Implantable device and forming method therefor, neural signal acquisitor, and neural stimulator

Abstract

Provided are an implantable device and a forming method therefor, a neural signal acquisitor, and a neural stimulator. The implantable device comprises: an electrode assembly, an upper housing assembly, and a lower housing assembly, the upper housing assembly being fixedly connected to the lower housing assembly. The upper housing assembly comprises: a cover plate; a fixing ring surrounding and connected to the cover plate; and a first sealing member. The first sealing member fills or encapsulates a connection gap between the cover plate and the fixing ring from an outer side of the implantable device, or covers the cover plate from the outer side of the implantable device while filling or encapsulating the connection gap between the cover plate and the fixing ring. The technical solution provided by the present invention enables hermetic sealing of partial or entire portions of the implantable device to prolong the service life of the implantable device, while ensuring maximum avoidance of damage to biological tissues during functional operation of the implantable device.

Description

Implantable device and forming method thereof, neural signal collector and neural stimulator

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on December 25, 2023, with application number 202311803875.0, and invention name “Implantable device and method for forming same, neural signal collector and neural stimulator”, and the Chinese patent application filed with the China Patent Office on December 25, 2023, with application number 202311802178.3, and invention name “Implant and method for forming same, neural signal collector and neural stimulator”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present invention relates to the technical field of medical devices, and in particular to an implantable device and a forming method thereof, a neural signal collector and a neural stimulator. Background Art

[0003] Implantable devices are widely used in a variety of medical fields, including cardiology, orthopedics, neurosurgery, and plastic surgery. Implantable devices can take the form of artificial joints, pacemakers, brain implants, implantable defibrillators, and other devices, and can be used to treat conditions such as heart disease, arthritis, trauma, and neurological disorders.

[0004] The technical research, development, and manufacturing of implantable devices require the integrated application of knowledge and techniques from multiple disciplines, including materials science, biomedical engineering, and mechanical engineering. Factors such as material selection, surface treatment, structural design, and biocompatibility all play a key role in the quality and safety of implantable devices. Among these, the sealing performance of implantable devices is a crucial aspect.

[0005] Implantable device sealing refers to the ability to maintain a good seal at the interface between the implant and biological tissue. This seal effectively prevents intrusion of external substances such as tissue fluid and bacteria, maintaining a stable and clean environment within the tissue. Implantable device sealing is crucial for preventing infection, rejection, and implant damage.

[0006] The sealing performance of implantable devices usually depends on the selection of materials, surface treatment and design structure. In terms of material selection, it is necessary to consider that the material has good biocompatibility and corrosion resistance, and can contact with biological tissue and form a reliable sealing interface. In terms of surface treatment, it is necessary to improve the smoothness and biocompatibility of the surface to enhance the sealing performance. In terms of design structure, it is necessary to consider the fit between the implantable device and the surrounding tissue to ensure that there are no gaps and no penetration between the implantable device and the human tissue. In the existing technology, it is often necessary to assemble multiple components of the implantable device, such as welding multiple components using a brazing process, or bonding multiple components with adhesives, in order to ensure the sealing performance of the equipment.

[0007] However, the solder or adhesive used in the prior art often contains components that are harmful to the organism. For example, the solder may contain heavy metal components. Once the implantable device is implanted into biological tissue, the heavy metal components may slowly seep into the biological tissue, seriously affecting the health of the organism.

[0008] There is an urgent need for an implantable device that can not only collect physiological signals of a living organism and stimulate the physiological state of biological tissue, but also achieve airtight sealing of part or all of the implantable device to increase the service life of the implantable device and ensure that the implantable device avoids causing damage to the biological tissue to the greatest extent possible while completing its own function. Summary of the Invention

[0009] The technical problem solved by the present invention is to provide an implantable device and a method for forming the same, a neural signal collector and a neural stimulator, which can not only realize the collection of physiological signals of a living body and physiological stimulation of biological tissues, but also realize airtight sealing of part or all of the implantable device to increase the service life of the implantable device and ensure that the implantable device avoids damage to biological tissues to the greatest extent while completing its own functions.

[0010] To solve the above technical problems, an embodiment of the present invention provides an implantable device, which includes: an electrode assembly, an upper shell assembly and a lower shell assembly, wherein the upper shell assembly is fixedly connected to the lower shell assembly; the upper shell assembly includes: a cover plate; a fixing ring, which surrounds the cover plate and is connected to the cover plate; and a first seal, which fills or encapsulates the connection gap between the cover plate and the fixing ring from the outside of the implantable device, or the first seal covers the cover plate from the outside of the implantable device and fills or encapsulates the connection gap between the cover plate and the fixing ring; wherein the electrode assembly is fixedly connected to the lower shell assembly.

[0011] Optionally, the cover plate includes a central area and an edge area, and the thickness of the cover plate in the edge area gradually decreases in the direction away from the central area; wherein the fixing ring coaxially surrounds the cover plate, and a recessed groove is provided between the inner side wall of the fixing ring and the outer side wall of the cover plate, and the recessed groove is filled with the first sealing member.

[0012] Optionally, one or more of the following is satisfied: the material of the cover plate is ceramic or glass; the material of the fixing ring is metal; the cover plate and the fixing ring are connected by brazing.

[0013] Optionally, the electrode assembly has a plurality of connection contacts, and the implantable device further includes a feedthrough assembly, and the connection contacts are electrically connected to the circuit device inside the implantable device via the feedthrough assembly.

[0014] Optionally, the feedthrough assembly includes: a ceramic part, in which a plurality of conductive columns are embedded that vertically pass through the ceramic part, and the conductive columns are adapted to the connection contacts; a metal part, which surrounds the ceramic part and is connected to the ceramic part; wherein the connection contacts are electrically connected to the circuit device inside the implantable device via the conductive columns.

[0015] Optionally, the electrode assembly and the feedthrough assembly are relatively fixedly connected using surface mounting technology.

[0016] Optionally, the edge of one of the upper shell component and the lower shell component has an annular protrusion, and the edge of the other of the upper shell component and the lower shell component has an annular recess adapted to the annular protrusion, wherein the upper shell component and the lower shell component are fixedly connected in a relatively sealed manner.

[0017] Optionally, the side surface of the annular protrusion and the side surface of the annular recess are relatively fixedly connected by using a laser welding process.

[0018] Optionally, the first sealing member fills or encapsulates a connection gap between the annular protrusion and the annular recess from the outside of the implantable device.

[0019] Optionally, the material of the first sealing component is a combination of one or more of the following which are injected and cured in a liquid state or a fluid state: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin PPSU.

[0020] Optionally, the feedthrough assembly has a protrusion or a recess adapted to the electrode assembly, and the multiple connection contacts of the electrode assembly are electrically connected to the connection points of the circuit device via the feedthrough assembly.

[0021] Optionally, the implantable device has a second seal capable of encapsulating the electrode assembly and the feedthrough assembly.

[0022] Optionally, the feedthrough assembly includes: a ceramic part, wherein a side of the ceramic part adjacent to the electrode assembly has a protrusion or a recess adapted to the electrode assembly, and a side of the ceramic part away from the electrode assembly is electrically connected to a connection point of the circuit device; and a metal part, wherein the metal part surrounds the ceramic part and is connected to the ceramic part; wherein the metal part is connected to the lower shell assembly.

[0023] Optionally, one or more of the following is met: the ceramic part is zirconia ceramic, alumina ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum oxide ceramic; the metal part is titanium, titanium alloy or stainless steel; the lower shell component is titanium, titanium alloy or stainless steel; the metal part is brazed to the ceramic part; and / or the metal part is laser welded to the lower shell component.

[0024] Optionally, a plurality of conductive pillars vertically penetrating the ceramic part are embedded on the top surface of the protruding portion or the bottom surface of the recessed portion of the ceramic part; wherein the plurality of connection contacts of the electrode assembly correspond one-to-one to the conductive pillars and are electrically connected to the connection points of the circuit device via the conductive pillars.

[0025] In order to solve the above technical problems, an embodiment of the present invention provides a neural signal collector, which includes the above implantable device.

[0026] In order to solve the above technical problems, an embodiment of the present invention provides a neurostimulator, which includes the above implantable device.

[0027] To solve the above technical problems, an embodiment of the present invention provides a method for forming the above-mentioned implantable device, the formation method comprising: providing the electrode assembly, an upper shell assembly and a lower shell assembly, the upper shell assembly comprising a cover plate and a fixing ring, the fixing ring surrounding the cover plate and connected to the cover plate, wherein the cover plate and the fixing ring are connected by brazing; using a laser welding process to perform a relatively sealed fixed connection on the upper shell assembly and the lower shell assembly; using a surface mounting process to fix the electrode assembly to the lower shell assembly; from the outside of the implantable device, using a first sealant to fill or encapsulate the connection gap between the cover plate and the fixing ring, or using the first sealant to cover the cover plate and fill or encapsulate the connection gap between the cover plate and the fixing ring; and using a second sealant to encapsulate the electrode assembly and the connection between the electrode assembly and the lower shell assembly.

[0028] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0029] In an embodiment of the present invention, after the fixing ring surrounds the cover plate and is connected to the cover plate, the first sealing member is used to fill or encapsulate the connection gap between the cover plate and the fixing ring from the outside of the implantable device, so that the connection gap portion of the implantable device can be better sealed, for example, to achieve an airtight seal, thereby preventing adverse components remaining in the connection gap during the corresponding connection process from leaking out of the implantable device into the biological tissue after the implantable device is implanted into the biological tissue. By using the first sealing member to cover the cover plate from the outside of the implantable device and fill or encapsulate the connection gap between the cover plate and the fixing ring, the entire cover plate and the connection gap portion of the implantable device can be better sealed, for example, to achieve an airtight seal, thereby achieving complete encapsulation of the upper shell component, preventing adverse components remaining on the cover plate and in the connection gap during the corresponding connection process from leaking out of the implantable device into the biological tissue after the implantable device is implanted into the biological tissue, thereby improving the service life of the implantable device and ensuring that the implantable device can perform its own function while avoiding damage to the biological tissue to the greatest extent.

[0030] Furthermore, the thickness of the cover plate in the edge area gradually decreases in the direction away from the central area, and a recessed groove is provided between the inner side wall of the fixing ring and the outer side wall of the cover plate, and the recessed groove is filled with the first sealing member, so that more first sealing member material can be filled by setting the recessed groove, and the cross-sectional shape of the recessed groove, which is larger at the top and smaller at the bottom, can improve the fit between the first sealing member material and the upper shell assembly, thereby further improving the sealing effect and enhancing the anti-leakage performance.

[0031] Furthermore, since the upper shell component is made of ceramic or glass and metal connected by brazing, heavy metals (such as molybdenum or tungsten) may be introduced in the brazing process of the two, and heavy metal (such as molybdenum or tungsten) residues may easily occur at the connection between the two or near the connection. At this time, it is very necessary to adopt the technical solution described in the embodiment of the present invention to prevent the adverse components remaining in the connection gap in the corresponding brazing process from seeping from the implantable device into the biological tissue after the implantable device is implanted into the biological tissue, so as to avoid damage to the biological tissue to the greatest extent.

[0032] Furthermore, the feedthrough assembly includes a ceramic component and a metal component surrounding the ceramic component and connected to the ceramic component and also connected to the lower shell assembly, which can provide better electrical connection effect and airtightness.

[0033] Furthermore, by providing annular protrusions and annular recesses on the upper shell component and the lower shell component, the sealing effect between the upper shell component and the lower shell component can be improved.

[0034] Furthermore, the side surface of the annular protrusion and the side surface of the annular recess are relatively fixedly connected by using a laser welding process. Compared with brazing or bonding, the residue of adverse components (such as heavy metal solder or poor adhesive) can be further reduced, thereby maximizing the protection of biological tissues.

[0035] Furthermore, the first sealant fills or encapsulates the connecting gap between the annular protrusion and the annular recess from the outside of the implantable device, which can further effectively achieve airtight sealing of the implantable device and prevent adverse components inside the implantable device (such as materials that are not biocompatible inside the implantable device) from seeping out from the connecting gap between the annular protrusion and the annular recess.

[0036] The technical problem solved by the present invention is to provide an implant that can be detachable, requiring only the easily damaged parts to be disassembled and replaced without scrapping the entire product, thereby effectively controlling production costs.

[0037] To solve the above technical problems, an embodiment of the present invention provides an implant, comprising: an electrode assembly, the electrode assembly having a plurality of connection contacts; a probe assembly, the probe assembly comprising: a plurality of probes adapted to the connection contacts, and the probes being in detachable electrical contact with the corresponding connection contacts; a limiting component, the limiting component being detachably connected to the probes and used to limit the position and orientation of the probes; and a sealing layer, the sealing layer sealing the portion of the electrode assembly having the plurality of connection contacts and the limiting component.

