Method of straddling an intraosseous nerve

• US 20040064137A1
• Filed: 09/30/2002
• Published: 04/01/2004
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Patel, Samit, Pellegrino, Richard, Ryan, Thomas, Crombie, John S., Papineau, Paula
• Granted Patent: US 6,907,884 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/0044 Spinal cord

Abstract

This invention relates to a method of straddling an intraosseous nerve with an energy transmitting device to improve the therapeutic treatment of the nerve.

Claims

1. A method of therapeutically treating a bone having an intraosseous nerve ION defining first and second sides of the bone, comprising the steps of:

a) inserting an energy device having an active and a return electrode into the bone,

b) placing the active electrode on the first side of the bone and the return electrode on the second side of the bone to define a total heating zone therebetween, and

c) applying a sufficiently high frequency voltage between the active and return electrodes to generate a current therebetween to resistively heat the total heating zone sufficient to denervate the ION.

2. The method of claim 1 wherein the bone is a vertebral body and the ION is a BVN.

3. The method of claim 2 wherein the bone is healthy bone.

4. The method of claim 3 wherein the total heating zone comprises a resistive heating zone and a conductive heating zone, and the BVN is therapeutically treated by both the resistive heating zone and the conductive heating zone.

5. The method of claim 4 wherein the resistive heating zone therapeutically heats a length L₁ of the ION, the total heating zone therapeutically heats a length L_T of the ION, and the length L₁ is at least 25% of the total length LT of ION.

6. The method of claim 4 wherein the resistive heating zone has a peak temperature T_IR, the conductive heating zone has a peak temperature T_IC, and the peak temperature T_IR of the resistive zone is no more than 15°

C. greater than the peak temperature T_IC of the conductive heating zone.

7. The method of claim 3 wherein the BVN is therapeutically treated essentially by a conductive heating zone.

8. The method of claim 7 wherein the total heating zone comprises a resistive heating zone and a conductive heating zone, and the BVN is therapeutically treated by essentially only the conductive heating zone.

9. The method of claim 8 wherein the BVN is separated from the resistive heating zone by a distance of no more than 10 mm.

10. The method of claim 7 wherein the total heating zone comprises two resistive heating zones separated by a conductive heating zone.

11. The method of claim 3 wherein the step of inserting includes a step of inserting a cannula into the bone.

12. The method of claim 11 wherein the cannula has a bore having a stylet received therein.

13. The method of claim 12 wherein the stylet is the probe.

14. The method of claim 12 wherein the cannula is the probe.

15. The method of claim 11 wherein the cannula is withdrawn prior to insertion of the probe to create a bone hole, and the probe is inserted into the bone hole.

16. The method of claim 11 wherein the cannula is inserted into the bone prior to insertion of the probe, and the probe is inserted into the cannula bore.

17. The method of claim 3 wherein each electrode has an inner face, and the inner faces create an angle 2δ

therebetween of no more than 60 degrees.

18. The method of claim 17 wherein the angle 2δ

is no more than 30 degrees.

19. The method of claim 17 wherein the angle 2δ

is no more than 1 degree.

20. The method of claim 3 wherein the total heating zone has a peak temperature of between 80°

C. and 95°

C.

21. The method of claim 3 wherein the total heating zone has a peak temperature of between 86°

C. and 94°

C.

22. The method of claim 3 wherein the electrodes are spaced apart by a distance of between 5 mm and 25 mm.

23. The method of claim 3 wherein the electrodes are spaced apart by a distance of between 5 mm and 15 mm.

24. The method of claim 3 wherein the electrodes are spaced apart by a distance of between 10 mm and 15 mm.

25. The method of claim 3 wherein the energy device comprises a first probe having an active electrode and a second probe having a return electrode.

26. The method of claim 3 the step of inserting comprises the steps of:

inserting a first probe having an active electrode into a first pedicle, and

inserting a second probe having the return electrode into a second pedicle.

27. The method of claim 3 wherein the step of applying a voltage is sufficient to raise the minimum temperature in the total heating zone to at least 50°

C. for between about 2 minutes and about 10 minutes.

28. The method of claim 3 wherein the step of applying a voltage is sufficient to raise the minimum temperature in the total heating zone to at least 60°

C. for between about 0.5 minutes and about 1.5 minutes.

29. The method of claim 3 wherein the BVN has a posterior portion, and the step of applying is sufficient to denervate only the posterior portion of the BVN.

30. A method of therapeutically treating a vertebral body having a basivertebral nerve BVN defining first and second sides of the vertebral body, comprising the steps of:

a) determining a BVN residence zone within which the BVN likely resides, the BVN residence zone having a first side and a second side,

b) inserting an energy device having an active and a return electrode into the vertebral body,

c) placing the active electrode on the first side of the residence zone and the return electrode on the second side of the residence zone to define a total heating zone therebetween, and

d) applying a sufficiently high frequency voltage between the active and return electrodes to generate a current therebetween to resistively heat the total heating zone to a temperature sufficient to denervate the BVN.

