CN214633398U - Implanted double-wire micro ceramic feed-through connector - Google Patents
Implanted double-wire micro ceramic feed-through connector Download PDFInfo
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- CN214633398U CN214633398U CN202023212546.3U CN202023212546U CN214633398U CN 214633398 U CN214633398 U CN 214633398U CN 202023212546 U CN202023212546 U CN 202023212546U CN 214633398 U CN214633398 U CN 214633398U
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- 239000007943 implant Substances 0.000 claims description 13
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 7
- 229910052719 titanium Inorganic materials 0.000 claims description 7
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- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 4
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Abstract
The utility model relates to an implanted medical equipment technical field, especially an implanted double-wire miniature ceramic feed-through connector. The embedded micro ceramic feed-through connector aims at solving the problems that an embedded micro ceramic feed-through connector existing in the existing market is based on a customized product, a manufacturer is required to design and manufacture a new product according to the requirements of customers, and the embedded micro ceramic feed-through connector has the advantages of long manufacturing period in the early stage, more limit in delivery period, large adjustment difficulty of products in the later stage, high risk and unfavorable volume production. The utility model discloses a two wire settings can use one or more product basis to cooperate and reach the effect the same with the customization product as a product basis. Through setting up that wire initial length is fixed, the later stage is tailor according to the customer's demand, has saved the input in earlier stage, and the delivery phase is short, has also reduced the later stage product adjustment degree of difficulty, reduces the risk, and through verifying for a long time, the reliability is high, and the volume production of being convenient for.
Description
Technical Field
The utility model relates to an implanted medical equipment technical field, especially an implanted double-wire miniature ceramic feed-through connector.
Background
The electrical stimulation therapy is a clinical treatment means which generates stimulation signals through specific equipment and acts on specific target spots to achieve a treatment effect, and has wide application prospects in nervous systems, dyskinesia and other diseases.
The typical electrical stimulation treatment equipment comprises an external control device and an implant implanted into a human body, wherein an electrode of the implant acquires an electric signal of a target spot, the electric signal is transmitted to an internal circuit through a lead and a ceramic feed-through connector to realize monitoring, and the internal circuit transmits a specific electric signal to the target spot at the electrode through the ceramic feed-through connector and the lead in sequence to realize the purpose of electrical stimulation treatment.
The implanted ceramic feed-through connector is a key component of an implant body, is also a key for realizing electric stimulation signal transmission, and plays roles in signal transmission/filtering, insulation and sealing. A typical ceramic feed-through connector comprises an outer ring metal flange, an insulator, a sealing body and a signal transmission lead, wherein the outer ring metal flange plays a role in supporting and fixing; the insulator is used for realizing the insulation, sealing and filtering functions among the wires; the conducting wire is used for signal transmission; the sealing body is used for realizing the sealing connection among all the components. Currently, the implantable ceramic feed-through connector is widely applied to three types of implantable medical devices, such as an artificial cochlea, a brain pacemaker, various nerve stimulators, a cardiac pacemaker, a cardiac defibrillator artificial heart, a bionic eye and the like.
Because the implanted ceramic feed-through connector needs to be implanted into a human body, the requirements on sealing property, biocompatibility, temperature shock resistance and insulation and wave filtering property are strict, and before the implanted ceramic feed-through connector is applied to the human body, strict tests are required to ensure long-term safety and reliability after the implanted ceramic feed-through connector is implanted into the human body. At the same time, implantable ceramic feedthrough connectors are moving towards this miniaturization in order to save space as much as possible.
The feed-through connectors currently in clinical use are mainly products of foreign companies such as Medtronic in the united states. PCT patent application (application publication No. CN 102483994 a) by madtonic corporation, usa, into china, designed a ceramic assembly of brazed feedthroughs. The patent is only concerned with the requirements for surface cracking and roughness of the insulator. The invention patent of the national Qinghua university (publication No. CN 102872529A) designs a ceramic feed-through connector for an implantable electrical stimulator, which supplements the problems of assembly and the like, but does not describe and explain the performance of the ceramic feed-through connector in detail and has certain limitation. In practical application, the ceramic feed-through connector still has great improvement space, so that the ceramic feed-through connector is more matched with a lead bending and laser welding process in the subsequent application process.
The number of leads led out from an implant is generally even, different customer requirements require that an implanted micro ceramic feed-through connector existing in the current market is based on a customized product, and manufacturers need to design and manufacture new products according to the requirements of customers, so that the following problems exist:
1. the manufacturing period is long, the delivery period is limited, and the requirement of a client is difficult to match;
2. the early research and development cost investment of product mold opening and proofing is very high;
3. the later adjustment of the product needs to be invested again, so that the risk is high;
4. the new design is not verified for a long time, and flaws are inevitable in the design process.
