Defibrillator housing with conductive polymer coating

• US 6,295,474 B1
• Filed: 03/13/1998
• Issued: 09/25/2001
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: Intermedics Incorporated
• Original Assignee: Intermedics Incorporated
• Inventors: Munshi, M. Zafar Amin
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/042,255
• Time in Patent Office: 1,292 Days
• Field of Search: 607/5, 607/7, 607/8, 607/36, 607/121, 607/120
• US Class Current: 607/121
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49218 with deforming
• CPC Class Codes: Y10T 29/4922 with molding of insulation

Abstract

An ionically conductive polymeric composition for coating a hot can defibrillator electrode. A polymeric coating, such as polyethylene oxide containing NaCl or a similar ionic medium, coats and fills the pores of a high surface area electrode to provide a continuous ionic network from the can to the adjacent body tissue. In certain embodiments, the underlying high surface area, porous electrode is made by chemically etching a smooth electrode surface, such as that of a conventional titanium housing, followed by applying a thin coating of a noble metal such as platinum. In other embodiments, a noble metal or an oxide thereof, such as platinum black or iridium oxide, is applied to a titanium housing to form a porous, high surface area electrode. The conductive polymeric coating is then applied over the porous noble metal or metal oxide. The electrically conductive polymeric material is biocompatible, chemically and mechanically stable and does not dissolve or leach out over the useful lifetime of the defibrillator. A hot can defibrillator employing the new polymeric coating avoids development of high polarization at the can/tissue interface and maintains a more uniform defibrillation threshold than conventional implantable defibrillators, thus increasing the feasibility of pectoral implantation, particularly in a “dry pocket” environment.

Claims

1. An implantable electrode for cardiac stimulators comprising:

an electrically conductive titanium substrate, the substrate having a rough surface;

an oxidation resistant layer, selected from the group consisting of platinum, ruthenium, rhodium, palladium, osmium, iridium and alloys thereof, the oxidation resistant layer deposited on and substantially conforming to the substrate rough surface resulting in an oxidation resistant layer having a rough exposed surface; and

an electrically conductive polymeric layer deposited on and substantially conforming to the oxidation resistant layer rough surface, resulting in the polymeric layer having a smooth outer surface, the electrically conductive polymeric layer comprising a polymer and an ionic medium admixed with the polymer, the polymer having a molecular weight of about 100,000-10,000,000 daltons.

2. An implantable electrode for cardiac stimulators comprising:

an electrically conductive titanium substrate, the substrate having a smooth surface;

a porous oxidation resistant layer, selected from the group of metal and metal oxides consisting of platinum, platinum black, and oxides of platinum, ruthenium, rhodium, palladium, osmium, and iridium, the porous oxidation resistant layer deposited on and substantially conforming to the substrate surface resulting in an oxidation resistant layer having a rough exposed surface; and

an electrically conductive polymeric layer deposited on and substantially conforming to the oxidation resistant layer rough surface, resulting in the polymeric layer having a smooth outer surface, the electrically conductive polymeric layer comprising a polymer and an ionic medium admixed with the polymer, the polymer having a molecular weight of about 100,000-10,000,000 daltons.

3. An implantable electrode comprising:

a conductive metal substrate having a rough porous surface; and

an electrically conductive polymeric coating covering the conductive substrate surface forming a substantially smooth surface.

4. The electrode of claim 3 wherein the conductive substrate is titanium.

5. An implantable electrode comprising:

a conductive substrate;

an electrically conductive polymeric coating covering at least a portion of the conductive substrate forming a smooth surface; and

a layer of an oxidation resistant metal between the conductive substrate and the electrically conductive polymeric coating.

6. The electrode of claim 5 wherein the oxidation resistant metal is selected from the group consisting of platinum, ruthenium, rhodium, palladium, osmium, iridium and alloys thereof.

