Continuous analyte monitor

Abstract

A continuous analyte monitor device includes a sensor and an electrical substrate. The sensor has (i) an in vivo portion including at least one electrode, and (ii) an ex vivo portion extending from the in vivo portion and including at least one electrical contact operably connected to the at least one electrode. The electrical substrate includes at least one base portion and at least one flexible portion extending from the at least one base portion. The at least one base portion is fixedly mounted relative to a housing of the continuous analyte monitor device. The at least one flexible portion includes a first contact pad. The at least one flexible portion is movable relative to the at least one base portion against the ex vivo portion, such that the electrical substrate biases the at least one flexible portion against a first side of the ex vivo portion.

Description

CONTINUOUS ANAUYTE MONITORField

[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 thecontroller 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 and an electrical substrate. The sensor has (i) an in vivo portion including at least one electrode, and (ii) an ex vivo portion extending from the in vivo portion and including at least one electrical contact operably connected to the at least one electrode. The electrical substrate includes at least one base portion and at least one flexible portion extending from the at least one base portion. The at least one base portion is fixedly mounted relative to a housing of the continuous analyte monitor device. The at least one flexible portion includes a first contact pad. The at least one flexible portion is movable relative to the at least one base portion against the ex vivo portion, such that (i) the electrical substrate biases the at least one flexible portion against a first side of the ex vivo portion, (ii) the first contact pad is electrically connected to the at least one electrical contact, and (iii) the at least one flexible portion and the at least one base portion are noncoplanar.

[0007] In an embodiment, the at least one electrical contact includes (i) a first electrical contact operably connected to the at least one electrode and located on a first side of the ex vivo portion, and (ii) a second electrical contact operably connected to the at least one electrode and located on an opposite second side of the ex vivo portion. The at least one base portion includes a first base portion and a second base portion. The at least one flexible portion includes a first flexible portion extending from the first base portion, and a second flexible portion extending from the second base portion. The first contact pad is mounted on the first flexible portion, and a second contact pad is mounted on the second flexible portion. The ex vivo portion is positioned between the first flexible portion and the second flexible portion, such that (i) the electrical substrate biases the first flexible portion against the first side of the ex vivo portion with the first contact pad electrically connected to the first electrical contact, (ii) the electrical substrate biases the second flexible portion against the second side of the ex vivo portion with the second contact pad electrically connected to the at least one second electrical contact, (iii) the first flexibleportion is noncoplanar with the first base portion, and (iv) the second flexible portion is noncoplanar with the second base portion.

[0008] According to a further embodiment, the first flexible portion defines a plurality of first digits, and the second flexible portion defines a plurality of second digits. The plurality of second digits are interdigitated with the plurality of first digits at least when the ex vivo portion is spaced apart from the electrical substrate. The first contact pad is mounted on one of the digits of the plurality of first digits, and the second contact pad is mounted on one of the digits of the plurality of second digits. The first flexible portion biases the plurality of first digits against the first side of the ex vivo portion, and the second flexible portion biases the plurality of second digits against the opposite second side of the ex vivo portion.

[0009] In a further embodiment, the at least one base portion and the at least one flexible portion are coplanar when the ex vivo portion is spaced apart from the electrical substrate.

[0010] According to another embodiment, the first flexible portion and the second flexible portion are biased against each other when the ex vivo portion is spaced apart from the electrical substrate.

[0011] Another embodiment includes a connector configured to press the at least one flexible portion against the ex vivo portion. The connector is a clip that presses the at least one flexible portion against the ex vivo portion with spring tension.

[0012] In a further embodiment, the housing includes a first housing portion and a second housing portion configured to operably connect to the first housing portion. The first housing portion is configured to receive the ex vivo portion of the sensor and the electrical substrate. The connector is integrated into the second housing portion, and the connector presses the at least one flexible portion against the ex vivo portion when the second housing portion is operably connected to the first housing portion.

[0013] An embodiment further includes a plurality of supports extending from the housing. The ex vivo portion is positioned between the supports of the plurality of supports, such that the ex vivo portion is held substantially perpendicular to a plane defined by a receiving surface of the housing. The at least one base portion of the electrical substrate is positioned against the receiving surface.

[0014] In another embodiment, the sensor is configured to react to at least one analyte in interstitial fluid of a person that corresponds to a blood glucose concentration level of the person.

[0015] According to another exemplary embodiment of the disclosure, a method of assembling a continuous analyte monitor device, includes supporting an ex vivo portion of a sensor with a plurality of supports extending from a first housing portion of the continuous analyte monitor device. The method further includes moving an electrical substrate relative to the supported ex vivo portion from a spaced apart position to a seated position, such that in the seated position (i) the electrical substrate biases at least one flexible portion of the electrical substrate toward the ex vivo portion, (ii) a first contact pad of the at least one flexible portion is electrically connected to at least one electrical contact of the ex vivo portion, and (iii) the at least one flexible portion and at least one base portion of the electrical substrate are noncoplanar, the at least one flexible portion extending from the at least one base portion. The sensor further includes an in vivo portion including at least one electrode operably connected to the at least one electrical contact.

