Controller and implantable nerve collection stimulator

Abstract

The utility model belongs to the field of implantable medical treatment, and particularly relates to a controller and an implantable nerve collection stimulator. According to the controller, the shell is divided into the metal shell and the ceramic shell according to the packaging characteristic of the shell material, the metal connecting layer is arranged on the ceramic shell in advance before the component is installed, the metal connecting layer is connected with the metal shell to realize integral packaging, the brazing process of ceramic and ceramic packaging is avoided after the component is installed, and the cost is reduced. The influence of a brazing process on internal components of the packaging body is effectively avoided, and the packaging requirement between a metal shell and a ceramic shell is met.

Description

Technical Field

[0001] The utility model belongs to the field of implantable medicine, and in particular relates to a controller and an implantable neural collection stimulator. Background Art

[0002] In the related technologies of implantable neural regulation devices, the use of coil wireless coupling to achieve real-time energy interaction is a conventional means of miniaturizing implants and eliminating battery risks. In order to prevent eddy current heating generated between the coil and the metal shell of the controller, there are also technologies that attempt to replace the metal shell with a ceramic shell, install the components, circuits, etc. inside the two ceramic shells, and then metallize the two ceramic shells and braze them together to complete the packaging process. However, in the brazing process, the brazing material needs to be melted to fill the gaps and diffuse with the base material. The melted brazing material can easily enter the interior of the package from the gap between the two ceramic shells, affecting or even damaging the internal components and circuits. Utility Model Content

[0003] The utility model provides a controller and an implantable neural collection stimulator to meet the packaging requirements between a ceramic shell and a metal shell.

[0004] In order to solve the above technical problems, in the first aspect, the utility model provides a controller, comprising: a ceramic shell, a metal shell and a circuit board; wherein a metal connecting layer is fixedly arranged on the bottom of the ceramic shell to connect the metal shell through a metal connector to form a package; a coil insulated from the metal connecting layer is fixedly arranged on the bottom of the ceramic shell; a feedthrough assembly insulated from the metal shell is fixedly arranged on the bottom of the metal shell; the circuit board is located inside the package, and its two sides are electrically connected to the coil and the feedthrough assembly respectively.

[0005] Furthermore, the metal connection layer is configured as a first metal coating; the first metal coating is an annular coating arranged along the bottom edge of the ceramic shell, and an insulating tape is arranged between the first metal coating and the coil.

[0006] Further, the coil is configured as a second metal coating located on the bottom surface of the ceramic shell and etched into a coil shape.

[0007] Furthermore, it also includes: a functional coating; the functional coating includes: an insulating coating and / or an electromagnetic shielding coating located on the surface of the coil.

[0008] Further, the coil is configured as a metal body coil mounted on the bottom of the ceramic housing.

[0009] Furthermore, it also includes: a functional sheet layer; the functional sheet layer is configured as an insulating sheet and / or an electromagnetic shielding sheet installed at the bottom of the coil.

[0010] Furthermore, a mounting hole is provided on the outer peripheral side of the metal connecting piece.

[0011] Furthermore, the metal shell includes: a metal lower cover provided with a through hole and a bottom cover detachably mounted on the outer wall of the metal lower cover; the feedthrough assembly includes a ceramic flange, a plurality of feed pins embedded in the ceramic flange and a third metal coating located on the edge of the ceramic flange; wherein the ceramic flange is fixedly mounted at the through hole of the metal lower cover by the third metal coating.

[0012] In a second aspect, the utility model provides an implantable neural collection stimulator, comprising: the controller, the outer side of which is wrapped with silicone; and a collection stimulation sensor, which is located outside the controller and electrically connected to the feedthrough component.

[0013] The beneficial effect of the utility model is that the controller of the utility model divides the shell into a metal shell and a ceramic shell according to the packaging characteristics of the shell material, and then integrates some components inside the shell with the two shells respectively. A metal connection layer is provided on the ceramic shell before the components are installed. During assembly, the circuit board is electrically connected to the coil and the feed-through component respectively, and then connected to the metal shell through the metal connection layer to realize the overall packaging. After the components are installed, the brazing process of ceramic and ceramic packages is avoided, which effectively avoids the influence of the brazing process on the components inside the package, and meets the packaging requirements between the metal shell and the ceramic shell.

[0014] Other features and advantages of the utility model will be described in the following description, and partly become apparent from the description, or understood by practicing the utility model. The purpose and other advantages of the utility model are realized and obtained by the structures specifically pointed out in the description, claims and drawings.

