Flexible implantable medical device

Abstract

An implantable medical device includes a first segment and second segment that are each hermetically sealed. The first segment houses a battery, and the second segment houses electronic circuitry. A connection mechanically couples the first segment and the second segment. The connection is configured to flex to enable movement of the first segment relative to the second segment. The connection is not hermetic.

Description

Atty Ref. No. A0011528W001FLEXIBLE IMPLANTABLE MEDICAL DEVICE

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 682,596, filed August 13, 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The disclosure relates to implantable medical devices.BACKGROUND

[0003] Medical devices may be used to monitor physiological signals of a patient. For example, some medical devices are configured to sense cardiac electrogram (EGM) signals, e.g., electrocardiogram (ECG) signals, indicative of the electrical activity of the heart via electrodes. Some medical devices are configured to detect occurrences of cardiac arrhythmia, often referred to as episodes, based on the cardiac EGM and, in some cases, data from additional sensors. Example arrhythmia types include asystole, bradycardia, ventricular tachycardia, supraventricular tachycardia, wide complex tachycardia, atrial fibrillation, atrial flutter, ventricular fibrillation, atrioventricular block, premature ventricular contractions, and premature atrial contractions. The medical devices may store the cardiac EGM and other data collected during a time period including an episode as episode data. The medical device may also store episode data for a time period in response to user input, e.g., from the patient.SUMMARY

[0004] In general, the disclosure describes example implantable medical devices (IMDs) that include segments and are configured to allow the segments to “flex” or move relative to each other. That is, instead of having an entirely rigid body, an IMD may have flexible connections (e.g., joints) between segments, potentially avoiding drawbacks usually associated with increased IMD length (e.g., increased risk of patient discomfort, mechanical failure, etc.). Each segment of the IMD may be relatively rigid compared to the flexible connections between them. Each segment of the IMD may include one or more components of the IMD (e.g., a battery, electronic circuitry, etc.), and the segmentsAtty Ref. No. A0011528W001 may be in electrical communication with each other via the flexible connections. While the segments themselves may be hermetically sealed, the flexible connections may not be hermetically sealed, which may reduce manufacturing complexity.

[0005] In some examples, an implantable medical device includes a first segment that is hermetically sealed, wherein the first segment houses a battery; a second segment that is hermetically sealed, wherein the second segment houses electronic circuitry; and a connection mechanically coupling the first segment and the second segment, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

[0006] In some examples, a method includes forming a first segment of an implantable medical device, wherein the first segment is hermetically sealed, and wherein the first segment houses a battery; forming a second segment of the implantable medical device, wherein the second segment is hermetically sealed, and wherein the second segment houses electronic circuitry; and mechanically coupling the first segment and the second segment with a connection, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

[0007] In some examples, an implantable medical device includes a first segment that is hermetically sealed, wherein the first segment houses a battery; a second segment that is hermetically sealed, wherein the second segment houses electronic circuitry includes a dielectric substrate including a first major surface and a second major surface; a patterned layer connected to the first major surface of the dielectric substrate by a laser bond; and a ferrule including a body and a flange extending from the body, wherein the flange is welded to a welding portion of the patterned layer that is disposed between the flange and the first major surface of the dielectric substrate such that the ferrule is hermetically sealed to the dielectric substrate; and a connection mechanically coupling the first segment and the second segment, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

[0008] The details of one or more examples of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, andAtty Ref. No. A0011528W001 advantages of the disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0009] FIG. l is a conceptual diagram illustrating an example of a medical device system in accordance with techniques of this disclosure.

[0010] FIG. 2 is a conceptual diagram of an example implantable medical device in accordance with techniques of this disclosure.

[0011] FIGS. 3A-3D are conceptual diagrams illustrating an example connection of an implantable medical device in accordance with techniques of this disclosure.

[0012] FIGS. 4A-4C are conceptual diagrams illustrating example connections of various implantable medical devices in accordance with techniques of this disclosure.

[0013] FIGS. 5A-5D are conceptual diagrams illustrating an example outermost layer of a connection of an implantable medical device in accordance with techniques of this disclosure.

[0014] FIG. 6 is a conceptual diagram illustrating another example implantable medical device in accordance with techniques of this disclosure.

[0015] FIG. 7A is a block diagram illustrating an example configuration of an implantable medical device in accordance with techniques of this disclosure.

[0016] FIG. 7B is a block diagram illustrating an example configuration of an implantable medical device in accordance with techniques of this disclosure.

[0017] FIG. 8 is a cross-sectional view of one example of a segment of implantable medical device in accordance with techniques of this disclosure.

[0018] FIG. 9 is a flow diagram illustrating an example technique for making an implantable medical device in accordance with techniques of this disclosure.DETAILED DESCRIPTION

[0019] An implantable medical device (IMD) is a device configured to be partially or completely inserted, grafted, or placed into the human body, either temporarily or permanently. In some examples, the IMD may replace, support, or enhance a biological structure, monitor bodily functions, or deliver medication directly where needed. An IMD may be introduced into the body through surgical or medical intervention and is intendedAtty Ref. No. A0011528W001 to remain after the procedure. Examples of IMDs may include cardiovascular devices (e.g., a cardiac monitor), neurostimulators, etc.

[0020] In general, a bulky IMD can pose significant problems and limitations for both patients and healthcare providers. For example, a bulky IMD can complicate the surgical procedure, often requiring larger incisions, longer surgery times, and a higher risk of complications during implantation. By contrast, an IMD with a thin profile may be easier to insert into the body. However, sufficient volume is needed to house components and to provide sufficient separation for adequate sensing of electrical signals. These design constraints may lead to a longer profile that could lead to a greater risk of patient discomfort, tissue perforation, mechanical failure, etc.

[0021] In accordance with techniques of this disclosure, an IMD may include segments that are coupled via flexible connections that provide sufficient pressure relief as to avoid complications such as those listed above. For example, the IMD components (e.g., battery, electronics, sensors, antenna, etc.) may be separated into segments that can be attached via flexible joining structures, thereby reducing the risk of patient discomfort, tissue perforation, mechanical failure, etc. Additionally, the techniques may allow for a modular manufacturing process, where an IMD containing the minimum segments (e.g., a first segment for the battery and a second segment for the electronic circuitry) can be configured for other uses by adding supplemental segments providing additional capabilities. The connections between the segments may be robust enough to withstand movement and flexing inside the body without compromising the hermetic properties of each segment of the IMD.

[0022] FIG. l is a conceptual diagram illustrating an example of a medical device system 2 in accordance with techniques of this disclosure. In some examples, IMD 10 is implanted outside of a thoracic cavity of patient 4 (e.g., subcutaneously in the pectoral location illustrated in FIG. 1). IMD 10 may be positioned near the sternum near or just below the level of the heart of patient 4, e.g., at least partially within the cardiac silhouette. IMD 10 may include a plurality of electrodes configured to sense electrical signals (e.g., a cardiac electrogram (EGM)). In some examples, IMD 10 may be a cardiac monitor.

[0023] External device 12 is a computing device configured for wireless communication with IMD 10. External device 12 may be, as examples, a mobile telephone or other computing device of patient 4 or another user, or a computing device detected toAtty Ref. No. A0011528W001 communication with IMD 10. External device 12 may be configured to communicate with a computing system 23 via a network 25. In some examples, external device 12 may provide a user interface and allow a user to interact with IMD 10. Computing system 23 may comprise computing devices configured to allow a user to interact with IMD 10, or data collected from IMD 10, via network 25.