[0016] In a further embodiment, the method includes connecting a second housing portion to the first housing portion with the electrical substrate in the seated position. The second housing portion defines a connector configured to hold the at least one flexible portion against the ex vivo portion when the second housing portion is connected to the first housing portion. The connector defines a wedge-shaped space having inclined surfaces that presses the at least one flexible portion against the ex vivo portion.

[0017] In yet another embodiment, the method includes applying a connector to the at least one flexible portion and the ex vivo portion with the electrical substrate in the seated position, and connecting a second housing portion to the first housing portion. The second housing portion defines a space to receive the applied connector.

[0018] According to another embodiment, the at least one electrical contact includes (i) a first electrical contact operably connected to the at least one electrode and located on a first side of the ex vivo portion, and (ii) a second electrical contact operably connected to the at least one electrode and located on an opposite second side of the ex vivo portion. The at least one base portion includes a first base portion and a second base portion. The at least one flexible portion includes a first flexible portion extending from the first base portion and a second flexible portion extending from the second base portion. The first contact pad is mounted on the first flexible portion. The second contact pad is mounted on the second flexible portion. When the electrical substrate is moved from the spaced apart position to the seated position (i) theelectrical substrate biases the first flexible portion against the first side of the ex vivo portion with the first contact pad electrically connected to the at least one first electrical contact, (ii) the electrical substrate biases the second flexible portion against the second side of the ex vivo portion with the second contact pad electrically connected to the at least one second electrical contact, (iii) the first flexible portion is noncoplanar with the first base portion, and (iv) the second flexible portion is noncoplanar with the second base portion.

[0019] In a further embodiment of the method the first flexible portion defines a plurality of first digits, the second flexible portion defines a plurality of second digits, and the first contact pad is mounted on one of the digits of the plurality of first digits. The second contact pad is mounted on one of the digits of the plurality of second digits, and the plurality of second digits are interdigitated with the plurality of first digits at least when the electrical substrate is in the spaced apart position. Moving the electrical substrate from the spaced apart position to the seated position (i) biases the plurality of first digits against the first side of the ex vivo portion, and (ii) biases the plurality of second digits against the second side of the ex vivo portion.

[0020] In another embodiment, the first flexible portion and the second flexible portion are coplanar when the electrical substrate is in the spaced apart position.

[0021] In a further embodiment, the plurality of supports support the ex vivo portion substantially perpendicular to a plane defined by a receiving surface of the housing on which the at least one base portion is positioned.Brief Description of the Figures

[0022] 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:

[0023] 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;

[0024] FIG. 2 is a perspective view of the CAM device of FIG. 1 shown partially in block diagram form;

[0025] FIG. 3 illustrates an elevational view of a sensor of the CAM device of FIG. 1 ;

[0026] FIG. 4 shows a plan view of an electrical substrate of the CAM device of FIG. 1 ;

[0027] FIG. 5 is a cross sectional view showing the electrical substrate of FIG. 4 in three positions relative to a lower housing portion of the CAM device and the sensor as supported by the lower housing portion;

[0028] FIG. 6 is a cross sectional view of the CAM device of FIG. 1 with a connector applied to the electrical substrate and the sensor;

[0029] FIG. 7 is a flowchart illustrating an exemplary method of operating the CAM system of FIG. 1 ;

[0030] FIG. 8 is a plan view of another embodiment of the sensor of the CAM device shown in a first position;

[0031] FIG. 9 is a perspective view showing the sensor of FIG. 8 in a bent configuration;

[0032] FIG. 10 is a plan view of another embodiment of the electrical substrate of theCAM device;

[0033] FIG. 11 is a perceptive view showing the electrical substrate of FIG. 10 seated on the lower housing portion of the CAM device;

[0034] FIG. 12 is a perspective view showing the sensor positioned between flexible portions of the electrical substrate of FIG. 10.

[0035] FIG. 13 is a plan view of another embodiment of the electrical substrate of the CAM device;

[0036] FIG. 14 is a perspective view illustrating the electrical substrate of FIG. 13 seated on the lower housing portion of the CAM device with the sensor received between flexible portions of the electrical substrate; and

[0037] FIG. 15 is a cross sectional view of another embodiment of the housing of the CAM device including a wedge connector integrated into an upper housing portion.Detailed Description

[0038] 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 principlesof the disclosure as would normally occur to one skilled in the art to which this disclosure pertains.

[0039] 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.

[0040] 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).

[0041] The terms “comprising,” “including,” “having,” and the like, as used with respect to embodiments of the disclosure, are synonymous.

