Techniques for positioning therapy delivery elements within a spinal cord or a brain

• US 6,795,737 B2
• Filed: 08/21/2001
• Issued: 09/21/2004
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Schendel, Michael, Gielen, Frans, Petersen, Daryle, Rise, Mark T., King, Gary W., Starkebaum, Warren
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/934,001
• Publication Number:
  US 20010053885A1
• Time in Patent Office: 1,127 Days
• Field of Search: 607/43, 607/45, 607/117, 607/50-51, 607/142, 607/152
• US Class Current: 607/117
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• 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 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Apparatus and techniques to address the problems associated with lead migration, patient movement or position, histological changes, neural plasticity or disease progression. Disclosed are techniques for implanting a lead having therapy delivery elements, such as electrodes or drug delivery ports, within a vertebral or cranial bone so as to maintain these elements in a fixed position relative to a desired treatment site. The therapy delivery elements may thereafter be adjusted in situ with a position control mechanism and/or a position controller to improve the desired treatment therapy, such as electrical stimulation and/or drug infusion to a precise target. The therapy delivery elements may be positioned laterally in any direction relative to the targeted treatment site or toward or away from the targeted treatment site. A control system maybe provided for open- or closed-loop feedback control of the position of the therapy delivery elements as well as other aspects of the treatment therapy.

Claims

1. A method for providing treatment therapy to a targeted tissue by means of a therapy delivery device and at least one therapy delivery element coupled to the therapy delivery device, the method comprising the steps of:

(a) implanting at least one lead having at least one therapy delivery element so that the therapy delivery element lies in communication near the targeted tissue, the targeted tissue being neural tissue in the brain;

(b) coupling a proximal end of the lead to the therapy delivery device;

(c) operating the therapy delivery device to provide treatment therapy to the targeted tissue via the implanted therapy delivery element; and

(d) adjusting at any time after the step of implanting, the position of at least one implanted therapy delivery element relative to the targeted tissue.

2. A method as claimed in claim 1, wherein the therapy delivery device is a pump and the therapy delivery element is a catheter.

3. A method as claimed in claim 1, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of the therapy delivery device in response to the sensor signal.

4. A method as claimed in claim 1, wherein the therapy delivery device is a signal generator and the therapy delivery element is an electrode.

5. A method as claimed in claim 4, wherein the step of adjusting includes the step of positioning the electrode laterally from the lead.

6. A method as claimed in claim 4, wherein the step of adjusting includes the step of positioning the electrode from the lead toward or away from the targeted tissue.

7. A method as claimed in claim 1, wherein the step of adjusting includes the step of sensing a condition of a response to the treatment therapy and the step of adjusting is performed in response to the step of sensing.

8. A method as claimed in claim 7, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of the therapy delivery device in response to the sensor signal.

9. A method as claimed in claim 7, wherein the step of sensing a condition of a response to the treatment therapy includes sensing neural activity evoked by the therapy.

10. A system for providing treatment therapy to targeted tissue comprising in combination:

(a) a therapy delivery device;

(b) at least one therapy delivery element coupled to the therapy delivery device for providing treatment therapy to the targeted tissue;

(c) at least one position control mechanism coupled to the at least one therapy delivery element for adjusting, at any time after implanting the therapy delivery element, the position of the at least one therapy delivery element relative to the targeted tissue; and

(d) a first sensor for generating a first sensor signal related to a condition of a body,

wherein the at least one position control mechanism is capable of adjusting the position of at least one of the therapy delivery elements in response to the first sensor signal.

11. A system of claim 10, wherein the therapy delivery device is a signal generator and the therapy delivery element is an electrode.

12. A system of claim 10, wherein the therapy delivery device is a pump and the therapy delivery element is a catheter.

13. A system of claim 10, wherein the first sensor senses the body'"'"'s response to the treatment therapy.

14. A system of claim 10, further comprising:

(d) control means for regulating the operation of the therapy delivery device in response to the first sensor signal.

15. A system of claim 10, further comprising:

(e) a second sensor for generating a second sensor signal indicative a condition to be treated; and

(f) control means for regulating the operation of the therapy delivery element in response to the second sensor signal.

