CN2910251Y - Sealing means for implanting electrical stimulator - Google Patents

Sealing means for implanting electrical stimulator Download PDF

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Publication number
CN2910251Y
CN2910251Y CN 200620022818 CN200620022818U CN2910251Y CN 2910251 Y CN2910251 Y CN 2910251Y CN 200620022818 CN200620022818 CN 200620022818 CN 200620022818 U CN200620022818 U CN 200620022818U CN 2910251 Y CN2910251 Y CN 2910251Y
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China
Prior art keywords
sealing
top cover
electrode catheter
feedthrough
plug
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Expired - Lifetime
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CN 200620022818
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Chinese (zh)
Inventor
李路明
郝红伟
陈昭阳
刘方军
马伯志
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Tsinghua University
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Tsinghua University
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Abstract

A sealing means for implanting electrical stimulator belongs to implanting medical apparatus manufacturing technical field, which comprises a metallic titanium casing (1), an electrode duct (2), a fastening screw hole (7), a sealing chamber (8), a top cover (9), a feed through (10), a sealing groove (11), an interior channel (12) and an exterior channel (13), wherein, the metallic titanium casing (1) encloses the circuit of an implanting pulse generator; the top cover (9) is connected with the pulse generator casing (1) and the electrode duct (2); the two sealing rings (4), (5) of the connector needle (3) and the connector ring (6) of the electrode duct (2) are of interference fit with the exterior channel (13) and the interior channel (12); the conducting wire (15) connected to the electrode duct (2) passes through a medical silicon rubber tube (16) to form a silicon rubber coating for sealing. The utility model has the advantages of simple structure, ideal biocompatibility and sealing performance, convenient surgical operation, easy manufacture and low price.