[0042] 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.

[0043] With reference to FIG. 2, disclosed herein is a structure and a method 700 (FIG. 7) of easily connecting a sensor 136 of the CAM device 104 to an electrical substrate 138 of the CAM device 104, so that a processor 140 of the CAM device 104 is configured to operate the sensor 136 by receiving electrical signals from the sensor 136 and or by monitoring an electrical response of the sensor 136. The structure and the method 700 disclosed herein provide for arobust 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.

[0044] The CAM device 104 includes a transceiver 128, a memory 132, a battery 134, the sensor 136, and the electrical substrate 138 each operably connected to the processor 140. The CAM device 104 also includes a corresponding housing 144 in which the transceiver 128, the memory 132, the battery 134, the sensor 136, the electrical substrate 138, and the processor 140 are at least partially located.

[0045] 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®, near-field 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.

[0046] 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.

[0047] 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. In an exemplary embodiment, the processor 140 uses the electrical connection to the sensor 136 to generate electronic data 120, which are a measure of the blood glucose concentration level of the person 116, from the electrical reaction of the sensor 136 to the glucose concentration of the interstitial fluid.

[0048] As shown 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.

[0049] With reference to FIG. 3, the sensor 136 includes an in vivo portion 148 and an ex vivo portion 152 extending from the in vivo portion 148. 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 of the person 112. Glucose is an exemplary analyte to which the sensor 136 is configured to react electrically. 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 in which the in vivo portion 148 is implanted and the ex vivo portion 152 is not implanted.

[0050] As shown in FIG. 3, the in vivo portion 148 of the sensor 136 includes three 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. The in vivo portion 148 includes from one to ten of the electrodes 156. The in vivo portion 148 is positioned / implanted under the skin 112 of the person 116 and in contact with the interstitial fluid 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 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 1 12.

[0051] In FIG. 3, the ex vivo portion 152 of the sensor 136 includes five electrical contacts 160 that are each electrically connected to a corresponding one of the electrodes 156. In the illustrated example, three of the electrical contacts 160 are mounted on a first side of the ex vivo portion 152, and two of the electrical contacts 160 (shown in broken lines) are mounted on an opposite second side of the ex vivo portion 152. In another embodiment, the ex vivo portion 152 includes from one to twenty of the electrical contacts 160. The ex vivo portion 152 is located outside or above the skin 112 of the person 116 and within the housing 144 when the CAM device 104 is mounted on the person 116.

[0052] In an example, the in vivo portion 148 is a thin wire-like structure that is flexible and that extends directly from the ex vivo portion 152. The in vivo portion 148 is shown in a straight configuration in FIG. 3 and in a bent or flexed configuration in FIG. 2. The in vivo portion 148 is wire-like so that it can be injected by the skin piercing device and so that the in vivo portion 148 is comfortably positioned below the skin 112 of the person 116. The ex vivo portion 152 is a larger flattened portion of the sensor 136 that defines an area 164 for positioning the electrical contacts 160. The larger size of the ex vivo portion 152 as compared to the in vivo portion 148 simplifies the electrical connection between the sensor 136 and the electrical substrate 138. The sensor 136, in another embodiment, is any sensor 136 that includes the electrical contacts 160 and the electrodes 156 configured to monitor the predetermined analyte.

[0053] The predetermined analyte monitored by the CAM system 100 and sensed (or reacted to) by the sensor 136 is any substance that is the subject of chemical analysis. For example, the analyte, in one embodiment, is glucose. That is, the sensor 136 is configured to react to at least one analyte in the interstitial fluid of the person 116 that corresponds to a blood glucose concentration level of the person 116. 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.

[0054] 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 are 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.

[0055] With reference again to FIG. 2, the housing 144 of the CAM device 104 includes a lower housing shell 210 and an upper housing shell 214 configured to be operably connected to the lower housing shell 210. The housing 144 is mounted on the skin 112 of the person 116, as is shown in FIG. 1, with an adhesive (not shown) applied to the lower housing portion 210. In one embodiment, the housing 144 is mounted on the upper arm area of the person 116. hi 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.

[0056] As shown in the example of FIG. 2, the lower housing shell 210 defines a receiving surface 168 and a sensor opening 174, and includes a plurality of supports 178. The receiving surface 168 of the lower housing shell 210 is configured to receive the transceiver 128, the memory 132, the battery 134, at least the ex vivo portion 152 of the sensor 136, the electrical substrate 138, and the processor 140. The receiving surface 168 defines a plane 180 (FIG. 5).

[0057] The sensor opening 174 is an opening in the receiving surface 168 and completely through the lower housing portion 210 through which the sensor 136 extends. In particular, the in vivo portion 148 extends through the opening 174 to reach the person 116. The in vivo portion 148 may be injected through the sensor opening 174 by the skin piercing device.

