 32A-32A is a cross-sectional view of the sensor inserter in a third position, wherein the sensor inserter is removed from the physiological characteristic sensor at the insertion site. DETAILED DESCRIPTION

[0048] The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the present invention or the application and uses of such embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration." Any specific implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other specific implementations. Furthermore, no intention is to be bound by any expressed or implied theory presented in the preceding technical field, background, summary, or the following detailed description.

[0049] Certain terms may be used in the following description for reference only and are therefore not intended to be limiting. For example, terms such as "top," "bottom," "upper," "lower," "above," and "below" may be used to refer to directions in the accompanying drawings to which reference is made. Terms such as "front," "rear," "back," "side," "outside," and "inside" may be used to describe the orientation and / or position of parts of a component within a consistent but arbitrary reference frame, as made clear by reference to the text and associated drawings describing the component in question. Such terms may include the words specifically mentioned above, their derivatives, and words of similar meaning. Similarly, the terms "first," "second," and other such numerical terms referring to structures do not imply a sequence or order unless the context clearly indicates so.

[0050] As used herein, the term "axial" refers to a direction that is generally parallel to or coincident with the axis of rotation, axis of symmetry, or centerline of one or more components. For example, in a cylinder or disk having a centerline and generally circular ends or opposing faces, the "axial" direction may refer to a direction that extends generally parallel to the centerline between the opposing ends or faces. In some cases, the term "axial" may be used for non-cylindrical (or otherwise radially symmetric) components. For example, the "axial" direction of a rectangular housing containing a rotating shaft may be considered to be a direction that is generally parallel to or coincident with the axis of rotation of the shaft. In addition, as used herein, the term "radially" may refer to the direction or relationship of components relative to a line extending outward from a common centerline, axis, or similar reference, such as in a plane of a cylinder or disk that is perpendicular to the centerline or axis. In some cases, components may be considered to be "radially" aligned even though one or both of the components may not be cylindrical (or otherwise radially symmetric). Furthermore, the terms "axial" and "radial" (and any derivatives) may encompass directional relationships that are not precisely aligned (e.g., oblique) with respect to the true axial and radial dimensions, provided that the relationships are primarily in the respective nominal axial or radial directions. As used herein, the term "transverse" refers to an axis that intersects another axis at an angle such that the axis is neither substantially perpendicular nor substantially parallel to the other axis.

[0051] As used herein, the term module refers to any hardware, software, firmware, electronic control component, processing logic and / or processor device, alone or in any combination, including but not limited to: application specific integrated circuits (ASICs), electronic circuits, processors (shared, dedicated, or groups) and memories that execute one or more software or firmware programs, combinational logic circuits and / or other suitable components that provide the described functionality.

[0052] The embodiments of the present disclosure may be described herein from the perspective of schematic, functional and / or logical block components and various processing steps. It should be understood that such block components can be implemented by any number of hardware, software and / or firmware components configured to perform the specified functions. For example, the embodiments of the present disclosure may employ various integrated circuit components, such as memory elements, digital signal processing elements, logic elements, lookup tables, etc., which may perform various functions under the control of one or more microprocessors or other control devices. In addition, those skilled in the art will understand that the embodiments of the present disclosure may be practiced in conjunction with any number of systems, and the fluid infusion devices described herein are merely exemplary embodiments of the present disclosure.

[0053] For the sake of brevity, conventional techniques related to other functional aspects of signal processing, data transmission, signaling, control and systems (and the various operating components of the systems) may not be described in detail herein. In addition, the connecting lines shown in the various figures included herein are intended to represent exemplary functional relationships and / or physical connections between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may exist in the embodiments of the present disclosure.

[0054] The following description relates to various embodiments of a physiological characteristic sensor system that includes a physiological characteristic sensor and a sensor inserter. The system described herein prevents or mitigates the effects of accidental misoperation of the sensor inserter during use, and also enables the sensor inserter to be properly disposed of once the physiological characteristic sensor is connected to the user. It should be noted that although the physiological characteristic sensor is described herein as a continuous glucose monitor, it should be understood that the physiological characteristic sensor may include various other sensors (such as heart monitors, body temperature sensors, EKG monitors, etc.), medical devices and / or other components intended to be attached to the user's body. Therefore, although the non-limiting examples described below relate to medical devices for treating diabetes (more specifically, continuous glucose monitors), the embodiments of the disclosed subject matter are not limited thereto.

[0055] Typically, the glucose sensor used together with the adhesive patch is a continuous glucose sensor of the type used by diabetic users. For the sake of brevity, the conventional aspects and technology related to the manufacture of glucose sensor and glucose sensor may not be described in detail here. In this regard, the known and / or conventional aspects of glucose sensor and its manufacture may belong to, but are not limited to, the type described below: U.S. Patent No. 6,892,085, No. 7,468,033 and No. 9,295,786; and U.S. Patent Application No. 2009 / 0299301 (these U.S. Patents are each incorporated herein by reference). In addition, for the sake of brevity, the conventional aspects and technology related to sensor inserter may not be described in detail here. In this regard, the known and / or conventional aspects of sensor inserter may belong to, but are not limited to, the type described in U.S. Patent No. 10,413,183 (this U.S. Patent is incorporated herein by reference).

[0056] refer to Figure 1 , Figure 1 is a perspective view of a physiological characteristic sensor system 100. In one example, the physiological characteristic sensor system 100 includes a physiological characteristic sensor 102 and a sensor inserter 104. Figure 2 , the components of the physiological characteristic sensor 102 are coupled together as a single unit. The physiological characteristic sensor 102 and the sensor inserter 104 can be packaged together for use by a consumer or user.

[0057] In one example, reference Figure 3 The physiological characteristic sensor 102 includes a housing 106, an antenna 108, a sensor connector 110, a power supply assembly 112, a glucose sensor 114, at least one sealing member 116, a printed circuit board assembly 118, and a coupling member or adhesive patch 120. The housing 106 is constructed from a polymer-based material and is molded, cast, formed by additive manufacturing, or the like. In this example, the housing 106 is generally rectangular; however, the housing 106 can have any desired shape that cooperates with the sensor inserter 104 to couple the physiological characteristic sensor 102 to an anatomical structure. For example, the housing 106 has rounded corners to reduce snagging on the user's clothing. In one example, the housing 106 is a two-piece housing including a first top housing portion 122 and a second bottom housing portion 124. The top housing portion 122 and the bottom housing portion 124 cooperate to enclose the antenna 108, the sensor connector 110, the power supply assembly 112, a portion of the glucose sensor 114, the at least one sealing member 116, and the printed circuit board assembly 118. The top housing portion 122 includes an aperture 126 that enables a portion of the sensor inserter 104 to pass through the housing 106 to couple the physiological characteristics sensor 102 to the anatomical structure. The bottom housing portion 124 includes a second aperture 128 that cooperates with the aperture 126 to enable a portion of the sensor inserter 104 and the glucose sensor 114 to pass through the housing 106. The bottom housing portion 124 may also include one or more dividers or compartments to help accommodate components of the physiological characteristics sensor 102. Additionally, the bottom housing portion 124 may define a channel 130 around the perimeter of the bottom housing portion 124 to help couple the top housing portion 122 to the bottom housing portion 124.