16. A system of claim 10, wherein the at least one therapy delivery element is part of a paddle lead.

17. A system of claim 10, wherein the at least one therapy delivery element is part of a paddle lead having at least one cavity for holding fluid, wherein a change in fluid within the lead would direct the at least one therapy delivery element of the lead toward or away from targeted tissue.

18. A system of claim 10, wherein the at least one therapy delivery element is part of a paddle lead having at least one bellow, wherein expansion or compression of the bellow would direct the at least one of the therapy delivery element of the lead toward or away from targeted tissue.

19. A system of claim 10, wherein the at least one therapy delivery element is part of a paddle lead having at least one piston, wherein expansion or compression of the piston would direct the at least one therapy delivery element of the lead toward or away from targeted tissue.

20. A system of claim 10, wherein the at least one therapy delivery element is part of a paddle lead having at least one piston and at least one spring, wherein expansion or compression of the piston or spring would direct the at least one of the therapy delivery element of the lead toward or away from targeted tissue.

21. A system of claim 10, wherein the at least one therapy delivery element is part of a paddle lead having a dorsal side and further comprising:

(e) at least one inflatable balloon-like-member attached to a dorsal side or a lateral side of the paddle lead and capable of being filled with fluid, wherein the addition or removal of fluid from at least one of the balloon-like members would direct the at least one therapy delivery element of the lead relative targeted tissue.

22. A system of claim 21, wherein the balloon-like member has one or more areas of inelastic material.

23. A system of claim 22, wherein the dorsal side or the lateral side has a hinge coupling two relatively rigid members.

24. A system of claim 10, further comprising electrodes that are part of a paddle lead further comprising at least one glider means attached to the paddle lead capable of positioning at least a portion of the paddle lead relative to the targeted tissue.

25. A system of claim 10, further comprising electrodes that are part of a paddle lead further comprising at least one bendable wire means attached to the paddle lead capable of positioning at least a portion of the paddle lead relative to the targeted tissue.

26. A system of claim 10, further comprising electrodes that are part of a paddle lead further comprising

at least one gear mechanism attached to the paddle lead capable of positioning at least a portion of the paddle lead relative to the targeted tissue.

27. A system of claim 10, wherein the at least one therapy delivery element is part of an implantable lead and wherein the lead has:

i. An elongate central portion; and

ii. a least one extendable member having an end, the extendable member depending from the central portion and being adapted to assume a compact position, in which the end is disposed in close proximity to the central portion, and an extended position, in which the end is disposed at a location distal from the central portion,

wherein the at least one therapy delivery element is positioned at least on the extendable member.

28. An implantable lead for providing therapy to a body comprising:

(a) an elongate central portion;

(b) at least one extendable member having an end, the extendable member depending from the central portion and being adapted to assume a compact position, in which the end is disposed in close proximity to the central portion, and an extended position, in which the extendable member is disposed at an angle laterally from the central portion by a span that incorporates a resilient material to urge the span to toward the extended position; and

(c) at least one therapy delivery element disposed on the extendable member for delivering therapy to the body, wherein the lead is a paddle lead.

29. The implantable lead according to claim 28, wherein the extendable member may be elongated outwardly from the central portion to position the therapy delivery element toward or away from targeted tissue.

30. The implantable lead according to claim 28, wherein the extendable member includes a lever to adjust the angle of the extendable member.

31. An implantable lead for providing therapy to a body comprising:

(a) a paddle lead having an elongate central portion; and

(b) at least one extendable member having an end, the extendable member depending from the central portion and being adapted to assume a compact position, in which the end is disposed in close proximity to the central portion, and an extended position, in which the end is disposed at a location distal from the central portion;

(c) at least one therapy delivery element disposed on the extendable member for delivering therapy to the body;

(d) a lever coupled near the end of the extendable member and the central portion capable of selectively adjusting the direction of extension of the extendable member relative to the central portion.

32. The implantable lead according to claim 31, wherein the extendable member may be elongated outwardly from the end to direct the therapy delivery element toward or away from targeted tissue.

33. A system for providing neurostimulation therapy to targeted tissue comprising in combination:

(a) a signal generator;

(b) at least one housing member implantable within a bone near the targeted tissue and adjustable relative to the bone; and

(c) at least one electrode coupled to said signal generator and attached to a distal end of the housing member for providing electrical stimulation to the targeted tissue.

