Gastrointestinal stimulation lead

• US 7,519,433 B2
• Filed: 08/25/2004
• Issued: 04/14/2009
• Est. Priority Date: 08/25/2004
• Status: Active Grant

• Current Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Transneuronix, Inc. (Medtronic Plc)
• Inventors: Foley, Stephen T.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): PATEL, NATASHA
• Application Number:
  US10/926,160
• Publication Number:
  US 20060047323A1
• Time in Patent Office: 1,693 Days
• Field of Search: 607115- 6, 607/121, 607/122, 607/124, 607/133, 607126- 8, 600373- 5, 600/377, 600/380, 600/386
• US Class Current: 607/133
• 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 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An implantable lead device and method for implanting the lead, wherein the lead device electrically stimulates tissue within a patient'"'"'s body and more particularly the lead device stimulates gastrointestinal tissue. The implantable lead may be inserted through the tissue with minimal expansion of the penetration tunnel and attached to the tissue being stimulated with minimal efforts or apparatus. The implantable lead has flexible properties thus minimizing the potential for electrode erosion, maximizing tissue compliance, and minimizing the mechanical stress concentration that may result in fatigue failure in the lead.

Claims

1. An implantable electrostimulation device for attachment to tissue to be stimulated within a patient'"'"'s body, said-device comprising:

an elongated body having a proximal end and a distal end;

an electric connection terminal at or near the proximal end for connection to a power source;

at least one flexible electrode at or near the distal end;

at least one electrical conductor extending through the elongated body from the flexible electrode to the electrical connection terminal whereby an electrical pathway may be formed between the flexible electrode, the electrical connection terminal, and the tissue to be stimulated; and

a substantially flexible anchoring loop at or near the distal end, the substantially flexible anchoring loop adapted to remain substantially flexible in substantially all configurations and positions,

wherein the anchoring loon has a normal, open position in which the loop has a diameter that is larger than a diameter of the flexible electrode, and

wherein the elongated body is narrow at a position between the flexible electrode and the anchoring loop to allow the anchoring loop to be positioned for attachment within the patient'"'"'s body.

2. The device of claim 1, wherein the tissue to be stimulated is gastrointestinal tissue.

3. The device of claim 1, wherein the flexible electrode is configured as a helical coil.

4. The device of claim 3, wherein the helical coil has a sufficiently exposed surface area to provide an electrical interface between the device and the tissue to be stimulated.

5. The device of claim 3, wherein the helical coil does not significantly stretch along its longitudinal axis when placed under tension along its longitudinal axis.

6. The device of claim 3, wherein the helical coil has been coated or impregnated with a conductive material.

7. The device of claim 6, wherein the helical coil has a flexible silicone or polymer base that is coated or impregnated with the conductive material.

8. The device of claim 1, wherein the anchoring loop comprises a silicone elastomer or polymer loop.

9. The device of claim 1, wherein the anchoring loop is attached within the patient'"'"'s body by sutures or staples.

10. The device of claim 1, wherein the anchoring loop has a closed position and the open position.

11. The device of claim 10, wherein the anchoring loop in the closed position has a diameter of about the same as or less than the flexible electrode'"'"'s diameter.

12. The device of claim 10, wherein the flexible loop is configured to collapse from the open position to the closed position when tension is applied substantially along a longitudinal axis of the elongated body, and to assume the open position when the tension has been removed.

13. The device of claim 11, wherein the anchoring loop can be folded back to lie flat on the tissue.

14. The device of claim 11, wherein the proximal end of the elongated body can be passed through the anchoring loop to capture or surround the tissue.

15. The device of claim 1, wherein the narrowing between the flexible electrode and the anchoring loop prevents the anchoring loop from tightening or constricting the tissue.

16. The device of claim 1, wherein a surgical clip is applied at the narrowing between the flexible electrode and the anchoring loop to prevent the anchoring loop from tightening or constricting the tissue.

17. An implantable electrostimulation device for attachment to tissue to be stimulated within a patient'"'"'s body, said device comprising:

an elongated body having a proximal end and a distal end;

an electrical connection terminal at or near the proximal end for connection to a power source;

a penetration mechanism at the distal end to penetrate the tissue to be stimulated;

a quick release connecting mechanism adjacent to the penetration mechanism to allow the penetration mechanism to be detached from the elongated body once the implanted device has been properly located within the tissue;

at least one flexible electrode towards the distal end;

at least one electrical conductor extending through the elongated body from the electrical connection terminal to the flexible electrode, whereby an electrical pathway may be formed between the flexible electrode, the electrical connection terminal, and the tissue to be stimulated; and

a substantially flexible anchoring loop at or near the distal end, wherein the anchoring loop has a normal, open position in which the loop has a diameter that is larger than a diameter of the flexible electrode, and wherein the elongated body narrows between the flexible electrode and the anchoring loop to allow the anchoring loop to be positioned for attachment with the patient'"'"'s body, the substantially flexible anchoring loop adapted to remain substantially flexible in substantially all configurations and positions.

