Wireless implantable device enclosure with internal power supply

Abstract

To provide an improved sensor and a method for improving specimen measurement capability regarding an implantable device including specimen monitoring and power supply.SOLUTION: An implantable device includes a housing, circuitry within the housing, and a power source attached to the housing and electrically connected to the circuitry. The device may include electrically conductive connectors configured to electrically connect positive and negative terminals of the power source to the circuitry. The device may include a power source terminal enclosure attached to the power source and configured to enclose the positive and negative terminals of the power source. The power source terminal enclosure may include holes through which the electrically conductive connectors pass. The device may include a housing cap enclosure attached to the power source terminal enclosure and to an open end of the housing. The housing cap enclosure may enclose the circuitry within the housing and includes passages through which the electrically conductive connectors pass.SELECTED DRAWING: None

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 994,809, filed March 25, 2020, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE INVENTION

[0003] The present invention relates generally to analyte monitoring and to implantable devices that include a power source. [Background technology]

[0003]

[0004] Background Considerations

[0005] An implantable sensor that does not have a charge storage device may rely exclusively on an external device for operating power (e.g., to operate its circuitry to take measurements and communicate data to an external device). The sensor and external device may each include an inductive element (e.g., a coil). The sensor can receive power from an external device when the external device generates an electrodynamic field using its inductive element and the sensor's inductive element and the external device are magnetically coupled within the electrodynamic field. However, without an internal power source, the sensor is dormant when it is not located in the vicinity of the external device (i.e., when the sensor's inductive element and the external device are not coupled within the electrodynamic field generated by the external device).

[0004]

[0006] For example, a sensor without a charge storage device may be implanted in a human patient's arm, and when the human patient wears an armband with the external device therein, the sensor may be positioned in proximity to the external device. The sensor may be able to take analyte measurements and transmit data to the external device while the patient is wearing the armband, but the sensor may not be able to take analyte measurements while the patient is not wearing the armband (e.g., because the human patient is swimming or showering), resulting in gaps in the analyte measurement information. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0007] Therefore, there is a need for improved sensors and methods of using them that improve the ability of the sensors to perform analyte measurements. [Means for solving the problem]

[0006]

[0008] One embodiment of the present invention may provide an implantable device including a housing, a circuit, a power source, a conductive connector, a power source terminal enclosure, and a housing cap enclosure. The power source may be attached to the housing. The power source may include a positive terminal and a negative terminal electrically connected to the circuit. The conductive connector may be configured to electrically connect the positive terminal and the negative terminal of the power source to the circuit. The power source terminal enclosure may be attached to the power source and configured to seal the positive terminal and the negative terminal of the power source. The housing cap enclosure may be attached to the power source terminal enclosure and also attached to an open end of the housing, the housing cap enclosure sealing the circuit within the housing.

[0007]

[0009] In some embodiments, the power terminal enclosure may include a hole through which the conductive connector passes. In some embodiments, the housing cap enclosure includes: The housing cap enclosure may include a passageway through which the conductive connector extends. In some embodiments, the housing cap enclosure may include a passageway through which one or more supports attached to and extending from the power source extend.

[0008]

[0010] In some embodiments, the device may further include a spring configured to establish an electrical connection between one of the conductive connectors and the positive terminal of the power source, hi some embodiments, the power source terminal enclosure may enclose the spring.

[0009]

[0011] In some embodiments, the device may further include one or more supports attached to and extending from the power source, the one or more supports configured to support attachment of the power source to the housing. In some embodiments, the one or more supports may have a diameter larger than a diameter of the conductive connector. In some embodiments, the supports may be made from a material that is not conductive. In some embodiments, the power terminal enclosure may include a hole through which the support passes. In some embodiments, the housing cap enclosure may include a passage through which the support passes.

[0010]

[0012] In some embodiments, the device may further include one or more substrates within the housing, and the circuitry may include one or more circuit components mounted on or fabricated within the one or more substrates. In some embodiments, the one or more circuit components may include one or more light sources and one or more light receivers.

[0011]

[0013] In some embodiments, the circuit may include an inductive element. In some embodiments, the inductive element may include a conductor and a magnetic core. In some embodiments, the device may further include one or more analyte indicators on or within a portion of an exterior surface of the housing. In some embodiments, the power source may be a battery. In some embodiments, the device may be hermetically sealed. In some embodiments, the implantable device may further include a drug-eluting polymer matrix coating at least a portion of the power terminal enclosure and / or the housing cap enclosure.

