Hermetically sealed implantable medical device and method of forming the same

Abstract

Embodiments of the present disclosure relate to implantable medical devices (IMDs). In an example embodiment, an IMD includes a power source and a housing that encloses the power source. The housing includes a first side and a second side that extend along a longitudinal axis between a first end and a second end, wherein the first side is opposite the second side and the first end is opposite the second end, and wherein a first distance between the first end and the second end is greater than a second distance between the first side and the second side. The IMD further includes a printed circuit board disposed on the first side of the base and electrically coupled to the power source. The IMD further includes a non-conductive housing disposed on the printed circuit board and hermetically sealing the printed circuit board, the non-conductive housing including an outer surface. And, the IMD includes a first electrode and a second electrode disposed on the outer surface of the non-conductive housing, wherein the first outer electrode is coupled to the printed circuit board by a first trace and the second outer electrode is coupled to the printed circuit board by a second trace.

Description

[0001] Related Applications

[0002] This application claims priority to provisional application number 62 / 976,079, filed February 13, 2020, the entirety of which is incorporated herein by reference. TECHNICAL FIELD

[0003] Embodiments of the present disclosure relate to medical devices and systems for sensing physiological parameters and / or delivering therapy. More particularly, embodiments of the present disclosure relate to devices and methods for hermetically sealed implantable medical devices. BACKGROUND

[0004] Implantable medical devices (IMDs) can be configured to sense physiological parameters and / or provide therapy, and can include one or more electrodes for performing various aspects of these functions. IMDs can also include an antenna for communicating with other devices. Conventionally, devices such as programmers have been used to cause IMDs to take various actions, such as, for example, marking recordings of physiological parameters, initiating communications with other devices, and the like. SUMMARY

[0005] Exemplary embodiments of the present disclosure include, but are not limited to, the following examples.

[0006] In Example 1, an implantable medical device (IMD) configured to sense one or more physiological parameters of a subject, the IMD comprising: a power source; a housing enclosing the power source, the housing comprising a first side, a second side, a first end, and a second end, wherein the first side is opposite the second side and the first end is opposite the second end, and wherein a first distance between the first end and the second end is greater than a second distance between the first side and the second side; a printed circuit board disposed on the first side of the housing and conductively coupled to the power source; a non-conductive housing disposed on and sealing the printed circuit board, the non-conductive housing comprising an outer surface; and a first electrode and a second electrode disposed on the outer surface of the non-conductive housing, wherein the first outer electrode is coupled to the printed circuit board by a first trace and the second outer electrode is coupled to the printed circuit board by a second trace.

[0007] In Example 2, the IMD of Example 1, wherein the non-conductive housing is formed of a liquid crystal polymer or an epoxy resin.

[0008] In Example 3, the IMD of any of Examples 1-2, wherein the connector traces are secured to the housing by one or more frames.

[0009] In Example 4, the IMD of Example 3, wherein the frames are composed of a non-conductive material and create a boundary to limit movement of the traces.

[0010] In Example 5, the IMD of any one of Examples 1-4, wherein the apparatus further comprises an antenna disposed within or on the non-conductive housing and coupled to the circuit board.

[0011] In Example 6, the IMD of Example 5, wherein the antenna comprises a first portion disposed parallel to the longitudinal axis.

[0012] In Example 7, the IMD of Example 6, wherein the antenna further comprises a second portion disposed perpendicular to the longitudinal axis.

[0013] In Example 8, the IMD of any one of Examples 1-7, wherein the outer surface of the IMD comprises an outer seal configured to hermetically seal the IMD with respect to the ambient environment.

[0014] In Example 9, the IMD of Example 8, wherein the outer seal is an atomic deposition layer.

[0015] In Example 10, the IMD of any one of Examples 1-9, wherein the housing is composed of a metallic material.

[0016] In Example 11, the IMD of any one of Examples 1-10, further comprising a third electrode and a fourth electrode disposed on the outer surface of the housing.

