Knitted electrode assembly for an active implantable medical device

• US 8,923,984 B2
• Filed: 08/28/2009
• Issued: 12/30/2014
• Est. Priority Date: 09/17/2008
• Status: Active Grant

• Current Assignee: Saluda Medical Pty Ltd.
• Original Assignee: Saluda Medical Pty Ltd.
• Inventors: Parker, John L., Robinson, David
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US12/549,899
• Publication Number:
  US 20100070008A1
• Time in Patent Office: 1,950 Days
• Field of Search: 607/37, 607/45, 607/2, 607/5, 600/378
• US Class Current: 607/116
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: D04B 1/12 characterised by thread material
• CPC Class Codes: D10B 2401/16 antistatic; conductive
• CPC Class Codes: D10B 2403/02 Cross-sectional features for three-dimensional features D10B2403/033
• CPC Class Codes: D10B 2403/02431 with electronic components, e.g. sensors or switches

Abstract

An active implantable medical device (AIMD). The AIMD comprises an electronics module; and a knitted electrode assembly comprising: at least one biocompatible, electrically non-conductive filament arranged in substantially parallel rows each stitched to an adjacent row, and at least one biocompatible, electrically conductive filament intertwined with the at least one non-conductive filament, and configured to be electrically connected to the electronics module.

Claims

1. An active implantable medical device (AIMD), comprising:

an electronics module; and

a knitted electrode assembly having an intermeshed loop structure, the knitted electrode assembly further comprising;

at least one biocompatible, electrically non-conductive filament arranged in substantially parallel rows each row stitched to an adjacent row with one or more loops, and

at least one biocompatible, electrically conductive filament intertwined with the at least one row of non-conductive filament, the at least one electrically conductive filament formed on an exterior surface of the electrode assembly to form an electrode on the exterior surface of the electrode assembly, and the at least one conductive filament configured to be electrically connected to the electronics module.

2. The AIMD of claim 1, wherein the at least one non-conductive filament consists of a single continuous non-conductive filament.

3. The AIMD of claim 1, wherein the at least one conductive filament consists of a plurality of conductive filaments each intertwined with separate rows of non-conductive filament.

4. The AIMD of claim 1, wherein a section of the at least one conductive filament is wound around a section of the one or more loops of the at least one non-conductive filament, and wherein the knitted electrode assembly consists of:

substantially parallel rows of the at least one non-conductive filament having the conductive filament wound there around.

5. The AIMD of claim 1, wherein the at least one conductive filament is arranged in at least one row substantially parallel to a section of the at least one non-conductive filament.

6. The AIMD of claim 1, wherein the knitted electrode assembly is constructed and arranged as an elongate tube.

7. The AIMD of claim 6, wherein the knitted electrode assembly further comprises:

a biocompatible, electrically non-conductive cylindrical support structure positioned in the knitted tube such that the tube is disposed on the surface of the support structure.

8. The AIMD of claim 1, wherein the electrode assembly forms a substantially planar sheet.

9. The AIMD of claim 1, further comprising:

at least one active component positioned in the electrode assembly.

10. The AIMD of claim 9, wherein the at least one active component comprises an actuator.

11. The AIMD of claim 9, wherein the at least one active component comprises a hermetically sealed electronics package.

12. The AIMD of claim 1, wherein the at least one non-conductive filament comprises a drug-eluting polymer.

13. The AIMD of claim 1, wherein the at least one non-conductive filament comprises a thermo-softening plastic material.

14. The AIMD of claim 1, wherein the at least one non-conductive filament comprises an insulated conductive wire configured for use in measuring strain experienced by one or more sections of the electrode assembly.

15. The AIMD of claim 1, wherein a section of the conductive filament between the intertwined portion and the electronics module has a helical shape formed from coils.

16. The AIMD of claim 15, wherein the section of the conductive filament between the intertwined portion and the electronics module is woven into one or more loops of a plurality of the rows.

17. The AIMD of claim 1, wherein the electronics module is configured to generate electrical stimulation signals, and wherein the intertwined portion of the conductive filament is configured to deliver the stimulation signals to tissue of a recipient of the AIMD.

18. The AIMD of claim 1, wherein the intertwined portion of the conductive filament is configured to sense a nerve impulse generated by the tissue of the recipient, and to transmit an electrical signal representing the nerve impulse to the electronics module.

19. A method for manufacturing a knitted implantable electrode assembly having an intermeshed loop structure comprising:

providing at least one biocompatible, electrically non-conductive filament, and at least one biocompatible, electrically conductive filament; and

knitting the at least one non-conductive filament into substantially parallel rows each row stitched to and adjacent row with one or more loops, with the at least one conductive filament intertwined with the at least one row of non-conductive filament, the at least one electrically conductive filament formed on an exterior surface of the electrode assembly to form an electrode on the exterior surface of the electrode assembly, and the at least one conductive filament configured to be electrically connected to an electronics module.

20. The method of claim 19, wherein the at least one non-conductive filament consists of a continuous single non-conductive filament, and wherein the method comprises:

knitting the single non-conductive filament into substantially parallel rows each stitched to an adjacent row with the at least one conductive filament intertwined with the non-conductive filament.

21. The method of claim 19, wherein the at least one conductive filament consists of a plurality of conductive filaments, and wherein the method further comprises:

knitting the at least one non-conductive filament such that the plurality of conductive filaments are each intertwined with separate rows of the non-conductive filament.

22. The method of claim 19, further comprising:

winding the at least one conductive filament around a section of one or more loops of the at least one non-conductive filament prior to knitting; and

knitting the least non-conductive filament having the conductive filament wound there around into substantially parallel rows each stitched to an adjacent row.

23. The method of claim 19, further comprising:

concurrently knitting the at least one conductive filament with a section of the at least one non-conductive filament such that the at least one conductive filament forms at least one row substantially parallel to the section of at least one non-conductive filament.

24. The method of claim 19, wherein knitting the at least one non-conductive filament into the substantially parallel rows comprises:

circular knitting the at least one non-conductive filament into an elongate tube.

25. The method of claim 24, further comprising:

positioning a biocompatible, electrically non-conductive cylindrical support structure in the interior of the elongate tube.

26. The method of claim 19, wherein knitting the at least one non-conductive filament into the substantially parallel rows comprises:

flat knitting an electrode assembly to form a substantially planar sheet.

27. The method of claim 19, further comprising:

positioning one or more active components in the electrode assembly.

28. The method of claim 19, wherein providing the at least one non-conductive filament comprises:

providing at least one non-conductive filament comprising a drug-eluting polymer.

29. The method of claim 19, wherein providing the at least one non-conductive filament comprises:

providing at least one non-conductive filament that comprises a thermo-softening plastic material.

30. The method of claim 29, further comprising:

molding the electrode assembly into a desired shape.

31. The method of claim 19, wherein providing the at least one non-conductive filament comprises:

providing at least one insulated conductive wire configured for use in measuring strain experienced by one or more sections of the electrode assembly.

32. The method of claim 19, wherein the conductive filament is configured to be electrically connected to an electronics module, and wherein the method further comprises:

forming a section of the conductive filament between the intertwined portion and the electronics module into a helical shape using coils.

33. The method of claim 32, wherein the electrode assembly is a circular knit elongate tube, and wherein forming the section of the conductive filament into a helical shape comprises:

forming the helical shape during the circular knitting process.

34. The method of claim 32, further comprising:

weaving the section of the conductive filament between the intertwined portion and the electronics module into one or more loops of a plurality of the rows.