Catheter with thin film electrodes and method for making same

• US 6,208,881 B1
• Filed: 10/20/1998
• Issued: 03/27/2001
• Est. Priority Date: 10/20/1998
• Status: Expired due to Term

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Micropure Medical, Inc.
• Inventors: Champeau, Eugene J.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/176,009
• Time in Patent Office: 889 Days
• Field of Search: 607/116, 607/119, 607/122, 600/373, 600/374, 600/377
• US Class Current: 600/374
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6852 Catheters

Abstract

An electrical lead for sensing electrical activity with the body of the patient and for applying electrical energization to selected body tissue comprises an elongated, flexible polymeric lead body having one or more conductors extending the length thereof, the conductors being connected at their distal end to electrode pads where the pads each comprise a multilayer thin metallic film structure formed on the surface of the lead body where the overall thickness of the composite electrodes are less than about 5 microns. As such, the electrodes do not adversely impact the ability of the distal end portion of the catheter to flex and conform to tissue structures where sensing is to be taken and therapy delivered via the lead.

Claims

1. An electrode assembly, comprising:

(a) a lead body having a proximal end and a distal end and including at least one conductor extending from the proximal end to a predetermined zone located proximate the distal end; and

(b) at least one electrode on a surface of the lead body in said predetermined zone, the electrode comprising a conductive pad electrically connected to a conductor, the pad comprising a plurality of superimposed metallic film layers, at least one layer having a nanocrystalline structure.

2. The lead as in claim 1 wherein the plurality of layers are interlaced to one another.

3. The lead as in claim 1 wherein the lead body is a polymer selected from a group/consisting of polyurethane, polyamide, silicone rubber, polyethylene, PVC, polyimide, PTFE, FEP and blends thereof.

4. The lead as in claim 1 wherein at least one conductor is a metal selected from a group consisting of Ni, Ti, Cr, stainless steel and alloys thereof.

5. The lead as in claim 1 wherein the at least one conductor is a copper.

6. The lead as in claim 1 wherein the at least one conductor is a NiCr alloy.

7. The lead as in claim 1 herein the at least one conductor is embedded in the lead body.

8. The lead as in claim 1 wherein the lead body has an outside diameter in a range of from about 2 F to about 11.5 F.

9. The lead as in claim 1 wherein the pad is an annulus.

10. The lead as in claim 9 wherein a distal end portion of the lead body has a predetermined shape configuration in a free state.

11. The lead as in claim 1 wherein the at least one conductor is supported on an exterior surface of the lead body.

12. The lead as in claim 11 wherein the at least one conductor has a non-conductive covering thereover.

13. The lead as in claim 12 wherein the at least one conductor comprises a deposit thin film strip having a thickness less than about 50 microns.

14. The lead as in claim 13 wherein the deposited thin film strip is a metal selected from a group consisting of Al, Ag, Au, Pd, Ti, Cr, Ni, Pt, Ir, Cu, alumel, chromel, Constantin, and alloys thereof.

15. The lead in claim 1 wherein an innermost layer of the conductive pad is a etal selected from a group consisting of Ti, Cr, Ni, and Al.

16. The lead as in claim 15 wherein the layer adjacent the innermost layer of the conductive pad is a metal selected from a group consisting of Pd and Pt.

17. The lead as in claim 6 wherein the layer adjacent the innermost layer has a thickness between 500 Å

and 50 microns.

18. The lead as in claim 15 wherein the innermost layer has a thickness less than about 5 microns.

19. The lead as in claim 1 wherein an outermost layer of the conductive pad is a metal selected from a group consisting of Au, Pt and Pt—

Ir.

20. The lead as in claim 19 wherein the outermost layer of the conductive pad has a thickness between 500 Å

and 50 microns.

21. The lead as in claim 19 wherein a layer adjacent the outermost layer of the conductive pad is a metal selected from a group consisting of Ag, Pt, Cu and Au.

22. The lead as in claim 21 wherein the layer adjacent the outermost layer has a thickness in a range from about 500 Å

to about 250 microns.

23. The lead as in claim 1 and further including means for selectively cooling the at least one electrode.

24. The lead as in claim 23 wherein the means for cooling includes means for perfusing a cooling fluid through a lumen in the polymer lead body from said proximal end to locations adjacent the spaced apart zones.

25. An electrode assembly, comprising:

(a) a lead body having a proximal end, a distal end and including at least one conductor supported by the lead body, the conductor extending from the proximal end to a predetermined zone located proximate the distal end; and

(b) at least one electrode on a surface of the lead body in the predetermined zone, the electrode comprising a conductive pad electrically connected to a conductor, the pad comprising a plurality of superimposed metallic film layers, wherein an interface between at least two layers is interlaced.

26. The lead as in claim 25 wherein the lead body is a polymer selected from a group consisting of polyurethane, polyamide, silicone rubber, polyethylene, PVC polyimide PTFE and FEP and blends thereof.

