MOLDED HEADER CONNECTED TO A MEDICAL DEVICE BY LATERAL DEFORMATION OF A SLEEVE/FEEDTHROUGH PIN SUB-ASSEMBLY

• US 20100038132A1
• Filed: 06/01/2009
• Published: 02/18/2010
• Est. Priority Date: 08/13/2008
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Kustra, Gabriel A., Coffed, James, KINNEY, JAMES
• Granted Patent: US 8,346,362 B2
• Time in Patent Office: Days
• US Class Current: 174/659
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: Y10T 29/49208 by assembling plural parts

Abstract

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 numerous feedthrough wires in a dense, non-linear, scattered format 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 wire comprising a distal end connected to the terminal and a proximal end connected to a connector sleeve. Methods for making the header assembly and for connecting the header assembly to the implantable medical device are also disclosed.

Claims

1. 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 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, the header assembly comprising:

a) an insulative body that is mountable at a bottom surface thereof on the housing of the medical device; and

b) at least one conductor subassembly comprising;

i) a terminal supported by the insulative body, wherein the terminal is directly connectable to the at least one conductor lead;

ii) a conductor wire comprising a distal end connected to the terminal, and a proximal end;

iii) a feedthrough adaptor holder/interconnector having a slidable upper plate and a slidable lower plate wherein the upper plate and the lower plate have through holes that extend from the top of the upper plate to the bottom of the lower plate; and

iv) a connector sleeve comprising an outer surface, a distal end including a distal bore, a proximal end including a proximal bore, wherein the distal end of the connector sleeve is supported by the insulative body, the proximal end of the intermediate conductor wire is disposed within the distal bore of the connector sleeve, a portion of the connector sleeve is positioned in the feedthrough adaptor holder/interconnector, and the proximal bore of the connector sleeve is connectable to the at least one feedthrough wire of the implantable medical device.

2. The header assembly of claim 1 wherein the implantable device is comprised of a plurality of feedthrough wires extending from the control circuitry and through a wall of the housing, and wherein the header assembly further comprises a corresponding plurality of conductor subassemblies.

3. The header assembly of claim 2 wherein the insulative body is comprised of an extended boss supporting the distal end and a central region of each of the connector sleeves.

4. The header assembly of claim 1 wherein the insulative body is of a molded polymeric material.

5. The header assembly of claim 1 wherein the terminal, the conductor wire, and the connector are each selected from the group consisting of titanium, nickel-titanium alloy, stainless steel, platinum, iridium, niobium, palladium, and mixtures thereof.

6. The header assembly of claim 1 wherein the connector sleeve is of a cylindrical shape.

7. The header assembly of claim 1 wherein the medical device is selected from the group consisting of a hearing assist device, a neurostimulator, a cardiac pacemaker, a drug pump, a cardiac defibrillator, and an obesity control device.

8. The header assembly of claim 1 wherein an interstice is between the insulative body'"'"'s bottom surface and the medical device'"'"'s top surface, and wherein the conductive connector sleeve'"'"'s proximal end including the proximal bore is disposed within the interstice.

9. The header assembly of claim 8 wherein the interstice between the insulative body'"'"'s bottom surface and the medical device'"'"'s top surface is filled with a liquid sealant after the feedthrough wires and the connectors are securely joined.

10. The header assembly of claim 1 wherein the slidable upper plate'"'"'s through holes and the slidable lower plate'"'"'s through holes are aligned, each aligned through hole receiving one connector sleeve and each connector sleeve'"'"'s proximal bore receiving one feedthrough wire from the medical device.

11. The header assembly of claim 1 wherein the slidable upper plate'"'"'s through holes and the slidable lower plate'"'"'s through holes are misaligned after each connector sleeve'"'"'s proximal bore receives one feedthrough wire from the medical device so the connector sleeve and the medical device'"'"'s feedthrough wire are crimped together.

12. A method for making a header assembly for connecting an implantable medical device'"'"'s feedthrough wire to a conductor lead terminating within a patient intended to be assisted by the medical device, the method comprising the steps of:

a) obtaining a medical device comprising a housing containing control circuitry, an electrical energy storage device, and at least two feedthrough wires in a dense, non-linear format extending from the control circuitry and through a wall of the housing;

b) forming a conductor subassembly comprising the steps of;

i) providing a conductive connector sleeve comprising an outer surface, a distal end, a central region, and a proximal end including a proximal bore;

ii) providing a feedthrough adapter holder/interconnector comprised of a slidable upper plate shaped body and a slidable lower plate shaped body, wherein each slidable plate shaped body has an upper surface, a lower surface, a side wall, and a plurality of through holes that correspond to at least the number of feedthrough wires, each through hole extends from the slidable upper plate shaped body'"'"'s upper surface to the slidable lower plate shaped body'"'"'s lower surface, each through hole having a diameter sized to enable a press fit with a portion of the conductive connector sleeve;

