Implant and forming method thereof, neural signal collector and neural stimulator

Abstract

The invention discloses an implant and a forming method thereof, a neural signal collector and a neural stimulator, and the implant comprises an electrode assembly which is provided with a plurality of connecting contacts; the probe assembly comprises a plurality of probes which are matched with the connecting contacts, and the probes are in separable electric contact with the corresponding connecting contacts; the limiting component is detachably connected with the probe and is used for limiting the position and the orientation of the probe; and the sealing layer is used for sealing the part, provided with the plurality of connecting contacts, of the electrode assembly and the limiting component. According to the invention, the implant can be detached, only the easily damaged part needs to be detached and replaced, the whole product does not need to be scrapped, and the production cost is effectively controlled.

Description

Technical Field

[0001] The present invention 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. Background Art

[0002] With the rapid development of medical device technology, implanting medical devices in the body is increasingly being used to restore some functions of organisms, to treat diseases or prolong life. Specifically, by implanting medical devices in the body, the organism can be tested, or it can be used to replace diseased organs and exert the functions and effects of diseased organs.

[0003] Since medical devices are often difficult to remove after implantation or may cause significant harm to the organism during the removal phase, effective testing and screening of products is required before implantation.

[0004] However, current implantable medical devices are often non-detachable after production, 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.

[0005] There is an urgent need for an implant that can be improved to make it detachable, so that when problems occur with vulnerable parts of the product (such as electrode assemblies, etc.), only the vulnerable parts need to be disassembled and replaced without scrapping the entire product, thereby effectively controlling production costs. Summary of the invention

[0006] The technical problem solved by the present invention is to provide an implant that can be detachable and only requires disassembly and replacement of vulnerable parts without scrapping the entire product, thereby effectively controlling production costs.

[0007] 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 are 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.

[0008] 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 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 the sealing layer and the through hole area.

[0009] Optionally, the solder joint 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.

[0010] 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.

[0011] Optionally, the material of the sealing layer is a combination of one or more of the following after being injected and cured in a liquid state or a fluid state: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin PPSU.

[0012] Optionally, one side of the orifice plate away from the electrode assembly is a step structure with 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, which can produce a sealed connection between the protrusion of the orifice plate and the recessed portion of the feedthrough assembly.

[0013] Optionally, the first sealing ring is located on an 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 elastically sealing contact with an inner side wall of the recessed portion.

[0014] 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.

[0015] Optionally, the feedthrough assembly includes: a ceramic component, wherein a side of the ceramic component adjacent to the electrode assembly has the recessed portion, and a side away from the electrode assembly is in electrical contact with a connection point of the circuit device; and a metal component, which surrounds the ceramic component and is connected to the ceramic component; wherein the metal component is connected to the base shell.

[0016] Optionally, the ceramic part is zirconium oxide ceramic, aluminum oxide ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum oxide ceramic; the metal part is titanium, titanium alloy or stainless steel; the substrate 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 substrate shell.

[0017] 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 electrically contacted with the connection points of the circuit device via the conductive pillars.

[0018] Optionally, the implant further includes: a second sealing ring, which can generate a sealed connection between a bottom step of the step structure of the orifice plate surrounding the protrusion and a surface of the feed-through assembly surrounding the recess.

[0019] 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.

[0020] Optionally, a second sealing groove is provided on the surface of the bottom step of the step structure surrounding the protruding portion, wherein the second sealing ring is embedded in the second sealing groove.

[0021] 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.

[0022] 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.

[0023] Optionally, the support plate is a silicon plate, a glass plate or a silicon carbide plate.

[0024] In order to solve the above technical problems, an embodiment of the present invention provides a neural signal collector, comprising the above implant.

[0025] In order to solve the above technical problems, an embodiment of the present invention provides a neural stimulator, comprising the above implant.

[0026] 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.

[0027] 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 with 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 probe is electrically contacted with the corresponding connecting contacts via the circuit board.

