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

Abstract

The invention discloses an implantable device and a forming method thereof, a neural signal collector and a nerve stimulator, the implantable device comprises an electrode assembly, an upper shell assembly and a lower shell assembly, and the upper shell assembly is fixedly connected with the lower shell assembly; the upper shell assembly comprises a cover plate; the fixing ring surrounds the cover plate and is connected with the cover plate; and the first sealing element is used for filling or encapsulating a connecting gap between the cover plate and the fixing ring from the outer side of the implantable device, or the first sealing element covers the cover plate from the outer side of the implantable device and is used for filling or encapsulating the connecting gap between the cover plate and the fixing ring. According to the technical scheme provided by the invention, airtight sealing can be carried out on part or all of the implantable device, so that the service life of the implantable device is prolonged, and the implantable device is ensured to avoid damage to organism tissues to the greatest extent while completing own functions.

Description

Technical Field

[0001] 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

[0002] Implantable devices are widely used in many medical fields, including cardiology, orthopedics, neurosurgery, plastic surgery, etc. Implantable devices can be in the form of artificial joints, pacemakers, brain implant electrodes, implantable defibrillators, etc., and can be used to treat heart disease, arthritis, trauma, neurological diseases and other diseases.

[0003] The technical research and development and manufacturing of implantable devices require the comprehensive application of knowledge and technology from multiple disciplines such as 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 them, the sealing of implantable devices is a very important aspect.

[0004] The sealing property of implantable devices refers to the good sealing performance of the interface between the implantable device and the biological tissue, which can effectively prevent the invasion of external substances such as biological tissue fluid and bacteria into the implantable device and keep the internal environment of the biological tissue stable and clean. The sealing property of implantable devices is of great significance for preventing infection, rejection reaction and implant damage.

[0005] The sealing performance of implantable devices usually depends on the selection of materials, surface treatment and design structure. In material selection, it is necessary to consider that the material has good biocompatibility and corrosion resistance, and can contact with biological tissues 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 or penetrations between the implantable device and human tissue. In the prior art, it is often necessary to assemble multiple components of an implantable device, such as welding multiple components using a brazing process, or bonding multiple components with adhesives, to ensure the sealing performance of the equipment.

[0006] 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 the biological tissue, the heavy metal components may slowly seep into the biological tissue, seriously affecting the health of the organism.

[0007] 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 tissues, 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 can avoid causing damage to biological tissues to the greatest extent while completing its own functions. Summary of the invention

[0008] 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 the 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 can avoid causing damage to biological tissues to the greatest extent while completing its own functions.

[0009] 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 sealer, 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 sealer 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.

[0010] 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 wall of the fixing ring and the outer wall of the cover plate, and the recessed groove is filled with the first sealing member.

[0011] 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.

[0012] 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 a circuit device inside the implantable device via the feedthrough assembly.

[0013] Optionally, the feedthrough assembly includes: a ceramic component, in which a plurality of conductive posts are embedded that vertically penetrate the ceramic component, and the conductive posts are adapted to the connecting contacts; and a metal component, which surrounds the ceramic component and is connected to the ceramic component; wherein the connecting contacts are electrically connected to the circuit device inside the implantable device via the conductive posts.

[0014] Optionally, the electrode assembly and the feedthrough assembly are relatively fixedly connected using surface mounting technology.

[0015] 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.

[0016] Optionally, the side surface of the annular protrusion and the side surface of the annular recess are relatively fixedly connected by laser welding.

[0017] Optionally, the first sealant fills or encapsulates a connection gap between the annular protrusion and the annular depression from the outside of the implantable device.

[0018] 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.

[0019] Optionally, the feedthrough assembly has a protrusion or a recess that matches 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.

[0020] Optionally, the implantable device has a second seal, which is capable of encapsulating the electrode assembly and the feedthrough assembly.

