SELECTIVE STIMULATION SYSTEMS AND SIGNAL PARAMETERS FOR MEDICAL CONDITIONS

• US 20100137938A1
• Filed: 10/27/2009
• Published: 06/03/2010
• Est. Priority Date: 10/27/2008
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Luxembourg Holdings SMI S.A.R.L.
• Inventors: O'Connor, Richard W., Imran, Mir A., Kishawi, Eyad, Kramer, Jeffery M., Mossop, Brian J.
• Granted Patent: US 9,056,197 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Devices, systems and methods are provided for targeted treatment of a variety of conditions, particularly conditions that are associated with or influenced by the nervous system, such as pain. Targeted treatment of such conditions is provided with minimal deleterious side effects, such as undesired motor responses or undesired stimulation of unaffected body regions. This is achieved by directly neuromodulating a target anatomy associated with the condition while minimizing or excluding undesired neuromodulation of other anatomies.

Claims

1. A system for stimulating at least a portion of a target dorsal root comprising:

a lead having at least one electrode, wherein the lead is configured to be positioned so that at least one of the at least one electrodes is able to stimulate the at least a portion of the target dorsal root; and

an implantable pulse generator connectable with the lead, wherein the generator provides a stimulation signal to the lead which has an energy below an energy threshold for stimulating a ventral root associated with the target dorsal root while the lead is so positioned.

2. A system as in claim 1, wherein the at least a portion of the target dorsal root comprises a dorsal root ganglion.

3. A system as in claim 1, wherein the stimulation signal has a current amplitude of less than or equal to approximately 4 mA.

4. A system as in claim 2, wherein the current amplitude is less than or equal to approximately 800 μ

A.

5. A system as in claim 1, wherein the at least one of the at least one electrodes has an average electrode surface area of less than or equal to approximately 6 mm².

6. A system as in claim 5, wherein the average electrode surface area is less than or equal to approximately 4 mm².

7. A system as in claim 1, further comprising a second lead having at least one electrode, wherein the second lead is configured to be positioned so that at least one of its electrodes is able to stimulate at least a portion of a second target dorsal root, and wherein the second lead is connectable to the implantable pulse generator which provides a stimulation signal to the second lead, wherein the stimulation signal to the second lead has an energy below an energy threshold for stimulating a ventral root associated with the second target dorsal root while the second lead is so positioned.

8. A system as in claim 7, wherein the target dorsal root and the second target dorsal root are on different spinal levels.

9. A system as in claim 7, wherein the stimulation signal to the lead and the stimulation signal to the second lead are different.

11. A system as in claim 1, wherein the target spinal neural tissue comprises a dorsal root ganglion.

10. A system for stimulating a target neural tissue of the central nervous system comprising:

a lead having at least one electrode, wherein the lead is configured to be positioned so that at least one of the at least one electrodes is able to stimulate the target neural tissue; and

an implantable pulse generator connectable with the lead, wherein the generator provides a stimulation signal having a current amplitude which is less than 100 μ

A.

12. A system for stimulating at least a portion of a target dorsal root comprising:

a lead having at least one electrode, wherein the lead is configured to be positioned so that at least one of the at least one electrodes is able to stimulate the at least a portion of the target dorsal root when provided a stimulation signal; and

an implantable pulse generator connectable with the lead, wherein the generator provides the stimulation signal which has an energy of less than approximately 100 nJ per pulse.

13. A system as in claim 12, wherein the stimulation signal has an energy of less than approximately 50 nJ per pulse.

14. A system as in claim 13, wherein the stimulation signal has an energy of less than approximately 10 nJ per pulse.

15. A system as in claim 12, wherein the at least a portion of the target dorsal root comprises a dorsal root ganglion.

16. A system for stimulating at least a portion of a target dorsal root comprising:

a lead having at least one electrode, wherein the lead is configured to be positioned so that at least one of the at least one electrodes is able to stimulate the at least a portion of the target dorsal root when provided a stimulation signal; and

an implantable pulse generator connectable with the lead, wherein the generator provides a stimulation signal which has a current amplitude of less than 4 mA.

17. A system for stimulating at least a portion of a target dorsal root comprising:

a lead having at least one electrode, wherein the lead is configured so that at least one of the at least one electrodes is positionable on or near the at least a portion of the target dorsal root; and

an implantable pulse generator connectable with the lead, wherein the generator provides a stimulation signal to the at least one of the at least one electrode which selectively stimulates the at least a portion of the target dorsal root due to at least one signal parameter.

18. A system as in claim 17, wherein the at least one signal parameter includes current amplitude.

19. A system as in claim 18, wherein the current amplitude is less than or equal to approximately 4 mA.

20. A system as in claim 17, wherein the at least one signal parameter includes pulse width, and wherein the pulse width is less than 500 μ

s.