[0058] The supports 178 extend from the receiving surface 168 toward the upper housing shell 214 and are also referred to herein as mechanical locator stops. As shown in FIG. 2, the lower housing shell 210 includes four of the supports 178. In other embodiments, the lower housing shell 210 includes from two to ten of the supports 178. The supports 178 are also referred to as guide pins. With reference to FIGs. 2 and 5, the supports 178 are positioned to receive and to support the ex vivo portion 152, with the ex vivo portion 152 positioned between the supports 178. In particular, a channel 184 (FIG. 2) is defined between the supports 178 in which the ex vivo portion 152 is positioned and supported. A width of the channel 184 is based on a corresponding width of the ex vivo portion 152. In an example, a width of the channel 184 is from one to five millimeters and may be from 0.5 to fifteen millimeters in other embodiments. The supports 178 are arranged in a staggered configuration in FIG. 2, in other embodiments, the supports 178 are arranged in an aligned configuration.

[0059] The supports 178 hold the ex vivo portion 152 in a fixed position relative to the lower housing portion 210 and the receiving surface 168. Specifically, as shown in FIGs. 2 and 5, the supports 178 hold the ex vivo portion 152 substantially perpendicular to the plane 180 of the lower housing shell 210 that is defined by the receiving surface 168. As used herein, the term “substantially perpendicular” includes positions of ex vivo portion 152 within ten degrees of perpendicular.

[0060] In one embodiment, the supports 178 have a predetermined height and may come into contact with corresponding elements (not shown) of the top housing portion 214. The predetermined height of the supports 178 is selected so that contact pads 228 of the electrical substrate 138 and the electrical contacts 160 of the sensor 136 are in proper alignment when the electrical substrate 138 is in a seated position (FIG. 5) on the ex vivo portion 152.

[0061] With reference to FIGs. 4 and 5, the electrical substrate 138 includes a first base portion 204, a second base portion 208, a first flexible portion 212 extending from the first base portion 204, and a second flexible portion 216 extending from the second base portion 208. The electrical substrate 138, in one embodiment, is formed from flexible printed circuit board (flexible PCB) material. In a hybrid configuration, the base portions 204, 208 are formed from ridged PCB (or another rigid material) and the flexible portions 212, 216 are formed from flexible PCB. The base portions 204, 208 of the electrical substrate 138 are fixedly mountedrelative to the housing 144. That is, the base portions 204, 208 are fixedly mounted on the receiving surface 168 of the lower housing portion 210.

[0062] As shown in FIG. 4, in one embodiment, the flexible portions 212, 216 each include a plurality of digits 220. FIG. 4 is a top view of the electrical substrate 138 with the electrical substrate 138 spaced apart from the sensor in a normal position, a relaxed position, or a spaced apart position. In the spaced apart position, the digits 220 of the left flexible portion 212 are interdigitated with the digits 220 of the right flexible portion 216. FIG. 4 illustrates that the base portions 204, 208 and the flexible portions 212, 216 are coplanar when the electrical substrate 138 is spaced apart from the ex vivo portion 152 of the sensor 136. The left base portion 204 and the right base portion 208, in one embodiment, are mechanically connected to each other by additional substrate material (PCB and / or flexible PCB), such that movement of left base portion 204 relative to the right base portion 208 along at least one axis is prevented.

[0063] The left flexible portion 212 includes from one to ten of the digits 220 and the right flexible portion 216 includes from one to ten of the digits 220. Each digit 220 of the electrical substrate 138 includes a corresponding electrical contact pad 228. The electrical contact pads 228 are mounted on a corresponding side of the flexible portions 212, 216 for connection with the electrical contacts 160 of the ex vivo portion 152 of the sensor 136. In the example of FIG. 4, there are two contact pads 228 mounted on the left flexible portion 212, and there are three contact pads 228 mounted on the right flexible portion 216. Corresponding electrical traces (not shown) electrically connect the contact pads 228 to the processor 140 or to any other electrical element of the CAM device 104. In an embodiment, the electrical contact pads 228 are sized larger than the electrical contacts 160 in order to provide tolerance during placement of the electrical substrate 138 against the sensor 136.