Description

The sealing device that is used for implanted electric stimulator
Technical field
This utility model relates to the sealing device that is used for implanted electric stimulator, belongs to implantation medical equipment manufacturing technology field.
Background technology
Implanted electric stimulator can be divided into cardiac pacemaker, brain depth stimulator, spinal cord stimulation device, peripheral nerve stimulation device, muscle stimulator etc. according to the difference of stimulation location.Implanted electric stimulator is made up of pulse generator and electrode catheter two parts, and the pulse signal that pulse generator sends is transferred to the target spot tissue by electrode catheter, plays the electronic stimulation effect.
During operation, behind implantable pulse generator and the electrode catheter, again the two is coupled together respectively, do as a whole long-term retention in vivo.Because use implanted electric stimulator to need above-mentioned operation assembling process, and long-term heeling-in in human body for the several years, so that sealing property requires is very high, sealing device had both related to pulse generator, also related to electrode catheter.At first, need prevent long-term effectively that moisture from entering the enclosure interior of pulse generator, in order to avoid cause circuit to damage; Secondly, the feedthrough that the pulse generator housing is drawn and the lead that links to each other with feedthrough all need sealing reliably and with long-term, not only with the tissue insulation, avoid leaking electricity, and do not insulate between on the same group feedthrough/lead, avoid short circuit.In addition, the sealing device of implanted electric stimulator guaranteeing on the above-mentioned sealing property basis, also requires in the operation process easy for installationly, and the joint of related seals member is solid and reliable, causes the tissue fluid seepage in order to avoid get loose in human body, causes electric leakage or short circuit.
The implanted electric stimulator of clinical practice at present mainly is The foreign chicken products such as Medtronic, and price is high, and scheme for sealing is unexposed.The sealing device of domestic implanted electric stimulator is mainly used in heart heartstart, China's utility model patent " implantable cardiac pacemaker screw hole sealing device " (patent No. 00261359.X) has designed the sealing-plug assembly, by fall trapezoid sealing-plug and the sealing stick harness be assembled, during operation the sealing-plug assembly is dipped in silicone oil, pull out the sealing stick harness after filling in screw hole, thereby the embedding sealing-plug is realized the sealing to the cardiac pacemaker screw hole.But this patent only relates to this link of screw hole in the integral sealing scheme, and need be assembled in operation process by the doctor, and sealing effectiveness depends on doctor's responsibility and skills involved in the labour fully, so there is hidden danger in sealing reliability.
Summary of the invention
At the deficiencies in the prior art, the purpose of this utility model is to provide sealing device permanently effective, reliable, easy to use for implanted electric stimulator.
For realizing above-mentioned purpose, the technical solution of the utility model realizes with following mode:
The sealing device that is used for implanted electric stimulator, it is characterized in that: with the circuit of Titanium shell (1) encapsulation Implantable Pulse Generator, after drawing feedthrough (10), the weld seam of laser welding metal titanium shell (1) and feedthrough (10) flange, the integral sealing of formation pulse generator; Connect pulse generator shell (1) and electrode catheter (2) with top cover (9),, seal with room temperature vulcanized silicone rubber at the junction design seal groove (11) of top cover (9) with Titanium shell (1); To trip bolt hole (7) and the trip bolt in being installed in adopt sealing-plug (14) to seal; Design two sealing rings (4), (5) are gone up in two adapters (3), (6) at electrode catheter, constitute annular seal space (8) with sealing-plug (14) in top cover (9) inside; Lead (15) is adopted the technology that covers medical grade silicon rubber pipe (16), form the silicone rubber clad and seal.
By above-mentioned technical scheme, described top cover (9) is a polyurethane material, uses Shooting Technique to make; Described sealing-plug (14) and sealing ring (4), (5) are silastic material, use mold pressing, high temperature curing process to make.
By above-mentioned technical scheme, sealing-plug (14) and sealing ring (4), (5) have good elasticity, form interference fit with the wall of top cover (9) bore passages (12), (13), the air in assembling process in the compression chamber, the gaseous environment of outside environment forms back pressure annular seal space (8) relatively.
This utility model compared with prior art not only simple in structure, biocompatibility and good airproof performance, is convenient to operation technique, and makes handling ease, cheap.
Description of drawings
Fig. 1 is the sealed structural representation of implanted electric stimulator of the present utility model, wherein, and 1 Titanium shell; 2 electrode catheters; 7 trip bolt holes; 8 annular seal spaces; 9 top covers; 10 feedthroughs; 11 seal grooves; 12 internal channels; 13 outer tunnels.
