One piece header assembly for an implantable medical device

• US 7,167,749 B2
• Filed: 11/05/2003
• Issued: 01/23/2007
• Est. Priority Date: 11/05/2002
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Wilson Greatbatch Technologies, Inc.
• Inventors: Faltisco, David A., Biggs, James C., Warchocki, David D., McNamara, George
• Primary Examiner(s): Pezzuto; Robert E.
• Assistant Examiner(s): Heller; Tammie K.
• Application Number:
  US10/701,849
• Publication Number:
  US 20040093038A1
• Time in Patent Office: 1,175 Days
• Field of Search: 607/10, 607/36, 607/37, 607/27, 439/909
• US Class Current: 607/36
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

A header assembly mounted to a medical device for connecting to at least one conductor lead terminating at a target organ or portion of the body intending to be assisted is described. The header assembly comprises a body of polymeric material supporting at least one unitary conductor wire. The conductor wire connects between a feedthrough wire exiting the medical device and a terminal block into which the conductor lead plugs. Various structures are described for connecting the conductor wire to the feedthrough wire.

Claims

1. A header assembly for connecting an implantable medical device to a conductor lead terminating at a body organ 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) a body mountable on the housing for the medical device, wherein the body has a sidewall extending to a bottom wall disposable immediately adjacent to the medical device housing and wherein a connection inlet is provided in the body sidewall extending to the bottom wall at the sidewall;

b) at least one terminal supported by the body, wherein the terminal is directly connectable to the conductor lead; and

c) an intermediate conductor supported by the body, the intermediate conductor having a distal end connected to the terminal and a proximal end comprising a step residing in the connection inlet in the body and there being securable to the feedthrough wire in a lap joint construction.

2. The header assembly of claim 1 wherein the body is of a polymeric material.

3. The header assembly of claim 1 wherein the body includes a first inlet that receives a bracket secured to the housing and a second inlet and wherein with the bracket received in the first inlet, a wedge is receivable in the second inlet and a bracket inlet to secure the header assembly to the medical device.

4. The header assembly of claim 1 wherein the housing for the medical device comprises mating first and second clam shells.

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

6. The header assembly of claim 1 wherein the intermediate conductor is a unitary member.

7. The header assembly of claim 1 wherein the sidewall comprising the body has spaced apart opposed portions and wherein the connection inlet extends to the bottom wall at both opposed portions of the sidewall.

8. A header assembly for connecting an implantable medical device to a conductor lead terminating at a body organ 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) a body mountable on the housing for the medical device, wherein the body has a sidewall extending to a bottom wall disposable immediately adjacent to the medical device housing and wherein a connection inlet is provided in the bottom wall;

b) at least one terminal supported by the body, wherein the terminal is directly connectable to the conductor lead; and

c) an intermediate conductor supported by the body, the intermediate conductor having a distal end connected to the terminal and a proximal end comprising an enlarged head having a bore into which the distal end of the feedthrough wire is receivable and connectable, wherein the enlarged head has a groove in communication with the bore, and a spring is nested in the groove so that when the feedthrough wire is received in the bore, the spring contacts the feedthrough wire.

9. The header assembly of claim 8 wherein the groove is an annular groove and the spring is an annular member supported in the groove to surround the feedthrough wire.

10. The header assembly of claim 8 wherein the spring is a leaf spring.

11. A method for connecting an implantable medical device to a conductor terminating at a body organ intended to be assisted by the medical device, comprising the steps of:

a) providing the medical device having a housing containing control circuitry, at least one electrical energy storage device and at least one feedthrough wire extending from the control circuitry through a wall of the housing to a distal end located outside the housing;

b) providing a body having a sidewall extending to a bottom wall and wherein a connection inlet is provided in the body sidewall extending to the bottom wall at the sidewall, the body supporting at least one terminal and at least one intermediate conductor, wherein the intermediate conductor has a distal end connected to the terminal and a proximal end comprising a step;

c) mounting the body on the medical device with the distal end of the feedthrough wire residing in the Connection inlet in the body and disposed in a lapped relationship with the step at the proximal end of the intermediate conductor;

d) connecting the distal end of the feedthrough wire to the proximal end of the intermediate conductor in a lap joint construction; and

e) back filling a polymeric material in the connection inlet to prevent body fluids from coming into contact with the lap joint connection between the intermediate conductor and the feedthrough wire.

12. The method of claim 11 including providing the body of a polymeric material.

13. The method of claim 11 including providing the body comprising a first inlet that receives a bracket secured to the housing and a second inlet and including the step of mounting the header assembly on the medical device with the bracket received in the first inlet and moving a wedge into the second inlet and a bracket inlet thereby securing the header assembly to the medical device.