[0058] For example, reference Figure 4, top housing portion 122 is received within channel 130. Top housing portion 122 is coupled to bottom housing portion 124 within channel 130 by welding, adhesive, or the like. Typically, top housing portion 122 is coupled to bottom housing portion 124 to prevent fluids, such as air and water, from entering housing 106. Additionally, in one example, bottom housing portion 124 includes a cylindrical post 132 coupled to a mating cylindrical post 134 of top housing portion 122 to couple top housing portion 122 to bottom housing portion 124 around aperture 126 and second aperture 128. Cylindrical post 132 further defines a first angled surface 132a, and mating cylindrical post 134 further defines a second angled surface 134a. First angled surface 132a is angled upward from the inner periphery of cylindrical post 132 toward the outer periphery of cylindrical post 132. The second angled surface 134a is angled upward from the outer periphery of the mating cylindrical post 134 toward the inner periphery of the mating cylindrical post 134. Figure 5 , the angled surfaces 132a, 134a cooperate to define a diamond-shaped cavity 136 that extends around the perimeter of the orifice 126 and the second orifice 128. The diamond-shaped cavity 136 compresses the at least one sealing member 116 to form a seal around the glucose sensor 114, as will be discussed. In one example, the top housing portion 122 and the bottom housing portion 124 are coupled around the top surfaces of the cylindrical post 132 and the mating cylindrical post 134 to maintain compression of the at least one sealing member 116.

[0059] Return Reference Figure 6 , antenna 108 is coupled to top housing portion 122. In this example, antenna 108 is coupled to a post 138 of top housing portion 122 by heat staking, ultrasonic welding, or the like. In one example, antenna 108 is any suitable antenna 108 that enables two-way communication between physiological characteristic sensor 102 and a user's portable electronic device. Thus, generally, antenna 108 enables wireless communication between physiological characteristic sensor 102 and another device, including, but not limited to, an infusion pump, a handheld device (tablet, smartphone, etc.), or other monitoring device. In some examples, antenna 108 may include, but is not limited to, a near-field communication (NFC) antenna, an RF radio antenna, a far-field communication antenna, a wireless communication system configured to communicate using the IEEE 802.11 standard or via a wireless local area network (WLAN) using cellular data communication, a Bluetooth antenna, and the like. In one example, antenna 108 of physiological characteristic sensor 102 is a Bluetooth Low Energy (BLE) antenna.

[0060] In one example, reference Figure 7, the antenna 108 is electrically coupled to and in communication with the PCB assembly 118 via the spring contacts 140. Thus, the antenna 108 is coupled to the PCB assembly 118 without soldering, which reduces manufacturing complexity and time. In this example, the PCB assembly 118 includes two spring contacts 140, however, the PCB assembly 118 can have any suitable contact configuration to couple the antenna 108 to the PCB assembly 118 when the top housing portion 122 is assembled to the bottom housing portion 124. Thus, generally, with reference to Figure 7A The antenna 108 is coupled to the housing 106 such that the antenna 108 is electrically coupled to the printed circuit board assembly 118 when the top housing portion 122 of the housing 106 is assembled to the bottom housing portion 124 .

[0061] Alternatively, refer to Figure 8 , antenna 108' is shown. Antenna 108' is substantially the same as antenna 108, but antenna 108' includes a spring contact 140'. Antenna 108' enables wireless communication between the physiological characteristic sensor 102 and another device, which other device includes but is not limited to an infusion pump, a handheld device (tablet, smart phone, etc.), or other monitoring device. In some examples, antenna 108 may include but is not limited to a near field communication (NFC) antenna, an RF radio antenna, a far field communication antenna, a wireless communication system configured to communicate using the IEEE 802.11 standard or through a wireless local area network (WLAN) using cellular data communication, a Bluetooth antenna, etc. In one example, antenna 108' of physiological characteristic sensor 102 is a Bluetooth low energy (BLE) antenna. In this example, spring contact 140' is formed integrally with antenna 108'. Spring contact 140' is defined as a portion of antenna 108' that is folded over itself. Reference Figure 9 , spring contacts 140′ touch contact pads 141 of PCB assembly 118 to electrically couple antenna 108′ to PCB assembly 118, allowing antenna 108′ to communicate with PCB assembly 118. Thus, antenna 108′ is coupled to PCB assembly 118 without soldering, which reduces manufacturing complexity and time.

[0062] Return Reference Figure 3 , the sensor connector 110 provides contact force between the glucose sensor 114 and the printed circuit board assembly 118. In one example, the sensor connector 110 is constructed of a polymer-based material and is cast, molded, additively manufactured, etc. When the top housing portion 122 is coupled to the bottom housing portion 124, the sensor connector 110 is held against the glucose sensor 114 by the top housing portion 122, which in turn holds or maintains the glucose sensor 114 electrically coupled to the printed circuit board assembly 118.

[0063] The power supply assembly 112 provides power to the printed circuit board assembly 118. In one example, the power supply assembly 112 includes at least one battery 142, a first top contact or first battery contact 144, and a second bottom contact or second battery contact 146. In this example, the at least one battery 142 includes two batteries 142, each of which is a button cell battery. For example, each of the batteries 142 is a 1.55 volt (V) battery. The first battery contact 144 and the second battery contact 146 are each formed from a metal or metal alloy and can be stamped, cast, etc. The first battery contact 144 includes two spring tabs 148 interconnected by a body 150.

[0064] refer to Figure 10 , the first battery contact 144 is shown coupled to the top housing portion 122. The first battery contact 144 is typically coupled to the top housing portion 122 by ultrasonic welding or heat stake welding using stakes 152. The stakes 152 are larger to protect the first battery contact 144 during coupling of the top housing portion 122 to the bottom housing portion 124. The body 150 can define an opening 150a to receive the stake 152. The first battery contact 144 is typically coupled to the top housing portion 122 by the body 150 so that the spring tab 148 is free to move relative to the body 150. By enabling the spring tab 148 to move relative to the body 150, reference Figure 11 During the coupling of the top housing portion 122 to the bottom housing portion 124, the first battery contact 144 self-balances when a torque is applied due to the compression of the spring tab 148. This self-balancing of the first battery contact 144 by the spring tab 148 minimizes damage to the first battery contact 144 during the coupling of the top housing portion 122 to the bottom housing portion 124. In addition, by being movable, the spring tab 148 limits the reaction force applied to the top housing portion 122 during use of the physiological characteristic sensor 102. Return to Reference Figure 3 , the first battery contact 144 is symmetrical about the longitudinal axis of the first battery contact 144 .

