WO2025178614A1

WO2025178614A1 - Continuous analyte monitor

Info

Publication number: WO2025178614A1
Application number: PCT/US2024/016612
Authority: WO
Inventors: Connor KREHBIEL; Justin Brett LYBBERT; Hans Jensen
Original assignee: Roche Diabetes Care Inc
Current assignee: Roche Diabetes Care Inc
Priority date: 2024-02-21
Filing date: 2024-02-21
Publication date: 2025-08-28
Anticipated expiration: 2026-08-21

Abstract

A continuous analyte monitor device includes a sensor, a first and second substrate, and at least one second electrical contact. The sensor includes (i) an in vivo portion having at least one electrode, and (ii) an ex vivo portion having at least one first electrical contact operably connected to the at least one electrode. The first substrate is configured to receive the sensor. The movable second substrate is configurable in (i) a first position in which a distal end of the second substrate is spaced apart from the first substrate, and (ii) a second position in which the distal end is against the first substrate and the sensor. The at least one second electrical contact is mounted on the first substrate or the distal end of the second substrate. In the second position the ex vivo portion is prevented from moving relative to the first substrate and the second substrate.

Description

CONTINUOUS ANAUYTE MONITOR

Field

[0001] This disclosure relates to the field of continuous analyte monitors, and, in particular, to forming and maintaining a robust electrical and mechanical connection to a sensor of the continuous analyte monitor.

Background

[0002] In many fields of medical treatment and healthcare, the monitoring of certain body functions is required. Some of the monitored body functions are related to analyte levels in the blood or interstitial fluid of the person. For example, glucose is an exemplary analyte and people with diabetes monitor their blood glucose concentration level as a typical part of their daily routine in order to manage their insulin levels. Preferably, the blood glucose concentration level is measured at least several times per day, so that the person can determine when to initiate a responsive medication (such as insulin or an insulin analog) when certain limits are exceeded. In order not to unduly disrupt the daily routine of the person, in many cases a portable medical test device is used. Many different types of portable medical test devices for monitoring various body functions and the associated analytes are commercially available.

[0003] One type of portable medical test device is a continuous analyte monitor (“CAM”) system, which, in the context of the above example, is also referred to as a continuous glucose monitor (“CGM”) system. The typical CAM system includes a body-worn device that communicates electronically with a computing device, such as a smartphone, that runs a corresponding application or “app.” A benefit of the CGM system is that the person’s blood glucose concentration level is monitored periodically. For example, the CGM system may generate a new blood glucose concentration level reading every five minutes. Another benefit of the CGM system is that users do not have to prick their finger to draw blood for testing throughout the day. As a result, CGM systems have become popular with people with diabetes. [0004] Typically, the body-worn device of a CAM system includes a sensor extending from an exterior housing. A portion of the sensor is positioned under the skin of the person in contact with interstitial fluids. An opposite end of the sensor is electrically connected to a controller of the body- worn device. In order for the controller to accurately and reliably operate the sensor, a robust electrical and mechanical connection should be formed between the controller and the sensor. The electrical and mechanical connection, however, is typically difficult to establish in a robust, efficient, and economical way.

[0005] Based on the above, it is desirable to improve the structure and the process of electrically and mechanically connecting the sensor of a CAM device, such as a CGM device.

Summary

[0006] According to an exemplary embodiment of the disclosure, a continuous analyte monitor device includes a sensor, a first substrate, a movable second substrate, and at least one second electrical contact. The sensor includes (i) an in vivo portion having at least one electrode, and (ii) an ex vivo portion having at least one first electrical contact operably connected to the at least one electrode. The first substrate is configured to receive the sensor. The movable second substrate is configurable in (i) a first position in which a distal end of the second substrate is spaced apart from the first substrate and the sensor, and (ii) a second position in which the distal end is against the first substrate and the sensor. The at least one second electrical contact is mounted on the first substrate or the distal end of the second substrate. In the second position (i) the at least one first electrical contact is in electrical connection with the at least one second electrical contact, and (ii) the ex vivo portion is prevented from moving relative to the first substrate and the second substrate.

[0007] In an embodiment, the continuous analyte monitor device also includes a support frame and a block. The support frame is operably connected to the first substrate and includes a ceiling. The distal end of the second substrate is at least partially located between the first substrate and the ceiling. The block is configured to be positioned between the ceiling and the second substrate to press the second substrate against the first substrate and the sensor, such that the second substrate is held in the second position.

[0008] According to one embodiment, the block is a battery, and the support frame is a battery support frame electrically connected to the battery. The resiliency of the battery support frame presses the battery against the second substrate.

[0009] In another embodiment, the continuous analyte monitor device also includes a housing including a first shell and a second shell that is operably connected to the first shell. The housing holds the second substrate in the second position when the second shell is operably connected to the first shell. [0010] According to an embodiment, the second shell includes a protrusion that is positioned against the second substrate when the second shell is operably connected to the first shell.

[0011] In a further embodiment, the first shell defines a first v-shaped slot configured to receive the first substrate and the second substrate, and the second shell defines a second v- shaped slot configured to receive the first substrate and the second substrate. Connection of the second shell to the first shell causes the first v-shaped slot and the second v-shaped slot to compress the first substrate and the second substrate against the ex vivo portion of the sensor. [0012] The continuous analyte monitor device, in another embodiment, includes a plurality of guide pins extending from the first substrate. The second substrate is located between the plurality of guide pins in the second position, such that the second substrate is aligned with the ex vivo portion of the sensor.

[0013] In a further embodiment, the second substrate is a flexible printed circuit board, and the first substrate is a flexible printed circuit board or a rigid printed circuit board. The in vivo portion is movable relative to the first substrate and the second substrate when the second substrate is in the second position.

[0014] According to another embodiment, the second substrate is biased to the first position.

[0015] The continuous analyte monitor device, in another embodiment, includes an intermediate substrate located between a proximal end of the second substrate and the distal end of the second substrate, such that the second substrate defines an inner substrate portion and an outer substrate portion. The second substrate is a flexible printed circuit board, and the first substrate and the intermediate substrate are rigid printed circuit boards. The intermediate substrate is movable relative to the first substrate by flexing the inner substrate portion.

[0016] In a further embodiment, the continuous analyte monitor device includes a connector configured to operably connect a proximal end of the second substrate to the first substrate.

[0017] According to another exemplary embodiment of the disclosure, a method of assembling a continuous analyte monitor device includes positioning a sensor between a first substrate and a second substrate with the second substrate in a first position. A proximal end of the second substrate is fixedly connected to the first substrate, and a distal end of the second substrate movable relative to the first substrate. The sensor includes an in vivo portion and an ex vivo portion. The method further includes moving the second substrate toward the first substrate from the first position to a second position to electrically connect the ex vivo portion to at least one of the first substrate and the second substrate, and holding the second substrate in the second position to prevent movement of the ex vivo portion relative to the first substrate and the second substrate.

[0018] In an embodiment, the method also includes inserting a block between a ceiling of a support frame and the second substrate to hold the second substrate in the second position. The support frame extends from the first substrate. The second substrate is at least partially located between the first substrate and the ceiling in the first position and the second position.