[0015] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the specific implementation methods of the utility model or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] Figure 1 It is a three-dimensional diagram of the controller of the utility model (without silica gel);

[0018] Figure 2 It is a three-dimensional diagram of the controller (wrapped with silica gel) of the utility model;

[0019] Figure 3 It is a schematic diagram of the positions of the coil and the metal connection layer of the utility model;

[0020] Figure 4 This is a cross-sectional view of the internal structure of the controller (coil is coated) of the utility model;

[0021] Figure 5 It is an exploded view of the controller of the utility model (the coil is a coating);

[0022] Figure 6 It is an exploded diagram of the controller of the utility model (the coil is a metal coil);

[0023] Figure 7 It is a three-dimensional diagram of the metal lower cover of the utility model;

[0024] Figure 8 It is a three-dimensional diagram of the metal connector (with mounting holes) of the utility model;

[0025] Fig. 9 It is a stereoscopic diagram of the implantable neural collection stimulator of the utility model;

[0026] Fig.10 It is a bottom view of the implantable neural collection stimulator of the utility model;

[0027] Fig.11 It is a stereoscopic diagram of the collection stimulation sensor of the utility model;

[0028] In the figure:

[0029] Controller 1, ceramic housing 11, ceramic upper cover 111, metal connecting layer 112, metal connecting piece 113, mounting hole 1131, coil 114, coil end 1141, insulating tape 115, metal housing 12, metal lower cover 121, through hole 1211, feed-through assembly 122, ceramic flange 1221, feed pin 1222, bottom cover 123, bottom cover hole 1231, circuit board 13, functional sheet layer 14;

[0030] Silica gel 2;

[0031] Collection stimulation sensor 3, terminal 31, circuit carrier sheet 32, electrode sheet 33, bending portion 34. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solution and advantages of the embodiments of the utility model clearer, the technical solution of the utility model will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0033] Example 1

[0034] In order to meet the implantation requirements, it is necessary to consider the strength, volume, and electrical connectivity of the internal devices of the controller, as well as the subsequent packaging process. In the actual production process, the production process is generally to assemble the components inside the controller first, then realize the overall packaging of the upper and lower shells, and finally encapsulate them. In related technologies, ceramic materials and ceramic materials are generally connected together using a brazing process. In order to meet the biocompatibility requirements of the implant, gold materials are generally used as brazing materials. During the brazing process, the brazing material needs to melt, which will damage the electrical connectivity of the components and circuits inside the controller, making the production process of the controller difficult to achieve.

[0035] Example 1

[0036] In view of this, if Figure 1-Figure 8 As shown, this embodiment 1 provides a controller 1, including: a ceramic shell 11, a metal shell 12 and a circuit board 13. The ceramic shell 11 includes: a ceramic upper cover 111; a metal connection layer 112 is arranged on the bottom of the ceramic upper cover 111 to connect the metal shell 12 through a metal connector 113 to form a package body; a coil 114 is also arranged on the bottom of the ceramic upper cover 111. The metal shell 12 includes: a metal lower cover 121; a feedthrough component 122 is insulated and arranged on the bottom of the metal lower cover 121. Before packaging, the circuit board 13 is first placed inside the package body, and the two sides of the circuit board 13 are electrically connected to the coil 114 and the feedthrough component 122 respectively; then the metal connection layer is fixedly connected to the metal shell 12 by means of the metal connector 113 to complete the packaging process of the ceramic shell 11 and the metal shell 12.

[0037] Optional, see Figure 5 , the metal connector 113 is annular. Preferably, see Figure 8 A mounting hole 1131 is provided on the outer peripheral side of the metal connector 113, and the controller can be fixedly mounted on the body tissue of the subject by medical screws.

[0038] As an optional implementation of the metal connection layer.

[0039] See Figure 3, the metal connection layer 112 is configured as a first metal coating; the first metal coating is an annular coating provided along the bottom edge of the ceramic housing 12, and an insulating tape 115 is provided between the first metal coating and the coil 114. Since the ceramic housing 12 is hollow inside, its edge surface and the bottom middle surface are not on the same plane, and a gap is formed between the two in both the width and thickness of the ceramic housing 12 to accommodate the insulating tape 115.