[0065] Second battery contact 146 includes two second spring tabs 154 that are separate or uninterconnected from each other. Second spring tabs 154 are electrically and physically coupled to PCB assembly 118 such that when top housing portion 122 is coupled to bottom housing portion 124, spring tabs 148 and 154 compress to electrically couple batteries 142 together in series and to PCB assembly 118.

[0066] The glucose sensor 114 is an electrochemical sensor that includes glucose oxidase, as is well known to those familiar with glucose sensor technology. The glucose oxidase enables the glucose sensor 114 to monitor the blood glucose level of a diabetic patient or user by reacting glucose with oxygen. Similarly, while certain embodiments relate to glucose sensors, the technology described herein can be adapted for use with any of a variety of sensors known in the art. Typically, the distal end 114a of the glucose sensor 114 is cannulated and can be positioned within the user's subcutaneous tissue via an insertion needle of the sensor inserter 104 to measure glucose oxidase.

[0067] In one example, the glucose sensor 114 includes a base 156 coupled to the distal end 114a of the glucose sensor 114 at an angle of approximately ninety degrees. The base 156 couples the glucose sensor 114 to the printed circuit board assembly 118. In this example, the base 156 includes two coupling apertures 158. The coupling apertures 158 are spaced apart on the base 156 and couple or anchor the glucose sensor 114 to the printed circuit board assembly 118. In one example, reference is made to Figure 12 , the base 156 is shown coupled to the printed circuit board assembly 118 via coupling apertures 158. In this example, the bottom housing portion 124 includes coupling posts 160 that extend through holes 118b defined in the printed circuit board assembly 118 to mate with the coupling apertures 158, respectively. Each coupling aperture 158 includes a coupling tab 158a. Figure 13 , when the corresponding coupling apertures 158 are placed over the corresponding coupling posts 160, the coupling tabs 158a are bendable to securely couple the base 156, and therefore the glucose sensor 114, to the bottom housing portion 124. Coupling the base 156 to the coupling posts 160 also electrically and mechanically couples the glucose sensor 114 to the printed circuit board assembly 118. The coupling tabs 158a extend into the coupling apertures 158 such that bending of the coupling posts 160 against the coupling tabs 158a creates an interference fit between the coupling tabs 158a and the coupling posts 160, thereby retaining the glucose sensor 114 on the printed circuit board assembly 118. The interference fit between the coupling apertures 158 and the coupling posts 160 also prevents sliding movement of the glucose sensor 114 relative to the printed circuit board assembly 118.

[0068] Return Reference Figure 3 The at least one sealing member 116 includes two sealing members 116a and 116b. The sealing members 116a and 116b include O-rings made of an elastomeric material. Figure 5, sealing members 116a, 116b are positioned on either side of the base 156 of the glucose sensor 114 and around the distal end 114a to prevent water or fluid from entering the housing 106. The top housing portion 122 is assembled to the bottom housing portion 124 so that the angled surfaces 132a, 134a contact and compress the sealing members 116a, 116b, which causes the sealing members 116a, 116b to deform and fill the space around the distal end 114a. The deformation of the sealing members 116a, 116b caused by the top housing portion 122 seals around the distal end 114a of the glucose sensor 114 and prevents fluid from entering the housing 106. Thus, the deformation of the sealing members 116a, 116b forms a seal between the top housing portion 122 and the bottom housing portion 124 around the distal end 114a of the glucose sensor 114. The seal formed between the top housing portion 122 and the distal end 114a by sealing member 116a and the seal formed between the bottom housing portion 124 and the distal end 114a by sealing member 116b are formed without the need for adhesives, greases or other components to ensure a watertight seal, which reduces manufacturing complexity.

[0069] refer to Figure 3 PCB assembly 118 includes a controller or control module 162. Control module 162 includes at least one processor and computer-readable storage devices or media mounted to printed circuit board 164. Printed circuit board 164 is electrically and mechanically coupled to spring contacts 140 and electrically couples battery 142, glucose sensor 114, and antenna 108 to control module 162. Thus, battery 142, glucose sensor 114, and antenna 108 communicate with control module 162. The processor can be any custom or commercially available processor, a central processing unit (CPU), an auxiliary processor among several processors associated with control module 162, a semiconductor-based microprocessor (in the form of a microchip or chipset), a macroprocessor, any combination thereof, or any device generally used to execute instructions. Computer-readable storage devices or media can include volatile and non-volatile memory, such as read-only memory (ROM), random access memory (RAM), and keep-alive memory (KAM). KAM is persistent or non-volatile memory that can be used to store various operating variables when the processor is powered off. The computer-readable storage device or medium may be implemented using any of a variety of known memory devices, such as a PROM (programmable read-only memory), an EPROM (electrical PROM), an EEPROM (electrically erasable PROM), flash memory, or any other electrical, magnetic, optical, or combination memory device capable of storing data, some of which represent executable instructions, used by the control module 162 to control components associated with the physiological characteristic sensor 102.

[0070] The instructions may include one or more separate programs, each of which includes an ordered list of executable instructions for implementing logical functions. When executed by a processor, the instructions receive and process input signals, execute logic, calculations, methods, and / or algorithms for controlling components of the physiological characteristic sensor 102, and generate signals to components of the physiological characteristic sensor 102 based on the logic, calculations, methods, and / or algorithms to monitor the glucose sensor 114 and control the antenna 108. Although only one control module 162 is shown, embodiments of the physiological characteristic sensor 102 may include any number of control modules that communicate via any suitable communication medium or combination of communication media and cooperate to process signals from the glucose sensor 114, transmit signals received from the glucose sensor 114 via the antenna 108, execute logic, calculations, methods, and / or algorithms, and generate control signals to control features of the physiological characteristic sensor 102.

[0071] In various embodiments, the one or more instructions of the control module 162, when executed by the processor, receive and process signals from the glucose sensor 114 to determine the user's blood glucose level. The one or more instructions of the control module 162, when executed by the processor, also transmit the blood glucose level to a portable electronic device associated with the user via the antenna 108.

[0072] The printed circuit board assembly 118 also includes a magnetic sensor 119. The magnetic sensor 119 observes magnetic fields, including but not limited to those generated by the sensor inserter 104 ( Figure 14 ) and generates one or more sensor signals based on the observation of the magnetic field. In one example, the processor receives the sensor signal from the magnetic sensor 119 and activates the physiological characteristics sensor 102 to monitor blood glucose levels. In other words, based on the observation of changes in the magnetic field, such as due to separation of the magnet 214 from the physiological characteristics sensor 102, the physiological characteristics sensor 102 is activated to monitor blood glucose levels. The magnetic sensor 119 is electrically and mechanically coupled to the printed circuit board 164 and communicates with the control module 162. In one example, the magnetic sensor 119 is a tunneling magnetoresistive (TMR) sensor. In the presence of the magnetic field generated by the magnet 214, the cooperative use of the magnetic sensor 119 and the magnet 214 allows the physiological characteristics sensor 102 to remain in a low-power state, which preserves the life of the battery 142 before the physiological characteristics sensor 102 is deployed (i.e., when the physiological characteristics sensor 102 is idle).

