External component encapsulation in active implantable medical devices

Abstract

An implantable medical device is described. The implantable medical device includes a housing for receiving and hermetically sealing an active component. A head is attached to the housing and surrounds other components of the device. A communication antenna is encapsulated in a biocompatible material and attached to the outer surface of the housing. The communication antenna is electrically connected to the active component via an access window in the head. After a connection is established, the access window is backfilled.

Description

Technical Field

[0001] The present invention relates to an implantable device, a system including the implantable medical device, and a method for forming the implantable medical device. Background Technology

[0002] Implantable medical devices typically include electronic devices, batteries, antennas, and other active and passive components. These components are hermetically sealed within an enclosure or otherwise encapsulated to prevent moisture ingress. For example, a communication antenna can be attached to an enclosure, and a header can be formed in the appropriate location through overmolding (e.g., using biocompatible epoxy resin to encapsulate the component). Summary of the Invention

[0003] Various examples related to implantable medical devices, implantable systems, and methods for forming implantable medical devices are described.

[0004] One general aspect includes an implantable device comprising: a housing including a cap and a sidewall connected to the cap. The implantable device also includes electronic components disposed within an internal volume of the housing. The implantable device further includes a set of conductive leads electrically connected to the electronic components and extending through the housing. The implantable device also includes a communication antenna disposed on an outer surface of the sidewall and including a body and a patch, the patch including a set of conductive terminals, wherein the body is coated with a biocompatible material and the set of conductive terminals is electrically connected to the set of conductive leads.

[0005] Another general aspect includes a method comprising: providing a housing including electronic components. The method further includes a cover that engages a head to at least surround the housing, wherein an access window is formed at a peripheral edge of the head and a set of conductive leads extends from the electronic components through the access window. The method also includes attaching a communication antenna to an outer surface of a sidewall of the housing. The communication antenna includes a body and electrical terminal blocks corresponding in size and shape to the access window, and aligning a set of conductive terminals disposed in the electrical terminal blocks with the set of conductive leads.

[0006] Another general aspect includes a system comprising an implantable medical device and an antenna. The implantable medical device further includes a housing for accommodating electronic components, the housing including a cover and a side portion connected to the cover. The implantable medical device also includes a set of conductive leads extending from the electronic components through the cover to the exterior of the housing. The antenna is connected to the outer surface of the side portion at a mounting location. The antenna includes a body portion encapsulated in a biocompatible material, a tab portion connected to the body portion, and a set of conductive terminals disposed in the tab portion and aligned with the set of conductive leads when the antenna is connected to the outer surface at the mounting location.

[0007] Another general aspect includes a device comprising: a housing including a cover and sidewalls. The device also includes electronic components disposed within an internal volume of the housing and including multiple conductive leads extending through the cover. The device further includes one or more electrical components connected to an outer surface of the cover and electrically connected to a first portion of the multiple conductive leads. The device also includes a head encapsulating the one or more electrical components and including an access window through which a second portion of the multiple conductive leads extends. The access window is sized to receive a patch for a communication antenna.

[0008] Another general aspect includes a device comprising: a housing for housing electronic components. The housing includes a cover and sidewalls connected to the cover. The device also includes a set of conductive pins extending through the cover of the housing. The device further includes a communication antenna connected to an outer surface of the sidewalls, the communication antenna including a set of conductive terminals. The set of conductive pins is received by and electrically connected to the set of conductive terminals. Attached Figure Description

[0009] The accompanying drawings, which are incorporated in and form part of this specification, illustrate one or more specific examples and, together with the description of the examples, serve to illustrate the principles and implementation of the specific examples.

[0010] Figure 1 A perspective view of an implantable medical device based on at least one example is shown.

[0011] Figure 2 It shows at least one example Figure 1 An exploded view of an implantable medical device.

[0012] Figure 3 A perspective view of a communication antenna according to at least one example is shown.

[0013] Figure 4A A perspective view of a first formed state of an implantable medical device according to at least one example is shown.

[0014] Figure 4B It shows at least one example Figure 4A A perspective view of the second formation state of an implantable medical device.

[0015] Figure 4C It shows at least one example Figure 4A A perspective view of the third formation state of an implantable medical device.

[0016] Figure 4D It shows at least one example Figure 4A A perspective view of the fourth formation state of an implantable medical device.

[0017] Figure 5 It shows at least one example Figure 4D An enlarged view of a portion of the implantable device shown in the image.

[0018] Figure 6 It shows at least one example Figure 1 End view of an implantable medical device.

[0019] Figure 7 A flowchart illustrating a process for forming an implantable medical device, based on at least one example, is shown. Detailed Implementation

[0020] Examples are described herein in the context of implantable medical devices, such as implantable pulse generators (“IPGs”) or other such devices for neuromodulation. Those skilled in the art will recognize that the following description is illustrative only and is not intended to be limiting in any way. For example, the features described with respect to implantable medical devices are applicable to any other medical device implanted in the human body. Embodiments of the examples shown in the accompanying drawings will now be described in detail. The same reference numerals will be used throughout the drawings and the following description to refer to the same or similar items.

[0021] For clarity, not all the general features of the examples described herein are shown and described. It will be understood, of course, that in the development of any such practical implementation, many implementation-specific decisions must be made to achieve the developer’s specific goals, such as complying with constraints related to the application and business, and these specific goals will vary from implementation to implementation and from developer to developer.