18. The device of claim 17, wherein the tissue to be stimulated is gastrointestinal tissue.

19. The device of claim 18, wherein the flexible electrode is configured as a helical coil.

20. The device of claim 18, wherein the anchoring loop is attached within the patient'"'"'s body by sutures or staples.

21. The device of claim 19, wherein the helical coil has a sufficiently exposed surface area to provide an electrical interface between the device and the tissue to be stimulated.

22. The device of claim 21, wherein the helical coil does not significantly stretch along its longitudinal axis when placed under tension along its longitudinal axis.

23. The device of claim 21, wherein the helical coil has been coated or impregnated with a conductive material.

24. The device of claim 23, wherein the helical coil has a flexible silicone or polymer base that is coated or impregnated with the conductive material.

25. The device of claim 17, wherein the flexible electrode is configured as a helical coil.

26. The device of claim 17, wherein the anchoring loop comprises a silicone elastomer or polymer loop.

27. The device of claim 17, wherein the anchoring loop has a closed position and the open position.

28. The device of claim 27, wherein the diameter of the anchoring loop in the closed position is less than or equal to the diameter of the flexible electrode.

29. The device of claim 27, wherein the anchoring loop assumes an open position when the anchoring loop is positioned for attachment within the patient'"'"'s body.

30. The device of claim 27, wherein the flexible loop is configured to collapse from the open position to the closed position when tension is applied substantially along a longitudinal axis of the elongated body, and to assume the open position when the tension has been removed.

31. The device of claim 28, wherein the proximal end of the elongated body can be passed through the anchoring loop to capture or surround the tissue.

32. The device of claim 28, wherein the anchoring loop can be folded back to lie flat on the tissue.

33. The device of claim 17, wherein the narrowing between the flexible electrode and the anchoring loop allows the anchoring loop to be positioned on the tissue for anchoring into the tissue.

34. The device of claim 17, wherein the narrowing between the flexible electrode and the anchoring loop prevents the anchoring loop from tightening or constricting the tissue.

35. The device of claim 34, wherein a surgical clip is applied at the narrowing between the flexible electrode and the anchoring loop to prevent the anchoring loop from tightening or constricting the tissue.

36. A method for implanting an electrostimulation device for attachment to tissue to be stimulated within a patients body, said method comprising:

forming a penetration tunnel within gastric tissue to be stimulated such that the penetration tunnel does not completely penetrate a wall of the stomach;

positioning an elongated body device with a distal end and a proximal end in the penetration tunnel within the gastric tissue to be stimulated, wherein the elongated body has at least one flexible electrode at or near the distal end and the electrical connection terminal at or near the proximal end for connection to a power source;

forming an electrical pathway between the flexible electrode, the electrical connection terminal, and the tissue to be stimulated, wherein the electrical conductor extends through the elongated body from the electric connection terminal to the flexible electrode; and

attaching a substantially flexible anchoring loop located at or near the distal end within the patient'"'"'s body, wherein the anchoring loop has a normal, open position in which the loop has a diameter that is larger than a diameter of the flexible electrode, and wherein the elongated body is narrow between the flexible electrode and the anchoring loop.

37. The method of claim 36, wherein the tissue to be stimulated is gastrointestinal tissue.

38. The method of claim 37, wherein the flexible electrode is configured as a helical coil.

39. The method of claim 38, wherein the helical coil has a sufficiently exposed surface area to provide an electrical interface between the device and the tissue to be stimulated.

40. The method of claim 38, wherein the helical coil has been coated or impregnated with a conductive material.

41. The method of claim 39, wherein the helical coil does not significantly stretch along its longitudinal axis when placed under tension along its longitudinal axis.

42. The method of claim 40, wherein the helical coil has a flexible silicone or polymer base that is coated or impregnated with the conductive material.

43. The method of claim 36, wherein the flexible electrode is configured as a helical coil.

44. The method of claim 36, wherein the anchoring loop comprises a silicone elastomer or polymer loop.

45. The method of claim 36, wherein the anchoring loop is attached within the patient'"'"'s body by sutures or staples.

46. The method of claim 36, wherein the anchoring loop has a closed position and the open position.

47. The method of claim 46, wherein the diameter of the anchoring loop in the closed position is less than or equal to the diameter of the flexible electrode.