Fig. 2 is the sealed structural representation of electrode catheter of the present utility model.Wherein, 3 connector pins; 4 inner seal rings; 5 outer seal rings; 6 connector rings; 15 leads; 16 medical grade silicon rubber pipes.
Fig. 3 is the structural representation of single needle feedthrough of the present utility model.
Fig. 4 is the structural representation of crosspointer feedthrough of the present utility model.
Fig. 5 is the structural representation of sealing-plug of the present utility model, and wherein, 14 is sealing-plug.
The specific embodiment
Below in conjunction with accompanying drawing, specific embodiments of the present utility model is described.
Fig. 1 is the sealed structural representation of implanted electric stimulator of the present utility model.Wherein, 1 Titanium shell; 2 electrode catheters; 7 trip bolt holes; 8 annular seal spaces; 9 top covers; 10 feedthroughs; 11 seal grooves; 12 internal channels; 13 outer tunnels.This device is made of Titanium shell (1), electrode catheter (2), trip bolt hole (7), annular seal space (8), top cover (9), feedthrough (10), seal groove (11), internal channel (12) and outer tunnel (13).Wherein, electrode catheter (2) is made of connector pin (3), inner seal ring (4), outer seal ring (5), connector ring (6), lead (15) and medical grade silicon rubber pipe (16), as shown in Figure 2, Fig. 2 is the sealed structural representation of electrode catheter of the present utility model.The circuit part of Titanium shell (1) encapsulation embedded nerve stimulator after circuit is drawn feedthrough (10) internally, adopts the weld seam of laser welded seal Titanium shell (1) and feedthrough (10) flange, forms the integral sealing of pulse generator.Described feedthrough (10) is the metal-ceramic sealing structure, the integral sealing that forms with Titanium shell (1) has good air-tightness, tissue liquid and moisture thereof can not enter pulse generator inside in the life-time service process, have guaranteed the operate as normal of circuit.The feedthrough of using can be that (as shown in Figure 3: Fig. 3 is the structural representation of single needle feedthrough of the present utility model in two single needle feedthroughs.), (as shown in Figure 4: Fig. 4 is the structural representation of crosspointer feedthrough of the present utility model also can to use a crosspointer feedthrough.)。Use the crosspointer feedthrough, can be less with a feedthrough, thus reduce girth joint between a shell and the feedthrough flange, the reliability that raising seals.Top cover (9) adopts the polyurethane material injection moulding to make, go out seal groove (11) in bottom design, fill the room temperature vulcanization medical grade silicon rubber during assembling, be full of the space between top cover (9) and the shell (1), guarantee the sealed insulation of top cover (9) interior metal parts and tissue.The indoor design of top cover (9) two closed cavity (8) passages different independently with internal diameter, wherein the internal diameter of outer tunnel (13) is bigger than the internal diameter of internal channel (12).Go up the employing mold pressing at the connector pin (3) of electrode catheter (2) with connector ring (6) and process two ring of silicone rubber,sealing (4) and (5) that external diameter is different with high temperature curing process, its external diameter is all bigger than the internal diameter size of corresponding passage (12) and (13), because elastic sealing ring (4) and (5) have better elastic, produce certain compression, form interference fit with passage (12) and (13).Simultaneously, because the external diameter of sealing ring (4), has guaranteed that installing electrodes conduit (2) is easy in the operation process less than the internal diameter of outer tunnel (13).
Trip bolt hole (7) seals with silicone rubber seal plug (14), and sealing-plug (14) is made with mold pressing and high temperature curing process, has better elastic, produces certain compression, forms interference fit with trip bolt hole (7).Fig. 5 is the structural representation of sealing-plug.Wherein, 14 is sealing-plug.Blank is trip bolt hole (7) and trip bolt position.(section) sealing-plug (14) is the straw hat shape, and inner chamber is used to hold trip bolt, and end during assembling that diameter is bigger is inwardly filled in trip bolt hole (7).During operation, directly the allen driver that diameter is tiny penetrates sealing-plug (14), tightens trip bolt and extracts and get final product, because sealing-plug (14) high resiliency and be in compressive state passes the slit of causing with sealing screwdriver automatically, guarantees to seal.
Sealing-plug (14) is together with sealing ring (4) and (5), form elastomeric interference fit with the wall of annular seal space (8), air in assembling process in the compression chamber, the gaseous environment of outside has certain normal pressure relatively, form the back pressure annular seal space, thereby implanted electric stimulator in implant into body after, tissue fluid is difficult to penetrate into top cover (9) inside, increased the reliability of sealing.
The lead of electrode catheter (15) is made for metal material, adopts the technology cover medical grade silicon rubber pipe (16), forms the silicone rubber clad, guarantees between lead and the lead, the insulation between lead and the tissue, avoids the generation of electric leakage and short circuit phenomenon.