[0017] In Example 12, a method of forming a hermetically sealed implantable apparatus, comprising: disposing a circuit board subassembly onto a housing that encloses a power source; disposing a first segment of a connector trace along the housing and a second segment of the connector trace to extend from the housing, wherein a first end of the connector trace is connected to the circuit board subassembly; disposing one or more frames on the first segment of the connector trace to hold the first segment of the connector trace in place; forming a non-conductive housing on the subassembly to create an enclosure that exposes a portion of the second segment of the connector trace above an outer surface of the non-conductive housing; removing the portion of the second segment of the connector trace exposed above the outer surface; and disposing two electrodes on the outer surface of the non-conductive housing and connecting the two electrodes to the connector trace.

[0018] In Example 13, the method of Example 12, wherein the electrodes are disposed on the other surface of the non-conductive housing by one of a laser welding, deposition, sputtering, or spray / inkjet method.

[0019] In Example 14, the method of Example 13, wherein a hermetic seal is applied to the implantable apparatus after the electrodes are disposed on the outer surface.

[0020] In Example 15, the method of any one of Examples 12-14, further comprising forming an antenna within or on the non-conductive housing.

[0021] In Example 16, an implantable medical device (IMD) configured to sense one or more physiological parameters of a subject, the IMD comprising: a power source; a housing enclosing the power source, the housing comprising a first side and a second side extending along a longitudinal axis between a first end and a second end, wherein the first side is opposite the second side and the first end is opposite the second end, and wherein a first distance between the first end and the second end is greater than a second distance between the first side and the second side; a printed circuit board disposed on the first side of the base and conductively coupled to the power source; a non-conductive housing disposed on and hermetically sealing the printed circuit board, the non-conductive housing comprising an outer surface; and a first electrode and a second electrode disposed on the outer surface of the non-conductive housing, wherein the first outer electrode is coupled to the printed circuit board by a first trace and the second outer electrode is coupled to the printed circuit board by a second trace.

[0022] In Example 17, the IMD of Example 16, wherein the non-conductive housing is formed of a liquid crystal polymer or an epoxy resin.

[0023] In Example 18, the IMD of Example 16, wherein the connector traces are secured to the housing by one or more frames.

[0024] In Example 19, the IMD of Example 18, wherein the frames are composed of a non-conductive material and create a boundary to limit movement of the traces.

[0025] In Example 20, the IMD of Example 16, wherein the device further comprises an antenna disposed within or on the non-conductive housing and coupled to the circuit board.

[0026] In Example 21, the IMD of Example 20, wherein the antenna comprises a first portion disposed parallel to the longitudinal axis.

[0027] In Example 22, the IMD of Example 21, wherein the antenna further comprises a second portion disposed perpendicular to the longitudinal axis.

[0028] In Example 23, the IMD of Example 16, wherein the outer surface of the IMD comprises an outer seal configured to hermetically seal the IMD with respect to the ambient environment.

[0029] In Example 24, the IMD of Example 23, wherein the outer seal is an atomic deposition layer.

[0030] In Example 25, the IMD of Example 16, wherein the housing is composed of a metallic material.

[0031] In Example 26, the IMD of Example 16, further comprising a third electrode and a fourth electrode disposed on the outer surface of the housing.

[0032] In Example 27, a method of forming a hermetically sealed implantable device, comprising: disposing a circuit board subassembly onto a housing that encloses a power source; disposing a first segment of a connector trace along the housing and a second segment of the connector trace to extend from the housing, wherein a first end of the connector trace is connected to the circuit board subassembly; disposing one or more frames over the first segment of the connector trace to hold the first segment of the connector trace in place; forming a non-conductive enclosure over the subassembly to create an enclosure that exposes a portion of the second segment of the connector trace above an outer surface of the non-conductive enclosure; removing the portion of the second segment of the connector trace exposed above the outer surface; and disposing two electrodes on the outer surface of the non-conductive enclosure and connecting the two electrodes to the connector trace.

[0033] In Example 28, the method of Example 27, wherein the first segment of the connector trace is attached to the printed circuit board by a technique that welds the components together.

[0034] In Example 29, the method of Example 27, wherein the electrodes are disposed on the other surface of the non-conductive enclosure by a technique of one of laser welding, deposition, sputtering, or spray / inkjet methods.

[0035] In Example 30, the method of Example 27, wherein a hermetic seal is applied to the implantable device after the electrodes are disposed on the outer surface.

[0036] In Example 31, the method of Example 30, wherein the applied hermetic seal is atomic layer deposition.