[0024] In some examples, computing system 23 includes one or more handheld computing devices, computer workstations, servers or other networked computing devices. In some examples, computing system 23 may include one or more devices, including processing circuitry and storage devices, that implement a monitoring system 450. Computing system 23, network 25, and monitoring system 450 may be implemented by the Medtronic Carelink™ Network or other patient monitoring system, in some examples.

[0025] In general, an IMD must include various components, such as a battery and electronic circuitry, in order to operate. As these components require a certain amount of physical space, the IMD must adhere to a minimum size (i.e., the IMD cannot be miniaturized without limitation). However, relatively large (e.g., long, bulky, etc.) IMDs may increase the likelihood of various issues, such as patient discomfort, tissue perforation, mechanical failure, etc. Additionally, an IMD may need to be hermetically sealed to protect the IMD from bodily fluids. For example, hermetic sealing may be required to ensure that sensitive electronics are insulated from moisture and other environmental factors that could degrade performance over time. Also, if a battery- powered IMD is not properly sealed, there may be a risk of leakage, which could harm a patient.

[0026] In accordance with techniques of this disclosure, IMD 10 may include segments that are coupled via flexible connections that provide sufficient pressure relief as to avoid complications. For example, the IMD components (e.g., battery, electronics, sensors, antenna, etc.) may be separated into segments that can be attached via flexible connections, thereby reducing the risk of patient discomfort, tissue perforation, mechanical failure, etc. The connections between the segments may be robust enough to withstand movement and flexing inside the body without compromising the hermetic properties of each segment of the IMD. In this way, IMD 10 may provide sufficient volume to house the IMD components without being straight or rigid, potentially reducing pressure on surrounding tissue. Additionally, the techniques may allow for a modular manufacturingAtty Ref. No. A0011528W001 process, where a base IMD containing the minimum segments can be configured for other uses by adding supplemental segments providing additional capabilities.

[0027] FIG. 2 is a conceptual diagram of IMD 10 in accordance with techniques of this disclosure. As shown in FIG. 2, IMD 10 may include two or more segments, such as segments 22A-22B (collectively, “segments 22”). Each of segments 22 may house one or more components of IMD 10, shielding the components from the harsh environment of the human body, which could otherwise damage the functionality of IMD over time. For example, each of segments 22 may be hermetically sealed to protect sensitive electronic components from bodily fluids and prevent any potential harm to the body from the components.

[0028] In the example of FIG. 2, segment 22 A may include a battery, and segment 22B may include electronic circuitry. By separating the components in this way, IMD 10 may be more modular. For example, segments 22 may effectively be interchangeable units or modules that are coupled (e.g., mechanically, electrically, communicatively, etc.) via a flexible connection 24. Furthermore, IMD 10 may include any number of segments 22 and connections 24. For example, although not illustrated in FIG. 2, three or more segments 22 may be “daisy chained,” or wired together (e.g., in a sequence), with each of segments 22 providing additional functionality for IMD 10. In general, irrespective of the number of segments 22, connection 24 may facilitate the usage of different sizes of batteries depending on the longevity needs of the patient, without requiring a dramatically different device design or manufacturing process.

[0029] Although the battery and electronic circuitry are separated in different segments 22 in the above example, the components do not need to be separated. For example, segment 22A may include both a battery and electronic circuitry, and segment 22B may include both a battery and electronic circuitry (other configurations of components are also contemplated by this disclosure). The battery in each of segments 22 may power the co-located electronic circuitry. In turn, the battery (or batteries) may not deliver an electrical current through connection 24, reducing the risk of corrosion (e.g., because an electrical current, such as a DC bias from a battery, may initiate electrolysis, which can lead to corrosion).

[0030] Segments 22 (or rather the components within segments 22) may be configured to perform a specific function and combined with other segments 22 to enable theAtty Ref. No. A0011528W001 operation of IMD 10 (indeed, segments 22 may not even be able to operate independently of each other because the components may be part of a larger system). This approach may consequently offer several benefits, such as increased flexibility in design (e.g., easy customization of IMD 10 to suit a specific medical application), ease of upgrades and repairs (e.g., segments can be easily replaced), and a streamlined manufacturing process (e.g., segments 22 can be produced independently, which can lead to economies of scale and reduce production costs).

[0031] Connection 24 may be configured to couple adjacent segments 22, such as segment 22 A and segment 22B. Connection 24 may be formed from a flexible material (e.g., a polymer) to enable movement of segments 22 relative to each other. Connection 24 may be sufficiently robust to withstand movement and flexing inside the body while maintaining a hermetic seal (e.g., maintain the hermeticity of segments 22). However, connection 24 may not necessarily be hermetic (e.g., may not define or otherwise provide a hermetic cavity), which may reduce manufacturing complexity.

[0032] For example, connection 24 may be configured to couple with feedthrough pins, such as feedthrough pins 26A of segment 22A and feedthrough pins 26B of segment 22B (collectively, “feedthrough pins 26”). Feedthrough pins 26A of segment 22A may establish an electrical connection between the inside and outside of segment 22A, which may be a hermetically sealed enclosure. Similarly, feedthrough pins 26B of segment 22B may establish an electrical connection between the inside and outside of segment 22B, which may be a hermetically sealed enclosure.

[0033] As such, each of segments 22 may have hermetic feedthroughs that are inserted and electrically connected in nonhermetic connection 24. Thus, connection 24 may facilitate the electric communication between feedthrough pins 26 of segment 22A and segment 22B in a way that maintains a controlled environment inside each of segments 22, protecting the components of IMD from external conditions that could potentially damage the components or alter performance.

[0034] In some examples, connection 24 may be configured as a push pin connector, e.g., as a receptacle for pins pushed into connection 24. For example, connection 24 may be a fastening device that couples feedthrough pins 26 when feedthrough pins 26 are inserted into connection 24. Feedthrough pins may then be permanently fixed into position by creating a laser-induced bond between feedthrough pins 26 and connection 24.Atty Ref. No. A0011528W001

[0035] In another example, connection 24 may have no electrical interconnect, e.g., may not provide an electrical connection between segments. Instead, in some examples, connection may include other communicative and flexible interconnects between segments 22. In some examples, connection 24 may include a transparent or translucent material that optionally includes a light pipe or guide which allows proprietary or non-proprietary wireless communication utilizing light to transmit data between segment 22A and segment 22B (example: LiFi). Light based communication with no electrical connections may completely eliminate material migration due to corrosion since there is no voltage differential. In one instance, information can be transmitted from segment 22 A using a blinking light emitting diode (LED), and segment 22B may utilize a photodiode to convert the time-domain light back to data. In yet another example, connection 24 may have no electrical or other physical power / data transfer media, but utilize wireless power transfer, wireless telemetry, or near-field coupling to transmit data or power between segment 22A and segment 22B.

[0036] As an example, segments 22 may each include a battery and electronic circuitry, and connection 24 may only allow digital signals to pass through the interconnect. The digital signals may be bipolar digital signals (e.g., a type of digital signal modulation where the signal transitions occur between two different voltage levels with zero voltage representing the baseline) such that there is no DC component to reduce the risk of corrosion. Segments 22 may communicate to each other by implementing a digital communication protocol with an average DC voltage of zero to reduce the risk of corrosion. Example digital communication protocols may include bipolar NRZ, bipolar RZ, an AC alternating current solution (such as amplitude or frequency modulation or an AC signal), etc.