Claims (4)

1, the sealing device that is used for implanted electric stimulator, it is characterized in that this device is made up of Titanium shell (1), electrode catheter (2), trip bolt hole (7), annular seal space (8), top cover (9), feedthrough (10), seal groove (11), internal channel (12) and outer tunnel (13); Wherein, electrode catheter (2) is made of connector pin (3), inner seal ring (4), outer seal ring (5), connector ring (6), lead (15) and medical grade silicon rubber pipe (16) again;
The Implantable Pulse Generator circuit is installed in the Titanium shell (1), and feedthrough (10) is drawn, the seam laser welded seal of titanium shell (1) and feedthrough (10) flange;
Top cover (9) connects pulse generator shell (1) and electrode catheter (2), in the junction of top cover (9) and titanium shell (1) seal groove (11) is arranged;
The inside of top cover (9) is two independently closed cavity (8) two passages different with internal diameter: outer tunnel (13) and internal channel (12); Trip bolt hole (7) and be installed in trip bolt adopt sealing-plug (14) sealing; On the connector pin (3) of electrode catheter (2) and connector ring (6), two sealing rings (4) and (5) are arranged, two sealing rings (4) and (5) and outer tunnel (13) and internal channel (12) interference fit;
Two sealing rings (4), (5) constitute annular seal space (8) with sealing-plug (14) in top cover (9) inside;
Lead (15) employing that is connected on the electrode catheter (2) covers medical grade silicon rubber pipe (16) sealing.
2, the sealing device that is used for implanted electric stimulator according to claim 1 is characterized in that, the internal diameter of described outer tunnel (13) is bigger than the internal diameter of internal channel (12).
3, the sealing device that is used for implanted electric stimulator according to claim 1 is characterized in that, described top cover (9) is a polyurethane material.
4, the sealing device that is used for implanted electric stimulator according to claim 1 is characterized in that: described sealing-plug (14) and two sealing rings (4), (5) are silastic material.
CN 200620022818 2006-03-10 2006-03-10 Sealing means for implanting electrical stimulator Expired - Lifetime CN2910251Y (en)

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Application Number Priority Date Filing Date Title
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Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102641555A (en) * 2012-04-01 2012-08-22 广东省医疗器械研究所 Implantable heart pacemaker packaging device and implantable heat pacemaker packaging method
CN101468237B (en) * 2007-12-26 2012-10-17 中国科学院声学研究所 Stimulator for implantation in vivo
CN102824692A (en) * 2012-09-12 2012-12-19 清华大学 Feed-through connector for implantable medical device and manufacturing method
CN102872529A (en) * 2012-10-22 2013-01-16 清华大学 Ceramic feed-through connector for implantable electrical stimulator and method for manufacturing ceramic feed-through connector
CN103768712A (en) * 2014-01-17 2014-05-07 北京品驰医疗设备有限公司 Deep brain electric stimulation system implanted in head
CN104602760A (en) * 2013-05-03 2015-05-06 艾尔弗雷德·E·曼科学研究基金会 High reliability wire welding for implantable devices
CN106178263A (en) * 2011-08-02 2016-12-07 美敦力公司 Airtight feedthrough
CN107106850A (en) * 2014-12-24 2017-08-29 美敦力公司 Feed-through component and the method for forming feed-through component
CN107106851A (en) * 2014-12-24 2017-08-29 美敦力公司 Gas-tight seal encapsulation including feed-through component
CN107106852A (en) * 2014-12-24 2017-08-29 美敦力公司 Implantable medical device
CN107666938A (en) * 2015-06-19 2018-02-06 Pixium视野股份公司 Airtight housing and the electronic packing piece for implanted device
CN108325082A (en) * 2010-10-26 2018-07-27 美敦力公司 Chip scale package including power supply
CN109364372A (en) * 2018-12-13 2019-02-22 北京品驰医疗设备有限公司 Head components, impulse generator and implantation type electric stimulation system
CN110975144A (en) * 2019-12-19 2020-04-10 杭州诺为医疗技术有限公司 Implantable pulse generator and electrode thereof
CN112076392A (en) * 2020-09-24 2020-12-15 清华大学 Feedthrough assembly for implantable medical device and method of making same
CN112190835A (en) * 2020-09-17 2021-01-08 北京品驰医疗设备有限公司 Connecting mechanism of implantable medical device and manufacturing method thereof
CN112999516A (en) * 2021-04-07 2021-06-22 丹源医学科技(杭州)有限公司 Surgical suture curved hole structure of implant device and forming method thereof
CN113054294A (en) * 2021-03-02 2021-06-29 清华大学 Battery for active implanted medical instrument
US11419552B2 (en) 2015-12-21 2022-08-23 Medtronic, Inc. Sealed package and method of forming same