[0028] Optionally, the electrode assembly and the limiting component are fixedly sealed and connected to each other, including: the electrode assembly and the circuit board are fixedly sealed and connected to each other, and the circuit board and the orifice plate are fixedly sealed and connected to each other; a probe in the probe assembly is used 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 the sealing layer and the through hole area.

[0029] Optionally, the solder joint 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 sealed and fixed to each other, including: using a bonding process to connect the non-central area of ​​the circuit board with the non-central area of ​​the orifice plate to block the sealing layer and the through-hole area.

[0030] Optionally, the electrode assembly and the orifice plate are fixedly sealed and connected to each other, including: connecting the electrode assembly and the orifice plate using a reflow soldering process.

[0031] 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.

[0032] Optionally, a sealing layer is used to seal the portion of the electrode assembly having the multiple connecting contacts and the limiting component, including: pouring the material of the sealing layer in a liquid or 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.

[0033] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0034] In an embodiment of the present invention, by adopting a plurality of 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 detachably connected to the probe, the position and orientation of the probe can be restricted while the probe and the limiting component can be detachable; and then by adopting a sealing layer to seal the portion of the electrode assembly having the plurality of 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, thereby achieving a balance 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, thereby effectively controlling the cost.

[0035] Furthermore, the limiting component includes a perforated plate and a circuit board. By setting the perforated plate to have a through-hole area including a plurality of 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, with one side having solder points adapted to the connection contacts, and the other side having 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 the limiting component and the through-hole area, which can effectively avoid 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.

[0036] 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 and 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 biological body.

[0037] 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, effectively maintaining the quality of the implant while saving costs.

[0038] Furthermore, the material of the sealing layer is a combination of one or more of the following which are 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 in vivo environment of the organism.

[0039] 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 to reduce costs.

[0040] 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.

[0041] Furthermore, the feedthrough assembly includes a metal part connected to the base shell, 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 shell. In addition, compared with only using ceramic parts to form the feedthrough assembly, the scheme 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 inside it in the in vivo environment of the biological body, and improving the quality and reusability of the base retained by disassembly.

[0042] Furthermore, a plurality of conductive pillars vertically penetrating the ceramic component are embedded on the bottom surface of the recessed portion of the ceramic component, so that electrical connection can be achieved through the conductive pillars embedded in the ceramic component. Compared with using holes to allow the probe to pass through, the sealing performance can be further improved, and the circuit components in the substrate can be better protected.

[0043] 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 sealing effect can be further enhanced after the base and the orifice plate are detachably connected by adopting the second sealing ring, thereby improving the sealing between the base and the orifice plate while being able to retain the base by disassembly to reduce costs.

[0044] 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.

[0045] 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 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 electrode assembly adjacent to the rear end, so that the deformation degree of the electrode assembly can be reduced by utilizing the hardness of the support plate, so that the plurality of connecting contacts can be adapted to the plurality of 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.

[0046] Furthermore, by first fixing the electrode assembly and the limiting component in a sealed connection, and 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 realize 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 the cost.

[0047] Furthermore, the limiting component includes a perforated plate, the perforated plate has a through hole area, and the through hole area includes a plurality of 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.

[0048] Furthermore, the electrode assembly and the limiting component are fixedly sealed and connected to each other, including: the electrode assembly and the circuit board are fixedly sealed and connected to each other, and the circuit board and the orifice plate are fixedly sealed and connected to each other; the probe in the probe assembly is passed 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 the sealing layer 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.

[0049] Furthermore, the solder joint 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 and connected to each other, including: using a bonding process to connect the non-central area of ​​the circuit board with the non-central area of ​​the orifice plate to block the sealing layer and the through-hole area. By using the 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.

[0050] Furthermore, a reflow soldering process is used to connect the electrode assembly and the orifice plate to achieve a 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.