34. A system of claim 33, further comprising

(d) a collar implantable within a bone near the neural tissue, and wherein the housing member is insertable with the collar and is adjustable relative to the collar.

35. An implantable paddle-like lead for providing treatment therapy to targeted tissue of a body comprising:

(a) a middle portion having at least one central therapy delivery element on a ventral side;

(b) at least two end portions, each end portion having at least one end therapy delivery element on the ventral side; and

(c) a fluid reservoir portion along the middle portion capable of receiving fluid and expanding the middle portion such that the central therapy delivery element is positioned away from a dorsal side of the lead.

36. An implantable paddle-like lead for providing treatment therapy to targeted tissue of a body comprising:

(a) a middle portion having at least one central therapy delivery element on a ventral side;

(b) at least two end portions, each end portion having at least one end therapy delivery element on the ventral side; and

(c) a piston coupling the front side and a back side of the lead capable of expanding the middle portion such that the central therapy delivery element is positioned away from a dorsal side of the lead.

37. An implantable paddle-like lead for providing treatment therapy to targeted tissue of a body comprising:

(a) a middle portion having at least one central therapy delivery element on a ventral side;

(b) at least two end portions, each end portion having at least one end therapy delivery element on the ventral side; and

(c) at least one bellows coupling the front side and a back side of the lead capable of expanding the middle portion such that the central therapy delivery element is positioned away from a dorsal side of the lead.

38. An implantable paddle-like lead for providing treatment therapy to targeted tissue of a body comprising:

(a) a ventral side having at least one therapy delivery element;

(b) a dorsal side opposite the ventral side;

(c) at least one balloon-like member attached to the dorsal side of the lead, the balloon-like member capable of expanding by receiving a fluid,

whereby expansion of the balloon-like member results in positioning the at least one therapy delivery element closer to or further from the targeted tissue, wherein the balloon-like member has a relatively rigid component along a dorsal side of the member.

39. An implantable paddle-like lead of claim 38, wherein the relatively rigid component has a hinge coupling two relatively rigid members.

40. An implantable paddle-like lead for providing treatment therapy to targeted tissue of a body comprising:

(a) a ventral side having at least one therapy delivery element;

(b) at least one glider mechanism attached to the ventral side of the lead capable of movement; and

(c) a membrane covering the glider means,

whereby movement of the glider mechanism results in lead expansion and positioning the at least one therapy delivery element closer to or further from the targeted tissue.

41. An implantable paddle-like lead for providing treatment therapy to targeted tissue of a body comprising:

(a) a ventral side having at least one therapy delivery element;

(b) at least one flexible wire means attached to the ventral side of the lead capable of flexing; and

(c) a membrane covering the flexible wire means,

whereby flexing of the flexible wire means results in lead expansion and positioning the at least one therapy delivery element closer to or further from the targeted tissue.

42. An implantable paddle-like lead for providing treatment therapy to targeted tissue of a body comprising:

(a) a ventral side having at least one therapy delivery element;

(b) at least one gear mechanism attached to the lead capable of rotating; and

(c) at least one arm coupled to the gear;

whereby rotation of at least one arm results in lead expansion and positioning the at least one therapy delivery element closer to or further from the targeted tissue.

43. A method for providing treatment therapy to a targeted neural tissue by means of a therapy delivery device and at least one therapy delivery element coupled to the therapy delivery device, the method comprising the steps of:

(a) implanting at least one lead having at least one therapy delivery element within a bone so that the therapy delivery element lies within the bone and in communication near a the targeted tissue;

(b) coupling a proximal end of the lead to the therapy delivery device;

(c) operating the therapy delivery device to provide treatment therapy to the targeted tissue via the implanted therapy delivery elements

(d) sensing a symptom of a condition to be treated and generating a sensor signal; and

(e) regulating the operation of a signal generator in response to the sensor signal.

44. A method of claim 43, wherein the bone is a vertebral bone.

45. A method for providing treatment therapy to a targeted tissue by means of a therapy delivery device and at least one therapy delivery element coupled to the therapy delivery device, the method comprising the steps of:

(a) implanting at least one lead having at least one therapy delivery element, so that the therapy delivery element lies in communication near the targeted tissue, the therapy delivery element comprising a catheter;

(b) coupling a proximal end of the lead to the therapy delivery device;

(c) operating the therapy delivery device to provide treatment therapy to the targeted tissue via the implanted therapy delivery element; and

(d) adjusting at any time after the step of implanting, the position of at least one implanted therapy delivery element relative to the targeted tissue.