[0012]

[0014] Another aspect of the invention may provide a method of manufacturing an implantable device. The method may include disposing a circuit in a housing. After disposing the circuit in the housing, the method may include filling the housing with epoxy up to an initial epoxy fill line. The method may include filling the housing with epoxy up to the initial epoxy fill line, and then curing the epoxy. The method may include connecting a conductive connector to a contact pad of the circuit. The method may include placing the conductive connector within the passage of the housing cap enclosure. The method may include placing the conductive connector within the passage of the housing cap enclosure, and then filling a remaining space within the housing between the initial epoxy fill line and the end of the housing with epoxy. The method may include curing the epoxy in a remaining space within the housing between the initial epoxy fill line and the end of the housing.

[0013]

[0015] In some embodiments, the method may further include disposing one or more supports attached to and extending from the power supply within the passageway of the housing cap enclosure. In some embodiments, the method may further include connecting conductive connectors to the positive and negative terminals of the power supply.

[0014]

[0016] In some embodiments, connecting the conductive connectors to the positive and negative terminals of the power source may include pressing a spring at an end of one of the conductive connectors against the positive terminal of the power source and compressing the spring. After the connector is placed within the passage of the housing cap enclosure, a surface of the housing cap enclosure abuts against the power supply terminal enclosure attached to the power supply, sealing the positive and negative terminals of the power supply.

[0015]

[0017] Yet another aspect of the present invention may provide an implantable device including a housing, a circuit at least partially within the housing, a power source, first and second conductive connectors, and a coupler. The power source may include a positive terminal and a negative terminal electrically connected to the circuit. The first conductive connector may be configured to electrically connect the positive terminal of the power source to the circuit. The second conductive connector may be configured to electrically connect the negative terminal of the power source to the circuit. The coupler may be between the housing and the power source. The coupler may be attached to the power source and may include one or more supports extending from the coupler into the housing.

[0016]

[0018] In some embodiments, the coupler may include a second conductive connector. In some embodiments, the one or more supports may be made of a material that is not conductive. In some embodiments, the coupler may have a cylindrical portion, and the one or more supports may extend from the cylindrical portion.

[0017]

[0019] In some embodiments, the device may include one or more substrates within the housing, and the circuitry may include one or more circuit components mounted on or fabricated within the one or more substrates. In some embodiments, the one or more circuit components may include one or more light sources and one or more light receivers.

[0018]

[0020] In some embodiments, the circuit may include an inductive element. In some embodiments, the inductive element may include a conductor and a magnetic core. In some embodiments, the inductive element may extend into the coupler.

[0019]

[0021] In some embodiments, the circuit may include contact pads, and the device may further include bonding wires electrically connecting the first and second conductive connectors to the contact pads. In some embodiments, the device may include one or more analyte indicators on or within a portion of an exterior surface of the housing. In some embodiments, the power source may be a battery. In some embodiments, the device may be hermetically sealed. In some embodiments, the device may include a spring configured to establish an electrical connection between the first conductive connector and a positive terminal of the power source. In some embodiments, the implantable device may further include a drug-eluting polymer matrix coating at least a portion of the coupler.

[0020]

[0022] Yet another aspect of the present invention may provide a method for manufacturing an implantable device. The method may include disposing a circuit in a housing. The method may include, after disposing the circuit in the housing, filling the housing with epoxy up to the initial epoxy fill line. The method may include, after filling the housing with epoxy up to the initial epoxy fill line, curing the epoxy. The method may include inserting one or more supports of a coupler into the housing. The method may include connecting first and second conductive connectors to contact pads of the circuit with the one or more supports of the coupler inserted into the housing. The method may include attaching the coupler to a power source. The method may include filling at least a remaining space in the housing between the initial epoxy fill line and an end of the housing with epoxy. The method may include curing the epoxy in at least a remaining space in the housing between the initial epoxy fill line and the end of the housing.

[0021]

[0023] In some embodiments, attaching the coupler to the power source may include connecting the first conductive connector to a positive terminal of the power source. In some embodiments, connecting the first conductive connector to the positive terminal of the power source may include pressing a spring on an end of the first conductive connector against the positive terminal of the power source and compressing the spring.

[0022]

[0024] In some embodiments, attaching the coupler to the power source may include connecting the second conductive connector to a negative terminal of the power source. In some embodiments, after inserting the one or more supports of the coupler into the housing, a surface of the coupler abuts a surface of the housing.

[0023]

[0025] Further variations encompassed by the systems and methods are described below in the detailed description of the invention.