[0051] Furthermore, a sealing layer is used to seal the portion of the electrode assembly having the multiple connecting contacts and the limiting component, including: pouring the material of the sealing layer in a liquid or 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 connecting contact area of ​​the electrode assembly, so that the multiple connecting 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 in vivo environment of the biological body. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Figure 1 is a stereoscopic diagram of an implant according to an embodiment of the present invention;

[0053] Figure 2 is a schematic diagram of the assembly structure of various components of an implant in an embodiment of the present invention;

[0054] Figure 3 is an exploded view of some components of an implant according to an embodiment of the present invention;

[0055] Figure 4 is a schematic cross-sectional structure diagram of some components of an implant after assembly according to an embodiment of the present invention;

[0056] Figure 5 is a schematic cross-sectional structure diagram of another implant according to an embodiment of the present invention;

[0057] Figure 6 is a schematic cross-sectional structure diagram of another implant according to an embodiment of the present invention;

[0058] Figure 7 It is a flow chart of a method for forming an implant according to an embodiment of the present invention.

[0059] Description of reference numerals:

[0060] Implant first part 100, implant second part 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 part 1011, metal part 1012, substrate 102, circuit device 103. DETAILED DESCRIPTION

[0061] 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, etc.), the entire product needs to be scrapped, resulting in excessively high production costs.

[0062] 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 poured with glue to form a fixed connection component to form a non-detachable implant.

[0063] In an embodiment of the present invention, by adopting a plurality of 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 detachably connected to the probe, the position and orientation of the probe can be restricted while the probe and the limiting component can be detachable; and then by adopting a sealing layer to seal the portion of the electrode assembly having the plurality of 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, thereby achieving a balance 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, thereby effectively controlling the cost.

[0064] 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.

[0065] Combined with reference Figure 1 and Figure 2 , Figure 1 is a stereoscopic diagram of an implant according to an embodiment of the present invention, Figure 2 It is a schematic diagram of the assembly structure of various components of an implant in an embodiment of the present invention.

[0066] 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.

[0067] The implant may include an implant first part 100 and an implant second part 110, and the implant first part 100 and the implant second part 110 may be assembled in a detachable manner.

[0068] The implant first part 100 and the implant second part 110 can be assembled by means of a bolt 120 .

[0069] Furthermore, the bolt 120 can also be connected by a screw, and the material of the screw can be titanium metal to improve hardness, corrosion resistance and reduce weight.

[0070] It is understandable that in the embodiments 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.

[0071] Reference Figure 3 , Figure 31 is an exploded diagram of some components of an implant according to an embodiment of the present invention. Specifically, it can be regarded as an exploded diagram of a specific implementation of the second part 110 of the implant.

[0072] Specifically, the implant may include an electrode assembly 116 , a probe assembly, and a sealing layer 117 .

[0073] One side of the electrode assembly 116 may have a plurality of connection contacts (eg, Figure 3 The electrode assembly 116 shown is on a side facing away from the sealing layer 117).

[0074] Furthermore, the plurality of connection contacts located on one side of the electrode assembly 116 may be distributed in an array.

[0075] 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 .

[0076] Furthermore, the electrode assembly may have a flexible electrode structure, and / or the circuit board is a ceramic circuit board, a glass circuit board or a printed circuit board (PCB).

[0077] Specifically, the connection contacts may be located on another side of the electrode assembly 116 that is not shown in the figure, and correspond one-to-one with the soldering points (Pad) of the circuit board 115 to achieve transmission of electrical signals.

[0078] 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.

[0079] 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.

[0080] The limiting component is detachably connected to the probe 113 and is used to limit the position and orientation of the probe 113 .

[0081] 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.

[0082] 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.

[0083] In the 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, 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 113 in the probe assembly and other subsequent structural parts in the implant (such as the matrix, etc.) can be retained by disassembly, effectively controlling the cost.

[0084] Furthermore, the circuit board 115 has a solder point area, one side of the solder point area has solder points that are adapted to the connecting contacts, represented by dotted graphics in the figure, and the other side of the solder point area has solder points that are 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 connecting contacts via the circuit board 115.

[0085] The orifice plate 114 may have a through-hole region, wherein the through-hole region includes a plurality of through-holes corresponding to the probes 113 one by one, which are represented by hole-shaped patterns in the figure, and each probe 113 passes through a corresponding through-hole.