[0022] In an illustrative example, the implantable medical device includes its active components (e.g., electronics and batteries), which are either housed within a metal housing or encapsulated in an epoxy resin head. The epoxy resin head includes an access window through which conductive leads from the active components are accessible. A communication antenna formed in a ceramic substrate is wholly or partially encapsulated in epoxy resin as part of a separate process and is attached to the outer surface of the metal housing, separate from the head. A tab located on top of the antenna includes conductive terminals that mate with the conductive leads during assembly. The tab is sized and shaped to have a shape corresponding to the access window, but with slightly smaller dimensions to ensure the tab fits within the access window. Once mated, the conductive leads are electrically connected to the conductive terminals using a laser welding process or other suitable process. Silicone or other biocompatible materials are then applied to fill the access window. Spheres of this material are also applied to the peripheral edge of the antenna adjacent to the head and between the head to create a smooth transition between the antenna and the head.

[0023] Conventional overmolding of the head component can prove challenging due to the complex fixtures required to hold all components in place during molding, the additional time needed to surround all components with epoxy resin, and the additional time required to cure the arrangement. However, compared to wrapping the head around the communication antenna, it reduces the amount of time required for epoxy resin to flow around the complex geometry of the top of the head and reduces the amount of curing time for the epoxy head. Furthermore, pre-molded heads can be practical due to the simpler geometry of the top of the housing, which can reduce production costs and time. Because the communication antenna and head are formed using different processes, designers can choose custom epoxy resins with different properties compared to the head (e.g., one for the head and another different for encapsulating the antenna). Forming the communication antenna separately from the head also improves the uniformity of epoxy resin thickness. This ensures more predictable operation of the communication antenna, which may be affected by non-uniform surfaces. Forming the communication antenna separately from the head allows for the complete curing cycle of the communication antenna, as the antenna does not include any active components that may be damaged during the curing cycle. Finally, as described, attaching the communication antenna to the outer surface of the housing allows for the parallel manufacturing of both the antenna and the implantable medical device (without an antenna), thus gaining the benefits of parallelization.

[0024] This illustrative example is given to introduce the reader to the general topics discussed herein, and this disclosure is not limited to this example. The following sections describe various additional, non-limiting examples of insect storage and distribution systems.

[0025] Now refer to the attached diagram, Figure 1 and Figure 2 Perspective views and exploded views of an example implantable medical device 100 assembled according to at least one example are shown. The implantable medical device 100 shown is an implantable pulse generator (“IPG”) medical device for providing neuromodulation therapy. To provide such therapy, the implantable medical device 100 is inserted into the patient’s tissue and connected to a neural interface (not shown). The neural interface is placed at a target location within the patient’s body. The implantable medical device 100 then uses the neural interface to transmit electrical signals to the target location and records the responses collected by the neural interface. Because the implantable medical device 100 will be inserted or otherwise implanted into the patient’s skin, the implantable medical device 100 has small shape factors (e.g., approximately 40 mm long, approximately 20 mm high, and approximately 7 mm wide in this example) and smooth edges to reduce the possibility of irritation or injury to the patient during and after insertion. In some examples, the implantable medical device 100 is larger or smaller than the listed dimensions.

[0026] like Figure 1As shown, generally speaking, the implantable medical device 100 includes a housing 102, sometimes referred to as a canister, a head 104, and a communication antenna 106. The housing 102 is configured to house active components of the implantable medical device 100, such as one or more batteries 108 and electronic components 110. The housing 102 is hermetically sealed, thereby protecting the active components from moisture exposure. The head 104 is configured to encapsulate other active and / or passive components, such as a charging antenna 112 and a connector stack 114 mounted to the housing 102. For example, as... Figure 4A As shown, the charging antenna 112 and connector stack 114 are shown mounted on the cover of the housing 102.

[0027] The connection point between the head 104 and the outer shell 102 is also airtightly sealed to prevent moisture from entering the head space of the implantable medical device 100. For example, as Figure 4B As shown, the head 104 can be formed of epoxy resin that is overmolded and extends below the top surface of the housing 102 such that the head 104 surrounds at least a portion of the top surface of the housing 102 and the sidewalls of the housing 102. Figure 4B In the middle, the peripheral edge 119 of the head 104 extends below the peripheral edge 121 of the outer casing 102. For example... Figure 5 As shown in more detail, the access window 116, sometimes referred to as the welding window, which is fabricated and shaped to the required dimensions to correspond to the patch 118 of the communication antenna 106, is also defined in the head 104. The access window 116 defines a cut-out area of ​​the head 104 to provide access to components within the head 104.

[0028] The communication antenna 106, formed as part of a separate process, is connected to the housing 102, such that the patch 118 is fitted within the access window 116. Figure 4C As shown. This allows electrical connections to be formed between components of the implantable medical device 100, which has a communication antenna 106. (As illustrated...) Figure 4D As shown, once these connections have been made, backfill 120 is applied to access window 116, and in some examples, to air gap 154 ​​between communication antenna 106 and head 104.

[0029] Turning now to the outer casing 102, the outer casing 102 includes a lid 122 and a container 124 having at least one side. The outer casing 102 is formed of a metallic material, such as titanium or other biocompatible metallic materials. In some examples, some or a portion of the outer casing 102 is formed of a different rigid material, which may or may not be metallic, such as a biocompatible epoxy resin. As used herein, the term biocompatible material refers to the property of having no toxic or harmful effects on biological systems, especially human biological systems, and the ability of the material to coexist harmoniously with tissues without causing harmful changes.

[0030] The container 124 and the lid 122 together define the internal volume of the housing 102. A battery 108 or other such power source, along with electronic components 110, are mounted within the internal volume, for example, to the inner surface of the container 124. The container 124 may be formed from a single material or more than one material. Depending on the shape of the container 124, it may include more than one side, such as a front side where the communication antenna 106 is mounted, a rear side opposite the front side, two lateral sides, and a bottom opposite the lid 122.