14. A header assembly for connecting an implantable medical device to a conductor lead terminating at a body organ 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) a body mountable on the housing for a medical device;

b) at least one terminal supported by the body, and being directly connectable to the conductor lead; and

c) an intermediate conductor supported by the body, the intermediate conductor having a distal end connected to the terminal and a proximal end comprising a step that is securable to the feedthrough wire in a lap joint construction.

15. A header assembly for connecting an implantable medical device to a conductor lead terminating at a body organ 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) a body mountable on the housing for a medical device;

b) at least one terminal supported by the body, and being directly connectable to the conductor lead;

c) an intermediate conductor supported by the body, the intermediate conductor having a distal end connected to the terminal and a proximal end directly connectable to the feedthrough wire; and

d) wherein the body includes a first inlet that receives a bracket secured to the housing and a second inlet and wherein with the bracket received in the first inlet, a wedge is receivable in the second inlet and a bracket inlet to secure the header assembly to the medical device.

16. The header assembly of claim 15 wherein the bracket is either L-shaped or U-shaped.

17. A header assembly for connecting an implantable medical device to a conductor lead terminating at a body organ 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) a body mountable on the housing for the medical device, wherein the body has a sidewall extending to a bottom wall with a connection inlet provided in the body sidewall extending to the bottom wall at the sidewall, the bottom wall positionable immediately adjacent to the medical device housing, wherein the body includes a first inlet that receives a bracket secured to the housing and a second inlet and wherein with the bracket received in the first inlet, a wedge is receivable in the second inlet and a bracket inlet to secure the header assembly to the medical device;

b) at least one terminal supported by the body, wherein the terminal is directly connectable to the conductor lead; and

c) an intermediate conductor supported by the body, the intermediate conductor having a distal end connected to the terminal and a proximal end residing in the connection inlet in the body and there being directly connectable to the feedthrough wire.

18. The header assembly of claim 17 wherein the bracket is either L-shaped or U-shaped.

19. A header assembly for connecting an implantable medical device to a conductor lead terminating at a body organ intended to be assisted by the medical device comprising a housing of mating first and second clam shells in either an overlapping or butt welded construction and 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) a body mountable on the mating first and second housing clam shells in either the overlapping or butt welded construction, wherein the body has a sidewall extending to a bottom wall disposable immediately adjacent to the medical device housing and wherein a connection inlet is provided in the body sidewall extending to the bottom wall at the sidewall;

b) at least one terminal supported by the body, wherein the terminal is directly connectable to the conductor lead; and

c) an intermediate conductor supported by the body, the intermediate conductor having a distal end connected to the terminal and a proximal end residing in the connection inlet in the body and there being directly connectable to the feedthrough wire.

20. A method for connecting an implantable medical device to a conductor terminating at a body organ intended to be assisted by the medical device,:

comprising the steps of;

a) providing the medical device having a housing containing control circuitry, at least one electrical energy storage device and at least one feedthrough wire extending from the control circuitry through a wall of the housing to a distal end located outside the housing;

b) providing a body having a sidewall extending to a bottom wall and wherein a connection inlet is provided in the bottom wall, the body supporting at least one terminal and at least, one intermediate conductor, wherein the intermediate conductor has a distal end connected to the terminal and a proximal end comprising an enlarged head having a bore comprising a groove supporting a spring;

c) mounting the body on the medical device with the distal end of the feedthrough wire received in the bore of the enlarged head of the intermediate conductor residing in the connection inlet in the body with the spring contacting the feedthrough wire; and

d) back filling a polymeric material in the connection inlet to prevent body fluids from coming into contact with the connect ion between the intermediate conductor and the feedthrough wire.

21. The method of claim 20 including providing the groove as an annular groove and the spring as an annular member supported in the groove surrounding the feedthrough wire.

22. The method of claim 20 including providing the spring as a leaf spring.

23. A method for connecting an implantable medical device to a conductor terminating at a body organ intended to be assisted by the medical device, comprising the steps of:

a) providing the medical device having a housing containing control circuitry, at least one electrical energy storage device and at least one feedthrough wire extending from the control circuitry through a wall of the housing to a distal end located outside the housing;

b) providing a body having a sidewall extending to a bottom wall and wherein a connection inlet is provided in the body sidewall extending to the bottom wall at the sidewall and including providing the body comprising a first inlet and a second inlet, the body supporting at least one terminal and at least one intermediate conductor, wherein the intermediate conductor has a distal end connected to the terminal and a proximal end;

c) securing the body on the medical device with the distal end of the feedthrough wire residing in the connection inlet in the body and disposed in a connectable relationship with the proximal end of the intermediate conductor and with the first inlet of the body receiving a bracket secured to the housing, and moving a wedge into the second inlet and a bracket inlet thereby securing the header assembly to the medical device;

d) connecting the distal end of the feedthrough wire to the proximal end of the intermediate conductor; and

e) back filling a polymeric material in the connection inlet to prevent body fluids from coming into contact with the connection between the intermediate conductor and the feedthrough wire.