[0086] After the sealing layer 117 seals the limiting component, there is a gap between the sealing layer 117 and the through hole area.

[0087] It should be particularly pointed out that by setting up the circuit board 115, the through hole of the orifice plate 114 can be protected, effectively preventing the through hole 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.

[0088] 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 a plurality of through-holes corresponding one to one with the probe 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 a solder point adapted to the connection contact, and the other side has a solder point 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 the limiting component 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.

[0089] 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 and the through hole area.

[0090] 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.

[0091] 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 the ring-type adhesive connection.

[0092] 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 and 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 biological body.

[0093] 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 is bonded to the non-central area of ​​the orifice plate 114 by epoxy resin.

[0094] 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 insulating 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 for better application in the medical device field involved in the embodiments of the present invention.

[0095] In a specific implementation, the orifice plate 114 may also be formed of PPSU material.

[0096] Specifically, by utilizing the characteristics of PPSU, such as good rigidity and toughness, resistance to temperature 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.

[0097] 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, molding materials and injection molding materials, and is particularly suitable for application in the field of medical devices involved in the embodiments of the present invention.

[0098] It is understandable that other appropriate bonding materials, such as polyvinyl alcohol glue, etc., may also be used to bond the circuit board 115 and the orifice plate 114 .

[0099] 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 is bonded to the non-central area of ​​the orifice plate 114 by epoxy resin, so that the electrode assembly 116 can be sealed and protected while the probe 113 can be 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.

[0100] Furthermore, 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 state or a fluid state: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin (PPSU).

[0101] 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.

[0102] In an embodiment of the present invention, the material of the sealing layer 117 is a combination of one or more of the following that are 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 in vivo environment of the biological body.

[0103] Further, Figure 3 The implant shown may further include a first sealing ring 111 and a second sealing ring 112 for improving the sealing effect of the assembled implant first part 100 and the implant second part 110 .

[0104] Combined with reference Figure 3 and Figure 4 , Figure 4 It is a schematic diagram of the cross-sectional structure of some components of an implant after assembly in an embodiment of the present invention. Figure 4 Can be considered as Figure 3 Schematic diagram of the cross section of the device obtained after assembling the various components.

[0105] In a specific implementation, after the electrode assembly 116 and the limiting component are fixedly sealed and connected to each other, a 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.

[0106] 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.

[0107] Among them, the electrode site area ( Figure 4 1162 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.

[0108] Specifically, the electrode assembly 116 may include an electrode wire and a support plate, and 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.

[0109] 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.

[0110] The conductive 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.

[0111] 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.

[0112] The support plate 1163 may be a silicon plate, a glass plate or a silicon carbide plate. By arranging the connection contact area and a portion of the wire area 1162 on the support plate 1163, the hardness of the support plate 1163 may be utilized to reduce the deformation degree of the electrode assembly 116.

[0113] 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 multiple electrode sites are located in the electrode site area; a wire area 1162, the wire area 1162 is located between the multiple electrode sites and the multiple 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 multiple connection contacts are located in the connection contact area, wherein the multiple connection contacts 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 portion of the wire area adjacent to the rear end; wherein, the sealing layer 117 covers the support plate 1163 and a portion 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.

[0114] Reference Figure 5 , Figure 5 It is a schematic diagram of the cross-sectional structure of another implant in an embodiment of the present invention.

[0115] in, Figure 5 The second implant portion 110 shown may be similar to the above and Figure 3 and Figure 4 The second implant part 110 is shown, and the other components can be similar to those described above and Figure 1 and Figure 2 An implant first part 100 is shown.

[0116] Specifically, the implant may further include: a base 102 , wherein the base 102 includes a base shell, a feed-through component 101 and an internal circuit device 103 .

[0117] The orifice plate 114 is far away from the electrode assembly 116 (see Figure 4 ) may have a stepped structure with a protrusion, and the through hole area may be located on the protrusion.

