Modular stimulation lead network

• US 7,590,454 B2
• Filed: 03/12/2004
• Issued: 09/15/2009
• Est. Priority Date: 03/12/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Garabedian, Robert J., Wallace, Michael P.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US10/799,271
• Publication Number:
  US 20050203599A1
• Time in Patent Office: 2,013 Days
• Field of Search: 607/46, 607115-118
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A medical kit and method for treating an ailment, such as chronic pain is provided. The kit comprises first and second medical leads, e.g., stimulation leads. Each lead comprises an elongated body and at least one operative element. The first medical lead comprises a coupling mechanism, such as a slot, and the second medical lead comprises a complementary mechanism, such as a rail, that slidably engages the coupling mechanism of the first medical lead. The method may comprise delivering the first medical lead into a patient'"'"'s body, e.g., into the epidural space of the patient, and delivering the second medical lead into the patient'"'"'s body by sliding the complementary coupling mechanism of the second medical lead along the coupling mechanism of the first medical lead.

Claims

1. A method of treating a disorder in a patient using stimulation kit having a first tissue stimulation lead comprising a first elongated body, a first stimulation element, and a coupling mechanism longitudinally extending along at least a portion of the first elongated body, and a second tissue stimulation lead comprising a second elongated body, a second stimulation element, and a complementary coupling mechanism configured to slidably engage the first coupling mechanism, the method comprising:

delivering the first stimulation lead into an epidural space of the patient'"'"'s spine; and

delivering the second stimulation lead into the epidural space by sliding the complementary coupling mechanism along the coupling mechanism, such that the proximal end of the first elongated body extends from the opening in the patient'"'"'s back, and the second elongated body is entirely received within the patient'"'"'s spine.

2. The method of claim 1,

wherein the second elongated body is shorter than the first elongated body.

3. The method of claim 1, wherein at least one of the first and second elongated bodies is cylindrically-shaped.

4. The method of claim 1, wherein the greatest cross-sectional dimension of at least one of the first and second elongated bodies is 5 mm or less.

5. The method of claim 1, wherein the first and second stimulation elements are electrodes.

6. The method of claim 1, wherein the first and second stimulation elements are mounted on the respective first and second elongated bodies.

7. The method of claim 1, wherein the first and second stimulation elements are configured to face a single direction when the complementary coupling mechanism slidably engages the coupling mechanism.

8. The method of claim 1, wherein each of the first and second stimulation leads comprises a plurality of stimulation elements.

9. The method of claim 1, wherein the coupling mechanism and complementary coupling mechanism are configured to slidably engage each other in a rail and slot arrangement.

10. The method of claim 1, wherein the complementary coupling mechanism is configured to extend along only a distal portion of the second elongated body.

11. The method of claim 1, wherein the first and second stimulation leads are delivered into the epidural space through a percutaneous opening.

12. The method of claim 1, further comprising conveying stimulation energy from the first and second stimulation elements into neural tissue within the patient'"'"'s spine.

13. The method of claim 12, wherein the disorder is chronic pain.

14. A method of treating a disorder in a patient, comprising:

delivering a first stimulation lead into the epidural space of the patient'"'"'s spine;

delivering a second stimulation lead into the epidural space by slidably engaging the second stimulation lead along the first stimulation lead; and

deploying the second stimulation lead from the first stimulation lead.

15. The method of claim 14, wherein the first and second stimulation leads are delivered into the epidural space through a percutaneous opening.

16. The method of claim 14, further comprising implanting the first and second stimulation leads within the patient'"'"'s spine.

17. The method of claim 14, further comprising coupling the first and second stimulation leads to a stimulation source.

18. The method of claim 14, wherein the disorder is chronic pain.

19. The method of claim 17, further comprising conveying stimulation energy from the stimulation source to the first and second stimulation leads to stimulate neural tissue within the patient'"'"'s spine.

20. The method of claim 19, wherein the stimulation energy is electrical energy.

21. The method of claim 19, wherein the stimulation energy is focused into the neural tissue.

22. The method of claim 14, further comprising:

delivering a third stimulation lead into the epidural space by slidably engaging the third stimulation lead along the first stimulation lead; and

deploying the third stimulation lead from the first stimulation lead.

23. The method of claim 14, further comprising inserting a delivery device into the epidural space, wherein the first stimulation lead is introduced through the delivery device into the epidural space.

24. The method of claim 23, wherein the delivery device is one of an introducer or needle.

25. A stimulation kit, comprising:

a first tissue stimulation lead comprising a first elongated body, a first stimulation element, and a first coupling mechanism longitudinally extending along at least a portion of the first elongated body; and

a second tissue stimulation lead comprising a second elongated body, a second stimulation element, and a first complementary coupling mechanism configured to slidably engage the first coupling mechanism, wherein the second elongated body is configured to deploy from the first elongated body by slidably disengaging at least a portion of the complementary coupling mechanism from the coupling mechanism, and wherein the second elongated body is configured to be actively changed from a first geometry to a second geometry after deployment from the first elongated body.

