IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0632421
(2009-12-07)
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등록번호 |
US-8103348
(2012-01-24)
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발명자
/ 주소 |
- Coffed, James
- Kinney, James
- Biggs, James C.
- Gray, Joseph
- Bonitati, Jr., Donald A.
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출원인 / 주소 |
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대리인 / 주소 |
|
인용정보 |
피인용 횟수 :
11 인용 특허 :
11 |
초록
▼
A method for providing a header assembly for connecting an implantable medical device to at least one conductor lead terminating within a patient intended to be assisted by the medical device is provided. The implantable medical device is comprised of at least one feedthrough wire extending from the
A method for providing a header assembly for connecting an implantable medical device to at least one conductor lead terminating within a patient intended to be assisted by the medical device is provided. The implantable medical device is comprised of at least one feedthrough wire extending from the control circuitry and through a wall of the housing. The header assembly is comprised of an insulative body that is mountable on the housing of the medical device. The insulative body supports at least one conductor subassembly comprising a terminal that is directly connectable to the conductor lead, an intermediate conductor comprising a distal end connected to the terminal and a proximal end connected to a connector. Methods for making the header assembly and for connecting the header assembly to the implantable medical device are also disclosed.
대표청구항
▼
1. A method for making a header assembly for connecting an implantable medical device to at least one conductor lead terminating within a patient intended to be assisted by the medical device, the method comprising the steps of: a) providing at least one conductive connector comprising an outer surf
1. A method for making a header assembly for connecting an implantable medical device to at least one conductor lead terminating within a patient intended to be assisted by the medical device, the method comprising the steps of: a) providing at least one conductive connector comprising an outer surface, a distal end including a distal bore, a central region, and a proximal end including a proximal bore;b) providing a feedthrough adapter holder comprised of a plate shaped body including an upper surface, a lower surface, a side wall, and at least one through hole extending from the upper surface to the lower surface, the through hole having a diameter sized to enable movement of the conductive connector therein;c) moving the at least one connector into the at least one through hole, such that the plate shaped body of the feedthrough adapter holder is engaged with the central section of the at least one connector;d) drilling a through hole from the outer surface into the proximal bore of the at least one connector;e) displacing the at least one connector into engagement with the feedthrough adapter holder so that the holder contacts the proximal end of the at least one connector, including the through hole from the outer surface thereof into the proximal bore thereof;f) providing at least one conductor wire comprising a distal end and a proximal end, and inserting the proximal end of the at least one conductor wire into the distal bore of the connector, and joining the at least one conductor wire to the at least one connector;g) positioning the at least one conductor wire in a fixture so that its distal end is joinable to a terminal;h) providing at least one terminal, and joining the terminal to the distal end of the at least one conductor wire to form at least one conductor subassembly comprising the conductive connector, the conductor wire, and the terminal;i) placing the holder and the at least one conductor subassembly in a mold cavity;j) molding a polymeric material as a monolithic header body around the at least one conductor subassembly to form the header assembly;k) removing the header assembly from the mold; andl) removing the feedthrough adapter holder from the proximal end of the at least one conductive connector. 2. The method of claim 1 wherein the step of placing the at least one conductor subassembly in a mold cavity includes engaging the at least one terminal with a mold insert provided in the shape of a conductor lead connector, so as to form an opening in the header body for connecting a conductor lead connector to the terminal. 3. The method of claim 1 wherein the step of placing the at least one conductor subassembly in a mold cavity includes placing a mold insert within the mold cavity, wherein the mold insert comprises a recessed cavity comprising a bottom surface and a side surface terminating at an upper surface, and wherein the feedthrough adapter holder is disposed in the recessed cavity such that the lower surface of the recessed cavity is contiguous with the lower surface of the feedthrough adapter holder, and the side surface of the recessed cavity is contiguous with the side wall of the feedthrough adapter holder. 4. The method of claim 3 wherein the upper surface of the feedthrough adapter holder is located below the upper surface of the mold insert and within the recessed cavity thereby forming a boss cavity, and wherein the header body comprises a boss formed within the boss cavity. 5. The method of claim 4 wherein the at least one through hole in the feedthrough adapter holder is comprised of a counter bore, and wherein the bottom surface of the mold insert is comprised of at least one pedestal disposed in the counter bore of the at least one through hole in the feedthrough adapter holder. 6. The method of claim 1 wherein the header assembly is comprised of a plurality of conductor subassemblies each comprised of a conductive connector, a conductor wire, and a terminal. 7. The method of claim 6 wherein there are eight connectors supported in the molded polymeric header body in two groups of four. 8. The method of claim 1 wherein the feedthrough adapter holder consists essentially of polysulfone polymeric or polyetheretherketone. 9. The method of claim 1 wherein the terminal, the intermediate conductor, and the connector of the at least one conductor subassembly consist essentially of titanium or MP35N. 10. The method of claim 1 further comprising the step of forming the at least one conductor wire into the desired shape to be supported within the polymeric header body prior to the step of positioning the at least one conductor wire in the fixture. 