27. The lead as in claim 25 wherein the at least one conductor is a metal selected from the group consisting of Ni, Ti, Cr, stainless steel and alloys thereof.

28. The lead as in claim 25 wherein the at least one conductor is NiTi alloy.

29. The lead as in claim 25 wherein the at least one conductor is NiCr alloy.

30. The lead as in claim 25 wherein the plurality of layers possess a non-columnar, nanocrystalline structure exhibiting overlapping planar platelet regions.

31. The lead as in claim 25 wherein the at least one conductor is embedded in the lead body.

32. The lead as in claim 25 wherein the lead body has an outside diameter in a range of from about 2 F to about 11.5 F.

33. The lead as in claim 25 and further including means for selectively cooling said plurality of electrodes.

34. The lead as in claim 33 wherein the means for cooling includes means for perfusing a cooling fluid through a lumen in the polymer lead body from said proximal end to locations adjacent the spaced apart zones.

35. The lead as in claim 25 wherein the pad is an annulus.

36. The lead as in claim 35 wherein a distal end portion of the lead body has a predetermined shape configuration in a free state.

37. The lead as in claim 25 wherein the at least one conductor is supported on an exterior surface of the lead body.

38. The lead as in claim 37 wherein the at least one conductor has a non-conductive covering thereover.

39. The lead as in claim 38 wherein the at least one conductor comprises a deposited thin film strip having a thickness less than about 50 microns.

40. The lead as in claim 39 wherein the deposited thin film strip is a metal selected from a group consisting of Al, Ag, Au, Pd, Ti, Cr, Ni, Pt, Ir, Cu, alumel, chromel, constantin, and alloys thereof.

41. The lead as in claim 25 wherein the first layer is an innermost layer of the conductive pad and is a metal selected from a group consisting of Ti, Cr, Ni and Al.

42. The lead as in claim 41 wherein the innermost layer has a thickness less than 5 microns.

43. The lead as in claim 41 wherein the layer is adjacent the innermost layer of the conductive pad is a metal selected from a group consisting of Pd and Pt.

44. The lead as in claim 43 wherein the layer adjacent the innermost layer has a thickness between 500 Å

and 50 micron.

45. The lead as in claim 25 wherein is an outermost layer of the conductive pad and is a metal selected from a group consisting of Au, Pt and Pt—

Ir.

46. The lead as in claim 45 wherein the outermost layer of the conductive pad ha hickness between 500 Å

and 50 micron.

47. The lead as in claim 45 wherein layer is adjacent the outmost layer the conductive pad is a metal selected from a group consisting of Ag, Pt, Au and Cu.

48. The lead as in claim 47 wherein the layer adjacent the outermost layer has a thickness in a range from about 500 Å

to about 50 microns.

49. A method of manufacturing electrical leads comprising the steps of:

(a) providing an elongated, flexible, polymeric lead body having a proximal end, a distal end and at least one flexible conductor extending therebetween, the conductor being uninsulated in a zone proximate the distal end;

(b) placing at least a distal end portion of the polymeric lead body in a evacuatable chamber;

(c) drawing a vacuum in said chamber;

(d) introducing accelerated ions into the chamber to bombard the distal end portion of the lead body;

(e) concurrently with step (d), evaporating a first metal and directing a vapor of the first metal onto the zone on the lead body where the flexible conductor is uninsulated to create a first metal film layer of a predetermined thickness in the zone; and

(f) repeating steps (d) and (e) using a second metal for depositing a vapor of the second metal as a film onto the film layer of the first metal.

50. The method of claim 49 and further including the steps of:

(a) before step (e), masking the distal end portion of the lead body to form a plurality of discrete areas on the distal end portion of the lead body on which the metal film layers are formed.

51. The method of claim 49 wherein the ions being introduced are selected from a group consisting of Ar, N, O.

52. The method of claim 49 and further including the steps of:

(g) following step (f), evaporating a third metal and directing a vapor of the third metal onto the film of the second metal to form a third film layer while introducing accelerated ions into the chamber to bombard the distal end portion of the lead body.

53. The method as in claim 52 wherein the third metal film layer has a thickness less than about 50 microns.

54. The method as in claim 53 wherein the third metal is selected from a group consisting of Ag, Pt, Au and Cu.

55. The method of claim 52 and further including the steps of:

(h) following step (g), evaporating a fourth metal and directing a vapor of the fourth metal onto the third film layer while introducing accelerated ions into the chamber to bombard the distal end portion of the lead body.

56. The method of claim 55 wherein the fourth metal film layer has a thickness between 500 Å

and 1 micron.

57. The method of claim 56 wherein the fourth metal is selected from a group consisting of Au, Pt and Pt—

Ir.

