Implantable coronary sinus lead and lead system

• US 20030220677A1
• Filed: 05/22/2002
• Published: 11/27/2003
• Est. Priority Date: 05/22/2002
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Morgan, Kevin L., Doan, Phong D., Williams, Sheldon, Helland, John R., Schimke, Kerwyn, Jenney, Christopher R.
• Granted Patent: US 6,968,237 B2
• Time in Patent Office: Days
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An implantable stimulation lead is disclosed for placement in the coronary sinus region and its associated coronary vessels overlying the left side of a patient'"'"'s heart. The lead comprises at least one proximal connector; at least one tissue stimulation electrode; at least one conductor coupled between the at least one proximal connector and the at least one stimulation electrode; and a lead body including a housing of insulating material enclosing the at least one conductor, the lead body having a relatively flexible distal portion of, for example, silicone rubber, having a length corresponding to the coronary sinus region of the heart, and a stiffer proximal portion of, for example, polyurethane. A robust transition joint comprising telescoped sections of the distal and proximal portions of the lead body couples the two portions of the lead body.

Also provided is a versatile lead delivery system including a stylet stop disposed within the distal portion of the lead body. The stylet stop defines an aperture dimensioned to pass a guide wire but not the enlarged distal tip of a stylet. The lead includes a tip electrode having a longitudinally extending bore dimensioned to permit passage of the guide wire through the tip electrode.

Claims

1. An implantable stimulation lead comprising:

at least one proximal connector;

at least one tissue stimulation electrode;

at least one conductor coupled between the at least one proximal connector and the at least one stimulation electrode; and

a lead body comprising a housing of insulating material enclosing the at least one conductor, the lead body having a relatively flexible distal portion having a length corresponding to a coronary sinus region of a heart, the distal portion of the lead body carrying the at least one tissue stimulation electrode, the lead body further having a proximal portion extending from the at least one proximal connector to a proximal portion/distal portion interface at the proximal extremity of the distal portion of the lead body, wherein the proximal portion is stiffer than the distal portion.

2. The lead of claim 1 in which:

when the lead body is implanted, the proximal portion/distal portion interface resides distal of a coronary os so that a distal end of the stiffer proximal portion resides in the coronary sinus.

3. The lead of claim 1 in which:

the distal portion of the lead body comprises silicone rubber.

4. The lead of claim 1 in which:

the proximal portion of the lead body comprises polyurethane.

5. The lead of claim 1 in which:

the at least one stimulation electrode also senses electrical signals produced by the heart.

6. The lead of claim 1 in which:

the at least one stimulation electrode comprises a defibrillation electrode.

7. The lead of claim 6 in which:

the defibrillation electrode is formed of a material selected from the group consisting of a flexible, conductive polymer;

a metal coil;

a plurality of metal rings; and

at least one conductive surface coating.

8. The lead of claim 1 in which:

the lead body is isodiametric.

9. The lead of claim 1 in which:

the flexible distal portion of the lead body has an outer diameter that is smaller than that of the stiffer proximal portion so as to facilitate access to narrow, distal coronary vessels.

10. An implantable stimulation lead suitable for placement in the coronary sinus region and its associated coronary vessels overlying the left side of a patient'"'"'s heart, the lead comprising:

at least one proximal connector;

at least one tissue stimulation electrode;

at least one conductor coupled between the at least one proximal connector and the at least one stimulation electrode; and

a lead body comprising a housing of insulating material enclosing the at least one conductor, the lead body having a relatively flexible distal portion having a length corresponding to the coronary sinus region of the heart, the distal portion of the lead body carrying the at least one tissue stimulation electrode, the lead body further defining a proximal portion that is stiffer than the distal portion and that extends from the at least one proximal connector to a proximal portion/distal portion interface at the proximal extremity of the distal portion of the lead body, the distal portion of the lead body being configured to engage the wall of the coronary vessel in which the distal portion of the lead body is implanted to passively anchor the distal portion of the lead body in the coronary vessel.

11. The lead of claim 10 in which:

the distal portion of the lead body is configured with at least one bend.

12. The lead of claim 11 in which:

the distal portion of the lead body is configured with at least one S-shaped bend.