[0064] With reference to FIG. 6, the CAM device 104 further includes a connector 230 that is configured press the left flexible portion 212 and the right flexible portion 216 against the ex vivo portion 152 of the sensor 136. Specifically, FIG. 6 shows the CAM device 104 in an assembled configuration in which the upper housing portion 214 is connected to the lower housing portion 210. The connector 230 is applied to the flexible portions 212, 216 before the housing portions 210, 214 are connected together and after the electrical substrate 138 has been seated on the receiving surface 168 and the sensor 136. In an exemplary embodiment, the connector 230 is a clip or a “binder-clip” style of connector that uses spring tension to clamp theflexible portions 212, 216 against the sensor 136. When the connector 230 is applied, the contact pads 228 of the electrical substrate 138 are held firmly against the electrical contacts 160 of the sensor 136 to establish a robust electrical and mechanical connection therebetween. The electrical and mechanical connection remains fully in tact as the person 116 performs all types of activities including physical work, running, and sleeping while wearing the CAM device 104. [00651 As shown in FIG. 6, the upper housing portion 214 defines a space 234 to at least partially receive the applied connector 230. The space 234, in one embodiment, prevents contact between the housing 144 and the connector 230. In another embodiment, the space 234 is correspondingly shaped to receive the connector 230 and to contact at least a top side of the connector 230, which tends to prevent movement and dislodgement of the connector 230 from the electrical substrate 138 during use of the CAM device 104.

[0066] As shown in FIG. 7, a method 700 is for assembling the CAM device 104 and, in particular, for establishing a robust electrical and mechanical connection between the electrical substrate 138 and the sensor 136. The electrical connection enables the processor 140 to electrically connect to the sensor 136 through the electrical substrate 138.

[0067] At block 704, the method 700 includes supporting the ex vivo portion 152 of the sensor 136 on the receiving surface 168 of the lower housing portion 210. The method 700 begins with the housing portions 210, 214 separated. Typically, the transceiver 128, the memory 132, the battery 134, and the processor 140 are mounted on the receiving surface 168 or on a corresponding PCB or other electrical board I substrate positioned on the receiving surface 168. Next, the sensor 136 is mounted on the lower housing portion 210. Mounting the sensor 136 includes positioning the in vivo portion 148 relative to the sensor opening 174 and positioning the ex vivo portion 152 in the channel 184 defined by the supports 178. The in vivo portion 148 is moved and / or bent relative to the ex vivo portion 152 to a position that is suitable for later being implanted in the person 116.

[0068] The ex vivo portion 152 is positioned in the channel 184 so that the ex vivo portion 152 is substantially perpendicular to the receiving surface 168. The supports 178 are configured to support and to hold the ex vivo portion 152 in the substantially perpendicular position without any further elements. The supports 178, in some embodiments also fix the position of the ex vivo portion 152 in a channel direction 240 (FIG. 2) so that the ex vivo portion152 is positioned properly to receive the electrical substrate 138. The channel direction 240 is parallel to a longitudinal extent of the channel 184.

[0069] Next, as identified at block 708, the electrical substrate 138 is moved into position on the supported ex vivo portion 152 of the sensor 136. With reference to FIG. 5, the electrical substrate 138 is shown in three positions during the moving of the electrical substrate 138 relative to the ex vivo portion 152. In the top position (electrical substrate 138 shown in broken lines), the electrical substrate 138 is in the spaced apart position in which the elements of the electrical substrate 138 are coplanar. In the top position, there is no bending or flexing of the flexible portions 212, 216 relative to the base portions 204, 208. In the middle position (electrical substrate 138 shown in broken lines) contact is made between the flexible portions 212, 216 and the ex vivo portion 152, and the downward movement of the electrical substrate 138 begins to bend and flex the flexible portions 212, 216. In the middle position, the digits 220 have been bent relative to the base portions 204, 208.

[0070] The electrical substrate 138 reaches the seated position when the base portions 204, 208 are positioned against or are supported by the receiving surface 168 and the ex vivo portion 152 is positioned in a gap between the first and second flexible portions 212, 216. In the seated position, the electrical substrate 138 is shown in solid lines in FIG. 5. In the seated position, the left flexible portion 212 is noncoplanar with the left base portion 204, and the right flexible portion 216 is noncoplanar with the right base portion 208.

[0071] In the seated position, the flexible portions 212, 216 are biased with a biasing force toward the ex vivo portion 152, and the contact pads 228 are electrically connected to the electrical contacts 160 of the ex vivo portion 152. Specifically, the contact pads 228 on the digits 220 of the left flexible portion 212 are positioned against and biased toward the electrical contacts 160 on the left side of the ex vivo portion 152, and the contact pads 228 on the digits 220 of the right flexible portion 216 are positioned against and biased toward the electrical contacts 160 on the right side of the ex vivo portion 152.

[0072] The biasing force is generated by the flexed flexible portions 212, 216 and tends to cause the flexible portions 212, 216 to return to the coplanar orientation of the spaced apart position. The biasing force corresponds to a resiliency of the flexible portions 212, 216 and can be increased by making the flexible portions 212, 216 more resilient and can be decreased by making the flexible portions 212, 216 less resilient. In the seated position, an electrical andmechanical connection is formed between the electrical substrate 138 and the sensor 136 due to the biasing of the flexible portions 212, 216 against corresponding sides of the ex vivo portion 152. The ex vivo portion 152 is “sandwiched” between the flexible portions 212, 216 when the electrical substrate 138 is in the seated position.