[0040] Specifically, firstly, a ceramic material is sintered into a ceramic upper cover 111 that meets the structural design requirements, and then a ceramic metallization process, such as a DPC diameter copper plating process, is used on the bottom surface of the ceramic upper cover 111. The ceramic upper cover 111 is used as a substrate, and the inner circle of the bottom surface of the ceramic upper cover 111 is covered. The outer circle of the bottom surface of the ceramic upper cover 111 is copper-plated by a sputtering process to generate the metal connection layer 112, and then the metal connector 113 is welded to the metal connection layer 112 by a brazing process. During the brazing process, since the components or circuits of the controller 1 are not installed on the ceramic upper cover 111, the interior of the ceramic upper cover 111 is empty, so a simple tooling (such as a plug or an anti-plating film, etc.) can be used to prevent the molten brazing material from entering the interior of the ceramic upper cover 111, or the brazing material entering the interior of the ceramic upper cover 111 can be removed after brazing.

[0041] Optionally, the metal connection layer 112 is made of, for example, but not limited to, copper and copper alloys, zinc and zinc alloys, or gold and gold alloys; the metal connector 113 is made of, for example, but not limited to, medical metals, such as titanium alloys. Preferably, in order to improve the medical safety of the implant, the metal connection layer 112 and the solder are made of gold and gold alloys, and the metal connector 113 and the metal lower cover 121 are made of titanium and titanium alloys, and are connected together by, for example, but not limited to, laser welding to form a package. In this way, the controller 1 of this case forms a package with an upper shell of ceramic material and a lower shell of titanium and titanium alloy material, which can not only avoid the packaging process between ceramic materials, but also improve the strength of the controller 1 with the help of the titanium and titanium alloy material of the lower shell. Among them, copper and copper alloys, zinc and zinc alloys, or gold and gold alloys on the surface of ceramics belong to the existing technology of ceramic surface metallization. In this case, only the process parameters of sputtering are adaptively adjusted, and no substantial technical improvements are made. The brazing process of the metal connection layer 112 and the metal connector 113 can be a conventional process selected according to the brazing material. In this case, only the process parameters of the brazing are adaptively adjusted, and no substantial technical improvement is made. The overall package between the metal connector 113 and the metal lower cover 121 can be, for example but not limited to, laser welding, which can avoid the welding process affecting the components and circuits inside the package. In this case, only the process parameters of the laser welding are adaptively adjusted, and no substantial technical improvement is made.

[0042] Optional, see Figure 3The insulating tape 115 can be a ceramic upper cover without coating, or an insulating layer can be coated on the ceramic upper cover or an insulator can be set to act as an insulating tape to improve the electrical insulation between the coil 114 and the metal connection layer 112.

[0043] As an optional implementation of the coil.

[0044] In order to realize the integrated design of the ceramic housing 11, see Figure 3 , the coil 114 is configured as a second metal coating located on the bottom surface of the ceramic upper cover 111 and etched into a coil shape. A ceramic metallization process, such as a DPC diameter copper plating process, is used on the bottom surface of the ceramic upper cover 111. Specifically, the first ceramic upper cover 111 that has completed the first metal coating is used as a substrate, and a simple tooling (such as an anti-plating film, etc.) is used to cover the outer circle (corresponding to the position of the first metal coating) and the middle circle (corresponding to the position of the insulating tape) on the bottom surface of the ceramic upper cover 111. The sputtering process is used to plate copper on the inner circle of the bottom surface of the ceramic upper cover 111 to generate a second metal coating, and then the second metal coating is etched into a coil shape that meets the design requirements using a photolithography process, and the coil terminal 1141 and the circuit board 13 are electrically connected through the coil lead.

[0045] Optionally, in order to meet the use requirements of the coil, the thickness of the second metal coating is 0.1-0.5 mm, preferably 0.2 mm, 0.3 mm, and the material of the second metal coating is, for example, but not limited to, copper and copper alloys, zinc and zinc alloys, or gold and gold alloys. Sputtering process and photolithography process are both conventional technologies. In this case, only adaptive adjustments are made to the process parameters, and no substantial technical improvements are made.

[0046] Preferably, the material of the second metal coating is the same as that of the first metal coating, and both are made of gold and gold alloys, so the second metal coating and the first metal coating can be completed by the same sputtering process. Specifically, the ceramic cover 111 is used as a substrate, and a simple tooling (such as anti-plating film, etc.) is used to cover the middle circle (corresponding to the position of the insulating tape) on the bottom surface of the ceramic cover 111, and the inner and outer circles on the bottom surface of the ceramic cover 111 are plated with gold by the sputtering process to generate the second metal coating and the first metal coating, respectively, and the insulating tape is a ceramic surface without gold plating. The thickness of the coating is based on the coil thickness requirements, and then the second metal coating is etched into a coil shape that meets the design requirements by a photolithography process. Of course, the entire bottom surface of the ceramic cover can also be coated with metal, and then the unnecessary parts are removed by photolithography to form a coil 114, an insulating tape 115, and a metal connection layer 112.