[0031] Electronic component 110 includes one or more electronic parts configured for signal processing. For example, electronic component 110 may include a system-on-a-chip (“SOC”) or system-in-package (“SIP”) comprising any suitable combination of components for digital signal processing, analog signal processing, mixed signal processing, and / or the like, which may be present on the surface of a PCB assembly or embedded therein. Such components may include, for example, a microcontroller, memory, timing sources, one or more digital interfaces, one or more analog interfaces, voltage regulators, and / or any other suitable components. Electronic component 110 may be configured to receive electrical signals from a neural interface, process those signals, and provide additional signals to the neural interface.

[0032] In some examples, electronic component 110 includes a processing device and a computer-readable medium, such as random access memory (“RAM”) coupled to the processing device. The processing device can execute computer-executable program instructions stored in the memory, such as executing one or more computer programs. Such a processing device may include a microprocessor, a digital signal processor (“DSP”), an application-specific integrated circuit (“ASIC”), a field-programmable gate array (“FPGA”), a state machine, or other processing device for processing electrical signals received from a neural interface. Such a processing device may further include programmable electronic devices, such as a PLC, a programmable interrupt controller (“PIC”), a programmable logic device (“PLD”), a programmable read-only memory (“PROM”), an electrically programmable read-only memory (“EPROM” or “EEPROM”), or other similar devices.

[0033] The processing device may include or be able to communicate with a medium (such as a computer-readable storage medium) that may store instructions that, when executed by the processing device, cause the processing device to perform steps implemented or assisted by the processing device. Examples of computer-readable media may include, but are not limited to, memory chips, ROM, RAM, ASICs, or any other storage device from which the processing device can read or write information.

[0034] Container 124 includes smooth edges to minimize stimulation during and after implantation. For example, as shown, container 124 has an elongated rectangular shape with a rounded bottom (i.e., the side opposite to cap 122). The vertical edges of container 124 are also rounded. In some examples, container 124 has a shape different from the one shown (e.g., circular, oval, square, etc.).

[0035] Container 124 includes one or more tabs 138. Tabs 138 can be used to manipulate container 124 during manufacturing, implantation, or other times. In some examples, tabs 138 may be removable. For example, tabs 138 may include brittle joints so that they can be removed prior to implantation. In some examples, container 124 does not include tabs 138.

[0036] Once the internal components have been installed in container 124, lid 122 is sealed to the sides(s) of container 124. For example, the peripheral edge of the opening of container 124 may be welded to the peripheral edge of lid 122. In this example, lid 122 is formed of a metallic material similar to that of container 124. Lid 122 may include a small hole that can be used to backfill the internal volume of the container with helium or other inert gas to provide an inert atmosphere within the internal volume. The small hole can then be welded closed. Container 124 and lid 122 form a sealed shell when joined.

[0037] The cover 122 also includes a feedthrough 126. The feedthrough 126 is an opening extending through the cover 122 and into the internal volume. The feedthrough 126 is used to pass through a set of feedthrough pins 128. The feedthrough pins 128 are conductive terminals that connect to one or more of the power supply 108, electronic components 110, or other components within the container 124. In some examples, the feedthrough pins 128 transmit electrical signals in the form of data and / or power. A first portion 128a of the feedthrough pin 128 is used for electrical connection to the connector stack 114 for stimulation and sensing purposes via a neural interface. A second portion 128b of the feedthrough pin 128 is used for electrical connection to the communication antenna 106. A third portion 128c of the feedthrough pin is used for electrical connection to the charging antenna 112. Although a single feedthrough 126 is illustrated, in some examples, more than one feedthrough 126 is used, any of which may extend through the cover 122 and / or sidewalls of the container 124. For example, the first portion 128a and the third portion 128c of the feedthrough pin 128 can extend through the cover 122, and the second portion 128b of the feedthrough pin 128 can extend through the front sidewall of the container 124.

[0038] Turning now to connector stack 114 and charging antenna 112, connector stack 114 is configured to receive a neural interface. For example, connector stack 114 may include port 129 to receive a plug of the neural interface. Connector stack 114 is fixedly mounted to cover 122 and electrically connected to a first portion 128a of feedthrough pin 128. The neural interface may include multiple conductive leads connected together in the plug. Once the plug is inserted into port 129, the conductive leads are connected to electronics 110 via feedthrough pin 128a. In this example, the long axis of connector stack 114 is aligned with the long axis of housing 102, although other alignments may be used in some examples.

[0039] The charging antenna 112 is configured to receive electromagnetic fields (e.g., from an external charger) that are converted and used to charge the battery 108. The charging antenna 112 takes the form of a coil wound around a mandrel; however, the charging antenna 112 may employ different form factors. In some examples, the charging antenna 112 receives signals at a different frequency than the communication antenna 106. The charging antenna 112 is fixedly mounted to the cover 122 and electrically connected to the third portion 128c of the feedthrough pin 128. In this example, the long axis of the charging antenna 112 is aligned with the long axis of the housing 102, although other alignment methods may be used in some examples.

[0040] Now turn to head 104, as Figure 4B As shown in further detail, the head 104 is formed of a biocompatible material such as epoxy resin. The head 104 is formed or pre-formed in place and mounted to the cover 122. The head 104 is configured to encapsulate the connector stack 114 and the charging antenna 112. As previously mentioned, the head 104 includes an access window 116. The access window 116 is fabricated and shaped to correspond to the size and shape of the patch 118 according to required dimensions. Therefore, the access window 116 serves as a block-out to allow access to the patch 118. Figure 4B As shown, access window 116 also enables access to a second portion 128b of feedthrough pin 128, such as a second portion 128b that is bent at approximately 90 degrees and extends toward the outer side surface of head 104.

[0041] The head 104 also includes one or more openings 130. Opening 130a is configured to receive a retaining screw 132 and a diaphragm 134. Opening 130b is configured to receive a strain relief device 136. In some examples, the plug of the neural interface is inserted into the connector stack 114 through opening 130b and strain relief device 136.