[0019] According to another embodiment, the block is a battery, and a resiliency of the support frame presses the battery against the second substrate to apply a compressive force on the ex vivo portion between the first substrate and the second substrate.

[0020] In one embodiment, the second substrate is electrically connected to a first terminal of the battery, and the support frame is electrically connected to an opposite second terminal of the battery.

[0021] In another embodiment, the first substrate is mounted on a first shell of a housing of the continuous analyte monitor device. A second shell of the housing is connected to the first shell to hold the second substrate in the second position.

[0022] In a further embodiment, the method includes folding the second shell onto the first shell to mechanically connect the second shell to the first shell. First electrical components are mounted on the first shell, and second electrical components are mounted on the second shell. A flexible electrical connection strip extends from the first shell and the second shell to electrically connect the first electrical components to the second electrical components.

[0023] According to another embodiment, the in vivo portion includes at least one electrode, and the ex vivo portion includes at least one first electrical contact operably connected to the at least one electrode. At least one second electrical contact is mounted on the first substrate or the second substrate. The method further includes forming an electrical connection between the at least one first electrical contact and the at least one second electrical contact by moving the second substrate to the second position. [0024] In another embodiment, holding the second substrate in the second position includes compressing the ex vivo portion between the first substrate and the second substrate to prevent the movement of the ex vivo portion.

[0025] In a further embodiment, the method also includes positioning a housing of the continuous analyte monitor device on the skin of a person, and moving the in vivo portion to a position under the skin of the person after the second substrate has been held in the second position.

Brief Description of the Figures

[0026] The above-described features and advantages, as well as others, should become more readily apparent to those of ordinary skill in the art by reference to the following detailed description and the accompanying figures in which:

[0027] FIG. 1 is a block diagram of a person and a CAM system, a CAM device of the CAM system is mounted on the person and is in communication with a remote controller of the CAM system;

[0028] FIG. 2 is a block diagram of the CAM device of FIG. 1;

[0029] FIG. 3A illustrates a lower substrate, an upper substrate, and a sensor of the CAM device of FIG. 1 with the upper substrate in a raised position;

[0030] FIG. 3B illustrates the lower substrate, the upper substrate, and the sensor of FIG. 3A with the upper substrate in a lowered position;

[0031] FIG. 4 illustrates an interior housing of the CAM device of FIG. 1 including the lower substrate, the upper substrate, and the sensor of FIG. 3, the interior housing is shown in an open configuration;

[0032] FIG. 5 is a cross-sectional view taken along the line V-V of FIG. 4 showing the interior housing in a closed configuration and located within an exterior housing that is also in a closed configuration;

[0033] FIG. 6 is a flowchart illustrating a method for assembling the CAM device of FIG. 1;

[0034] FIG. 7A illustrates another embodiment of the lower substrate, the upper substrate, and the sensor of the CAM device of FIG. 1, a support frame is connected to the lower substrate and a block is positioned near the substrates; [0035] FIG. 7B is a top view of the embodiment of FIG. 7 A;

[0036] FIG. 7C is a side view of the embodiment of FIGs. 7A and 7B, with the block in a second position that secures the sensor to the upper substrate and the lower substrate;

[0037] FIG. 8 is a first view of a circuit package for use with the CAM device of FIG. 1, the circuit package includes a lower printed circuit board connected to an upper printed circuit board by a flexible connector;

[0038] FIG. 9 is a second view of the circuit package of FIG. 8;

[0039] FIG. 10 is a third view of the circuit package of FIG. 8;

[0040] FIG. 11 A shows another embodiment of the lower substrate, the upper substrate, and the sensor of the CAM device of FIG. 1, the upper substrate is shown in a raised position;

[0041] FIG. 1 IB shows the embodiment of FIG. 11 A with the upper substrate in a lowered position;

[0042] FIG. 12A shows another embodiment of the lower substrate, the upper substrate, and the sensor of the CAM device of FIG. 1, the upper substrate is shown in a raised position;

[0043] FIG. 12B shows the embodiment of FIG. 12A with the upper substrate in a lowered position;

[0044] FIG. 13 shows another embodiment of the lower substrate, the upper substrate, and the sensor of the CAM device of FIG. 1, the interior housing includes housing shells defining a pair of v-shaped slots in which the substrates are located;

[0045] FIG. 14 shows another embodiment of the lower substrate, the upper substrate, and the sensor of the CAM device of FIG. 1, the upper substrate is shown in a raised position; and

[0046] FIG. 15 shows yet another embodiment of the lower substrate, the upper substrate, and the sensor of the CAM device of FIG. 1, the upper substrate is shown in a raised position and guide pins extend from the lower substrate.

Detailed Description

[0047] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and described in the following written specification. It is understood that no limitation to the scope of the disclosure is thereby intended. It is further understood that this disclosure includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles of the disclosure as would normally occur to one skilled in the art to which this disclosure pertains.

[0048] Aspects of the disclosure are disclosed in the accompanying description. Alternate embodiments of the disclosure and their equivalents may be devised without parting from the spirit or scope of the disclosure. It should be noted that any discussion herein regarding “one embodiment,” “an embodiment,” “an exemplary embodiment,” and the like indicate that the embodiment described may include a particular feature, structure, or characteristic, and that such particular feature, structure, or characteristic may not necessarily be included in every embodiment. In addition, references to the foregoing do not necessarily comprise a reference to the same embodiment. Finally, irrespective of whether it is explicitly described, one of ordinary skill in the art would readily appreciate that each of the particular features, structures, or characteristics of the given embodiments may be utilized in connection or combination with those of any other embodiment discussed herein.

[0049] For the purposes of the disclosure, the phrase “A and/or B” means (A), (B), or (A and B). For the purposes of the disclosure, the phrase “A, B, and/or C” means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C).

[0050] The terms “comprising,” “including,” “having,” and the like, as used with respect to embodiments of the disclosure, are synonymous.

[0051] As shown in FIG. 1 a continuous analyte monitor (“CAM”) system 100 includes a CAM device 104 and a remote controller 108. The CAM device 104, which is also referred to as a patch or a CAM patch, is mounted on skin 112 of a person 116 and is configured to generate electronic data 120 corresponding to a monitored analyte of the person 116. The electronic data 120 is transmitted from the CAM device 104 to the remote controller 108 to be shown on a display 124 of the remote controller 108, for example. In an exemplary embodiment, the monitored analyte is a blood glucose concentration level, the CAM system 100 is a continuous glucose monitor (“CGM”) system, and the CAM device 104 is a CGM device.

[0052] Disclosed herein is a structure and a method 600 (FIG. 6) of easily and robustly connecting a sensor 136 (FIG. 2) of the CAM device 104 to electronic substrates 172, 176 (FIG. 3A) of the CAM device 104, so that a processor 140 (FIG. 2) of the CAM device 104 is configured to perform operations on the electronic data 120 coming from the sensor 136. The structure and the method 600 disclosed herein provide for a robust electrical and mechanical connection that simplifies manufacturing of the CAM device 104. Each aspect of the CAM system 100 is described below, and several embodiments and approaches are disclosed.

[0053] With reference to FIG. 2, the CAM device 104 includes a transceiver 128, a memory 132, and a sensor 136 each operably connected to a processor 140. The CAM device 104 also includes a corresponding housing 144 in which the transceiver 128, the memory 132, the sensor 136, and the processor 140 are at least partially located.