SUMMERY OF THE UTILITY MODEL
To the problem and not enough that exist among the prior art, the utility model provides a miniature ceramic feed-through connector of implanted twin-wire, whole size is less, and the maximum diameter of metal flange lasso is 4mm, sets up as a product basis through the twin-wire, can use one or more product basis to cooperate to reach the effect the same with the customization product. Through setting up that wire initial length is fixed, the later stage is tailor according to the customer demand, has saved the input in earlier stage, and the delivery period is short, and through verifying for a long time, the reliability is high.
In order to achieve the above object, the utility model provides a following technical scheme: an embedded double-wire micro ceramic feed-through connector comprises a metal flange, an insulator, a wire and a sealing body, wherein the metal flange is sleeved outside the insulator, through holes corresponding to the wire in a one-to-one manner are formed in the insulator, the wire is arranged in the through holes in a penetrating manner, the upper end of the wire is used for connecting a signal output end inside the implant, the lower end of the wire is used for connecting an external extension wire, the sealing body used for connecting and sealing is arranged between the wire and the insulator and between the insulator and the metal flange, an inner groove used for supporting and fixing the insulator is formed in the bottom of the metal flange in a protruding mode towards the inner side, and the cross section of the inner groove is T-shaped; the wire is two wire settings, and the initial length of wire is fixed, and the later stage can be tailor as required.
Specifically, the upper surface of the insulator is higher than the upper surface of the metal flange, and the height difference between the upper surface of the insulator and the upper surface of the metal flange is 0.1-0.2 mm. The method is favorable for spreading and wetting the fused sealing body, forms a smooth brazing angle, improves the reliability of connection and sealing, and can adjust the position of the insulator during assembly.
Specifically, the through hole on the insulator is a cylindrical hole, a counter bore concentric with the cylindrical hole is formed at the upper part of the cylindrical hole and used for arranging a sealing body for connecting the sealed insulator and the corresponding lead, and the gap between the inner wall of the cylindrical hole and the lead is 10-20 μm. The design of setting up insulator cylindricality hole and counter sink can furthest reduce the interval between the signal transmission wire, under the prerequisite of guaranteeing insulating properties, can reach minimum distance between the signal transmission wire. The volume of the ceramic feed-through connector can be greatly reduced, which is beneficial to realizing the miniaturization of the whole electrostimulation implant. The reserved gap between the inner wall of the cylindrical hole and the wire facilitates the capillary action of the brazing filler metal of the sealing body and reduces the influence of the thermal expansion coefficient on the sealing quality.
Specifically, the inner groove has a groove width of 0.12mm and a groove depth of 0.12 mm. The position of the insulator can be well fixed, and redundant clamps are not required to be designed and manufactured for fixing the insulator in the brazing process, so that the cost can be saved, and the yield can be improved; meanwhile, due to the fact that the design of the interior of the implant is complex, the lead of the feed-through connector needs to be bent in the follow-up using process, the cavity of the inner groove part of the metal flange can be filled with colloid in the follow-up process, and damage to the lead in the bending process is avoided.
Specifically, the cross section of the insulator is circular or rectangular with round corners, the circle centers of the cylindrical holes are arranged according to an equilateral triangle or a circle, and the distance between the leads is 1 mm. Set up the volume that can be very big reduction single miniature ceramic feed-through connector like this, cooperate a plurality of basic products to accomplish simultaneously according to the product demand each other and be connected with the implant, because the centre of a circle in each cylindricality hole is arranged according to equilateral triangle or circular, can realize the reasonable cooperation distribution of a plurality of basic products on the implant, also reduced the volume of implant.
Specifically, the bottom of the metal flange protrudes outwards to form a positioning flange for fixing the metal flange, and the thickness of the positioning flange is between 0.12 and 0.25 mm. The arrangement is that when the metal flange is connected with the shell of the implant in a sealing mode through laser welding subsequently, the laser welding part is far away from the brazing sealing part, the influence of external heat input on the sealing part in the laser welding process is avoided, meanwhile, the subsequent laser welding of shells with different thicknesses can be achieved through different step thicknesses, and the applicability is high.
Specifically, the sealing body is made of gold, titanium or alloy materials.
Specifically, the inner wall of the metal flange is parallel to the outer wall of the insulator, and the gap between the inner wall of the metal flange and the outer wall of the insulator is between 20 and 30 micrometers. The provision of the reserved gap facilitates the capillary action of the brazing filler metal of the sealing body and reduces the influence of the thermal expansion coefficient on the sealing quality.
Specifically, the wire is a cylindrical metal filament with the diameter of 0.33-0.4 mm. The diameter and the initial length of the wire are set to meet the requirements of different products, and the applicability is high.
Compared with the prior art, the beneficial effects of the utility model reside in that:
1. the double-conductor setting of single product is as basic product, according to customer's product demand, can carry out a plurality of basic product combinations and reach the product demand, has saved the input of early stage, and the delivery phase is short, and passes through long-term verification, and the reliability is high, conveniently quantifies production.