13. The lead of claim 10 in which:

the distal portion of the lead body has an outer surface at least a portion of which surface is texturized to aid in passively anchoring the distal portion.

14. An implantable stimulation lead suitable for placement in the coronary sinus region and its associated coronary vessels overlying the left side of a patient'"'"'s heart, the lead comprising:

at least one proximal connector;

at least one tissue stimulation electrode;

at least one conductor coupled between the at least one proximal connector and the at least one stimulation electrode; and

a lead body of insulating material enclosing the at least one conductor, the lead body having a relatively flexible distal portion having a length corresponding to the coronary sinus region of the heart, the distal portion of the lead body carrying the at least one tissue stimulation electrode, the lead body further having a proximal portion that is stiffer than the distal portion and that extends from the at least one proximal connector to a joint coupling the distal and proximal portions of the lead body.

15. The lead of claim 14 in which:

the joint coupling the distal and proximal portions comprises a butt joint.

16. The lead of claim 15 in which:

the distal and proximal portions are bonded together at the buff joint with medical adhesive.

17. The lead of claim 14 in which:

the distal and proximal portions are coupled at a sleeve joint wherein a sleeve couples reduced diameter sections of the distal and proximal portions of the lead body.

18. The lead of claim 17 in which:

the sleeve is bonded with medical adhesive to the reduced diameter sections of the distal and proximal portions of the lead body.

19. The lead of claim 14 in which:

the joint comprises telescoped sections of the distal and proximal portions of the lead body.

20. The lead of claim 19 in which:

the telescoped section of the distal portion overlaps the telescoped section of the proximal portion of the lead body.

21. The lead of claim 19 in which:

the telescoped section of the proximal portion overlaps the telescoped section of the distal portion of the lead body.

22. The lead defined in claim 19 in which:

the telescoped sections are bonded with a medical adhesive.

23. The lead of claim 19 in which:

the telescoped sections of the distal and proximal portions of the lead body comprise a cored out section of the distal portion of the lead body and a reduced diameter section of the proximal portion of the lead body.

24. The lead of claim 23 in which:

the cored out section of the distal portion of the lead body has an inner diameter smaller than the outer diameter of the reduced diameter section of the proximal portion of the lead body whereby an interference fit exists between the cored out and reduced diameter sections.

25. The lead of claim 23 in which:

the cored out and reduced diameter sections are bonded to each other by medical adhesive.

26. The lead of claim 14 in which:

the at least one conductor comprises the series combination of a cable conductor and a coil conductor, the cable conductor having a proximal end electrically connected to the at least one proximal connector, the cable conductor having a distal end, the coil conductor having a distal end electrically connected to the at least one tissue stimulation electrode and a proximal end electrically connected to the distal end of the cable conductor.

27. The lead of claim 26 in which:

the coil conductor is made of MP35N; and

the cored out section of the distal portion of the lead body has a length greater than that of the reduced diameter section of the proximal portion of the lead body so as to define a space between the distal ends of the reduced diameter and cored out sections, the space being filled with medical adhesive thereby isolating the proximal end of the coil conductor from the proximal portion of the lead body.

28. The lead of claim 26 in which:

the joint includes a transition tube, the coil conductor having a proximal end including a plurality of windings disposed about the transition tube, the cable conductor having a distal end in electrical communication with the plurality of windings.

29. The lead of claim 28 in which:

the electrical communication between the distal end of the cable conductor and the plurality of windings at the proximal end of the coil conductor is effected by a crimp tube clamping the distal end of the cable conductor to the windings.

30. The lead of claim 28 in which:

the electrical communication between the distal end of the cable conductor and the plurality of windings at the proximal end of the coil conductor is effected by a weld.

31. The lead of claim 28 in which:

the transition tube has a distal part and a proximal part, the windings at the proximal end of the coil conductor being disposed about the distal part of the transition tube;

and which further includes;

a tubular liner of low friction material, the liner being disposed within a lumen in the proximal portion of the lead body, the liner having a distal end slipped over the proximal part of the transition tube.