[0021] Optionally, the feedthrough assembly includes: a ceramic component, wherein a side of the ceramic component adjacent to the electrode assembly has a protrusion or a recess adapted to the electrode assembly, and a side of the ceramic component away from the electrode assembly is electrically connected to a connection point of the circuit device; and a metal component, wherein the metal component surrounds the ceramic component and is connected to the ceramic component; wherein the metal component is connected to the lower shell assembly.

[0022] Optionally, one or more of the following is satisfied: 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 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.

[0023] Optionally, a plurality of conductive pillars vertically penetrating the ceramic component are embedded on the top surface of the protruding portion or the bottom surface of the recessed portion of the ceramic component; wherein the plurality of connecting contacts of the electrode assembly correspond one-to-one to the conductive pillars and are electrically connected to the connecting points of the circuit device via the conductive pillars.

[0024] 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.

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

[0026] To solve the above technical problems, an embodiment of the present invention provides a method for forming the above implantable device, the forming 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 relatively seal and fix 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.

[0027] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0028] In an embodiment of the present invention, after the fixing ring surrounds the cover plate and is connected to the cover plate, the first sealant 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 the adverse components remaining in the connection gap in the corresponding connection process from seeping into the biological tissue from the implantable device after the implantable device is implanted into the biological tissue. By using the first sealant 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 the adverse components remaining on the cover plate and in the connection gap in the corresponding connection process from seeping into the biological tissue from the implantable device after the implantable device is implanted into the biological tissue, so as to improve the service life of the implantable device and ensure that the implantable device avoids damage to the biological tissue to the greatest extent while completing its own function.

[0029] 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 wall of the fixing ring and the outer wall of the cover plate, and the recessed groove is filled with the first seal, so that more first seal material can be filled by setting the recessed groove, and the fit between the first seal material and the upper shell assembly can be improved by the cross-sectional shape of the recessed groove which is larger at the top and smaller at the bottom, thereby further improving the sealing effect and enhancing the anti-seepage performance.

[0030] 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 metals (such as molybdenum or tungsten) may easily remain 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.

[0031] Furthermore, the feedthrough assembly includes a ceramic component and also includes a metal component surrounding the ceramic component and connected to the ceramic component and also connected to the lower shell component, which can provide better electrical connection effect and airtightness.

[0032] Furthermore, by providing annular protrusions and annular depressions 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.

[0033] Furthermore, a laser welding process is used to achieve a relatively fixed connection between the side surface of the annular protrusion and the side surface of the annular depression. 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.

[0034] Furthermore, the first sealant fills or encapsulates the connecting gap between the annular protrusion and the annular depression 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 biocompatible materials inside the implantable device) from seeping out from the connecting gap between the annular protrusion and the annular depression. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 is a schematic diagram of the assembly structure of an upper shell component of an implantable device in an embodiment of the present invention;

[0036] Figure 2 is an exploded view of an implantable device according to an embodiment of the present invention;

[0037] Figure 3 is a schematic cross-sectional structure diagram of an upper shell component of an implantable device after assembly in an embodiment of the present invention;

[0038] Figure 4 is a schematic cross-sectional structure diagram of another implantable device in an embodiment of the present invention;

[0039] Figure 5 It is a flow chart of a method for forming an implantable device in an embodiment of the present invention.

[0040] Description of reference numerals:

[0041] A first sealing member 111 , a cover plate 112 , a fixing ring 113 , a lower shell assembly 114 , a feedthrough assembly 115 , an electrode assembly 116 , a second sealing member 117 , a ceramic member 1151 , a conductive column 1152 , and a metal member 1153 . DETAILED DESCRIPTION

[0042] 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 an adhesive. 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 encountered 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.