21. A system as in claim 17, wherein the at least a portion of the target dorsal root comprises a dorsal root ganglion.

24. A system as in claim 20, wherein the current amplitude is adjustable in increments of 25 μ

A or less.

22. A system for stimulating a target dorsal root ganglion comprising:

a lead having at least one electrode, wherein the lead is configured so that at least one of the at least one electrodes is positionable on or near the target dorsal root ganglion; and

an implantable pulse generator connectable with the lead, wherein the generator energizes the at least one of the at least one electrodes which selectively stimulates the target dorsal root ganglion due to its proximity to the target dorsal root ganglion.

23. A system for stimulating a target neural tissue of the central nervous system comprising:

a lead having at least one electrode, wherein the lead is configured to be positioned so that at least one of the at least one electrodes is able to stimulate the target neural tissue; and

an implantable pulse generator connectable with the lead, wherein the generator provides a stimulation signal having a current amplitude which is adjustable in increments of 50 μ

A or less.

25. A method of stimulating at least a portion of a target dorsal root comprising:

positioning a lead having at least one electrode so that at least one of the at least one electrodes is on or near the at least a portion of the target dorsal root; and

energizing at least one of the at least one electrodes with an energy level below an energy threshold for stimulating a ventral root associated with the target dorsal root while the lead is so positioned.

26. A method as in claim 25, wherein energizing comprises providing a stimulation signal having a current amplitude of less than or equal to approximately 4 mA.

27. A method as in claim 26, wherein the current amplitude is less than or equal to approximately 1.0 mA.

28. A method as in claim 25, wherein positioning the lead comprises advancing the lead using an epidural approach.

29. A method as in claim 28, wherein positioning the lead comprises advancing the lead using an antegrade approach.

30. A method as in claim 25, wherein positioning the lead comprises advancing the lead using transforamenal approach from outside of the spinal column.

31. A system as in claim 25, wherein the at least a portion of the target dorsal root comprises a dorsal root ganglion.

32. A method as in claim 25, wherein the average electrode surface area is less than or equal to approximately 4 mm².

33. A method as in claim 25, further comprising

positioning a second lead having at least one electrode so that at least one of its at least one electrodes is on or near at least a portion of a second target dorsal root, and

energizing at least one of the at least one electrodes of the second lead with an energy level below an energy threshold for stimulating a ventral root associated with the second target dorsal root while the second lead is so positioned.

34. A method as in claim 33, wherein the target dorsal root and the second target dorsal root are on different spinal levels.

35. A method as in claim 33, wherein the energy level of the lead and the second lead are different.

36. A method of stimulating a target spinal neural tissue within an epidural space comprising:

positioning a lead having at least one electrode, so that at least one of the at least one electrodes is able to stimulate the target spinal neural tissue; and

energizing the at least one of the at least one electrodes with a stimulation signal which has a current amplitude which is less than 100 μ

A.

37. A method of stimulating at least a portion of a target dorsal root comprising:

positioning a lead having at least one electrode, so that at least one of the at least one electrodes is able to stimulate the at least a portion of the target dorsal root; and

energizing the at least one of the at least one electrodes with a stimulation signal which has an energy of less than approximately 100 nJ per pulse.

38. A method for stimulating at least a portion of a target dorsal root comprising:

positioning a lead having at least one electrode, so that at least one of the at least one electrodes is able to stimulate the at least a portion of the target dorsal root; and

energizing the at least one of the at least one electrodes with a stimulation signal which has a current amplitude of less than 4 mA.

39. A method for stimulating at least a portion of the target dorsal root comprising:

positioning a lead having at least one electrode so that at least one of the at least one electrode is on or near the at least a portion of the target dorsal root; and

energizing at least one of the at least one electrodes with a stimulation signal which selectively stimulates the at least a portion of the target dorsal root due to at least one signal parameter.

40. A method for stimulating a target neural tissue of the central nervous system comprising:

positioning a lead having at least one electrode so that at least one of the at least one electrode is able to stimulate the target neural tissue; and

energizing at least one of the at least one electrodes with a stimulation signal having a current amplitude which is adjustable in increments of 50 μ

A or less.

41. A method of treating a condition associated with a spinal neural tissue, wherein the treatment is applied substantially within a single dermatome, the method comprising:

positioning a lead having at least one electrode so that at least one of the at least one electrodes is in proximity to the spinal neural tissue within an epidural space; and

energizing the at least one of the at least one electrodes so as to stimulate the spinal neural tissue causing a treatment effect within the single dermatome while maintaining body regions outside of the single dermatome substantially unaffected.

42. A method as in claim 41, wherein energizing the at least one electrode comprises energizing the at least one of the at least one electrode so as to stimulate the spinal neural tissue causing a treatment affect within a particular body region within the single dermatome while maintaining body regions outside of the particular body region substantially unaffected.

