Novel early intervention spinal treatment methods and devices for use therein

• US 20030181963A1
• Filed: 03/21/2002
• Published: 09/25/2003
• Est. Priority Date: 03/21/2002
• Status: Active Grant

• Current Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Original Assignee: Depuy Acromed Incorporated (Johnson & Johnson)
• Inventors: Pellegrino, Richard C., Reynolds, Martin
• Granted Patent: US 6,736,835 B2
• Time in Patent Office: Days
• US Class Current: 607/96
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

There is provided a device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion,

b) first and second treatment sources, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first tissue site, the second treatment source is adapted to therapeutically treat a second different tissue site, and

wherein the first and second different tissue sites are selected from the group consisting of:

i) a first intervertebral disc,

ii) a first vertebra,

iii) a first spinal ligament, and

iv) a first spinal facet joint capsule,

v) a second intervertebral disc,

vi) a second vertebra,

vii) a second spinal ligament, and

viii) a second spinal facet joint capsule.

Claims

1. A device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion, b) first and second treatment sources, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first tissue site, the second treatment source is adapted to therapeutically treat a second different tissue site, and

wherein the first and second different tissue sites are selected from the group consisting of;

i) a first intervertebral disc,

ii) a first vertebra,

iii) a first spinal ligament, and

iv) a first spinal facet joint capsule,

v) a second intervertebral disc,

vi) a second vertebra,

vii) a second spinal ligament, and

viii)a second spinal facet joint capsule.

2. The device of claim 1 wherein each of the treatment sources are energy output sources.

3. The device of claim 1 wherein each of the first and second treatment sources comprise ultrasound transducers.

4. The device of claim 2 wherein the at least one ultrasound transducers is individually controllable.

5. The device of claim 1 wherein the first and second sources each have a surface energy flux, and the surface energy flux of the first source is different than the surface energy flux of the second source.

6. The device of claim 5 wherein the surface energy flux of the first source is at least twice as large as the surface energy flux of the second source.

7. The device of claim 6 wherein the first and second sources emit energy in first and second directions, the directions defining an angle therebetween of between 45 and 135 degrees.

8. The device of claim 1 wherein the first and second sources each have a surface flux density, and the surface flux density of the first source is different than the surface flux density of the second source.

9. The device of claim 8 wherein the surface flux density of the first source is twice as large as the surface flux density of the second source.

10. The device of claim 1 wherein the first and second sources have respective emission angles α

and β

, and wherein a is different than β

.

11. The device of claim 10 wherein the first and second sources emit energy in first and second directions, the directions defining an angle therebetween of between 135 and 225 degrees.

12. The device of claim 1 wherein the angle is between 160 and 200 degrees.

13. The device of claim 1 wherein the angle is between 175 and 185 degrees.

14. The device of claim 1 wherein the angle is between 80 and 100 degrees.

15. The device of claim 1 wherein the first and second sources respectively comprise first and second ultrasound transducers respectively having first and second ceramic component compositions, and the first ceramic component composition is different than the second ceramic component composition.

16. The device of claim 1 wherein the first and second sources respectively comprise first and second ultrasound transducers respectively having first and second ceramic components, and the first ceramic component has a first wall thickness and the second ceramic component has a second wall thickness, and the first wall thickness is different than the second wall thickness.

17. The device of claim 16 wherein the first thickness is at least 20% greater than the second thickness.

18. The device of claim 1 wherein the first and second sources respectively comprise first and second ultrasound transducers having first and second ceramic components, wherein the first ceramic component has a first coating thereon and the second ceramic component has a second coating thereon, and the first coating is different than the second coating.

19. The device of claim 1 further comprising:

c) a third treatment source located at the distal portion of the probe,

wherein the third treatment source is adapted to treat a third tissue site having the same tissue structure as the first tissue site.

20. The device of claim 19 further comprising:

d) a fourth treatment source located in the distal portion of the probe, wherein the fourth treatment source is adapted to treat a fourth tissue site having the same tissue structure as the second tissue site.

21. The device of claim 20 wherein the first, second, third and fourth sources emit energy in first, second, third and fourth directions, the directions respectively defining an angle γ

between the first and second directions, an angle δ

between the first and third direction, and an angle ε

between the first and fourth directions, wherein angle γ

is between 80 and 100 degrees, angle δ

is between 170 and 190 degrees, angle ε

is between 260 and 280 degrees.

22. The device of claim 1 wherein at least one of the first and second treatment sources comprises a microwave source.

23. The device of claim 1 wherein the first tissue site is the first intervertebral disc and the second different tissue site is the first vertebra.