58. The method of claim 55 and further including the step of:

(a) thermally annealing the first, second, third and fourth metal film layers to stress relieve said layers.

59. The method of claim 55 wherein the metals comprising the first, second, third and fourth film layers are evaporated by one of electron beam evaporation, thermal evaporation, RF sputtering and plasma sputtering.

60. The method as in claim 55 wherein the ions are accelerated sufficiently to shot peen the first, second, third and fourth metal film layers into an adjacent underlying surface whereby adhesion of the metal film layers to one another is achieved.

61. The method as in claim 55 wherein the ions are accelerated sufficiently to impart a nanocrystalline structure to said metal film layers.

62. The method of claim 49 wherein the first and second metal film layers each have a thickness between 500 Å

and 1 micron.

63. The method as in claim 62 wherein the first metal is selected from a group consisting of Ti, Cr, Ni and Al.

64. The method of claim 62 wherein the second metal film layer is selected from a group consisting of Pd and Pt.

65. The method of any one of claims 49-57 wherein the polymer comprising the polymeric lead body is selected from a group consisting of PTFE, PET, PVC, PFA, e-PTFE, polyethylene, silicone rubber, polyurethane, polyamide, polyimide, PEP and blends and alloys thereof.

66. The method as in any one of one of claims 49-57 wherein the at least one conductor is contained within the lead body, except in said zone proximate the distal end.

67. The method as in any one of one claims 49-57 wherein the at least one conductor is supported on an exterior surface of the lead body and coated with an insulating layer except in said zone proximate the distal end.

69. The method of claim 62 wherein the first and second metal film layers each having a thickness in a range between 500 Å

and 1 micron.

70. The method as in claim 65 wherein the first metal is selected from a group consisting Ti, Cr, Ni, and Al.

71. The method of claim 65 wherein the second metal film layer is selected from a group consisting of Pd and Pt.

72. The method as of claim 65 and further including the steps of:

(a) before step (d), masking the distal end portion of the lead body to form a plurality of discrete areas on the distal end portion of the lead body on which the metal film layers are formed.

73. The method of claim 65 wherein the ions being introduced are selected from a group consisting of Ar, N, and O.

74. The method of claim 65 and further including the steps of:

(g) following step (f), vapor depositing a third metal film layer on the film of the second metal and thereafter; and

(h) introducing accelerated ions into the chamber to bombard the third metal layer.

75. The method as in claim 63 wherein the third metal film layer has a thickness less than about 50 microns.

76. The method as in claim 75 wherein the third metal is selected from a group consisting of Ag, Pt, Au and Cu.

77. The method of claim 74 and further including the steps of:

(i) following step (h), vapor depositing a fourth metal film layer on the third metal film layer and thereafter;

(j) ion bombarding the fourth metal film layer.

78. The method of claim 77 wherein the metals comprising the first, second, third and fourth film layers are evaporated by one of electron beam evaporation, thermal evaporation, RF sputtering and plasma sputtering.

79. The method as in claim 77 wherein the ions are accelerated sufficiently to shot peen the first, second, third and fourth metal film layers into an adjacent underlying surface whereby adhesion of the metal film layers to one another is achieved.

80. The method as in claim 77 wherein the ions are accelerated sufficiently to impart a nanocrystalline structure to said metal film layers.

81. The method as in claim 77 wherein the fourth metal film layer has a thickness between 500 A and 1 micron.

82. The method of claim 81 wherein the fourth metal is selected from a group consisting of Au, Pt, and Pt—

Ir.

83. The method of any one of claims 65-82 wherein the polymer comprising the polymeric lead body is selected from a group consisting of PTFE, PET, PVC, PFA, e-PTFE, polyethylene, silicone rubber, polyurethane, polyamide, polyimide, FEP and blends and alloys thereof.

84. The method as in any one of claims 65-82 wherein the at least one conductor is contained within the lead body, except in said zone proxim ate the distal end.

85. The method as in any one of claims 65-82 wherein the at least one conductor is supported on an exterior surface of the lead body and is coated with an insulating layer except in said zone proximate the distal end.

68. A method of manufacturing electrical leads comprising the steps of:

(a) providing an elongated, flexible, polymeric lead body having a proximal end, a distal end and at least one flexible conductor extending therebetween, the conductor being uninsulated in a zone proximate the distal end;

(b) placing at least a distal end portion of the polymeric lead body in a evacuatable chamber;

(c) drawing a vacuum in said chamber;

(d) evaporating a first metal and directing the vapor of the first metal onto the zone on the lead body where the flexible conductor is uninsulated to create a first metal film layer of a predetermined thickness in the zone;

(e) introducing accelerated ions into the chamber to bombard the first metal film layer; and

(f) repeating steps (d) and (e) using a second metal for depositing a vapor of the second metal as a film onto the film layer of the first metal and ion bombarding the film of the second metal.