[0054] The transceiver 128, in one embodiment, is configured for the wired and/or wireless exchange of data with the remote controller 108. The transceiver 128 includes one or more modems, processors, memories, oscillators, antennas, or other hardware conventionally included in a communications module to enable electronic communications with various other devices. For example, the transceiver 128 may exchange electronic data using a wireless local area network (“Wi-Fi”), a personal area network, Bluetooth®, ncar-ficld communication (“NFC”), ultra-wide band (“UWB”), a cellular network, and/or any other wireless network protocol. Accordingly, the transceiver 128 is compatible with any desired wireless communication standard or protocol including, but not limited to, IEEE 802.11, IEEE 802.15.1 (“Bluetooth®”), Global System for Mobiles (“GSM”), and Code Division Multiple Access (“CDMA”). In one embodiment, the transceiver 128 operably connects the CAM device 104 to the Internet for data exchange with any other Internet-connected device. In another embodiment, the transceiver 128 transmits and receives data directly from the remote controller 108 without being connected to the Internet. The transceiver 128 is also referred to herein as a network adapter, a network device, and/or a network communication module.

[0055] As shown in FIG. 2, the memory 132 of the CAM device 104 is configured to store data and program instructions that, when executed by the processor 140, enable the CAM device 104 to perform various operations described herein. The memory 132 is any type of electronic device capable of storing information accessible by the processor 140, such as a memory card, read only memory (“ROM”), random access memory (“RAM”), a hard drive, a solid state drive, a disc, flash memory, or any of various other computer-readable media serving as data storage devices, as will be recognized by those of ordinary skill in the art. The memory 132 is also referred to herein as a non-transitory computer readable medium, a non-transitory, and a non-transitory memory. The memory 132 stores the electronic data 120 generated by the processor 140 from the sensor 136.

[0056] The sensor 136, as shown in FIG. 2, includes an in vivo portion 148 and an ex vivo portion 152. In one embodiment, the sensor 136 is an enzyme-based amperometric biosensor that is configured to electrically react to glucose concentrations in the interstitial fluid 158 (FIG. 5). Glucose is an exemplary analyte to which the sensor 136 is configured to react. In other embodiments, the sensor 136 reacts to glucose concentrations according to other suitable structural configurations and methodologies. The sensor 136 is referred to as a semi-implantable sensor.

[0057] The in vivo portion 148 of the sensor 136 includes, for example, two electrodes 156 configured to have an electrical response corresponding to a monitored predetermined analyte, such as, for example, the glucose concentration level of the interstitial fluid 158 (FIG. 5). The in vivo portion 148 may include from one to ten of the electrodes 156. In the illustrated example, the in vivo portion 148 is positioned under the skin 112 of the person 116 and in contact with the interstitial fluid 158 (FIG. 5) of the person 116. The in vivo portion 148 is not typically positioned in contact with blood of the person 116. A skin piercing device (not shown) of the CAM device 104 includes a needle (not shown) that injects the in vivo portion 148 of the sensor 136 through the skin 112 after the CAM device 104 is mounted on the person 116 (or as part of the mounting process). The in vivo portion 148 remains below the skin 112 during operation of the CAM device 104. The in vivo portion 148 is easily removable from under the skin 112 by separating the CAM device 104 from the skin 112 and moving the CAM device 104 away from the skin 112.

[0058] The ex vivo portion 152 of the sensor 136 includes, for example, two electrical contacts 160 that are each electrically connected to a corresponding one of the electrodes 156. In one embodiment, the ex vivo portion 152 includes the same number of electrical contacts 160 as the number of electrodes 156. The electrical contacts 160 are electrically connected to the electrodes 156. At least a portion of the ex vivo portion 152 is located outside or above the skin 112 of the person 116 when the CAM device 104 is mounted on the person 116.

[0059] In an example, the sensor 136 is a substantially cylindrical wire-like structure that is flexible, and the electrical contacts 160 extend around a circumference of the sensor 136 so that electrical connection of the sensor 136 to the processor 140 is simplified. In another embodiment, the electrical contacts 160 include flat areas (not shown) for electrical connection to corresponding contacts 180, 192 (FIG. 3A). The sensor 136, in another embodiment, is any sensor 136 that includes electrical contacts 160 and electrodes 156 configured to monitor the predetermined analyte.

[0060] The predetermined analyte monitored by the CAM system 100 and sensed by the sensor 136 is any substance that is the subject of chemical analysis. For example, the analyte, in one embodiment, is glucose. Embodiments of the CAM system 100 configured for sensing glucose are also referred to as CGM systems that include CGM devices for mounting on the person 116. The CAM system 100 is configurable for monitoring any predetermined analyte including non-glucose analytes such as ketones, lactate, oxygen, alcohol, and others. To configure the CAM system 100 for monitoring a predetermined analyte, the composition of the sensor 136 is configured accordingly. For example, the material from which the electrodes 156 arc formed is selected so that the sensor 136 has a suitable electrical response to the presence, absence, amount, concentration, and/or level of the predetermined analyte. Suitable electrical responses include, but are not limited to, changes in resistance, capacitance, and inductance as can be detected by the processor 140.

[0061] With reference still to FIG. 2, the processor 140 of the CAM device 104 is configured to execute instructions to operate the CAM system 100 to enable the features, functionality, characteristics, and/or the like as described herein. The processor 140 generally comprises one or more processors which may operate in parallel or otherwise in concert with one another. It will be recognized by those of ordinary skill in the art that the term “processor” as used herein includes any hardware system, hardware mechanism, or hardware component that processes data, signals, or other information. Accordingly, the processor 140 may include a system with a central processing unit, graphics processing units, multiple processing units, dedicated circuitry for achieving functionality, programmable logic, or other processing systems. The processor 140 uses the electrical connection to the sensor 136 to generate the electronic data 120, which are a measure of the blood glucose concentration level of the person 116, from the reaction of the sensor 136 to the glucose concentration of the interstitial fluid 158.

[0062] The housing 144 of the CAM device 104 is mounted on the skin 112 of the person 116, as is shown in FIG. 1, with an adhesive 164 (FIG. 5). In one embodiment, the housing 144 is mounted on the upper arm area of the person 116. In other embodiments, the housing 144 is mounted in any other desired and medically-suitable location, as may depend on the structure and the physiology of the person 116. The housing 144 is also referred to herein as an exterior housing 144, and the CAM device 104 also includes an interior housing 146 (FIGs. 4 and 5) that is positioned within the exterior housing 144.

[0063] In FIG. 1, the remote controller 108 of the CAM system 100 is illustrated as a smartphone or mobile device and includes the display 124, a touchscreen input device, a speaker output device, a processor, and corresponding electronic memory. In other embodiments, the remote controller 108 is provided as a dedicated remote device, a laptop computer, a desktop computer, a tablet computer, or any other type of computing device configured for electronic communication with the CAM device 104. Moreover, in some embodiments, the remote controller 108 is provided as a program or application (i.e., “app”) residing on a non-transitory electronic memory of a corresponding smartphone, mobile device, dedicated remote device, or the like.