32. The lead of claim 26 in which:

at least the proximal portion of the lead body comprises a multilumen housing, the cable conductor being contained within one of the lumens of the multilumen housing.

33. The lead of claim 32 in which:

the distal portion of the lead body comprises a multilumen housing, the coil conductor being contained within one of the lumens of the multilumen housing of the distal portion.

34. The lead of claim 32 in which:

a tubular liner of low friction material is contained within another one of the lumens of the multilumen lead body.

35. The lead of claim 34 in which:

the tubular liner is contained within the proximal portion of the lead body.

36. The lead of claim 34 in which:

the tubular liner is contained within both the proximal and distal portions of the lead body.

37. The lead of claim 34 in which:

the tubular liner comprises PTFE.

38. An implantable stimulation lead suitable for placement in the coronary sinus region and its associated coronary vessels overlying the left side of a patient'"'"'s heart, the lead comprising:

at least one proximal connector;

a tip electrode;

at least one conductor coupled between the at least one proximal connector and the tip electrode;

a lead body comprising a housing of insulating material enclosing the at least one conductor and defining at least one lumen, the lead body defining a relatively flexible distal portion having a length corresponding to the coronary sinus region of the heart, the distal portion of the lead body carrying the tip electrode, the lead body further defining a stiffer proximal portion extending from the at least one proximal connector to a proximal portion/distal portion interface at the proximal extremity of the distal portion of the lead body; and

a stylet stop disposed within the distal portion of the lead body, the stylet stop defining an aperture dimensioned to pass a guide wire but not a distal tip of a stylet, and wherein the tip electrode includes a longitudinally extending bore dimensioned to permit passage of the guide wire through the tip electrode.

39. The lead of claim 38 in which:

the stylet stop comprises a tubular member having an inner wall, the tubular member including an annular protuberance projecting inwardly from the inner wall of the tubular member, the annular protuberance defining the aperture, whereby the stylet, inserted in a lumen of the lead, is advanced within the lumen until the enlarged distal tip of the stylet engages the annular protuberance.

40. An implantable stimulation lead system suitable for placement in the coronary sinus region and its associated coronary vessels overlying the left side of a patient'"'"'s heart, the lead system comprising:

at least one proximal connector;

at least one tissue stimulation electrode;

at least one conductor coupled between the at least one proximal connector and the at least one stimulation electrode;

a lead body including a housing of insulating material enclosing the at least one conductor, the lead body having a relatively flexible distal portion having a length corresponding to the coronary sinus region of the heart, the distal portion of the lead body carrying the at least one tissue stimulation electrode, the lead body further having a stiffer proximal portion extending from the at least one proximal connector to a proximal portion/distal portion interface at the proximal extremity of the distal portion of the lead body;

a delivery system insertable into a lumen of the lead body to enable placement of the flexible distal portion of the lead body into one of the coronary vessels of the coronary sinus region; and

a fixation mechanism, located on the lead body, to anchor the flexible distal portion of the lead body in the coronary sinus region.

41. The lead system of claim 40 in which:

when the lead body is implanted, the proximal portion/distal portion interface resides distal of the coronary os so that a distal end of the stiffer proximal portion resides in the coronary sinus.

42. The lead system of claim 40, wherein:

the delivery system includes a guide wire; and

the at least one electrode comprises a tip electrode having a bore for passing the guide wire therethrough.

43. The lead system of claim 40, wherein:

the delivery system includes a stylet having a distal end configured to engage a stop surface within a part of the lumen disposed within the distal portion of the lead body.

44. The lead system of claim 43, wherein:

the distal end of the stylet has a taper terminating in an enlarged tip.

45. The lead system of claim 44, wherein:

a stylet stop is disposed within the distal end portion of the lead proximal of the tip electrode, the stylet stop defining an aperture dimensioned to pass a guide wire but not the enlarged distal tip of a stylet, and wherein the tip electrode includes a longitudinally extending bore dimensioned to permit passage of the guide wire through the tip electrode.

46. The lead system of claim 45, wherein:

the stylet stop comprises a tubular member having an inner wall, the tubular member including an annular protuberance projecting inwardly from the inner wall of the tubular member, the annular protuberance defining the aperture, whereby the stylet, inserted in a lumen of the lead, is advanced within the lumen until the enlarged distal tip of the stylet engages the annular protuberance.