48. The method of claim 46, wherein the anchoring loop assumes an open position when the anchoring loop is positioned for attachment within the patient'"'"'s body.

49. The method of claim 36, wherein the narrowing between the flexible electrode and the anchoring loop allows the anchoring loop to be positioned on the tissue for anchoring into the tissue.

50. The method of claim 49, wherein the anchoring loop can be folded back to lie flat on the tissue.

51. The method of claim 49, wherein the proximal end of the elongated body can be passed through the anchoring loop to capture or surround the tissue.

52. The method of claim 36, wherein the narrowing between the flexible electrode and the anchoring loop prevents the anchoring loop from tightening or constricting the tissue.

53. The method of claim 52, wherein a surgical clip is applied at the narrowing between the flexible electrode and the anchoring loop to prevent the anchoring loop from tightening or constricting the tissue.

54. The method of claim 36, wherein the flexible loop is configured to collapse from the open position to the closed position when tension is applied substantially along a longitudinal axis of the elongated body, and to assume the open position when the tension has been removed.

55. A method for implanting an electrostimulation device for attachment to tissue to be stimulated within a patient'"'"'s body, said method comprising:

providing an electrostimulation device having an elongated body with a distal end and a proximal end, wherein the elongated body has at least one flexible electrode at or near the distal end and an electrical connection terminal at or near the proximal end for connection to a power source;

penetrating the tissue to be stimulated with the electrostimulation device using the penetration mechanism to form a penetration tunnel such that the penetration tunnel does not completely penetrate a wall of the stomach;

positioning the electrostimulation device within the penetration tunnel of the tissue to be stimulated;

forming an electrical pathway between the flexible electrode, the electrical connection terminal, and the tissue to be stimulated, wherein the electrical conductor extends through the elongated body from the electric connection terminal to the flexible electrode;

detaching the penetration mechanism from the electrostimulation device once the electrostimulation device has been located within the tissue to be stimulated, wherein a quick release connecting mechanism adjacent to the penetration mechanism allows the penetration mechanism to be detached; and

attaching a substantially flexible anchoring loop located at or near the distal end within the patient'"'"'s body, wherein the anchoring loop has a normal, open position in which the loop has a diameter that is larger than a diameter of the flexible electrode, and wherein the elongated body is narrow between the flexible electrode and the anchoring loop.

56. The method of claim 55, wherein the tissue to be stimulated is gastrointestinal tissue.

57. The method of claim 55, wherein the flexible electrode is configured as a helical coil.

58. The method of claim 56, wherein the flexible electrode is configured as a helical coil.

59. The method of claim 58, wherein the helical coil has a sufficiently exposed surface area to provide an electrical interface between the device and the tissue to be stimulated.

60. The method of claim 59, wherein the helical coil does not significantly stretch along its longitudinal axis when placed under tension along its longitudinal axis.

61. The method of claim 58, wherein the helical coil has been coated or impregnated with a conductive material.

62. The method of claim 61, wherein the helical coil has a flexible silicone or polymer base that is coated or impregnated with the conductive material.

63. The method of claim 55, wherein the anchoring loop comprises a silicone elastomer or polymer loop.

64. The method of claim 55, wherein the anchoring loop is attached within the patient'"'"'s body by sutures or staples.

65. The method of claim 55, wherein the anchoring loop has a closed position and the open position.

66. The method of claim 65, wherein the diameter of the anchoring loop in the closed position is less than or equal to the diameter of the flexible electrode.

67. The method of claim 65, wherein the anchoring loop assumes an open position when the anchoring loop is positioned for attachment within the patient'"'"'s body.

68. The method of claim 55, wherein the narrowing between the flexible electrode and the anchoring loop allows the anchoring loop to be positioned on the tissue for anchoring into the tissue.

69. The method of claim 68, wherein the anchoring loop can be folded back to lie flat on the tissue.

70. The device of claim 68, wherein the proximal end of the elongated body can be passed through the anchoring loop to capture or surround the tissue.

71. The method of claim 55, wherein the narrowing between the flexible electrode and the anchoring loop prevents the anchoring loop from tightening or constricting the tissue.

72. The method of claim 71, wherein a surgical clip is applied at the narrowing between the flexible electrode and the anchoring loop to prevent the anchoring loop from tightening or constricting the tissue.

73. The method of claim 65, wherein the flexible loop is configured to collapse from the open position to the closed position when tension is applied substantially along a longitudinal axis of the elongated body, and to assume the open position when the tension has been removed.