[0038] Optionally, the limiting component includes: a perforated plate, the perforated plate having a through-hole area, the through-hole area including a plurality of through-holes corresponding one-to-one to the probes, each probe passing through a corresponding through-hole; a circuit board, the circuit board having a solder point area, one side of the solder point area having solder points adapted to the connecting contacts, and the other side of the solder point area having solder points adapted to the probes, wherein the solder points on one side of the solder point area are electrically connected to the solder points on the other side, so that the probes are electrically contacted with the corresponding connecting contacts via the circuit board; wherein, after the sealing layer seals the limiting component, there is a gap between it and the through-hole area.

[0039] Optionally, the solder point area is located in the central area of ​​the circuit board, and the through-hole area is located in the central area of ​​the orifice plate; the non-central area of ​​the circuit board is bonded to the non-central area of ​​the orifice plate to block the sealing layer and the through-hole area.

[0040] Optionally, one or more of the following conditions are met: the material of the orifice plate is polyetheretherketone (PEEK); and the non-central area of ​​the circuit board and the non-central area of ​​the orifice plate are bonded to each other by epoxy resin.

[0041] Optionally, the material of the sealing layer is a combination of one or more of the following after being poured in a liquid state or a fluid state and cured: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin PPSU.

[0042] Optionally, a side of the orifice plate away from the electrode assembly is a step structure having a protrusion, and the through-hole area is located at the protrusion; the implant also includes: a base body, the base body including a base shell, a feedthrough assembly and an internal circuit device, wherein the feedthrough assembly has a recessed portion adapted to the protrusion of the orifice plate, and the probe assembly is electrically contacted with the connection point of the circuit device via the feedthrough assembly; a first sealing ring, the first sealing ring can produce a sealed connection between the protrusion of the orifice plate and the recessed portion of the feedthrough assembly.

[0043] Optionally, the first sealing ring is located on the outer side wall of the step of the protruding portion, and after the base and the orifice plate are detachably connected, the first sealing ring is in elastic and sealing contact with the inner side wall of the recessed portion.

[0044] Optionally, the outer side wall of the step of the protrusion has a first sealing groove, and the first sealing ring is embedded in the first sealing groove.

[0045] Optionally, the feedthrough assembly includes: a ceramic part, which has the recessed portion on a side adjacent to the electrode assembly and is in electrical contact with a connection point of the circuit device on a side away from the electrode assembly; and a metal part, which surrounds the ceramic part and is connected to the ceramic part; wherein the metal part is connected to the base shell.

[0046] Optionally, the ceramic part is zirconia ceramic, alumina ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum oxide ceramic; the metal part is titanium, titanium alloy or stainless steel; the base shell is titanium, titanium alloy or stainless steel; the metal part is brazed to the ceramic part; and / or the metal part is brazed to the base shell.

[0047] Optionally, a plurality of conductive pillars vertically penetrating the ceramic component are embedded in the bottom surface of the recessed portion of the ceramic component; wherein the probes in the probe assembly correspond one-to-one to the conductive pillars and are in electrical contact with the connection points of the circuit device via the conductive pillars.

[0048] Optionally, the implant further includes: a second sealing ring, which is capable of generating a sealed connection between the bottom step of the step structure of the orifice plate surrounding the protrusion and the surface of the feed-through assembly surrounding the recess.

[0049] Optionally, the second sealing ring is located on the surface of the bottom step of the step structure surrounding the protrusion, and after the base and the orifice plate are detachably connected, the second sealing ring is elastically and sealingly contacted with the surface of the feed-through assembly surrounding the recessed portion.

[0050] Optionally, a second sealing groove is provided on the surface of the bottom step of the step structure surrounding the protrusion, wherein the second sealing ring is embedded in the second sealing groove.

[0051] Optionally, the electrode assembly includes an electrode wire and a support plate, the electrode wire including: an electrode site area, the electrode site area is located at the front end of the electrode assembly, and a plurality of electrode sites are located in the electrode site area; a wire area, the wire area is located between the plurality of electrode sites and the plurality of connecting contacts, so that the electrode sites and the connecting contacts are electrically connected to each other correspondingly; and a connecting contact area, the connecting contact area is located at the rear end of the electrode assembly, and the plurality of connecting contacts are located in the connecting contact area, wherein the plurality of connecting contacts are located on the support plate, and the support plate is used to support the rear end of the electrode assembly and a portion of the wire area adjacent to the rear end; wherein the sealing layer covers the support plate and a portion of the wire area adjacent to the rear end.

[0052] Optionally, the electrode assembly has an electrode assembly structure, and / or the circuit board is a ceramic circuit board, a glass circuit board or a printed circuit board.

[0053] Optionally, the support plate is a silicon plate, a glass plate or a silicon carbide plate.

[0054] In order to solve the above technical problems, an embodiment of the present invention provides a neural signal collector, comprising the above implant.

[0055] To solve the above technical problems, an embodiment of the present invention provides a neurostimulator comprising the above implant.

[0056] To solve the above technical problems, an embodiment of the present invention provides a method for forming an implant, comprising: providing an electrode assembly and a probe assembly, the electrode assembly having a plurality of connection contacts, the probe assembly comprising a plurality of probes adapted to the connection contacts and a limiting component, wherein the limiting component is used to limit the position and orientation of the probes; performing a sealed connection between the electrode assembly and the limiting component in a fixed manner; using a sealing layer to seal the portion of the electrode assembly having the plurality of connection contacts and the limiting component; using the probe in the probe assembly to detachably penetrate the limiting component, and the probe is in detachable electrical contact with the corresponding connection contacts.

[0057] Optionally, the limiting component includes a perforated plate, the perforated plate having a through-hole area, the through-hole area including a plurality of through-holes corresponding one-to-one to the probes; the limiting component includes a circuit board, the circuit board having a solder point area, one side of the solder point area having solder points adapted to the connecting contacts, and the other side of the solder point area having solder points adapted to the probes, wherein the solder points on one side of the solder point area are electrically connected to the solder points on the other side, so that the probes are electrically contacted with the corresponding connecting contacts via the circuit board.

[0058] Optionally, the electrode assembly and the limiting component are fixedly sealed and connected to each other, including: fixing the electrode assembly and the circuit board with each other and sealing the circuit board and the orifice plate with each other; using the probe in the probe assembly to penetrate the corresponding through hole, and the probe is electrically contacted with the corresponding electrode site via the circuit board; wherein, after the sealing layer seals the limiting component, there is a gap between it and the through hole area.

[0059] Optionally, the solder point area is located in the central area of ​​the circuit board, and the through-hole area is located in the central area of ​​the orifice plate; the circuit board and the orifice plate are fixedly sealed to each other, including: using a bonding process to connect the non-central area of ​​the circuit board and the non-central area of ​​the orifice plate to block the sealing layer and the through-hole area.

[0060] Optionally, the electrode assembly and the orifice plate are fixedly and sealed to each other, including: connecting the electrode assembly and the orifice plate using a reflow soldering process.

[0061] Optionally, the electrode assembly includes an electrode wire and a support plate, the electrode wire including: an electrode site area, the electrode site area is located at the front end of the electrode assembly, and a plurality of electrode sites are located in the electrode site area; a wire area, the wire area is located between the plurality of electrode sites and the plurality of connecting contacts, so that the electrode sites and the connecting contacts are electrically connected to each other correspondingly; and a connecting contact area, the connecting contact area is located at the rear end of the electrode assembly, and the plurality of connecting contacts are located in the connecting contact area, wherein the plurality of connecting contacts are located on the support plate, and the support plate is used to support the rear end of the electrode assembly and a portion of the wire area adjacent to the rear end; wherein the sealing layer covers the support plate and a portion of the wire area adjacent to the rear end.

[0062] Optionally, a sealing layer is used to seal the portion of the electrode assembly having the multiple connection contacts and the limiting component, including: pouring the material of the sealing layer in a liquid state or a fluid state so that the material of the sealing layer covers the support plate and a portion of the wire area adjacent to the rear end; and curing the material of the sealing layer.

[0063] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0064] In an embodiment of the present invention, by adopting multiple probes adapted to the connection contacts, and the probes are in detachable electrical contact with the corresponding connection contacts, the probes and the electrode assembly can be detachable; by adopting a limiting component that is detachably connected to the probe, the probe and the limiting component can be detachable while limiting the position and orientation of the probe; and then by adopting a sealing layer to seal the portion of the electrode assembly with the multiple connection contacts and the limiting component, the sealing effect of the electrode assembly and the limiting component can be effectively guaranteed on the basis of being able to remove the probe, and a balance can be achieved between the sealing requirements and the detachability requirements. Compared with the products in the prior art that are non-detachable, when problems occur in the vulnerable parts of the product (such as the electrode assembly, etc.), the entire product needs to be scrapped. By adopting the solution of the embodiment of the present invention, the probe in the probe assembly and other subsequent structural parts in the implant (such as the matrix, etc.) can be retained by disassembly, effectively controlling costs.

[0065] Furthermore, the limiting component includes a hole plate and a circuit board. By setting the hole plate to have a through-hole area including multiple through-holes corresponding one to one with the probes, the limiting component and the probe can be detachably connected; by setting the circuit board to have a solder point area, and one side has solder points adapted to the connection contacts, and the other side has solder points adapted to the probes, the probe can still have electrical detection performance on the basis of being detachable; after the limiting component is sealed by setting a sealing layer, there is a gap between it and the through-hole area, which can effectively avoid the clogging of the through-hole area by the material of the sealing layer, and further achieve the detachability of the probe while retaining the sealing effect of the sealing layer, thereby improving the balance between the sealing requirements and the detachability requirements.

[0066] Furthermore, by bonding the non-central area of ​​the circuit board to the non-central area of ​​the orifice plate to block the sealing layer from the through-hole area, the sealing between the circuit board and the orifice plate can be effectively improved, further improving the protection of the electrode assembly in the in vivo environment of the organism.

[0067] Furthermore, the material of the orifice plate is polyetheretherketone (PEEK); the non-central area of ​​the circuit board and the non-central area of ​​the orifice plate are bonded by epoxy resin, so that the electrode assembly can be sealed and protected while the probe can be effectively protected during the insertion and removal of the probe, further improving the quality and reusability of the probe retained by disassembly, and effectively maintaining the quality of the implant while saving costs.

[0068] Furthermore, the material of the sealing layer is a combination of one or more of the following after being injected and cured in a liquid or fluid state: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin PPSU, so that the sealing effect can be effectively improved through the fluidity of the liquid or fluid, thereby further improving the effective protection of vulnerable parts (such as electrode assemblies, etc.) in the internal environment of the biological body.

[0069] Furthermore, by arranging the orifice plate to have a protruding portion, the base to have a feedthrough assembly, and the feedthrough assembly to have a recessed portion, and then arranging a first sealing ring capable of producing a sealed connection between the protruding portion of the orifice plate and the recessed portion of the feedthrough assembly, the first sealing ring can be used to enhance the sealing effect after the base and the orifice plate are detachably connected, thereby improving the sealing between the base and the orifice plate while being able to retain the base by disassembly and reduce costs.

[0070] Furthermore, the first sealing ring is located on the outer side wall of the step of the protruding part. Since the gap between the outer side wall of the step of the protruding part and the inner side wall of the step of the recessed part is less affected by the gravity of the upper structure, arranging the first sealing ring here can improve the sealing effect more evenly.

[0071] Furthermore, the feedthrough assembly includes a metal part connected to the base housing, and a ceramic part, and is electrically contacted with the connection point of the circuit device through the ceramic part, thereby improving the sealing between the feedthrough assembly and the base housing. Compared with forming the feedthrough assembly using only ceramic parts, the solution of the embodiment of the present invention can be used to enhance the support and hardness while improving the sealing by using a metal part surrounding the ceramic part, thereby further improving the effective protection of the base and the circuit devices therein in the in vivo environment of the biological body, and improving the quality and reusability of the base retained by disassembly.

[0072] Furthermore, the bottom surface of the recessed portion of the ceramic part is embedded with a plurality of conductive pillars that vertically penetrate the ceramic part, so that electrical connection can be achieved through the conductive pillars embedded in the ceramic part. Compared with using holes to allow the probe to pass through, the sealing can be further improved and the circuit devices in the substrate can be better protected.

[0073] Furthermore, by providing a second sealing ring located on the surface of the bottom step surrounding the protrusion of the step structure, and elastically sealingly contacting the surface of the feed-through assembly surrounding the recessed portion, the second sealing ring can be used to further enhance the sealing effect after the base and the orifice plate are detachably connected, thereby improving the sealing between the base and the orifice plate while being able to retain the base by disassembly and reduce costs.