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101468237B (en) * 2007-12-26 2012-10-17 中国科学院声学研究所 Stimulator for implantation in vivo
CN108325082A (en) * 2010-10-26 2018-07-27 美敦力公司 Chip scale package including power supply
CN106178263A (en) * 2011-08-02 2016-12-07 美敦力公司 Airtight feedthrough
CN102641555B (en) * 2012-04-01 2014-08-20 广东省医疗器械研究所 Implantable heart pacemaker packaging device and implantable heat pacemaker packaging method
CN102641555A (en) * 2012-04-01 2012-08-22 广东省医疗器械研究所 Implantable heart pacemaker packaging device and implantable heat pacemaker packaging method
CN102824692A (en) * 2012-09-12 2012-12-19 清华大学 Feed-through connector for implantable medical device and manufacturing method
CN102824692B (en) * 2012-09-12 2015-02-18 清华大学 Feed-through connector for implantable medical device and manufacturing method
CN102872529A (en) * 2012-10-22 2013-01-16 清华大学 Ceramic feed-through connector for implantable electrical stimulator and method for manufacturing ceramic feed-through connector
CN102872529B (en) * 2012-10-22 2014-12-24 清华大学 Ceramic feed-through connector for implantable electrical stimulator and method for manufacturing ceramic feed-through connector
CN104602760A (en) * 2013-05-03 2015-05-06 艾尔弗雷德·E·曼科学研究基金会 High reliability wire welding for implantable devices
CN103768712A (en) * 2014-01-17 2014-05-07 北京品驰医疗设备有限公司 Deep brain electric stimulation system implanted in head
CN103768712B (en) * 2014-01-17 2016-06-08 北京品驰医疗设备有限公司 A kind of lesions located in deep brain system implanted at head
CN107106850A (en) * 2014-12-24 2017-08-29 美敦力公司 Feed-through component and the method for forming feed-through component
CN107106851A (en) * 2014-12-24 2017-08-29 美敦力公司 Gas-tight seal encapsulation including feed-through component
CN107106852A (en) * 2014-12-24 2017-08-29 美敦力公司 Implantable medical device
CN107106850B (en) * 2014-12-24 2021-02-09 美敦力公司 Feedthrough assembly and method of forming a feedthrough assembly
US11950387B2 (en) 2014-12-24 2024-04-02 Medtronic, Inc. Methods for forming hermetically-sealed packages including feedthrough assemblies
CN107106852B (en) * 2014-12-24 2021-08-03 美敦力公司 Implantable medical device
CN107666938A (en) * 2015-06-19 2018-02-06 Pixium视野股份公司 Airtight housing and the electronic packing piece for implanted device
US11419552B2 (en) 2015-12-21 2022-08-23 Medtronic, Inc. Sealed package and method of forming same
US11744518B2 (en) 2015-12-21 2023-09-05 Medtronic, Inc. Sealed package and method of forming same
CN109364372B (en) * 2018-12-13 2023-09-05 北京品驰医疗设备有限公司 Top cover component, pulse generator and implantable electrical stimulation system
CN109364372A (en) * 2018-12-13 2019-02-22 北京品驰医疗设备有限公司 Head components, impulse generator and implantation type electric stimulation system
CN110975144A (en) * 2019-12-19 2020-04-10 杭州诺为医疗技术有限公司 Implantable pulse generator and electrode thereof
CN110975144B (en) * 2019-12-19 2024-02-06 杭州诺为医疗技术有限公司 Implantable pulse generator and electrode thereof
CN112190835A (en) * 2020-09-17 2021-01-08 北京品驰医疗设备有限公司 Connecting mechanism of implantable medical device and manufacturing method thereof
CN112076392A (en) * 2020-09-24 2020-12-15 清华大学 Feedthrough assembly for implantable medical device and method of making same
CN113054294A (en) * 2021-03-02 2021-06-29 清华大学 Battery for active implanted medical instrument
CN113054294B (en) * 2021-03-02 2023-04-07 清华大学 Battery for active implanted medical instrument
CN112999516A (en) * 2021-04-07 2021-06-22 丹源医学科技(杭州)有限公司 Surgical suture curved hole structure of implant device and forming method thereof

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GR01 Patent grant
CX01 Expiry of patent term

Granted publication date: 20070613

EXPY Termination of patent right or utility model