[0043] In an embodiment of the present invention, after the fixing ring surrounds the cover plate and is connected to the cover plate, the first sealant 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 the adverse components remaining in the connection gap in the corresponding connection process from seeping into the biological tissue from the implantable device after the implantable device is implanted into the biological tissue. By using the first sealant 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 the adverse components remaining on the cover plate and in the connection gap in the corresponding connection process from seeping into the biological tissue from the implantable device after the implantable device is implanted into the biological tissue, so as to improve the service life of the implantable device and ensure that the implantable device avoids damage to the biological tissue to the greatest extent while completing its own function.

[0044] 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.

[0045] Reference Figure 1 and Figure 2 , Figure 1 is a schematic diagram of the assembly structure of an upper shell component of an implantable device in an embodiment of the present invention, Figure 2 It is an exploded view of an implantable device in an embodiment of the present invention.

[0046] The implantable device may include: an electrode assembly 116 , an upper shell assembly and a lower shell assembly 114 .

[0047] The upper shell component can be fixedly connected to the lower shell component 114 , and the electrode component 16 can be fixedly connected to the lower shell component 114 .

[0048] The upper shell component of the implantable device may include: a cover plate 112 , a fixing ring 113 and a first sealing member 111 .

[0049] The fixing ring 113 surrounds the cover plate 112 and is connected to the cover plate 112 .

[0050] In a first specific implementation of the embodiment of the present invention, the first sealing member 111 fills or encapsulates the connection gap between the cover plate 112 and the fixing ring 113 from the outside of the implantable device.

[0051] Figure 2The exploded view shown shows this specific embodiment, in which the first sealing member 111 is annular and fills or encloses the connection gap between the cover plate 112 and the fixing ring 113 .

[0052] Furthermore, the material of the cover plate 112 is ceramic or glass, the material of the fixing ring 113 is metal, and the cover plate 112 is connected to the fixing ring 113 by brazing. In a specific embodiment, the material of the cover plate 112 can allow the circuit device inside the implantable device to exchange signals and energy with the external terminal device, such as wireless signal transmission and wireless energy transmission.

[0053] In a specific implementation, the metal material may be, for example, copper, aluminum, cobalt, titanium, silver, gold, molybdenum, tungsten, etc.

[0054] The ceramic material may be, for example, zirconium oxide ceramics, aluminum oxide ceramics, calcium phosphorus ceramics, zirconium silicon phosphorus ceramics, aluminum oxide ceramics, and the like.

[0055] In an embodiment of the present invention, 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 metals (such as molybdenum or tungsten) may easily remain 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.

[0056] 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 a connection gap between the cover plate 112 and the fixing ring 113 .

[0057] Specifically, in the second specific implementation, 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 .

[0058] In the 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 in the corresponding connection process from seeping out of the implantable device into the biological tissue after the implantable device is implanted into the biological tissue. Furthermore, 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, 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 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 increasing 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.

[0059] 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 .

[0060] Reference Figure 3 , Figure 3 It is a schematic diagram of the cross-sectional structure of an upper shell component of an implantable device after assembly in an embodiment of the present invention.

[0061] Figure 3 The illustrated cover plate 112 may include a central region and an edge region, and a thickness of the cover plate 112 in the edge region gradually decreases in a direction away from the central region.

[0062] The fixing ring 113 coaxially surrounds the cover plate 112 , and a concave groove is provided between the inner side wall of the fixing ring 113 and the outer side wall of the cover plate 112 , so that the first sealing member 111 can be used to fill the concave groove.

[0063] In a specific implementation, since the thickness of the cover plate 112 in the edge area gradually decreases in the direction away from the central area, the cross-sectional shape of the recessed groove is wide at the top and narrow at the bottom. Compared with the conventionally formed connecting gap, the first seal 111 has better fit in the recessed groove.

[0064] In the 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 wall of the fixing ring 113 and the outer wall of the cover plate 112 and is filled with the first seal 111, so that more first seal material can be filled by setting the recessed groove, and the fit of the first seal material can be improved by the cross-sectional shape of the recessed groove which is wider at the top and narrower at the bottom, thereby further improving the sealing effect and enhancing the anti-seepage performance.