[0037] In Example 32, a hermetically sealed implantable medical device (IMD), the IMD comprising: a power source; a housing that encloses the power source; a printed circuit board disposed on a first side of the housing and conductively coupled to the power source; a non-conductive enclosure disposed on and hermetically sealing the printed circuit board, the non-conductive enclosure comprising an outer surface; and at least one electrode disposed on the outer surface of the non-conductive enclosure.

[0038] In Example 33, the IMD of Example 32, wherein the device further comprises an antenna disposed within or on the non-conductive enclosure and connected to the printed circuit board.

[0039] In Example 34, the IMD of Example 33, wherein the antenna comprises a first portion parallel to a longitudinal axis between a first end and a second end of the power source and a second portion perpendicular to the longitudinal axis.

[0040] In Example 35, the IMD of Example 32, wherein the at least one electrode comprises a plurality of electrodes.

[0041] While several embodiments are disclosed herein, other embodiments of the disclosure will become apparent to those skilled in the art upon examination of the following detailed description of the illustrative embodiments. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive. BRIEF DESCRIPTION OF DRAWINGS

[0042] Figure 1 is a schematic diagram of a system having an implantable medical device (IMD) and a receiving device according to embodiments of the present disclosure.

[0043] Figure 2 is a perspective view of a hermetically sealed IMD according to embodiments of the present disclosure.

[0044] Figure 3A is a perspective view of a portion of a sealed IMD according to embodiments of the present disclosure.

[0045] Figure 3B is a perspective view of a power subassembly and printed circuit board having connector traces and a guide frame according to embodiments of the present disclosure.

[0046] Figure 4 is a schematic diagram of an electrical subassembly according to embodiments of the present disclosure.

[0047] Figure 5 is a schematic diagram of an IMD and an electrical subassembly operating with a receiving device according to embodiments of the present disclosure.

[0048] Figure 6 is a front view of a printed circuit board and power subassembly according to embodiments of the present disclosure.

[0049] Figure 7 is a flowchart of a method of forming a hermetically sealed IMD according to embodiments of the present disclosure.

[0050] While the subject matter disclosed herein can be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail herein. However, it should be understood that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the subject matter disclosed herein as defined by the appended claims.

[0051] Although the term "block" can be used herein to connote different elements employed in the illustrative examples, the term should not be interpreted as implying any requirement that the various steps be performed in a particular order or that the various steps be performed at all, unless and except when the order of individual steps is explicitly mentioned. DETAILED DESCRIPTION

[0052] The size of an implantable medical device (IMD) is limited due to being implanted within a patient's body. Due to these limitations, the power source of the IMD can be a limiting factor of how much functionality can be incorporated into the IMD. Thus, it can be useful to transmit sensor measurements to an external device for processing the sensor measurements. IMDs typically include a header made of a non-conductive material to transmit the sensor measurements to the external device. However, including the header can reduce the size of the power source that can be included in the IMD. Embodiments disclosed herein provide a solution to this problem.

[0053] Figure 1 is a schematic diagram of a system 100 including an IMD 102 implanted within a patient's body 104 and configured to communicate with a receiving device 106. In embodiments, the IMD 102 can be implanted subcutaneously within an implant location or pocket of a patient's chest or abdomen and can be configured to monitor (e.g., sense and / or record) physiological parameters associated with the patient's heart 108. In embodiments, the IMD 102 can be an implantable cardiac monitor (ICM) (e.g., an implantable diagnostic monitor (IDM), an implantable loop recorder (ILR), etc.) configured to record physiological parameters such as, for example, one or more cardiac activation signals, heart sounds, blood pressure measurements, oxygen saturation, and / or the like.

[0054] In certain instances, the IMD 102 can be configured to monitor physiological parameters that can include one or more signals indicative of a patient's physical activity level and / or metabolic level, such as an acceleration signal. In certain instances, the IMD 102 can be configured to monitor physiological parameters associated with one or more other organs, systems, and / or the like. The IMD 102 can be configured to sense and / or record at regular intervals, continuously, and / or in response to a detected event. In certain instances, such a detected event can be detected by one or more sensors of the IMD 102, another IMD (not shown), an external device (e.g., the receiving device 106), and / or the like. Further, the IMD 102 can be configured to detect a variety of physiological signals that can be used in conjunction with various diagnostic, therapeutic, and / or monitoring implementations. For example, the IMD 102 can include sensors or circuitry for detecting respiratory system signals, cardiac system signals, and / or signals related to patient activity. In certain instances, the IMD 102 can be configured to sense intrathoracic impedance from which a variety of respiratory parameters can be derived, including, for example, respiratory tidal volume and minute ventilation. Sensors and associated circuitry can be incorporated with the IMD 102 for detecting one or more body motion or body posture and / or position related signals. For example, an accelerometer and / or a GPS device can be used to detect patient activity, patient positioning, body orientation, and / or torso position.