[0024]

[0026] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate various non-limiting embodiments of the present invention, in which like reference numbers indicate identical or functionally similar elements. [Brief explanation of the drawings]

[0025] [Figure 1]

[0027] 1 is a schematic diagram illustrating a system embodying aspects of the present invention; [Figure 2A]

[0028] 1 is a perspective view of an implantable device embodying aspects of the present invention; [Figure 2B] 1 is a perspective view of a portion of an implantable device embodying aspects of the present invention. [Figure 3A]

[0029] 1 is a side view of an implantable device embodying aspects of the present invention. [Figure 3B] 1 is a side view of a portion of an implantable device embodying aspects of the present invention. [Figure 3E] 1 is a side view of an implantable device embodying aspects of the present invention. [Figure 3CD]

[0030] 3C and 3D are perspective and cross-sectional views of a coupler configured to attach a housing and power source to an implantable device, embodying aspects of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0026]

[0031] FIG. 1 is a schematic diagram of an exemplary system 50 embodying aspects of the present invention. In some embodiments, system 50 may be an analyte monitoring system. In some embodiments, system 50 may be a continuous analyte monitoring system (e.g., a continuous glucose monitoring system). In some embodiments, system 50 may include one or more of implantable device 100, external device 101, and display device 107. In some embodiments, implantable device 100 may be an analyte sensor. In some embodiments, implantable device 100 may be a miniature, fully implantable sensor that measures the amount or concentration of an analyte (e.g., glucose) in a medium (e.g., interstitial fluid) of a living animal (e.g., a living human). However, this is not required, and in some alternative embodiments, implantable device 100 may be a partially implantable (e.g., transcutaneous) device. Additionally, although embodiments of the present invention are described with respect to an analyte monitoring system in which implantable device 100 is an analyte sensor, this is not required. In some alternative embodiments, implantable device 100 is not a sensor, but instead is a different type of implantable device, such as, for example, without limitation, an insulin pump, a pacemaker, or an electrical / thermal therapy device.

[0027]

[0032] In some embodiments, the external device 101 may be an external wearable device (e.g., attached via an armband, wristband, waistband, or adhesive patch). In some embodiments, the external device 101 may communicate remotely with the implantable device 100 (e.g., via near field communication (NFC)). In some embodiments, the external device 101 may communicate with the implantable device 100 to initiate measurements and receive measurements from the implantable device 100. In some embodiments, the external device 101 may be a transceiver. In some embodiments, the external device 101 may be a smartphone (e.g., an NFC-enabled smartphone). In some embodiments, the external device 101 may communicate information (e.g., one or more analyte measurements) wirelessly (e.g., via a Bluetooth™ communication standard such as, but not limited to, Bluetooth Low Energy) to a handheld application running on the display device 107 (e.g., a smartphone).

[0028]

[0033] FIG. 2A is a perspective view of implantable device 100 of system 50 according to some embodiments. FIG. 2B is a perspective view of portion A of implantable device 100 as shown in FIG. 2A. FIG. 3A is a side view of implantable device 100 of system 50 according to some alternative embodiments. FIG. 3B is a side view of portion B of implantable device 100 as shown in FIG. 3A. In some embodiments, implantable device 100 may be a wireless analyte sensor. In some embodiments, implantable device 100 may be an analyte sensor. In some embodiments, the analyte sensor may detect the presence, amount, and / or concentration of an analyte (e.g., glucose, oxygen, cardiac markers, low-density lipoprotein (LDL), high-density lipoprotein (HDL), or triglycerides). In some embodiments, implantable device 100 may be an optical sensor (e.g., a fluorometer). In some embodiments, implantable device 100 may be a chemical or biochemical sensor.

[0029]

[0034] In some embodiments, as shown in Figures 2A, 2B, 3A, and 3B, implantable device 100 may include a power source 202, an inductive element 204, one or more substrates 206, and / or a housing 208. In some embodiments, housing 208 may be a body, a shell, a capsule, or a container. In some embodiments, housing 208 may be rigid and / or biocompatible. In some embodiments, housing 208 may include a polymer (e.g., PMMA) sleeve or silicone tubing. However, this is not required, and in other embodiments, different materials and / or shapes may be used for housing 208.

[0030]

[0035] In some embodiments, implantable device 100 may include one or more analyte indicators (e.g., analyte indicator 334 in FIG. 3E ), such as, for example, a polymer graft or hydrogel coated, diffused, adhered, embedded, or grown on or in at least a portion of the exterior surface of housing 208. In some embodiments, as shown in FIGS. 2A and 3A , housing 208 may include one or more cutouts or depressions 209, and one or more analyte indicators may be disposed (partially or entirely) in cutouts or depressions 209. In some embodiments, the one or more analyte indicators may be porous, allowing an analyte (e.g., glucose) in the medium (e.g., interstitial fluid) to diffuse into the one or more analyte indicators.

[0031]

[0036] In some embodiments, the one or more analyte indicators may exhibit one or more detectable properties (e.g., optical properties) that vary according to the amount or concentration of analyte in the vicinity of the one or more indicators. Alternatively, the multiple analyte indicators may emit an amount of emitted light that varies according to the amount or concentration of analyte in the vicinity of the one or more indicators. In some embodiments, the one or more analyte indicators may include one or more analyte indicator molecules (e.g., fluorescent analyte indicator molecules) that may be distributed throughout the one or more analyte indicators. In some embodiments, the one or more analyte indicators may be phenylboron-based analyte indicators. However, phenylboron-based analyte indicators are not required, and in some alternative embodiments, implantable device 100 may include a different analyte indicator, such as, for example, without limitation, a glucose oxidase-based indicator, a glucose dehydrogenase-based indicator, or a glucose binding protein-based indicator.