[0064] As shown in FIGs. 3A and 3B, a lower substrate 172 (i.e., first substrate) and an upper substrate 176 (i.e., second substrate) are configured to mechanically connect to the sensor 136. At least one of the substrates 172, 176 electrically connects the sensor 136 to the processor 140 and/or to any other electrical component of the CAM device 104. In an embodiment, the processor 140 is mounted on or electrically connected to one of the substrates 172, 176.

[0065] The lower substrate 172 is configured to receive the sensor 136 and includes, in this example, two electrical contacts 180 configured to electrically connect to corresponding electrical contacts 160 of the sensor 136. The electrical contacts 180 are mounted on the lower substrate 172. The electrical contacts 180 are flat conductive areas of the lower substrate 172, and are also referred to herein as “pads.” The lower substrate 172, in one embodiment, is a rigid printed circuit board (“PCB”). In other embodiments, however, the lower substrate 172 is a flexible PCB or a hybrid rigid/llexible PCB. The lower substrate 172 includes electrical leads 184 (also referred to as traces) that electrically connect the contacts 180 to the processor 140 through a connector 188. hr other embodiments, the lower substrate 172 includes from zero to ten of the contacts 180. The contacts 180 and the leads 184 provide direct electrical sensor signal pathways from the sensor 136 to the electrical components of the CAM device 104 including the processor 140. [0066] The upper substrate 176 is movably connected to the lower substrate 172, and is also referred to as a movable second substrate, a floating finger, and a flexible finger. In the illustrated example, the upper substrate 176 includes two electrical contacts 192 (shown in phantom) on a side of the upper substrate 176 facing the lower substrate 172. The electrical contacts 192 are flat conductive areas of the upper substrate 176. The electrical contacts 192 are mounted on the upper substrate 176. The contacts 192 are configured to electrically connect to corresponding electrical contacts 160 of the sensor 136. The upper substrate 176, in one embodiment, is a flexible PCB. In other embodiment, however, the upper substrate 176 is a rigid PCB. The upper substrate 176 includes electrical leads 196 (shown in phantom) that electrically connect the contacts 192 to the processor 140 through the connector 188. In other embodiments, the upper substrate 176 includes from zero to ten of the contacts 192. In some embodiments, the upper substrate 176 is made to be more robust by the addition of thickeners into the flexible PCB, thereby allowing for more mechanical support.

[0067] The upper substrate 176 defines a distal end 202 and a proximal end 204. The distal end 202 is movable relative to the lower substrate 172 to a raised first position (FIG. 3A) and a lowered second position (FIG. 3B). The distal end 202 is not mechanically connected to the lower substrate 172, thereby enabling movement of the upper substrate 176 to the raised and lowered positions. In one embodiment, the distal end 202 is biased to the raised position, such that when no outside forces are imparted on the distal end 202, the upper substrate 176 is in the raised position. In such an embodiment, the raised position is a default position or a normal position of the upper substrate 176. The proximal end 204 is fixedly connected to the lower substrate 172 by a suitable electrical and mechanical connector 188. The proximal end 204 of the upper substrate 176 is not movable relative to the lower substrate 172.

[0068] The connector 188, as shown in FIGs. 3 A and 3B, is provided as a flat flexible cable (“FFC”) connector or a flexible printed cable (“FPC”) connector. In another embodiment, the connector 188 is provided by soldering contacts (not shown) of the upper substrate 176 directly to contacts (not shown) of the lower substrate 172. Any other type of connector 188 may be utilized that locks the substrates 172, 176 in place. For example, the upper substrate 176 may include a zero insertion force (“ZIF”) tail for connection to a suitable ZIF receiver mounted on the lower substrate 172. [0069] As noted, in FIG. 3A, the upper substrate 176 is shown in the raised position in which the distal end 202 is spaced apart from the lower substrate 172. Also in FIG. 3A, the sensor 136 is shown as being received by the lower substrate 172. The sensor 136 is received by the lower substrate 172 when (i) the electrical contacts 160 of the sensor 136 are positioned on the electrical contacts 180 of the lower substrate 172, and (ii) the electrical contacts 160 of the sensor 136 are positioned below the electrical contacts 192 of the upper substrate 176 in the areas identified with the circles 206. The electrical contacts 192 move to the position of the circles 206 when the upper substrate 176 is in the lowered position.

[0070] With reference to FIG. 3B, the upper substrate 176 is shown in the lowered position in which the distal end 202 has been moved in the direction 208 (FIG. 3A) toward the lower substrate 172 and the sensor 136. In the lowered position, the distal end 202 of the upper substrate 176 is positioned against the lower substrate 172 and the sensor 136, with the sensor 136 sandwiched between the substrates 172, 176. The upper substrate 176 is held in the lowered position in order to form a robust mechanical and electrical connection between the electrical contacts 180, 192 of the substrates 172, 176 and the electrical contacts 160 of the sensor 136. That is, in the lowered position (i.e., the second position) (i) the electrical contacts 180, 192 of the substrates 172, 176 are in electrical connection with the electrical contacts 160 of the sensor 136, and (ii) the ex vivo portion 152 of the sensor 136 is prevented from moving relative to the substrates 172, 176. The in vivo portion 148 of the sensor 136 is movable relative to the substrates 172, 176 when the upper substrate 176 is in the lowered position to enable injection of the in vivo portion 148 through the skin 112.

[0071] FIGs. 4 and 5 illustrate an exemplary embodiment of the interior housing 146 of the CAM device 104 for holding the substrates 172, 176 with the upper substrate 176 in the lowered position that robustly secures the sensor 136 and provides the strong electrical connection to the sensor 136. The interior housing 146 includes a lower shell 210 (a first shell) and an upper shell 214 (a second shell) that are operably connected by a flexible connector 218 (i.e., a flexible electrical connection strip). In FIG. 4, the interior housing 146 is shown in an open position that does not hold the upper substrate 176 in the lowered position. The interior housing 146 is configurable in a closed position, as shown in FIG. 5. In the closed position, the upper shell 214 is operably connected to the lower shell 210 and the interior housing 146 holds the upper substrate 176 in the lowered position. Due to the shape of interior housing 146 and the manner in which the interior housing 146 closes, the interior housing 146 is referred to as a “sandwich”-type of housing or a “taco”-type of housing.

[0072] FIG. 4 illustrates that both of the substrates 172, 176 arc mounted on the lower shell 210 of the interior housing 146. With the interior housing 146 in the open position of FIG.

4, the distal end 202 of the upper substrate 176 is biased away from the lower substrate 172 to the raised position to enable convenient placement of the sensor 136 on the lower substrate 172. The sensor 136 is shown as being received by the lower substrate 172 in FIG. 4. In this embodiment, the upper substrate 176 is a flexible PCB that springs to the raised position when the interior housing 146 is in the open position. Accordingly, the upper substrate 176 may have a curved configuration in the default state.

[0073] In FIG. 4, the lower substrate 172 and the upper substrate 176 arc mounted on the lower shell 210 by the connector 188. Additionally or alternatively, the lower substrate 172 may be glued or soldered to the lower shell 210, for example, hi yet another embodiment, the lower shell 210 of the interior housing 146 is a rigid PCB that includes the electrical contacts 180 and is itself the lower substrate 172. That is, the electrical contacts 180 may be formed directly on the lower shell 210, such that the lower shell 210 is also the lower substrate 172.