31. A method of therapeutically treating a vertebral body having a basivertebral nerve BVN, comprising the steps of:

a) providing an energy device having an active electrode having a first face and a return electrode having a second face into the vertebral body, and

b) placing the active electrode in the vertebral body to face a first direction,

c) placing the return electrode in the vertebral body to face a second direction, the first and second faces defining an angle 2δ

of no more than 60 degrees, and

d) applying a sufficiently high frequency voltage difference between the active and return electrodes to generate a current therebetween to produce a total heating zone to therapeutically heat the BVN.

32. The method of claim 31 wherein the electrodes have a conical shape.

33. The method of claim 32 wherein each electrode has a proximal diameter D_P and a distal diameter D_D, and the proximal diameter is no more than 20% of the distal diameter.

34. The method of claim 31 wherein the electrodes have a frusto-conical shape.

35. The method of claim 34 wherein each electrode has a proximal diameter D_P and a distal diameter D_D, and the proximal diameter is at least 25% of the distal diameter.

36. The method of claim 31 wherein each electrode has a proximal diameter D_P and a distal diameter D_D, and the proximal diameter D_P is greater than the distal diameter D_D.

37. The method of claim 31 wherein the electrodes are sectored.

38. The method of claim 31 wherein the angle 2δ

is no more than 30 degrees.

39. The method of claim 31 wherein the angle 2δ

is no more than 1 degree.

40. The method of claim 31 wherein the electrodes are disposed essentially parallel.

41. A method of therapeutically treating a vertebral body having a basivertebral nerve BVN, comprising the steps of:

a) providing an energy device having an active electrode and a return electrode,

b) placing the active and return electrodes in the vertebral body to define an electrode axis, the axis forming an angle β

of between 50 and 90 degrees with the BVN, and

c) applying a sufficiently high frequency voltage difference between the active and return electrodes to generate a current therebetween to produce a total heating zone to therapeutically heat the BVN.

51. The device of claim 41 wherein the means for creating first and second bores within a bone is adapted to create first and second bores within a vertebral body.

42. An intraosseous nerve denervation device, comprising:

a) a first probe having an active electrode and a first lead,

b) a second probe having a return electrode and a second lead,

c) means for creating first and second bores within a bone for accommodating the first and second probes,

d) a power supply capable of generating a voltage difference between the active and return electrodes, the supply having third and fourth leads,

wherein the first and third leads are in electrical connection, and the second and fourth leads are in electrical connection.

43. The device of claim 42 wherein the means for creating first and second bores comprises a cannula having a bore therethrough adapted to receive the first probe.

44. The device of claim 43 wherein the means for creating first and second bores further comprises a stylet adapted to be received within the bore of the cannula.

45. The device of claim 42 wherein the electrodes have a conical shape.

46. The device of claim 43 wherein each electrode has a proximal diameter D_P and a distal diameter D_D, and the proximal diameter is no more than 20% of the distal diameter.

47. The device of claim 42 wherein the electrodes have a frusto-conical shape.

48. The device of claim 45 wherein each electrode has a proximal diameter D_P and a distal diameter D_D, and the proximal diameter is at least 25% of the distal diameter.

49. The device of claim 42 wherein each electrode has a proximal diameter D_P and a distal diameter D_D, and the proximal diameter D_P is greater than the distal diameter D_D.

50. The device of claim 42 wherein the electrodes are sectored.

52. A method of therapeutically treating a healthy vertebral body having a basivertebral nerve BVN, comprising the steps of:

a) providing an energy device having an active and a return electrode,

b) inserting the active electrode into the healthy vertebral body,

c) inserting the return electrode into the healthy vertebral body,

d) placing the active electrode on a first side of the healthy vertebral body and the return electrode on a second side of the healthy vertebral body, and

e) applying a sufficiently high frequency voltage difference between the active and return electrodes to generate a current therebetween to produce a total heating zone to therapeutically heat the BVN.

53. An intraosseous nerve denervation system comprising:

a) a first probe having a first electrode and a first lead in electrical connection with the first electrode,

wherein the first electrode has a proximal end having a proximal diameter and a distal end having a distal diameter, and the proximal end diameter is less than the distal end diameter, and

b) a second probe having a first electrode and a first lead in electrical connection with the first electrode,

wherein the first electrode has a proximal end having a proximal diameter and a distal end having a distal diameter, and the proximal end diameter is less than the distal end diameter,

wherein the first and second electrode are disposed so that the electrodes are parallel.

54. The system of claim 53 further comprising:

c) means for creating first and second bores within a bone for accommodating the first and second probes.

55. An intraosseous nerve denervation system comprising:

a) a first probe having;

i) a distal portion having a first electrode,

ii) a proximal portion comprising a first lead in electrical connection with the first electrode, and

iii) a pivot pivotally connecting the proximal and distal portions of the probe.

56. The system of claim 55 further comprising:

b) means for creating a first bore within a bone for accommodating the probe.

57. An intraosseous nerve denervation system comprising:

a) a first probe having;

i) a distal portion having a pivot,

ii) a proximal portion comprising a first lead in electrical connection with the first electrode, and

iii) an arm pivotally extending from the distal portion and having a first electrode.