[0032]

[0037] 2A and 3A, implantable device 100 may include one or more light sources 210 that emit excitation light over a range of excitation wavelengths. In some embodiments, the excitation wavelength range may be a range of wavelengths that interact with an analyte indicator (e.g., one or more of analyte indicators 334 of FIG. 3E). In some embodiments, the excitation light may be ultraviolet (UV) light.

[0033]

[0038] 2A and 3A, implantable device 100 may include one or more optical receivers 212 (e.g., photodiodes, phototransistors, photoresistors, or other light-sensitive elements). In some embodiments, one or more optical receivers 212 may be configured to detect a detectable property of the analyte indicator and output an analyte signal indicative of the amount or concentration of the analyte in a medium within the body of a living animal. In some embodiments, one or more optical receivers 212 may be configured to output an analyte signal indicative of the amount of emitted light (e.g., fluorescent light) received by one or more optical receivers 212.

[0034]

[0039] In some embodiments, as shown in Figures 2A, 2B, 3A, and 3B, implantable device 100 may include one or more substrates 206 on one side of inductive element 204. In some embodiments, although not shown in Figures 2A, 2B, 3A, and 3B, implantable device 100 may additionally include one or more substrates 206 on the opposite side of inductive element 204. In some embodiments, one or more substrates 206 may be a circuit board (e.g., a printed circuit board (PCB) or a flexible PCB) on which one or more of the circuit components (e.g., analog and / or digital circuit components) may be mounted or otherwise attached. However, in some alternative embodiments, one or more substrates 206 may be a semiconductor substrate.

[0035]

[0040] In embodiments where the substrate 206 is a semiconductor substrate, one or more of the circuit components may be fabricated on the substrate 206. For example, the fabricated circuit components may include analog and / or digital circuits. Also, in some embodiments where the substrate 206 is a semiconductor substrate, circuit components may be mounted or otherwise attached to the semiconductor substrate in addition to the circuit components fabricated on the semiconductor substrate. In other words, in some semiconductor substrate embodiments, some or all of the circuit components, which may include discrete circuit elements, integrated circuits (e.g., application specific integrated circuits (ASICs)), and / or other electronic components (e.g., non-volatile memory), may be fabricated on the semiconductor substrate, with the remainder of the circuit components fixed to the semiconductor substrate, thereby providing communication paths between the various fixed components.

[0036]

[0041] In some embodiments, as shown in FIGS. 2A and 3A, one or more of the light sources 210 are mounted on one or more substrates 206 or In some embodiments, one or more of the optical receivers 212 may be mounted on or fabricated in one or more substrates 206. In some embodiments, one or more of the light sources 210 may be mounted on one or more substrates 206, one or more of the optical receivers 212 may be fabricated in one or more substrates 206, and all or a portion of the circuit components may be fabricated in one or more substrates 206. In some embodiments, as shown in FIGS. 2B, 3A, and 3B, the implantable device 100 may additionally or alternatively have one or more circuit components 214 (e.g., capacitors) mounted on the inductive element 204.

[0037]

[0042] In some embodiments, implantable device 100 may communicate with external device 101. In some embodiments, external device 101 may be an electronic device that communicates with implantable device 100 to provide commands (e.g., measurement commands) to implantable device 100 and / or receive measurement data (e.g., optical receiver and / or temperature sensor readings) from implantable device 100. The measurement data may include one or more readings from one or more optical receivers 212 of implantable device 100 and / or one or more readings from one or more temperature sensors of implantable device 100. In some embodiments, external device 101 may calculate the analyte concentration from the measurement data received from implantable device 100. However, it is not required that external device 101 perform the analyte concentration calculation itself; in some alternative embodiments, external device 101 may instead communicate / relay the measurement data received from implantable device 100 to another device that calculates the analyte concentration. In other alternative embodiments, implantable device 100 may perform the analyte concentration calculation.

[0038]

[0043] In some embodiments, the inductive element 204 of the implantable device 100 may act as an antenna. In some embodiments, the external device 101 may communicate with the implantable device 100 via an inductive magnetic link to achieve passive telemetry for data transfer. In some embodiments, the inductive element 204 may be, for example, a ferrite-based micro-antenna. In some embodiments, as shown in FIG. 2A , the inductive element 204 may include a conductor 216 in the form of a coil and a magnetic core 218. In some embodiments, the core 218 may be, for example, without limitation, a ferrite core. In some embodiments, the inductive element 204 may be connected to circuitry (e.g., an application specific integrated circuit (ASIC)) of the implantable device 100. In some embodiments, the implantable device 100 may rely on the external device 101 to provide a data link to communicate data from the implantable device 100 to the external device 101.

