Implantable stimulation electrodes with non-native metal oxide coating mixtures

• US 5,683,443 A
• Filed: 02/07/1995
• Issued: 11/04/1997
• Est. Priority Date: 02/07/1995
• Status: Expired due to Term

• Current Assignee: Intermedics Incorporated (Boston Scientific Corporation)
• Original Assignee: Intermedics Incorporated (Boston Scientific Corporation)
• Inventors: Bonnerup, Chris A., Munshi, M. Zafar A., Rosborough, John P.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/384,755
• Time in Patent Office: 1,001 Days
• Field of Search: 607/116, 607/119, 607/115, 607/121, 128/642
• US Class Current: 607/121
• 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 1/0565 Electrode heads

Abstract

The invention relates to an improved stimulation electrode for cardiac pacing and defibrillating, methods of manufacturing same, and methods of using same. Specifically, the electrodes of the invention by virtue of the methods of manufacturing and using, demonstrate improved capabilities of stimulating and sensing neuromuscular tissues. The electrodes have enhanced electrically-accessible surface areas which are coated with oxides of valve metals.

Claims

1. An implantable stimulation electrode, comprising:

a metal surface essentially devoid of native metal oxides further comprising a metal selected from the group of metals consisting of valve metals or their alloys;

said metal surface further comprising an electrically-accessible area;

said electrically-accessible area further comprising a macroscopically-enhanced surface area;

said macroscopically-enhanced area further comprising a microscopically-enhanced surface area; and

,

a non-native coating upon said metal surface comprising a mixture of at least two metal oxides selected from the group of metal oxides consisting of oxides of valve metals, noble metals, alloys of valve metals, alloys of noble metals, mixtures of valve and noble metals, said metal oxide or metal oxides capable of reversible reduction-oxidation.

2. The implantable stimulation electrode of claim 1, wherein said electrode comprises a pacing electrode.

3. The implantable stimulation electrode of claim 1, wherein said electrode comprises a defibrillating electrode.

4. The implantable stimulation electrode of claim 1, wherein said valve metals or their alloys further comprise iridium, iridium alloys, titanium, titanium alloys, platinum, platinum alloys, tantalum, and tantalum alloys.

5. The implantable stimulation electrode of claim 1, wherein said macroscopically-enhanced area further comprises indentations.

6. The implantable stimulation electrode of claim 5, wherein said indentation comprises a multiplicity of tube-shaped receptacles.

7. The implantable stimulation electrode of claim 6, wherein said receptacles are between about 10 and 90% of the depth of said metal surface.

8. The implantable stimulation electrode of claim 6, wherein said receptacles are between about 20 and 100 micrometers in diameter.

9. The implantable stimulation electrode of claim 6, wherein said receptacles are between about 20 and 30 micrometers in diameter.

10. The implantable stimulation electrode of claim 6, wherein said receptacles occur at a density of at least 10 to 400 receptacles per square millimeter of said metal surface.

11. The implantable stimulation electrode of claim 6, wherein said receptacles occur at a density of at least 150 to 350 receptacles per square millimeter of said metal surface.

12. The implantable stimulation electrode of claim 6, wherein said receptacles occur at a density of at least 250 to 300 receptacles per square millimeter of said metal surface.

13. The implantable stimulation electrode of claim 5, wherein said indentation enhances the electrically-accessible area by a factor of at least 100% to 300%.

14. The implantable stimulation electrode of claim 1, wherein said macroscopically-enhanced area further comprises corrugations.

15. The implantable stimulation electrode of claim 14, wherein said corrugation enhances the electrically-accessible area by a factor of at least 50 to 100%.

16. The implantable stimulation electrode of claim 14, wherein said corrugation enhances the electrically-accessible area by a factor of at least 70 to 90%.

17. The implantable stimulation electrode of claim 14, wherein said corrugation enhances the electrically-accessible area by a factor of at least 85%.

18. The implantable stimulation electrode of claim 1, wherein said microscopically-enhanced area further comprises a chemically-corroded area.