[0073] Next, at block 712 of the method 700, the electrical substrate 138 is secured to the ex vivo portion 152 of the sensor 136. As described above, according to one approach, the electrical substrate 138 is secured with the connector 230 (FIG. 6) which is configured to apply a compressive force to the flexible portions 212, 216 and the ex vivo portion 152, which holds the contact pads 228 against the electrical contacts 160. The connector 230 is applied by opening jaws of the connector 230 against a spring force generated by the connector 230. Then, the opened connector 230 is applied to the seated electrical substrate 138 and the jaws arc released. The spring force of the connector 230 holds the connector 230 and the electrical substrate 138 in place relative to the ex vivo portion 152. According to another approach, no connector 230 is applied and the biasing force generated by the flexed or bent flexible portions 212, 216 holds the contact pads 228 against the electrical contacts 160 with a pressure fit.

[0074] After the electrical substrate 138 is secured in position with the connector 230 or any other means, then the upper housing portion 214 is connected to the lower housing portion 210 to further assemble the CAM device 104.

[0075] The CAM device 104, including the electrical substrate 138 and the supported ex vivo portion 152 of the sensor 136, eliminates and / or reduces dedicated connector components for connecting the sensor 136 the electrical substrate 138. The ex vivo portion 152 is held upright using the supports 178 extending from the support surface 168 of the lower housing portion 210. The electrical substrate 138 has the flexible portions 212, 216 that bend or flex to receive the ex vivo portion 152 and that form a pressure fit to establish the electrical and mechanical connection between the contact pads 228 and the electrical contacts 160. The connector 230, when used, makes the electrical and mechanical connection even more robust, but is not required. The interdigitated configuration allows any desired number of contact pads 228 and corresponding electrical contacts 160 for use with the sensor 136 having any corresponding number of sensing modalities.

[0076] The CAM device 104 is an improvement over current designs, which are architecturally complex and bulky. Moreover, current designs result in sensor form factors thatare not easily manufactured, costly, and do not provide consistent and predictable electrical connections. Current designs also are not conducive to low profile sensor housings, which can lead to reliability issues and lower consumer adoption. The design and structural configuration of the CAM device 104 improves all of these issues.

[0077] As shown in FIGs. 8 and 9, in another embodiment the sensor 336 has a “T”- shape. The sensor 336 includes an ex vivo portion 352 having at least one electrical contact 360 and an in vivo portion 348 having at least one electrode 356. The electrical contacts 360 are electrically connected to the electrodes 356. The ex vivo portion 352 is configured for electrical and mechanical connection to the electrical substrate 138 in the same manner as the ex vivo portion 152 of the sensor 136. The “T”-shape sensor 336 is shown in a straight configuration in FIG. 8 and in a bent or flexed configuration in FIG. 9. The sensor 336 is formed from a flexible material. The sensor 336 is easily adapted to have any desired number of electrical contacts 360 by increasing or decreasing a width of the ex vivo portion 352. The sensor 336 allows for additional axial space for the skin piercing device.

[0078] FIGs. 10-12 illustrate an alternative embodiment electrical substrate 438. The electrical substrate 438 is an overlap configuration that includes a left base portion 404, a right base portion 408, a left flexible portion 412, and a right flexible portion 416. Corresponding electrical contact pads 428 are included on the flexible portions 412, 416. The left base portion 404 and the right base portion 408, in one embodiment, are mechanically connected to each other by additional base portion material, such that movement of left base portion 404 relative to the right base portion 408 is prevented along at least one axis.

[0079] As shown in FIG. 10, the left and right flexible portions 412, 416 are positionable in an overlapped configuration when the electrical substrate 438 is in the spaced apart position. In FIG. 10, the left flexible portion 412 is positioned below the right flexible portion 416.

[0080] The electrical substrate 438 is connectable to the ex vivo portion 152 according to at least two approaches. With reference to FIG. 11 in a first approach, the electrical substrate 438 is positioned on the receiving surface 168 and then the flexible portions 412, 416 are lifted so that the left flexible portion 412 is biased against the right flexible portion 416 when the ex vivo portion 152 is spaced apart from the electrical substrate 438. Next, as shown in FIG. 12, the ex vivo portion 152 is inserted between the flexible portions 412, 416 and between the supports 178 to establish the electrical and mechanical connection between the contact pads 428 and theelectrical contacts 160. According to a second approach, the ex vivo portion 152 is first supported by the supports 178 and then the electrical substrate 438 is moved into position by pressing the flexible portions 412, 416 against the supported ex vivo portion 152, similar to the approach illustrated in FIG. 5.