[0118] The feedthrough component 101 may have a recessed portion adapted to the protruding portion of the aperture plate 114 , and the probe component may be electrically contacted with a connection point of the circuit device via the feedthrough component 101 .

[0119] 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 feed-through assembly 101 .

[0120] Specifically, the orifice plate 114 and the base 102 may be detachably connected by bolt connection, or by screw connection or the various connection methods mentioned above, which will not be described in detail here.

[0121] The implant may further include: a first sealing ring 111 .

[0122] 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 component 101 .

[0123] Further, 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.

[0124] Furthermore, the material of the first sealing ring 111 may be an elastic material, such as rubber or other appropriate thermosetting elastomer or thermoplastic elastomer.

[0125] In the embodiment of the present invention, the orifice plate 114 is provided with a protruding portion, the substrate is provided with a feedthrough component 101, and the feedthrough component 101 is provided with a recessed portion, and then a first sealing ring 111 capable of generating a sealed connection between the protruding portion of the orifice plate 114 and the recessed portion of the feedthrough component 101 is provided. By adopting the first sealing ring 111, after the substrate 102 and the orifice plate 114 are detachably connected, the sealing effect can be enhanced, thereby improving the sealing property, such as air tightness, between the substrate 102 and the orifice plate 114 while being able to retain the substrate 102 by disassembly to reduce costs.

[0126] Furthermore, since the gap between the step outer side wall of the protruding portion and the step inner side wall of the recessed portion is less affected by the gravity of the upper structure, disposing the first sealing ring 111 here can improve the sealing effect more evenly.

[0127] It should be particularly pointed out 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 be reused to reduce costs.

[0128] Furthermore, the outer side wall of the step of the protruding portion may have a first sealing groove, and the first sealing ring 111 may be embedded in the first sealing groove.

[0129] In an embodiment of the present invention, by setting a first sealing groove, the position of the first sealing ring 111 can be better defined, so that after the base 102 and the orifice plate 114 are detachably connected, the sealing effect is further enhanced, thereby improving the sealing between the base 102 and the orifice plate 114 while being able to retain the base 102 by disassembly to reduce costs.

[0130] Furthermore, the feedthrough assembly 101 may include a ceramic component 1011 and a metal component 1012 .

[0131] Among them, 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.

[0132] 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.

[0133] 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.

[0134] In the 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 the ceramic part 1011 is used to achieve electrical contact with the connection point of the circuit device, thereby improving the sealing between the feedthrough assembly 101 and the base housing. In addition, compared with only using the ceramic part 1011 to form the feedthrough assembly, the scheme 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.

[0135] Furthermore, the bottom surface of the recessed portion of the ceramic component 1011 may be embedded with a plurality of conductive pillars vertically penetrating the ceramic component 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.

[0136] In a specific implementation, the conductive pillar can be made of conductive materials, such as metal materials or polysilicon materials, etc. The metal material can be, for example, copper, aluminum, cobalt, titanium, silver, gold, molybdenum, tungsten, etc.

[0137] 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 can be further improved, and the circuit device 103 in the substrate 102 can be better protected.

[0138] Furthermore, the implant may also include a second sealing ring 112 .

[0139] The second sealing ring 112 can generate a sealed connection, especially a gas-tight connection, between the bottom step of the step structure of the orifice plate 114 surrounding the protrusion and the surface of the feed-through component 101 surrounding the recess.

[0140] 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 sealingly contacted.

[0141] In an embodiment of the present invention, by providing a sealed connection between the bottom step of the step structure surrounding the protrusion of the orifice plate 114 and the surface of the feed-through assembly 101 surrounding the recessed portion, the sealing effect can be further enhanced by adopting a second sealing ring 112 after the base 102 and the orifice plate 114 are detachably connected, thereby improving the sealing, such as air tightness, between the base 102 and the orifice plate 114 while being able to retain the base 102 by disassembly to reduce costs.

[0142] 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.