[0047] Optionally, the controller 1 further includes: a functional coating; the functional coating includes: an insulating coating and / or an electromagnetic shielding coating located on the surface of the coil. Of course, the insulating coating can cover the surface of the second metal coating by spraying; the electromagnetic shielding coating can cover the surface of the second metal coating or the insulating coating by spraying. The coating of the electromagnetic shielding coating is, for example, but not limited to, conventional copper-based coatings and nickel-based coatings.

[0048] Specifically, the specific preparation steps of the coil coating controller include: preparing a ceramic shell; preparing a metal shell; packaging, connecting the ceramic shell with the metal shell to form a package body; and injecting silicone on the outside of the package body.

[0049] Optionally, the preparation of the ceramic shell includes: sintering to form a ceramic upper cover; metalizing the bottom of the ceramic upper cover to form a metal coating; etching the metal coating to form an inner circle metal layer, a middle circle insulating layer and an outer circle metal layer from the inside to the outside; fixing the outer circle metal layer to a metal connector; spraying an insulating coating on the surface of the metal coating; the preparation of the metal shell includes: sintering to form a ceramic flange with a feed pin inside; fixing the ceramic flange to the inside of the metal lower cover.

[0050] Optionally, the package includes: electrically connecting one end of the feed pin and the coil to the circuit board respectively; passing the sensor lead of the collection stimulation sensor through the bottom cover and electrically connecting it to the other end of the feed pin; fixing the metal lower cover on the metal connector; and covering the back cover of the metal lower cover to form the package body.

[0051] The coil of this embodiment uses the ceramic metallization process that meets the packaging requirements of the ceramic shell and the metal lower cover. A metal coating can be generated on the bottom of the ceramic upper cover through a sputtering process. After photolithography, a coil, an insulating tape, a metal connection layer (such as a metal layer) fixedly arranged from the inside to the outside are formed along the bottom of the ceramic upper cover. Figure 2 As shown), the metal connector is brazed on the surface of the metal connection layer, and then an insulating layer and / or an electromagnetic shielding coating is coated on the surface of the metal coating to finally form an integrated ceramic shell. Figure 4 Since the coil, metal connection layer, insulation layer and other components are fixed on the ceramic cover in the form of coating, no additional fixing parts need to be designed. While ensuring that the volume of the controller remains unchanged, the thickness of the ceramic cover can be effectively increased to 1-2mm, which improves the strength of the ceramic cover. At the same time, it also effectively reduces the number of components to be assembled, making the assembly process simpler.

[0052] As another optional implementation of the coil.

[0053] See Figure 6The coil 114 is configured as a metal coil mounted on the bottom of the ceramic housing, such as but not limited to a copper coil. The controller 1 further includes: a functional sheet 14; the functional sheet 14 is configured as an insulating sheet and / or an electromagnetic shielding sheet mounted on the bottom of the coil. The coil 114, the insulating sheet, and the electromagnetic shielding sheet can all be mounted by means of clamping, gluing, etc.

[0054] The electromagnetic shielding sheet is configured as a nanocrystalline magnetic shielding sheet, and its thickness is 0.05-0.1 mm, preferably 0.09 mm.

[0055] Preferably, the electromagnetic shielding sheet and the insulating sheet can be processed integrally to form an electromagnetic shielding insulator.

[0056] As an optional implementation of the metal housing 12 .

[0057] See Figure 4 , Figure 5 , Figure 6 , Figure 7 The metal shell 12 includes: a metal lower cover 121 with a through hole 1211 and a bottom cover 123 detachably mounted on the outer wall of the metal lower cover 121; the feedthrough assembly 122 includes a ceramic flange 1221, a plurality of feed pins 1222 embedded in the ceramic flange 1221, and a third metal coating located at the edge of the ceramic flange 1221; wherein the ceramic flange 1221 is fixedly mounted at the through hole 1211 of the metal lower cover 121 through the third metal coating. The third metal coating is realized by the ceramic metallization process as described above, which will not be described in detail here.

[0058] Optionally, the feed needle 1222 is a platinum-iridium alloy, which is added to the ceramic material before sintering, and after sintering, a ceramic flange 1221 with the feed needle 1222 embedded inside is formed. Both ends of the feed needle 1222 pass through the ceramic flange 1221 to be electrically connected to the coil 114 through the coil lead and to the collection stimulus sensor 3 through the terminal 31, respectively.