[0074] Furthermore, by providing a second sealing groove on the surface of the bottom step surrounding the protrusion of the step structure, the sealing effect can be further enhanced by adopting a second sealing ring and a second sealing groove after the base and the orifice plate are detachably connected, thereby improving the sealing between the base and the orifice plate while being able to retain the base by disassembly and reduce costs.

[0075] Furthermore, the electrode assembly includes an electrode wire and a support plate, and the electrode wire includes: an electrode site area, the electrode site area is located at the front end of the electrode assembly, and multiple electrode sites are located in the electrode site area; a wire area, the wire area is located between the multiple electrode sites and the multiple connecting contacts, so that the electrode sites and the connecting contacts are electrically connected to each other correspondingly; and a connecting contact area, the connecting contact area is located at the rear end of the electrode assembly, and the multiple connecting contacts are located in the connecting contact area, wherein the multiple connecting contacts are located on the support plate, and the support plate is used to support the rear end of the electrode assembly and a part of the wire area adjacent to the rear end; wherein the sealing layer covers the support plate and a part of the wire area electrode assembly adjacent to the rear end, so that the hardness of the support plate can be used to reduce the deformation degree of the electrode assembly, so that the multiple connecting contacts can be adapted to the multiple probes, and after being covered by the sealing layer, the problem of reduced sealing effect caused by gaps caused by deformation can be effectively improved.

[0076] Furthermore, by first fixing the electrode assembly and the limiting component in a sealed connection, then using a sealing layer to seal the portion of the electrode assembly having the multiple connection contacts and the limiting component, and then using the probe in the probe assembly to detachably penetrate the limiting component, the probe is in detachable electrical contact with the corresponding connection contacts, which can easily achieve the detachability between the probe and the electrode assembly and the detachability between the probe and the limiting component, while reducing damage to the probe caused by repeated disassembly and insertion, and effectively ensuring the sealing effect of the electrode assembly and the limiting component, thereby achieving a balance between the sealing requirements and the detachability requirements while further controlling costs.

[0077] Furthermore, the limiting component includes a perforated plate, the perforated plate has a through-hole area, and the through-hole area includes multiple through-holes corresponding one to one with the probes; the limiting component includes a circuit board, the circuit board has a solder point area, one side of the solder point area has solder points adapted to the connecting contacts, and the other side of the solder point area has solder points adapted to the probes, wherein the solder points on one side of the solder point area are electrically connected to the solder points on the other side, so that the probes are electrically contacted with the corresponding connecting contacts via the circuit board, which can easily realize a detachable connection between the limiting component and the probe and the detachability of the probe.

[0078] Furthermore, the electrode assembly and the limiting component are fixedly sealed and connected to each other, including: fixing the electrode assembly and the circuit board to each other and sealing the circuit board to the orifice plate to each other; using the probe in the probe assembly to pass through the corresponding through-hole, and the probe is electrically contacted with the corresponding electrode site via the circuit board; wherein, after the sealing layer seals the limiting component, there is a gap between it and the through-hole area, which can easily achieve a detachable connection between the limiting component and the probe, and achieve the electrical detection performance of the probe on the basis of detachability, while reducing damage to the probe due to repeated disassembly and insertion, effectively avoiding clogging of the through-hole area by the material of the sealing layer, and further achieving the detachability of the probe while retaining the sealing effect of the sealing layer, thereby improving the balance between the sealing requirements and the detachability requirements.

[0079] Furthermore, the solder joint area is located in the center area of ​​the circuit board, and the through-hole area is located in the center area of ​​the orifice plate. The circuit board and the orifice plate are fixedly and sealed together, including: bonding a non-center area of ​​the circuit board to a non-center area of ​​the orifice plate to isolate the sealing layer from the through-hole area. The bonding process not only seals and protects the electrode assembly, but also effectively protects the probe during insertion and removal, further improving the quality and reusability of the probe retained after removal, effectively maintaining the quality of the implant while saving costs.

[0080] Furthermore, a reflow soldering process is used to connect the electrode assembly and the orifice plate to achieve a mutually fixed sealed connection between the electrode assembly and the orifice plate. Compared with other mutually fixed connection methods, it can improve the sealing while reducing the impact of factors such as temperature and vibration on the electrode assembly, further improving the quality of the implant.

[0081] Furthermore, a sealing layer is used to seal the portion of the electrode assembly having the multiple connection contacts and the limiting component, including: pouring the material of the sealing layer in a liquid state or a fluid state so that the material of the sealing layer covers the support plate and a portion of the wire area adjacent to the rear end; curing the material of the sealing layer, and the hardness of the support plate can be used to reduce the degree of deformation of the connection contact area of ​​the electrode assembly, so that the multiple connection contacts can be adapted to the multiple probes, and after being covered by the sealing layer, the problem of reduced sealing effect caused by gaps caused by deformation can be effectively improved, and the sealing effect can be effectively improved through the liquid or fluid state fluidity of the sealing layer material, thereby further improving the effective protection of vulnerable parts (such as electrode assemblies, etc.) in the internal environment of the biological body. BRIEF DESCRIPTION OF THE DRAWINGS

[0082] FIG1 is a schematic diagram of the assembly structure of an upper shell component of an implantable device according to an embodiment of the present invention;

[0083] FIG2 is an exploded view of an implantable device according to an embodiment of the present invention;

[0084] FIG3 is a schematic cross-sectional view of an upper shell assembly of an implantable device after assembly according to an embodiment of the present invention;

[0085] FIG4 is a schematic cross-sectional view of another implantable device according to an embodiment of the present invention;

[0086] FIG5 is a flow chart of a method for forming an implantable device according to an embodiment of the present invention;

[0087] FIG6 is a perspective view of an implant according to an embodiment of the present invention;

[0088] FIG7 is a schematic diagram of the assembly structure of various components of an implant according to an embodiment of the present invention;

[0089] FIG8 is an exploded view of some components of an implant according to an embodiment of the present invention;

[0090] FIG9 is a schematic cross-sectional view of the assembled components of an implant according to an embodiment of the present invention;

[0091] FIG10 is a schematic cross-sectional view of another implant according to an embodiment of the present invention;

[0092] FIG11 is a schematic cross-sectional view of another implant according to an embodiment of the present invention;

[0093] FIG12 is a flow chart of a method for forming an implant according to an embodiment of the present invention.

[0094] Explanation of the accompanying drawings: First sealing member 111, cover plate 112, fixing ring 113, lower shell assembly 114, feed-through assembly 115, electrode assembly 116, second sealing member 117, ceramic member 1151, conductive column 1152, metal member 1153; First part of implant 100, second part of implant 110, bolt 120, first sealing ring 111, second sealing ring 112, probe 113, orifice plate 114, circuit board 115, electrode assembly 116, connecting contact 1161, wire area 1162, support plate 1163, sealing layer 117, feed-through assembly 101, ceramic member 1011, metal member 1012, substrate 102, circuit device 103. DETAILED DESCRIPTION

[0095] As mentioned above, in existing implantable medical devices, it is often necessary to assemble multiple components of the implantable device, such as welding multiple components using a brazing process, or bonding multiple components using adhesives. Since existing solders or adhesives may contain components that are harmful to biological tissues, such as heavy metals (such as molybdenum or tungsten) used in the brazing process or defective products when using adhesives, these adverse components may come into contact with biological tissues, easily causing damage to biological tissues and seriously affecting the health of the organism.

[0096] In an embodiment of the present invention, after the fixing ring surrounds the cover plate and is connected to the cover plate, the first sealing member is used to fill or encapsulate the connection gap between the cover plate and the fixing ring from the outside of the implantable device, so that the connection gap portion of the implantable device can be better sealed, for example, to achieve an airtight seal, thereby preventing adverse components remaining in the connection gap during the corresponding connection process from leaking out of the implantable device into the biological tissue after the implantable device is implanted into the biological tissue. By using the first sealing member to cover the cover plate from the outside of the implantable device and fill or encapsulate the connection gap between the cover plate and the fixing ring, the entire cover plate and the connection gap portion of the implantable device can be better sealed, for example, to achieve an airtight seal, thereby achieving complete encapsulation of the upper shell component, preventing adverse components remaining on the cover plate and in the connection gap during the corresponding connection process from leaking out of the implantable device into the biological tissue after the implantable device is implanted into the biological tissue, thereby improving the service life of the implantable device and ensuring that the implantable device can perform its own function while avoiding damage to the biological tissue to the greatest extent.

[0097] In order to make the above-mentioned objects, features and beneficial effects of the present invention more obvious and easy to understand, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0098] 1 and 2 , FIG. 1 is a schematic diagram of the assembly structure of an upper shell component of an implantable device according to an embodiment of the present invention, and FIG. 2 is an exploded view of an implantable device according to an embodiment of the present invention.

[0099] The implantable device may include an electrode assembly 116 , an upper shell assembly, and a lower shell assembly 114 .

[0100] The upper shell assembly can be fixedly connected to the lower shell assembly 114 , and the electrode assembly 16 can be fixedly connected to the lower shell assembly 114 .

[0101] The upper shell component of the implantable device may include: a cover plate 112 , a fixing ring 113 and a first sealing member 111 .

[0102] The fixing ring 113 surrounds the cover plate 112 and is connected to the cover plate 112 .

[0103] In a first specific implementation of the embodiment of the present invention, the first sealing member 111 fills or encloses the connection gap between the cover plate 112 and the fixing ring 113 from the outside of the implantable device.

[0104] The exploded view shown in FIG. 2 shows this specific embodiment. The first sealing member 111 is annular and fills or encloses the connection gap between the cover plate 112 and the fixing ring 113 .

[0105] Furthermore, the cover plate 112 is made of ceramic or glass, the fixing ring 113 is made of metal, and the cover plate 112 and the fixing ring 113 are connected by brazing. In a specific embodiment, the material of the cover plate 112 allows for signal and energy exchange between the circuit components within the implantable device and an external terminal device, such as wireless signal transmission and wireless energy transmission.

[0106] In a specific implementation, the metal material may be, for example, copper, aluminum, cobalt, titanium, silver, gold, molybdenum, tungsten, etc.

[0107] The ceramic material may be, for example, zirconia ceramic, alumina ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic, aluminum oxide ceramic, etc.

[0108] In an embodiment of the present invention, since the upper shell component is made of ceramic or glass and connected to metal by brazing, heavy metals (such as molybdenum or tungsten) may be introduced in the brazing process of the two, and heavy metal (such as molybdenum or tungsten) residues may easily occur at the connection between the two or near the connection. At this time, it is very necessary to adopt the technical solution described in the embodiment of the present invention to prevent the adverse components remaining in the connection gap in the corresponding brazing process from seeping from the implantable device into the biological tissue after the implantable device is implanted into the biological tissue, so as to avoid damage to the biological tissue to the greatest extent.

[0109] In a second specific implementation of the embodiment of the present invention, the first sealing member 111 covers the cover plate 112 from the outside of the implantable device and fills or encapsulates the connection gap between the cover plate 112 and the fixing ring 113 .

[0110] Specifically, in the second specific embodiment, the first sealing member 111 not only fills or encloses the connection gap between the cover plate 112 and the fixing ring 113 , but also covers the cover plate 112 .

[0111] In an embodiment of the present invention, after the fixing ring 113 surrounds the cover plate 112 and is connected to the cover plate 112, the first sealing member 111 is used to fill or encapsulate the connection gap between the cover plate 112 and the fixing ring 113 from the outside of the implantable device, so that the connection gap portion of the implantable device can be better sealed, for example, to achieve an airtight seal, thereby preventing the adverse components remaining in the connection gap during the corresponding connection process from leaking from the implantable device into the biological tissue after the implantable device is implanted into the biological tissue. By using the first sealing member 111 to cover the cover plate 112 from the outside of the implantable device, the implantable device can be sealed. And filling or encapsulating the connection gap between the cover plate 112 and the fixing ring 113 can better seal the entire cover plate 112 and the connection gap portion of the implantable device, for example, to achieve airtight sealing, or even airtight encapsulation, thereby achieving complete encapsulation of the upper shell component, preventing adverse components remaining on the cover plate 112 and in the connection gap during the corresponding connection process from seeping into the biological tissue after the implantable device is implanted into the biological tissue, thereby improving the service life of the implantable device and ensuring that the implantable device avoids damage to the biological tissue to the greatest extent while completing its own function.

[0112] In a specific implementation, the sealing effect can be further improved by improving the connection portion between the cover plate 112 and the fixing ring 113 .

[0113] 3 , which is a schematic cross-sectional view of an upper shell assembly of an implantable device after assembly according to an embodiment of the present invention.