[0143] Specifically, Figure 5 As shown, the second sealing ring 112 can be elastically sealed in contact with the upper orifice plate 114 and the lower substrate 102, respectively, to achieve a sealing effect. For example, optionally, the second sealing ring 112 can be elastically sealed in contact with the upper orifice plate 114 and the feedthrough component 101 (such as the metal member 1012) of the lower substrate 102, respectively, to achieve a multi-layer sealing effect.

[0144] 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, thereby being able to retain the base 102 by disassembly to reduce costs, while improving the sealing between the base 102 and the orifice plate 114 and 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.

[0145] Reference Figure 6 , Figure 6 is a schematic cross-sectional structure diagram of another implant according to an embodiment of the present invention. Figure 5 The different contents are explained in the following sections.

[0146] 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 surface per unit length is located 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 increases from the inside to the outside.

[0147] 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.

[0148] exist Figure 6 In the partial enlarged schematic diagram shown by the dotted ellipse, the lower surface of the orifice plate 114 has three unit lengths from the inside to the outside. The inverse tangent of the ratio of the horizontal width to the vertical height of the internal unit length surface is angle a1 (that is, the ratio of the horizontal width to the vertical height is the tangent value of angle a1, tan a1), the middle is angle a2, and the outer part is angle a3, then a1>a2>a3.

[0149] It should be pointed out that although Figure 6 Three unit lengths are used as an example for illustration. However, 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 the actual situation. Figure 6 It does not constitute a restriction.

[0150] The step of etching the lower surface of the orifice plate 114 is performed under the 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.

[0151] In an embodiment of the present invention, after the orifice plate 114 is formed, under the 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, a laser etching process is used to etch the lower surface of the orifice plate 114, so that the lower surface of the orifice plate 114 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 from the inside to the outside gradually decreases, so that the lower surface of the orifice plate 114 has a slope, and the slope is gradually reduced from the inside to the outside, for example, a surface morphology that gradually changes from steeper to gentler is obtained, and the distance between the orifice plate 114 and the substrate 102 is slowly reduced through the gentler surface of the outer part, and more gas areas are retained in more areas through the steeper surface of the inner part to form a gas pressure against the external liquid, thereby further improving the sealing between the substrate 102 and the orifice plate 114.

[0152] 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 structure, and can provide better sealing performance. The design in the embodiment of the present invention can improve the sealing effect more evenly.

[0153] In an embodiment of the present invention, a neural signal collector is also provided, comprising the above and Figures 1 to 6 Any of the implants shown.

[0154] 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 for processing the electrical signals collected by the electrode assembly and transmitting the processed signals to a terminal device outside the biological body.

[0155] In an embodiment of the present invention, a neural stimulator is also provided, comprising the above and Figures 1 to 6 Any of the implants shown.

[0156] Furthermore, the neurostimulator may include an implant, and the circuit device inside the implant may include a signal transmission device for transmitting a stimulation signal emitted by a terminal device outside the organism to a specific area of ​​the organism.

[0157] Among them, the signal transmission device can be connected to the electrode assembly through the feedthrough component and the probe assembly, so that it can receive the stimulation signal sent 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 component, 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 component, the probe assembly and the electrode assembly have good airtightness, especially in a high-pressure environment. The application requirements of airtightness can also be met. 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.

[0158] Reference Figure 7 , Figure 7 1 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:

[0159] 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;

[0160] Step S72: The electrode assembly and the limiting component are fixedly sealed and connected to each other;

[0161] Step S73: using a sealing layer to seal the portion of the electrode assembly having the plurality of connection contacts and the limiting component;

[0162] Step S74: using a probe in the probe assembly to detachably penetrate the limiting component, the probe being in detachable electrical contact with the corresponding connection contact.

[0163] 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 realize 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 the cost.

[0164] 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 a plurality of 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.

[0165] Furthermore, the electrode assembly and the limiting component are fixedly sealed and connected to each other, including: the electrode assembly and the circuit board are fixedly sealed and connected to each other, and the circuit board and the orifice plate are fixedly sealed and connected to each other; the probe in the probe assembly is used 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 the sealing layer and the through hole area.