26. The stimulation kit of claim 25, wherein at least one of the first and second elongated bodies is cylindrically-shaped.

27. The stimulation kit of claim 25, wherein the greatest cross-sectional dimension of at least one of the first and second elongated bodies is 5 mm or less.

28. The stimulation kit of claim 25, wherein the first and second stimulation elements are electrodes.

29. The stimulation kit of claim 25, wherein the first and second stimulation elements are mounted on the respective first and second elongated bodies.

30. The stimulation kit of claim 25, wherein the first and second stimulation elements are configured to face a single direction when the first complementary coupling mechanism slidably engages the first coupling mechanism.

31. The stimulation kit of claim 25, wherein each of the first and second stimulation leads comprises a plurality of stimulation elements.

32. The stimulation kit of claim 25, wherein the first coupling mechanism and first complementary coupling mechanism are configured to slidably engage each other in a rail and slot arrangement.

33. The stimulation kit of claim 25, wherein the second complementary coupling mechanism extends along only a distal portion of the second elongated body.

34. The stimulation kit of claim 25, wherein the second elongated body is shorter than the first elongated body.

35. The stimulation kit of claim 25, wherein the second elongated body is pre-curved.

36. The stimulation kit of claim 25, further comprising a stylet configured to be introduced through the second elongated body to change the second elongated body from the first geometry to the second geometry.

37. The stimulation kit of claim 25, wherein the second stimulation lead comprises a pullwire configured to be pulled to change the second elongated body from the first geometry to the second geometry.

38. The stimulation kit of claim 25, wherein the first stimulation lead comprises another coupling mechanism longitudinally extending along at least a portion of the first elongated body, the stimulation kit further comprising a third stimulation lead comprising a third elongated body, a stimulation element mounted on the third elongated body, and another complementary coupling mechanism configured to slidably engage the other coupling mechanism, wherein the third elongated body is configured to deploy from the first elongated body by slidably disengaging at least a portion of the other complementary coupling mechanism from the other coupling mechanism.

39. The stimulation kit of claim 25, further comprising a stimulation source configured to be coupled to the first and second stimulation leads.

40. A method of treating a disorder in a patient using the stimulation kit of claim 25, comprising:

delivering the first stimulation lead into the epidural space of the patient'"'"'s spine;

delivering the second stimulation lead into the epidural space by sliding the complementary coupling mechanism along the coupling mechanism; and

deploying the second elongated body from the first elongated body by slidably disengaging at least a portion of the complementary coupling mechanism from the coupling mechanism.

41. The method of claim 40, wherein the first and second stimulation leads are delivered into the epidural space through a percutaneous opening.

42. The method of claim 40, further comprising conveying stimulation energy from the first and second stimulation elements into neural tissue within the patient'"'"'s spine.

43. The method of claim 40, wherein the disorder is chronic pain.

44. A stimulation kit, comprising:

a first tissue stimulation lead comprising a first elongated body, a first stimulation element, and a first coupling mechanism longitudinally extending along at least a portion of the first elongated body; and

a second tissue stimulation lead comprising a second elongated body, a second stimulation element, and a first complementary coupling mechanism configured to slidably engage the first coupling mechanism, wherein the complementary coupling mechanism does not extend along a portion of the second elongated body, and the second elongated body is configured to deploy from the first elongated body by bowing the portion of the second elongated body away from the first elongated body.

45. The stimulation kit of claim 44, wherein at least one of the first and second elongated bodies is cylindrically-shaped.

46. The stimulation kit of claim 44, wherein the greatest cross-sectional dimension of at least one of the first and second elongated bodies is 5 mm or less.

47. The stimulation kit of claim 44, wherein the first and second stimulation elements are electrodes.

48. The stimulation kit of claim 44, wherein the first and second stimulation elements are mounted on the respective first and second elongated bodies.

49. The stimulation kit of claim 44, wherein the first and second stimulation elements are configured to face a single direction when the first complementary coupling mechanism slidably engages the first coupling mechanism.

50. The stimulation kit of claim 44, wherein each of the first and second stimulation leads comprises a plurality of stimulation elements.

51. The stimulation kit of claim 44, wherein the first coupling mechanism and first complementary coupling mechanism are configured to slidably engage each other in a rail and slot arrangement.

52. The stimulation kit of claim 44, wherein the second complementary coupling mechanism extends along only a distal portion of the second elongated body.