[0114] The cover plate 112 shown in FIG. 3 may include a central region and an edge region, and the thickness of the cover plate 112 in the edge region gradually decreases in a direction away from the central region.

[0115] The fixing ring 113 coaxially surrounds the cover plate 112 . A recessed groove is defined between the inner sidewall of the fixing ring 113 and the outer sidewall of the cover plate 112 , so that the first sealing member 111 can be used to fill the recessed groove.

[0116] In a specific implementation, since the thickness of the cover plate 112 in the edge area gradually decreases in the direction away from the center area, the cross-sectional shape of the recessed groove is wide at the top and narrow at the bottom. Compared with the conventionally formed connection gap, the first seal 111 has better fit in the recessed groove.

[0117] In an embodiment of the present invention, the thickness of the cover plate 112 in the edge area gradually decreases in the direction away from the central area, and a recessed groove is provided between the inner side wall of the fixing ring 113 and the outer side wall of the cover plate 112 and is filled with the first sealing member 111, so that more first sealing member material can be filled by setting the recessed groove, and the cross-sectional shape of the recessed groove, which is wider at the top and narrower at the bottom, can improve the fit of the first sealing member material, thereby further improving the sealing effect and enhancing the anti-seepage performance.

[0118] Furthermore, the implantable device may further include a feedthrough assembly 115 for achieving electrical connection between the electrode assembly 116 and circuit components inside the implantable device.

[0119] 2 , and in combination with FIG. 4 , FIG. 4 is a schematic cross-sectional view of another implantable device according to an embodiment of the present invention.

[0120] As shown in the figure, the electrode assembly 116 may have multiple connection contacts (not visible in the figure), and the implantable device further includes a feedthrough assembly 115, and the connection contacts are electrically connected to the circuit device inside the implantable device via the feedthrough assembly 115.

[0121] Specifically, the feedthrough assembly 115 is used to transmit signals or electrical energy. Since the feedthrough assembly 115 in the embodiment of the present invention is used in an implantable device, it needs to meet the requirement of good sealing in addition to transmitting signals or electrical energy.

[0122] Furthermore, the feedthrough component 115 may include: a ceramic part 1151, in which a plurality of conductive columns 1152 are embedded that vertically penetrate the ceramic part 1151, and the conductive columns 1152 are adapted to the connection contacts; a metal part 1153, which surrounds the ceramic part 1151 and is connected to the ceramic part 1151, and the metal part 1153 is also connected to the lower shell component 114; wherein the connection contacts are electrically connected to the circuit devices inside the implantable device via the conductive columns 1152.

[0123] In a specific implementation, the conductive pillars 1152 can be made of a conductive material, such as a metal material, or a metal alloy material or a non-metallic material with good conductivity, such as a graphite material, a polysilicon material, etc. The metal material can be, for example, copper, aluminum, cobalt, titanium, silver, gold, molybdenum, tungsten, etc.

[0124] The ceramic component 1151 can be zirconium oxide ceramic, aluminum oxide ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum oxide ceramic.

[0125] In a specific implementation of the present invention, a micro-hole penetrating the entire ceramic member 1151 can be formed by laser processing or etching to obtain a feedthrough hole. Then, the feedthrough hole can be filled with a conductive material, such as a metal material, to obtain the feedthrough assembly 115.

[0126] In some embodiments, the feedthrough hole may have a diameter between 50 microns and 500 microns.

[0127] In some embodiments, there may be multiple feedthrough components 115 , and the multiple feedthrough components 115 may be arranged in an array. Each feedthrough component 115 may be connected to a corresponding pin or solder joint of a circuit device.

[0128] In some embodiments, after forming the feedthrough hole and before filling the conductive material, a metal layer can be formed on the inner wall of the feedthrough hole. This can better prevent the formation of bubbles / air gaps in the feedthrough assembly 115, so that the feedthrough assembly 115 has better electrical connection effect and airtightness.

[0129] In an embodiment of the present invention, the feedthrough assembly 115 may include a ceramic part 1151, and may also include a metal part 1153 surrounding the ceramic part 1151 and connected to the ceramic part 1151 and also connected to the lower shell assembly 114, thereby providing better electrical connection effect and airtightness.

[0130] Furthermore, the electrode assembly 116 and the feedthrough assembly 115 may be relatively fixedly connected using surface mount technology.

[0131] Surface Mount Technology (SMT) is a process technology for mounting electronic components directly onto the surface of a circuit board (such as a printed circuit board).

[0132] As shown in the figure, the electrode assembly 116 may include an electrode support plate (e.g., an electrode silicon plate) and an electrode wire, wherein the electrode wire is attached to the surface of the electrode silicon plate. The electrode wire may have multiple connection contacts at the rear end, for example. For example, in a specific embodiment, the front end of the electrode wire has multiple electrode sites for collecting electrical signals in biological tissue or transmitting external electrical stimulation signals to biological tissue, and the multiple electrode sites correspond one-to-one to the multiple connection contacts.

[0133] In an embodiment of the present invention, by adopting surface mount technology to relatively fix the electrode assembly 116 and the feedthrough assembly 115, a tightly fitting electrical connection between the electrode assembly 116 and the feedthrough assembly 115 can be achieved, effectively avoiding the introduction of adverse components, and through the fitting connection between the electrode assembly 116 and the feedthrough assembly 115, the risk of leakage of internal materials of the implantable device is further reduced.

[0134] Furthermore, the edge of one of the upper shell component and the lower shell component 114 may have an annular protrusion, and the edge of the other of the upper shell component and the lower shell component 114 may have an annular recess adapted to the annular protrusion, wherein the upper shell component and the lower shell component 114 are fixedly connected in a relatively sealed manner.

[0135] The protruding direction of the annular protrusion on the edge of one of the upper shell component and the lower shell component 114 may be toward the other, and the recessed direction of the annular recess is adapted to the protruding direction.

[0136] As shown in Figure 2, the edge of the fixing ring 113 of the upper shell component can have an annular protrusion, and the direction of the annular protrusion is toward the lower shell component 114. The edge of the lower shell component 114 can have an annular recess, and the direction of the annular recess is toward the fixing ring 113 of the upper shell component, so that in the combined form of the implantable device shown in Figure 4, a relatively sealed fixed connection structure as circled by the dotted ellipse is obtained.

[0137] In the embodiment of the present invention, by providing annular protrusions and annular recesses on the upper shell component and the lower shell component 114 , the sealing effect between the upper shell component and the lower shell component 114 can be improved.

[0138] Furthermore, the side surface of the annular protrusion and the side surface of the annular recess can be relatively fixedly connected by using a laser welding process.

[0139] In an embodiment of the present invention, the side surface of the annular protrusion and the side surface of the annular recess are relatively fixedly connected using a laser welding process. Since laser welding can complete welding without introducing other types of materials (such as flux, solder, etc.), compared with brazing or bonding, it can further reduce the risk of introducing materials that have adverse effects on biological tissues, thereby improving the degree of protection for biological tissues.

[0140] Furthermore, the first sealing member 111 fills or encapsulates the connection gap between the annular protrusion and the annular recess from the outside of the implantable device.

[0141] In a specific implementation, it can be implemented by adopting a multi-round filling or encapsulation process, or it can be implemented by adopting a single-round filling or encapsulation process.

[0142] In a first specific embodiment, in the first round of filling or encapsulation process, the first seal 111 can first fill or encapsulate the connection gap between the cover plate 112 and the fixing ring 113 from the outside of the implantable device, or the first seal 111 can first cover the cover plate 112 from the outside of the implantable device and fill or encapsulate the connection gap between the cover plate 112 and the fixing ring 113, and then perform a relatively sealed fixed connection between the upper shell component and the lower shell component 114, and then in the second round of filling or encapsulation process, the first seal 111 can fill or encapsulate the connection gap between the annular protrusion and the annular recess.

[0143] By adopting multiple rounds of filling or encapsulation processes, the sealing effect of filling or encapsulation can be improved, and further better anti-leakage performance can be obtained.

[0144] In a second specific embodiment, a single-round filling or encapsulation process can be used, and the first sealing member 111 can fill or encapsulate the connection gap between the cover plate 112 and the fixing ring 113 from the outside of the implantable device, and fill or encapsulate the connection gap between the annular protrusion and the annular recess from the outside of the implantable device. Alternatively, the first sealing member 111 can cover the cover plate 112 from the outside of the implantable device and fill or encapsulate the connection gap between the cover plate 112 and the fixing ring 113, and fill or encapsulate the connection gap between the annular protrusion and the annular recess from the outside of the implantable device.

[0145] By adopting a single-round filling or encapsulation process, not only can the sealing efficiency of filling or encapsulation be improved, but also the production cost can be reduced.

[0146] In an embodiment of the present invention, the first seal 111 fills or encapsulates the connecting gap between the annular protrusion and the annular recess from the outside of the implantable device, which can further effectively prevent adverse components inside the implantable device (such as materials that are not biocompatible inside the implantable device) from seeping out from the connecting gap between the annular protrusion and the annular recess.

[0147] Furthermore, the material of the first sealing member 111 may be a combination of one or more of the following which are poured in a liquid state or a fluid state and solidified: epoxy resin, silicone, polyetheretherketone PEEK, and polyphenylene sulfone resin PPSU.

[0148] In an embodiment of the present invention, the material of the first sealing member 111 is a combination of one or more of the following which are injected and solidified in a liquid state or a fluid state: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin PPSU, thereby effectively improving the sealing effect through the fluidity of the liquid or fluid.

[0149] Furthermore, the feedthrough component 115 may have a protrusion or a recess adapted to the electrode component 116 , and the plurality of connection contacts of the electrode component 116 are electrically connected to the connection points of the circuit device via the feedthrough component 115 .

[0150] In a specific implementation of the embodiment of the present invention, the feedthrough assembly 115 may have a protrusion.

[0151] As shown in Figure 2, the lower surface of the feedthrough assembly 115 (not visible in the figure) can have a protrusion, and a portion of the electrode assembly 116 (for example, a portion with multiple connection contacts) can be placed on the protrusion, thereby obtaining a structure as framed by the dotted line in the combined form of the implantable device shown in Figure 4.

[0152] In a specific embodiment in which the feedthrough assembly 115 has a protrusion, since the electrode wire of the electrode assembly 116 is attached to the surface of the electrode support plate (e.g., an electrode silicon plate), the electrode support plate can provide a support plane and support force for the electrode wire. The surface of the protrusion of the feedthrough assembly 115 can cooperate with the surface of the electrode support plate of the electrode assembly 116, for example, perfectly fit, thereby helping to achieve electrical connection between multiple connection contacts of the electrode wire of the electrode assembly 116 and the conductive columns of the ceramic part of the feedthrough assembly 115, that is, helping to achieve electrical connection between the electrode assembly 116 and the feedthrough assembly 115.

[0153] In another specific implementation of the embodiment of the present invention, the feedthrough assembly 115 may have a recessed portion.

[0154] It should be pointed out that when the feedthrough assembly 115 has a recessed portion, a groove (not visible in the figure) that is adapted to the electrode support plate of the electrode assembly 116 can also be formed on the feedthrough assembly 115, so that the electrode support plate of the electrode assembly 116 can be placed in the recessed portion in a shape-fitting manner, and the electrode wire of the electrode assembly 116 can be extended to the outside of the implantable device in a manner attached to the electrode support plate.

[0155] In a specific embodiment in which the feedthrough assembly 115 has a recessed portion, since the electrode support plate of the electrode assembly 116 can be placed in the recessed portion in a shape-fitting manner, the electrode wire of the electrode assembly 116 can be extended to the outside of the implantable device by being attached to the electrode support plate, thereby improving the positional definition of the electrode assembly 116, thereby providing better protection for the electrode assembly 116 and facilitating subsequent sealing of the electrode assembly 116 and the feedthrough assembly 115.

[0156] Furthermore, the implantable device may have a second seal 117 , which can enclose the electrode assembly 116 and the feedthrough assembly 115 .

[0157] The material of the second sealing member 117 may be the same as or different from the material of the first sealing member 111 .

[0158] Furthermore, the material of the second sealing member 117 may be a combination of one or more of the following which are poured in a liquid state or a fluid state and then cured: epoxy resin, silicone, polyetheretherketone PEEK, and polyphenylene sulfone resin PPSU.

[0159] It should be noted that if the material of the second sealing member 117 is consistent with that of the first sealing member 111 , the production cost can be effectively reduced and the production efficiency can be improved by reusing the process flow.