[0055] For purposes of illustration and not limitation, various embodiments of devices that can be used in accordance with the present disclosure to record physiological parameters are described herein in the context of an IMD implantable under the skin in a patient's chest region.

[0056] As shown, IMD 102 can include a housing 110 having two electrodes 112 and 114 integrated to and / or coupled to the housing 110. According to certain examples, IMD 102 can include any number of electrodes (and / or other types of sensors, such as, for example, thermometers, barometers, pressure sensors, optical sensors, motion sensors, and / or the like) in any number of various types of configurations, and housing 110 can include any number of different shapes, sizes, and / or features. In certain examples, IMD 102 can be configured to sense and record physiological parameters. For example, IMD 102 can be configured to activate (e.g., periodically, continuously, upon detection of an event, and / or the like), record (e.g., physiological parameters) in a memory, and transfer the recorded data to receiving device 106. For example, in the housing of IMD 102, IMD 102 can activate, record cardiac signals for a period of time, deactivate, and / or activate to transfer the recorded signals to receiving device 106.

[0057] In various examples, receiving device 106 can be, for example, a programmer, a controller, a patient monitoring system, and / or the like. Although shown as an external device in Figure 1 receiving device 106 can include an implantable device configured to communicate with IMD 102, which can be, for example, a control device, another monitoring device, a pacemaker, an implantable defibrillator, a cardiac resynchronization therapy (CRT) device, and / or the like, and can be an implantable medical device known in the art or later developed for providing therapy and / or diagnostic data regarding a patient and / or IMD 102. In certain examples, IMD 102 can be a pacemaker, an implantable cardioverter defibrillator (ICD) device, or a cardiac resynchronization therapy (CRT) device. In certain examples, IMD 102 can include defibrillation and pacing / CRT capabilities (e.g., a CRT-D device).

[0058] According to embodiments of the present disclosure, system 100 can be used to implement coordinated patient measurement and / or monitoring, diagnosis, and / or therapy. System 100 can include, for example, one or more patient internal medical devices, such as IMD 102, and one or more patient external medical devices, such as receiving device 106. Receiving device 106 can be configured to perform monitoring, and / or diagnosis and / or therapy functions external to the patient (i.e., not invasively implanted within the patient). Receiving device 106 can be positioned on the patient, near the patient, or at any location external to the patient.

[0059] The IMD 102 and the receiving device 106 can communicate via a wireless link. For example, the IMD 102 and the receiving device 106 can be coupled via a short-range radio link such as Bluetooth, IEEE 802.11, and / or proprietary wireless protocols. The communication link can facilitate one-way and / or two-way communication between the IMD 102 and the receiving device 106. Data and / or control signals can be transmitted between the IMD 102 and the receiving device 106 to coordinate the functions of the IMD 102 and / or the receiving device 106. Patient data can be downloaded periodically or on command from one or more of the IMD 102 and the receiving device 106. Physicians and / or patients can communicate with the IMD 102 and the receiving device 106, for example, to obtain patient data or to initiate, terminate, or modify records and / or treatments.

[0060] Figure 1 The illustrative system 100 shown is not intended to imply any limitation on the scope of use or functionality of embodiments throughout the subject matter disclosed herein. The illustrative system 100 should also not be construed as having the same... Figure 1 Any dependencies or requirements relating to any individual component or combination of components shown herein. For example, in an embodiment, illustrative system 100 may include additional components. Furthermore, in an embodiment, Figure 1 Any one or more components depicted herein can be integrated with various components in other components depicted herein (and / or components not shown). Any number of other components or combinations of components can be integrated with... Figure 1 The illustrative system 100 described herein is integrated, and all of these are considered to be within the scope of this disclosure.