[0042] like Figure 3 As shown in more detail below, according to Bluetooth The standard operating communication antenna 106 includes a radiating surface 140 attached to the substrate 142 and a ground plane (not shown) located opposite (i.e., the side facing the container 124). In some examples, the communication antenna 106 is configured differently according to different standard operations. The communication antenna 106 is used to transmit and receive information related to the operation of the implantable medical device 100, such as measured parameters, configuration data, status data, control signals, and any other information related to the medical device 100. The communication antenna 106 can enable pairing / communication with a second device such as a programming unit, charger, mobile phone, or other externally located device. In some examples, the communication antenna 106 enables pairing / communication with other internally located devices.

[0043] The ceramic substrate 142 includes a tab 118 and a body 144. Therefore, the tab 118 and body 144 are formed of the same material and are part of the same substrate 142. A radiating surface 140 is attached to the substrate 142 in any suitable manner. For example, the radiating surface 140 may be deposited, printed, or otherwise attached to the substrate (e.g., pre-formed and glued). The shape of the radiating surface 140 may vary depending on the desired RF characteristics. In some examples, the radiating surface 140 has a flat top surface and is in the form of a rectangular metal plate. In other examples, the radiating surface 140 may take other shapes. Two ferrules are used to connect each of these circuits, which are electrically isolated from each other at the antenna level (some connections exist on the PCBA side).

[0044] The communication antenna 106 also includes a set of conductive terminals 146 located in the patch 118. A first conductive terminal 146 is electrically connected to the radiating surface 140 via a set of conductive traces 148. A second conductive terminal 146 is electrically connected to a ground plane via a second set of conductive traces (not shown). After the radiating surface 140, conductive terminals 146, and conductive traces 148 have been formed, the body 144 is completely or partially encapsulated in a biocompatible and radio frequency (RF) compatible material, such as epoxy or other suitable materials, i.e., in encapsulation 150. As used herein, the term RF compatible material refers to materials that allow RF signals to pass through. In some examples, RF compatible material is an RF transparent material or a material through which RF fields can pass without generating heat.

[0045] In some examples, the entire body 144 (e.g., all surfaces) may be encapsulated in package 150, except for the back surface opposite container 124 (e.g., exposed back package), except for a portion of the back surface opposite container 124 (e.g., partially exposed back package), or any other suitable combination of surfaces or portions of surfaces may be encapsulated. The body 144 is horizontally and vertically centered within package 150. The depth of package 150 on the front side of communication antenna 106 may be approximately 0.8 mm and the depth on the rear side may be approximately 0.3 mm. In some examples, the depth is greater than 0.8 mm or less than 0.3 mm. These depths can be selected to adjust certain parameters of communication antenna 106. For example, the operation of radiating surface 140 may depend on the depth of package 150 and / or the properties of the epoxy resin used for package 150. In some examples, the epoxy resin used to encapsulate 150, the head 104, and other parts of the implantable medical device 100 is EPO-TEK MED-301 epoxy resin. In other examples, other epoxy resins with different properties are used, such as medical-grade epoxy resin.

[0046] like Figure 4C As shown, the communication antenna 106 is attached to the outer surface of the container 124 (e.g., the mounting location) using any suitable adhesive. For example, additional epoxy, glue, or other adhesives can be applied to the rear side of the communication antenna 106 and / or the outer surface of the container 124, and these two parts can be bonded together. The communication antenna 106 is positioned on the outer surface of the container 124 in such a way that the tab 118 is aligned with the access window 116 and a narrow air gap 154 ​​is formed between the peripheral edge 119 of the head 104 and the peripheral edge 123 of the communication antenna 106. The air gap 154 ​​can provide volume for the backfill material 120 in subsequent processing steps (such as... Figure 4D (The following is the information to be filled in during the subsequent processing steps shown.) Figure 6 As shown, when backfill material 120 is applied, the air gap 154 ​​is filled.

[0047] like Figure 5 As shown, after the communication antenna 106 is connected to the container 124 of the housing 102, the set of conductive terminals 146 is electrically connected to the second portion 128b of the set of feedthrough pins 128. In some examples, the set of conductive terminals 146 are plated through-holes, fabricated to the required dimensions and configured to receive the feedthrough pins 128. In some examples, the conductive terminals 146 include a collar for receiving the feedthrough pins 128. The electrical connection between the feedthrough pins 128 and the conductive terminals 146 is achieved using laser welding. In some examples, crimping, welding, or any other suitable mechanical and / or energy method is used to form the electrical connection.

[0048] Now turn to backfill material 120, although in Figure 2 The middle part is shown as a rigid component, but the backfill material 120 is generally considered to have rigidity when applied to the implantable medical device 100. Figure 2 The backfill 120 is a liquid biocompatible material of the shape shown. The purpose of the backfill 120 is to seal the volume of the access window 116 and, in doing so, to isolate the electrical connections formed in the patch 118 from external moisture. Another purpose of the backfill 120 is to provide a smooth transition between the peripheral edge 119 of the head 104 and the peripheral edge 123 of the communication antenna 106. In this way, the backfill 120 can create a filled transition between these two portions. This distributes stress over a wider area and achieves a smooth transition between the two portions. In some examples, the backfill 120 extends around additional portions of the peripheral edge of the communication antenna 106 (e.g., vertical and horizontal peripheral edges). The backfill 120 can be formed from silicone, epoxy, silicone-epoxy mixtures, other flowable liquid adhesives, and / or any suitable combination of more than one material.