[0160] In an embodiment of the present invention, by providing a second seal 117 to encapsulate the electrode assembly and the feedthrough assembly, the surface of the electrode assembly 116 of the implantable device, the surface of the feedthrough assembly 115 and the connecting parts thereof can be better sealed, effectively preventing residual substances in the processing of the electrode assembly 116 and the feedthrough assembly 115 from posing a threat to the safety of biological tissues.

[0161] It should be noted that, in a specific embodiment, the first seal 111 and the second seal 117 can be provided successively, for example, the first seal 111 is formed first by a single round or multiple rounds of filling or encapsulation process, and then the second seal 117 is formed.

[0162] In another embodiment, at least a portion of the first seal 111 and the second seal 117 may be formed simultaneously, for example, by using the same filling or encapsulation process to form at least a portion of the first seal 111 and the second seal 117 simultaneously.

[0163] Furthermore, the feedthrough assembly 115 may include: a ceramic part, wherein a side of the ceramic part adjacent to the electrode assembly 116 has a protrusion or a recess adapted to the electrode assembly 116, and a side of the ceramic part away from the electrode assembly 116 is electrically connected to the connection point of the circuit device; a metal part, wherein the metal part surrounds the ceramic part and is connected to the ceramic part; wherein the metal part is connected to the lower shell assembly 114.

[0164] In a specific implementation of the embodiment of the present invention, a surface of the ceramic piece adjacent to the electrode assembly 116 may have a protrusion adapted to the electrode assembly 116 .

[0165] As shown in Figure 2, the lower surface of the ceramic part of the feedthrough assembly 115 (not visible in the figure) can have a protrusion, and a portion of the electrode assembly 116 (for example, a portion with multiple connection contacts) can be placed on the protrusion of the ceramic part, thereby obtaining a structure as framed by the dotted line in the combined form of the implantable device shown in Figure 4.

[0166] In a specific embodiment in which the ceramic part of the feedthrough assembly 115 has a protrusion, since the electrode wire of the electrode assembly 116 is attached to the surface of the electrode support plate (e.g., an electrode silicon plate), the electrode support plate can provide a support plane and support force for the electrode wire. The surface of the protrusion of the ceramic part of the feedthrough assembly 115 can cooperate with the surface of the electrode support plate of the electrode assembly 116, for example, perfectly fit, thereby helping to achieve electrical connection between multiple connection contacts of the electrode wire of the electrode assembly 116 and the conductive columns of the ceramic part of the feedthrough assembly 115, that is, helping to achieve electrical connection between the electrode assembly 116 and the feedthrough assembly 115.

[0167] In another specific implementation of the embodiment of the present invention, a surface of the ceramic piece adjacent to the electrode assembly 116 may have a recessed portion adapted to the electrode assembly 116 .

[0168] It should be pointed out that when the ceramic part of the feedthrough assembly 115 has a recessed portion, a groove (not visible in the figure) adapted to the electrode support plate of the electrode assembly 116 can also be formed on the ceramic part of the feedthrough assembly 115, so that the electrode support plate of the electrode assembly 116 can be placed in the recessed portion in a shape-fitting manner, and the electrode wire of the electrode assembly 116 can be extended to the outside of the implantable device in a manner attached to the electrode support plate.

[0169] In a specific embodiment in which the ceramic part of the feedthrough assembly 115 has a recessed portion, since the electrode support plate of the electrode assembly 116 can be placed in the recessed portion in a shape-fitting manner, the electrode wire of the electrode assembly 116 can be extended to the outside of the implantable device by being attached to the electrode support plate, thereby improving the positional definition of the electrode assembly 116, thereby providing better protection for the electrode assembly 116 and facilitating subsequent sealing of the electrode assembly 116 and the feedthrough assembly 115.

[0170] Furthermore, a plurality of conductive pillars vertically penetrating the ceramic part are embedded on the top surface of the protruding portion or the bottom surface of the recessed portion of the ceramic part; wherein the plurality of connection contacts of the electrode assembly 116 correspond one-to-one to the conductive pillars and are electrically connected to the connection points of the circuit device via the conductive pillars.

[0171] It should be noted that the metal part surrounds the ceramic part and is connected to the ceramic part, and the conductive column is formed in the feedthrough hole that runs through the entire ceramic part. In the direction perpendicular to the extension direction of the feedthrough hole, the metal part and the ceramic part may be flush or not.

[0172] The metal component is connected to the lower shell component 114 , thereby achieving a fixed connection between the feed-through component 115 and the lower shell component 114 .

[0173] Furthermore, the ceramic part can be zirconia ceramic, alumina ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum oxide ceramic; the metal part can be titanium, titanium alloy or stainless steel; the lower shell component can be titanium, titanium alloy or stainless steel; the metal part is brazed to the ceramic part; and / or the metal part is laser welded to the lower shell component.

[0174] In an embodiment of the present invention, by selecting appropriate materials to form ceramic parts, selecting appropriate materials to form metal parts, selecting appropriate materials to form the lower shell assembly 114, selecting appropriate connection methods to connect the metal parts to the ceramic parts, and selecting appropriate connection methods to connect the metal parts to the lower shell assembly 114, a better balance can be achieved between improving airtight sealing, reducing production costs and improving production efficiency.

[0175] In a specific implementation, for more details about ceramic components and metal components, please refer to the description of the implantable device shown in the foregoing text and Figures 1 to 4, which will not be repeated here.

[0176] In an embodiment of the present invention, a neural signal collector is further provided, comprising any one of the implantable devices described above and shown in FIG. 1 to FIG. 4 .

[0177] Furthermore, the neural signal collector may include an implantable device, and the internal circuit devices of the implantable device may include amplification, filtering and analog-to-digital conversion devices and signal transmission devices, which are used to process the electrical signals collected by the electrode assembly and transmit the processed signals to a terminal device outside the biological body.

[0178] In an embodiment of the present invention, a neurostimulator is further provided, comprising any one of the implantable devices described above and shown in FIG. 1 to FIG. 4 .

[0179] Furthermore, the neurostimulator may include an implantable device, and the internal circuit device of the implantable device may include a signal transmission device for transmitting the stimulation signal emitted by the terminal device outside the organism to a specific area of ​​the organism.

[0180] In which, the signal transmission device can be connected to the electrode assembly through a feedthrough assembly, so that it can receive stimulation signals emitted by a terminal device outside the organism, for example, through Bluetooth or a wireless network, and transmit the stimulation signals to the electrode assembly, and further transmit them to the biological tissue of the organism through the electrode assembly to achieve stimulation and treatment of specific areas of the organism.

[0181] After an implantable device including a feedthrough assembly and an electrode assembly is implanted in a living organism, it will be surrounded by body fluids. To ensure the normal operation of the neural signal collector and neural stimulator, it is necessary to ensure that the signal transmission device, feedthrough assembly, electrode assembly, and other devices are all airtight, especially in high-pressure environments. Compared to existing neural signal collectors and neural stimulators, the neural signal collector and neural stimulator in the embodiments of the present invention are more able to balance the application requirements of cost and airtightness.

[0182] 5, which is a flow chart of a method for forming an implantable device according to an embodiment of the present invention. The method may include steps S51 to S55:

[0183] Step S51: providing the electrode assembly, an upper shell assembly, and a lower shell assembly, wherein the upper shell assembly includes a cover plate and a fixing ring, wherein the fixing ring surrounds the cover plate and is connected to the cover plate, wherein the cover plate and the fixing ring are connected by brazing;

[0184] Step S52: using a laser welding process to relatively seal and fix the upper shell assembly to the lower shell assembly;

[0185] Step S53: using a surface mounting process to securely connect the electrode assembly to the lower housing assembly;

[0186] Step S54: filling or encapsulating the connection gap between the cover plate and the fixing ring with a first sealant from the outside of the implantable device, or covering the cover plate with the first sealant and filling or encapsulating the connection gap between the cover plate and the fixing ring; and

[0187] Step S55: using a second sealant to encapsulate the electrode assembly and the connection portion between the electrode assembly and the lower case assembly.

[0188] It should be noted that the serial numbers of the steps in this embodiment do not limit the execution order of the steps.

[0189] Among them, the cover plate and the fixing ring are connected by brazing. Since heavy metals (such as molybdenum or tungsten) may be introduced in the brazing connection process between ceramics or glass and metals by brazing, it is easy for heavy metals (such as molybdenum or tungsten) to remain at the connection point or near the connection point. At this time, it is very necessary to adopt the technical solution described in the embodiment of the present invention to prevent the adverse components (such as heavy metals) remaining in the connection gap in the corresponding brazing process from seeping from the implantable device into the biological tissue after the implantable device is implanted into the biological tissue, so as to avoid damage to the biological tissue to the greatest extent.

[0190] By using a laser welding process to relatively seal and fix the upper shell component and the lower shell component, compared with brazing or bonding, the residue of adverse components (such as heavy metal solder or poor adhesive) can be further reduced, thereby maximizing the protection of biological tissue.

[0191] By adopting a surface mounting process, the electrode assembly is fixedly connected to the lower shell assembly, thereby achieving a tightly fitting electrical connection between the electrode assembly and the lower shell assembly, effectively avoiding the introduction of adverse components, and further reducing the risk of leakage of internal materials of the implantable device through the fitting connection between the electrode assembly and the lower shell assembly.

[0192] In an embodiment of the present invention, after the fixing ring surrounds the cover plate and is connected to the cover plate, the first sealing member is used to fill or encapsulate the connection gap between the cover plate and the fixing ring from the outside of the implantable device, so that the connection gap portion of the implantable device can be better sealed, for example, to achieve an airtight seal, thereby preventing adverse components remaining in the connection gap during the corresponding connection process from leaking out of the implantable device into the biological tissue after the implantable device is implanted in the biological tissue. By using the first sealing member to cover the cover plate from the outside of the implantable device and fill or encapsulate the connection gap between the cover plate and the fixing ring, the entire cover plate and the connection gap portion of the implantable device can be better sealed, for example, to achieve an airtight seal, or even an airtight encapsulation, thereby achieving complete encapsulation of the upper shell assembly, preventing adverse components remaining on the cover plate and in the connection gap during the corresponding connection process from leaking out of the implantable device into the biological tissue after the implantable device is implanted in the biological tissue, thereby improving the service life of the implantable device and ensuring that the implantable device can perform its own function while avoiding damage to the biological tissue to the greatest extent.

[0193] In an embodiment of the present invention, by providing a second seal 117 to encapsulate the electrode assembly and the feedthrough assembly, the surface of the electrode assembly 116 of the implantable device, the surface of the feedthrough assembly 115 and the connecting parts thereof can be better sealed, effectively preventing residual substances in the processing of the electrode assembly 116 and the feedthrough assembly 115 from posing a threat to the safety of biological tissues.

[0194] As can be seen from the above, the various steps shown in FIG5 are interrelated and work together to prevent adverse components on or within the implantable device from threatening the safety of biological tissues.

[0195] The present invention also relates to the technical field of medical devices, and in particular to an implant and a forming method thereof, a neural signal collector and a neural stimulator.

[0196] With the rapid development of medical device technology, the use of implantable medical devices to restore some functions of an organism, treat disease, or prolong life is becoming increasingly widespread. Specifically, implanting medical devices can be used to monitor the organism or replace diseased organs, restoring their functions and benefits.

[0197] Since medical devices are often difficult to remove after implantation or may cause significant harm to the organism during the removal stage, effective testing and screening of the products is required before implantation.

[0198] However, current implantable medical devices are often non-detachable after manufacture, which means that when problems arise with vulnerable parts of the product (such as electrode components), the entire product needs to be scrapped, resulting in excessively high production costs.

[0199] There is an urgent need for an implant that can be improved to make it detachable. When problems occur with vulnerable parts of the product (such as electrode assemblies), only the vulnerable parts need to be disassembled and replaced without scrapping the entire product, thereby effectively controlling production costs.

[0200] In the prior art, implantable medical devices are often designed to be non-detachable, which means that when problems arise with vulnerable parts of the product (such as electrode assemblies), the entire product needs to be scrapped, resulting in excessively high production costs.

[0201] After research, it was found that in the existing assembly technology, the various parts are first assembled according to the steps, and then the mold is used to inject glue to form a fixed connection component to form a non-detachable implant.

[0202] In an embodiment of the present invention, by adopting multiple probes adapted to the connection contacts, and the probes are in detachable electrical contact with the corresponding connection contacts, the probes and the electrode assembly can be detachable; by adopting a limiting component that is detachably connected to the probe, the probe and the limiting component can be detachable while limiting the position and orientation of the probe; and then by adopting a sealing layer to seal the portion of the electrode assembly with the multiple connection contacts and the limiting component, the sealing effect of the electrode assembly and the limiting component can be effectively guaranteed on the basis of being able to remove the probe, and a balance can be achieved between the sealing requirements and the detachability requirements. Compared with the products in the prior art that are non-detachable, when problems occur in the vulnerable parts of the product (such as the electrode assembly, etc.), the entire product needs to be scrapped. By adopting the solution of the embodiment of the present invention, the probe in the probe assembly and other subsequent structural parts in the implant (such as the matrix, etc.) can be retained by disassembly, effectively controlling costs.