58. The system of claim 57 further comprising:

b) means for creating a first bore within a bone for accommodating the first probe.

59. An intraosseous nerve denervation system comprising:

a) a first probe having a first electrode and a first lead in electrical connection with the first electrode,

wherein the first electrode has a proximal end having a proximal diameter and a distal end having a distal diameter, and

wherein the proximal end diameter is less than the distal end diameter.

60. The system of claim 59 further comprising:

b) means for creating a first bore within a bone for accommodating the probe.

61. An intraosseous nerve denervation system, comprising:

a) a cannula having a longitudinal bore defining a first axis,

b) a stylet having an outer diameter adapted to be received within the longitudinal bore and a distal tip adapted to penetrate cortical bone, and

c) a first probe comprising;

d) an outer diameter adapted to be received within the longitudinal bore, and

i) a first electrode, and

ii) a lead in electrical connection with the first electrode.

62. An intraosseous nerve denervation system, comprising:

a) a cannula having a longitudinal bore defining a first axis,

b) a stylet having an outer diameter adapted to be received within the longitudinal bore and a distal tip adapted to penetrate cortical bone, and

c) a first probe comprising;

i) an outer diameter adapted to be received within the longitudinal bore, and

ii) a first electrode, and

iii) a lead in electrical connection with the first electrode.

63. An intraosseous nerve denervation system comprising:

a) a first probe having;

i) an active electrode having a first surface area, and

ii) a first lead in electrical connection with the first electrode,

b) a second probe having;

i) a return electrode having a first surface area, and

ii) a second lead in electrical connection with the second electrode,

wherein the first surface area is at least two times greater than the second surface area, and,

c) means for creating first and second bores within a bone for accommodating the first and second probes.

64. The system of claim 63 wherein the first surface area is at least five times greater than the second surface area.

65. An intraosseous nerve denervation system, comprising:

a) a cannula having a longitudinal bore,

b) a stylet having an outer diameter adapted to be received within the longitudinal bore and a distal tip adapted to penetrate cortical bone, and

c) a first probe comprising;

i) an outer diameter adapted to be received within the longitudinal bore, and

ii) a first electrode, and

iii) a lead in electrical connection with the first electrode.

66. An intraosseous nerve denervation system comprising:

a) a first probe having a first electrode and a first lead in electrical connection with the first electrode,

wherein the first electrode has a proximal end having a proximal diameter and a distal end having a distal diameter, and the proximal end diameter is greater than the distal end diameter.

67. The system of claim 66 further comprising:

b) means for creating a first bore within a bone for accommodating the probe.

68. A method of therapeutically treating a vertebral body having a BVN, comprising the steps of:

a) providing a first energy device having distal and proximal active electrodes,

b) providing a second energy device having distal and proximal return electrodes,

c) placing the first and second energy devices in the vertebral body to define a first distance between the distal active electrode and the distal return electrode, and a second distance between the proximal active electrode and the proximal return electrode, wherein the first distance is less than the second distance,

d) applying a first high frequency voltage between the distal active and distal return electrodes, and

e) applying a second high frequency voltage between the proximal active and proximal return electrodes, wherein the first high frequency voltage is less than the second high frequency voltage.

69. A method of therapeutically treating a vertebral body having a BVN, comprising the steps of:

a) providing an energy device having an active and a return electrode,

b) inserting the active electrode into the vertebral body,

c) inserting the return electrode into the vertebral body,

d) applying a sufficiently high frequency voltage difference between the active and return electrodes to generate a current therebetween to produce a total heating zone having a diameter of at least 0.5 cm and a steady state temperature of at least 50°

C.

70. The method of claim 69 wherein the total heating zone has a peak temperature of between 80°

C. and 95°

C.

71. The method of claim 69 wherein the total heating zone has a peak temperature of between 86°

C. and 94°

C.

72. The method of claim 69 wherein the total heating zone has a volume of at least 1 cc of bone.

73. The method of claim 69 wherein the total heating zone has a volume of at least 3 cc of bone.

74. The method of claim 69 wherein the total heating zone has a steady state temperature of at least 60°

C.

75. A method of therapeutically treating a vertebral body having an outer cortical bone region and an inner cancellous bone region, and a BVN having a trunk extending from the outer cortical bone region into the inner cancellous region and a branches extending from the trunk to define a BVN junction, comprising the steps of:

a) inserting an energy device into the vertebral body, and

b) exclusively depositing energy within the inner cancellous bone region of the vertebral body between, but exclusive of the BVN junction and the outer cortical bone region, to denervate the BVN.

76. The method of claim 75 wherein the energy is deposited in a region of the vertebral body located between 60% and 90% of the distance between the posterior and anterior ends of the vertebral body.

77. A device for denervating an intraosseous nerve ION in a bone, comprising:

a) a fixed probe having a first electrode thereon in electrical connection with the powder supply,

c) a pivotable probe comprising a second electrode having a proximal portion pivotally engaged to the fixed probe.