43. A method as in claim 42, wherein the spinal neural tissue comprises a dorsal root ganglion and the treatment effect comprises paresthesia.

44. A method as in claim 43, wherein the particular body region comprises a foot.

45. A method of treating a condition of a patient, wherein the condition is associated with a portion of a dorsal root ganglion and is not substantially associated with other portions of the dorsal root ganglion, the method comprising:

positioning a lead having at least one electrode so that at least one of the at least one electrode resides in proximity to the portion of a dorsal root ganglion; and

providing a stimulating signal to the at least one of the at least one electrode so as to stimulate the portion of the dorsal root ganglion in a manner that affects the condition while not substantially stimulating the other portions.

46. A method as in claim 45, wherein the condition comprises pain.

47. A method as in claim 45, wherein affecting the condition comprises alleviating the pain without causing a perceptible motor response.

48. A method as in claim 45, wherein the condition is sensed by a patient at a location within a dermatome, and wherein the other portions of the dorsal root ganglion are associated with other locations within the dermatome.

49. A method as in claim 45, wherein the stimulating signal has a current amplitude of less than or equal to approximately 4 mA.

50. A method as in claim 49, wherein the stimulating signal has a current amplitude of less than or equal 1 mA.

51. A method as in claim 45, wherein positioning the lead comprises advancing the lead using an epidural approach.

52. A method of providing subdermatomal stimulation comprising:

positioning a lead having at least one electrode so that at least one of the at least one electrode resides near a dorsal root ganglion within a dermatome; and

providing a stimulating signal to the at least one of the at least one electrode so as to stimulate the dorsal root ganglion in a manner which affects a condition in a subdermatomal region of the dermatome.

53. A system for stimulating a portion of a dorsal root ganglion, wherein the portion of the dorsal root ganglion is associated with a particular region within a dermatome, the system comprising:

a lead having at least one electrode, wherein the lead is configured to be positioned so that at least one of the at least one electrode is able to stimulate the portion of the dorsal root ganglion;

a pulse generator connectable with the lead, wherein the generator provides a stimulation signal to the at least one of the at least one electrode which stimulates the portion of the dorsal root ganglion to cause an effect within the particular region of the dermatome.

54. A system as in claim 53, wherein the combination of the at least one of the at least one electrode and the stimulation signal create an electric field having a shape which allows for stimulation of the portion of the dorsal root ganglion while substantially excluding other portions of the dorsal root ganglion.

55. A system as in claim 54, wherein the at least one of the at least one electrode comprises two electrodes spaced 0.250 inches apart from approximate center to center of each electrode.

56. A system as in claim 54, wherein the stimulation signal has a current amplitude of less than or equal to approximately 4 mA.

57. A method as in claim 56, wherein the stimulating signal has a current amplitude of less than or equal 1 mA.

58. A system as in claim 54, wherein the stimulation signal has an energy of less than approximately 100 nJ per pulse.

59. A system for providing subdermatomal stimulation within a patient comprising:

a lead having at least one electrode, wherein the lead is configured so that the at least one electrode is positionable in proximity to a dorsal root ganglion associated with a dermatome; and

a pulse generator connectable with the lead, wherein

the generator provides a first stimulation signal to at least one of the at least one electrode to create a first electric field which stimulates the dorsal root ganglion causing a first effect within a first body region of the dermatome and

the generator provides a second stimulation signal to at least one of the at least one electrode to create a second electric field which stimulates the dorsal root ganglion causing a second effect within a second body region of the dermatome.

60. A system as in claim 59, wherein the first and second stimulation signals have different stimulation parameters.

61. A system as in claim 59, wherein the at least one of the at least one electrodes receiving the first stimulation signal differs from the at least one of the at least one electrodes receiving the second stimulation signal.

62. A system as in claim 59, wherein the first and second electric fields have different shapes.

63. A system as in claim 59, wherein the first and second electric fields have different sizes.

64. A system as in claim 59, wherein the first effect comprises relief from pain.

65. A system as in claim 59, wherein the first body region resides along a foot of the patient and the second body region resides along a back of the patient.

66. A method for providing subdermatomal stimulation within a patient comprising:

positioning a lead having at least one electrode in proximity to a dorsal root ganglion associated with a dermatome;

applying a stimulation signal to the at least one electrode which stimulates the dorsal root ganglion causing an effect within a first body region of the dermatome; and

repositioning the lead along the dorsal root ganglion so that the application of the stimulation signal to the least one electrode stimulates the dorsal root ganglion to cause a second effect within a second body region of the dermatome.

67. A method as in claim 66, wherein the first effect comprises relief from pain.

68. A method as in claim 66, wherein the first body region resides along a foot of the patient and the second body region resides along a back of the patient.