[0074] The upper shell 214, as shown in FIG. 4, includes a protrusion 220. The protrusion 220 extends from a roof 224 of the upper shell 214 and defines a pressing surface 228. The pressing surface 228 is substantially planar. The pressing surface 228 is substantially parallel to a main surface 232 of the lower shell 210 when the interior housing 146 is in the closed position. The protrusion 220 is also referred to herein as a skeleton of the interior housing 146. [0075] With reference to FIG. 5, the interior housing 146 is shown in the closed position and located within the exterior housing 144. In the closed position, the lower shell 210 is operably connected to the upper shell 214, such that the interior housing 146 is fixed in the closed position. Although not illustrated, the housing shells 210, 214, in one embodiment, include connectors that interlock or otherwise connect to each other to secure or to lock the interior housing 146 in the closed position.

[0076] When the interior housing 146 is moved to the closed position, the pressing surface 228 of the protrusion 220 presses against (and is positioned against) the upper substrate 176 to hold the upper substrate 176 in the lowered position that establishes the electrical connection and mechanical connection of the sensor 136. The interior housing 146 defines an opening 236 through which the sensor 136 extends in order to reach the person 116.

[0077] The transceiver 128, memory 132, and processor 140 are mounted on or are included in the interior housing 146; however, these elements 128, 132, 140 are not shown in FIGs. 4 and 5. The electrical components of the CAM device 104 (including at least the transceiver 128, the memory 132, and the processor 140) may be mounted within material of the housing shells 210, 214 and/or the electrical components of the CAM device 104 may be mounted on any surface of the housing shells 210, 214.

[0078] The flexible connector 218 of the interior housing 146 is a flexible electrical connection strip that mechanically and electrically links the upper shell 214 and the lower shell 210. As such, electronic data may be transmitted between electrical components (128, 132, 140) mounted in different housing shells 210, 214 through the flexible connector 218, such as when the processor 140 is mounted on the lower shell 210 and the transceiver 128 is mounted on the upper shell 214.

[0079] The exterior housing 144 shown in FIG. 5 includes a top shell 244 and a bottom shell 248 that are operably connected. The interior housing 146 is at least partially located within the exterior housing 144. In one embodiment, the exterior housing 144 is a decorative housing that is contacted by the person 116 when handling the CAM device 104. The exterior housing 144 defines an opening 252 through which the sensor 136 extends in order to reach the person 116. In FIG. 5, the exterior housing 144 is shown mounted on the skin 112 of the person 116 (FIG. 1) with the adhesive 164. The in vivo portion 148 of the sensor 136 is shown inserted through the skin 112 with the electrodes 156 in contact with the interstitial fluid 158.

[0080] As shown in FIG. 6, a method 600 is for assembling the CAM device 104. In block 604, the method 600 includes positioning the sensor 136 on the lower substrate 172 with the upper substrate 176 in the raised position. Positioning the sensor 136 includes moving the ex vivo portion 152 between the distal end 202 of the upper substrate 176 and the lower substrate 172, and aligning the electrical contacts 160 of the ex vivo portion 152 with the electrical contacts 180, 192 on the substrates 172, 176. Since the substrates 172, 176 are spaced apart from each other, the sensor 136 is easily and quickly positioned and received by the lower substrate 172. Dielectric grease may be positioned on the electrical contacts 180 of the lower substrate 172 to cause the ex vivo portion 152 of the sensor 136 to stick to the lower substrate 172 and to hold the sensor 136 in the received position on the lower substrate 172.

[0081] Next, as identified in block 608, the method 600 includes moving the upper substrate 176 toward the lower substrate 172. The upper substrate 172 is moved until the ex vivo portion 152 of the sensor 136 is sandwiched and/or wedged between the substrates 172, 176. The movement of the distal end 202 of the upper substrate 176 may occur as a result of closing the inner housing portions 210, 214, or by being pressed with a tool or finger. When the upper substrate 176 is moved to the lowered position, the electrical contacts 180, 192 of the substrates 172, 176 are positioned against the electrical contacts 160 of the sensor 136. This pressing forms a robust, safe, and reliable electrical connection between the substrates 172, 176 and the sensor 136. The substrates 172, 176 and means of electrical connection also minimize space and reduce component costs.

[0082] In block 612, the method 600 includes holding the upper substrate 176 in the lowered position. The holding may be accomplished by fixedly connecting the housing portions 210, 214 in the closed in position, such as by folding the upper shell 214 onto the lower shell 210 and causing any connectors to interlock. When the interior housing 146 is in the closed position, the protrusion 220 is pressed against the upper substrate 176, which squeezes the ex vivo portion 152 of the sensor 136 between substrates 172, 176. The squeezing is a compressive force imparted on the ex vivo portion 152 that prevents movement, including horizontal movement, vertical movement, and translational movement, of the ex vivo portion 152 relative to the substrates 172, 176.

[0083] In one embodiment, when the ex vivo portion 152 is compressed between the substrates 172, 176, the sensor 136 is permanently mechanically and electrically connected to the substrates 172, 176. As used herein, a permanent connection is one that requires destruction of one of the connected components in order to separate the connected components. In the case of the CAM device 104, when the sensor 136 is pulled to the right in FIG. 3B for example, the sensor 136 typically breaks due to the applied tensile force, and no movement of the connected ex vivo portion 152 occurs relative to the substrates 172, 176.

[0084] After the interior housing 146 is secured in the closed position to establish the robust electrical and mechanical connection to the sensor 136, the interior housing 146 is mounted in the exterior housing 144. The exterior housing 144 is then positioned on the person 116 in a medically- suitable location. During the positioning of the exterior housing 144, the skin piercing device is activated to inject the in vivo portion 148 of the sensor 136 through the skin 112 and to position the in vivo portion 148 in contact with the interstitial fluid 158 located under the skin 112. The secure connection of the ex vivo portion 152 to the substrates 172, 176 prevents any movement of the ex vivo portion 152 during the injection of the in vivo portion 148.

[0085] FIGs. 7A, 7B, and 7C illustrate another embodiment of the structure used to hold the upper substrate 176 in the lowered position to prevent movement of the ex vivo portion 152 of the sensor 136 relative to the substrates 172, 176. As shown, a support frame 304 and a block 308 are used to secure the position of the upper substrate 176.

[0086] With reference to FIGs. 7 A and 7B, the support frame 304 is operably connected to the lower substrate 172. The support frame 304 includes feet 312, struts 316, and a ceiling 320. The feet 312 arc electrically and mechanically connected to the lower substrate 172 in order to mount the support frame 304 on the lower substrate 172. The struts 316 extend from the feet 312 and/or the lower substrate 172. The ceiling 320 is curved and extends from the struts 316. The ceiling 320 connects a left strut 316 to a right strut 316. The ceiling 320 is electrically and mechanically connected to the struts 316 and the feet 312. The feet 312 in one embodiment, are soldered to the lower substrate 172 to form the mechanical and electrical connection of the support frame 304 to the lower substrate 172. A gap 324 is defined between the ceiling 320 and the lower substrate 172.