[0049] Figure 7 A flowchart is shown illustrating a process 700 for forming an implantable medical device, such as implantable medical device 100, according to at least one example. Process 700 begins at block 702, providing a housing 102 that defines a container 124 for housing electronic components 110. Process 700 may further include mounting a power supply 108 and / or at least one of the electronic components 110 within the container 124.

[0050] In box 704, process 700 includes engaging head 104 to surround at least the top of housing 102. In some examples, this may include attaching a pre-manufactured head 104 in place or forming head 104 in place. Head 102 includes an access window 116 located at a peripheral edge 119 of head 102. At least some portions of a set of conductive leads extend through access window 116. For example, as Figure 4A As shown, after passing through the feedthrough 126, the feedthrough pin 128a includes a bend of approximately 90 degrees to position the distal end of the feedthrough pin 128a in a position where it can mate with the conductive terminal 146 of the patch 118 of the communication antenna 106.

[0051] In block 706, process 700 includes attaching communication antenna 106 to the outer surface of a sidewall of housing 102. In this example, communication antenna 106 includes a body 144 and electrical terminal tabs (e.g., tab 118), the terminal tabs being indexed in access window 116 and aligning the set of conductive terminals 146 disposed in the terminal tab 118 with the set of conductive leads. In some examples, when communication antenna 106 is attached to housing 102, the terminal tabs extend beyond the peripheral edge 121 of housing 102 (e.g., beyond cover 122).

[0052] In some examples, the body 144 of the communication antenna 106 is encapsulated in a biocompatible material such as encapsulation 150. In some examples, the head 104 is formed of different biocompatible materials, such as different epoxy resins with different properties. Different epoxy resins can be selected to provide different radio frequency (RF) characteristics; some are used for the communication antenna 106, and some are used for the charging antenna 112.

[0053] In some examples, frame 706 includes applying an adhesive to at least one of the communication antenna 106 or the sidewall (e.g., the wall of container 124) and engaging the communication antenna 106 and the sidewall with the adhesive disposed between the communication antenna 106 and the sidewall.

[0054] In some examples, process 700 further includes electrically connecting the set of conductive terminals 146 to the set of conductive leads. In some examples, this includes using laser welding.

[0055] In some examples, process 700 further includes placing backfill material 120 in access window 116 after connecting communication antenna 106 to at least cover the set of conductive terminals 146. In this example, this step includes placing communication antenna 106 in such a way that it forms an air gap 154 ​​between peripheral edge 119 of head 102 and peripheral edge 123 of communication antenna 106. In this example, backfill material 120 is also placed in air gap 154 ​​to create a transition between head 102 and communication antenna 106.

[0056] In some examples, process 700 further includes forming a communication antenna 106 prior to execution block 706. This may include forming a body 144 and an electrical terminal patch 118 in a ceramic substrate 142, forming a metal plate as a radiating surface 140 in the body 144 of the ceramic substrate 142, forming the pair of conductive terminals 146 in the electrical terminal patch 118, forming a pair of conductive traces 148 in the ceramic substrate 142 that electrically connect the metal plate to the radiating surface 140 and at least one of the conductive terminals 146, and encapsulating the body 144 in a biocompatible material (e.g., encapsulation 150) without encapsulating the electrical terminal patch 118.

[0057] In some examples, process 700 further includes forming a set of conductive leads (e.g., feedthrough pins 128) extending from electronic component 110 and through housing 102. In some examples, the set of conductive leads extends through feedthroughs 126 disposed in cover 122 of housing 102.

[0058] Further examples are described below to aid in understanding this disclosure.

[0059] Example 1. In this example, an apparatus is provided, comprising:

[0060] The outer casing includes a lid and side walls connected to the lid;

[0061] Electronic components are housed within the internal volume of the casing;

[0062] A set of conductive leads, electrically connected to electronic components and extending through the housing; and

[0063] A communication antenna is disposed on the outer surface of a sidewall and includes a body and a tab. The tab includes a set of conductive terminals, wherein the body is coated with a biocompatible material and the set of conductive terminals is electrically connected to the set of conductive leads.

[0064] Example 2. In this example, an apparatus of any one of the foregoing or subsequent examples is provided, further comprising:

[0065] The charging antenna connected to the cover; and

[0066] The connector stack connects to the lid.

[0067] The second set of conductive leads extends through the housing and electrically connects the electronic components to at least one of the connector stacks or charging antennas.

[0068] Example 3. In this example, an apparatus of any of the foregoing or subsequent examples is provided, further comprising an epoxy head stacked around the charging antenna and connector.

[0069] Example 4. In this example, an apparatus of any of the foregoing or subsequent examples is provided, wherein each of the set of conductive leads extends through the cover of the housing in a first direction and includes a bend that orients the distal end of the respective conductive lead in a second direction.

[0070] Example 5. In this example, an apparatus of any of the foregoing examples or subsequent examples is provided, wherein the housing hermetically seals the internal volume.

[0071] Example 6. In this example, an apparatus of any of the foregoing or subsequent examples is provided, wherein the biocompatible material is RF compatible.

[0072] Example 7. In this example, an apparatus of any of the foregoing examples or subsequent examples is provided, wherein the communication antenna further includes a first metal plate formed on a first side of a ceramic substrate and a second metal plate formed on a second side of the ceramic substrate, and the set of conductive terminals is electrically connected to at least one of the first or second metal plates via a set of conductive traces.

[0073] Example 8. In this example, an apparatus of any of the foregoing or subsequent examples is provided, wherein the body and the tab are formed of a ceramic substrate, and a metal plate is disposed in the body.

[0074] Example 9. In this example, a method is provided, including

[0075] Provides a housing including electronic components;

[0076] A head is connected to a cover at least surrounding the housing, wherein an access window is formed at the peripheral edge of the head, and a set of conductive leads extend from the electronic components and pass through the access window; and

[0077] The communication antenna is connected to the outer surface of the side wall of the housing. The communication antenna includes a body and an electrical terminal patch that corresponds in size and shape to the access window and aligns a set of conductive terminals disposed in the electrical terminal patch with the set of conductive leads.