[0065] Furthermore, the implantable device may also include a feedthrough assembly 115 for achieving electrical connection between the electrode assembly 116 and the circuit device inside the implantable device.

[0066] Continue to refer to Figure 2 , and combined with reference Figure 4 , Figure 4 It is a schematic diagram of the cross-sectional structure of another implantable device in an embodiment of the present invention.

[0067] As shown in the figure, the electrode assembly 116 may have a plurality of 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 .

[0068] 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.

[0069] Furthermore, the feedthrough component 115 may include: a ceramic part 1151, in which a plurality of conductive columns 1152 are embedded and vertically penetrate the ceramic part 1151, and the conductive columns 1152 are adapted to the connecting 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 connecting contacts are electrically connected to the circuit devices inside the implantable device via the conductive columns 1152.

[0070] In a specific implementation, the conductive pillar 1152 can be made of a conductive material, such as a metal material, or a metal alloy material or a non-metal 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.

[0071] The ceramic member 1151 may be zirconium oxide ceramic, aluminum oxide ceramic, calcium phosphate ceramic, zirconium silicon phosphate ceramic or aluminum oxide ceramic.

[0072] In a specific implementation of the embodiment 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, a conductive material, such as a metal material, can be filled in the feedthrough hole to obtain the feedthrough assembly 115.

[0073] In some embodiments, the diameter of the feedthrough hole may be between 50 microns and 500 microns.

[0074] In some embodiments, there may be a plurality of feedthrough components 115, and the plurality of 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.

[0075] In some embodiments, after the feedthrough hole is formed and before the conductive material is filled, a metal layer may be formed on the inner wall of the feedthrough hole, thereby better avoiding the formation of bubbles / air gaps in the feedthrough assembly 115, so that the feedthrough assembly 115 has better electrical connection effect and air tightness.

[0076] 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.

[0077] Furthermore, the electrode assembly 116 and the feedthrough assembly 115 may be relatively fixedly connected using surface mounting technology.

[0078] 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).

[0079] 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, and the electrode wire is attached to the surface of the electrode silicon plate. The electrode wire may have a plurality of connection contacts at the rear end, for example. For example, in a specific embodiment, the front end of the electrode wire has a plurality of electrode sites for collecting electrical signals in biological tissues or transmitting electrical stimulation signals from the outside to biological tissues, and the plurality of electrode sites correspond one to one with the plurality of connection contacts.

[0080] In an embodiment of the present invention, by using surface mounting 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 tightly 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.

[0081] 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.

[0082] 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.

[0083] like Figure 2 The edge of the fixing ring 113 of the upper shell assembly shown may have an annular protrusion, and the direction of the annular protrusion is toward the lower shell assembly 114, and the edge of the lower shell assembly 114 may have an annular recess, and the direction of the annular recess is toward the fixing ring 113 of the upper shell assembly, so that Figure 4 In the combined form of the implantable device shown, a relatively sealed fixed connection structure is obtained as circled by the dotted ellipse.

[0084] In the embodiment of the present invention, by providing annular protrusions and annular depressions 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.

[0085] 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.

[0086] In an embodiment of the present invention, the side surface of the annular protrusion and the side surface of the annular depression are relatively fixedly connected by 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, the risk of introducing materials that have adverse effects on biological tissues can be further reduced, thereby improving the degree of protection of biological tissues.

[0087] Furthermore, the first sealing member 111 fills or seals the connection gap between the annular protrusion and the annular depression from the outside of the implantable device.

[0088] In a specific implementation, it can be implemented by using multiple rounds of filling or encapsulation processes, or it can be implemented by using a single round of filling or encapsulation processes.

[0089] In a first specific embodiment, in a first round of filling or encapsulation process, the first sealant 111 may 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 sealant 111 may 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 relatively seal and fix the upper shell assembly 114 to the lower shell assembly 114, and then in a second round of filling or encapsulation process, the first sealant 111 may fill or encapsulate the connection gap between the annular protrusion and the annular depression.