[0073] Adhesive patch 120 is coupled to bottom housing portion 124 and attaches bottom housing portion 124 and therefore glucose sensor 114 to an anatomical structure, such as the skin of the user. Adhesive patch 120 can be made of a flexible and breathable material with one or more adhesive layers, such as cloth, a bandage-like material, etc. For example, suitable materials may include polyurethane, polyethylene, polyester, polypropylene, polytetrafluoroethylene (PTFE) or other polymers, onto which one or more adhesive layers are applied. Adhesive patch 120 can be coupled to bottom housing portion 124 by adhesive, ultrasonic welding, etc.

[0074] In one example, to assemble the physiological characteristic sensor 102, with the bottom housing portion 124 formed, the second battery contact 146 is coupled to the bottom housing portion 124. With the control module 162 and the spring contact 140 coupled to the printed circuit board 164, the printed circuit board 164 is coupled to the bottom housing portion 124 such that the coupling post 160 passes through the aperture 118b ( Figure 12 ). Sealing member 116b is coupled to bottom housing portion 124 adjacent cylindrical post 132. Brief Reference Figure 12 , the glucose sensor 114 is coupled to the bottom housing portion 124 by aligning the coupling apertures 158 with the coupling posts 160. The base 156 is advanced toward the printed circuit board assembly 118, which causes the coupling tabs 158a to bend. The bending of the coupling tabs 158a holds the glucose sensor 114 on the bottom housing portion 124 and electrically couples it to the printed circuit board assembly 118. Figure 4 , the distal end 114a of the glucose sensor 114 extends through the sealing member 116b and through the second aperture 128 . The battery 142 is positioned within the bottom housing portion 124 so as to be coupled to a second battery contact 146 .

[0075] Return Reference Figure 3 , in the case of forming the top housing portion 122, the first battery contact 144 is on the body 150 ( Figure 10 ) is coupled to the top housing portion 122. Antennas 108, 108' are coupled to the top housing portion 122 ( Figure 6 ). Sealing member 116a is positioned opposite sealing member 116b. Top housing portion 122 is coupled to bottom housing portion 124 such that top housing portion 122 is received within channel 130. Coupling top housing portion 122 to bottom housing portion 124 causes angled surfaces 132a, 134a to compress sealing members 116a, 116b to form a seal around distal end 114a of glucose sensor 114. Coupling top housing portion 122 to bottom housing portion 124 also causes spring tab 148 ( Figure 3) electrically couples the batteries 142 together in series. Additionally, coupling the top housing portion 122 to the bottom housing portion 124 electrically couples the antenna 108 to the spring contacts 140 of the printed circuit board assembly 118. Generally, the physiological characteristic sensor 102 provides reduced assembly time and improved manufacturability.

[0076] Return Reference Figure 2 In various embodiments, the physiological characteristic sensor 102 is coupled to a sensor inserter 104 to transport and deliver the physiological characteristic sensor 102 to the user. The sensor inserter 104 can be manipulated by the user to couple the glucose sensor 114 and the physiological characteristic sensor 102 to the user. Figure 14 , the sensor inserter 104 includes a needle inserter 198, a plunger 200, a first biasing member or insertion spring 202, a needle retractor 204, a second biasing member or retraction spring 206, a frame 208, a sensor holder 210, a sensor carrier 212, a magnet 214, and a cap 216. In this example, the cap 216 includes a membrane 218, as will be discussed further herein.

[0077] The needle inserter 198 is constructed of a polymer-based material and is cast, molded, additively manufactured, etc. Figure 15 , shows the needle inserter 198 coupled to the physiological characteristic sensor 102. Typically, the needle inserter 198 is coupled to the physiological characteristic sensor 102 before the physiological characteristic sensor 102 is coupled to the sensor inserter 104, which allows for ease of assembly. The needle inserter 198 includes a carrier 220 and an insertion needle 222. The carrier 220 is overmolded onto the insertion needle 222. The carrier 220 includes a pair of arms 224. Each of the arms 224 extends from either side of a carrier base 226. The carrier base 226 provides a graspable portion for coupling the needle inserter 198 to the physiological characteristic sensor 102. The arms 224 each include an arm tab 228. Reference Figure 16 , the arm tab 228 is coupled to and engages the lip 230 of the needle retractor 204. As will be discussed, the engagement between the arm tab 228 and the lip 230 enables the needle retractor 204 to remove the insertion needle 222 from the anatomical structure. Return to Reference Figure 15 The insertion needle 222 is typically a stainless steel needle that extends a distance beyond the distal end 114a of the glucose sensor 114 to couple the glucose sensor 114 to the anatomical structure.

[0078] Return Reference Figure 14The plunger 200 is constructed from a biocompatible polymer and can be molded, cast, printed, or the like. The plunger 200 surrounds the frame 208 and includes a plurality of threads 236 defined around a surface of the outer housing 600 adjacent to the second bottom end 200b. The threads 236 removably couple the cap 216 to the plunger 200, as will be discussed. The plunger 200 is shaped to correspond to the shape of the physiological characteristics sensor 102 so that when the sensor inserter 104 is used to couple the physiological characteristics sensor 102 to an anatomical structure, the user intuitively understands the positioning and orientation of the physiological characteristics sensor 102. This allows the user to position the sensor inserter 104 by feel without having to visually inspect the insertion site, such as the back of the arm. In one example, the first tip 200a of the plunger 200 includes a recess or dimple coaxial with the insertion needle 222, enabling the user to visually inspect the position of the distal end 114a within the anatomical structure.

[0079] Return Reference Figure 2 The plunger 200 further defines a first inner guide surface 238 and a second inner guide surface 240. Each of the first inner guide surface 238 and the second inner guide surface 240 extends radially inward from the inner surface of the plunger 200. In this example, each of the first inner guide surface 238 and the second inner guide surface 240 extends from the first top end 200a toward the bottom end 200b. In one example, the first inner guide surface 238 includes a slot that cooperates with a track 242 defined within the needle retractor 204. The engagement of the track 242 with the slot guides the needle retractor 204 toward the top end 200a of the plunger 200, ensuring that the insertion needle 222 associated with the needle inserter 198 coupled to the needle retractor 204 remains within the plunger 200 after deployment of the physiological characteristics sensor 102. The second inner guide surface 240 cooperates with the sensor carrier 212 to guide the sensor carrier 212 during deployment of the physiological characteristics sensor 102. The plunger 200 also includes a plurality of protrusions 244 extending radially inwardly and spaced apart around the inner periphery of the plunger 200. The protrusions 244 cooperate with slots 246 defined in the frame 208. Generally, the protrusions 244 and slots 246 cooperate to guide movement of the plunger 200 relative to the frame 208. The plunger 200 also includes frame protrusions 247. The frame protrusions 247 extend radially inwardly and are defined around the periphery of the plunger 200. As will be discussed, when the sensor inserter 104 is in the second position, the frame protrusions 247 cooperate with the frame 208 to release the physiological characteristic sensor 102.