24. The device of claim 1 wherein the first tissue site is the first intervertebral disc and the second different tissue site is the first spinal ligament.

25. The device of claim 1 wherein the first tissue site is the first intervertebral disc and the second different tissue site is the first spinal facet joint capsule.

26. The device of claim 1 wherein the first tissue site is the first vertebra and the second different tissue site is the first spinal ligament.

27. The device of claim 1 wherein the first tissue site is the first spinal ligament and the second different tissue site is the first spinal facet joint capsule.

28. The device of claim 1 wherein the first tissue site is the first vertebra and the second tissue site is the second vertebra.

29. The device of claim 1 wherein the first tissue site is the first intervertebral disc and the second tissue site is the second intervertebral disc.

30. The device of claim 1 wherein the first tissue site is the first spinal ligament and the second tissue site is the second spinal ligament.

31. The device of claim 1 wherein the first tissue site is the first spinal facet joint capsule and the second tissue site is the second spinal facet joint capsule.

32. The device of claim 1 wherein the first tissue site is the first vertebra and the second tissue site is the second vertebra, and wherein the first treatment source is adapted to treat a vertebral body portion of the first vertebra and the second treatment source is adapted to treat a vertebral body portion of the second vertebra.

33. The device of claim 1 wherein the first tissue site is the first vertebra and the second tissue site is the first intervertebal disc, and wherein the first treatment source is adapted to treat a vertebral body portion of the first vertebra.

49. The method of claim 45 wherein the device is the device of claim 12, wherein, during step a), the first and second sources are oriented so that the first source faces an upper vertebral endplate and the second source faces a lower vertebral endplate and further comprising the step of:

d) rotating the device approximately 90°

so that the first source faces a first portion of an annulus fibrosus located within the disc, and the second source faces a second portion of an annulus fibrosus located within the disc.

50. The method of claim 49 further comprising the step of:

e)energizing the first source and second source so that the first source heats a first portion of the annulus fibrosus, and the second source heats a second portion of the annulus fibrosus.

34. A device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion,

b) first and second treatment sources adapted to therapeutically treat an intervertebral disc, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first component of the intervertebral disc, and

the second treatment source is adapted to therapeutically treat a second different component of the intervertebral disc.

35. The device of claim 34 wherein the first treatment source is adapted to therapeutically treat at least a portion of an annulus fibrosus within the intervertebral disc, and the second treatment source is adapted to therapeutically treat at least a portion of a nucleus pulposus within the intervertebral disc.

36. The device of claim 34 wherein the first treatment source is adapted to therapeutically treat at least an interior component of the intervertebral disc, and the second treatment source is adapted to therapeutically treat a surface component of the intervertebral disc.

37. A device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion,

b) first and second treatment sources adapted to therapeutically treat a vertebra, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first component of the vertebra, and

the second treatment source is adapted to therapeutically treat a second different component of the vertebra.

38. The device of claim 37, wherein the first treatment source is adapted to therapeutically treat at least a portion of a basivertebral nerve trunk located within a cancellous bone portion of a vertebral body portion of the vertebra, and

the second treatment source is adapted to therapeutically treat at least a portion of the basivertebral nerve endings located within an endplate bone portion of a vertebral body portion of the vertebra.

39. A device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion,

b) first and second treatment sources adapted to therapeutically treat a spinal facet joint capsule, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first component of the spinal facet joint capsule, and

the second treatment source is adapted to therapeutically treat a second different component of the spinal facet joint capsule.

40. The device of claim 39, wherein the first treatment source is adapted to therapeutically treat a nerve fibril contained within a ligament of the spinal facet joint capsule, and the second treatment source is adapted to therapeutically treat a nerve fibril within a cartilagenous articular surface of the capsule.

41. The device of claim 39, wherein the first treatment source is adapted to therapeutically treat a collagen fiber portion of a ligament of the spinal facet joint capsule, and the second treatment source is adapted to therapeutically treat a nerve fibril within a cartilagenous articular surface of the capsule.

42. A device for therapeutically treating back or leg pain, comprising:

a) probe having a proximal portion and a distal portion,

b) first and second treatment sources, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first vertebral body, the second treatment source is adapted to therapeutically treat a second vertebral body wherein the first treatment source is adapted to therapeutically treat at least a portion of a basivertebral nerve trunk located within a cancellous bone portion of the first vertebral body, and

the second treatment source is adapted to therapeutically treat a nerve ending located within an endplate bone portion of the second vertebral body.

