WO2019119217A1

WO2019119217A1 - Implant encapsulation structure, and sealing cover thereof

Info

Publication number: WO2019119217A1
Application number: PCT/CN2017/116968
Authority: WO
Inventors: 彭勃; 赵赛赛; 吴天准
Original assignee: 深圳先进技术研究院
Priority date: 2017-12-18
Filing date: 2017-12-18
Publication date: 2019-06-27

Abstract

An implant encapsulation structure and a sealing cover (1) thereof. The sealing cover (1) comprises a cover member (11) and a soldering portion (12) provided at a periphery of the cover member (11). An upper portion of the cover member (11) is provided with a protruding portion (13) capable of being in contact with a bodily fluid. If a silicone rubber layer (3) has been injection molded on an outer surface of the cover member (11), an upper surface (31) of the silicone rubber layer (3) and an upper surface (131) of the protruding portion (13) are on the same plane. The implant encapsulation structure and the sealing cover (1) thereof use the protruding portion (13) at the upper portion of the sealing cover (1) to resolve a grounding issue arising during the process of outputting a stimulation signal of a neural electrode of an implant, thereby improving the stimulation effect and the safety of the neural electrode.

Description

Implant package structure and sealing cover thereof

Technical field

The present invention relates to the field of medical device technology, and in particular, to an implant package structure and a sealing cover thereof.

Background technique

Most active implanted devices use silicon-based electronic devices to perform sensing or therapeutic functions. Because silicon substrates are not biocompatible, higher-density feedthroughs and peripheral circuits are required for better stimulation. Implanted ultra-high density, airtight, biocompatible electronic packaging has become an inevitable choice.

In the prior art, the biocompatible ceramic is used to perform this function, but the direct encapsulation of the ceramic cannot guarantee that the electronic device is in a waterless environment for a long time, and a closed cavity having mechanical support performance and biocompatibility is required, and therefore the implementation is required. In the example, the closed cavity structure of the titanium cover and the titanium ring.

Summary of the invention

The object of the present invention is to provide an implant package structure and a sealing cover thereof, which can solve the grounding problem in the output process of the nerve electrode stimulation signal of the implant by sealing the protruding portion at the top of the cover, and improve the stimulation effect of the nerve electrode and safety.

The above object of the present invention can be achieved by the following technical solutions:

The invention provides a sealing cover of an implant packaging structure, the sealing cover comprises a cover body and a welding portion disposed on an outer edge of the cover, the top of the cover body is provided with a protruding portion capable of contacting body fluid, In a state in which the outer surface of the cover is injection molded with a silica gel layer, the top surface of the silica gel layer is in the same plane as the top surface of the protruding portion.

The present invention also provides an implant package structure comprising a sealing cover as described above, the implant package structure further having a ceramic substrate, and a sealing ring is weldedly connected between the ceramic substrate and the sealing cover.

The invention has the advantages and advantages of the implant packaging structure and the sealing cover thereof: the invention can achieve good contact between the implant packaging structure and the body fluid through the design of the protruding portion on the sealing cover, and is greatly reduced. The implant package structure and the eyeball friction prevent secondary damage to the eye tissue, solve the grounding problem in the process of implanting the nerve electrode stimulation signal output, and improve the stimulation effect and safety of the nerve electrode. In addition, through the design of the welded portion on the sealing cover, the effect of welding and sealing with the sealing ring can be achieved well, the sealing property of the implant packaging structure is solved, and the implant packaging structure after being wrapped by the silica gel is subsequently Better sealing.

DRAWINGS

Figure 1 is a front cross-sectional view of a sealing cover of the present invention.

Figure 2 is a front cross-sectional view showing the silicone resin layer injection molded on the sealing cover of the present invention.

3 is a top plan view of an embodiment of a sealing cover of the present invention.

4 is a top plan view of another embodiment of a sealing cover of the present invention.

Figure 5 is a perspective view of the sealing cover of the embodiment of Figure 3.

Figure 6 is a front cross-sectional view of the implant package structure of the present invention.

Detailed ways

The technical solutions in the embodiments of the present invention are clearly and completely described in the following with reference to the accompanying drawings in the embodiments of the present invention. It is obvious that the described embodiments are only a part of the embodiments of the present invention, but not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.

Embodiment 1

As shown in FIG. 1 to FIG. 5, the present invention provides a sealing cover 1 for an implant packaging structure, the sealing cover 1 comprising a cover 11 and a welded portion 12 disposed at an outer edge of the cover 11, the cover The top of the body 11 is provided with a projection 13 capable of contacting the body fluid, and the top surface 31 of the silicone layer 3 and the projection 13 are in a state where the outer surface of the cover 11 is molded with the silica gel layer 3. The top surfaces 131 are located in the same plane.

