In situ apparatus for generating an electrical current in a biological environment

• US 5,360,440 A
• Filed: 03/09/1992
• Issued: 11/01/1994
• Est. Priority Date: 03/09/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Andersen, Erik
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US07/847,911
• Time in Patent Office: 967 Days
• Field of Search: 128/784, 128/785, 606/191, 606/194, 606/195, 606/198, 604/21, 607/75, 607/115, 607/116
• US Class Current: 607/115
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An apparatus for the in situ generation of an electrical current in a biological environment characterized by including an electrolytic fluid. The apparatus comprises first and second electrodes of differing electrochemical potentials separated by an insulator. The apparatus is adapted to be implanted in the environment. The presence of the electrolytic fluid and formation of a current path by hyperplastic cells bridging the electrodes enables electrolysis to occur and a direct current to pass through the current path to impede hyperplastic cell growth.

Claims

1. Apparatus for the in situ generation of an electrical current in a biological environment including electrically conductive tissue and an electrolyte, said current generation apparatus comprising first and second layers of electrically conductive materials of different electrochemical potentials and an insulating third layer intermediate and contiguous said first and second layers, each of said layers having a passage therethrough into which proximate conductive tissue cells can expand to bridge said first and second layers, whereby said apparatus, when immersed in the electrolyte, generates electrolytically an electrical current through the bridging conductive tissue cells.

2. Apparatus for the in situ generation of electrical current as recited in claim 1 wherein each of the materials of said first, second and third layers are selected from a group that are compatible with the biological environment including the conductive tissue and the electrolytes.

3. Apparatus for the in situ generation of electrical current as recited in claim 2 wherein said first and second layers are materials selected from the group consisting of iron, tantalum and silver and an aluminum magnesium alloy.

4. Apparatus for the in situ generation of electrical current as recited in claim 3 wherein said first and second layers are formed of iron and tantalum respectively.

5. Apparatus for the in situ generation of electrical current as recited in claim 3 wherein said first and second layers are formed of silver and tantalum respectively.

6. Apparatus for the in situ generation of electrical current as recited in claim 3 wherein said first and second layers are formed of an aluminum magnesium alloy and tantalum respectively.

7. Apparatus for the in situ generation of electrical current as recited in claim 2 wherein said insulating layer is inert in the biological environment.

8. Apparatus for the in situ generation of electrical current as recited in claim 7 wherein said insulating layer is a polymer.

9. Apparatus for the in situ generation of electrical current as recited in claim 7 wherein said conductive layers and insulating layer are foraminous and collectively form a permeable membrane.

10. Apparatus for the in situ generation of electrical current as recited in claim 2 wherein said first, second and third layers collectively form a planar apparatus.

11. Apparatus for the in situ generation of electrical current as recited in claim 2 wherein said first, second and third layers collectively form a substantially tubular structure.

12. Apparatus for the in situ generation of electrical current as recited in claim 11 wherein at least one of said first and second layers provides a self-supporting structure.

13. A stent assembly for insertion in a vessel having a boundary vessel wall with tissue cells and containing an electrolytic fluid comprising, as a nested structure:

A. an inner stent formed of a conductive material with a first electrochemical potential,

B. an outer stent formed of a conductive material with a second electrochemical potential that differs from the first electrochemical potential, and

C. an intermediate insulating means for electrically isolating said inner and outer stents from each other, said stent assembly, in a vessel, having a passage therethrough into which proximate conductive cells can expand, and forming an electrolytic generator when the electrolytic fluid in the vessel contacts said stent assembly and when the conductive tissue cells form a conductive path bridging said inner and outer stents.

14. A stent assembly as recited in claim 13 wherein said stents are composed from materials selected from the group consisting of aluminum, silver, iron, tantalum and alloy of aluminum magnesium.

15. A stent assembly as recited in claim 14 wherein one of said stents is formed of iron and the other of said stents is formed of tantalum whereby said tantalum comprises a cathode and said iron comprises an anode.

16. A stent assembly as recited in claim 14 wherein one of said stents is formed of silver and the other of said stents is formed of tantalum whereby said tantalum comprises a cathode and said silver comprises an anode.

17. A stent assembly as recited in claim 14 wherein one of said stents is formed of a tantalum filament in an open mesh, self-supporting structure.

18. A stent assembly as recited in claim 14 wherein said insulating layer is composed of a polymer.

19. A stent assembly as recited in claim 14 wherein said insulating means is composed of polyethylene.

20. A stent assembly as recited in claim 13 wherein each of said stents and insulating means are foraminous.

21. A method for generating current for transfer through hyperplastic cells that form proximate a vessel in an environment including an electrolytic fluid comprising the step of positioning in the vessel a multiple layer structure having first and second layers of electrically conductive mesh formed of materials of different electrochemical potentials that are insulated from one another, and enabling the hyperplastic cells to bridge the layers in the presence of electrolytic fluid thereby generating an electrical current through the bridge that impedes the growth of the hyperplastic cells.

22. A method as recited in claim 21 wherein the multiple layer structure comprises multiple sheets, said method additionally comprising the steps of locating the sheets proximate existent hyperplastic cells and forming the sheets to conform the multiple layer structure to the profile of the hyperplastic cells.

23. A method as recited in claim 21 wherein the first and second layers are formed of concentric tubular structures separated by a tubular insulating member, said method additionally comprising locating the multi-layer structure in tubular form at the walls of the vessel.

24. A method as recited in claim 23 wherein at least one of the layers is formed of loosely interlocked knitted loops of a metal filament and said multi-layer structure is adapted for being compacted to a small radial size for introduction lengthwise into the vessel, said method additionally comprising the step of expanding the multi-layer structure to engage the vessel walls.

25. Apparatus for the in situ generation of an electrical current in an electrically conductive biological environment with an electrolyte, said current generation apparatus comprising first and second foraminous layers of electrically conductive materials of different electrochemical potentials and a foraminous insulating third layer intermediate said first and second layers whereby said first and second layers, when immersed in the electrolyte become coupled conductively to the biological environment and generate electrolytically an electrical current for transfer through the biological environment.

26. Apparatus for the in situ generation of electrical current as recited in claim 25 wherein each of the materials of said first, second and third layers are selected from a group that are compatible with the biological environment and the electrolytes in that environment.

27. Apparatus for the in situ generation of electrical current as recited in claim 25 wherein said first and second layers are materials selected from the group consisting of iron, tantalum and silver and an aluminum magnesium alloy.

28. Apparatus for the in situ generation of electrical current as recited in claim 27 wherein said first and second layers are formed of iron and tantalum respectively.

29. Apparatus for the in situ generation of electrical current as recited in claim 27 wherein said first and second layers are formed of silver and tantalum respectively.

30. Apparatus for the in situ generation of electrical current as recited in claim 27 wherein said first and second layers are formed of an aluminum magnesium alloy and tantalum respectively.

31. Apparatus for the in situ generation of electrical current as recited in claim 27 wherein said insulating layer is inert in the biological environment.

32. Apparatus for the in situ generation of electrical current as recited in claim 31 wherein said insulating layer is a polymer.

33. Apparatus for the in situ generation of electrical current as recited in claim 25 wherein said first, second and third layers collectively form a planar apparatus.

34. Apparatus for the in situ generation of electrical current as recited in claim 25 wherein said first, second and third layers collectively form a substantially tubular wall structure.

35. Apparatus for the in situ generation of electrical current as recited in claim 34 wherein at least one of said first and second layers provides a self-supporting structure.