[0090] By adopting multiple rounds of filling or encapsulation processes, the sealing effect of filling or encapsulation can be improved, and further better anti-seepage performance can be obtained.

[0091] In a second specific embodiment, a single-round filling or encapsulation process may be used, and the first sealant 111 may 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 depression from the outside of the implantable device. Alternatively, the first sealant 111 may 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 depression from the outside of the implantable device.

[0092] 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.

[0093] In an embodiment of the present invention, the first sealant 111 fills or encapsulates the connecting gap between the annular protrusion and the annular depression from the outside of the implantable device, which can further effectively prevent adverse components inside the implantable device (such as biocompatible materials inside the implantable device) from seeping out from the connecting gap between the annular protrusion and the annular depression.

[0094] Furthermore, the material of the first sealing member 111 may be 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.

[0095] 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, so that the sealing effect can be effectively improved by the fluidity of the liquid or the fluid.

[0096] Furthermore, the feedthrough component 115 may have a protrusion or a recess that matches 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 .

[0097] In a specific implementation of the embodiment of the present invention, the feed-through component 115 may have a protrusion.

[0098] like Figure 2 As shown, the lower surface (not visible in the figure) of the feedthrough assembly 115 may have a protrusion, and a portion of the electrode assembly 116 (for example, a portion having a plurality of connection contacts) may be placed on the protrusion, so that Figure 4 In the combined form of the implantable device shown, a structure as outlined by a dotted line is obtained.

[0099] 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, and 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 facilitating 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, facilitating electrical connection between the electrode assembly 116 and the feedthrough assembly 115.

[0100] In another specific implementation of the embodiment of the present invention, the feed-through component 115 may have a recessed portion.

[0101] It should be pointed out that, in the case where 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 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 of being attached to the electrode support plate.

[0102] In the 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 in a manner of being attached to the electrode support plate, thereby improving the positional limitation 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.

[0103] Furthermore, the implantable device may have a second seal 117 , which can encapsulate the electrode assembly 116 and the feedthrough assembly 115 .

[0104] The material of the second sealing member 117 may be consistent with or different from the material of the first sealing member 111 .

[0105] Furthermore, the material of the second sealing member 117 may be 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.

[0106] It should be pointed out 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.

[0107] In an embodiment of the present invention, by providing a second sealant 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, thereby effectively preventing residual substances in the processing technology of the electrode assembly 116 and the feedthrough assembly 115 from posing a threat to the safety of biological tissues.

[0108] It should be noted that, in a specific embodiment, the first seal 111 and the second seal 117 may be provided successively, for example, the first seal 111 is formed by a single round or multiple rounds of filling or encapsulation process, and then the second seal 117 is formed.

[0109] In another specific embodiment, at least a portion of the first seal 111 and the second seal 117 may be formed simultaneously, for example, at least a portion of the first seal 111 and the second seal 117 may be formed simultaneously using the same round filling or encapsulation process.

[0110] Furthermore, the feedthrough assembly 115 may include: a ceramic component, wherein a side of the ceramic component adjacent to the electrode assembly 116 has a protrusion or a recess adapted to the electrode assembly 116, and a side of the ceramic component away from the electrode assembly 116 is electrically connected to a connection point of the circuit device; a metal component, wherein the metal component surrounds the ceramic component and is connected to the ceramic component; wherein the metal component is connected to the lower shell assembly 114.

[0111] 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 .

[0112] like Figure 2As shown, the lower surface (not visible in the figure) of the ceramic member of the feedthrough assembly 115 may have a protrusion, and a portion of the electrode assembly 116 (for example, a portion having a plurality of connection contacts) may be placed on the protrusion of the ceramic member, so that Figure 4 In the combined form of the implantable device shown, a structure as outlined by a dotted line is obtained.