[0037] By including flexible connections, IMD 10 may retain the advantages of a longer profile without the disadvantages of a longer profile. For example, by having a longer profile, IMD 10 may have a greater distance between electrodes or other sensor elements. Increasing the distance between the electrodes, for example, may enhance the ability of the electrodes to detect small changes in electrical potential over a larger volume of tissue, improving the signal-to-noise ratio (SNR) by capturing a more significant differential signal. Accordingly, IMD 10 may be better able to measure various electrical properties within the body, such as voltage differences, impedance, or bioelectric signals.Atty Ref. No. A0011528W001

[0038] In another example, multiple instances of segments 22 with greater electrode separation may allow tissue impedance measures to be taken across a larger area resulting in a measurement with more clinical utility. Separately, multiple of segments 22 each having the ability to inject current and measure voltage would allow for enhanced local resolution of tissue impedance resulting in a better measurement. Flexible connections can also enable a larger radio frequency telemetry antenna in the longer device profile allowing use of frequencies that have less attenuation in the human body, possibly enhancing telemetry reliability and lowering power consumption.

[0039] At the same time, the flexibility of IMD 10 may make the longer length of IMD 10 less of an issue for patient 4 by reducing the risk of patient discomfort, tissue perforation, mechanical issues, etc. For example, by having flexible connections (segments 22 may be relatively rigid compared to connections 24), IMD 10 may better resist bending failure (e.g., 3-point bend failure modes). In contrast, a rigid connection may not accommodate mechanical stresses well, which may lead to cracks or fractures.

[0040] It should be noted that one or more of segments 22 may be connected to a segment or module that is not hermetic. For example, segment 22A may be hermetic, but segment 22B may be a coil or antenna for communication and / or wireless power transfer.

[0041] FIGS. 3A-3D are conceptual diagrams illustrating an example connection 24 of IMD 10 in accordance with techniques of this disclosure. As shown in the example of FIG. 3 A, connection 24 may couple (e.g., mechanically, electrically, communicatively, etc.) segments 22 of IMD 10. Connection 24 may be in the shape of a pigtail (e.g., helically- shaped) that can freely flex (within a range) in various directions. However, as shown in subsequent figures (e.g., FIG. 4C), connection 24 may be configured to primarily flex in specific planes. In other words, connection 24 may be configured to have limited degrees of freedom that constrain the possible geometries of IMD 10. In any case, the flexibility of connection 24 may provide strain relief that may prevent excessive force being applied to IMD 10, reduce pressure on tissue, etc.

[0042] As shown in FIG. 3B, connection 24 may receive feedthrough pins 26 to electrically connect segments 22 of IMD 10. In some examples, feedthrough pins 26 may be potted to connection 24 with a compound, such as an epoxy, glass, silicone, or urethane-based material. For example, feedthrough pin 26 A may be potted into an end wall 27A of connection 24, and feedthrough pin 26B may be potted into an end wall 27BAtty Ref. No. A0011528W001 of connection 24. Potting (e.g., filling the space around the feedthrough pins) may provide a barrier against bodily fluids and other environmental contaminants that could potentially damage or interfere with the electrical connections. Segments 22 may be coupled to end wall 27A and end wall 27B. For example, although not shown in FIGS. 3B-3D, segment 22A and connection 24 may share end wall 27A, and segment 22B and connection 24 may share end wall 27B.

[0043] Feedthrough pins 26 may be coupled to a conductor 28 that is electrically conductive (in this way electrically coupling segments 22). For example, conductor 28 may be welded to feedthrough pins 26. Conductor 28 may be a flexible member, such as one or more wires (e.g., helically twisted) that can bend or otherwise flex. Conductor 28 may be formed from a metal, such as a memory shape alloy (e.g., nitinol). If formed from a memory shape alloy, conductor 28 may be configured to transition to a specific shape when exposed to the warm environment in the patient’s body. In some examples, conductor 28 may transition from a flat state to an anticipated bend angle between segments 22 to match the local curvature of the implant location. The specific shape may be designed to secure IMD 10 within the body and resist the likelihood of IMD 10 moving or migrating from an intended position (e.g., implant position), which may be crucial for proper functioning of IMD 10.

[0044] As shown in the example of FIG. 3C, connection 24 may include one or more insulating layers. The one or more insulating layers may include a first insulating layer 30 (“first layer 30”) that surrounds conductor 28 (e.g., first layer 30 may be a sheath). First layer 30 may be highly flexible, allowing first layer 30 to conform to the shape of the surrounding tissue. Additionally, first layer 30 may be configured to resist the ingress of bodily fluids into connection 24, protecting connection 24 from corrosion or degradation over time. First layer may be formed from a biocompatible material (e.g., a polymer), reducing the risk of rejection or adverse reactions. First layer 30 may be electrically insulative.

[0045] As shown in the example of FIG. 3D, connection 24 may further include a second insulating layer 32 (“second layer 32”) that surrounds first layer 30. Second layer 32 may have similar properties as first layer 30 (e.g., second layer 32 may be formed from a polymer and may be a sheath). However, second layer 32 may differ from first layer 30 in that second layer may be stiffer (e.g., less flexible). By being stiffer, second layer 32Atty Ref. No. A0011528W001 may be configured to better handle mechanical stresses, such as compressive or tensile stresses, without undergoing significant deformation.

[0046] In some examples, connection 24 may include a keying feature (not shown) that ensures first layer 30 and second layer 32 properly couple with connection 24. For example, the keying feature may ensure correct orientation and alignment of first layer 30 and second layer 32 relative to connection 24, preventing incorrect assembly that could lead to malfunction or damage.

[0047] In some examples, conductor 28 may be overmolded with an elastomer such as silicone rubber or other biocompatible elastomer. For example, first layer 30 and optionally second layer 32 may be conformal coatings with protective and insulating properties. First layer 30 and optionally second layer 32 may be a polymer coating (e.g., Parylene, Polyethylene Glycol, Polyurethane, etc.) or another type of coating that protects against moisture, chemicals, corrosive substances, etc. First layer 30 and second layer 32 may also be biocompatible and electrically insulating. In some examples, first layer 30 and second layer 32 may be applied by vapor deposition, spray coating, dip coating etc.

[0048] FIGS. 4A-4E are conceptual diagrams illustrating example connections of various IMDs in accordance with techniques of this disclosure. In general, a variety of connections are contemplated by this disclosure. For example, FIGS. 4A shows an IMD 10A having a connection 24 A that couples segment 22 A and segment 22B. Connection 24 A may include a flexible printed circuit board (PCB) configured to flex and bend (e.g., in one or more planes). Connection 24A may be formed from flexible materials such as polyimide or polyester film, which allow connection 24A to conform and flex during normal operation. The flexible PCB may electrically couple segment 22A and segment 22B.

[0049] In the example of FIG. 4B, an IMD 10B has connections 24B-24C coupling segments 22C-22E. As shown in FIG. 4B, connection 24B may couple segment 22C and segment 22D, and connection 24C may couple segment 22D and segment 22E. In the example of FIG. 4C, a connection 24D includes a flexible PCB having a different form factor than those discussed above.

[0050] FIGS. 5A-5D are conceptual diagrams illustrating an example outermost layer 34 of connection 24. As shown in FIGS. 5A-5D, outermost layer 34 may be formed from metal (e.g., as shown in FIGS. 5A-5C) or any other suitable material. Outermost layer 34Atty Ref. No. A0011528W001 may define slots 36 configured to make outermost layer 34 flexible. Slots 36 may make outermost layer 34 flexible by introducing areas that can deform under stress, allowing outermost layer 34 to bend or twist without breaking. Thus, slots 36 may serve as a series of controlled weak points or hinges within outermost layer 34. In some examples, outermost layer 34 may include polymer encapsulation to stop tissue from growing into slots 36 (e.g., as shown in FIG. 5D).