iii) moving the conductive connector sleeve into a through hole such that the slidable upper plate shaped body and the slidable lower plate shaped body of the feedthrough adapter holder/interconnector engages with a portion of the conductive connector sleeve'"'"'s central region;

iv) interconnecting the conductor wire'"'"'s proximal end to the conductive connector sleeve at or near the conductive connector sleeve'"'"'s distal end; and

v) interconnecting the conductor wire'"'"'s distal end to the conductor lead'"'"'s terminal;

c) placing the conductor subassembly in a mold cavity;

d) molding a polymeric material as a monolithic header body around the conductor subassembly to form the header assembly;

e) removing the header assembly from the mold;

f) positioning the connector sleeve'"'"'s proximal end and/or the through hole over a medical device'"'"'s at least two feedthrough wires, so each connector'"'"'s proximal bore receives a feedthrough wire; and

g) crimping the connector sleeve to the feedthrough wire by moving one slidable plate in a first direction and the other slidable plate in an opposite direction or no movement at all.

13. The method of claim 12 wherein the step of placing the 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.

14. The method of claim 12 wherein the step of placing the conductor subassembly in a mold cavity includes placing a mold insert within the mold cavity, and 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/interconnector 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.

15. The method of claim 12 wherein the header assembly is comprised of a plurality of conductor subassemblies, each subassembly comprised of a conductive connector sleeve, a conductor wire, and a terminal.

16. The method of claim 12 wherein the feedthrough adapter holder/interconnector is selected from the group consisting of polysulfone polymeric material or polyetheretherketone material.

17. The method of claim 12 wherein the terminal, the conductor wire, and the conductive connector sleeve are each selected from the group consisting of titanium, nickel-titanium alloy, stainless steel, platinum, iridium, niobium, palladium, and mixtures thereof.

18. The method of claim 12 wherein the step of joining the conductor wire to the conductive connector is performed by welding the conductor wire'"'"'s proximal end into the conductive connector'"'"'s distal bore.

19. The method of claim 12 wherein the step of positioning the connector'"'"'s proximal end and/or the through hole over a medical device'"'"'s plurality of feedthrough wires forms an interstice between the header assembly'"'"'s bottom surface and the medical device'"'"'s top surface, and wherein the conductive connector'"'"'s proximal end including the proximal bore is disposed within the interstice.

20. The method of claim 19 further comprising the step of filling the interstice between the insulative body'"'"'s bottom surface and the medical device'"'"'s top surface with a liquid sealant after the feedthrough wires and the connectors are securely joined.

21. The method of claim 12 wherein the medical device is selected from the group consisting of a hearing assist device, a neurostimulator, a cardiac pacemaker, a drug pump, a cardiac defibrillator, and an obesity control device.

22. 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 two feedthrough wires positioned in a dense, non-linear format, and 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) a plurality of conductor wires that at least equal the number of feedthrough wires and each conductor wire comprising a distal end connected to the terminal, and a proximal end; and

iii) a feedthrough adaptor holder/interconnector having a slidable upper plate and a slidable lower plate wherein the upper plate and the lower plate have a plurality of through holes that at least equal the number of feedthrough wires and that extend from the top of the upper plate to the bottom of the lower plate; and

iv) a plurality of connector sleeves that at least equal the number of feedthrough wires, each connector sleeve comprising a distal end, a central region, a proximal end including a proximal bore, wherein the distal end of the connector sleeve is supported by the insulative body, the proximal end of the conductor wire interconnects to the connector sleeve, a portion of the central region is positioned in the feedthrough adaptor holder/interconnector, and the proximal bore of each connector sleeve is connectable to one feedthrough wire of the implantable medical device;

c) positioning the header assembly proximate to the implantable device, wherein each feedthrough wire is disposed in a respective proximal bore of the connector sleeve, and the bottom surface of the insulative body and the wall of the housing of the implantable medical device form an interstice; and

d) moving one slidable plate in a first direction and the other slidable plate in an opposite direction or not moved at all, to thereby crimp the feedthrough wire of the implantable medical device to the connector sleeve of the at least one conductor subassembly.

23. The method of claim 22 further comprising the step of filling the interstice with a curable liquid sealant.

24. The method of claim 23 wherein the curable liquid sealant consists essentially of an organopolysiloxane.

25. The method of claim 22 wherein the at least one feedthrough wire of the implantable medical device and the connector are each selected from the group consisting of titanium, nickel-titanium alloy, stainless steel, platinum, iridium, niobium, palladium, and mixtures thereof.