53. The stimulation kit of claim 44, wherein the second elongated body is shorter than the first elongated body.

54. The stimulation kit of claim 44, wherein the first stimulation lead comprises another coupling mechanism longitudinally extending along at least a portion of the first elongated body, the stimulation kit further comprising a third stimulation lead comprising a third elongated body, a stimulation element mounted on the third elongated body, and another complementary coupling mechanism configured to slidably engage the other coupling mechanism, wherein the third elongated body is configured to deploy from the first elongated body by bowing the portion of the third elongated body away from the first elongated body.

55. The stimulation kit of claim 44, further comprising a stimulation source configured to be coupled to the first and second stimulation leads.

56. A method of treating a disorder in a patient using the stimulation kit of claim 44, comprising:

delivering the first stimulation lead into the epidural space of the patient'"'"'s spine;

delivering the second stimulation lead into the epidural space by sliding the complementary coupling mechanism along the coupling mechanism; and

deploying the second elongated body from the first elongated body by bowing the portion of the second elongated body away from the first elongated body.

57. The method of claim 56, wherein the first and second stimulation leads are delivered into the epidural space through a percutaneous opening.

58. The method of claim 56, further comprising conveying stimulation energy from the first and second stimulation elements into neural tissue within the patient'"'"'s spine.

59. The method of claim 56, wherein the disorder is chronic pain.

60. A stimulation kit, comprising:

a first tissue stimulation lead comprising a first elongated body, a first stimulation element, and a first coupling mechanism longitudinally extending along at least a portion of the first elongated body; and

a second tissue stimulation lead comprising a second elongated body, a second stimulation element, and a first complementary coupling mechanism configured to slidably engage the first coupling mechanism, wherein the second stimulation lead comprises a flap on which the second stimulation element is disposed, the flap extending along a portion of the complementary coupling mechanism, and configured to be secured by the coupling mechanism when the portion of the complementary coupling mechanism slidably engages the coupling mechanism and released by the coupling mechanism when the portion of the complementary coupling mechanism slidably disengages the coupling mechanism.

61. The stimulation kit of claim 60, wherein at least one of the first and second elongated bodies is cylindrically-shaped.

62. The stimulation kit of claim 60, wherein the greatest cross-sectional dimension of at least one of the first and second elongated bodies is 5 mm or less.

63. The stimulation kit of claim 60, wherein the first and second stimulation elements are electrodes.

64. The stimulation kit of claim 60, wherein the first and second stimulation elements are mounted on the respective first and second elongated bodies.

65. The stimulation kit of claim 60, wherein the first and second stimulation elements are configured to face a single direction when the first complementary coupling mechanism slidably engages the first coupling mechanism.

66. The stimulation kit of claim 60, wherein each of the first and second stimulation leads comprises a plurality of stimulation elements.

67. The stimulation kit of claim 60, wherein the first coupling mechanism and first complementary coupling mechanism are configured to slidably engage each other in a rail and slot arrangement.

68. The stimulation kit of claim 60, wherein the second complementary coupling mechanism extends along only a distal portion of the second elongated body.

69. The stimulation kit of claim 60, wherein the second elongated body is shorter than the first elongated body.

70. The stimulation kit of claim 60, wherein the first stimulation lead comprises another coupling mechanism longitudinally extending along at least a portion of the first elongated body, the stimulation kit further comprising a third stimulation lead comprising a third elongated body, a third stimulation element mounted on the third elongated body, and another complementary coupling mechanism configured to slidably engage the other coupling mechanism, wherein the third stimulation lead comprises another flap on which the third stimulation element is disposed, the other flap extending along a portion of the other complementary coupling mechanism, and configured to be secured by the other coupling mechanism when the portion of the other complementary coupling mechanism slidably engages the other coupling mechanism and released by the other coupling mechanism when the portion of the other complementary coupling mechanism slidably disengages the other coupling mechanism.

71. The stimulation kit of claim 60, further comprising a stimulation source configured to be coupled to the first and second stimulation leads.

72. A method of treating a disorder in a patient using the stimulation kit of claim 60, comprising:

delivering the first stimulation lead into the epidural space of the patient'"'"'s spine;

delivering the second stimulation lead into the epidural space by sliding the complementary coupling mechanism along the coupling mechanism;

slidably engaging the portion of the complementary coupling mechanism to secure the flap; and

slidably disengaging the portion of the complementary coupling mechanism to release the flap.

73. The method of claim 72, wherein the first and second stimulation leads are delivered into the epidural space through a percutaneous opening.

74. The method of claim 72, further comprising conveying stimulation energy from the first and second stimulation elements into neural tissue within the patient'"'"'s spine.

75. The method of claim 72, wherein the disorder is chronic pain.