[0166] In the embodiment of the present invention, it is possible to easily achieve a detachable connection between the limiting component and the probe, and to achieve that the probe can still have electrical detection performance on the basis of being detachable, while reducing damage to the probe due to repeated disassembly and insertion, and effectively avoiding 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.

[0167] Furthermore, the solder joint 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 sealed and connected 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.

[0168] 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.

[0169] Furthermore, the electrode assembly and the orifice plate are fixedly sealed and connected to each other, including: connecting the electrode assembly and the orifice plate by a reflow soldering process.

[0170] 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 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 influence of factors such as temperature and vibration on the electrode assembly, thereby further improving the quality of the implant.

[0171] Further, 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.

[0172] 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.

[0173] In an embodiment of the present invention, a sealing layer is used to seal the portion of the electrode assembly having the multiple connecting 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 connecting 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 in vivo environment of the biological body.

[0174] It should be understood that the term "and / or" in this article is only a description of the association relationship of the associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article indicates that the associated objects before and after are in an "or" relationship.

[0175] The "plurality" appearing in the embodiments of the present application refers to two or more.

[0176] The first, second, etc. descriptions appearing in the embodiments of the present 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 the present application, and cannot constitute any limitation on the embodiments of the present application.

[0177] 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 protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. An implant, characterized in that: include: an electrode assembly having a plurality of connection contacts; A probe assembly, the probe assembly comprising: a plurality of probes adapted to the connection contacts, wherein the probes are in detachable electrical contact with the corresponding connection contacts; A limiting component, which is detachably connected to the probe and is used to limit the position and orientation of the probe; A sealing layer is used to seal the portion of the electrode assembly having the plurality of connection contacts and the limiting component.

2. The implant according to claim 1, characterized in that The limiting component comprises: An orifice plate, wherein the orifice plate has a through-hole area, wherein the through-hole area includes a plurality of through-holes corresponding to the probes one by one, and each probe passes 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 connection 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 connection contacts via the circuit board; After the sealing layer seals the limiting component, there is a gap between the sealing layer and the through hole area.

3. The implant according to claim 2, characterized in that The solder joint 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.

4. The implant according to claim 3, characterized in that Meet one or more of the following: The material of the orifice plate is polyetheretherketone (PEEK); The non-central area of ​​the circuit board is bonded to the non-central area of ​​the orifice plate by epoxy resin.

5. The implant according to any one of claims 1 to 4, characterized in that: The material of the sealing layer is a combination of one or more of the following after being injected and cured in a liquid state or a fluid state: epoxy resin, silicone, polyetheretherketone PEEK and polyphenylene sulfone resin PPSU.

6. The implant according to claim 2, characterized in that A side of the orifice plate away from the electrode assembly is a step structure with a protrusion, and the through hole area is located at the protrusion; The implant also includes: A substrate, the substrate comprising a substrate housing, a feedthrough assembly and an internal circuit device, wherein the feedthrough assembly has a recessed portion adapted to the protruding portion of the aperture plate, and the probe assembly is electrically contacted with a connection point of the circuit device via the feedthrough assembly; A first sealing ring is provided, wherein the first sealing ring is capable of creating a sealed connection between the protruding portion of the aperture plate and the recessed portion of the feed-through assembly.

7. The implant according to claim 6, characterized in that The first sealing ring is located on the outer side wall of the step of the protruding portion, and after the base body 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.

8. The implant according to claim 7, characterized in that The step outer side wall of the protruding portion has a first sealing groove, and the first sealing ring is embedded in the first sealing groove.

9. The implant according to claim 6, characterized in that The feedthrough assembly comprises: A ceramic member, wherein a side of the ceramic member adjacent to the electrode assembly has the recessed portion, and a side away from the electrode assembly is in electrical contact with a connection point of the circuit device; a metal member, the metal member surrounding the ceramic member and connected to the ceramic member; Wherein, the metal part is connected to the base shell.