[0039]

[0044] In some embodiments, the circuitry of implantable device 100 may include inductive element 204, circuit components (e.g., one or more light sources 210 and / or one or more light receivers 212) mounted on or fabricated within one or more substrates 206, and / or one or more circuit components 214 mounted on inductive element 204. In some embodiments, the circuitry of implantable device 100 may be powered by power source 202.

[0040]

[0045] In some embodiments, power source 202 may be a charge storage device. In some embodiments, power source 202 may be a battery (e.g., a rechargeable battery such as a lithium-ion battery), a capacitor, or a supercapacitor. In some embodiments, at least the exterior of power source 202 may be made of a biocompatible material, such as, for example, without limitation, stainless steel or a titanium alloy. In some embodiments, power source 202 may include a positive terminal (cathode) 220 and a negative terminal (anode) 222.

[0041]

[0046] In some embodiments, as shown in FIGS. 2A , 2B , 3A , and 3B , one or more couplers may attach the power source 202 to the housing 208. In some embodiments, as shown in FIGS. 2A and 2B , the one or more couplers attaching the power source 202 to the housing 208 may include a power source terminal enclosure 224 and a housing cap enclosure 226. In some embodiments, conductive connectors 228 and 230 may electrically connect the positive terminal 220 and the negative terminal 222, respectively, of the power source 202 to the circuitry of the implantable device 100. In some embodiments, the attachment of the power source 202 to the housing 208 may be supported by one or more supports 232. In some embodiments, the circuitry of the implantable device 100 may extend away from the power source 202 along the longitudinal axis of the power source, as shown in FIG. 2A .

[0042]

[0047] In some embodiments, the conductive connectors 228 and 230 may be rods or beams that include or are made from a conductive material. In some embodiments, bond wires 234 may electrically connect the conductive connectors 228 and 230 to contact pads 236 on the inductive element 204. In some embodiments, a spring 238 (e.g., a V-shaped spring) may be attached (e.g., welded) to one end of the conductive connector 228. In some embodiments, the spring 238 may be made of a conductive material and may establish an electrical connection between the connector 228 and the positive terminal 220 of the power source 202. In some embodiments, the spring 238 may be pressed against and compressed against the positive terminal 220 of the power source 202 when the housing 208 and the power source 202 are attached to one another.

[0043]

[0048] In some embodiments, one or more supports 232 may be reinforcing rods, bars, or beams. In some embodiments, one or more supports 232 may be attached to and extend from power source 202. In some embodiments, one or more supports 232 may have a larger diameter than conductive connectors 228 and 230. In some embodiments, one or more supports 232 may be made from a material that is not electrically conductive.

[0044]

[0049] In some embodiments, as shown in FIG. 2B , power terminal enclosure 224 may be cup-shaped (e.g., a hollow cylinder with a flat bottom 224 b and an open top). However, other shapes (e.g., a hollow right-angle prism with a flat bottom and an open top) may be used in alternative embodiments. In some embodiments, power terminal enclosure 224 may enclose positive terminal 220 and negative terminal 222 of power source 202. In some embodiments, power terminal enclosure 224 may enclose spring 238. In some embodiments, bottom 224 b of power terminal enclosure 224 may have holes 224 c through which conductive connectors 228 and 230 and one or more supports 232 extend. In some embodiments, power terminal enclosure 224 may be made of a biocompatible material. In some embodiments, power terminal enclosure 224 may be made of a biocompatible metal, such as, for example, but not limited to, stainless steel or titanium. In some embodiments, power terminal enclosure 224 may be attached (e.g., welded) to power supply 202. In some embodiments, power terminal enclosure 224 may be attached to power supply 202 by laser welding.

[0045]

[0050] In some embodiments, the housing cap enclosure 226 may have a solid cylindrical shape. However, other shapes (e.g., a solid rectangular prism shape) may be used in alternative embodiments. In some embodiments, the housing cap enclosure 226 may be made of a biocompatible material, such as, without limitation, glass or ceramic. In some embodiments, the housing cap enclosure 226 may have a periphery through which the conductive connectors 228 and 230 and one or more supports 232 extend. , passages, or feedthroughs 240. In some embodiments, housing cap enclosure 226 may include a first flat surface that abuts and attaches to bottom 224b of power terminal enclosure 224. In some embodiments, housing cap enclosure 226 may be attached to bottom 224b of power terminal enclosure 224 by brazing. In some embodiments, housing cap enclosure 226 may include a first flat surface that abuts and attaches to open end 208a of housing 208. In some embodiments, housing cap enclosure 226 may enclose the circuitry of implantable device 100 within housing 208.

