Medical electrical lead employing load bearing sleeve

• US 7,155,293 B2
• Filed: 01/29/2003
• Issued: 12/26/2006
• Est. Priority Date: 01/29/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Krishnan, Mohan, Westlund, Randy, Scheiner, Avram
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): Gedeon, Brian T.
• Application Number:
  US10/353,793
• Publication Number:
  US 20040147993A1
• Time in Patent Office: 1,427 Days
• Field of Search: 607/116, 607/119, 607121-123
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A medical electrical lead employs a load bearing sleeve arrangement. A medical electrical lead includes an outer sleeve, having proximal and distal ends, and is formed of a first material. At least one electrical conductor is situated within the outer sleeve and extends between the proximal and distal ends of the outer sleeve. At least one electrode is electrically coupled to the electrical conductor. A load bearing sleeve extends between the proximal and distal ends of the outer sleeve. The load bearing sleeve is formed of a second material different from the first material. The load bearing sleeve offers resistance to axial loading forces applied to the lead. The load bearing sleeve can be coextensive with the outer sleeve or extend along at least the majority of the length of the outer sleeve.

Claims

1. A medical electrical lead, comprising:

an outer sleeve formed of a first material comprising a flexible polymer material, the outer sleeve having a proximal end and a distal end;

an electrical conductor situated within the outer sleeve and extending between the proximal and distal ends of the outer sleeve;

at least one electrode electrically coupled to the electrical conductor; and

a load bearing sleeve extending between the proximal and distal ends of the outer sleeve, the load bearing sleeve formed of a second material different from the first material, the second material comprising an ultra-high molecular weight polymeric material, the load bearing sleeve offering resistance to axial loading forces applied to the lead.

2. The lead of claim 1, wherein the load bearing sleeve extends along at least a majority of a length of the outer sleeve.

3. The lead of claim 1, wherein the load bearing sleeve is substantially coextensive with the outer sleeve.

4. The lead of claim 1, wherein the load bearing sleeve is situated between the outer sleeve and the electrical conductor.

5. The lead of claim 4, wherein an outer surface of the electrode is situated at an exposed portion of the outer sleeve, and an inner surface of the electrode contacts an electrode interface surface of the load be,aring sleeve, such that the electrode is electrically coupled to the electrical conductor through the electrode interface surface.

6. The lead of claim 4, wherein an outer surface of the electrode is situated at an exposed portion of the outer sleeve, and an inner surface of the electrode is electrically coupled to the electrical conductor via a gap in a surface of the load bearing sleeve.

7. The lead of claim 6, further comprising an electrically conductive filler or element provided within the gap.

8. The lead of claim 1, wherein the electrode is situated within a gap in the outer sleeve and a portion of the load bearing sleeve protrudes through the gap so as to extend over an outer surface of the electrode, such that an inner surface of the electrode is electrically coupled to the electrical conductor.

9. The lead of claim 8, wherein the second material of the load bearing sleeve comprises a biocompatible material.

10. The lead of claim 1, wherein the electrical conductor comprises a coil conductor, and the load bearing sleeve is situated within a longitudinally extending cavity of the coil conductor.

11. The lead of claim 10, wherein the longitudinally extending cavity of the load bearing sleeve defines an open lumen of the lead.

12. The lead of claim 11, wherein the open lumen is dimensioned for receiving a guide wire.

13. The lead of claim 11, wherein the open lumen is dimensioned for receiving a sensor catheter.

14. The lead of claim 1, wherein the electrical conductor comprises a coil conductor, and the load bearing sleeve is situated within a longitudinally extending cavity of the coil conductor, the medical electrical lead further comprising a second load bearing sleeve situated between the outer sleeve and the coil conductor.

15. The lead of claim 1, wherein the ultra-high molecular weight polymeric material comprises PTFE or ePTFE.

16. The lead of claim 1, wherein the first material of the outer sleeve comprises silicone or polyurethane, and the second material of the load bearing sleeve comprises PTFE or ePTFE.