2. The initial length of wire is fixed, and the later stage can be tailor according to the product demand, reduces product later stage adjustment cost, reduces the risk.
3. The inward convex inner groove at the bottom of the metal flange is arranged to be T-shaped, so that the insulator can stably fall to the bottom, and the upper surface of the insulator is ensured not to incline.
4. The step design outside the metal flange, thickness setting is 0.12-0.25mm, can realize follow-up laser welding with different thickness casings, and the suitability is strong.
Drawings
FIG. 1 is a schematic view of a micro feedthrough connector
In the figure: 1. a wire; 2. a sealing body; 3. an insulator; 4. a metal flange; 5. an inner tank.
Detailed Description
The invention will be further elucidated with reference to the drawings in an embodiment of the invention.
Example 1
Referring to fig. 1, an implantable dual-lead micro ceramic feed-through connector includes a metal flange 4, an insulator 3, a lead 1 and a sealing body 2, the metal flange 4 is sleeved outside the insulator 3, the insulator 3 is provided with through holes corresponding to the lead 1 one by one, the lead 1 is inserted into the through holes, the upper end of the lead 1 is used for connecting a signal output end inside the implant, the lower end is used for connecting an external extension lead, the sealing body 2 for connecting and sealing is arranged between the lead 1 and the insulator 3 and between the insulator 3 and the metal flange 4, the bottom of the metal flange 4 protrudes inwards to form an inner groove 5 for supporting and fixing the insulator 3, and the cross section of the inner groove 5 is T-shaped; wire 1 is the double-conductor setting, and 1 initial length of wire is fixed, and the later stage can be tailor as required.
Furthermore, the upper surface of the insulator 3 is higher than the upper surface of the metal flange 4, and the height difference between the upper surface of the insulator 3 and the upper surface of the metal flange 4 is 0.1-0.2 mm; the through hole on the insulator 3 is a cylindrical hole, a countersunk hole concentric with the cylindrical hole is formed at the upper part of the cylindrical hole and is used for arranging a sealing body 4 for connecting the sealing insulator 3 and the corresponding lead 1, and the gap between the inner wall of the cylindrical hole and the lead 1 is between 10 and 20 mu m; the width of the inner groove 5 is 0.12mm, and the depth of the inner groove is 0.12 mm; the cross section of the insulator 3 is circular or round corner rectangle, the circle centers of the cylindrical holes are arranged according to equilateral triangle or circle, and the distance between the leads 1 is 1 mm; the bottom of the metal flange 4 protrudes outwards to form a positioning convex edge for fixing the metal flange, and the thickness of the convex edge is between 0.12 and 0.25 mm; the sealing body 2 is made of gold or alloy material and does not contain active elements such as titanium, zirconium, hafnium, niobium and the like; the inner wall of the metal flange 4 is parallel to the outer wall of the insulator 3, and the gap between the inner wall of the metal flange 4 and the outer wall of the insulator 3 is between 20 and 30 mu m; the wire 1 is a cylindrical metal filament with a diameter of 0.33-0.4 mm.
The lead 1 is arranged according to actual needs and is made of materials such as platinum, palladium, niobium and alloy thereof with small contact resistance and biocompatibility; the metal flange 4 plays a role in fixing and supporting, and is generally made of titanium, niobium, alloy thereof and other materials with high structural strength and biocompatibility; the insulator 3 plays a role of insulation and filtering, and is usually made of ceramic or composite ceramic material with good insulation performance, high structural strength and good sealing performance.
The working principle is as follows: 1. depositing a biocompatible composite metal plating layer containing elements such as titanium, palladium, zirconium, niobium, cobalt and the like on the contact surface of the insulator 3 with the lead 1, the metal flange 4 and the seal body 2 so as to ensure the spreading and wetting of the seal body 2 on the surface of the insulator 3 in the brazing process;
2. cleaning the lead 1, the metal flange 4, the insulator 3 and the sealing body 2 in a degreasing machine for 10-15min by steam, and then drying in an oven (air, temperature of 150 ℃, time of 40 min);
3. assembling each part according to the combination relationship among the parts, and fixing the positions of the lead 1 and the metal flange 4 by using a clamp;
4. placing the assembled component into a vacuum brazing furnace, heating to 1100-;
5. the ceramic feedthrough connector cooled to room temperature was ultrasonically cleaned for 10-20min and then oven dried (air, temperature 150 ℃ C., time 40 min). Thus obtaining a two-wire micro feedthrough connector in which the body 2 is gold or its alloy.
Example 2
This example differs from example 1 in that: the sealing body 2 contains active elements such as titanium, zirconium, hafnium, niobium, or alloys.