46. A method as claimed in claim 45, wherein the targeted tissue is neural tissue.

47. A method as claimed in claim 46, wherein the neural tissue is in the spinal cord.

48. A method as claimed in claim 46, wherein the neural tissue is in the brain.

49. A method as claimed in claim 45, wherein the targeted tissue is neural ganglia.

50. A method as claimed in claim 45, wherein the targeted tissue is muscle tissue.

51. A method as claimed in claim 45, wherein the therapy delivery device comprises a pump in fluid communication with therapy delivery element.

52. A method as claimed in claim 45, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of a signal generator in response to the sensor signal.

53. A method as claimed in claim 45, wherein the step of adjusting includes the step of sensing a condition of a response to the treatment therapy and the step of adjusting is performed in response to the step of sensing.

54. A method as claimed in claim 53, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of the signal generator in response to the sensor signal.

55. A method as claimed in claim 53, wherein the step of sensing a condition of a response to the treatment therapy includes sensing neural activity evoked by the therapy.

56. A system for providing treatment therapy to targeted tissue comprising in combination:

(a) a therapy delivery device;

(b) at least one therapy delivery element comprising a catheter coupled to the therapy delivery device for providing treatment therapy to the targeted tissue;

(c) at least one position control mechanism coupled to the at least one therapy delivery element for adjusting, at any time after implanting the therapy delivery element, the position of the at least one therapy delivery element relative to the targeted tissue; and

(d) a first sensor for generating a first sensor signal related to a condition of a body, the position control mechanism capable of adjusting the position of at least one of the therapy delivery elements in response to the first sensor signal.

57. A system of claim 56, wherein the therapy delivery device comprises a signal generator and the therapy delivery element further comprises an electrode.

58. A system of claim 56, wherein the therapy delivery device comprises a pump.

59. A system of claim 56, wherein the first sensor senses the body'"'"'s response to the treatment therapy.

60. A system of claim 56, further comprising:

(e) control means for regulating the operation of the therapy delivery device in response to the first sensor signal.

61. A system of claim 56, further comprising:

(e) a second sensor for generating a second sensor signal indicative a condition to be treated; and

(f) control means for regulating the operation of the therapy delivery element in response to the second sensor signal.

62. A system of claim 56, wherein the therapy delivery element is part of a paddle lead.

63. A system of claim 56, wherein the therapy delivery element is part of a paddle lead having at least one cavity for holding fluid, wherein a change in fluid within the lead would direct at least one of the therapy delivery elements of the lead toward or away from targeted tissue.

64. A system of claim 56, wherein the at least one therapy delivery element is part of a paddle lead having at least one bellow, wherein expansion or compression of the bellow would direct the at least one therapy delivery element of the lead toward or away from targeted tissue.

65. A system of claim 56, wherein the at least one therapy delivery element is part of a paddle lead having at least one piston, wherein expansion or compression of the piston would direct at least one of the at least one therapy delivery element of the lead toward or away from targeted tissue.

66. A system of claim 56, wherein the at least one therapy delivery element is part of a paddle lead having at least one piston and at least one spring, wherein expansion or compression of the piston or spring would direct the at least one therapy delivery element of the lead toward or away from targeted tissue.

67. A system of claim 56, wherein the at least one therapy delivery element is part of a paddle lead having a dorsal side and further comprising:

(e) at least one inflatable balloon-like-member attached to a dorsal side or a lateral side of the paddle lead and capable of being filled with fluid, wherein the addition or removal of fluid from at least one of the balloon-like members would direct the at least one therapy delivery element of the lead relative targeted tissue.

68. A system of claim 67, wherein the balloon-like member has one or more areas of inelastic material.

69. A system of claim 67, wherein the dorsal side or the lateral side has a hinge coupling two relatively rigid members.

70. A system of claim 56, further comprising electrodes that are part of a paddle lead further comprising at least one glider means attached to the paddle lead capable of positioning at least a portion of the paddle lead relative to the targeted tissue.

71. A system of claim 56, further comprising electrodes that are part of a paddle lead further comprising at least one bendable wire means attached to the paddle lead capable of positioning at least a portion of the paddle lead relative to the targeted tissue.