17. The lead of claim 1, wherein the first material of the outer sleeve has a tensile strength of less than about 5,000 psi, and the second material of the load bearing sleeve has a tensile strength greater than about 5,500 psi.

18. The lead of claim 1, wherein the first material of the outer sleeve exhibits a tensile elongation of greater than about 300%, and the second material of the load bearing sleeve exhibits a tensile elongation of less than about 100%.

19. The lead of claim 1, wherein the load bearing sleeve has a wall thickness ranging between about 0.001 inches and about 0.01 inches.

20. The lead of claim 1, wherein the load bearing sleeve has a wall thickness ranging between about 0.002 inches and about 0.006 inches.

21. The lead of claim 1, wherein the lead comprises a plurality of lumens.

22. The lead of claim 1, wherein the electrical conductor comprises a cable or a wire.

23. A medical electrical lead, comprising:

an outer sleeve formed of a first material comprising a flexible polymer material, the outer sleeve having a proximal end and a distal end;

an electrical conductor situated within the outer sleeve and extending between the proximal and distal ends of the outer sleeve;

at least one electrode electrically coupled to the electrical conductor; and

a load bearing sleeve extending between the proximal and distal ends of the outer sleeve, a majority of a length of the load bearing sleeve positioned within the outer sleeve, the load bearing sleeve formed of a second material having a tensile strength greater than that of the first material and a tensile elongation less than that of the first material, the second material comprising an ultra-high molecular weight polymeric material, an inner surface of a portion of the load bearing sleeve extending over an outer surface of the at least one electrode, and an outer surface of the load bearing sleeve portion exposed through a gap in the outer sleeve.

24. The lead of claim 23, wherein the load bearing sleeve is substantially coextensive with the outer sleeve.

25. The lead of claim 23, wherein the load bearing sleeve is situated between the outer sleeve and the electrical conductor.

26. The lead of claim 23, wherein the electrical conductor comprises a coil conductor.

27. The lead of claim 23, wherein the electrical conductor comprises a cable or wire.

28. The lead of claim 23, wherein the ultra-high molecular weight polymeric material comprises PTFE or ePTFE.

29. The lead of claim 23, wherein the first material of the outer sleeve comprises silicone or polyurethane, and the second material of the load bearing sleeve comprises PTFE or ePTFE.

30. The lead of claim 23, wherein the first material of the outer sleeve has a tensile strength of less then about 5,000 psi, and the second material of the load bearing sleeve has a tensile strength greater than about 5,500 psi.

31. The lead of claim 23, wherein the first material of the outer sleeve exhibits a tensile elongation of greater than about 300%, and the second material of the load bearing sleeve exhibits a tensile elongation of less than about 100%.

32. The lead of claim 23, wherein the load bearing sleeve has a wall thickness ranging between about 0.001 inches and about 0.01 inches.

33. The lead of claim 23, wherein the load bearing sleeve has a wall thickness ranging between about 0.002 inches and about 0.006 inches.

34. The lead of claim 23, wherein the lead comprises a plurality of lumens.

35. A method of implanting a medical electrical lead into a cardiac structure of a patient'"'"'s heart, comprising:

providing a guiding catheter for longitudinally guiding the lead, the lead having an open lumen and comprising;

an outer sleeve formed of a first material comprising a flexible polymer material, the outer sleeve having a proximal end and a distal end;

an electrical conductor situated within the outer sleeve and extending between the proximal and distal ends of the outer sleeve;

at least one electrode electrically coupled to the electrical conductor; and

a load bearing sleeve extending between the proximal and distal ends of the outer sleeve, the load bearing sleeve formed of a second material different from the first material, the second material comprising an ultra-high molecular weight polymeric material, the load bearing sleeve offering resistance to axial loading forces applied to the lead;

inserting the guiding catheter into a chamber of the patient'"'"'s heart via an access vessel; and

inserting the lead through the guiding catheter via the open lumen to implant the lead within or on the cardiac structure.