43. A device for therapeutically treating back or leg pain, comprising:

a)a probe having a proximal portion and a distal portion,

b)first and second treatment sources, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first vertebral body, the second treatment source is adapted to therapeutically treat a second vertebral body, wherein the first treatment source is adapted to therapeutically treat at least a portion of a basivertebral nerve trunk located within a cancellous bone portion of the first vertebral body, and

the second treatment source is adapted to therapeutically treat at least a portion of a basivertebral nerve trunk located within a cancellous bone portion of the second vertebral body.

44. A device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion,

b) first and second treatment sources, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first vertebral body, the second treatment source is adapted to therapeutically treat a second vertebral body, wherein the first treatment source is adapted to therapeutically treat a nerve ending located within an endplate portion of the first vertebral body, and

the second treatment source is adapted to therapeutically treat at least a portion of a nerve ending located within an endplate bone portion of the second vertebral body.

45. A method of denervating nerves in a vertebral body, comprising the steps of:

a) providing a device having a treatment source,

b) placing the treatment source inside the human body but outside the vertebral body, and

c) activating the treatment source to cause energy to flow from the treatment source and into the vertebral body in an amount sufficient to denervate at least a portion of a basivertebral nerve in the vertebral body.

46. The method of claim 45 wherein the activation step causes energy to flow from the treatment source and into the vertebral endplate in an amount sufficient to denervate a nerve ending located in an endplate portion of the vertebral body.

47. The method of claim 45 wherein the activation step causes at least half of the energy flowing from the treatment source to flow into the vertebral body.

48. The method of claim 45 wherein the treatment source comprises an ultrasound transducer.

51. The method of claim 45 wherein the first treatment source has a first power level and the second source has a second different power level.

52. The method of claim 45 wherein the placement of the device within the human body is within an intervertebral disc adjacent the vertebral body.

53. A method of denervating nerves in a healthy vertebral body, comprising the steps of:

a) providing a device comprising at least one treatment source selected from the group consisting of an ultrasound transducer, a microwave source, a UV source, and a exothermic chemical source,

b) placing the treatment source into the healthy vertebral body, and

c) activating the device to cause energy to flow from the ultrasound source and into the healthy vertebral body in an amount sufficient to denervate at least a portion of a basivertebral nerve in the healthy vertebral body.

54. The method of claim 53 wherein the device is an implant.

55. The method of claim 53 wherein the device comprises a probe.

56. The method of claim 55 further comprising the step of d) withdrawing the treatment source from the healthy vertebral body.

57. The method of claim 53 wherein the activation step heats the entire vertebral body.

58. The method of claim 53 wherein the treatment source is an ultrasound transducer.

59. The method of claim 57, wherein step c) causes denervation of at least a portion of a basivertebral nerve trunk located in a cancellous bone portion of the vertebral body.

60. The method of claim 57, wherein step c) causes denervation of at least a portion of a basivertebral nerve ending located in an endplate portion of the vertebral body.

61. A method of denervating nerves in a healthy vertebral body, comprising the steps of:

a) providing a device comprising a cooling source,

b) placing the cooling source in the healthy vertebral body, and

c) activating the device to cool the healthy vertebral body in an amount sufficient to denervate at least a portion of a basivertebral nerve in the healthy vertebral body.

62. The method of claim 61 wherein the device is an implant.

63. The method of claim 61 wherein the device comprises a probe.

64. The method of claim 63 further comprising the step of d) withdrawing the treatment source from the healthy vertebral body.

65. The method of claim 61 wherein the activation step cools the entire vertebral body.

66. The method of claim 61, wherein step d) causes denervation of at least a portion of a basivertebral nerve trunk located in a cancellous bone portion of the vertebral body.

67. The method of claim 61, wherein step d) causes denervation of at least a portion of a nerve ending located in an endplate portion of the vertebral body.

68. A method of treating an intervertebral disc, comprising the steps of:

a) providing a device comprising an energy output source,

b) placing the energy output source into the human body, and

c) energizing the energy output source to cause energy to flow from the energy output source and into a vertebral endplate in an amount sufficient to heat the vertebral endplate to a temperature which causes heat transfer from the vertebral endplate to the intervertebral disc in an amount sufficient to cause at least one of collagen shrinkage or nerve denervation within the intervertebral disc.

69. The method of claim 68 wherein the energy output source is an ultrasound transducer.

70. The method of claim 68 wherein the energy output source is an RF source.

71. A method of treating back or leg pain, comprising the step of therapeutically treating first and second different tissue sites with a single device, each tissue site being selected from the group consisting of:

i) a first intervertebral disc,

ii) a first vertebra,

iii) a first spinal ligament,

iv) a first spinal facet joint capsule,

v) a second intervertebral disc,

vi) a second vertebra,

vii) a second spinal ligament, and

viii)a second spinal facet joint capsule.