[0051] Outermost layer 34 may be formed from a material that is elastic (e.g., has the ability to return to an original shape after being deformed). Slots 36 may increase the elasticity of outermost layer 34 locally around each of slots 36, enhancing the overall flexibility of outermost layer 34 without permanently deforming outermost layer 34.

[0052] FIG. 6 is a conceptual diagram illustrating an example configuration of IMD 10 in accordance with techniques of this disclosure. As shown in FIG. 6, connection 24 may not necessarily connect adjacent segments 22 of IMD 10. Instead, connection 24 may be at a most distal or proximal end of IMD 10 such that connection 24 is only connected to feedthrough pins 26 of one segment 22 of IMD 10. In these examples, connection 24 may include one or more sensors 58, such as an electrode (in some examples, the housing of IMD 22, such as the housing of one of segments 22, may be the other electrode). By being positioned at the most distal or proximal end of IMD 10, the length of the dipole (e.g., the distance between a pair of electrodes or sensors) may be greater, potentially improving signal strength and / or sensitivity.

[0053] Increasing the length of the dipole may enhance the ability of sensor 58 to detect small changes in electrical potential over a larger volume of tissue, which can improve the signal-to-noise ratio (SNR) by capturing a more significant differential signal, As a result, sensor 58 may better measure electrical properties within the body, such as voltage differences, impedance, or bioelectric signals, which is useful for electrocardiography (ECG), electroencephalography (EEG), electrical impedance tomography (EIT), etc.

[0054] As also shown in FIG. 6, connection 24 may include components other than sensor 58, such as a communication circuitry 54. Due to the additional space provided by connection 24, the components may be increased in size to improve performance. For example, communication circuitry 54 may have a larger surface area for better coupling to an external device. In examples where connection 24 includes a recharge coil, a largerAtty Ref. No. A0011528W001 surface area may improve coupling efficiency, enhance magnetic field distribution, increase power transfer, improve heat dissipation, enhance tolerance to misalignment, etc., while also minimizing patient discomfort with the flexible form factor.

[0055] FIG. 7A is a block diagram illustrating an example configuration of IMD 10. In the illustrated example, IMD 10 includes processing circuitry 50 sensing circuitry 52, communication circuitry 54, memory 56, sensors 58, switching circuitry 60, electrodes 62A, 62B (hereinafter “electrodes 62”), and a battery 64. Any of the circuitry described with reference to FIG. 7A may be an example of electronic circuitry.

[0056] Although illustrated in FIG. 7 A as residing in a common housing of IMD 10, the various components of IMD 10 may reside in different segments 22 of IMD 10 and electrically communicate via one or more connections 24 or wirelessly between different segments 22. For example, segment 22A may house processing circuitry 50, and segment 22B may house battery 64. Similarly, other circuitry (e.g., sensing circuitry 52, communication circuitry 54, etc.) may be included in segment 22A, segment 22B, or another segment of IMD 10. Alternatively, components of IMD 10, such as electrodes 62, may be positioned outside of segments 22 but still connected to segments 22.

[0057] Processing circuitry 50 may include fixed function circuitry and / or programmable processing circuitry. Processing circuitry 50 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, processing circuitry 50 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processing circuitry 50 herein may be embodied as software, firmware, hardware or any combination thereof.

[0058] In some examples, memory 56 includes computer-readable instructions that, when executed by processing circuitry 50, cause IMD 10 and processing circuitry 50 to perform various functions attributed herein to IMD 10 and processing circuitry 50.Memory 56 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random-access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media.Atty Ref. No. A0011528W001

[0059] Sensing circuitry 52 may be selectively coupled to electrodes 62 via switching circuitry 60 as controlled by processing circuitry 50. Sensing circuitry 52 may monitor signals from electrodes 62 in order to monitor electrical activity, such as electrical activity of a heart of patient 4 of FIG. 1. In some examples, processing circuitry 50 may identify features of a sensed cardiac EGM to detect an episode of cardiac arrhythmia of patient 4.

[0060] In some examples, processing circuitry 50 transmits, via communication circuitry 54, the episode data for patient 4 to an external device, such as external device 12 of FIG. 1. For example, IMD 10 may send digitized cardiac EGM and other episode data to network 25 for processing by monitoring system 450 of FIG. 1.

[0061] In some examples, IMD 10 includes one or more sensors 58, such as one or more accelerometers, microphones, optical sensors, impedance sensors, chemical sensors, and / or pressure sensors. In some examples, sensing circuitry 52 may include one or more filters and amplifiers for filtering and amplifying signals received from one or more of electrodes 62 and / or other sensors 58. In some examples, sensing circuitry 52 and / or processing circuitry 50 may include a rectifier, filter and / or amplifier, a sense amplifier, comparator, and / or analog-to-digital converter. Processing circuitry 50 may determine values of physiological parameters of patient 4 based on signals from sensors 58.

[0062] Communication circuitry 54 may include any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as external device 12. Communication circuitry 54 may be configured to communicate using any of a variety of wireless communication schemes, such as Bluetooth® or Bluetooth Low Energy®. Under the control of processing circuitry 50, communication circuitry 54 may receive downlink telemetry from, as well as send uplink telemetry to, external device 12 or another device with the aid of an internal or external antenna. In some examples, processing circuitry 50 may communicate with a networked computing device via an external device (e.g., external device 12) and a computer network, such as the Medtronic CareLink® Network developed by Medtronic, pic, of Dublin, Ireland.

[0063] In some examples, the electronic circuitry of IMD 10 (e.g., processing circuitry 50, sensing circuitry 52, communication circuitry 54, etc.) may be manufactured using waferscale fabrication technology. For example, the electronic circuitry may include one or more of a base substrate, a conductive circuit pattern, a passive component layer, an active layer, an interconnect arrangement, etc. The passive component layer, the activeAtty Ref. No. A0011528W001 layer, the interconnect arrangement, etc. may together form a multilayer component stack for the electronic circuitry.

[0064] The base substrate may be formed from an appropriate material that accommodates waferscale manufacturing. In this regard, the base substrate may be formed from (or include) a semiconductor material such as silicon, a glass material, a ceramic material, sapphire material, polymer material, plastic material, a composite material, etc.

[0065] A conductive circuit pattern may be formed overlying an interior surface of the base substrate. In some examples, the circuit pattern may be formed directly on the interior surface to provide the desired electrical paths, connections, and traces for the component layers of IMD 10. Accordingly, the circuit pattern can be considered to be an integral feature of the base substrate in some examples.

[0066] Waferscale fabrication technology is discussed in, for example, U.S. Patent No. 8,796,109, U.S. Patent No. 9,120,287, U.S. Patent No. 9,688,053, U.S. Patent No.9,171,721, U.S. Patent No. 8,666,505, U.S. Patent No. 9,968,794, U.S. Patent No. 10,098,589, and U.S. Patent No. 11,865,639, the entirety of each of which is incorporated by reference herein. Waferscale fabrication technology is also discussed in more detail below.

[0067] FIG. 7B is a block diagram illustrating an example configuration of IMD 10. In the illustrated example, IMD 10 segments 22 that include various components of IMD 10. In the example shown in FIG. 7B, segment 22A includes processing circuitry 50, sensing circuitry 52, and memory 56; segment 22B includes battery 64. Connection 24 may be configured to couple segments 22. Segments 22 may be hermetically sealed, but connection 24 may not be hermetically sealed.

[0068] For ease of illustration, FIG. 7B represents a simplified configuration of IMD 10 (e.g., compared to FIG. 7B). That said, IMD 10 may include more or fewer components than those shown in FIG. 7B (as well as include additional segments 22), and other arrangements of the components (e.g., which of segments 22 the components are located) are contemplated by this disclosure.