[0046]

[0051] In some embodiments, after the circuitry of implantable device 100 is placed within housing 208, housing 208 may be filled with epoxy up to initial epoxy fill line 242. In some embodiments, the epoxy may create a transmissive optical cavity within housing 208. In some embodiments, the transmissive optical cavity may be formed from a suitable optically transmissive polymer material, such as, for example, an acrylic polymer (e.g., polymethyl methacrylate (PMMA)). However, this is not required, and in other embodiments, a different material may be used for the transmissive optical cavity.

[0047]

[0052] In some embodiments, after housing 208 is filled with epoxy up to initial epoxy fill line 242, the epoxy may be allowed to cure. In some embodiments, conductive connectors 228 and 230 may be connected to contact pads 236 of the circuitry of implantable device 100 (e.g., by soldering bonding wires 234 to contact pads 236). In some embodiments, after conductive connectors 228 and 230 and one or more supports 232 are in place within passages or feedthroughs 240 of housing cap enclosure 226, the remaining space within housing 208 between initial epoxy fill line 242 and open end 208a of housing 208 is filled with epoxy, and the epoxy is then allowed to cure.

[0048]

[0053] In some embodiments, implantable device 100, including power supply 202, power terminal enclosure 224, housing cap enclosure 226, and housing 208, may be hermetically sealed.

[0049]

[0054] In some alternative embodiments, as shown in FIGS. 3A and 3B , a coupler 324 may attach the housing 208 and the power source 202. In some embodiments, the coupler 324 may be between the housing 208 and the power source 202. In some embodiments, the implantable device 100, including the power source 202, the coupler 324, and the housing 208, may be hermetically sealed. In some embodiments, as shown in FIG. 3B , the implantable device 100 may include first and second conductive connectors 228 and 230. In some embodiments, the first conductive connector 228 may be configured to electrically connect the positive terminal 220 of the power source 202 to a circuit. In some embodiments, the second conductive connector 230 may be configured to electrically connect the negative terminal 222 of the power source 202 to a circuit. In some embodiments, as shown in FIG. 3B , the coupler 324 may include a flat surface 326 that abuts the power source 202. In some embodiments, coupler 324 may be attached (e.g., by laser welding) to generator 202. In some embodiments, the circuitry of implantable device 100 may extend along the longitudinal axis of generator 202 in a direction away from generator 202, as shown in FIG.

[0050]

[0055] In some embodiments, the first conductive connector 228 may be a rod or beam that includes or is made from a conductive material. In some embodiments, the second conductive connector 230 may include a conductive material (e.g., gold plating). In this embodiment, bond wires 234 may electrically connect the first and second conductive connectors 228 and 230 to contact pads 236 of the circuit (e.g., contact pads 236 on the inductive element 204). In some embodiments, as shown in FIG. 3B, one or both of the first and second conductive connectors 228 and 230 may not extend from the coupler 324 but may instead be housed with the coupler 324. However, this is not required, and in some alternative embodiments, one or both of the first and second conductive connectors 228 and 230 may extend from the coupler 324 into the housing 208. In some embodiments, the inductive element 204 may extend into the coupler 324, as shown in FIG. 3B.

[0051]

[0056] In some embodiments, a spring (e.g., a V-shaped spring such as spring 238 shown in FIG. 2B) may be attached (e.g., welded) to one end of conductive connector 228. In some embodiments, spring 238 may be made of a conductive material and may establish an electrical connection between connector 228 and positive terminal 220 of power source 202. In some embodiments, spring 238 may be pressed against and compressed against positive terminal 220 of power source 202 when housing 208 and power source 202 are attached to one another.

[0052]

[0057] 3C and 3D are perspective and cross-sectional views, respectively, of a coupler 324 according to some embodiments. In some embodiments, as shown in FIGS. 3B-3D, the coupler 324 may include one or more supports 232. In some embodiments, the one or more supports 232 may be reinforcing rods, bars, or beams. In some embodiments, the one or more supports 232 may be attached to and / or integral with the coupler 324. In some embodiments, the one or more supports 232 may be made of a material that is not electrically conductive. While the coupler 324 in the illustrated embodiment includes three supports 232, this is not required, and in some alternative embodiments, the coupler 324 may include more or fewer supports 232 (e.g., 1, 2, 4, 5, 6, or 10 supports 232). In some embodiments, as shown in FIGS. 3A and 3B, the one or more supports 232 may extend from the coupler 324 into the housing 208.

[0053]

[0058] In some embodiments, as shown in Figures 3B-3D, coupler 324 may include second conductive connector 230. In some embodiments, as shown in Figure 3C, coupler may have a cylindrical portion with one or more supports 232 extending from the cylindrical portion. In some embodiments, as shown in Figure 3B, coupler 324 may include a flat surface 328 that abuts housing 208. In some embodiments, coupler 324 and housing 208 may be held together (e.g., by a hardened epoxy within housing 208 and / or coupler 324).