[0203] In order to make the above-mentioned objects, features and beneficial effects of the present invention more obvious and easy to understand, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0204] 6 and 7 , FIG. 6 is a perspective view of an implant according to an embodiment of the present invention, and FIG. 7 is a schematic diagram of the assembly structure of various components of an implant according to an embodiment of the present invention.

[0205] The implant can be fixed to a reliable position in the body, such as the skull, by means of bone screws via four hanging holes.

[0206] The implant may include a first implant part 100 and a second implant part 110 , and the first implant part 100 and the second implant part 110 may be assembled in a detachable manner.

[0207] The first implant part 100 and the second implant part 110 can be assembled by means of a screw 120 .

[0208] Furthermore, the bolts 120 may be connected by screws, and the material thereof may be titanium metal to improve hardness, corrosion resistance and reduce weight.

[0209] It is understandable that in the embodiment of the present invention, other appropriate detachable assembly methods may also be used, such as magnetic connection, binding connection, lock connection, fastening belt connection, etc.

[0210] 8 , which is an exploded view of some components of an implant according to an embodiment of the present invention, and more specifically, an exploded view of a specific embodiment of the second portion 110 of the implant.

[0211] Specifically, the implant may include an electrode assembly 116 , a probe assembly, and a sealing layer 117 .

[0212] A surface of the electrode assembly 116 may have a plurality of connection contacts (eg, located on a surface of the electrode assembly 116 facing away from the sealing layer 117 as shown in FIG. 8 ).

[0213] Furthermore, the plurality of connection contacts located on one side of the electrode assembly 116 may be distributed in an array.

[0214] The probe assembly may include a plurality of probes 113 and a limiting component, and the limiting component may include a hole plate 114 and a circuit board 115 .

[0215] Furthermore, the electrode assembly may have a flexible electrode structure, and / or the circuit board may be a ceramic circuit board, a glass circuit board or a printed circuit board (PCB).

[0216] Specifically, the connection contacts may be located on the other side of the electrode assembly 116 (not shown in the figure), corresponding one-to-one to the solder joints (Pad) of the circuit board 115 to achieve transmission of electrical signals.

[0217] A plurality of probes 113 are adapted to the connection contacts, and the probes 113 are in separable electrical contact with the corresponding connection contacts.

[0218] Furthermore, the probe 113 may be an elastic probe, so that the electrical contact performance can be enhanced due to the elastic pressure during the process of making electrical contact with the corresponding connection contact.

[0219] The limiting component is detachably connected to the probe 113 and is used to limit the position and orientation of the probe 113 .

[0220] As shown in the figure, through the limiting function of the limiting component, one end of the probe 113 can be in detachable electrical contact with the connection contact, such as a detachable connection, and the other end of the probe 113 can be in detachable electrical contact with the first part 100 of the implant.

[0221] The sealing layer 117 seals the portion of the electrode assembly 116 having the plurality of connection contacts and the limiting component to form an airtight seal.

[0222] In an embodiment of the present invention, by adopting a plurality of probes 113 adapted to the connection contacts, and the probes 113 are in detachable electrical contact with the corresponding connection contacts, the probes 113 and the electrode assembly 116 can be detachable; by adopting a limiting component detachably connected to the probe 113, the position and orientation of the probe 113 can be restricted while the probe 113 and the limiting component can be detachable; and then by adopting a sealing layer 117 to seal the portion of the electrode assembly 116 having the plurality of connection contacts and the limiting component, the sealing effect of the electrode assembly 116 and the limiting component can be effectively guaranteed on the basis of being able to remove the probe 113, thereby achieving a balance between the sealing requirements and the detachability requirements. Compared with the products in the prior art that are non-detachable, resulting in the need to scrap the entire product when a problem occurs with the vulnerable parts of the product (such as the electrode assembly, etc.), the solution of the embodiment of the present invention can retain the probe 113 in the probe assembly and other subsequent structural parts in the implant (such as the matrix, etc.) by disassembly, effectively controlling costs.

[0223] Furthermore, the circuit board 115 has a solder point area, one side of the solder point area has solder points adapted to the connection contacts, represented by a dotted graphic in the figure, and the other side of the solder point area has solder points adapted to the probe 113, wherein the solder points on one side of the solder point area are electrically connected to the solder points on the other side, so that the probe 113 is electrically contacted with the corresponding connection contacts via the circuit board 115.

[0224] The orifice plate 114 may have a through-hole region, which includes a plurality of through-holes corresponding to the probes 113 , which are represented by hole-shaped patterns in the figure. Each probe 113 passes through a corresponding through-hole.

[0225] After the sealing layer 117 seals the limiting component, there is a gap between it and the through hole area.

[0226] It should be pointed out in particular that by setting up the circuit board 115, the through holes of the orifice plate 114 can be protected, effectively preventing the through holes in the orifice plate 114 from being blocked when the sealing layer 117 is subsequently used to seal the electrode assembly 116, thereby providing a basis for the detachability of the probe 113.

[0227] In an embodiment of the present invention, the limiting component includes a perforated plate 114 and a circuit board 115. By setting the perforated plate 114 to have a through-hole area including multiple through-holes corresponding one-to-one to the probes 113, the limiting component and the probe 113 can be detachably connected; by setting the circuit board 115 to have a solder point area, and one side has solder points adapted to the connection contacts, and the other side has solder points adapted to the probe 113, the probe 113 can still have electrical detection performance on the basis of being detachable; after the limiting component is sealed by setting a sealing layer 117, there is a gap between it and the through-hole area, which can effectively avoid the clogging of the through-hole area by the material of the sealing layer 117, and further while retaining the sealing effect of the sealing layer 117, the detachability of the probe 113 is achieved, thereby improving the balance between the sealing requirements and the detachability requirements.

[0228] Furthermore, the solder joint area can be located in the central area of ​​the circuit board 115, and the through-hole area can be located in the central area of ​​the orifice plate 114; the non-central area of ​​the circuit board 115 is bonded to the non-central area of ​​the orifice plate 114 to block the sealing layer 117 from the through-hole area.

[0229] Furthermore, the bonding of the non-central area may be a ring-type bonding connection surrounding the solder joint area and the through-hole area.

[0230] It is understandable that although it is also possible to select multiple locations in the non-central area for point-type adhesive connection, the sealing effect can be further enhanced by using a ring-type adhesive connection.

[0231] In an embodiment of the present invention, by bonding the non-central area of ​​the circuit board 115 to the non-central area of ​​the orifice plate 114 to block the sealing layer 117 from the through-hole area, the sealing between the circuit board 115 and the orifice plate 114 can be effectively improved, further improving the protection of the electrode assembly in the in vivo environment of the organism.

[0232] Furthermore, the implant may satisfy one or more of the following conditions: the material of the orifice plate 114 is polyetheretherketone (PEEK); and the non-central area of ​​the circuit board 115 and the non-central area of ​​the orifice plate 114 are bonded to each other by epoxy resin.

[0233] Specifically, by utilizing the physical and chemical properties of PEEK, such as high temperature resistance and chemical corrosion resistance, high temperature resistant structural materials and electrical insulation materials can be formed to prepare the orifice plate 114. It can also be composited with glass fiber or carbon fiber to prepare reinforced materials, which can be better applied in the medical device field involved in the embodiments of the present invention.

[0234] In a specific implementation, the orifice plate 114 may also be formed of PPSU material.

[0235] Specifically, by utilizing the characteristics of PPSU, such as good rigidity and toughness, resistance to heat and thermal oxidation, excellent creep resistance, resistance to corrosion by inorganic acids, alkalis, and salt solutions, resistance to ion radiation, non-toxicity, good insulation and self-extinguishing properties, and easy molding and processing, the orifice plate 114 can be prepared for application in the embodiments of the present invention.

[0236] Epoxy resin is a high molecular polymer with the molecular formula (C 11 H 12 O3) n , refers to a general term for a class of polymers containing two or more epoxy groups in the molecule. It has excellent physical, mechanical and electrical insulation properties, adhesion properties with various materials, and flexibility in its use process that other thermosetting plastics do not have. It can be made into coatings, composite materials, casting materials, adhesives, molded materials and injection molding materials, and is particularly suitable for application in the medical device field involved in the embodiments of the present invention.

[0237] It is understandable that other appropriate adhesive materials, such as polyvinyl alcohol adhesive, may also be used to bond the circuit board 115 and the orifice plate 114 .

[0238] In an embodiment of the present invention, the material of the orifice plate 114 is PEEK; the non-central area of ​​the circuit board 115 and the non-central area of ​​the orifice plate 114 are bonded by epoxy resin, so that the electrode assembly 116 can be sealed and protected while the probe 113 is effectively protected during the insertion and removal of the probe 113, further improving the quality and reusability of the probe 113 retained by disassembly, and effectively maintaining the quality of the implant while saving costs.

[0239] Furthermore, the material of the sealing layer 117 is a combination of one or more of the following resins that are poured in a liquid state or a fluid state and cured: epoxy resin, silicone, polyetheretherketone (PEEK) and polyphenylene sulfone resin (PPSU).

[0240] It should be pointed out that when the circuit board 115 and the orifice plate 114 are also bonded by epoxy resin, the epoxy resin is poured in a liquid or fluid state and then cured to form a sealing layer 117. The epoxy resin process flow can be reused to effectively reduce production costs and improve production efficiency.

[0241] In an embodiment of the present invention, the material of the sealing layer 117 is a combination of one or more of the following after being injected and cured in a liquid or fluid state: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin PPSU, so that the sealing effect can be effectively improved through the fluidity of the liquid or fluid, thereby further improving the effective protection of vulnerable parts (such as the electrode assembly 116, etc.) in the internal environment of the biological body.

[0242] Furthermore, the implant shown in FIG8 may further include a first sealing ring 111 and a second sealing ring 112 for improving the sealing effect of the assembled first implant portion 100 and the second implant portion 110 .

[0243] 8 and 9, FIG9 is a schematic cross-sectional view of the structure of an implant after assembly of some components according to an embodiment of the present invention. FIG9 can be regarded as a schematic cross-sectional view of the device obtained after assembly of the components in FIG8.

[0244] In a specific implementation, after the electrode assembly 116 and the limiting component are fixedly sealed and connected to each other, the sealing layer 117 is used to seal the portion of the electrode assembly 116 having the multiple connection contacts and the limiting component, and then the probe 113 in the probe assembly is used to detachably penetrate the limiting component, and the probe 113 is in detachable electrical contact with the corresponding connection contacts.

[0245] Furthermore, the electrode assembly 116 may include an electrode wire and a support plate 1163 , wherein the electrode wire includes an electrode site area, a wire area 1162 and a connection contact area.

[0246] The electrode site area (not clearly shown in FIG. 9 ) is located on the right side of the wire area 1162 , and the wire area 1162 is located between the electrode site area and the connection contact area.

[0247] Specifically, the electrode assembly 116 may include an electrode wire and a support plate. The electrode wire may have an electrode site area, a wire area 1162 and a connection contact area that are adjacent to each other in sequence.

[0248] The electrode site area may be located at the front end of the electrode assembly 116 , and a plurality of electrode sites may be located in the electrode site area.

[0249] The wire region 1162 may be located between the plurality of electrode sites and the plurality of connection contacts 1161 so that the electrode sites and the connection contacts 1161 are electrically connected to each other correspondingly.

[0250] The connection contact area can be located at the rear end of the electrode assembly, and the multiple connection contacts are located in the connection contact area, wherein the multiple connection contacts can be located on the support plate 1163, and the support plate 1163 can be used to support the rear end of the electrode assembly 116 and a portion of the wire area 1162 adjacent to the rear end.

[0251] The support plate 1163 may be a silicon plate, a glass plate, or a silicon carbide plate. By providing the connection contact area and a portion of the wire area 1162 on the support plate 1163 , the hardness of the support plate 1163 can be utilized to reduce the deformation of the electrode assembly 116 .