[0069] FIG. 8 is a cross-sectional view of one example of a segment including electronic circuitry fabricated using waferscale technology. Although segment 22B is illustrated in FIG. 8, the techniques may be applied to any of the segments described herein.Atty Ref. No. A0011528W001

[0070] Segment 22B can be a feedthrough assembly including one or more feedthrough pins 26. Segment 22B may include a dielectric substrate 112 having a first major surface 114 and a second major surface 116, feedthrough pins 26 disposed in the dielectric substrate, and a patterned layer 120 connected to the first major surface of dielectric substrate 112. In one or more examples, patterned layer 120 can be a patterned conductive layer. Segment 22B may further include a ferrule 122 that has a body 124 and a flange 126 extending from body 124. Ferrule 122 may be connected to a welding portion 128 of patterned conductive layer 120 that is disposed between flange 126 and first major surface 114 of dielectric substrate 112 such that ferrule 122 is hermetically sealed to dielectric substrate 112.

[0071] Dielectric substrate 112 can include any suitable material or materials. In one or more examples, dielectric substrate 112 can include a dielectric material, e.g., at least one of glass, quartz, silica, sapphire, silicon carbide, diamond, or gallium nitride. Further, dielectric substrate 112 can include at least one of a biocompatible material or one or more coatings or layers that can provide biocompatibility.

[0072] Dielectric substrate 112 can include any suitable dimensions, e.g., thicknesses. Further, dielectric substrate 112 can take any suitable shape or shapes. Dielectric substrate 112 can be a single, unitary substrate or multiple substrates joined together using any suitable technique or techniques.

[0073] Feedthrough pins 26 may be disposed in dielectric substrate 122. Feedthrough pins 26 can include any suitable feedthrough or feedthroughs that provide an electrical connection between first major surface 114 and second major surface 116 of the substrate. In one or more examples, segment 22B can include an array of feedthrough pins 26. Segment 22B can include any suitable number of feedthroughs, e.g., 1, 2, 3, 4, 5, 10, 20, or more feedthroughs. Each feedthrough pin 26 of segment 22B can be substantially identical in construction. In one or more examples, one or more feedthrough pins 26 can have characteristics that are different from one or more additional feedthroughs. Feedthrough pins 26 can include a via 130 disposed between first major surface 114 and second surface 116 of dielectric substrate 112. A conductive material 132 can be disposed in via 130 to provide an electrical pathway between first major surface 114 and second major surface 116 of dielectric substrate 112.Atty Ref. No. A0011528W001

[0074] Feedthrough pin 26 can include an external contact 134. In one or more examples, external contact 134 can be a portion of patterned conductive layer 120 that is disposed adjacent first major surface 114 of dielectric substrate 112. As used herein, the term “adjacent the first major surface of the substrate” means that an element or component is disposed closer to the first major surface of the substrate than to the second major surface of the substrate. In one or more examples, external contact 134 can be disposed on first major surface 114 of dielectric substrate 112. External contact 134 can be disposed over via 130 adjacent first major surface 114 of dielectric substrate 112. In one or more examples, External contact 134 can be electrically connected to conductive material 132 disposed in via 130. External contact 134 can be hermetically sealed to first major surface 114 of dielectric substrate 112 using any suitable technique or techniques.

[0075] Via 130 of feedthrough pins 26 can be any suitable dimensions and take any suitable shape. The size and shape of via 130 may be predicated on the thickness of dielectric substrate 112 and the techniques utilized to provide conductive material 132 that forms the electrical pathway between first major surface 114 and second major surface 116 of dielectric substrate 112. Exemplary shapes for via 130 can include parallel surface walls and / or tapered surface walls. Any suitable technique or techniques can be utilized to form via 130, e.g., drilling, chemical etching, laser etching, etc.

[0076] Feedthrough pins 26 can also include conductive material 132 disposed in via 130 to provide a conductive pathway between first major surface 114 and second major surface 116 of substrate 112. Conductive material 132 can include any suitable conductive material or conductive materials, e.g., copper, titanium, aluminum, chromium, nickel, gold, platinum, composites (e.g., silver-filled epoxies), and combinations thereof. Conductive material 132 can be disposed in via 130 to provide a conductive pathway from external contact 134 to one or more devices or contacts disposed on or adjacent second major surface 116 of dielectric substrate 112. In one or more examples, conductive material 132 can be disposed in via 130 such that it substantially fills via 130. In one or more examples, conductive material 132 can be disposed in via 130 along sidewalls of via 130 and the opening of via 130 at first major surface 114.

[0077] Feedthrough pins 26 can also include external contact 134. In one or more examples, external contact 134 can be adapted to electrically couple feedthrough pins 26 to a conductor or a contact of a device, e.g., a contact of a header of IMD 10. SuchAtty Ref. No. A0011528W001 conductors and contacts can be electrically coupled to external contact 134 using any suitable technique or techniques, e.g., soldering, physical contact, welding, etc. External contact 134 can include any suitable conductive material or combination of conductive materials, e.g., at least one of copper, silver, titanium, niobium, zirconium, tantalum, stainless steel, platinum, iridium, aluminum, Kovar, or nickel (including clad structures, laminates etc.). In one or more examples, external contact 134 can include two or more materials, e.g., bi-metals, clad laminates, etc.

[0078] In one or more examples, external contact 134 can be formed or disposed over via 130 on first major surface 114 of dielectric substrate 112. In one or more examples, external contact 134 can be formed separately from dielectric substrate 112 as a discrete member, or it could be patterned from a conductive sheet or foil.

[0079] External contact 134 may be electrically coupled to conductive material 132 that is disposed in via 130. In one or more examples, external contact 134 is in direct contact with conductive material 132 to electrically couple the contact to the conductive material. In one or more examples, one or more additional conductive layers (e.g., an interlayer 140) can be disposed between external contact 134 and conductive material 132 to electrically couple the external contact to the conductive material.

[0080] In one or more examples, external contact 134 is hermetically sealed to first major surface 114 of dielectric substrate 112. For example, in one or more examples, external contact 134 can be hermetically sealed to first major surface 114 of dielectric substrate 112 by a bond 135 that surrounds via 130. In one or more examples, bond 135 can be formed using a laser to provide a laser bond. By surrounding via 130 with bond 135 that hermetically seals external contact 134 to first major surface 114 of dielectric substrate 112, via 130 may be protected from the external environment. The electrical coupling between external contact 134 and conductive material 132 disposed in via 130 is, therefore, protected, and the integrity of this electrical pathway from first major surface 114 of the substrate to second major surface 116 can be maintained.

[0081] In one or more examples, feedthrough pins 26 can include an internal contact 136 disposed adjacent second major surface 116 of dielectric substrate 112. As used herein, the term “adjacent the second major surface of the substrate” means that an element or component is disposed closer to the second major surface than to the first major surface of the substrate. Internal contact 136 can include any suitable material or materials,Atty Ref. No. A0011528W001 e.g., the same materials utilized for external contact 134 or others, and can be formed using any suitable technique or techniques such as sputtering, plating, evaporating, etc. Further, internal contact 136 can take any suitable shape or shapes and have any suitable thickness in a direction normal to second major surface 116 of dielectric substrate 112, e.g., the same shapes and thicknesses as described regarding external contact 134, or other thicknesses and shapes such as conductive traces.

[0082] Internal contact 136 may be disposed over via 130 on second major surface 116 of dielectric substrate 112. Internal contact 136 can be electrically coupled to conductive material 132 disposed in via 130. The arrangement of external contact 134, via 130, and internal contact 136 facilitates creation of an electrical pathway between the external side adjacent to first major surface 114 and the interior side adjacent to second major surface 116. In one or more examples, internal contact 136 is hermetically sealed to second major surface 116 of dielectric substrate 112 using any suitable technique or techniques, e.g., by a bond (e.g., laser bond) that surrounds via 130.