11. The method of claim 1 wherein the step of drilling the through hole in the at least one connector is performed by electrical discharge machining or laser drilling. 12. The method of claim 1 wherein the step of joining the at least one conductor wire to the at least one connector is performed by welding the proximal end of the at least one conductor wire into the distal bore of the connector. 13. The method of claim 1 wherein the step of individually joining the at least one conductor wire to the at least one connector is performed by welding the proximal end of the at least one conductor wire to the distal end of the connector. 14. The method of claim 1 including removing the feedthrough adapter holder from the proximal end of the at least one conductive connector by engaging either groves or bores provided in opposed portions of the holder side wall. 15. A method for connecting a header assembly to an implantable medical device, comprising the steps of: a) providing the implantable medical device comprising a housing containing control circuitry, at least one electrical energy storage device, and at least one feedthrough wire extending from the control circuitry and through a wall of the housing;b) providing the header assembly comprised of an insulative body that is mountable at a bottom surface thereof to the housing of the medical device, and at least one conductor subassembly comprising: i) a terminal supported by the insulative body;ii) an intermediate conductor comprising a distal end connected to the terminal, and a proximal end; andiii) a connector comprising an outer surface, a distal end including a distal bore, a central region, a proximal end including a proximal bore, and a through hole extending from the outer surface into the proximal bore, wherein the distal end of the connector is supported by the insulative body, the proximal end of the intermediate conductor is disposed within the distal bore of the connector, and the proximal end of the connector including the through hole is exposed in a recess in the bottom surface of the insulative body;c) positioning the header assembly proximate to the implantable device wherein the at least one feedthrough wire is disposed in the proximal bore of the connector of the at least one conductor subassembly, and the bottom surface of the insulative body is proximate to the wall of the housing of the implantable medical device; andd) directing at least one laser beam through the through hole in the proximal bore of the connector and onto the at least one feedthrough wire disposed therein, to thereby connect the feedthrough wire of the implantable medical device to the connector of the at least one conductor subassembly. 16. The method of claim 15 further comprising the step of sealing the bottom surface of the insulative body of the header assembly to the wall of the housing of the implantable medical device. 17. The method of claim 16 wherein after the step of positioning the header assembly proximate to the implantable device, an interstice is present between at least a portion of the bottom surface of the insulative body proximate to the wall of the housing of the implantable medical device, and then filling the interstice with a curable liquid sealant. 18. The method of claim 17 wherein the curable liquid sealant consists essentially of an organopolysiloxane. 19. The method of claim 15 wherein the at least one feedthrough wire of the implantable medical device and the connector of the at least one conductor subassembly consist essentially of titanium or MP35N. 20. The method of claim 15 wherein: a) the implantable medical device is comprised of a plurality of feedthrough wires extending from the control circuitry and through the wall of the housing;b) the header assembly is comprised of a corresponding plurality of conductor subassemblies, each including a conductive connector comprising an outer surface, a distal end including a distal bore, a central region, a proximal end including a proximal bore, and a through hole extending from the outer surface into the proximal bore, wherein the distal end of the connector is supported by the insulative body, the proximal end of the intermediate conductor is disposed within the distal bore of the connector, and the proximal end of the connector including the through hole is exposed in a recess in the bottom surface of the insulative body, and wherein the proximal ends of the plurality of connectors are correspondingly positioned to receive the plurality of feedthrough wires of the implantable medical device in the proximal bores thereof;c) positioning the header assembly proximate to the implantable device such that each of the plurality of feedthrough wires are disposed individually in the correspondingly positioned proximal bores of the plurality of connectors; andd) directing a laser beam through the through holes in the proximal bores of the connectors and onto the individual feedthrough wires disposed therein to thereby weld the feedthrough wires of the implantable medical device to the connectors of the header assembly. 21. The method of claim 20 including providing six feedthrough wires positioned in a hexagonal pattern, and wherein there are six connectors positioned in a corresponding hexagonal pattern so that the feedthrough wires are disposable individually in the proximal bores of the connectors. 22. The method of claim 20 including providing eight feedthrough wires positioned in a pattern of two sets of four wires, and wherein there are eight connectors positioned in a corresponding pattern of two sets of four connectors so that the feedthrough wires are disposable individually in the proximal bores of the connectors. 23. The method of claim 22 wherein: a) the implantable medical device and the header assembly each comprise a proximal side and a distal side;b) the through holes in the proximal bores of a first group of connectors are viewable from the proximal side of the header assembly, and the through holes in the proximal bores of a second group of connectors are viewable from the distal side of the header assembly;c) directing the laser beam through the through holes in the proximal bores of the first group of connectors from the proximal side of the header assembly, and through the through holes in the proximal bores of the second group of connectors from the distal side of the header assembly.
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