47. The lead system of claim 40, wherein:

the at least one electrode comprises a defibrillation electrode.

48. The lead system of claim 47, wherein:

the defibrillation electrode is made of flexible material suitable for tracking the delivery means into a distal coronary vessel without stressing the vessel.

49. The lead system of claim 48, wherein:

the defibrillation electrode is made of a conductive polymer.

50. The lead system of claim 40, wherein:

the flexible distal portion of the lead body has an outer diameter smaller than that of the stiffer proximal portion so as to facilitate access to narrow, distal coronary vessels.

51. The lead system of claim 40, wherein:

the flexible distal portion of the insulating lead body is made of silicone rubber.

52. The lead system of claim 51, wherein:

the stiffer proximal portion of the insulating lead body is made of polyurethane.

53. A body implantable lead comprising:

a lead body defining a distal end portion having a tip electrode at a distal extremity of the distal end portion; and

a stylet stop within the distal end portion of the lead proximal of the tip electrode, the stylet stop defining an aperture dimensioned to pass a guide wire but not a distal tip of a stylet, and wherein the tip electrode comprises a longitudinally extending bore dimensioned to permit passage of the guide wire through the tip electrode.

54. The body implantable lead, as defined in claim 53, in which:

the stylet stop comprises a tubular member having an inner wall, the tubular member including an annular protuberance projecting inwardly from the inner wall of the tubular member, the annular protuberance defining the aperture, whereby the stylet, inserted in a lumen of the lead, is advanced within the lumen until the enlarged distal tip of the stylet engages the annular protuberance.

55. An implantable stimulation lead comprising:

at least one proximal connector;

at least one tissue stimulation electrode;

at least one conductor coupling the at least one proximal connector with the at least one stimulation electrode; and

a lead body of insulating material enclosing the at least one conductor, the lead body having a distal portion carrying the at least one tissue stimulation electrode, the lead body further having a proximal portion extending from the at least one proximal connector to a joint coupling the distal and proximal portions of the lead body, the joint comprising telescoped sections of the distal and proximal portions of the lead body, the telescoped sections of the distal and proximal portions of the lead body comprising a cored out section in one of the portions of the lead body and a reduced diameter section on the other of the portions of the lead body, the cored out section having an inner diameter smaller than the outer diameter of the reduced diameter section whereby an interference fit exists between the cored out and reduced diameter sections.

56. The lead of claim 55 in which:

the cored out and reduced diameter sections are bonded to each other by medical adhesive.

57. The lead of claim 55 in which:

the at least one conductor comprises the series combination of a cable conductor and a coil conductor, the cable conductor having a proximal end electrically connected to the at least one proximal connector, the cable conductor having a distal end, the coil conductor having a distal end electrically connected to the at least one tissue stimulation electrode and a proximal end electrically connected to the distal end of the cable conductor.

58. The lead of claim 57 in which:

the coil conductor is made of MP35N or MP35N/Ag; and

the cored out section of the distal portion of the lead body has a length greater than that of the reduced diameter section of the proximal portion of the lead body so as to define a space between the distal ends of the reduced diameter and cored out sections, the space being filled with medical adhesive thereby isolating the proximal end of the coil conductor from the proximal portion of the lead body.

59. The lead of claim 57 in which:

the joint includes a transition tube, the coil conductor having a proximal end including a plurality of windings disposed about the transition tube, the cable conductor having a distal end in electrical communication with the plurality of windings.

60. The lead of claim 59 in which:

the electrical communication between the distal end of the cable conductor and the plurality of windings at the proximal end of the coil conductor is effected by a crimp tube clamping the distal end of the cable conductor to the windings.

61. The lead of claim 59 in which:

the electrical communication between the distal end of the cable conductor and the plurality of windings at the proximal end of the coil conductor is effected by a weld.