[0083] Connected to first major surface 114 of the dielectric substrate 112 is patterned layer 120. Patterned layer 120 can include any suitable conductive or nonconductive material or materials, e.g., at least one of copper, silver, titanium, niobium, zirconium, tantalum, stainless steel, platinum, iridium, aluminum, Kovar, or nickel. In one or more examples, patterned conductive layer 120 can include a foil or foils disposed using any suitable technique or techniques. Patterned conductive layer 120 can include any suitable layers or sublayers.

[0084] Further, patterned conductive layer 120 can be disposed in any suitable pattern when connected to first major surface 114 of the dielectric substrate 112. In one or more examples, one or more portions of patterned conductive layer 120 can form one or more external contact 134 of one or more vias disposed in the dielectric substrate 112. Further, patterned conductive layer 120 can include one or more welding portions that can be utilized to connect ferrule 122 to the dielectric substrate 112 as is further described herein.

[0085] Any suitable technique or techniques can be utilized to dispose patterned conductive layer 120 on or adjacent first major surface 114 of the dielectric substrate 112. For example, patterned conductive layer 120 can be disposed on or adjacent first major surface 114 utilizing one or more of photolithography, etching, plasma vapor deposition, chemical vapor deposition, electroplating, laser bonding, etc. In one or more examples,Atty Ref. No. A0011528W001 patterned conductive layer 120 can be connected to first major surface 114 by one or more laser bonds 159.

[0086] In one or more examples, segment 22B can include a second patterned conductive layer 138 disposed on or adjacent second major surface 116 of the dielectric substrate 112. Second patterned conductive layer 138 can include any suitable patterned conductive layer, e.g., patterned conductive layer 120. In one or more examples, one or more portions of second patterned conductive layer 138 can provide one or more internal contact 136 of one or more feedthrough pins 26. The same design characteristics and possibilities described herein regarding the first patterned conductive layer 120 can be applied to the second patterned conductive layer 138.

[0087] Patterned conductive layer 120 can include any suitable number of layers. For example, patterned conductive layer 120 can include a conductive sublayer 160 and an interlayer 140 disposed between the conductive sublayer and first major surface 114 of the dielectric substrate 112. Interlayer 140 can include any suitable material or materials, e.g., titanium, niobium, tantalum, zirconium, and alloys thereof. Further, interlayer 140 can have any suitable dimensions. In one or more examples, interlayer 140 can have a thickness as measured in a direction orthogonal to first major surface 114 of the dielectric substrate 112 of at least 50 nanometers and no greater than 10 micrometers. The interlayer 140 can be disposed between the conductive sublayer 160 and first major surface 114 of the dielectric substrate 112 using any suitable technique or techniques, e.g., the same techniques described herein regarding patterned conductive layer 120. In one or more examples, the interlayer 140 and the conductive sublayer 160 can be disposed on first major surface 114 of dielectric substrate 112 and then patterned using any suitable technique or techniques. Further, second patterned conductive layer 138 can include any suitable number of layers.

[0088] Ferrule 122 may be connected to dielectric substrate 112. Ferrule 122 can include any suitable material or materials, e.g., at least one of titanium, niobium, or stainless steel. In one or more examples, ferrule 122 can include a conductive material. Ferrule 122 can take any suitable shape or shapes and have any suitable dimensions. For example, as shown in FIG. 2 , ferrule 122 can have an elliptical shape in a plane parallel to first major surface 114 of dielectric substrate 112. Further, flange 126 can also take an elliptical shape in the plane parallel to first major surface 114 of dielectric substrate 112.Atty Ref. No. A0011528W001

[0089] Ferrule 122 may include body 124 and flange 126 that extends from the body. Flange 126 can be integral with body 124 or manufactured separately and attached to the body using any suitable technique or techniques. Flange 126 can include the same material or materials utilized to form body 124. In one or more examples, flange 126 and body 124 can include different materials.

[0090] Ferrule 122 may be connected to welding portion 128 of patterned conductive layer 120 that is disposed between flange 126 and first major surface 114 of the dielectric substrate 112 such that ferrule 122 is hermetically sealed to the dielectric substrate. In one or more examples, ferrule 122 can be connected to second major surface 116 of the dielectric substrate 112. Further, in one or more examples, ferrule 122 can be connected to first major surface 114 and second major surface 116 of dielectric substrate 112, e.g., the ferrule can include a second flange that can be connected to the second major surface of the dielectric substrate. In one or more examples, a major surface 142 of flange 126 contacts the welding portion 128 of patterned conductive layer 120 when ferrule 122 is connected to the welding portion. In one or more examples, the major surface 142 of flange 126 is substantially parallel to first major surface 114 of the dielectric substrate 112.

[0091] Flange 126 can be welded to welding portion 128 of patterned conductive layer 120 using suitable technique or techniques. In one or more examples, flange 126 is welded to the welding portion 128 of patterned conductive layer 120 by a weld 144. Any suitable welding technique or techniques can be utilized to provide weld 144, e.g., laser welding. Further, Iweld 44 can take any suitable shape or shapes and have any suitable dimensions.

[0092] In one or more examples, ferrule 122 can be electrically connected to patterned conductive layer 120 using any suitable technique or techniques. As shown in FIG. 1, feedthrough pins 26 may be disposed in the dielectric substrate 112 that is electrically connected to flange 126 of ferrule 122. Feedthrough pins 26 may include a via 148 disposed between first major surface 114 and second major surface 116 of the dielectric substrate 112, and conductive material 150 disposed in via 130. The conductive material 150 is electrically connected to the welding portion 128 of patterned conductive layer 120 through interlayer 140 if present. The welding portion 128 of patterned conductive layer 120 is electrically connected to flange 126 of ferrule 122. Feedthrough pins 26 may also include an internal contact 152 disposed adjacent second major surface 116 of theAtty Ref. No. A0011528W001 dielectric substrate 112 and electrically connected to the conductive material 50 disposed in via 130. As a result, internal contact 152 is electrically connected to ferrule 122.

[0093] Segment 22B can also include one or more electronics or electronic components 154 disposed adjacent at least one of first major surface 114 or second major surface 116 of the dielectric substrate 112. Electronic components 154 may include electronic circuitry. Electronic component 154 can include any suitable circuit or component, e.g., at least one of a capacitor, transistor, integrated circuit, including controller or multiplexer, sensor, accelerometer, optical components such as emitters and detectors, etc. Although depicted as including one electronic component 154, the segment 22B can include any suitable number of electronic components. Further, electronic component 154 can be electrically connected to one or more feedthrough pins 26 using any suitable technique or techniques. In one or more examples, electronic component 154 is electrically connected to one or more feedthrough pins 26 by one or more device contacts 156. Such device contacts 156 can be electrically connected to one or more internal contacts 136 of feedthrough pins 126 using any suitable technique or techniques.

[0094] As mentioned herein, one or more examples of segment 22B can include patterned conductive layer 120 that is connected (e.g., hermetically sealed) to first major surface 114 of dielectric substrate 112 using any suitable technique or techniques, e.g., welding, laser welding, laser bonding, diffusion bonding, laser-assisted diffusion bonding, etc. In one or more examples, patterned conductive layer 120 can be connected to first major surface 114 using the laser diffusion bonding techniques described in co-owned U.S. Pat. No. 10,124,559 B2, entitled KINETICALLY LIMITED NANO-SCALE DIFFUSION BOND STRUCTURES AND METHODS.