[0061] Figure 2 It is a perspective view of IMD 102, which includes power supply housing 204, printed circuit board 206, non-conductive housing 208, first electrode 112, second electrode 114 and antenna 212.

[0062] In some embodiments, the power supply housing 204 is configured to surround the power supply (e.g., Figure 5 (The battery shown). Additionally, or alternatively, a printed circuit board 206 may be disposed on the surface of the power supply housing 204. According to an embodiment, the surface of the power supply housing 204 may be planar or nearly planar.

[0063] In some examples, the non-conductive housing 208 is molded over the power source housing 204 and the printed circuit board 206. In certain instances, the non-conductive housing 208 is configured to enclose components of the IMD 102 and electrical interconnections so as to hermetically seal the components of the IMD 102. Various embodiments include a non-conductive material of the non-conductive housing 208 characterized by dielectric properties. In certain instances, such material is a liquid crystal polymer or an epoxy resin.

[0064] The use of a non-conductive material can reduce the need for an epoxy head that is typically used to transmit signals, thereby allowing more space in the IMD 102 to be used for a larger power source housing 204, as explained in greater detail below.

[0065] The first and second electrodes 112, 114 can be disposed on an outer surface of the non-conductive housing 208 and coupled to the printed circuit board 206 through connector traces. In various embodiments, there can be two or more electrodes disposed on an outer surface of the non-conductive housing 208. In certain instances, there can be one or more external electrodes placed on a surface of the non-conductive housing that is located above and / or not located above the printed circuit board 206.

[0066] In various embodiments, the IMD 102 includes an antenna 212 disposed within or on the non-conductive housing 208 and connected to the printed circuit board 206. In certain instances, the antenna 212 can include a first portion disposed parallel to a longitudinal axis of the housing 204, where the longitudinal axis extends from a first end of the IMD 102 (e.g., first end 426a of the housing 402) to a second end of the IMD 102 (e.g., second end 426b of the housing 402). Figure 4 In certain instances, the antenna 212 can include a second portion coupled to the first portion, where the second portion is disposed perpendicular to the longitudinal axis of the housing. In further examples, the antenna 212 can include a third portion coupled to the second portion, where the third portion is disposed parallel to the longitudinal axis of the housing. Figure 4

[0067] In certain instances, the antenna 212 is positioned on or within the non-conductive housing 208 without contact with the conductive material of the power source housing 204 to preserve the normal functioning of the antenna 212. The positioning of the antenna 212 within or on the non-conductive housing 208 can reduce or eliminate the need for a header located at an end of the IMD 102, and / or increase the size of the power source housed in the power source housing 204 for the same size IMD 102. For example, the length of the power source can extend the length of the power source housing 204, whereas the power source can only partially extend the length of the power source housing 204 if the IMD 102 has a header. Thus, the power source can have a greater size without requiring a larger IMD 102 when there is no header. ​

[0068] In certain examples, the IMD 102 will be encased in an air-tight seal to provide a seal between the device and the surrounding environment. Further, the seal can be composed of an atomic layer deposition.

[0069] Figure 3A is a perspective view of the implantable device 102, including a non-conductive housing 308, a printed circuit board 306, a power source housing 304, and connector traces 314a, 314b. In certain examples, the IMD 102 uses the connector traces 314a, 314b to connect the electrodes 112, 114 to the printed circuit board 306.

[0070] Figure 3B is a front view of the printed circuit board 306 coupled to the power source housing 304, including frames 316a, 316b that guide and / or support the connector traces 314a, 314b. For example, the connector traces 314a, 314b are secured to the power source housing 306 by one or more frames 316a, 316b. In various embodiments, a first segment of the traces 316a, 316b are connected to the printed circuit board and extend along the housing 306, for example, along a longitudinal axis of the housing 304. In certain examples, a second segment of the traces can be arranged to extend from the power source housing 306, as shown. According to some embodiments, the frames 316a, 316b are configured to create a boundary for the connector traces 314a, 314b to reduce their movement within the medical device 102. In various embodiments, the frames 316a, 316b can be composed of a non-conductive material, for example, a plastic material. Although Figure 3B The illustrated embodiment of includes two connector traces, two frames, and two electrodes, but in certain instances, embodiments can include more than two connector traces and more than two frames and / or more than two electrodes.