The sealing cover 1 of the present invention is made of a titanium material, has a certain hardness, is not easily deformed, and can well protect internal circuits and chips placed in the implant packaging structure, and the roughness of the outer surface of the sealing cover 1 It is 0.6 μm to 0.8 μm. The sealing cap 1 is made of pure titanium and is a material widely recognized by the US Food and Drug Administration (FDA) and the Chinese Food and Drug Administration (CFDA) for more than 10 years. The sealing cover 1 can be applied to a package of one or more products of biomedical sensors, biochip plates, cardiac pacemakers, artificial retinas, cochlear implants, defibrillators and stimulators, the sealing cover 1 being particularly suitable for use in packaging A variety of retina products (eg, 128, 512 and 1000+ channel retina products) are packaged.

Specifically, the cover body 11 in the present embodiment has a substantially cylindrical shape. Of course, in other embodiments, the cover body 11 can also be designed as a rectangular parallelepiped or a polygonal prism structure according to actual needs, and is not limited herein. The top of the cover 11 is provided with a protrusion 13 which, in the embodiment, has a top surface roughness of less than 0.8 μm, which is cylindrical, which is located at the top middle position of the cover 11, of course, In other embodiments, the protrusion 13 may also be an elliptical cylinder or a polygonal prism, etc., and is not limited herein. The outer edge of the cover 11 is provided with a welded portion 12, in this embodiment, the welded portion 12 is a welding shoulder disposed on the outer edge of the cover body 11. The outer diameter D1 of the welding shoulder is smaller than the outer diameter D2 of the cover body 11. The welding shoulder is designed to ensure the gas of the sealed cavity of the implant package structure. Confidentiality. In the present embodiment, the projection 13 has a cross-sectional area greater than or equal to one-third of the cross-sectional area of the cover 11.

As shown in FIG. 2, when the outer surface of the lid body 11 is injection molded with the silica gel layer 3, the top surface 31 of the silica gel layer 3 is in the same plane as the top surface 131 of the projection portion 13. In this embodiment, the outer edge of the protruding portion 13 can be designed as a rounded structure or a right-angled structure, so that the protruding portion 13 can achieve the effect of being easily wrapped by the silica gel, and the silicone wrapped cover body 11 is solidified to form a silicone. Layer 3, the surface of the cover 11 wrapped by the silicone layer 3 is flat, and the protrusion 13 is exposed, which not only achieves good contact with body fluid, but also greatly reduces the implant package structure. Friction with the eye to prevent secondary damage to the eye tissue.

In an embodiment of the invention, the top surface of the cover 11 is provided with a recess 14 into which the silicone layer 3 can be injection molded. During the injection molding process of the silicone gel, the silica gel fills the entire recessed portion 14, which can well block the water vapor and oxygen from the gap between the protruding portion 13 and the silicone layer 3 into the implant package structure, and is excellent. Prevents the intrusion of body fluids to achieve the requirements of implanting the human body for more than 10 years.

In a possible embodiment, as shown in FIG. 3 , the recessed portion 14 is a ring groove 141 , and the ring groove 141 is disposed around the outer periphery of the protruding portion 13 , and the ring groove 141 can be combined with the protruding portion 13 . Concentrically disposed, or the ring groove 141 may also be disposed non-concentrically with the projections 13. As shown in FIG. 4, in another possible embodiment, the recessed portion 14 is composed of a plurality of grooves 142 which are disposed at intervals, and a plurality of grooves 142 are disposed around the outer periphery of the protruding portion 13, and the grooves 142 are defined. An annular structure is formed which may be arranged concentrically with the projections 13, or the annular structure may also be arranged non-concentrically with the projections 13.

In a specific embodiment of the present invention, as shown in FIG. 1 , the cover 11 and the protrusion 13 are all in a cylindrical shape, and the recess 14 is a ring groove 141 . The outer diameter D2 of the lid body 11 is 8 mm to 10 mm, preferably 10 mm, and the height h2 of the lid body 11 is 1.5 mm to 2.5 mm, preferably 1.9 mm. The outer diameter D3 of the protruding portion 13 is 4 mm to 6 mm, preferably 5 mm, and the height h3 of the protruding portion 13 is 0.2 mm to 0.3 mm, preferably 0.25 mm. The height h of the welded portion 12 is 0.25 mm to 0.35 mm, preferably 0.3 mm; the outer diameter D1 of the welded portion 12 is 8.5 mm to 9.5 mm, preferably 9.1 mm; and the inner diameter D6 of the welded portion 12 is 7 mm to 9 mm. It is preferably 8 mm. The width b of the cross section of the depressed portion 14 is 0.15 mm to 0.25 mm, preferably 0.2 mm; the distance D4 between the depressed portion 14 and the protruding portion 13 is 0.95 mm to 1.05 mm, preferably 1 mm; The inner diameter D5 of 14 is 6 mm to 8 mm, preferably 7 mm, and the depth h1 of the depressed portion 14 is 0.15 mm to 0.25 mm, preferably 0.2 mm.