[0095] Any suitable electromagnetic radiation can be utilized to form a bond between one or more portions of patterned conductive layer 120 and first major surface 114 of dielectric substrate 112. In one or more examples, the electromagnetic radiation can include laser light that can include any suitable wavelength or range of wavelengths. In one or more examples, the laser light can include light having a wavelength of at least 200 nm. In one or more examples, the laser light can include a wavelength of no greater than 10,000 nm. For example, laser light can include UV light, visible light, IR light, and combinations thereof. In one or more examples, a UV laser can be utilized to provide light having a wavelength of about 350 nm and a pulse width of 30 ns. In one or moreAtty Ref. No. A0011528W001 examples, the materials for dielectric substrate 112 and patterned conductive layer 120, and the power level and wavelength of the light used may be selected such that the light may not directly damage, ablate, warp, or cut the substrate and the patterned conductive layer, and such that the substrate and the patterned conductive layer retain their bulk properties.

[0096] FIG. 9 is a flow diagram illustrating an example technique for manufacturing an implantable medical device in accordance with techniques of this disclosure. Segments 22 may be formed to define a recess, cavity, or compartment within which one or more electronic components or circuitry (e.g., processing circuitry 50, battery 64, etc.) can be disposed (900). Segments 22 can be configured to completely surround and enclose (e.g., house) the electronic components. In other words, segments 22 may be hermetically sealed. In one or more examples, end walls 27 may need to be joined with segments 22 in order for segments 22 to be hermetically sealed.

[0097] The housing of segments 22 can include any suitable material or materials, e.g., metal, polymeric, ceramic, or inorganic materials. In one or more examples, the housing can include at least one of glass, quartz, silica, sapphire, silicon carbide, diamond, synthetic diamond, or gallium nitride (including clad structures, laminates etc.). In one or more examples, the housing can include at least one of copper, silver, titanium, niobium, zirconium, tantalum, stainless steel, platinum, iridium, aluminum, nickel, Kovar, or AlMg (including clad structures, laminates etc.).

[0098] Before hermetically sealing segments 22, electronic components may be positioned or otherwise disposed within segments 22 (902). The electronic components can include any suitable integrated circuit or device, such as those described in FIGS. 7A- 7B. The electronic components may be fabricated using any suitable technique or techniques, including but not necessarily limited to waferscale fabrication techniques described in greater detail in FIG. 8.

[0099] Connection 24 may be coupled to segments 22 to enable IMD 10 to flex (904). Connection 24 may include any suitable, flexible conductor, such as one or more wires, a flexible PCB, etc., to establish electrical communication between segments 22. In some examples, connection 24 may be a fastening device that couples feedthrough pins 26 when feedthrough pins 26 are inserted into connection 24. A laser-induced bond between feedthrough pins 26 and connection 24 may then permanently fix feedthrough pins 26 intoAtty Ref. No. A0011528W001 position. In some examples, Feedthrough pins 26 may be assembled together with segments 22 and then feedthrough pins 26 may be coupled to connection 24. In other examples, feedthrough pins 26 may be assembled together with connection 24, and then feedthrough pins 26 may be coupled to segments 22.

[0100] In various figures of this disclosure (e.g., FIGS. 3A-3D), connection 24 is illustrated as coaxial with segments 22. However, connection 24 does not have to be coaxial with segments 22. For example, connection 24 may not be aligned with the center of segments 22 but instead be aligned with a specific layer of segments 22 (e.g., a specific layer of an electronic component). In some examples, segments 22 including one or more components formed using waferscale technology may include a non-coaxial connection 24. For example, dielectric substrate 112 of an electronic circuitry may include feedthrough pins 26 but may not be in the middle of segments 22. In this configuration, connection 24 may be aligned with feedthrough pins 26 and therefore not coaxial with segments 22.

[0101] In some examples, one or more insulating layers may be added to connection 24 (906). For example, conductor 28 may be overmolded with an elastomer such as silicone rubber or other biocompatible elastomer. For example, first layer 30 and optionally second layer 32 may be conformal coatings with protective and insulating properties. In some examples, first layer 30 and second layer 32 may be applied by vapor deposition, spray coating, dip coating etc. In some examples, first layer 30 and / or second layer 32 may be a sheath that surrounds conductor 28.

[0102] This disclosure includes various examples, such as the following examples.

[0103] Example 1 : An implantable medical device includes a first segment that is hermetically sealed, wherein the first segment houses a battery; a second segment that is hermetically sealed, wherein the second segment houses electronic circuitry; and a connection mechanically coupling the first segment and the second segment, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

[0104] Example 2: The implantable medical device of example 1, wherein the first segment includes first feedthrough pins, and wherein the connection is configured to couple to the first segment by coupling to the first feedthrough pins.Atty Ref. No. A0011528W001

[0105] Example 3: The implantable medical device of example 1 or 2, wherein the second segment includes second feedthrough pins, and wherein the connection is configured to couple to the second segment by coupling to the second feedthrough pins.

[0106] Example 4: The implantable medical device of any of examples 1 to 3, wherein the connection includes a conductor formed from a memory shape alloy configured to transition, when positioned in a body of a patient, to a shape that reduces the likelihood of the implantable medical device moving or migrating from an implant position.

[0107] Example 5: The implantable medical device of any of examples 1 to 4, wherein the connection includes an insulating layer configured to resist the ingress of bodily fluids into the connection.

[0108] Example 6: The implantable medical device of example 5, wherein the insulating layer includes a first insulating layer, and the connection further includes a second insulating layer that surrounds the first insulating layer, wherein the second insulating layer is stiffer than the first insulating layer.

[0109] Example 7: The implantable medical device of any of examples 1 to 6, wherein the connection includes a flexible printed circuit board that electrically couples the first segment and the second segment.

[0110] Example 8: The implantable medical device of any of examples 1 to 7, wherein the connection is a first connection, and wherein the implantable medical device further includes: a third segment that is hermetically sealed; and a second connection mechanically coupling the second segment and the third segment, wherein the second connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the second connection is not hermetic.

[0111] Example 9: The implantable medical device of any of examples 1 to 8, wherein the connection is a first connection, and wherein the implantable medical device further includes a second connection mechanically coupled the second segment, wherein the second connection includes a sensor.

[0112] Example 10: The implantable medical device of any of examples 1 to 9, wherein the connection includes an outermost layer that defines one or more slots configured to increase the flexibility of the outermost layer.Atty Ref. No. A0011528W001

[0113] Example 11 : The implantable medical device of example 10, wherein the outermost layer includes polymer encapsulation to prevent tissue from growing into the one or more slots.

[0114] Example 12: The implantable medical device of any of examples 1 to 11, wherein the electronic circuitry is manufactured using waferscale fabrication technology.

[0115] Example 13: The implantable medical device of example 12, wherein the electronic circuitry includes a base substrate formed from at least one of a sapphire material or a ceramic material.

[0116] Example 14: A method includes forming a first segment of an implantable medical device, wherein the first segment is hermetically sealed, and wherein the first segment houses a battery; forming a second segment of the implantable medical device, wherein the second segment is hermetically sealed, and wherein the second segment houses electronic circuitry; and mechanically coupling the first segment and the second segment with a connection, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

[0117] Example 15: The method of example 14, wherein the first segment includes first feedthrough pins, and wherein the connection is configured to couple to the first segment by coupling to the first feedthrough pins.

[0118] Example 16: The method of example 14 or 15, wherein the second segment includes second feedthrough pins, and wherein the connection is configured to couple to the second segment by coupling to the second feedthrough pins.