[0087] The distal end 202 of the upper substrate 176 is at least partially located between the lower substrate 172 and the ceiling 320. In an example, the support frame 304 is formed from a conductive metal and is flexible. As such, the support frame 304 is a spring or a spring-like element, and the ceiling 320 is resiliently positioned to the location shown in FIG. 7A.

[0088] The block 308 is a rigid element that is configured to be positioned between the ceiling 320 of the support frame 304 and the upper substrate 176. In FIGs. 7A and 7B, the block 308 is shown spaced apart from the support frame 304. The block 308 is formed from a non- compressible material so that forces imparted on the block 308 from the support frame 304 are transmitted to the substrates 172, 176. A thickness 328 of the block 308 is greater than the gap 324 between the ceiling 320 and the lower substrate 172. As a result, an interference fit is formed between the block 308 and the support frame 304 when the block 308 is received by the support frame 304, as is shown in FIG. 7C. The block 308 may be a cube or a cylinder of non- conductive material, in one embodiment.

[0089] In one specific embodiment, the support frame 304 is a battery clip (i.e., a battery support frame or a holding clip) and the block 308 is a battery, such as a button cell battery, a watch battery, a coin battery, or other battery of a similar form factor. The battery supplies electricity for operating the CAM device 104. To this end, as shown in FIG. 7B, the upper substrate 176 includes an additional electrical contact 332 for electrically connecting to a first terminal 336 of the battery. The electrical contact 332 is electrically connected to the connector 188. The ceiling 320 contacts and electrically connects to an opposite second terminal 340 of the battery. The electrical contacts 192 of the upper substrate 176 are not shown in FIG. 7B. There is no direct electrical connection between the battery (i.e., block 308) and the sensor 136. Moreover, in the embodiment illustrated in FIGs. 7A, 7B, and 7C, the floating upper substrate 176 is large enough to completely cover the electrical contacts 180 (see FIG. 3A) on the lower substrate 172 to prevent the battery (i.e., block 308) from directly contacting the electrical contacts 180. In other embodiments, a width of the upper substrate 176 is greater than a width or a diameter of the block 308 / battery.

[0090] According to a method of use, first the sensor 136 is received by the lower substrate 172 with the upper substrate 176 in the raised position. Then, the upper substrate 176 is pressed against the sensor 136 and the lower substrate 172 in an automated fashion or manually (i.e., using a tool or a finger). Next, the block 308 is moved from a first position of FIGs. 7A and 7B to a second position of FIG. 7C by inserting the block 308 between the ceiling 320 and the upper substrate 176 by moving the block 308 in the direction 344. As noted, the thickness 328 of the block 308 is greater than the gap 324. Accordingly, to fit the block 308 between the ceiling 320 and the upper substrate 176, the struts 316 and the ceiling 320 are rotated slightly relative to the feet 312 toward the connector 188. The resiliency of the material of the support frame 304, however, causes the ceiling 320 and struts 316 to resist this rotation and to press firmly against the block 308. The firm pressure of the ceiling 320 against the non-compressible block 308 is transmitted to the upper substrate 176, the sensor 136, and the lower substrate 172 in order to hold the depressed upper substrate 176 in the lowered position and to form the robust mechanical and electrical connection of the sensor 136. The block 308 presses the upper substrate 176, the sensor 136, and the lower substrate 172 together with a compressive force to hold the upper substrate 176 in the lowered position, as shown in FIG. 7C. In the configuration of FIG. 7C with the block 308 in the second position (i.e., an inserted position), the sensor 136 is permanently connected to the substrates 172, 176. The sensor 136, however, can be removed or repositioned relative to the substrates 172, 176 by removing the block 308 from the support frame 320 to release the compressive force, such as by moving the block 308 to the first position (i.e., a separated or removed position).

[0091] Also in the configuration of FIG. 7C, when the block 308 is a battery, the terminal 340 of the battery is electrically connected to the support frame 304, and the terminal 336 of the battery is connected to the electrical contact 332 of the upper substrate 176, such that the CAM device 104 is supplied with electricity from the battery.

[0092] FIGs. 8-10 illustrate a circuit package 258 for use with the CGM 100 that includes a lower circuit board 260 (a first circuit board), an upper circuit board 264 (a second circuit board), and a flexible connector 266 (i.e., a flexible electrical connection strip) that mechanically and electrically connects the circuit boards 260, 264. The circuit boards 260, 264 and the flexible connector 266 are referred to collectively as a singular flex PCB. The circuit package 258 is positionable directly in the exterior housing 144. In another embodiment, the circuit package 258 is positioned in the interior housing 146 and the exterior housing 144. The identifiers “upper” and “lower” of the circuit boards 260, 264 are chosen for ease of explanation in the description of FIGs. 8-10 and may be reversed.

[0093] The circuit package 258 include a block shown as a battery 308, with the battery 308 received by a support frame shown as a holding clip 304. The holding clip 304 is mounted on the lower circuit board 260. The lower circuit board 260 also includes the lower substrate 172 and the upper substrate 176, which are configured to receive the sensor 136; however, the substrates 172, 176 are not visible in the configuration of the circuit package 258 shown in FIGs. 8-10. The battery 308 is configured to hold the upper substrate 176 in the lowered position to connect the sensor 136 to the substrates 172, 176 in the same manner as depicted and described in connection with FIGs. 7A, 7B, and 7C.

[0094] The circuit package 258 is shown in a folded or closed position in FIGs. 8-10 in which the upper circuit board 264 is folded onto the battery 308 that is received by the lower circuit board 260. Typically, the upper circuit board 264 is electrically insulated from the battery 308 in the folded configuration to prevent direct electrical contact between the battery 308 and the upper circuit board 264. The upper circuit board 264 is movable to an unfolded or open position by moving the upper circuit board 264 along the path 306 (FIG. 8). In the unfolded position the lower circuit board 260, the flexible connector 266, and the upper circuit board 264 are coplanar. The upper and lower circuit boards 260, 264 and the flexible connector 266 are shown as being flexible PCBs. Electrical components 268 (i.e., first electrical components and second electrical components) are mounted on each of the circuit boards 260, 264. The electrical components 268 are operably connected to each other by the flexible connector 266. The electrical components 268 are also operably connected to the battery 308. The exemplary electrical components 268 include the transceiver 128, the memory 132, the processor 140 and any other components used for operation of the CAM device 104.

[0095] The circuit package 258 is a compact and space-saving configuration that includes a robust and reliable connection to the sensor 136 using the pressing force from the holding clip 304 that retains the battery 308, according to the approach described in connection with FIGs. 7A, 7B, and 7C.

[0096] FIGs. 11A and 1 IB illustrate another embodiment of the lower substrate 172 and the upper substrate 176. As shown in FIG. 11 A, the upper substrate 176 is in the raised position in which the distal end 202 is spaced apart from the lower substrate 172. The upper substrate 176 includes an electrical contact 192 for electrically connecting to one of the electrical contacts 160 of the ex vivo portion 152 of the sensor 136. The upper substrate 176 extends from an edge 364 of the lower substrate 172. In an exemplary embodiment, the upper substrate 176 is formed as a flexible PCB, and the lower substrate 172 is provided as a rigid PCB. Accordingly, the configuration of FIG. 11 A is referred to as a hybrid rigid-flexible PCB design. The lower substrate 172 includes an electrical contact 180 for electrically connecting to one of the electrical contacts 160 of the ex vivo portion 152 of the sensor 136. The upper substrate 176, in one embodiment, is referred as being embedded in the lower substrate 172. In FIG. 11A, the upper substrate 176 is a direct integration into the rigid PCB of the lower substrate 172 and forms a hybrid flex -rigid component.