[0080] The insertion spring 202 is a helical coil spring constructed of a suitable biocompatible material, such as spring steel, that is wound to form the insertion spring 202. In one example, the insertion spring 202 is a tension spring that is received between the second inner guide surface 240 of the plunger 200 and the surface 212a of the sensor carrier 212. Generally, the insertion spring 202 expands as the sensor carrier 212 moves toward the second bottom end 208b of the frame 208 to couple the physiological characteristics sensor 102 to the user, and applies a spring force F1 along the longitudinal axis L to move the sensor carrier 212 toward the bottom end 208b of the frame 208, thereby deploying the physiological characteristics sensor 102.

[0081] The needle retractor 204 is coupled to the second annular protrusion 248 of the sensor carrier 212. Figure 14 , the needle retractor 204 includes a first portion 250 and a second portion 252. The first portion 250 has a larger diameter than the second portion 252. The first portion 250 includes one or more guide protrusions 254 that are spaced around the periphery of the first portion 250. The guide protrusions 254 contact the second annular protrusion 248. The second portion 252 is coupled to the needle inserter 198. The diameter of the second portion 252 is sized so that the retraction spring 206 is positioned between the first portion 250 and the sensor carrier 212 so as to surround the second portion 252, as shown. Figure 2 shown.

[0082] Continue to refer Figure 2 The retraction spring 206 is a helical coil spring constructed of a suitable biocompatible material, such as spring steel, that is wound to form the retraction spring 206. In one example, the retraction spring 206 is a compression spring that is received between the second portion 252 of the needle retractor 204 and the surface 212b of the sensor carrier 212. After deployment, the retraction spring 206 expands and applies a spring force F2 along the longitudinal axis L to move the needle retractor 204 toward the first inner guide surface 238 of the plunger 200, thereby retaining the insertion needle 222 within the sensor inserter 104.

[0083] The frame 208 is housed within the plunger 200. Typically, when the physiological characteristic sensor 102 is coupled to the sensor inserter 104, the frame 208 extends a distance beyond the plunger 200. The frame 208 is constructed of a biocompatible polymer and can be molded, cast, printed, etc. Figure 14, the frame 208 includes a first frame portion 260 and a second frame portion 262. The slot 246 is defined in the first frame portion 260 and extends from the top surface 208a of the frame 208 to the second frame portion 262. The second frame portion 262 surrounds the sensor carrier 212 so that the physiological characteristic sensor 102 is positioned within the second frame portion 262 of the frame 208. In one example, referring to Figure 17 , the second frame portion 262 includes at least one or more ribs 264 . Figure 17 2 is an end view of the physiological characteristics sensor 102 coupled to the sensor holder 210, and the sensor holder 210 is coupled to the frame 208. As shown, the ribs 264 are spaced around the inner periphery of the frame 208 and extend a distance to engage the sensor holder 210. As will be discussed, in a first position, the ribs 264 engage the sensor holder 210 to hold the physiological characteristics sensor 102. In a second position, the ribs 264 are released by contact between the frame protrusion 247 of the plunger 200 and the ribs 264, which causes the sensor holder 210 to release the physiological characteristics sensor 102 for deployment onto the anatomical structure.

[0084] The sensor holder 210 is coupled to and housed around the perimeter of the sensor carrier 212. In one example, the sensor holder 210 helps couple or retain the physiological characteristic sensor 102 to the sensor carrier 212. The sensor holder 210 can be constructed of a biocompatible polymer and can be molded, cast, printed, etc. Figure 17 , the sensor holder 210 includes at least one or more holder arms 266 spaced around the periphery of the sensor holder 210. Figure 17 , the sensor holder 210 is shown with the retainer arms 266 in a first, fired, or released state. Each of the retainer arms 266 is cantilevered from the sensor holder 210 and includes a contact surface 268 that retains the physiological characteristic sensor 102 in a second, pre-fired, or coupled state. In the first state, the contact surfaces 268 of the retainer arms 266 do not contact the physiological characteristic sensor 102, such that the physiological characteristic sensor 102 is released or detached from the sensor holder 210 when the retainer arms 266 are in the first state. In the first state, a gap 269 is defined between the distal end 266a of each of the retainer arms 266 and the surface 210b of the sensor holder 210.

[0085] refer to Figure 18In the second state, each of the ribs 264 of the frame 208 contacts a corresponding one of the retainer arms 266 to bias or compress the retainer arms 266 into the second state. In the second state, the gap 269 is substantially eliminated, and the tip 266a of each of the retainer arms 266 contacts the surface 210b of the sensor holder 210. In the second state, as shown in FIG. Figure 19 As shown, the contact surface 268 is held against the physiological characteristic sensor 102 to hold the physiological characteristic sensor 102 on the sensor holder 210. Figure 19 As shown, the contact surface 268 is generally L-shaped and at least partially contacts the surface 124 a of the bottom housing portion 124 of the physiological characteristic sensor 102 .

[0086] refer to Figure 20 , the sensor holder 210 is shown released from the frame 208 to deploy the physiological characteristic sensor 102 on the anatomical structure. The frame protrusion 247 of the plunger 200 contacts the rib 264 of the frame 208, which pushes the rib 264 outward, thereby releasing the retainer arm 266. The release of the retainer arm 266 moves the retainer arm 266 from the second state to the first state, as shown. Figure 21 As shown. Figure 21 , the retainer arm 266 has moved to the first state, which releases the contact surface 268 from the physiological characteristic sensor 102. By moving the retainer arm 266 from the second state to the first state, the user can separate the physiological characteristic sensor 102 from the sensor inserter 104 with little to no force and without disturbing the insertion site.