62. The lead of claim 59 in which:

the transition tube has a distal part and a proximal part, the windings at the proximal end of the coil conductor being disposed about the distal part of the transition tube;

and which further includes;

a tubular liner of low friction material, the liner being disposed within a lumen in the proximal portion of the lead body, the liner having a distal end slipped over the proximal part of the transition tube.

63. The lead of claim 58 in which:

at least the proximal portion of the lead body comprises a multilumen housing, the cable conductor being contained within one of the lumens of the multilumen housing.

64. The lead of claim 63 in which:

the distal portion of the lead body comprises a multilumen housing, the coil conductor being contained within one of the lumens of the multilumen housing of the distal portion.

65. The lead of claim 63 in which:

a tubular liner of low friction material is contained within another one of the lumens of the multilumen lead body.

66. The lead of claim 65 in which:

the tubular liner comprises PTFE.

67. An implantable stimulation lead comprising:

at least one proximal connector;

at least one tissue stimulation electrode;

at least one conductor coupling the at least one proximal connector with the at least one stimulation electrode;

a lead body of insulating material enclosing the at least one conductor, the lead body having a distal portion carrying the at least one tissue stimulation electrode, the lead body further having a proximal portion extending from the at least one proximal connector to a joint coupling the distal and proximal portions of the lead body, the joint comprising telescoped sections of the distal and proximal portions of the lead body, the telescoped sections of the distal and proximal portions of the lead body comprising a cored out section in one of the portions of the lead body and a reduced diameter section on the other of the portions of the lead body, the at least one conductor comprising the series combination of a first conductor within the proximal portion of the lead body and a second conductor within the distal portion of the lead body, a distal end of the first conductor being electrically connected within the joint to a proximal end of the second conductor, the cored out section of the distal portion of the lead body having a length greater than that of the reduced diameter section of the proximal portion of the lead body so as to define a space between the distal ends of the reduced diameter and cored out sections, the space being filled with medical adhesive thereby isolating the proximal end of the first conductor from the proximal portion of the lead body.

68. The lead of claim 67 in which:

the second conductor is made of MP35N or MP35N/Ag and the proximal portion of the lead body is made of polyurethane.

69. The lead of claim 67 in which:

the cored out and reduced diameter sections are bonded to each other by medical adhesive.

70. The lead of claim 67 in which:

the cored out section having an inner diameter smaller than the outer diameter of the reduced diameter section whereby an interference fit exists between the cored out and reduced diameter sections.

71. The lead of claim 67 in which:

the at least one conductor comprises the series combination of a cable conductor and a coil conductor, the cable conductor having a proximal end electrically connected to the at least one proximal connector, the cable conductor having a distal end, the coil conductor having a distal end electrically connected to the at least one tissue stimulation electrode and a proximal end electrically connected to the distal end of the cable conductor.

72. The lead of claim 71 in which:

the joint includes a transition tube, the coil conductor having a proximal end including a plurality of windings disposed about the transition tube, the cable conductor having a distal end in electrical communication with the plurality of windings.

73. The lead of claim 72 in which:

the electrical communication between the distal end of the cable conductor and the plurality of windings at the proximal end of the coil conductor is effected by a crimp tube clamping the distal end of the cable conductor to the windings.

74. The lead of claim 72 in which:

the electrical communication between the distal end of the cable conductor and the plurality of windings at the proximal end of the coil conductor is effected by a weld.

75. The lead of claim 72 in which:

the transition tube has a distal part and a proximal part, the windings at the proximal end of the coil conductor being disposed about the distal part of the transition tube;

and which further includes;

a tubular liner of low friction material, the liner being disposed within a lumen in the proximal portion of the lead body, the liner having a distal end slipped over the proximal part of the transition tube.

76. The lead of claim 71 in which:

at least the proximal portion of the lead body comprises a multilumen housing, the cable conductor being contained within one of the lumens of the multilumen housing.

77. The lead of claim 76 in which:

the distal portion of the lead body comprises a multilumen housing, the coil conductor being contained within one of the lumens of the multilumen housing of the distal portion.

78. The lead of claim 76 in which:

a tubular liner of low friction material is contained within another one of the lumens of the multilumen lead body.

79. The lead of claim 78 in which:

the tubular liner comprises PTFE.