[0097] With reference to FIG. 1 IB, in this embodiment, the upper substrate 176 is folded onto the lower substrate 172 with the distal end 202 moving the along the line 368 (FIG. 11 A). Then, the upper substrate 176 is held in the lowered position using the protrusion 220 or the block 308 and support frame 304, as previously described. Depending on the length of the upper substrate 176, a loop 372 (FIG. 1 IB) is formed that is useful for routing the upper substrate 176 over other electrical components mounted on the lower substrate 172, for example.

[0098] FIGs. 12A and 12B illustrate another embodiment of the lower substrate 172 and the upper substrate 176. As shown in FIG. 12A an intermediate substrate 380 is located between the proximal end 204 of the upper substrate 176 and the distal end 202 of the upper substrate 176. As such, the upper substrate 176 defines an inner substrate portion 384 and an outer substrate portion 388. The intermediate substrate 380 is located between the inner substrate portion 384 and the outer substrate portion 388. In this embodiment, the upper substrate 176 is a flexible PCB, and the lower substrate 172 and the intermediate substrate 380 are rigid PCB. The upper substrate 176 includes an electrical contact 192 for electrically connecting to one of the electrical contacts 160 of the ex vivo portion 152 of the sensor 136. The upper substrate 176 extends from the edge 364 of the lower substrate 172 and from edges 392 of the intermediate substrate 380. The upper substrate 176, in one embodiment, is referred as being embedded in the lower substrate 172. In FIG. 12A, the upper substrate 176 is a direct integration into the rigid PCB of the lower substrate 172 and the intermediate substrate 380 and forms a hybrid flex-rigid component. The lower substrate 172 includes an electrical contact 180 for electrically connecting to one of the electrical contacts 160 of the ex vivo portion 152 of the sensor 136. The intermediate substrate 380 is movable relative to the lower substrate 172 by flexing the inner substrate portion 384.

[0099] In this embodiment, the outer substrate portion 388 of the upper substrate 176 is folded onto the lower substrate 172 with the distal end 202 moving the along the line 368 (FIG. 12A). Then, the upper substrate 176 is held in the lowered position using the protrusion 220 or the block 308 and support frame 304, as previously described. The movement of the outer portion 388 of the upper substrate 176 causes the intermediate substrate 380 to flip over, such that side A points up in FIG. 12A when the upper substrate 176 is in the raised position, and opposite side B points up in FIG. 12B when the upper substrate 176 is in the lowered position. [0100] FIG. 13 illustrates another embodiment of the lower substrate 172 and the upper substrate 176, and corresponding structure used to hold the upper substrate 176 in the lowered position. FIG. 13 is a cross sectional view through the upper shell 214 of the interior housing 146 and the lower shell 210 of the interior housing 146. In this embodiment, for example, the upper substrate 176 and the lower substrate 172 are vertically oriented, but retain their names as previously described. Moreover, in this example, the upper substrate 176 and the lower substrate 172 are formed from the same material, such as flexible PCB to permit the bending of the substrates 172, 176. FIG. 13 illustrates the upper substrate 176 in the lowered position, in which the ex vivo portion 152 of the sensor 136 is sandwiched and held between the substrates 172, 176 and electrically connected to the substrates 172, 176. roion The upper shell 214 defines an upper v-shaped slot 404 (i.e., a first v-shaped slot) and the lower shell 210 defines a lower v-shaped slot 408 (i.e., a second v-shaped slot). The substrates 172, 176 are positioned in both of the v-shaped slots 404, 408. That is, the upper v- shaped slot 404 is configured to receive the substrates 172, 176, and the lower v-shaped slot 408 is configured to receive the substrates 172, 176. The upper and lower shells 210, 214 are shown connected to each other in FIG. 13 in a position that holds the upper substrate 176 in the lowered position. As the upper and lower shells 210, 214 are brought together, the v-shaped slots 404, 408 compress the substrates 172, 176 together and slightly bend the substrates 172, 176 toward each other as the substrates 172, 176 are brought closer to vertices 412, 416 of the v-shaped slots 404, 408. As shown in the FIG. 13, an exaggerated bend of the substrates 172, 176 shows the compressive force applied to the ex vivo portion 152 of the sensor 136. The v-shaped slots 404, 408 are also referred to herein as fixation teeth. As illustrated, the v-shaped slots 404, 408 are integral with the housing 144, in another embodiment, however, separate structures may define the v-shaped slots 404, 408, which are positioned within the housing 144 and are held in place by the closing of the shells 210, 214 of the housing 144.

[0102] FIG. 14 illustrates another embodiment of the lower substrate 172 and the upper substrate 176. The lower substrate 172 defines a step 420 from which the upper substrate extends 176. In FIG. 14, the upper substrate 176 is in the raised position. The lower substrate is provided as a rigid PCB, for example. The upper substrate 176 is a flexible PCB, for example. The upper substrate 176 is held in the lowered position (not shown) using the protrusion 220 or the block 308 and support frame 304, as previously described. The configuration of FIG. 14 includes a lower substrate 172 shown as a multilayer board, which is also referred to as an asymmetrical board.

[0103] FIG. 15 illustrates another embodiment of the lower substrate 172 and the upper substrate 176. The lower substrate 172 defines an opening 440 there-through from which the upper substrate 176 extends and is allowed to flex. The opening 440 extends completely or partially through the lower substrate 172. The lower substrate 172 extends from a corresponding edge 364. In FIG. 15, the upper substrate 176 is in the raised position. The lower substrate 172 is mounted on or is a rigid PCB, for example. The upper substrate 176 is a flexible PCB, for example.

[0104] As also shown in FIG. 15, a plurality of guide pins 434 extends from the lower substrate 172. In this embodiment, the lower substrate 172 includes from one to ten of the guide pins 434. The guide pins 434 may be extruded and may also be referred to herein as posts. A distance 438 between the guide pins 434 is based on a width 442 of the upper substrate 176. The upper substrate 176 is located between the guide pins 434 when the upper substrate 176 is moved to the lowered position. The guide pins 434 define a channel in which the upper substrate 176 is located when in the lowered position. The guide pins 434 align the upper substrate 176 with the ex vivo portion 152 as the upper substrate 176 is moved to the lowered position. The guide pins 434 prevent horizontal movement of the upper substrate 176. The upper substrate 176 is held in the lowered position using the protrusion 220 (FIG. 4) or the block 308 and support frame 304, as previously described. In one embodiment, the protrusion 220 includes corresponding openings (not shown) in the pressing surface 228 to receive the guide pins 434 and to enable the surface 228 of the protrusion 220 to seat fully against the upper substrate 176. In yet another embodiment, the guide pins 434 are formed on the protrusion 220 and are configured to be received in corresponding openings (not shown) formed in the lower substrate 172. The guide pins 434 form a channel on the bottom of the protrusion 220 in which the upper substrate 176 is positioned. The guide pins 434 are arranged in a staggered configuration in FIG. 15, in other embodiment, however, the guide pins 434 are arranged in an aligned configuration.