[0078] Example 10. In this example, a method of any of the foregoing examples or subsequent examples is provided, further comprising electrically connecting the set of conductive terminals to the set of conductive leads.

[0079] Example 11. In this example, a method of any of the foregoing examples or subsequent examples is provided, wherein the body of the communication antenna is formed from a ceramic substrate coated with a biocompatible material.

[0080] Example 12. In this example, a method from any of the foregoing or subsequent examples is provided, wherein the head is formed of a second biocompatible material.

[0081] Example 13. In this example, a method from any of the foregoing or subsequent examples is provided, wherein the electrical terminal tabs extend beyond the peripheral edge of the cover of the housing.

[0082] Example 14. In this example, a method of any of the foregoing examples or subsequent examples is provided, wherein electrically connecting the set of conductive terminals to the set of conductive leads includes at least one of welding, crimping, or laser welding.

[0083] Example 15. In this example, a method from any of the foregoing or subsequent examples is provided, wherein attaching the communication antenna to the outer surface of the sidewall includes:

[0084] Apply adhesive to at least one of the communication antennas or sidewalls; and

[0085] The communication antenna is fitted together with the side wall, and adhesive is placed between the communication antenna and the side wall.

[0086] Example 16. In this example, a method from any of the preceding or subsequent examples is provided, further including the formation of a header.

[0087] Example 17. In this example, a method from any of the preceding or subsequent examples is provided, wherein the header includes:

[0088] To form the head as a separate part; and

[0089] After the head is formed, it is fitted into the appropriate position on the cover of the outer shell.

[0090] Example 18. In this example, a method from any of the foregoing or subsequent examples is provided, further comprising placing backfill material in the access window after connecting the communication antenna to at least cover the set of conductive terminals.

[0091] Example 19. In this example, a method of any of the foregoing examples or subsequent examples is provided, wherein connecting a communication antenna to the outer surface of the sidewall includes connecting the communication antenna at a specific mounting location on the outer surface that defines an air gap between the head and the communication antenna, and wherein placing backfill material further includes placing the backfill material in the air gap.

[0092] Example 20. In this example, a method from any of the foregoing or subsequent examples is provided, further comprising forming the communication antenna at least in the following manner before connecting the communication antenna:

[0093] A body and electrical terminal contacts are formed in a ceramic substrate;

[0094] A metal plate is formed within the body of a ceramic substrate;

[0095] This set of conductive terminals is formed in the electrical terminal patch;

[0096] A pair of electrical traces are formed in the ceramic substrate to electrically connect the metal plate and the set of conductive terminals; and

[0097] The main body is encapsulated in a biocompatible material without encapsulating the electrical terminal contacts.

[0098] Example 21. In this example, a system is provided, comprising:

[0099] Implantable medical devices, including:

[0100] A housing for accommodating electronic components, the housing including a cover and sides connected to the cover;

[0101] as well as

[0102] A set of conductive leads extends from the electronic components through the cover to the outside of the housing; and

[0103] An antenna, connected to the outer surface of the side at the mounting location, includes:

[0104] The main component encapsulated in a biocompatible material;

[0105] The connecting piece portion that connects to the main body; and

[0106] A set of conductive terminals is disposed in the patch portion and aligned with the set of conductive leads when the antenna is connected to the outer surface in the mounting position.

[0107] Example 22. In this example, a system of any of the foregoing or subsequent examples is provided, wherein the antenna further includes a metal plate disposed in the body portion and a set of conductive traces extending between the metal plate and the set of conductive leads.

[0108] Example 23. In this example, a system of any of the foregoing or subsequent examples is provided, wherein when the antenna is attached to the outer surface at the mounting location, the distal end of the patch portion extends beyond the cover of the housing.

[0109] Example 24. In this example, a system of any of the foregoing or subsequent examples is provided, wherein the antenna comprises an elongated shape.

[0110] Example 25. In this example, a system of any of the foregoing examples or subsequent examples is provided, wherein the implantable medical device further includes a head for at least enclosing a housing, wherein an access window corresponding in shape to the patch portion is formed in the head.

[0111] Example 26. In this example, a system of any of the foregoing or subsequent examples is provided, wherein the biocompatible material is epoxy resin and the head is formed of the epoxy resin.

[0112] Example 27. In this example, a system provided in any of the foregoing or subsequent examples further includes backfill material to fill the access window and extend along at least a portion of the body adjacent to the access window.

[0113] Example 28. In this example, a system of any of the foregoing or subsequent examples is provided, wherein the antenna is based on Standard operating procedure.

[0114] Example 29. In this example, an apparatus is provided, comprising:

[0115] The outer casing includes the lid and sidewalls;

[0116] Electronic components are housed within the internal volume of the housing and include multiple conductive leads extending through a cover of the housing;

[0117] One or more electrical components are connected to the outer surface of the cover and electrically connected to the first portion of the plurality of conductive leads; and

[0118] The head encapsulates one or more electrical components and includes an access window, through which a second portion of the plurality of conductive leads extends, the access window being fabricated to the required dimensions to receive a patch of a communication antenna.

[0119] Example 30. In this example, an apparatus of any of the foregoing examples or subsequent examples is provided, further comprising a communication antenna, the communication antenna including a patch and a body.

[0120] Example 31. In this example, an apparatus of any of the foregoing or subsequent examples is provided, wherein the body of the communication antenna is attached to the outer surface of the sidewall such that the patch is aligned with the access window.