72. The method of claim 71 wherein the device comprises a probe having first and second treatment sources, and wherein the step of therapeutically treating comprises the steps of:

a) placing the device at least partially within the human body,

b) activating the first treatment source to treat the first tissue site,

c) activating the second treatment source to treat the second tissue site, and.

d) withdrawing the device from the human body.

73. The method of claim 71 wherein the device is an implant comprising first and second treatment sources, and the step of therapeutically treating comprises the steps of:

a) placing the implant substantially completely within the human body,

b) activating the first treatment source to treat the first tissue site.

c) activating the second treatment source to treat the second tissue site.

74. The method of claim 71 wherein step a) comprises placing the device into an intervertebral disc.

75. The method of claim 71 wherein step a) comprises placing the device between adjacent first and second vertebrae and outside an intervertebral disc therebetween.

76. The method of claim 71 wherein step a) comprises placing the device into a vertebral body portion of the first vertebra.

77. The method of claim 71 wherein the first tissue site is the first intervertebral disc.

78. The method of claim 77 wherein the step of therapeutically treating the first intervertebral disc comprises coagulating collagen within the disc.

79. The method of claim 77 wherein the step of therapeutically treating the first intervertebral disc comprises denervating at least a portion of a nerve within the disc.

80. The method of claim 77 wherein the step of therapeutically treating the first intervertebral disc comprises removing mass from within the disc.

81. The method of claim 71 wherein the first tissue site is the first vertebra.

82. The method of claim 81 wherein the step of therapeutically treating the first vertebra comprises denervating at least a portion of a basivertebral nerve within a vertebral body portion of the first vertebra.

83. The method of claim 71 wherein the first tissue site is the first vertebra and the second tissue site is the second vertebra.

84. The method of claim 71 wherein the first tissue site is the first intervertebral disc and the second tissue site is the second intervertebral disc.

85. The method of claim 71 wherein the first tissue site is the first spinal ligament, and the step of therapeutically treating the first spinal ligament comprises denervating a nerve within the first spinal ligament.

86. The method of claim 71 wherein the first tissue site is the first spinal ligament, and the step of therapeutically treating the first spinal ligament comprises shrinking collagen within the first spinal ligament.

87. The method of claim 71 wherein the first tissue site is the first spinal facet joint capsule.

88. The method of claim 87 wherein the step of therapeutically treating the first spinal facet joint capsule comprises denervating a nerve within the capsule.

89. The method of claim 87 wherein the step of therapeutically treating the first spinal facet joint capsule comprises shrinking a collagenous ligament of the capsule.

90. The method of claim 71 wherein the first tissue site is the first intervertebral disc and the second tissue site is the first vertebra.

91. The method of claim 90 wherein the step of therapeutically treating comprises heating an annulus fibrosus portion of the first intervertebral disc and denervating at least a portion of a basivertebral nerve located in the first vertebra.

92. The method of claim 91 further comprising the step of b) removing at least a portion of a nucleus pulposus located within the disc.

93. The method of claim 92 wherein the step of removing at least a portion of the nucleus pulposus includes the step of liquifying the nucleus pulposus.

94. The method of claim 71 wherein the first tissue site is the first intervertebral disc and the second tissue site is the first spinal ligament.

95. The method of claim 71 wherein the first tissue site is the first spinal facet joint capsule, and the second tissue site is the second spinal facet joint capsule.

96. The method of claim 71 wherein the first tissue site is the first vertebra and the second tissue site is the first spinal ligament.

97. The method of claim 71 wherein the first tissue site is the first spinal ligament, and the second tissue site is the second spinal ligament.

98. A method of treating back or leg pain, comprising the step of therapeutically treating first and second components within an intervertebral disc with a single device.

99. The method of claim 98, wherein the treatment occurs simultaneously.

100. The method of claim 98, wherein the treatment occurs sequentially.

101. The device of claim 98 wherein the first component is within an annulus fibrosus within the intervertebral disc, and the second component is within a nucleus pulposus within the intervertebral disc.

102. The device of claim 98 wherein the first component is an interior component of the intervertebral disc, and the second component is an surface component of the intervertebral disc.

103. A method of treating back or leg pain, comprising the step of therapeutically treating first and second different components within a vertebra with a single device.

104. The method of claim 103, wherein the treatment occurs simultaneously.

105. The method of claim 103, wherein the treatment occurs sequentially.

106. The method of claim 103, wherein the first component is at least a portion of a basivertebral nerve trunk located within a cancellous bone portion of a vertebral body portion of the vertebra, and the second component is at least a portion of a nerve ending located within an endplate portion of a vertebral body portion of the vertebra.