[0087] Return Reference Figure 14 , the sensor carrier 212 moves relative to the frame 208 to deploy the physiological characteristic sensor 102 onto the user. The sensor carrier 212 can be constructed of a biocompatible polymer and can be molded, cast, printed, etc. The sensor carrier 212 includes a support body 270 and a retaining flange 272. Figure 22 , the support body 270 is annular and includes concentric first and second annular protrusions 274, 248. The first annular protrusion 274 couples the sensor carrier 212 to the frame 208, and the second annular protrusion 248 couples the needle retractor 204 to the sensor carrier 212. The second annular protrusion 248 may also include opposing slots 276 that cooperate with the needle retractor 204 to couple the needle retractor 204 to the sensor carrier 212. Figure 23 The sensor carrier 212 further includes an insert buckle 278. The insert buckle 278 extends outward from the first annular protrusion 274 and is received in the slot 246 of the frame 208. Figure 23As shown, in the first position, the insertion catch 278 is spaced apart from the surface 246a of the slot 246 to prevent relative movement between the sensor carrier 212 and the frame 208. As will be discussed, with reference to FIG. Figure 24 , cap 216 applies force F3 to physiological characteristic sensor 102 in the first position, which causes insertion tab 278 of sensor carrier 212 to be spaced apart from surface 246a of frame 208 ( Figure 23 ) and is free floating. Return reference Figure 23 The space 280 defined between the insertion detent 278 and the surface 246a ensures that the sensor carrier 212 will not be inadvertently released if the sensor inserter 104 is accidentally misoperated in the first position. In other words, the space 280 ensures that the sensor inserter 104 remains in the first position until the user pushes the plunger 200 and prevents the sensor inserter 104 from accidentally moving from the first position to the second position.

[0088] Brief Reference Figure 2 When the plunger 200 moves relative to the frame 208, the ramp surface 279 defined inside the plunger 200 contacts the insertion buckle 278. The contact between the ramp surface 279 and the insertion buckle 278 causes the insertion buckle 278 ( Figure 23 ) deflects, thereby from the slot 246 ( Figure 23 ) and the frame 208 releases the insertion buckle 278 ( Figure 23 ). The sensor carrier 212 is released from the frame 208 so that the insertion spring 202 can apply a force F1 to couple the physiological characteristic sensor 102 to the anatomical structure.

[0089] refer to Figure 25 The retaining flange 272 is generally rectangular in shape and is coupled to the sensor holder 210. The retaining flange 272 includes a plurality of retaining tabs 284 and defines a contact surface 286 ( Figure 26 ). The retaining tab 284 couples the sensor holder 210 to the sensor carrier 212. Figure 26 , the contact surface 286 is continuous and defined around the perimeter of the retaining flange 272. When the physiological characteristic sensor 102 is deployed, the contact surface 286 will adhere to the adhesive patch 120 ( Figure 22 ) is pressed against the user's anatomy to ensure that the adhesive patch 120 is coupled to the user across the entire adhesive patch 120. Thus, the contact surface 286 provides improved adhesion of the adhesive patch 120 to the user's anatomy.

[0090] Return Reference Figure 14 , the magnet 214 is coupled to the cap 216. In this example, the magnet 214 is annular to couple to the cap 216. The magnet 214 comprises any suitable permanent magnet constructed of axially magnetized ferromagnetic material. In one example, reference Figure 27 , the magnet 214 generates a three-dimensional vector having radial component magnetic field lines 290 that cover a majority of the printed circuit board 164. By covering a majority of the printed circuit board 164, the magnetic sensor 119 can be moved or repositioned on the printed circuit board 164 while maintaining its response to the magnetic field provided by the magnet 214. Additionally, the radial component magnetic field lines 290 are axially symmetric, which results in the magnetic field being the same regardless of the axial positioning of the cap 216. This enables the cap 216 to be coupled to the plunger 200 at different final positions during assembly without affecting the magnetic field generated by the magnet 214. Thus, the magnet 214 also compensates for manufacturing tolerances, which reduces assembly time.

[0091] In this example, reference Figure 24 , the magnet 214 is coupled to the cap 216 by heat welding or ultrasonic welding and can be retained within the annular channel 292 defined in the protrusion 294 of the cap 216. The annular channel 292 may include a lip 296 that extends over the uppermost surface of the magnet 214 to further help couple the magnet 214 to the cap 216.

[0092] refer to Figure 2 , the cap 216 can be constructed of a biocompatible polymer and can be molded, cast, printed, etc. The cap 216 includes a protrusion 294, a cap base 298, and a sidewall 300. The protrusion 294 extends axially upward from the cap base 298 and defines an annular channel 292 coupled to the magnet 214. Brief Reference Figure 24 , the protrusion 294 terminates in a tip 302. The tip 302 applies a force F3 against the bottom housing portion 124, which causes the insertion buckle 278 ( Figure 23 ) floats within the slot 246. The tip 302 is generally annular, so that the force F3 is distributed over the annular surface 302a and is not a point load. The tip 302 also enables the adhesive patch 120 of the physiological characteristic sensor 102 to remain within the sensor inserter 104 without a backing layer. By eliminating the backing layer, the physiological characteristic sensor 102 is easier to deploy on the user.

[0093] Return Reference Figure 2 The cap base 298 has a first base surface 304 opposite a second base surface 306 and defines a plurality of openings 308 ( Figure 14 ). The first base surface 304 is coupled to or integrally formed with the protrusion 294. The second base surface 306 defines a circular recess 310 that receives the membrane 218. The membrane 218 is a gas permeable polymer material such as that manufactured by DuPont of Midland, Michigan. TM Manufactured It is coupled to the cap 216 along the surface of the recess 310 via, for example, an adhesive, a heat bond. The opening 308 is covered by the membrane 218. The opening 308 cooperates with the membrane 218 to enable sterilization of the physiological characteristic sensor 102 included in the sensor inserter 104. Typically, the plunger 200 and the cap 216 cooperate to form a seal so that during a sterilization procedure, sterilizing gas can penetrate into and out of the sensor inserter 104 through the opening 308 and sterilize the physiological characteristic sensor 102 and the interior of the sensor inserter 104. In one example, reference is made to Figure 27 , the bottom end 200b of the plunger 200 is coupled to the cap 216 with an interference fit that prevents fluids, such as air and liquids, from flowing into the sensor inserter 104. In this example, the sidewall 300 of the cap 216 includes a lip 312 that surrounds the cap 216 and receives the bottom end 200b of the plunger 200 with an interference fit. Typically, the bottom end 200b of the plunger 200 is slightly deflected to be received within the cap 216, which creates an interference fit between a surface 200c of the bottom end 200b and a surface 312a of the lip 312. The cap base 298 may also include a frame receiving channel 299 that receives the bottom end 208b of the frame 208. The frame receiving channel 299 typically mates tightly with the frame 208, preventing the frame 208 from deforming inward and disengaging from the cap 216 if the sensor inserter 104 is mishandled or dropped.

[0094] Return Reference Figure 2 The side wall 300 includes a lip 312, a plurality of threads 314, and a frame protrusion 316. The plurality of threads 314 are defined to be spaced apart from the lip 312. The plurality of threads 314 engage with the threads 236 of the plunger 200 to removably couple the cap 216 to the plunger 200. The frame protrusion 316 is connected to a thread 236 defined on the frame 208 ( Figure 14 ) cooperates with the threads 208c on the frame 208. In one example, the frame protrusions 316 act as threads, allowing the cap 216 to be screwed onto both the frame 208 and the plunger 200. By screwing the cap 216 onto both the frame 208 and the plunger 200, the frame 208 is locked in position relative to the plunger 200, which prevents the frame 208 from moving relative to the plunger 200 if the sensor inserter 104 is mishandled or dropped.