[0252] In an embodiment of the present invention, the electrode assembly 116 includes an electrode wire and a support plate, and the electrode wire includes: an electrode site area, the electrode site area is located at the front end of the electrode assembly 116, and a plurality of electrode sites are located in the electrode site area; a wire area 1162, the wire area 1162 is located between the plurality of electrode sites and the plurality of connection contacts 1161, so that the electrode sites and the connection contacts 1161 are electrically connected to each other correspondingly; and a connection contact area, the connection contact area is located at the rear end of the electrode assembly, and the plurality of connection contacts are located in the connection contact area, wherein the plurality of connection contacts are connected to each other. The contact 1161 is located on the support plate 1163, and the support plate 1163 is used to support the rear end of the electrode assembly 116 and a part of the wire area adjacent to the rear end; wherein, the sealing layer 117 covers the support plate 1163 and a part of the wire area electrode assembly 116 adjacent to the rear end, so that the hardness of the support plate 1163 can be used to reduce the deformation degree of the connection contact area of ​​the electrode assembly 116, so that the multiple connection contacts are adapted to the multiple probes, and after being covered by the sealing layer 117, the problem of reduced sealing effect caused by gaps caused by deformation can be effectively improved.

[0253] 10 , which is a schematic cross-sectional view of another implant according to an embodiment of the present invention.

[0254] 10 may be similar to the second implant part 110 described above and shown in FIG8 and FIG9 , and other components may be similar to the first implant part 100 described above and shown in FIG6 and FIG7 .

[0255] Specifically, the implant may further include: a base 102 , wherein the base 102 includes a base shell, a feedthrough assembly 101 and an internal circuit device 103 .

[0256] The surface of the orifice plate 114 away from the electrode assembly 116 (refer to FIG. 9 ) may be a step structure having a protrusion, and the through-hole region may be located on the protrusion.

[0257] The feedthrough assembly 101 may have a recessed portion adapted to the protruding portion of the aperture plate 114 , and the probe assembly may electrically contact the connection point of the circuit device via the feedthrough assembly 101 .

[0258] In a specific implementation, the implant can be assembled by placing the protruding portion of the orifice plate 114 in the recessed portion of the feedthrough assembly 101 .

[0259] Specifically, the orifice plate 114 and the base 102 may be detachably connected by bolt connection, or screw connection or the various connection methods mentioned above may be used, which will not be described in detail here.

[0260] The implant may further include: a first sealing ring 111 .

[0261] The first sealing ring 111 can generate a sealed connection, especially an airtight connection, between the protruding portion of the orifice plate 113 and the recessed portion of the feed-through assembly 101 .

[0262] Furthermore, the first sealing ring 111 is located on the outer side wall of the step of the protruding portion, and after the base and the orifice plate 114 are detachably connected, the first sealing ring 111 is in elastic and sealing contact with the inner side wall of the step of the recessed portion.

[0263] Furthermore, the first sealing ring 111 may be made of an elastic material, such as rubber or other appropriate thermosetting elastomers or thermoplastic elastomers.

[0264] In an embodiment of the present invention, the orifice plate 114 is provided with a protruding portion, the base body has a feedthrough assembly 101, and the feedthrough assembly 101 has a recessed portion, and a first sealing ring 111 is provided that can produce a sealed connection between the protruding portion of the orifice plate 114 and the recessed portion of the feedthrough assembly 101. By adopting the first sealing ring 111, the sealing effect can be enhanced after the base body 102 and the orifice plate 114 are detachably connected, thereby improving the sealing between the base body 102 and the orifice plate 114, such as airtightness, while being able to retain the base body 102 by disassembly and reduce costs.

[0265] Furthermore, since the gap between the outer side wall of the step of the protruding portion and the inner side wall of the step of the recessed portion is less affected by the gravity of the upper structural member, arranging the first sealing ring 111 here can more evenly improve the sealing effect.

[0266] It should be noted that the first sealing ring 111 and the second sealing ring 112 are detachably connected to the orifice plate 114 and the base 102. Therefore, in the embodiment of the present invention, the first sealing ring 111 and the second sealing ring 112 can also be reused to reduce costs.

[0267] Furthermore, the outer side wall of the step of the protrusion may have a first sealing groove, and the first sealing ring 111 may be embedded in the first sealing groove.

[0268] In an embodiment of the present invention, by providing a first sealing groove, the position of the first sealing ring 111 can be better defined, thereby further enhancing the sealing effect after the base 102 and the orifice plate 114 are detachably connected, thereby improving the sealing between the base 102 and the orifice plate 114 while being able to retain the base 102 by disassembly and reduce costs.

[0269] Furthermore, the feedthrough assembly 101 may include a ceramic component 1011 and a metal component 1012 .

[0270] In which, the side of the ceramic part 1011 adjacent to the electrode assembly 106 may have the recessed portion, and the side away from the electrode assembly 106 may be in electrical contact with the connection point of the circuit device; the metal part 1012 may surround the ceramic part 1011 and be connected to the ceramic part 1011, such as a sealed connection, especially an airtight connection; wherein, the metal part 1012 may be connected to the base shell, such as a sealed connection, especially an airtight connection.

[0271] Furthermore, the implant may satisfy one or more of the following conditions: the ceramic part 1011 may be zirconia ceramic, alumina ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum oxide ceramic; the metal part 1012 may be titanium, titanium alloy or stainless steel; the base shell may be titanium, titanium alloy or stainless steel; the metal part 1012 may be brazed to the ceramic part 1011; and / or the metal part 1012 may be brazed to the base shell.

[0272] Specifically, the feedthrough assembly 101 is used to transmit signals or electrical energy. Since the feedthrough assembly in the embodiment of the present invention is used in an implant, it needs to meet the requirement of good sealing in addition to transmitting signals or electrical energy.

[0273] In an embodiment of the present invention, the feedthrough assembly 101 includes a metal part 1012 connected to the base housing, and a ceramic part 1011, and electrical contact with the connection point of the circuit device is achieved through the ceramic part 1011, thereby improving the sealing between the feedthrough assembly 101 and the base housing. Compared with forming a feedthrough assembly using only the ceramic part 1011, the solution of the embodiment of the present invention can be used to enhance the support and hardness while improving the sealing by using the metal part 1012 surrounding the ceramic part 1011, thereby further improving the effective protection of the base 102 and the circuit devices therein in the in vivo environment of the biological body, and improving the quality and reusability of the base 102 retained by disassembly.

[0274] Furthermore, the bottom surface of the recessed portion of the ceramic part 1011 may be embedded with a plurality of conductive pillars vertically penetrating the ceramic part 1011; wherein the probes 113 in the probe assembly may correspond one-to-one to the conductive pillars and be electrically contacted with the connection points of the circuit device via the conductive pillars.

[0275] In a specific implementation, the conductive pillar can be made of a conductive material, such as a metal material or a polysilicon material. The metal material can be, for example, copper, aluminum, cobalt, titanium, silver, gold, molybdenum, tungsten, etc.

[0276] In an embodiment of the present invention, a plurality of conductive pillars vertically penetrating the ceramic part 1011 are embedded on the bottom surface of the recessed portion of the ceramic part 1011, so that electrical connection can be achieved through the conductive pillars embedded in the ceramic part 1011. Compared with using holes to allow the probe 113 to pass through, the sealing performance can be further improved, and the circuit device 103 in the substrate 102 can be better protected.

[0277] Furthermore, the implant may further include a second sealing ring 112 .

[0278] The second sealing ring 112 can generate a sealed connection, especially an airtight connection, between the bottom step of the step structure of the orifice plate 114 surrounding the protrusion and the surface of the feed-through assembly 101 surrounding the recess.

[0279] The second sealing ring 112 can be located on the surface of the bottom step of the step structure surrounding the protrusion, and after the base 102 and the orifice plate 114 are detachably connected, the second sealing ring 112 and the surface of the feed-through assembly 101 surrounding the recessed portion can be elastically and sealedly contacted.

[0280] In an embodiment of the present invention, by providing a sealed connection between the bottom step of the step structure of the orifice plate 114 surrounding the protrusion and the surface of the feed-through assembly 101 surrounding the recessed portion, a second sealing ring 112 can be used to further enhance the sealing effect after the base 102 and the orifice plate 114 are detachably connected, thereby improving the sealing between the base 102 and the orifice plate 114, such as airtightness, while being able to retain the base 102 by disassembly and reduce costs.

[0281] Furthermore, a second sealing groove (not shown) may be provided on the surface of the bottom step of the step structure surrounding the protrusion; wherein the second sealing ring 112 may be embedded in the second sealing groove.

[0282] Specifically, as shown in Figure 10, the second sealing ring 112 can be elastically and sealingly contacted with the upper orifice plate 114 and the lower base 102, respectively, to achieve a sealing effect. For example, optionally, the second sealing ring 112 can be elastically and sealingly contacted with the upper orifice plate 114 and the feedthrough assembly 101 (e.g., metal member 1012) of the lower base 102, respectively, to achieve a multi-layer sealing effect.

[0283] In an embodiment of the present invention, the sealing effect can be further enhanced by adopting a second sealing ring 112 and a second sealing groove after the base 102 and the orifice plate 114 are detachably connected. This can improve the sealing between the base 102 and the orifice plate 114 while being able to retain the base 102 by disassembly and reduce costs, thereby reducing the possibility of external liquid entering between the base 102 and the orifice plate 114 and corroding the electrode assembly 116 and the circuit device 103.

[0284] 11 , which is a schematic cross-sectional view of another implant according to an embodiment of the present invention, the differences from FIG. 10 will be described below.

[0285] Specifically, the lower surface of the orifice plate 114 in the further implant satisfies that the inverse tangent value of the ratio of the horizontal width to the vertical height of the unit length surface is located at (0°, 90°), and the inverse tangent value of the ratio of the horizontal width to the vertical height of the unit length surface gradually increases from the inside to the outside.

[0286] In an embodiment of the present invention, the lower surface of the orifice plate 114 can have a slope, and the slope gradually decreases from the inside to the outside, for example, a surface morphology gradually changes from steeper to gentler, thereby better preventing external liquid from entering between the substrate 102 and the orifice plate 114.

[0287] In the partially enlarged schematic diagram shown by the dotted ellipse in Figure 11, the lower surface of the orifice plate 114 has three unit lengths from the inside to the outside. For example, the inverse tangent of the ratio of the horizontal width to the vertical height of the unit length surface inside is angle a1 (that is, the ratio of the horizontal width to the vertical height is tan a1, the tangent of angle a1), the middle is angle a2, and the outer part is angle a3, then a1>a2>a3.

[0288] It should be noted that although three unit lengths are used as an example for illustration in FIG11 , in the specific application of the present invention, the length value of the unit length and the length value of the surface can be determined according to actual conditions, and FIG11 does not constitute a limitation thereto.

[0289] The step of etching the lower surface of the orifice plate 114 is performed under process conditions that the chamber pressure of the etching chamber is greater than or equal to a preset chamber pressure threshold and the etching power is greater than or equal to a preset power threshold.

[0290] In an embodiment of the present invention, after forming the orifice plate 114, a laser etching process is used to etch the lower surface of the orifice plate 114 under process conditions where the chamber pressure of the etching chamber is greater than or equal to a preset chamber pressure threshold and the etching power is greater than or equal to a preset power threshold, so that the lower surface of the orifice plate 114 satisfies the inverse tangent value of the ratio of the horizontal width to the vertical height of the surface per unit length at (0°, 90°), and the inverse tangent value of the ratio of the horizontal width to the vertical height of the surface per unit length gradually decreases from the inside to the outside. This allows the lower surface of the orifice plate 114 to have a slope, and the slope gradually decreases from the inside to the outside, for example, a surface morphology that gradually changes from steep to gentle. The gentle outer surface gradually reduces the distance between the orifice plate 114 and the substrate 102, and the steep inner surface retains more gas areas in more areas to form gas pressure against the external liquid, thereby further improving the sealing between the substrate 102 and the orifice plate 114.

[0291] Furthermore, by adopting a structure with a slope on the lower surface of the orifice plate 114, the second sealing ring 112 can be inclined, and the elasticity of the contact position with the orifice plate 114 is better. Compared with the vertical state, it is less susceptible to the gravity of the upper structural parts, and can provide better sealing performance. The design in the embodiment of the present invention can improve the sealing effect more evenly.

[0292] In an embodiment of the present invention, a neural signal collector is also provided, comprising any one of the implants described above and shown in FIG. 6 to FIG. 11 .

[0293] Furthermore, the neural signal collector may include an implant, and the circuit devices inside the implant may include amplification, filtering and analog-to-digital conversion devices and signal transmission devices, which are used to process the electrical signals collected by the electrode assembly and transmit the processed signals to a terminal device outside the biological body.

[0294] In an embodiment of the present invention, a neurostimulator is further provided, comprising any one of the implants described above and shown in FIG. 6 to FIG. 11 .

[0295] Furthermore, the neurostimulator may include an implant, and the circuit device inside the implant may include a signal transmission device for transmitting the stimulation signal emitted by the terminal device outside the organism to a specific area of ​​the organism.