The working principle is as follows: 1. cleaning the lead 1, the metal flange 4, the insulator 3 and the sealing body 2 in a degreasing machine for 10-15min by steam, and then drying in an oven (air, temperature of 150 ℃, time of 40 min);
2. assembling each part according to the combination relationship among the parts, and fixing the positions of the lead 1 and the metal flange 4 by using a clamp;
3. placing the assembled component into a vacuum brazing furnace, heating to 1100-;
4. the ceramic feedthrough connector cooled to room temperature was ultrasonically cleaned for 10-20min and then oven dried (air, temperature 150 ℃ C., time 40 min). Thereby obtaining a product with the sealing body 2 being active elements such as titanium, zirconium, hafnium, niobium or alloy.
The two-wire micro ceramic feedthrough connectors obtained in the above two examples were not damaged after the temperature shock test at-65 ℃ to +200 ℃ (atmospheric condition, 5 shock test cycles), the compressive strength of the product exceeded 125V, the insulation resistance between the wires exceeded 1G Ω, and the leakage rate was less than 5 × 10-9 atm.cc/SEC.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. All equivalent changes and modifications made according to the content of the claims of the present invention fall within the technical scope of the present invention.
Claims (9)
1. The utility model provides an embedded two wire miniature pottery feed through connector, including the metal flange, an insulator, wire and sealing body, the insulator outside is located to the metal flange cover, set up the through-hole with the wire one-to-one on the insulator, the wire is worn to locate in the through-hole, the wire upper end is used for connecting the signal output part of implant inside, the lower extreme is used for connecting outside extension wire, be provided with between wire and the insulator and between insulator and the metal flange and be used for connecting sealed sealing body, the inside side protrusion of metal flange bottom is formed with the inside groove that is used for supporting fixed insulator, its characterized in that: the cross section of the inner groove is T-shaped; the wire is double-wire setting, just the initial length of wire is fixed, and the later stage can be tailor as required.
2. The implantable two-wire micro-ceramic feedthrough connector of claim 1, wherein: the upper surface of the insulator is higher than the upper surface of the metal flange, and the height difference between the upper surface of the insulator and the upper surface of the metal flange is 0.1-0.2 mm.
3. The implantable two-wire micro-ceramic feedthrough connector of claim 1, wherein: the through hole on the insulator is a cylindrical hole, a counter bore concentric with the cylindrical hole is formed at the upper part of the cylindrical hole and used for arranging a sealing body for connecting the sealing insulator and a corresponding lead, and the gap between the inner wall of the cylindrical hole and the lead is 10-20 mu m.
4. The implantable two-wire micro-ceramic feedthrough connector of claim 1, wherein: the width of the inner groove is 0.12mm, and the depth of the inner groove is 0.12 mm.
5. The implantable two-wire micro-ceramic feedthrough connector of claim 3, wherein: the cross section of the insulator is circular or round-corner rectangular, the circle centers of the cylindrical holes are arranged according to an equilateral triangle or a circle, and the distance between the leads is 1 mm.
6. The implantable two-wire micro-ceramic feedthrough connector of claim 1, wherein: the bottom of the metal flange protrudes outwards to form a positioning convex edge for fixing the metal flange, and the thickness of the convex edge is between 0.12 and 0.25 mm.
7. The implantable two-wire micro-ceramic feedthrough connector of claim 1, wherein: the sealing body is made of gold, titanium or alloy materials.
8. The implantable two-wire micro-ceramic feedthrough connector of claim 1, wherein: the inner wall of the metal flange is parallel to the outer wall of the insulator, and the gap between the inner wall of the metal flange and the outer wall of the insulator is between 20 and 30 mu m.
9. The implantable two-wire micro-ceramic feedthrough connector of claim 1, wherein: the wire is a cylindrical metal filament with the diameter of 0.33-0.4 mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202023212546.3U CN214633398U (en) | 2020-12-28 | 2020-12-28 | Implanted double-wire micro ceramic feed-through connector |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202023212546.3U CN214633398U (en) | 2020-12-28 | 2020-12-28 | Implanted double-wire micro ceramic feed-through connector |
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| Publication Number | Publication Date |
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| CN214633398U true CN214633398U (en) | 2021-11-09 |
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| CN202023212546.3U Active CN214633398U (en) | 2020-12-28 | 2020-12-28 | Implanted double-wire micro ceramic feed-through connector |
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Address after: Room 101, Building 4, No. 188, Jialingjiang Road, High tech Zone, Suzhou City, Jiangsu Province, 215000 Patentee after: Moretek New Material Technology (SUZHOU) Co.,Ltd. Address before: 215004 Room 101, building 4, No. 188, Jialingjiang Road, Suzhou high tech Zone, Suzhou, Jiangsu Province Patentee before: Mokos new material technology (Suzhou) Co.,Ltd. |