19. The implantable stimulation electrode of claim 18, wherein said chemically-corroded area results from exposure to an acid.

20. The implantable stimulation electrode of claim 19, wherein said acid is oxalic acid.

21. The implantable stimulation electrode of claim 19, wherein said controlled chemical corrosion induces a density of pitting of at least 50,000-110,000 pits per square millimeter.

22. The implantable stimulation electrode of claim 19, wherein said controlled chemical corrosion results in a uniformity in the electrically-accessible surface characterized by a preferred aspect ratio.

23. The implantable stimulation electrode of claim 1, wherein said microscopically-enhanced area further comprises involutions caused by controlled ion-bombardment.

24. The implantable stimulation electrode of claim 1, wherein said mixture of at least two metal oxides further comprises a mixture of ruthenium oxide, iridium oxide, and tantalum oxide.

25. The implantable stimulation electrode of claim 24 wherein said mixture of ruthenium oxide, iridium oxide, and tantalum oxide comprises a ratio of 50:

25;

25 weight percent, respectively.

26. The implantable stimulation electrode of claim 1, wherein said electrode is capable of reducing the amount of acute coagulation of blood surrounding said electrode by 20-40% over that exhibited by a titanium electrode coated with iridium oxide, by virtue of the combination of said macroscopically-enhanced surface area, said microscopically-enhanced surface area, and said non-native coating.

27. The implantable stimulation electrode of claim 1, wherein said electrode is capable of reducing the amount of fibrotic growth surrounding said electrode by 20-40% over that exhibited by a titanium electrode coated with iridium oxide, by virtue of the combination of said macroscopically-enhanced surface area, said microscopically-enhanced surface area, and said non-native coating.

28. The implantable stimulation electrode of claim 1, wherein said electrode is capable of sensing of the electrical state of the excitable tissue most closely adjacent to said electrode by 150-600% over that exhibited by a titanium electrode coated with iridium oxide, by virtue of the combination of said macroscopically-enhanced surface area, said microscopically-enhanced surface area, and said non-native coating.

29. The implantable stimulation electrode of claim 1, wherein said electrode exhibits a higher pacing impedance, a lower sensing impedance, and a lower stimulation threshold over that exhibited by a titanium electrode coated with iridium oxide, by virtue of the combination of said macroscopically-enhanced surface area, said microscopically-enhanced surface area, and said non-native coating.

30. The implantable stimulation electrode of claim 1, wherein said electrode is a defibrillation electrode and exhibits a lower defibrillation threshold over that exhibited by a titanium electrode coated with iridium oxide, by virtue of the combination of said macroscopically-enhanced surface area, said microscopically-enhanced surface area, and said non-native coating.

34. A process for applying electrical pulses to a human heart comprising contacting said heart with the electrode of claim 1.

35. A method of improving the R-wave sensing capabilities of an implantable cardiac stimulation device comprising connecting said cardiac stimulation device to the electrode of claim 1.

36. A method of reducing the amount of coagulation of sera surrounding an implantable electrode comprising contacting said heart with the electrode of claim 1.

31. A method for making an improved metallic electrode for injecting charge into a biological tissue using controlled electrical pulses, said electrode made of a metal and having a metal surface, wherein the method consists of removing essentially all native metal oxides from said metal surface, macroscopically enhancing said metal surface, microscopically enhancing said metal surface and applying a coating upon said metal surface of a mixture of at least two metal oxides selected from the group of metal oxides consisting of oxides of valve metals, noble metals, alloys of valve metals, alloys of noble metals, mixtures of valve and noble metals, capable of reversible reduction-oxidation.

32. The improved metal electrode of claim 31 wherein said mixture of at least two metal oxides further comprises a mixture of ruthenium oxide, iridium oxide, and tantalum oxide.

33. The improved metal electrode of claim 32 wherein said mixture of ruthenium oxide, iridium oxide, and tantalum oxide comprises a ratio of 50:

25;

25 weight percent, respectively.