[0296] Among them, the signal transmission device can be connected to the electrode assembly through the feedthrough assembly and the probe assembly, so that it can receive the stimulation signal emitted by the terminal device outside the organism, for example, through Bluetooth or a wireless network, and transmit the stimulation signal to the electrode assembly, and further transmit it to the biological tissue of the organism through the electrode assembly, so as to achieve stimulation and treatment of specific areas of the organism. After the implant including the feedthrough assembly, the probe assembly and the electrode assembly is implanted into the organism, the implant will be surrounded by body fluids. In order to ensure the normal operation of the neurostimulator, it is necessary to ensure that the signal transmission device, the feedthrough assembly, the probe assembly and the electrode assembly and other devices have good airtightness, especially in a high-pressure environment, they can also meet the application requirements of airtightness. Compared with the neurostimulator in the prior art, the neurostimulator in the embodiment of the present invention can better meet the application requirements of both cost and airtightness.

[0297] Referring to Figure 12, Figure 12 is a flow chart of a method for forming an implant according to an embodiment of the present invention. The method may include steps S71 to S74:

[0298] Step S71: providing an electrode assembly and a probe assembly, wherein the electrode assembly has a plurality of connection contacts, and the probe assembly includes a plurality of probes adapted to the connection contacts and a limiting component, wherein the limiting component is used to limit the position and orientation of the probes;

[0299] Step S72: performing a fixed sealing connection between the electrode assembly and the limiting component;

[0300] Step S73: using a sealing layer to seal the portion of the electrode assembly having the plurality of connection contacts and the limiting component;

[0301] Step S74: using a probe in the probe assembly to detachably penetrate the limiting component, and the probe is in detachable electrical contact with the corresponding connection contact.

[0302] In an embodiment of the present invention, the electrode assembly and the limiting component are first fixedly sealed and connected to each other, and then a sealing layer is used to seal the portion of the electrode assembly having the multiple connection contacts and the limiting component. Then, the probe in the probe assembly is detachably passed through the limiting component, and the probe is in detachable electrical contact with the corresponding connection contacts. This can easily achieve the detachability between the probe and the electrode assembly and the detachability between the probe and the limiting component, while reducing damage to the probe due to repeated disassembly and insertion, and effectively ensuring the sealing effect of the electrode assembly and the limiting component, thereby achieving a balance between the sealing requirements and the detachability requirements while further controlling costs.

[0303] In an embodiment of the present invention, the limiting component includes a perforated plate, the perforated plate has a through-hole area, and the through-hole area includes multiple through-holes corresponding one to one with the probes; the limiting component includes a circuit board, the circuit board has a solder point area, one side of the solder point area has solder points adapted to the connecting contacts, and the other side of the solder point area has solder points adapted to the probes, wherein the solder points on one side of the solder point area are electrically connected to the solder points on the other side, so that the probe is electrically contacted with the corresponding connecting contacts via the circuit board, which can easily realize a detachable connection between the limiting component and the probe and the detachability of the probe.

[0304] Furthermore, the electrode assembly and the limiting component are fixedly sealed and connected to each other, including: fixing the electrode assembly and the circuit board with each other and sealing the circuit board and the orifice plate with each other; using the probe in the probe assembly to penetrate the corresponding through-hole, and the probe is electrically contacted with the corresponding electrode site via the circuit board; wherein, after the sealing layer seals the limiting component, there is a gap between it and the through-hole area.

[0305] In an embodiment of the present invention, it is possible to easily achieve a detachable connection between the limiting component and the probe, and to ensure that the probe still has electrical detection performance on the basis of being detachable, while reducing damage to the probe due to repeated disassembly and insertion, effectively avoiding clogging of the through-hole area by the material of the sealing layer, and further achieving the detachability of the probe while retaining the sealing effect of the sealing layer, thereby improving the balance between the sealing requirements and the detachability requirements.

[0306] Furthermore, the solder point area is located in the central area of ​​the circuit board, and the through-hole area is located in the central area of ​​the orifice plate; the circuit board and the orifice plate are fixedly sealed to each other, including: using a bonding process to connect the non-central area of ​​the circuit board and the non-central area of ​​the orifice plate to block the sealing layer and the through-hole area.

[0307] In an embodiment of the present invention, by adopting a bonding process, the electrode assembly can be sealed and protected, and the probe can be effectively protected during the insertion and removal of the probe, further improving the quality and reusability of the probe retained by disassembly, while saving costs and effectively maintaining the quality of the implant.

[0308] Furthermore, the electrode assembly and the orifice plate are fixedly and sealed to each other, including: connecting the electrode assembly and the orifice plate using a reflow soldering process.

[0309] In an embodiment of the present invention, a reflow soldering process is used to connect the electrode assembly and the orifice plate to achieve a mutually fixed sealed connection between the electrode assembly and the orifice plate. Compared with other mutually fixed connection methods, it can improve the sealing while reducing the impact of factors such as temperature and vibration on the electrode assembly, thereby further improving the quality of the implant.

[0310] Further, the electrode assembly includes an electrode wire and a support plate, and the electrode wire includes: an electrode site area, the electrode site area is located at the front end of the electrode assembly, and a plurality of electrode sites are located in the electrode site area; a wire area, the wire area is located between the plurality of electrode sites and the plurality of connecting contacts, so that the electrode sites and the connecting contacts are electrically connected to each other correspondingly; and a connecting contact area, the connecting contact area is located at the rear end of the electrode assembly, and the plurality of connecting contacts are located in the connecting contact area, wherein the plurality of connecting contacts are located on the support plate, and the support plate is used to support the rear end of the electrode assembly and a portion of the wire area adjacent to the rear end; wherein the sealing layer covers the support plate and a portion of the wire area adjacent to the rear end.

[0311] Furthermore, a sealing layer is used to seal the portion of the electrode assembly having the multiple connection contacts and the limiting component, including: pouring the material of the sealing layer in a liquid state or a fluid state so that the material of the sealing layer covers the support plate and a portion of the wire area adjacent to the rear end; and curing the material of the sealing layer.

[0312] In an embodiment of the present invention, a sealing layer is used to seal the portion of the electrode assembly having the multiple connection contacts and the limiting component, including: pouring the material of the sealing layer in a liquid state or a fluid state so that the material of the sealing layer covers the support plate and a portion of the wire area adjacent to the rear end; curing the material of the sealing layer, and the hardness of the support plate can be used to reduce the deformation degree of the electrode assembly, so that the multiple connection contacts are adapted to the multiple probes, and after being covered by the sealing layer, the problem of reduced sealing effect caused by gaps caused by deformation can be effectively improved, and the sealing effect can be effectively improved through the liquid or fluid state fluidity of the sealing layer material, thereby further improving the effective protection of vulnerable parts (such as electrode assemblies, etc.) in the internal environment of the biological body.

[0313] It should be understood that the term "and / or" as used herein simply describes an association between related objects, indicating that three possible relationships exist. For example, "A and / or B" can represent: A exists alone, A and B exist simultaneously, or B exists alone. Furthermore, the character " / " as used herein indicates that the related objects are in an "or" relationship.

[0314] The term "plurality" used in the embodiments of the present application refers to two or more.

[0315] The first, second, etc. descriptions appearing in the embodiments of this application are only used for illustration and distinction of the description objects. There is no order, nor does it indicate a special limitation on the number in the embodiments of this application, and cannot constitute any limitation on the embodiments of this application.

[0316] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be based on the scope defined by the claims.

Claims

1. An implantable device, characterized in that, The implantable device includes: an electrode assembly, an upper shell assembly, and a lower shell assembly, and the upper shell assembly is fixedly connected to the lower shell assembly; The upper shell assembly includes: A cover plate; A fixing ring that surrounds the cover plate and is connected to the cover plate; and A first seal that fills or encapsulates the connection gap between the cover plate and the fixing ring from the outside of the implantable device, or the first seal covers the cover plate from the outside of the implantable device and fills or encapsulates the connection gap between the cover plate and the fixing ring; Wherein, the electrode assembly is fixedly connected to the lower shell assembly.

2. The implantable device according to claim 1, wherein The cover plate includes a central region and an edge region, and the thickness of the cover plate in the edge region gradually decreases along the direction away from the central region; Wherein, the fixing ring coaxially surrounds the cover plate, and there is a recessed groove between the inner side wall of the fixing ring and the outer side wall of the cover plate, and the recessed groove is filled with the first seal.

3. The implantable device according to claim 1, wherein Meet one or more of the following: The material of the cover plate is ceramic or glass; The material of the fixing ring is metal; The cover plate and the fixing ring are connected by brazing.

4. The implantable device according to claim 1, wherein The electrode assembly has a plurality of connection contacts, and the implantable device further includes a feedthrough assembly, and the connection contacts are electrically connected to the circuit devices inside the implantable device via the feedthrough assembly.

5. The implantable device according to claim 4, characterized in that, The feedthrough assembly includes: A ceramic part, in which a plurality of conductive posts vertically penetrating the ceramic part are embedded, and the conductive posts are adapted to the connection contacts; A metal part that surrounds the ceramic part and is connected to the ceramic part; Wherein, the connection contacts are electrically connected to the circuit devices inside the implantable device via the conductive posts.

6. The implantable device according to claim 4, wherein, The electrode assembly and the feedthrough assembly are relatively fixedly connected by surface mount technology.

7. The implantable device according to any one of claims 1 to 6, wherein, One of the edges of the upper shell assembly and the lower shell assembly has a ring-shaped protrusion, and the other of the edges of the upper shell assembly and the lower shell assembly has a ring-shaped depression adapted to the ring-shaped protrusion, wherein, the upper shell assembly and the lower shell assembly are relatively hermetically fixedly connected.

8. The implantable device according to claim 7, wherein, The side surface of the ring-shaped protrusion and the side surface of the ring-shaped depression are relatively fixedly connected by a laser welding process.

9. The implantable device according to claim 8, wherein, The first seal fills or encapsulates the connection gap between the ring-shaped protrusion and the ring-shaped depression from the outside of the implantable device.

10. The implantable device according to any one of claims 1 to 6, wherein, The material of the first seal is a combination of one or more of the following poured and cured in a liquid state or a fluid state: epoxy resin, silicone, polyether ether ketone PEEK, and polyphenylene sulfone resin PPSU.

11. The implantable device according to claim 4, wherein, The feedthrough component has a protrusion or a recess adapted to the electrode component, and the plurality of connection contacts of the electrode component are electrically connected to the connection points of the circuit device via the feedthrough component.

12. The implantable device according to claim 4, characterized in that, The implantable device has a second seal that can encapsulate the electrode component and the feedthrough component.

13. The implantable device according to claim 11, wherein The feedthrough component includes: A ceramic member having, on a surface adjacent to the electrode component, a protrusion or a recess adapted to the electrode component, and the surface of the ceramic member away from the electrode component is electrically connected to the connection points of the circuit device; A metal member surrounding the ceramic member and connected to the ceramic member; Wherein, the metal member is connected to the lower housing component.

14. The implantable device according to claim 13, wherein Satisfy one or more of the following: The ceramic member is zirconia ceramic, alumina ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum trioxide ceramic; The metal member is titanium, titanium alloy or stainless steel; The lower housing component is titanium, titanium alloy or stainless steel; The metal member is brazed to the ceramic member; and / or The metal member is laser welded to the lower housing component.

15. The implantable device according to claim 13, wherein A plurality of conductive posts vertically penetrating the ceramic member are embedded on the top surface of the protrusion or the bottom surface of the recess of the ceramic member; Wherein, the plurality of connection contacts of the electrode component correspond to the conductive posts one by one and are electrically connected to the connection points of the circuit device via the conductive posts.

16. A neural signal collector, characterized in that, The nerve signal collector includes the implantable device according to any one of claims 1 to 15.

17. A nerve stimulator, characterized in that, The nerve stimulator includes the implantable device according to any one of claims 1 to 15.

18. A method for forming an implantable device according to any one of claims 1 to 15, characterized in that, The forming method includes: Providing the electrode component, the upper housing component and the lower housing component, the upper housing component includes a cover plate and a fixing ring, the fixing ring surrounds the cover plate and is connected to the cover plate, wherein, the cover plate and the fixing ring are connected by brazing; Using a laser welding process to fixedly connect the upper housing component and the lower housing component in a relatively sealed manner; Using a surface mount technology to fixedly connect the electrode component to the lower housing component; From the outside of the implantable device, using a first seal to fill or encapsulate the connection gap between the cover plate and the fixing ring, or using the first seal to cover the cover plate and fill or encapsulate the connection gap between the cover plate and the fixing ring; and Using a second seal to encapsulate the electrode component and the connection portion between the electrode component and the lower housing component.

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