[0119] Example 17: The method of any of examples 14 to 16, wherein the connection includes a conductor formed from a memory shape alloy configured to transition, when positioned in a body of a patient, to a shape that reduces the likelihood of the implantable medical device moving or migrating from an implant position.

[0120] Example 18: The method of any of examples 14 to 17, further including overmolding the connection with an insulating layer configured to resist the ingress of bodily fluids into the connection.

[0121] Example 19: The method of example 18, wherein the insulating layer includes a first insulating layer, and the connection further includes a second insulating layer thatAtty Ref. No. A0011528W001 surrounds the first insulating layer, wherein the second insulating layer is stiffer than the first insulating layer.

[0122] Example 20: The method of any of examples 14 to 19, wherein the connection includes a flexible printed circuit board that electrically couples the first segment and the second segment.

[0123] Example 21 : The method of any of examples 14 to 20, wherein the connection is a first connection, and wherein the method further includes: forming a third segment of the implantable medical device, wherein the third segment is hermetically sealed; and mechanically coupling the second segment and the third segment with a second connection, wherein the second connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the second connection is not hermetic.

[0124] Example 22: The method of any of examples 14 to 21, wherein the connection is a first connection, and wherein the method further includes mechanically coupling a second connection with the second segment, wherein the second connection includes a sensor.

[0125] Example 23: The method of any of examples 14 to 22, wherein the connection includes an outermost layer that defines one or more slots configured to increase the flexibility of the outermost layer.

[0126] Example 24: The method of example 23, further including encapsulating the outermost layer with a polymer to prevent tissue from growing into the one or more slots.

[0127] Example 25: The method of any of examples 14 to 24, wherein the electronic circuitry is manufactured using waferscale fabrication technology.

[0128] Example 26: The method of example 25, wherein the electronic circuitry includes a base substrate formed from at least one of a sapphire material or a ceramic material.

[0129] Example 27: An implantable medical device includes a first segment that is hermetically sealed, wherein the first segment houses a battery; a second segment that is hermetically sealed, wherein the second segment houses electronic circuitry includes a dielectric substrate including a first major surface and a second major surface; a patterned layer connected to the first major surface of the dielectric substrate by a laser bond; and a ferrule including a body and a flange extending from the body, wherein the flange isAtty Ref. No. A0011528W001 welded to a welding portion of the patterned layer that is disposed between the flange and the first major surface of the dielectric substrate such that the ferrule is hermetically sealed to the dielectric substrate; and a connection mechanically coupling the first segment and the second segment, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

[0130] Example 28: The implantable medical device of example 27, wherein the electronic circuitry further includes one or more feedthrough pins disposed in the dielectric substrate.

[0131] Example 29. The implantable medical device of Example 28, wherein the feedthrough pins comprise: a via disposed between the first major surface and the second major surface of the dielectric substrate; a conductive material disposed in the via; and an external contact disposed over the via adjacent the first major surface of the dielectric substrate, wherein the external contact is electrically connected to the conductive material disposed in the via.

[0132] Example 30. The implantable medical device of any of Examples 27 to29, wherein the connection electrically couples the first segment and the second segment.

[0133] Example 31. The implantable medical device of any of Examples 27 to30, wherein the connection communicatively couples the first segment and the second segment.

[0134] Example 32. The implantable medical device of Example 31, wherein the connection comprises a transparent material configured to communicatively couple the first segment and the second segment by facilitating the transmission of light between the first segment and the second segment.

[0135] Example 33. The implantable medical device of Example 31 or 32, wherein the connection is configured to facilitate the transmission of digital signals between the first segment and the second segment.

[0136] Example 34. The implantable medical device of Example 33, wherein the digital signals are bipolar digital signals with an average voltage of zero.

[0137] Example 35. The implantable medical device of any of Examples 27 to 34, wherein the first segment comprises first feedthrough pins, wherein the second segment comprises second feedthrough pins, and wherein the connection is configured toAtty Ref. No. A0011528W001 electrically couple the first segment and the second segment by coupling to the first feedthrough pins and the second feedthrough pins.

[0138] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module, unit, or circuit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units, modules, or circuitry associated with, for example, a medical device.

[0139] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0140] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” or “processing circuitry” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0141] Various examples of the disclosure have been described. These and other examples are within the scope of the following claims.

Claims

Atty Ref. No. A0011528W001WHAT IS CLAIMED IS:

1. An implantable medical device comprising: a first segment that is hermetically sealed, wherein the first segment houses a battery; a second segment that is hermetically sealed, wherein the second segment houses electronic circuitry; and a connection mechanically coupling the first segment and the second segment, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

2. The implantable medical device of claim 1, wherein the connection at least one of electrically or communicatively couples the first segment and the second segment.

3. The implantable medical device of claim 1 or 2, wherein the first segment comprises first feedthrough pins, wherein the second segment comprises second feedthrough pins, and wherein the connection is configured to electrically couple the first segment and the second segment by coupling to the first feedthrough pins and the second feedthrough pins.

4. The implantable medical device of any of claims 1 to 3, wherein the connection comprises a conductor formed from a memory shape alloy configured to transition, when positioned in a body of a patient, to a shape that reduces the likelihood of the implantable medical device moving or migrating from an implant position.

5. The implantable medical device of any of claims 1 to 4, wherein the connection comprises an insulating layer configured to resist the ingress of bodily fluids into the connection.

6. The implantable medical device of claim 5, wherein the insulating layer comprises a first insulating layer, and the connection further comprises a second insulating layer thatAtty Ref. No. A0011528W001 surrounds the first insulating layer, wherein the second insulating layer is stiffer than the first insulating layer.

7. The implantable medical device of any of claims 1 to 6, wherein the connection comprises a flexible printed circuit board that electrically couples the first segment and the second segment.

8. The implantable medical device of any of claims 1 to 7, wherein the connection is a first connection, and wherein the implantable medical device further comprises: a third segment that is hermetically sealed; and a second connection mechanically coupling the second segment and the third segment, wherein the second connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the second connection is not hermetic.

9. The implantable medical device of any of claims 1 to 8, wherein the connection is a first connection, and wherein the implantable medical device further comprises a second connection mechanically coupled the second segment, wherein the second connection comprises a sensor.

10. The implantable medical device of any of claims 1 to 9, wherein the connection comprises an outermost layer that defines one or more slots configured to increase the flexibility of the outermost layer.

11. The implantable medical device of claim 10, wherein the outermost layer comprises polymer encapsulation to prevent tissue from growing into the one or more slots.

12. The implantable medical device of any of claims 1 to 11, wherein the electronic circuitry is manufactured using waferscale fabrication technology.Atty Ref. No. A0011528W00113. The implantable medical device of claim 12, wherein the electronic circuitry comprises a base substrate formed from at least one of a sapphire material or a ceramic material.

14. An implantable medical device comprising: a first segment that is hermetically sealed, wherein the first segment houses a battery; a second segment that is hermetically sealed, wherein the second segment houses electronic circuitry comprising: a dielectric substrate comprising a first major surface and a second major surface; a patterned layer connected to the first major surface of the dielectric substrate by a laser bond; and a ferrule comprising a body and a flange extending from the body, wherein the flange is welded to a welding portion of the patterned layer that is disposed between the flange and the first major surface of the dielectric substrate such that the ferrule is hermetically sealed to the dielectric substrate; and a connection mechanically coupling the first segment and the second segment, wherein the connection is configured to flex to enable movement of the first segment relative to the second segment, and wherein the connection is not hermetic.

15. The implantable medical device of claim 14, wherein the electronic circuitry further comprises one or more feedthrough pins disposed in the dielectric substrate.

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