[0095] In one example, the cap 216 also includes a tamper evident band or tamper strip 320. The tamper strip 320 can be constructed of a biocompatible polymer and can be molded, cast, additively manufactured, etc. The tamper strip 320 can be formed by a plurality of bridges 320a ( Figure 1 ) is coupled to the cap 216, the plurality of bridges being breakable when the cap 216 is unscrewed or separated from the plunger 200. The tamper strip 320 may be integrally formed with the cap 216, and the bridges 320a ( Figure 1 ) can be defined by a post-processing step. The tamper band 320 provides a visual indication as to whether the cap 216 has been removed from the plunger 200. In this example, the plunger 200 also defines a tamper bead retaining wall 322 and a tamper bead retaining fastener 324 around the outer periphery of the plunger 200. Figure 29 , the tamper bead retaining wall 322 receives a corresponding tamper bead 326 defined on the tamper strip 320. The tamper bead retaining fastener 324 extends outward a distance greater than the tamper bead retaining wall 322 and is received in a corresponding groove 328. The tamper bead 326 on the tamper strip 320 vertically overlaps the tamper bead retaining fastener 324 so that when the user removes the cap 216, the tamper bead 326 of the tamper strip 320 contacts the tamper bead retaining fastener 324. The contact between the tamper bead 326 and the tamper bead retaining fastener 324, together with the force continuously applied by the user, causes the bridge 320a ( Figure 1 ) to separate the cap 216 from the tamper band 320, thereby leaving the tamper band 320 around the plunger 200 to visually indicate that the cap 216 has been removed.

[0096] In one example, reference Figure 14 To assemble the sensor inserter 104, the needle inserter 198 is coupled to the physiological characteristic sensor 102. The retraction spring 206 is positioned around the needle inserter 198. The needle inserter 198 is coupled to the needle retractor 204 such that the retraction spring 206 is disposed around the needle retractor 204. The sensor carrier 212 is coupled to the needle retractor 204, and the sensor holder 210 is coupled to the sensor carrier 212. The frame 208 is coupled to the sensor carrier 212. The insertion spring 202 is coupled to the sensor carrier 212, and the plunger 200 is coupled to the frame 208. The cap 216 having a membrane 218 and a tamper strip 320 coupled to the cap 216 is threadedly coupled to the plunger 200. The sensor inserter 104 including the physiological characteristic sensor 102 can be sterilized and shipped to the end user.

[0097] Once received, refer to Figure 30 , the user can remove the cap 216. When the user unscrews the cap 216, the tamper strip 320 moves along the bridge 320a ( Figure 1 ) breaks and remains coupled to the plunger 200. With the cap 216 removed, the physiological characteristic sensor 102 is exposed for insertion. Additionally, removing the cap 216 removes the magnetic field generated by the magnet 214. Based on the magnetic field from the magnetic sensor 119 ( Figure 3 ) sensor signal, the control module 162 ( Figure 3 ) starts monitoring the glucose sensor 114 ( Figure 3) sensor signal. In other words, removal of cap 216 activates physiological characteristic sensor 102 to monitor glucose sensor 114 and transmit blood glucose level through antenna 108, 108'. Figure 31 , the user can position the sensor inserter 104 at the desired insertion site, which may or may not be visible to the user. The user can depress the plunger 200, which releases the sensor carrier 212 ( Figure 14 ) and the holder arm 266 of the sensor holder 210 ( Figure 14 ). Sensor carrier 212 and holder arm 266 ( Figure 14 ) release to separate the physiological characteristic sensor 102 from the sensor inserter 104. Once the sensor carrier 212 is released from the frame 208 ( Figure 14 ) is released, the insertion spring 202 applies a force F1 to couple the physiological characteristic sensor 102 to the user, such as Figure 31A As shown. Figure 31A , the sensor inserter 104 is in the second position.

[0098] Usually, reference Figure 31B Once the insertion spring 202 deploys the sensor carrier 212, the retraction spring 206 applies a force F2 ( Figure 2 ) and retracts the needle retractor 204 upward, which in turn causes the needle inserter 198 ( Figure 14 ) is retracted into the plunger 200. Figure 31B In the embodiment, the sensor inserter 104 is in the third position. This prevents the user from accidentally contacting the insertion needle 222 ( Figure 14 ) and prevents reuse of the sensor inserter 104. Figure 32 and Figure 32A Once the physiological characteristic sensor 102 is coupled to the user at the insertion site, the sensor inserter 104 is removed from the insertion site and disposed of. The sensor inserter 104 remains Figure 32 and Figure 32A The third position in .

[0099] Although at least one exemplary embodiment has been presented in the foregoing detailed description, it should be understood that there are a large number of variations. It should also be understood that the one or more exemplary embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. On the contrary, the foregoing detailed description will provide a convenient roadmap for those skilled in the art to implement the one or more described embodiments. It should be understood that various changes may be made to the function and arrangement of the elements, including known equivalents and foreseeable equivalents at the time of filing this patent application, without departing from the scope defined by the claims.

[0100] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any process or method described herein can be performed in a different order, can be added, combined, or omitted entirely (e.g., not all described actions or events may be required to perform the technology). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the technology of the present disclosure can be performed by a combination of units or modules associated with, for example, a medical device.

[0101] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium may include a non-transitory computer-readable medium, which corresponds to a tangible medium such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0102] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Thus, the term "processor," as used herein, may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described techniques. Additionally, the present techniques may be fully implemented in one or more circuits or logic elements.

Claims

1. A physiological characteristic sensor system comprising: A physiological characteristic sensor comprising a housing, an antenna, and a sensor, the housing having a first housing portion coupled to a second housing portion, the second housing portion having a bottom region and a sidewall extending upward from the bottom region, wherein the first housing portion and the second housing portion cooperate to enclose a portion of the sensor and the antenna, wherein the antenna is coupled to the first housing portion to face a first surface of the second housing portion, and the portion of the sensor is coupled to the first surface; and A sensor inserter, the sensor inserter being configured to be coupled to the physiological characteristic sensor, the sensor inserter including a sensor holder, the sensor holder being configured to be coupled to the side wall of the second shell portion in a second state when the second shell portion is at least partially located within the sensor inserter, and being configured to be separated from the second shell portion of the physiological characteristic sensor in a first state when the second shell portion is at least partially located within the sensor inserter, the sensor holder including a central hole of the shell configured to receive the physiological characteristic sensor, and a plurality of retainer arms spaced around the periphery of the central hole to surround the shell of the physiological characteristic sensor, each of the plurality of retainer arms being capable of moving between a first state and a second state, in the first state, an end of each of the plurality of retainer arms being spaced from a surface of the sensor holder to define a gap, and in the second state, an end of each of the plurality of retainer arms contacting the surface of the sensor holder. 2 . The physiological characteristic sensor system of claim 1 , wherein the sensor inserter comprises a plunger movable relative to a frame, and a sensor carrier coupled to the frame, and the sensor holder is coupled to the sensor carrier. 3 . The physiological characteristic sensor system of claim 2 , wherein the frame has at least one rib that holds the sensor holder in the second state. 4 . The physiological property sensor system of claim 2 , wherein the sensor inserter includes a cap, and the cap is threadably coupled to the plunger and the frame such that the cap forms an interference fit with the end of the plunger.