[0121] Example 32. In this example, an apparatus of any of the foregoing or subsequent examples is provided, wherein the tab includes a set of conductive terminals electrically connected to a second portion of a conductive lead.

[0122] Example 33. In this example, an apparatus is provided, comprising:

[0123] A housing for accommodating electronic components, the housing including a cover and sidewalls connected to the cover;

[0124] A set of conductive pins extending through the cover of the housing; and

[0125] A communication antenna connected to the outer surface of the sidewall, the communication antenna including a set of conductive terminals.

[0126] The set of conductive pins is received by the set of conductive terminals and electrically connected to the set of conductive terminals.

[0127] Example 34. In this example, an apparatus of any of the foregoing examples or subsequent examples is provided, further comprising:

[0128] One or more electrical components connected to the cover; and

[0129] The head connects to the cover and encloses the cover and the one or more electrical components.

[0130] Example 35. In this example, a device of any of the foregoing or subsequent examples is provided, wherein the head physically contacts the sidewall.

[0131] Example 36. In this example, an apparatus of any of the foregoing or subsequent examples is provided, further comprising silicone backfill material that physically contacts at least a portion and the head of the communication antenna.

[0132] Therefore, the specification and drawings are to be considered illustrative rather than restrictive. However, it will be apparent that various modifications and changes can be made thereto without departing from the broader spirit and scope of this disclosure as set forth in the claims.

[0133] Other variations are within the spirit of this disclosure. Therefore, while the disclosed technology is readily adaptable to various modifications and alternative constructions, some of which are illustrated in the accompanying drawings and have been described in detail above. However, it should be understood that this disclosure is not intended to be limited to one or more specific forms disclosed, but rather is intended to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of this disclosure as defined in the appended claims.

[0134] In the context of describing the disclosed examples (especially in the context of the following claims), the terms “a” and “the”, and similar designations, shall be construed as covering both the singular and plural, unless otherwise stated herein or obviously contradicted by the context. Unless otherwise stated, the terms “comprising,” “having,” “including,” and “containing” shall be construed as open-ended terms (e.g., meaning “including but not limited to”). The term “connected” shall be construed as being partially or wholly contained, attached to, or joined together, even if something is present therein. Unless otherwise stated herein, the enumeration of numerical ranges herein is intended only as a concise way of referring separately to each individual value falling within that range, and each individual value is incorporated into the specification as if it were listed separately herein. Unless otherwise stated herein or obviously contradicted by the context, all methods described herein may be performed in any suitable order. The use of any and all examples or exemplary language (e.g., “such as”) provided herein is intended only to better illustrate the examples of this disclosure and does not constitute a limitation on the scope of this disclosure, unless otherwise stated. No language in the specification should be construed as indicating that any unclaimed element is essential to the practice of this disclosure.

[0135] Disjunctive language, such as the phrase “at least one of X, Y, or Z,” is generally understood in the context to mean that an item, term, etc., can be X, Y, or Z, or any combination thereof (e.g., X, Y, and / or Z). Therefore, such disjunctive language is generally not intended to, and should not, imply that certain examples require the existence of at least one of X, at least one of Y, or at least one of Z, each individually.

[0136] The word “or” is used here to encompass both inclusive and exclusive OR conditions. In other words, A or B or C includes any or all of the following alternative combinations suitable for a particular purpose: A alone; B alone; C alone; A and B only; A and C only; B and C only; and all three of A, B, and C.

[0137] Preferred examples of this disclosure are described herein, including the best modes known to the inventors for carrying out this disclosure. Variations of those preferred examples will likely become apparent to those skilled in the art upon reading the foregoing description. The inventors expect those skilled in the art to appropriately adopt such variations, and the inventors intend to implement this disclosure in a manner different from that specifically described herein. Therefore, this disclosure includes all modifications and equivalents to the content recited in the appended claims, where permitted by applicable law. Furthermore, unless otherwise stated herein or clearly contradicted by the context, any combination of the foregoing elements in all their possible variations is included in this disclosure.

[0138] All references cited herein, including publications, patent applications and patents, are incorporated into this text to the same extent that each reference is individually and specifically indicated to be incorporated by reference and elaborated in full herein.

Claims

1. An implantable device, comprising: The outer casing includes a lid and a sidewall connected to the lid; Electronic components are housed within the internal volume of the housing; A set of conductive leads is electrically connected to the electronic component and extends through the housing; The head, the cover connected to the outer casing, includes an access window, and A communication antenna, mounted on the outer surface of the sidewall, includes a body and a tab, the tab including a set of conductive terminals and corresponding in size and shape to the access window such that the access window receives the tab, wherein the body is coated with a biocompatible material, and the set of conductive terminals is electrically connected to the set of conductive leads.

2. The implantable device according to claim 1, wherein the main body of the communication antenna is not disposed within the head.

3. The implantable device according to claim 1, further comprising: A charging antenna connected to the cover; as well as The connector stack is connected to the cover. The second set of conductive leads extends through the housing and electrically connects the electronic components to at least one of the connector stack or the charging antenna.

4. The implantable device of claim 3, further comprising an epoxy head stacked around the charging antenna and the connector.

5. The implantable device according to claim 1, wherein, Each of the set of conductive leads extends through the cover of the housing in a first direction and includes a bend that orients the distal end of the respective conductive lead in a second direction.

6. The implantable device according to claim 1, wherein, The outer shell airtightly seals the internal volume.

7. The implantable device according to claim 1, wherein, The biocompatible material is RF compatible.

8. The implantable device according to any one of claims 1-7, wherein, The communication antenna further includes a metal plate formed on a ceramic substrate, and the set of conductive terminals is electrically connected to the metal plate via a set of conductive traces.

9. The implantable device according to claim 8, wherein, The main body and the tab are formed from the ceramic substrate, and the metal plate is disposed in the main body.