72. A system of claim 56, further comprising electrodes that are part of a paddle lead further comprising at least one gear mechanism attached to the paddle lead capable of positioning at least a portion of the paddle lead relative to the targeted tissue.

73. A system of claim 56, wherein the at least one therapy delivery element is part of an implantable lead and wherein the lead has:

an elongate central portion; and

at least one extendable member having an end, the extendable member depending from the central portion and being adapted to assume a compact position, in which the end is disposed in close proximity to the central portion, and an extended position, in which the end is disposed at a location distal from the central portion,

wherein the at least one therapy delivery element is positioned at least on the extendable member.

74. A system for providing treatment therapy to targeted tissue comprising in combination:

(a) a therapy delivery device;

(b) at least one therapy delivery element coupled to the therapy delivery device for providing treatment therapy to the targeted tissue, the at least one therapy delivery element being part of a paddle lead having a dorsal side or a lateral side;

(c) at least one position control mechanism coupled to the at least one therapy delivery element for adjusting, at any time after implanting the therapy delivery element, the position of the at least one therapy delivery element relative to the targeted tissue; and

(d) at least one inflatable balloon-like-member attached to a dorsal side or a lateral side of the paddle lead and capable of being filled with fluid, wherein the addition or removal of fluid from at least one of the balloon-like members would direct the at least one therapy delivery element of the lead relative targeted tissue.

75. A system of claim 74, wherein the balloon-like member has one or more areas of inelastic material.

76. A system of claim 74, wherein the dorsal side or the lateral side has a hinge coupling two relatively rigid members.

77. An implantable lead for providing therapy to a body comprising:

(a) an elongate central portion, the lead having a paddle portion;

(b) at least one extendable member having an end, the extendable member depending from the central portion and being adapted to assume a compact position, in which the end is disposed in close proximity to the central portion, and an extended position, in which the extendable member is disposed at an angle laterally from the central portion; and

at least one therapy delivery element disposed on the extendable member for delivering therapy to the body, wherein the extendable member may be elongated outwardly from the central portion to position the therapy delivery element toward or away from targeted tissue, wherein the extendable member includes a lever to adjust the angle of the extendable member.

78. A method for providing treatment therapy to a targeted tissue by means of a therapy delivery device and at least one therapy delivery element coupled to the therapy delivery device, the method comprising the steps of:

(a) implanting at least one lead having at least one therapy delivery element so that the therapy delivery element lies in communication near the targeted tissue, the targeted tissue being neural tissue of the brain;

(b) coupling a proximal end of the lead to the therapy delivery device;

(c) operating the therapy delivery device to provide treatment therapy to the targeted tissue via the implanted therapy delivery element; and

(d) adjusting at any time after the step of implanting, the position of at least one implanted therapy delivery element relative to the targeted tissue.

79. A method as claimed in claim 78, wherein the targeted tissue is on the surface of the brain.

80. A method as claimed in claim 79, wherein the targeted tissue is cortex.

81. A method as claimed in claim 78, wherein the targeted tissue is a surface of a brain ventricle.

82. A method as claimed in claim 78, wherein the targeted tissue is deep brain tissue.

83. A method as claimed in claim 78, wherein the therapy delivery device is a signal generator and the therapy delivery element is an electrode.

84. A method as claimed in claim 83, wherein the step of adjusting includes the step of positioning the electrode laterally from the lead.

85. A method as claimed in claim 83, wherein the step of adjusting includes the step of positioning the electrode from the lead toward or away from the targeted tissue.

86. A method as claimed in claim 78, wherein the therapy delivery device is a pump and the therapy delivery element is a catheter.

87. A method as claimed in claim 78, wherein the step of adjusting includes the step of sensing a condition of a response to the treatment therapy and the step of adjusting is performed in response to the step of sensing.

88. A method as claimed in claim 87, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of the therapy delivery device in response to the sensor signal.

89. A method as claimed in claim 87, wherein the step of sensing a condition of a response to the treatment therapy includes sensing neural activity evoked by the therapy.

90. A method as claimed in claim 78, further comprising the steps of:

(e) sensing a symptom indicative of a condition to be treated and generating a sensor signal; and

(f) regulating the operation of the therapy delivery device in response to the sensor signal.