Embodiment 2

As shown in FIG. 1 to FIG. 6 , the present invention further provides an implant package structure comprising a sealing cover 1 , the implant package structure further having a ceramic substrate 4 , the ceramic substrate 4 and the sealing cover 1 A seal ring 5 is connected between the welds. The sealing cover 1 is the sealing cover described in the first embodiment. The specific structure, working principle and beneficial effects of the sealing cover 1 are the same as those of the first embodiment, and are not described herein again.

Specifically, the ceramic substrate 4 is made of a biocompatible ceramic material, which is substantially flat, and the ceramic substrate 4 is provided with a plurality of through holes 41 (for example, through holes on the 128, 512 and 1000+ channel retina products, respectively Suitable for 128, 512 and 1000+ channel retina products), the through holes 41 can be filled with a biocompatible metal filler 42 for use with a chip packaged in an implant package structure Make an electrical connection. The sealing ring 5 is used for sealingly connecting the ceramic substrate 4 and the sealing cover 1 to form a sealed cavity 6 between the ceramic substrate 4, the sealing cover 1 and the sealing ring 5, and the sealing cavity 6 is filled with helium gas to protect the planting The chip placed in the package structure ensures the long-term effective operation of the chip.

In the present embodiment, the seal ring 5 is made of a titanium material, and the inner ring wall is provided with a step ring 51 radially inwardly. One end of the seal ring 5 is welded to the ceramic base 4, and the other end thereof is in contact with the seal cover 1. The welding portion 12 is a welded shoulder, and the welding shoulder abuts on the step ring 51. The sealing ring 5 and the sealing cover 1 just form a snap joint, and the two are stabilized by welding connection. The connection ensures the sealing performance of the sealed chamber 6.

The implant package structure of the invention can achieve good contact between the implant package structure and the body fluid through the design of the protrusion 13 on the sealing cover 1, thereby greatly reducing the friction of the implant package structure and the eyeball. It prevents secondary damage to the eye tissue, solves the grounding problem during the output of the nerve electrode stimulation signal of the implant, and improves the stimulation effect and safety of the nerve electrode. In addition, by the design of the welded portion 12 on the sealing cover 1, the effect of welding and sealing with the sealing ring 5 can be achieved well, the sealing property of the implant packaging structure is solved, and the implant after being wrapped by the silica gel is subsequently solved. The package structure is more sealed.

The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to be limiting. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art Modifications or equivalents are intended to be included within the scope of the appended claims.

Claims

A sealing cover of an implant package structure, wherein the sealing cover comprises a cover body and a welded portion disposed on an outer edge of the cover, the top of the cover body is provided with a protruding portion capable of contacting body fluid, In a state in which the outer surface of the cover is molded with a silica gel layer, the top surface of the silica gel layer is in the same plane as the top surface of the protruding portion.
The sealing cover of the implant package of claim 1, wherein the top of the cover is provided with a recess, and the silicone layer can be injection molded into the recess.
The sealing cover of the implant package according to claim 2, wherein the recess is a ring groove, and the ring groove is disposed around an outer circumference of the protrusion.
The sealing cover of the implant package structure according to claim 2, wherein the recessed portion is composed of a plurality of spaced apart grooves, and a plurality of the grooves are disposed around an outer circumference of the protruding portion.
A sealing cover for an implant package according to any one of claims 1 to 4, wherein the projection is cylindrical, elliptical or polygonal.
A sealing cover for an implant package according to claim 1, wherein said sealing cover is made of a titanium material.
A sealing cover for an implant package according to claim 1, wherein said projection has a top surface roughness of less than 0.8 μm.
A sealing cover for an implant package according to claim 1, wherein said projection has a cross-sectional area greater than or equal to one third of a cross-sectional area of said cover.
The sealing cover of the implant package of claim 1, wherein the welded portion is a welding shoulder disposed on an outer edge of the cover, the outer diameter of the welded shoulder being smaller than the outer portion of the cover path.
A sealing cover for an implant package according to claim 1, wherein said welded portion has a height of 0.25 mm to 0.35 mm.
A sealing cover for an implant package according to claim 1, wherein said cover has an outer diameter of 4 mm to 4.5 mm.
A sealing cover for an implant package according to claim 2, wherein said recess has a cross section having a width of from 0.15 mm to 0.25 mm.
An implant package structure, comprising the seal cover according to any one of claims 1 to 12, the implant package structure further having a ceramic substrate, the ceramic substrate being welded to the seal cover A sealing ring is attached.
The implant package structure of claim 13 wherein said ceramic substrate, said sealing cover, and A sealing cavity is formed between the sealing rings, and the sealing cavity is filled with helium gas.
The implant package of claim 13 wherein said seal ring is made of a titanium material.
The implant package of claim 13 wherein said seal ring is provided with a stepped ring radially inwardly, the weld of said seal cap abutting said step ring.