5. The physiological characteristic sensor system of claim 4, wherein the cap further comprises a tamper-evident strip having a plurality of bridges coupling the cap to the tamper-evident strip and configured to break when the cap is removed from the plunger. 6 . The physiological property sensor system of claim 4 , wherein the cap further comprises a magnet that is axially magnetized to generate a magnetic field, and the physiological property sensor comprises a magnet sensor responsive to the magnetic field.

7. The physiological property sensor system of claim 2, wherein the sensor carrier includes a retaining flange having a surface that is continuous around a perimeter of the retaining flange for coupling an adhesive patch associated with the physiological property sensor to an anatomical structure.

8. The physiological characteristic sensor system of claim 1, wherein a printed circuit board assembly is coupled to the first surface of the second housing portion, and the printed circuit board assembly includes at least one spring contact to electrically couple the antenna to the printed circuit board assembly.

9. The physiological characteristic sensor system of claim 8, wherein the first housing portion includes a first contact, a second contact is coupled to the printed circuit board, and at least one battery is coupled to the second contact and the second housing portion.

10. The physiological characteristic sensor system of claim 9, wherein the first contact comprises a pair of spring arms interconnected by a body, and the body is coupled to the first housing portion such that the pair of spring arms are movable relative to the body.

11. A physiological characteristic sensor system according to claim 1, wherein the physiological characteristic sensor includes a glucose sensor, a sealing member and a second sealing member, the sealing member is connected between the distal end of the glucose sensor and the first shell part, and the second sealing member is connected between the distal end of the glucose sensor and the second shell part.

12. A physiological characteristic sensor system according to claim 11, wherein the first shell portion includes a first angled surface, the first angled surface compresses the sealing member to form a seal, and the second shell portion includes a second angled surface, the second angled surface compresses the second sealing member to form a second seal.

13. A physiological characteristic sensor system comprising: a physiological characteristic sensor comprising a housing and a sensor, the housing having a first housing portion coupled to a second housing portion, the second housing portion having a bottom region and a sidewall extending upwardly from the bottom region, wherein the first housing portion and the second housing portion cooperate to enclose a portion of the sensor, and the portion of the sensor is coupled to a first surface of the second housing portion; and A sensor inserter configured to be coupled to the physiological characteristic sensor, the sensor inserter comprising a frame, a sensor carrier, and a sensor holder, the sensor carrier comprising a retaining flange, the sensor holder coupled to the sensor carrier to be received within the retaining flange, and the sensor carrier coupled to the frame, the frame having a plurality of ribs spaced around an inner periphery of the frame, the sensor holder comprising a central hole configured to receive the housing of the physiological characteristic sensor, and a plurality of retainer arms spaced around a periphery of the central hole to surround the housing of the physiological characteristic sensor, the plurality of retainer arms being configured to couple to the housing in a second state when the second housing portion is at least partially located within the sensor inserter. The side wall of the second housing portion of the physiological characteristic sensor extends upward from the bottom area and is configured to be separated from the second housing portion of the physiological characteristic sensor in a first state when the second housing portion is at least partially located within the sensor inserter, each of the plurality of retainer arms is capable of moving between a first state and a second state, in which, in the first state, the end of each of the plurality of retainer arms is spaced apart from the surface of the sensor holder to define a gap, and in the second state, the end of each of the plurality of retainer arms contacts the surface of the sensor holder, and each of the plurality of ribs biases the corresponding retainer arm of the plurality of retainer arms in the second state to eliminate the gap.

14. A physiological characteristic sensor system according to claim 13, wherein the sensor inserter includes a plunger capable of moving relative to the frame, and a cap, the cap being capable of being coupled to the plunger and the frame by threads so that the cap forms an interference fit with the end of the plunger, and the cap further includes a tamper-evident band having a plurality of bridge members, the plurality of bridge members coupling the cap to the tamper-evident band and being configured to break when the cap is removed from the plunger. 15 . The physiological property sensor system of claim 14 , wherein the cap further comprises a magnet that is axially magnetized to generate a magnetic field, and the physiological property sensor comprises a magnet sensor responsive to the magnetic field.

16. A physiological characteristic sensor system comprising: a physiological characteristic sensor comprising a housing, a sensor, an antenna, a printed circuit board assembly, and a battery, the housing having a first housing portion coupled to a second housing portion, the second housing portion having a bottom region and a sidewall extending upward from the bottom region, wherein the first housing portion and the second housing portion cooperate to enclose a portion of the sensor, the antenna, the printed circuit board assembly, and the battery, the antenna and a first contact coupled to the first housing portion, the printed circuit board assembly and the battery coupled to a first surface of the second housing portion, the portion of the sensor coupled to the printed circuit board assembly and the first surface of the second housing portion, the antenna and the battery in communication with the printed circuit board assembly, and the first contact comprising a pair of spring arms interconnected by a body, the body coupled to the first housing portion such that the pair of spring arms are movable relative to the body; and the physiological characteristic sensor comprising an adhesive patch coupled to the bottom region of the second housing portion; and A sensor inserter, the sensor inserter being configured to be connected to the physiological characteristic sensor, the sensor inserter including a sensor holder, the sensor holder being configured to be connected to the side wall of the second shell part in a second state when the second shell part is at least partially located within the sensor inserter, and being configured to be separated from the second shell part in a first state when the second shell part is at least partially located within the sensor inserter, the sensor holder including a central hole of the shell configured to receive the physiological characteristic sensor, and a plurality of retainer arms spaced around the periphery of the central hole to surround the shell of the physiological characteristic sensor, each of the plurality of retainer arms being capable of moving between a first state and a second state, in the first state, an end of each of the plurality of retainer arms being spaced from a surface of the sensor holder to define a gap, and in the second state, an end of each of the plurality of retainer arms contacting the surface of the sensor holder. 17 . The physiological characteristic sensor system of claim 16 , wherein the antenna comprises at least one spring contact, the at least one spring contact being in contact with the PCB assembly to enable communication between the antenna and the PCB assembly.

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