10. A method for forming an implantable device, comprising: Provides a housing including electronic components; A head is connected to a cover that at least surrounds the housing, wherein an access window is formed at the peripheral edge of the head, and a set of conductive leads extend from the electronic component and through the access window; as well as A communication antenna is connected to the outer surface of the side wall of the housing. The communication antenna includes a body and an electrical terminal patch, the electrical terminal patch being sized and shaped to correspond to the access window for reception by the access window, and aligning a set of conductive terminals disposed in the electrical terminal patch with the set of conductive leads.

11. The method of claim 10, further comprising electrically connecting the set of conductive terminals to the set of conductive leads.

12. The method according to claim 11, wherein, The main body of the communication antenna is formed from a ceramic substrate coated with a biocompatible material.

13. The method according to claim 12, wherein, The head is formed of a second biocompatible material.

14. The method of claim 10, wherein, The electrical terminal tabs extend beyond the peripheral edge of the cover of the housing.

15. The method of claim 10, wherein electrically connecting the set of conductive terminals to the set of conductive leads comprises at least one of welding and crimping.

16. The method of claim 10, wherein electrically connecting the set of conductive terminals to the set of conductive leads comprises laser welding.

17. The method of claim 10, wherein connecting the communication antenna to the outer surface of the sidewall comprises: Apply adhesive to at least one of the communication antenna or the sidewall; as well as The communication antenna is fitted together with the sidewall, and the adhesive is disposed between the communication antenna and the sidewall.

18. The method of claim 10, further comprising forming the head.

19. The method of claim 18, wherein forming the head comprises: The head is formed as a separate part; as well as After the head is formed, it is fitted into the appropriate position on the cover of the housing.

20. The method of claim 10, further comprising: After connecting the communication antenna, backfill material is placed in the access window to at least cover the set of conductive terminals.

21. The method of claim 20, wherein connecting the communication antenna to the outer surface of the sidewall includes connecting the communication antenna at a specific mounting location on the outer surface, the mounting location defining an air gap between the head and the communication antenna, and wherein placing the backfill material further includes placing the backfill material in the air gap.

22. The method according to any one of claims 10-21, further comprising, before connecting the communication antenna, forming the communication antenna by at least the following manner: The main body and the electrical terminal patch are formed in a ceramic substrate; A first metal plate is formed on a first side of the main body of the ceramic substrate; A second metal plate is formed on the second side of the main body of the ceramic substrate; The set of conductive terminals is formed in the electrical terminal patch; A set of electrical traces is formed in the ceramic substrate to electrically connect the first metal plate and the second metal plate to the set of conductive terminals; as well as The main body is encapsulated in a biocompatible material without encapsulating the electrical terminal contacts.

23. A system including an implantable medical device, comprising: The implantable medical device includes: A housing for accommodating electronic components, the housing including a cover and a side attached to the cover; A set of conductive leads extends from the electronic component through the cover to the outside of the housing; and A head, for at least enclosing the housing, includes an access window, and an antenna attached to the outer surface of the side at a mounting location, the antenna comprising... The main component encapsulated in a biocompatible material; The tab portion connected to the main body portion; and A set of conductive terminals is disposed in the contact patch portion and aligned with the set of conductive leads when the antenna is connected to the outer surface in the mounting position. An access window, corresponding in shape and size to the patch portion, is formed in the head to receive the patch portion.

24. The system according to claim 23, wherein, The antenna further includes a metal plate disposed in the main body portion and a set of conductive traces extending between the metal plate and the set of conductive leads.

25. The system according to claim 23, wherein, When the antenna is attached to the outer surface at the mounting position, the distal end of the tab portion extends beyond the cover of the housing.

26. The system according to claim 23, wherein, The antenna has an elongated shape.

27. The system according to claim 23, wherein, The biocompatible material is epoxy resin, and the head is formed of the epoxy resin.

28. The system of claim 23, further comprising backfill material to fill the access window and extend along at least a portion of the body portion adjacent to the access window.

29. The system according to any one of claims 23-28, wherein, The antenna is based on Standard operating procedure.

30. An implantable device comprising: The outer casing includes the lid and sidewalls; Electronic components are disposed within the internal volume of the housing and include multiple conductive leads extending through the cover of the housing; One or more electrical components are connected to the outer surface of the cover and electrically connected to a first portion of the plurality of conductive leads; as well as The head encapsulates one or more electrical components and includes an access window, through which a second portion of the plurality of conductive leads extends, the access window being fabricated to the required size to receive a patch of a communication antenna.

31. The implantable device of claim 30, further comprising the communication antenna, the communication antenna including the patch and the body.

32. The implantable device according to claim 31, wherein, The main body of the communication antenna is connected to the outer surface of the sidewall, such that the patch is aligned with the access window.

33. The implantable device according to claim 31, wherein, The connector includes a set of conductive terminals electrically connected to the second portion of the conductive lead.

34. An implantable device comprising: A housing for accommodating electronic components, the housing including a cover and sidewalls connected to the cover; One or more electrical components connected to the cover; A head, connected to and enclosing the cover and the one or more electrical components, including an access window; and A communication antenna is attached to the outer surface of the sidewall at a mounting location outside the head. The access window is sized and shaped to correspond to the patch of the communication antenna to receive the patch.

35. The implantable device of claim 34, further comprising a set of conductive pins extending through the cover of the housing, wherein the set of conductive pins is received by and electrically connected to a set of conductive terminals disposed in the terminal portion of the communication antenna.

36. The implantable device according to claim 34, wherein, The head physically contacts the sidewall.

37. The implantable device according to any one of claims 34-36, further comprising a silicone backfill material that physically contacts at least a portion of the communication antenna and the head.

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