[0105] In the examples and embodiments described above, the system 100 is configured to determine the blood glucose concentration of the person 116. In other embodiments, however, the system 100 is configured to determine and to monitor additional or other characteristics and/or analytes of the person 116. Accordingly, the system 100, using the sensor 136, may be configured to generate electronic data 120 corresponding to non-glucose analytes, such as ketones, lactate, oxygen, alcohol, and others. Depending on the embodiment, the system 100 may generate the electronic data 120 for only one predetermined analyte. In other embodiments, however, the system 100 generates the electronic data 120 for more than one predetermined analyte. [0106] Embodiments of the system 100 configured to generate the electronic data 120 based on more than one analyte utilize a multi-electrode sensor, such as the sensor 136 shown in FIG. 2. The multi-electrode sensor 136 includes more than one electrode 156 and/or includes a single electrode 156 that is sensitive to more than one analyte. For example, with reference to FIG. 2, the multi-electrode sensor 136 includes a left electrode 156 that is sensitive to glucose and a right electrode 156 that is sensitive to ketones. In this way, the system 100 is configured to generate the electronic data 120 for more than one analyte.

[0107] While the disclosure has been illustrated and described in detail in the drawings and foregoing description, the same should be considered as illustrative and not restrictive in character. It is understood that only the preferred embodiments have been presented and that all changes, modifications and further applications that come within the spirit of the disclosure are desired to be protected.

Claims

Claims What is claimed is:

1. A continuous analyte monitor device, comprising: a sensor having (i) an in vivo portion including at least one electrode, and (ii) an ex vivo portion including at least one first electrical contact operably connected to the at least one electrode; a first substrate configured to receive the sensor; a movable second substrate configurable in (i) a first position in which a distal end of the second substrate is spaced apart from the first substrate and the sensor, and (ii) a second position in which the distal end is against the first substrate and the sensor; and at least one second electrical contact mounted on the first substrate or the distal end of the second substrate, wherein in the second position (i) the at least one first electrical contact is in electrical connection with the at least one second electrical contact, and (ii) the ex vivo portion is prevented from moving relative to the first substrate and the second substrate.

2. The continuous analyte monitor device as claimed in Claim 1, further comprising: a support frame operably connected to the first substrate and including a ceiling, wherein the distal end of the second substrate is at least partially located between the first substrate and the ceiling; and a block configured to be positioned between the ceiling and the second substrate to press the second substrate against the first substrate and the sensor, such that the second substrate is held in the second position.

3. The continuous analyte monitor device as claimed in Claim 2, wherein: the block is a battery, the support frame is a battery support frame configured to be electrically connected to the battery, and a resiliency of the battery support frame presses the battery against the second substrate.

4. The continuous analyte monitor device as claimed in Claim 1, further comprising: a housing including a first shell and a second shell that is operably connected to the first shell, wherein the housing holds the second substrate in the second position when the second shell is operably connected to the first shell.

5. The continuous analyte monitor device as claimed in Claim 4, wherein the second shell includes a protrusion that is positioned against the second substrate when the second shell is operably connected to the first shell.

6. The continuous analyte monitor device as claimed in Claim 4, wherein: the first shell defines a first v-shapcd slot configured to receive the first substrate and the second substrate, the second shell defines a second v-shaped slot configured to receive the first substrate and the second substrate, and connection of the second shell to the first shell causes the first v-shaped slot and the second v-shaped slot to compress the first substrate and the second substrate against the ex vivo portion of the sensor.

7. The continuous analyte monitor device as claimed in Claim 1, further comprising: a plurality of guide pins extending from the first substrate, wherein the second substrate is located between the plurality of guide pins in the second position, such that the second substrate is aligned with the ex vivo portion of the sensor.

8. The continuous analyte monitor device as claimed in Claim 1, wherein: the second substrate is a flexible printed circuit board, the first substrate is a flexible printed circuit board or a rigid printed circuit board, and the in vivo portion is movable relative to the first substrate and the second substrate when the second substrate is in the second position.

9. The continuous analyte monitor device as claimed in Claim 1, wherein: the second substrate is biased to the first position.

10. The continuous analyte monitor device as claimed in Claim 1, further comprising: an intermediate substrate located between a proximal end of the second substrate and the distal end of the second substrate, such that the second substrate defines an inner substrate portion and an outer substrate portion, wherein the second substrate is a flexible printed circuit board, wherein the first substrate and the intermediate substrate are rigid printed circuit boards, and wherein the intermediate substrate is movable relative to the first substrate by flexing the inner substrate portion.

11. The continuous analyte monitor device as claimed in Claim 1, further comprising: a connector configured to operably connect a proximal end of the second substrate to the first substrate.

12. A method of assembling a continuous analyte monitor device, comprising: positioning a sensor between a first substrate and a second substrate with the second substrate in a first position, a proximal end of the second substrate fixedly connected to the first substrate and a distal end of the second substrate movable relative to the first substrate, the sensor including an in vivo portion and an ex vivo portion; moving the second substrate toward the first substrate from the first position to a second position to electrically connect the ex vivo portion to at least one of the first substrate and the second substrate; and holding the second substrate in the second position to prevent movement of the ex vivo portion relative to the first substrate and the second substrate.

13. The method as claimed in Claim 12, further comprising: inserting a block between a ceiling of a support frame and the second substrate to hold the second substrate in the second position, wherein the support frame extends from the first substrate, and wherein the second substrate is at least partially located between the first substrate and the ceiling in the first position and the second position.

14. The method as claimed in Claim 13, wherein: the block is a battery, and a resiliency of the support frame presses the battery against the second substrate to apply a compressive force on the ex vivo portion between the first substrate and the second substrate.

15. The method as claimed in Claim 14, wherein: the second substrate is electrically connected to a first terminal of the battery, and the support frame is electrically connected to an opposite second terminal of the battery.

16. The method as claimed in Claim 12, wherein: the first substrate is mounted on a first shell of a housing of the continuous analyte monitor device, and a second shell of the housing is connected to the first shell to hold the second substrate in the second position.

17. The method as claimed in Claim 16, further comprising: folding the second shell onto the first shell to mechanically connect the second shell to the first shell, wherein first electrical components are mounted on the first shell, wherein second electrical components are mounted on the second shell, and wherein a flexible electrical connection strip extends from the first shell and the second shell to electrically connect the first electrical components to the second electrical components.

18. The method as claimed in Claim 12, wherein: the in vivo portion includes at least one electrode, the ex vivo portion includes at least one first electrical contact operably connected to the at least one electrode, at least one second electrical contact is mounted on the first substrate or the second substrate, and the method further includes forming an electrical connection between the at least one first electrical contact and the at least one second electrical contact by moving the second substrate to the second position.

19. The method as claimed in Claim 12, wherein holding the second substrate in the second position includes compressing the ex vivo portion between the first substrate and the second substrate to prevent the movement of the ex vivo portion.

20. The method as claimed in Claim 12, further comprising: positioning a housing of the continuous analyte monitor device on the skin of a person; and moving the in vivo portion to a position under the skin of the person after the second substrate has been held in the second position.