[0071] Figure 4is a front-facing image of an assembly of the IMD 102 including the power source housing 404 and the printed circuit board 406. In various embodiments, the IMD 102 includes the power source housing 404 including a first side 424a and a second side 424b extending along a longitudinal axis between a first end 426a and a second end 426b. The first end 426a can be opposite the second end 426b, and the distance between the first end 426a and the second end 426b is greater than the distance between the first side 424a and the second side 424b. The first end 426a and the second end 426b can have equal dimensions 416. The first side 424a and the second side 424b can have equal dimensions 418. The dimensions of the power source included within the power source housing 404 can result in an increase or decrease in the dimension lengths 416, 418. In certain instances, as previously described, a larger power source is advantageous to the IMD 102. In these instances, a power source housing having a larger dimension length 416, 418 can be required. In certain instances, the power source housing 406 is composed of an electrically conductive material. In certain instances, this electrically conductive material is metal.

[0072] Figure 5 An electrical sub-assembly 500 is shown that can be removably and electrically coupled with the printed circuit board 306. The sub-assembly 500 is disposed on the power source housing 304 and includes a battery 544, a charging coil 540 for wirelessly charging the battery 544 using an external charging device 652.

[0073] The sub-assembly 500 can also include one or more connector blocks 548 that are fixed such that when the connector blocks 548 are attached to the printed circuit board 306, contacts 550 within the connector blocks 548 are in electrical contact with the traces 314 of the IMD 102. The number of contacts 550 can be the same as the number of traces 314 such that each contact 550 is in a one-to-one connection with each trace 314.

[0074] The sub-assembly 500 can also include control circuitry, such as a microcontroller 546, and one or more application specific integrated circuits (ASICs) 544, as appropriate. The one or more ASICs 544 can include current generation circuitry for providing stimulation pulses at one or more of the electrodes 112 and 114, and can also include telemetry modulation and demodulation circuitry for enabling bidirectional wireless communication at the antenna 212, battery charging and protection circuitry that can be coupled to the charging coil 540, decoupling capacitors in each current path to the electrodes 112 and 114, etc. The components are integrated via the printed circuit board (PCB) 306.

[0075] Figure 6Further shown are the above-referenced external components (e.g., receiving device 106), which can be used to communicate with IMD 102. Receiving device 106 can include external charger 652 and external controller 654. External controller 654 can be used to control and monitor IMD 102 via a bidirectional wireless communication link 658 through the patient's tissue. For example, external controller 654 can be used to monitor measurements made by electrodes 112 and 114.

[0076] Communications over wireless communication link 658 can occur via magnetic induction coupling between an antenna (not shown) in external controller 654 and antenna 212 in IMD 102. The magnetic field comprising link 658 can be modulated via frequency shift keying (FSK) or the like to encode transmitted data. Other methods can also be employed, including but not limited to short-range RF telemetry (e.g., Bluetooth, WiFi, Zigbee, MICS, etc.).

[0077] When battery 542 is rechargeable, external charger 652 can provide electrical power to recharge battery 542. Such power transmission can occur through the excitation of a charging coil (not shown) in external charger 552, which produces a magnetic field 656 that, in turn, excites charging coil 540 in subassembly 500, which is rectified, filtered, and used to recharge battery 542.

[0078] Further, antenna 212 can be positioned to face tissue, or positioned at a location closest to the skin side or outer side of the patient's body, so as to minimize or avoid RF interference by having less body tissue to transmit wireless data through. Further, in some examples, the integrated circuit includes a Kelvin connection to first electrode 110 and second electrode 114. In certain cases, subassembly 500 can include an accelerometer to determine whether IMD 102 has been turned or flipped over. The accelerometer can determine periods of electrode inactivity to determine a stable signal and select between first electrode 112 and second electrode 114.

[0079] Figure 7is a flowchart of a method of forming a hermetically sealed IMD 102. In various embodiments, the IMD 102 can be formed by disposing a printed circuit board subassembly onto a power source housing 720. Connector traces can then be disposed from the circuit board to a desired location above the circuit board 722. In certain instances, a first segment of the connector traces is disposed along the housing and a second segment of the connector traces is disposed to extend from the housing. In these examples, the first end of the connector traces is connected to the circuit board assembly. In certain instances, the first end of the connector traces is connected to the circuit board assembly by soldering the components together. In certain embodiments, one or more frames are disposed over the first segment of the connector traces to hold the first segment of the connector traces in place on the power source housing and printed circuit board subassembly.