[0081] As shown in FIGs. 13 and 14, another embodiment electrical substrate 538 is shown. The electrical substrate 538 is a side-by-side configuration that includes a left base portion 504, a right base portion 508, a left flexible portion 512, and a right flexible portion 516. Corresponding electrical contact pads 528 are included on the flexible portions 512, 516. The left base portion 504 and the right base portion 508, in one embodiment, are mechanically connected to each other by additional base portion material, such that movement of left base portion 504 relative to the right base portion 508 is prevented at least along one axis. The electrical substrate 538 is connectable electrically and mechanically to the ex vivo portion 152 in the same manner as described in connection with the flowchart of FIG. 6.

[0082] FIG. 15 illustrates an alternative embodiment of the housing 644 that includes a different configuration of the upper housing portion 614 that is referred to as a fixation cap. The upper housing portion 614 defines an integrated connector 630 that is configured to hold the left and right flexible portions 212, 216 against the ex vivo portion 152 when the upper housing portion 614 is connected to the lower housing portion 610. The connector 630 is wedge-shaped and is configured so that the inclined surfaces of the wedge each press a corresponding flexible portion 212, 216 against the ex vivo portion 152. In particular, as the upper housing portion 614 is moved downward to connect the lower housing portion 610, the ex vivo portion 152 and the flexible portions 212, 216 enter the space defined by the connector 630. Continued movement of the upper housing portion 614 toward the lower housing portion 610 wedges the flexible portions 212, 216 and the ex vivo portion 152 deeper into the narrowing wedge to apply a compressive to the elements 212, 216, 152 and to establish the robust electrical and mechanical connection.

[0083] In the examples and embodiments described above, the CAM system 100 is configured to determine the blood glucose concentration of the person 116. In other embodiments, however, the CAM system 100 is configured to determine and to monitor additional or other characteristics and / or analytes of the person 116. Accordingly, the CAM 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 CAM system 100 may generate the electronic data 120 for only one predetermined analyte. In other embodiments, however, the CAM system 100 generates the electronic data 120 for more than one predetermined analyte.

[0084] Embodiments of the CAM 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. 3. 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. 3, the multi-electrode sensor 136 includes a left electrode 156 that is sensitive to glucose, a right electrode 156 that is sensitive to ketones, and a middle electrode that is sensitive to a further analyte. In this way, the CAM system 100 is configured to generate the electronic data 120 for more than one analyte.

[0085] 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 pre I erred 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

ClaimsWhat 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 extending from the in vivo portion and including at least one electrical contact operably connected to the at least one electrode; and an electrical substrate including at least one base portion and at least one flexible portion extending from the at least one base portion, the at least one base portion fixedly mounted relative to a housing of the continuous analyte monitor device, the at least one flexible portion including a first contact pad, wherein the at least one flexible portion is movable relative to the at least one base portion against the ex vivo portion, such that (i) the electrical substrate biases the at least one flexible portion against a first side of the ex vivo portion, (ii) the first contact pad is electrically connected to the at least one electrical contact, and (iii) the at least one flexible portion and the at least one base portion are noncoplanar.

2. The continuous analyte monitor device as claimed in Claim 1, wherein: the at least one electrical contact includes (i) a first electrical contact operably connected to the at least one electrode and located on a first side of the ex vivo portion, and (ii) a second electrical contact operably connected to the at least one electrode and located on an opposite second side of the ex vivo portion, the at least one base portion includes a first base portion and a second base portion, the at least one flexible portion includes a first flexible portion extending from the first base portion, and a second flexible portion extending from the second base portion, the first contact pad is mounted on the first flexible portion, a second contact pad is mounted on the second flexible portion, and the ex vivo portion is positioned between the first flexible portion and the second flexible portion, such that (i) the electrical substrate biases the first flexible portion against the first side of the ex vivo portion with the first contact pad electrically connected to the first electricalcontact, (ii) the electrical substrate biases the second flexible portion against the second side of the ex vivo portion with the second contact pad electrically connected to the at least one second electrical contact, (iii) the first flexible portion is noncoplanar with the first base portion, and (iv) the second flexible portion is noncoplanar with the second base portion.

3. The continuous analyte monitor device as claimed in Claim 2, wherein: the first flexible portion defines a plurality of first digits, the second flexible portion defines a plurality of second digits, the plurality of second digits are interdigitated with the plurality of first digits at least when the ex vivo portion is spaced apart from the electrical substrate, the first contact pad is mounted on one of the digits of the plurality of first digits, and the second contact pad is mounted on one of the digits of the plurality of second digits.

4. The continuous analyte monitor device as claimed in Claim 3, wherein: the first flexible portion biases the plurality of first digits against the first side of the ex vivo portion, and the second flexible portion biases the plurality of second digits against the opposite second side of the ex vivo portion.

5. The continuous analyte monitor device as claimed in Claim 1, wherein the at least one base portion and the at least one flexible portion are coplanar when the ex vivo portion is spaced apart from the electrical substrate.