107. A method of treating back or leg pain, comprising the step of therapeutically treating first and second different components within a spinal facet joint capsule with a single device.

108. The method of claim 107, wherein the treatment occurs simultaneously.

109. The method of claim 107, wherein the treatment occurs sequentially.

110. The method of claim 107, wherein the first component is a loose collagen fiber portion of a ligament within the capsule, and the second component is a nerve fibril within a cartilagenous endplate of the capsule.

111. A method of treating back or leg pain, comprising the step of therapeutically treating first and second vertebral bodies with a single device.

112. The method of claim 111, wherein the treatment occurs simultaneously.

113. The method of claim 111, wherein the treatment occurs sequentially.

114. The device of claim 111, wherein the treatment therapeutically treats at least a portion of a basivertebral nerve trunk located within a cancellous bone portion of the first vertebral body, and a nerve ending ending located within an endplate bone portion of the second vertebral body.

115. The device of claim 111, wherein the treatment therapeutically treats at least a portion of a basivertebral nerve trunk located within a cancellous bone portion of the first vertebral body, and at least a portion of a basivertebral nerve ending located within a cancellous bone portion of the second vertebral body.

116. The device of claim 111, wherein the treatment therapeutically treats at least a portion of a basivertebral nerve ending located within an endplate portion of the first vertebral body, and a basivertebral nerve ending located within an endplate bone portion of the second vertebral body.

117. A method of thermally treating a bony tissue site and a soft tissue site, comprising the steps of:

a) providing a device having first and second treatment sources,

b) placing the treatment sources into a target site within the human body, activating the device to cause the first treatment source to therapeutically heat the bony tissue site, and to cause the second treatment source to therapeutically heat the soft tissue site.

118. The method of claim 117 wherein the bony tissue site is a vertebral body and the soft tissue site is an intervertebral disc.

119. The method of claim 118 wherein the first energy output source is an RF source.

120. The method of claim 119 wherein the second energy output source is an ultrasound source.

121. The method of claim 117 wherein the bony tissue site is a vertebra, the soft tissue site is an intervertebral disc, the first energy output source is an RF source, and the second energy output source is an ultrasound source.

122. The method of claim 118 wherein each treatment source is an ultrasound transducer, and the first treatment source emits less ultrasound energy than the second treatment source.

123. The method of claim 122 wherein the first treatment source is directed to a vertebral endplate, and the second treatment source is directed to an annulus fibrosus.

124. A device for therapeutically treating back or leg pain, comprising:

a) probe having a proximal portion and a distal portion,

b) a first treatment source, each source located in the distal portion of the probe,

wherein the first treatment source is adaptable to therapeutically treat a first tissue site with a first focus and a second different tissue site with a second focus,

wherein the first and second tissue sites are selected from the group consisting of;

i) a first intervertebral disc,

ii) a first vertebra,

iii) a first spinal ligament,

iv) a first spinal facet joint capsule,

v) a second interverterbal disc,

vi) a second vertebra,

vii) a second spinal ligament, and

viii) a second spinal facet joint capsule.

125. A device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion,

b) first and second treatment sources, each source located in the distal portion of the probe,

wherein the first treatment source is adapted to therapeutically treat a first local tissue site,

the second treatment source is adapted to therapeutically treat a second distant tissue site, and

wherein the first and second tissue sites are selected from the group consisting of;

i) a first intervertebral disc,

ii) a first vertebra,

iii) a first spinal ligament,

iv) a first facet joint capsule,

v) a second intervertebral disc,

vi) a second vertebra,

vii) a second spinal ligament, and

viii) a second spinal facet joint capsule.

126. A device for therapeutically treating back or leg pain, comprising:

a) a probe having a proximal portion and a distal portion,

b) first and second treatment sources, each source located in the distal portion of the probe and adapted to therapeutically treat at least a first tissue site,

wherein the first treatment source provides therapy by a form of energy which is different than that of the second treatment source.

127. The device of claim 126 wherein the first treatment source is an ultrasonic transducer and the second treatment source is a resistive heating element.

128. The device of claim 126 wherein the first treatment source is an ultrasonic transducer and the second treatment source is a microwave heating source.

129. The device of claim 126 wherein the first treatment source is an ultrasonic transducer and the second treatment source is an RF heating source.

130. The device of claim 129 wherein the RF heating source is bipolar.

131. The device of claim 129 wherein the first treatment source is an energy source and the second treatment source is a chemical delivery source.

132. The device of claim 131 wherein the energy source is an ultrasound transducer.

133. The device of claim 131 wherein the chemical delivery source is a source which delivers a pair of chemicals which when combined have an exothermic reaction.