10. The implant according to claim 9, characterized in that Meet one or more of the following: The ceramic piece is zirconium oxide ceramic, aluminum oxide ceramic, calcium phosphorus ceramic, zirconium silicon phosphorus ceramic or aluminum oxide ceramic; The metal part is titanium, titanium alloy or stainless steel; The base shell is made of titanium, titanium alloy or stainless steel; The metal part is connected to the ceramic part by brazing; and / or The metal part is connected to the base shell by brazing.

11. The implant according to claim 9, characterized in that A plurality of conductive pillars vertically penetrating the ceramic member are embedded on the bottom surface of the recessed portion of the ceramic member; The probes in the probe assembly correspond to the conductive pillars one by one, and are in electrical contact with the connection points of the circuit device via the conductive pillars.

12. The implant according to claim 9, characterized in that The implant also includes a second sealing ring capable of creating a sealed connection between a bottom step of the step structure of the aperture plate surrounding the protrusion and a surface of the feed-through assembly surrounding the recess.

13. The implant according to claim 12, characterized in that 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 elastically and sealingly contacts the surface of the feed-through assembly surrounding the recess.

14. The implant according to claim 13, characterized in that A second sealing groove is provided on the surface of the bottom step of the step structure surrounding the protruding portion, wherein the second sealing ring is embedded in the second sealing groove.

15. The implant according to claim 1, characterized in that The electrode assembly comprises an electrode wire and a support plate, and the electrode wire comprises: 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 being located between the plurality of electrode sites and the plurality of connection contacts so that the electrode sites and the connection contacts 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 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.

16. The implant according to claim 2, characterized in that The electrode assembly has a flexible electrode structure, and / or the circuit board is a ceramic circuit board, a glass circuit board or a printed circuit board.

17. The implant according to claim 15, characterized in that The support plate is a silicon plate, a glass plate or a silicon carbide plate.

18. A neural signal collector, characterized in that: Comprising an implant as claimed in any one of claims 1 to 17.

19. A neural stimulator, characterized in that: Comprising an implant as claimed in any one of claims 1 to 17.

20. A method for forming an implant, characterized in that: include: An electrode assembly and a probe assembly are provided, 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; The electrode assembly and the limiting component are fixedly and sealedly connected to each other; Using a sealing layer to seal the portion of the electrode assembly having the plurality of connection contacts and the limiting component; The probe in the probe assembly is used to detachably penetrate the limiting component, and the probe is in detachable electrical contact with the corresponding connection contact.

21. The method according to claim 20, characterized in that The limiting component includes a perforated plate, the perforated plate has a through hole area, and the through hole area includes a plurality of 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.

22. The method according to claim 21, characterized in that The electrode assembly and the limiting component are fixedly sealed and connected to each other, comprising: The electrode assembly and the circuit board are fixedly sealed and connected to each other, and the circuit board and the orifice plate are fixedly sealed and connected to each other; Using a probe in the probe assembly to penetrate the corresponding through hole, the probe is electrically contacted with the corresponding electrode site via the circuit board; After the sealing layer seals the limiting component, there is a gap between the sealing layer and the through hole area.

23. The method according to claim 21, characterized in that The solder joint 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 and sealed to each other, comprising: The non-central area of ​​the circuit board and the non-central area of ​​the orifice plate are connected by a bonding process to block the sealing layer and the through-hole area.

24. The method according to claim 21, characterized in that The electrode assembly and the orifice plate are fixedly and sealed to each other, comprising: The electrode assembly and the orifice plate are connected by a reflow soldering process.

25. The method according to any one of claims 20 to 24, characterized in that The electrode assembly comprises an electrode wire and a support plate, and the electrode wire comprises: 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 being located between the plurality of electrode sites and the plurality of connection contacts so that the electrode sites and the connection contacts 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 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.

26. The method according to claim 25, characterized in that The sealing layer is used to seal the portion of the electrode assembly having the plurality of connection contacts and the limiting component, including: Pouring the material of the sealing layer in a liquid or 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; The material of the sealing layer is cured.

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