[0080] A non-conductive housing can then be formed over the subassembly 724 to expose portions of the second segment of the connector traces. In certain instances, the portions of the second segment of the connector traces exposed above the outer surface are subsequently removed 726. In various embodiments, this step can be followed by attaching electrodes to the connector traces on the surface of the non-conductive housing 728. In certain instances, the electrodes can be attached to the connector traces on the surface by a method of laser welding, deposition, sputtering, or spray / inkjet. In various embodiments, after the electrodes are masked, a seal can be applied to the entire device to hermetically seal the device 730. In certain instances, this seal is atomic layer deposition. In certain instances, an antenna can be formed within or on the non-conductive housing.

[0081] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of the present disclosure also includes embodiments that do not include all of the described features. Thus, the scope of the present disclosure is intended to be encompass all such alternatives, modifications and variations, as well as all equivalents thereof.

Claims

1. An implantable medical device (IMD) configured to sense one or more physiological parameters of a subject, the IMD comprising: power supply; A housing surrounding the power supply, the housing including a first side, a second side, a first end, and a second end, wherein the first side is opposite to the second side, and the first end is opposite to the second end, and wherein a first distance between the first end and the second end is greater than a second distance between the first side and the second side; A printed circuit board is arranged on the first side of the housing and electrically coupled to the power source; A non-conductive housing disposed on the printed circuit board and hermetically sealing the printed circuit board, the non-conductive housing including an outer surface; and A first electrode and a second electrode are disposed on the outer surface of the non-conductive housing, wherein the first electrode is coupled to the printed circuit board via a first trace, and the second electrode is coupled to the printed circuit board via a second trace.

2. The IMD according to claim 1, wherein, The non-conductive shell is formed of liquid crystal polymer or epoxy resin.

3. The IMD according to any one of claims 1-2, wherein, The traces are fixed to the appropriate positions on the housing by one or more frames.

4. The IMD according to claim 3, wherein, The frame is made of a non-conductive material and creates boundaries to restrict the movement of the traces.

5. The IMD according to any one of claims 1-2, wherein, The device also includes an antenna disposed within or on the non-conductive housing and coupled to the circuit board.

6. The IMD according to claim 5, wherein, The antenna includes a first portion arranged parallel to the longitudinal axis.

7. The IMD according to claim 6, wherein, The antenna also includes a second part arranged perpendicular to the longitudinal axis.

8. The IMD according to any one of claims 1-2, wherein, The outer surface of the IMD includes an external seal configured to make the IMD hermetically sealed with respect to the surrounding environment.

9. The IMD according to claim 8, wherein, The external seal is an atomic deposition layer.

10. The IMD according to any one of claims 1-2, wherein, The outer shell is made of metallic material.

11. The IMD according to any one of claims 1-2, further comprising a third electrode and a fourth electrode disposed on the outer surface of the housing.

12. A method for forming an hermetically sealed implantable device, comprising: The circuit board components are arranged on a housing surrounding the power supply, the housing including a first side, a second side, a first end and a second end, wherein the first side is opposite to the second side and the first end is opposite to the second end, and wherein a first distance between the first end and the second end is greater than a second distance between the first side and the second side; A first segment of the connector trace is arranged along the housing, and a second segment of the connector trace is arranged to extend from the housing, wherein the first end of the connector trace is connected to the circuit board sub-assembly; One or more frames are arranged on the first segment of the connector trace to hold the first segment of the connector trace in place; A non-conductive housing is formed on the sub-assembly to create an enclosure that exposes a portion of the second segment of the connector trace above the outer surface of the non-conductive housing. Remove the portion of the second segment of the connector trace exposed above the outer surface; and Two electrodes are arranged on the outer surface of the non-conductive housing and connected to the connector traces.

13. The method according to claim 12, wherein, The electrodes are arranged on other surfaces of the non-conductive housing using one of the following techniques: laser welding, deposition, sputtering, or spraying / inkjet printing.

14. The method according to claim 13, wherein, After the electrodes are arranged on the outer surface, an airtight seal is applied to the implantable device.

15. The method according to any one of claims 12-14, further comprising forming an antenna within or on the non-conductive housing.

Images