[0059] Example 2

[0060] Based on Example 1, see Figure 9-11 , this embodiment 2 provides an implantable neural collection stimulator, including: the controller 1; the silica gel 2, wrapped on the outside of the controller 1; the collection stimulation sensor 3, located outside the controller 1 and electrically connected to the feedthrough component 122. Specifically, the silica gel 2 is wrapped on the bottom and side of the controller 1, and the top of the controller 1 is not wrapped with the silica gel 2, so that the top of the ceramic cover 11 is exposed.

[0061] Optionally, the collection stimulation sensor 3 includes: a terminal 31 connected to the feedthrough component 122, a circuit carrier sheet 32 ​​and an electrode sheet 33 connected to the terminal 31 in sequence, wherein the terminal 31 passes through the silicone 2 and the bottom cover hole 1231 and is electrically connected to the feed pin 1222; a bending portion 34 is provided at the connection between the circuit carrier sheet 32 ​​and the terminal 31 to keep the collection stimulation sensor 3 parallel to the controller 1 to prevent the conductive circuit in the circuit carrier sheet 32 ​​from being twisted.

[0062] In summary, the controller and implantable neural collection stimulator of the utility model integrate the coil and the ceramic shell, integrate the feedthrough assembly and the metal shell, and use the metal connection layer on the ceramic shell to realize the packaging of the ceramic shell and the metal shell. The final overall packaging process is the welding of the metal connection layer and the metal shell, which avoids the brazing process of ceramics and ceramics, and can effectively reduce the welding problems in the packaging process and avoid the damage of the welding temperature to the components and the connection circuit. In addition, the problem of eddy current heating generated by the coil is solved with the help of the ceramic shell, and the strength of the controller can be guaranteed by the metal shell, thereby meeting the implantation requirements.

[0063] In the description of the embodiments of the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0064] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0065] In the several embodiments provided in this application, it should be understood that the disclosed systems, devices and methods can be implemented in other ways. The device embodiments described above are only schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed.

[0066] Based on the above ideal embodiments of the utility model, the relevant staff can make various changes and modifications without deviating from the technical concept of the utility model through the above description. The technical scope of the utility model is not limited to the content of the specification, and its technical scope must be determined according to the scope of the claims.

Claims

1. A controller, characterized in that: include: Ceramic housing, metal housing and circuit board; in A metal connection layer is fixedly arranged on the bottom of the ceramic shell, so as to connect the metal shell through a metal connector to form a package; A coil insulated from the metal connection layer is fixedly arranged on the bottom of the ceramic shell; A feed-through assembly insulated from the metal shell is fixedly arranged on the bottom of the metal shell; The circuit board is located inside the packaging body, and two sides thereof are electrically connected to the coil and the feed-through component respectively.

2. The controller according to claim 1, characterized in that: The metal connection layer is configured as a first metal coating; The first metal coating is an annular coating arranged along the bottom edge of the ceramic shell, and an insulating tape is arranged between the first metal coating and the coil.

3. The controller according to claim 2, characterized in that: The coil is configured as a second metal coating located on the bottom surface of the ceramic housing and etched into a coil shape.

4. The controller according to claim 3, characterized in that: Also includes: Functional coatings; The functional coating includes: an insulating coating and / or an electromagnetic shielding coating located on the surface of the coil.

5. The controller according to claim 2, characterized in that: The coil is configured as a metal body coil mounted on the bottom of a ceramic housing.

6. The controller according to claim 5, characterized in that: Also includes: Functional sheet; The functional sheet layer is configured as an insulating sheet and / or an electromagnetic shielding sheet installed at the bottom of the coil.

7. The controller according to claim 1, characterized in that: The outer peripheral side of the metal connecting piece is provided with a mounting hole.

8. The controller according to claim 1, characterized in that: The metal shell comprises: a metal lower cover provided with a through hole and a bottom cover detachably mounted on the outer wall of the metal lower cover; The feedthrough assembly includes a ceramic flange, a plurality of feed pins embedded in the ceramic flange, and a third metal coating located at the edge of the ceramic flange; wherein The ceramic flange is fixedly mounted at the through hole of the metal lower cover through the third metal coating.

9. An implantable neural collection stimulator, characterized in that: include: The controller as claimed in claim 1, wherein the outer side of the controller is wrapped with silica gel; The acquisition stimulus sensor is located outside the controller and is electrically connected to the feedthrough component.

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