6. The continuous analyte monitor device as claimed in Claim 1, wherein the first flexible portion and the second flexible portion are biased against each other when the ex vivo portion is spaced apart from the electrical substrate.

7. The continuous analyte monitor device as claimed in Claim 1, further comprising: a connector configured to press the at least one flexible portion against the ex vivo portion.

8. The continuous analyte monitor device as claimed in Claim 7, wherein the connector is a clip that presses the at least one flexible portion against the ex vivo portion with spring tension.

9. The continuous analyte monitor device as claimed in Claim 7, wherein: the housing includes a first housing portion and a second housing portion configured to operably connect to the first housing portion, the first housing portion is configured to receive the ex vivo portion of the sensor and the electrical substrate, the connector is integrated into the second housing portion, and the connector presses the at least one flexible portion against the ex vivo portion when the second housing portion is operably connected to the first housing portion.

10. The continuous analyte monitor device as claimed in Claim 1, further comprising: a plurality of supports extending from the housing, wherein the ex vivo portion is positioned between the supports of the plurality of supports, such that the ex vivo portion is held substantially perpendicular to a plane defined by a receiving surface of the housing, and wherein the at least one base portion of the electrical substrate is positioned against the receiving surface.

11. The continuous analyte monitor device as claimed in Claim 1 , wherein the sensor is configured to react to at least one analyte in interstitial fluid of a person that corresponds to a blood glucose concentration level of the person.

12. A method of assembling a continuous analyte monitor device, comprising: supporting an ex vivo portion of a sensor with a plurality of supports extending from a first housing portion of the continuous analyte monitor device; and moving an electrical substrate relative to the supported ex vivo portion from a spaced apart position to a seated position, such that in the seated position (i) the electrical substrate biases at least one flexible portion of the electrical substrate toward the ex vivo portion, (ii) a first contact pad of the at least one flexible portion is electrically connected to at least oneelectrical contact of the ex vivo portion, and (iii) the at least one flexible portion and at least one base portion of the electrical substrate are noncoplanar, the at least one flexible portion extending from the at least one base portion, wherein the sensor further includes an in vivo portion including at least one electrode operably connected to the at least one electrical contact.

13. The method of assembling as claimed in claim 12, further comprising: connecting a second housing portion to the first housing portion with the electrical substrate in the seated position, wherein the second housing portion defines a connector configured to hold the at least one flexible portion against the ex vivo portion when the second housing portion is connected to the first housing portion.

14. The method of assembling as claimed in claim 13, wherein the connector defines a wedge- shaped space having inclined surfaces that presses the at least one flexible portion against the ex vivo portion.

15. The method of assembling as claimed in claim 12, further comprising: applying a connector to the at least one flexible portion and the ex vivo portion with the electrical substrate in the seated position; and connecting a second housing portion to the first housing portion.

16. The method of assembling as claimed in claim 15, wherein the second housing portion defines a space to receive the applied connector.

17. The method of assembling as claimed in claim 12, wherein: the at least one electrical contact includes (i) a first electrical contact operably connected to the at least one electrode and located on a first side of the ex vivo portion, and (ii) a second electrical contact operably connected to the at least one electrode and located on an opposite second side of the ex vivo portion, the at least one base portion includes a first base portion and a second base portion,the at least one flexible portion includes a first flexible portion extending from the first base portion and a second flexible portion extending from the second base portion, the first contact pad is mounted on the first flexible portion, a second contact pad is mounted on the second flexible portion, and when the electrical substrate is moved from the spaced apart position to the seated position (i) the electrical substrate biases the first flexible portion against the first side of the ex vivo portion with the first contact pad electrically connected to the at least one first electrical contact, (ii) the electrical substrate biases the second flexible portion against the second side of the ex vivo portion with the second contact pad electrically connected to the at least one second electrical contact, (iii) the first flexible portion is noncoplanar with the first base portion, and (iv) the second flexible portion is noncoplanar with the second base portion.

18. The method of assembling as claimed in claim 17, wherein: the first flexible portion defines a plurality of first digits, the second flexible portion defines a plurality of second digits, the first contact pad is mounted on one of the digits of the plurality of first digits, the second contact pad is mounted on one of the digits of the plurality of second digits, the plurality of second digits are interdigitated with the plurality of first digits at least when the electrical substrate is in the spaced apart position, and moving the electrical substrate from the spaced apart position to the seated position (i) biases the plurality of first digits against the first side of the ex vivo portion, and (ii) biases the plurality of second digits against the second side of the ex vivo portion.

19. The method of assembling as claimed in claim 17, wherein: the first flexible portion and the second flexible portion are coplanar when the electrical substrate is in the spaced apart position.

20. The method of assembling as claimed in claim 17, wherein the plurality of supports support the ex vivo portion substantially perpendicular to a plane defined by a receiving surface of the housing on which the at least one base portion is positioned.

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