36. The method of claim 35, further comprising:

providing a guide wire for longitudinally guiding the lead;

inserting the guide wire through the guiding catheter into the cardiac structure; and

inserting the lead through the guiding catheter and over the guide wire via the open lumen to implant the lead within or on the cardiac structure.

37. The method of claim 35, further comprising:

providing a sensor catheter;

inserting the sensor catheter through the open lumen to assist in locating the cardiac structure.

38. The method of claim 35, wherein the cardiac structure comprises a cardiac vessel.

39. The method of claim 35, wherein the load bearing sleeve extends along at least a majority of a length of the outer sleeve.

40. The method of claim 35, wherein the load bearing sleeve is substantially coextensive with the outer sleeve.

41. The method of claim 35, wherein the load bearing sleeve is situated between the outer sleeve and the electrical conductor.

42. The method of claim 35, wherein the electrode is situated within a gap in the outer sleeve and a portion of the load bearing sleeve protrudes through the gap so as to extend over an outer surface of the electrode, such that an inner surface of the electrode is electrically coupled to the electrical conductor.

43. The method of claim 35, wherein the load bearing sleeve is situated within a longitudinally extending cavity of the electrical conductor and defines the open lumen of the lead.

44. The method of claim 35, wherein the ultra-high molecular weight polymeric material comprises PTFE or ePTFE.

45. The method of claim 35, wherein the first material of the outer sleeve comprises silicone or polyurethane, and the load bearing sleeve comprises PTFE or ePTFE.

46. The method of claim 35, wherein the first material of the outer sleeve has a tensile strength of less than about 5,000 psi, and the load bearing sleeve has a tensile strength of greater than about 5,500 psi.

47. The method of claim 35, wherein the first material of the outer sleeve exhibits a tensile elongation of greater than about 300%, and the load bearing sleeve exhibits a tensile elongation of less than about 100%.

48. A medical electrical lead, comprising:

an outer sleeve formed of a first material comprising a flexible polymer material, the outer sleeve having a proximal end and a distal end, the outer sleeve comprising;

one or more first locations comprising a third material that substantially prevents tissue in-growth between the first locations and cardiac tissue contacting the first locations; and

one or more adhesion sites provided at the one or more first locations, the adhesion sites promoting tissue in-growth or attachment between the adhesion sites and cardiac tissue contacting the adhesion sites;

an electrical conductor situated within the outer sleeve and extending between the proximal and distal ends of the outer sleeve;

at least one electrode electrically coupled to the electrical conductor; and

a load bearing sleeve extending between the proximal and distal ends of the outer sleeve, the load bearing sleeve formed of a second material differing from the first material, the second material comprising an ultra-high molecular weight polymeric material, the load bearing sleeve offering resistance to axial loading forces applied to the lead.

49. The lead of claim 48, wherein the adhesion sites define apertures in the outer sleeve at the one or more first locations of the outer sleeve.

50. The lead of claim 48, wherein the adhesion sites comprise a material that promotes cardiac tissue in-growth or attachment at the adhesion sites.

51. The lead of claim 48, wherein the adhesion sites comprise exposed portions of the at least one electrode.

52. The lead of claim 48, wherein the adhesion sites comprise a structure having a porous surface that promotes cardiac tissue in-growth or attachment at the adhesion sites.

53. The lead of claim 48, wherein the third material comprises a first polymer material that substantially prevents tissue in-growth between the first locations and cardiac tissue contacting the first locations, and the adhesion sites comprise a fourth polymer material that promotes tissue in-growth or attachment between the adhesion sites and cardiac tissue contacting the adhesion sites.

54. The lead of claim 53, wherein the fourth polymer material has a porosity differing from that of the third polymer material.

55. The lead of claim 53, wherein the fourth polymer material has an average pore size differing from that of the third polymer material.

56. The lead of claim 53, wherein the fourth polymer material has a distribution of pore sizes differing from that of the third polymer material.

57. The lead of claim 53, wherein the fourth polymer material has a hydrophobicity differing from that of the third polymer material.

58. The lead of claim 48, wherein the second and third materials comprise ePTFE.