7. An implantable electrode comprising:

a conductive substrate; and

an electrically conductive polymeric coating covering at least a portion of the conductive substrate forming a smooth surface, the electrically conductive polymeric coating comprising a compound consisting of a polymer and an ionic medium admixed with the polymer, the polymer having a molecular weight large enough to avoid solubilization of the polymer or the ionic medium.

8. The electrode of claim 7 wherein the polymer is selected from the group consisting of polyethylene oxide, polyethylene terpthalate, hydrogels and polyacrylates.

9. The electrode of claim 7 wherein the polymer is polyethylene oxide having a molecular weight of about 100,000-10,000,000 daltons.

10. The electrode of claim 7 wherein the ionic medium is an ionizable compound adapted to not significantly alter a human recipient'"'"'s body chemistry.

11. The electrode of claim 7 wherein the ionic medium is NaCl.

12. The electrode of claim 7 wherein the compound further comprises a steroid.

13. The electrode of claim 7 wherein the compound further comprises an inorganic filler.

14. The electrode of claim 7 wherein the conductive substrate further comprising a porous electrically conductive layer covering at least a portion of the substrate, the electrically conductive polymeric coating permeates the porous layer.

15. The electrode of claim 14 wherein the porous electrically conductive layer is selected from the group consisting of metal and metal oxide.

16. The electrode of claim 14 wherein the porous electrically conductive layer is platinum black.

17. The electrode of claim 14 wherein the porous electrically conductive layer is a metal oxide selected from the group consisting of oxides of platinum, ruthenium, rhodium, palladium, osmium and iridium.

18. The electrode of claim 14 wherein the porous electrically conductive layer is iridium oxide.

19. An implantable electrode comprising:

a conductive substrate;

an electrically conductive polymeric coating covering at least a portion of the conductive substrate forming a smooth surface; and

a porous electrically conductive layer between the conductive substrate and the electrically conductive polymeric coating, the electrically conductive polymeric coating permeates the porous electrically conductive layer.

20. The electrode of claim 19 wherein the porous electrically conductive layer is selected from the group consisting of metal and metal oxide.

21. The electrode of claim 19 wherein the porous electrically conductive layer is platinum black.

22. The electrode of claim 19 wherein the porous electrically conductive layer is a metal oxide selected from the group consisting of oxides of platinum, ruthenium, rhodium, palladium, osmium and iridium.

23. The electrode of claim 19 wherein the porous electrically conductive layer is iridium oxide.

24. The electrode of claim 19 wherein the conductive substrate conforms to at least a portion of an enclosure.

25. The electrode of claim 19 wherein the conductive substrate is an enclosure adapted to house a stimulus generator.

26. An implantable electrode for cardiac stimulators comprising:

a substrate adapted to house a stimulus generator, at least a portion of the substrate is electrically conductive, the portion having a rough surface;

an oxidation resistant layer, selected from the group consisting of platinum, ruthenium, rhodium, palladium, osmium, iridium and alloys thereof, the oxidation resistant layer deposited on and substantially conforming to the substrate electrically conductive portion resulting in an oxidation resistant layer having a rough surface; and

an electrically conductive polymeric layer deposited on and substantially permeating to the oxidation resistant layer, resulting in the polymeric layer having a smooth outer surface.

27. The electrode of claim 26 wherein the electrically conductive polymeric layer comprising a polymer and an ionic medium admixed with the polymer.

28. An implantable electrode for cardiac stimulators comprising:

a substrate adapted to house a stimulus generator, at least a portion of the substrate is electrically conductive;

a porous oxidation resistant layer selected from the group of metal and metal oxides consisting of platinum, platinum black and oxides of platinum, ruthenium, rhodium, palladium, osmium, and iridium, the porous oxidation resistant layer deposited on the substrate electrically conductive portion resulting in an oxidation resistant layer having a rough surface; and

an electrically conductive polymeric layer deposited on and substantially permeating to the oxidation resistant layer, resulting in the polymeric layer having a smooth outer surface.

29. The electrode of claim 28 wherein the electrically conductive polymeric layer comprising a polymer and an ionic medium admixed with the polymer.