[0113] 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 supporting plane and supporting force for the electrode wire, and 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 facilitating 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, facilitating electrical connection between the electrode assembly 116 and the feedthrough assembly 115.

[0114] 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 .

[0115] It should be pointed out that, in the case where 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 of being attached to the electrode support plate.

[0116] 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 limitation 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.

[0117] Furthermore, a plurality of conductive pillars vertically penetrating the ceramic component are embedded on the top surface of the protruding portion or the bottom surface of the recessed portion of the ceramic component; wherein the plurality of connecting 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.

[0118] It should be noted that the metal part surrounds the ceramic part and is connected to the ceramic part, the conductive column is formed in the feedthrough hole that runs through the entire ceramic part, and the metal part and the ceramic part may be flush or not flush in the direction perpendicular to the extension direction of the feedthrough hole.

[0119] The metal component is connected to the lower shell component 114 , so that the feed-through component 115 and the lower shell component 114 can be fixedly connected.

[0120] 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.

[0121] 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.

[0122] In the specific implementation, more details about the ceramic parts and metal parts can be found in the previous text and Figures 1 to 4 The description of the implantable device shown will not be repeated here.

[0123] In an embodiment of the present invention, a neural signal collector is also provided, comprising the above and Figures 1 to 4 Any implantable device shown.

[0124] 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 for processing the electrical signals collected by the electrode assembly and transmitting the processed signals to a terminal device outside the biological body.

[0125] In an embodiment of the present invention, a neural stimulator is also provided, comprising the above and Figures 1 to 4 Any implantable device shown.

[0126] 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.

[0127] Among them, the signal transmission device can be connected to the electrode assembly through a feedthrough assembly, so that it can receive a stimulation signal emitted by a 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 to achieve stimulation and treatment of specific areas of the organism.

[0128] After the implantable device including the feedthrough assembly and the electrode assembly is implanted into the biological body, the implantable device will be surrounded by body fluids. In order to ensure the normal operation of the neural signal collector and the neural stimulator, it is necessary to ensure that the signal transmission device, the feedthrough assembly, the electrode assembly and other devices have good airtightness, especially in a high-pressure environment. The application requirements of airtightness can also be met. Compared with the neural signal collector and neural stimulator in the prior art, the neural signal collector and neural stimulator in the embodiment of the present invention can better take into account the application requirements of cost and airtightness.

[0129] Reference Figure 5 , Figure 5 1 is a flow chart of a method for forming an implantable device in an embodiment of the present invention. The method may include steps S51 to S55:

[0130] 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, 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;

[0131] Step S52: using a laser welding process to relatively seal and fix the upper shell assembly to the lower shell assembly;

[0132] Step S53: using a surface mounting process to fix the electrode assembly to the lower shell assembly;

[0133] Step S54: from the outside of the implantable device, using a first sealant to fill or seal the connection gap between the cover plate and the fixing ring, or using the first sealant to cover the cover plate and fill or seal the connection gap between the cover plate and the fixing ring; and

[0134] Step S55: using a second sealant to encapsulate the electrode assembly and the connection portion between the electrode assembly and the lower shell assembly.

[0135] It should be pointed out that the serial numbers of the steps in this embodiment do not limit the execution order of the steps.

[0136] 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 the ceramic or glass and the metal 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.

[0137] 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 unfavorable components (such as heavy metal solder or poor adhesive) can be further reduced, thereby maximizing the protection of biological tissues.

[0138] By adopting the surface mounting process, the electrode assembly is fixedly connected to the lower shell assembly, so that a tightly fitting electrical connection between the electrode assembly and the lower shell assembly can be achieved, effectively avoiding the introduction of adverse components, and through the fitting connection between the electrode assembly and the lower shell assembly, the risk of leakage of internal materials of the implantable device is further reduced.