[0054]

[0059] In some embodiments, the process of manufacturing implantable device 100 may include disposing a circuit (e.g., a circuit including inductive element 204, circuit elements mounted on inductive element 204, and / or circuit elements mounted on or fabricated in one or more substrates 206) at least partially within housing 208. After disposing the circuit at least partially within housing 208, the process may include filling housing 208 with epoxy up to an initial epoxy fill line. In some embodiments, the initial epoxy fill line may be such that contact pads 236 are not exposed and are not covered by the epoxy. In some embodiments, the initial epoxy fill line may additionally or alternatively be such that after the epoxy has cured, there is still space within housing 208 for inserting one or more supports 232 into housing 208.

[0055]

[0060] In some embodiments, the process may include filling the housing with epoxy up to the initial epoxy fill line and then curing the epoxy. In some embodiments, the cured epoxy may create a transmissive optical cavity within the housing 208. In some embodiments, the transmissive optical cavity may be formed from a suitable optically transmissive polymer material, such as, for example, an acrylic polymer (e.g., polymethyl methacrylate (PMMA)). However, this is not required, and in other embodiments, a different material may be used for the transmissive optical cavity.

[0056]

[0061] In some embodiments, the process may include inserting one or more supports 232 of coupler 324 into housing 208 (e.g., into the remaining space of housing 208 that is not filled with the cured epoxy). In some embodiments, after inserting one or more supports 232 of coupler 324 into housing 208, a surface of coupler 328 may abut a surface of housing 208.

[0057]

[0062] In some embodiments, the process may include connecting the first and second conductive connectors 228 and 230 to contact pads 236 of the circuit (e.g., contact pads 236 on the inductive element 204) with the one or more supports 232 of the coupler 324 inserted into the housing 208. In some embodiments, the first and second conductive connectors 228 and 230 may be connected to the contact pads 236 of the circuit by soldering bonding wires 234 to the contact pads 236.

[0058]

[0063] In some embodiments, the process may include attaching the coupler 324 to the power source 202 (e.g., by laser welding the coupler 324 to the flat surface 326). In some embodiments, attaching the coupler 324 to the power source 202 may include connecting the first conductive connector 228 to the positive terminal 220 of the power source 202. In some embodiments, connecting the first conductive connector 228 to the positive terminal 220 of the power source 202 may include pressing a spring (e.g., spring 238) at the end of the first conductive connector 238 against the positive terminal 220 of the power source 202 and compressing the spring 238. In some embodiments, attaching the coupler 324 to the power source 202 may include connecting the second conductive connector 230 to the negative terminal 222 of the power source 202.

[0059]

[0064] In some embodiments, the process may include filling with epoxy at least the remaining space within the housing 208 between the initial epoxy fill line and the end of the housing 208. In some embodiments, the epoxy may additionally fill all or a portion of the coupler 324. In some embodiments, all or a portion of the remaining space within the housing 208 and / or all or a portion of the coupler 324 may be filled with epoxy using small holes in the coupler 324.

[0060]

[0065] In some embodiments, the process may include curing the epoxy in at least the remaining space within the housing 208 between the initial epoxy fill line and the end of the housing 208. In some embodiments, because the one or more supports 232 of the coupler 324 are inserted into the housing 208, the cured epoxy in the remaining space and / or the coupler 324 may hold the coupler 324 and the housing 208 together.

[0061]

[0066] In some embodiments, implantable device 100 may include one or more drug-eluting polymer matrices. In some embodiments, implantable device 100 may include one or more drug-eluting polymer matrices (e.g., drug-eluting polymer matrix 330 shown in FIG. 3E) on all or a portion of the exterior surface of housing 208. In some embodiments, one or more drug-eluting polymer matrices on housing 208 The eluting polymer matrix may be disposed in one or more recesses in the housing 208. In some embodiments, the implantable device 100 may additionally or alternatively include one or more drug-eluting polymer matrices (e.g., drug-eluting polymer matrix 332 shown in FIG. 3E ) on all or a portion of the outer surface of one or more couplers that attach the power source 202 and the housing 208. In some embodiments, the one or more drug-eluting polymer matrices may be disposed on all or a portion of one or both of the power source terminal enclosure 224 and the housing cap enclosure 226. In some embodiments, as shown in FIG. 3E , the one or more drug-eluting polymer matrices 332 may be disposed on all or a portion of the coupler 324.

