ONE PIECE HEADER ASSEMBLY FOR AN IMPLANTABLE MEDICAL DEVICE

• US 20060047321A1
• Filed: 11/11/2005
• Published: 03/02/2006
• Est. Priority Date: 02/08/2001
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Wilson Greatbatch Technologies, Inc.
• Inventors: Faltisco, David A., Frenz, Norbert W. Jr., Biggs, James C.
• Granted Patent: US 7,751,893 B2
• Time in Patent Office: Days
• US Class Current: 607/37
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

The present invention is directed to a header assembly attachable to a medical device for the purpose of connecting its output terminals to at least one lead, the lead terminating at a target organ or portion of the body intending to be assisted. A number of leads are connectable to the header, including single and coaxial leads. The header assembly may be molded directly to the medical device or preformed and then attached to the device casing, either by mechanical fastener and/or chemical adhesive.

Claims

1. A header for an implantable medical device, the assembly comprising:

a) the implantable medical device comprising;

i) a first housing portion comprising a first major face wall supporting a first sidewall partially surrounding the first face wall except at a first open end;

ii) a second housing portion comprising a second major face wall supporting a second sidewall partially surrounding the second face wall except at a second open end;

iii) wherein the first and second housing portions are matable with the first and second open ends being in alignment with each other to provide a housing opening;

iv) control circuitry and at least one electrical energy storage device contained inside the housing with the first casing portion mated to the second casing portion; and

v) a lid for closing the housing opening;

b) the header comprising;

i) a body;

ii) the body supporting a terminal; and

iii) at least one feedthrough wire having a distal end connected to the terminal and a proximal end extending from the body; and

c) the lid having an upper surface to which the body is secured and an opening through which the feedthrough wire extends, the feedthrough wire being electrically insulated from the housing and the lid by a seal;

d) a first passageway extending into the body leading to the terminal, wherein a lead of a conductor is movable into the first passageway to connect the terminal with the conductor terminating at an organ intended to be assisted by the medical device; and

e) wherein the lid supporting the body is connected to the first housing portion mated to the second housing portion to close the medical device by closing the housing opening formed by the aligned first and second open ends of the housing portions with the proximal end of the feedthrough wire connected to the control circuitry contained therein.

2. The assembly of claim 1 wherein the body further supports third and fourth terminals having third and fourth lead openings aligned in a second co-axial relationship along a second bore communicating from outside the body to the third and fourth terminals.

3. The assembly of claim 2 wherein the first co-axial relationship of the first and second lead openings along the first bore is offset with respect to the second co-axial relationship of the third and fourth lead openings aligned along the second bore.

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

5. The assembly of claim 1 wherein a threaded member is receivable in first and second apertures provided in the respective first and second terminals.

6. The assembly of claim 5 wherein the second and fourth passageways are in communication with the first and second apertures in the respective first and second terminals.

7. The assembly of claim 1 wherein the first bore is sized to receive the lead of the conductor in the first and second lead openings of the first and second terminals.

8. The assembly of claim 1 wherein the first bore includes an annular channel supporting an O-ring for sealing about the lead of the conductor received in the first and second lead openings.

9. The assembly of claim 1 wherein the electrical energy storage device is selected from a battery and a capacitor and wherein the medical device is selected from the group consisting of a hearing assist device, neurostimulator, cardiac pacemaker, drug pump, and cardiac defibrillator.

10. 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 comprising at least a first and a second wall portions mateable together to provide the housing;

b) positioning control circuitry, at least one electrical energy storage device and at least one feedthrough wire nested in the first wall portion, the feedthrough wire extending from the control circuitry through the first wall portion of the housing to a distal end of the feedthrough wire located outside the first wall portion, wherein the first wall portion is not mated to the second wall portion;

c) molding a body of polymeric material supporting a terminal connectable to a lead of the conductor, wherein the body further includes a first passageway extending into the body leading to the terminal and a second passageway extending into the body in communication with the terminal and the first passageway;

d) positioning the body on the first wall portion of the housing with the distal end of the feedthrough wire extending through the first passageway to contact the terminal;

e) accessing the terminal through the second passageway to electrically connect the feedthrough wire to the terminal;

f) mating the second wall portion to the first wall portion to complete the housing for the medical device; and

g) connecting the lead of the conductor to the terminal.

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 comprising at least a first and a second wall portions which are mateable together to provide the housing;

b) positioning control circuitry, at least one electrical energy storage device and a first and a second feedthrough wires nested in the first wall portion, the feedthrough wires extending from the control circuitry through the first wall portion of the housing to first and second distal ends of the feedthrough wires located outside the first wall portion, wherein the first wall portion is not mated to the second wall portion;

c) molding a body of polymeric material having a bore communicating from outside the body to first and second terminals, wherein the terminals include first and second lead openings aligned in a co-axial relationship, and wherein the body further includes a first passageway extending into the body leading to the first terminal and a second passageway extending into the body in communication with the first terminal and the first passageway, and wherein the body further includes a third passageway extending into the body leading to the second terminal and a fourth passageway extending into the body in communication with the second terminal and the third passageway;

d) positioning the body on the first wall portion of the housing with the distal ends of the first and second feedthrough wires extending through the respective first and third passageways to contact the first and second terminals;

e) accessing the first terminal through the second passageway to electrically connect the distal end of the first feedthrough wire to the first terminal, and accessing the second terminal through the fourth passageway to electrically connect the distal end of second feedthrough wire to the second terminal;

f) mating the second wall portion to the first wall portion to complete the housing for the medical device; and

g) moving the lead of the conductor into the bore of the body with the lead received in the first and second lead openings aligned in the co-axial relationship.

12. The method of claim 11 including providing the housing having third and fourth feedthrough wires extending from the control circuitry and through the first wall portion of the housing to respective third and fourth terminals having third and fourth lead openings aligned in a second co-axial relationship along a second bore communicating from outside the body to the third and fourth terminals.

14. The method of claim 11 including providing the bore having an annular channel supporting an O-ring for sealing about a lead of the conductor received in the first and second lead openings of the first and second terminals.

15. The method of claim 11 including selecting the electrical energy storage device from a battery and a capacitor.

16. The method of claim 11 including selecting the medical device from the group consisting of a hearing assist device, neurostimulator, cardiac pacemaker, drug pump and cardiac defibrillator.

17. The method of claim 11 including selecting the first and second terminals from the group consisting of a terminal block, a sleeve, a ring-shaped member supporting a coil spring and a ring shaped member supporting at least one leaf spring.

18. The method of claim 11 including providing the first and second terminals having respective first and second apertures in communication with the first and second lead openings and the respective second and fourth passageways.

19. The method of claim 18 including threading a threaded member into the first and second apertures of the respective first and second terminals to retain the lead in place.

20. The method of claim 11 including providing the first and second wall portions as mating first and second clam shell housing portions closed by a lid.

13. The method of claim 111 including providing the housing for the medical device comprising mating first and second clam shell housing portions closed by a lid.