[0139] 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 airtight sealing, thereby preventing the adverse components remaining in the connection gap in the corresponding connection process from seeping into the biological tissue from the implantable device 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 airtight sealing, or even airtight encapsulation, thereby achieving complete encapsulation of the upper shell component, preventing the adverse components remaining on the cover plate and in the connection gap in the corresponding connection process from seeping into the biological tissue from the implantable device after the implantable device is implanted into the biological tissue, so as to improve the service life of the implantable device and ensure that the implantable device avoids damage to the biological tissue to the greatest extent while completing its own function.

[0140] In an embodiment of the present invention, by providing a second sealant 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, thereby effectively preventing residual substances in the processing technology of the electrode assembly 116 and the feedthrough assembly 115 from posing a threat to the safety of biological tissues.

[0141] From the above, we can see that Figure 5 The various steps shown are interrelated and work together to prevent harmful components on or in the implantable device from threatening the safety of biological tissues.

[0142] 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.

[0143] The "plurality" appearing in the embodiments of the present application refers to two or more.

[0144] 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.

[0145] 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 implantable device, characterized in that: The implantable device comprises: 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 comprises: Cover plate; a fixing ring, the fixing ring surrounding the cover plate and connected to the cover plate; and a first sealant, which fills or encloses a connection gap between the cover plate and the fixing ring from the outside of the implantable device, or covers the cover plate from the outside of the implantable device and fills or encloses a 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, characterized in that The cover plate comprises a central region and an edge region, and the thickness of the cover plate in the edge region gradually decreases in a direction away from the central region; 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.

3. The implantable device according to claim 1, characterized in that One or more of the following is met: the material of the cover plate is ceramic or glass; The material of the fixing ring is metal; The cover plate is connected to the fixing ring by brazing.

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

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

6. The implantable device according to claim 4, characterized in that: The electrode assembly and the feedthrough assembly are relatively fixedly connected by using surface mounting technology.

7. The implantable device according to any one of claims 1 to 6, characterized in that: 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.

8. The implantable device according to claim 7, characterized in that The side surface of the annular protrusion and the side surface of the annular depression are relatively fixedly connected by using a laser welding process.

9. The implantable device according to claim 8, characterized in that The first sealing member fills or encloses a connection gap between the annular protrusion and the annular depression from the outside of the implantable device.

10. The implantable device according to any one of claims 1 to 6, characterized in that: The material of the first sealing member 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.

11. The implantable device according to claim 4, characterized in that: The feedthrough component has a protrusion or a recess matched with the electrode component, and the plurality of connection contacts of the electrode component are electrically connected to 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 is capable of encapsulating the electrode assembly and the feedthrough assembly.

13. The implantable device according to claim 11, characterized in that The feedthrough assembly comprises: a ceramic member, wherein a side of the ceramic member adjacent to the electrode assembly has a protrusion or a recess adapted to the electrode assembly, and a side of the ceramic member away from the electrode assembly is electrically connected to 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 lower shell assembly.

14. The implantable device according to claim 13, characterized in that One or more of the following is satisfied: 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 lower shell component 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 laser welded to the lower shell assembly.

15. The implantable device according to claim 13, characterized in that A plurality of conductive pillars vertically penetrating the ceramic component are embedded on the top surface of the protruding portion or the bottom surface of the recessed portion of the ceramic component; wherein the plurality of connecting contacts of the electrode assembly correspond one-to-one to the conductive pillars and are electrically connected to the connecting points of the circuit device via the conductive pillars.

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

17. A neural stimulator, characterized in that: The neurostimulator comprises an implantable device as claimed in 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 comprises: 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, 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; The upper shell component and the lower shell component are relatively sealed and fixedly connected by using a laser welding process; The surface mounting process is adopted 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 a connection gap between the cover plate and the fixing ring, or using the first sealant to cover the cover plate and fill or encapsulate a connection gap between the cover plate and the fixing ring; and A second sealing member is used to encapsulate the electrode assembly and a connection portion between the electrode assembly and the lower case assembly.

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