[0062]

[0067] In some embodiments, the drug-eluting polymer matrix(es) may be applied to the sensor housing 208 and / or one or more couplers (e.g., coupler 324 or power terminal enclosure 224 and housing cap enclosure 226) via dipping or spray coating. In some alternative embodiments, the drug-eluting polymer matrix(es) may have a preformed shape, such as a ring or sleeve. In some alternative embodiments, the drug-eluting polymer matrix(es) may have a different shape. In some embodiments, as shown in FIG. 3E, the drug-eluting polymer matrix(es) 330 and 332 may wrap around a portion of the sensor housing 208 and / or a portion of the coupler 324. In some alternative embodiments, the drug-eluting polymer matrix(es) 330 and 332 may be wider or narrower than the drug-eluting polymer matrices 330 and 332 shown in FIG. 3E.

[0063]

[0068] One or more therapeutic agents may be dispersed within the one or more drug-eluting polymer matrices (e.g., one or more inert polymer matrices). In some embodiments, the one or more therapeutic agents may reduce or prevent neutrophil migration into the wound space, thus reducing or preventing the production of hydrogen peroxide and fibrous inclusions. Accordingly, in some embodiments, the one or more therapeutic agents may reduce the degradation of one or more analyte indicators (e.g., analyte indicator 334). In some embodiments, the one or more therapeutic agents that may be dispersed within the drug-eluting polymer matrix may include one or more anti-inflammatory agents, such as, for example, nonsteroidal anti-inflammatory agents (e.g., acetylsalicylic acid (aspirin) and / or isobutylphenylpropanoic acid (ibuprofen)). In some non-limiting embodiments, the one or more therapeutic agents dispersed within the drug-eluting polymer matrix may include one or more glucocorticoids. In some non-limiting embodiments, the one or more therapeutic agents may include one or more of dexamethasone, triamcinolone, betamethasone, methylprednisolone, beclomethasone, fludrocortisone, derivatives thereof, and analogs thereof. In some embodiments, the one or more therapeutic agents may reduce the production of hydrogen peroxide by neutrophils and macrophages.

[0064]

[0069]

[0023] Embodiments of the present invention have been fully described above with reference to the drawings. While the present invention has been described based on these preferred embodiments, it will be apparent to those skilled in the art that certain modifications, variations, and alternative constructions to the described embodiments may be made within the spirit and scope of the invention. For example, in some embodiments, implantable device 100 may include a bridging material with insulation.

Claims

1. 1. A method of manufacturing an implantable device, comprising: disposing the circuitry at least partially within the housing; After disposing the circuit at least partially within the housing, filling the housing with a first material up to an initial fill line; filling the housing with the first material up to the initial fill line and then curing the first material; connecting first and second conductive connectors to contact pads of said circuit; After hardening the first material, filling at least a remaining space within the housing between the hardened first material and an end of the housing with a second material; curing the second material; A method comprising:

2. The method of claim 1 , wherein the hardened first material defines a transmissive optical cavity within the housing.

3. The method of claim 1 , wherein the first material and the second material are epoxies.

4. The method of claim 1 further comprising the step of attaching the coupler to a power source.

5. The method of claim 4 , wherein the hardened second material fills a portion of the coupler.

6. The method of claim 4 , wherein the hardened second material fills all of the couplers.

7. 5. The method of claim 4, further comprising the step of inserting a portion of the coupler into the housing, wherein the first and second conductive connectors are connected to the contact pads of the circuit with one or more supports of the coupler inserted into the housing.

8. 8. The method of claim 7, wherein after inserting the portion of the coupler into the housing, a surface of the coupler abuts a surface of the housing.

9. The method of claim 7 , wherein the portion of the coupler that extends into the housing includes one or more supports.

10. The method of claim 7 , wherein the portion of the coupler that extends into the housing includes two or more supports.

11. The method of claim 4 , wherein attaching the coupler to the power source comprises connecting the first conductive connector to a positive terminal of the power source.

12. 12. The method of claim 11 , wherein connecting the first conductive connector to the positive terminal of the power source comprises: pressing a spring at an end of the first conductive connector against the positive terminal of the power source; and compressing the spring.

13. The method of claim 4 , wherein attaching the coupler to the power supply comprises connecting the second conductive connector to a negative terminal of the power supply.

14. A method for manufacturing an implantable device, comprising: disposing the circuitry at least partially within the housing; adding a first material to the housing; disposing the circuit at least partially within the housing and applying the first material to the housing, and then curing the first material, wherein the hardened first material defines a transmissive optical cavity within the housing; connecting first and second conductive connectors to contact pads of said circuit; After hardening the first material, filling at least a remaining space within the housing between the hardened first material and an end of the housing with a second material; curing the second material; A method comprising:

15. The method of claim 14, wherein the first material and the second material are epoxy.

16. The method of claim 14, further comprising the step of attaching the coupler to a power source.

17. The method of claim 16, wherein the hardened second material is filled into a portion of the coupler.

18. The method of claim 16, wherein the hardened second material fills all of the couplers.

19. The method of claim 14, wherein the step of adding the first material to the housing includes filling the housing with the first material up to an initial fill line.

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