Apparatus and method for the delivery of electrical current for interbody spinal arthrodesis

• US 6,120,502 A
• Filed: 05/27/1994
• Issued: 09/19/2000
• Est. Priority Date: 06/13/1988
• Status: Expired due to Term

• Current Assignee: Gary K. Michelson
• Original Assignee: Gary K. Michelson
• Inventors: Michelson, Gary Karlin
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/250,177
• Time in Patent Office: 2,307 Days
• Field of Search: 606/61, 606/62, 606/69-77, 623/17, 600/9, 600/13, 600/15, 607/50, 607/51, 607/52
• US Class Current: 606/247
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7074 Tools specially adapted for spinal fixation operations other than for bone removal or filler handling A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2821 Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30158 trapezoidal
• CPC Class Codes: A61F 2002/30179 : X-shaped
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/3037 : Translation along the common longitudinal axis, e.g. piston
• CPC Class Codes: A61F 2002/30398 : Sliding
• CPC Class Codes: A61F 2002/30405 : made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30789 : perpendicular with respect to each other
• CPC Class Codes: A61F 2002/30797 : internally-threaded
• CPC Class Codes: A61F 2002/30836 : knurled
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30843 : Pyramidally-shaped
• CPC Class Codes: A61F 2002/30845 : with cutting edges
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4485 : comprising three or more adjacent spinal implants
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• CPC Class Codes: A61F 2002/4619 : for extraction
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0026 : trapezoidal
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/205 : for promoting a biological process

Abstract

An electrical bone growth promotion apparatus and method for the delivery of electrical current to an implant surgically implanted within the intervertebral space between two adjacent vertebrae of the spine to promote bone growth and the fusion process to areas adjacent to the implant. The apparatus of the present invention comprises a self contained implant having a surgically implantable, renewable power supply and related control circuitry for delivering electrical current directly to the implant and thus directly to the area in which the promotion of bone growth is desired. The desired areas of bone growth promotion may be controlled by conducting negative charge only to the desired location of bone growth promotion.

Claims

1. A device for promoting bone growth comprising:

an implant having an outer surface sized for placement between and in contact with adjacent bone masses and having openings in said outer surface into which bone from the adjacent bone masses grows; and

means for energizing said implant to promote bone growth.

2. The device of claim 1 in which said energizing means is a power supply delivering an electric charge and further including control means for controlling delivery of said electrical charge.

3. The device of claim 2 in which said control means includes a wave form generator.

4. The device of claim 2 in which said control means includes a voltage generator.

5. The device of claim 2 in which said control means includes means for delivering intermittent pulses of current.

6. The device of claim 2 in which said control means includes means for providing alternating current.

7. The device of claim 2 in which said control means includes means for providing direct current.

8. The device of claim 2 in which said control means includes means for providing a sinusoidal current.

9. The device of claim 2 in which said control means includes means for generating electrical noise.

10. The device of claim 1 in which said energizing means comprises an electromagnetic field generator positioned external to the patient'"'"'s body inductively coupled to said implant.

11. The device of claim 10 further including means for storing electrical current generated by said generator.

12. The device of claim 1 in which said implant has a substantially hollow chamber having at least one access opening.

13. The device of claim 12 in which said energizing means is contained within said implant.

14. The device of claim 13 in which said energizing means is a power supply delivering an electric charge and further including control means for controlling delivery of said electrical charge, said control means being contained within said implant.

15. The device of claim 12 further including a cap for closing said access opening of said hollow chamber.

16. The device of claim 15 in which said control means attaches to said cap.

17. The device of claim 16, in which said energizing means attaches to said cap.

18. The device of claim 1 in which said energizing means delivers negative electrical charge to a first portion of said implant, said first portion being electrically conductive for delivering said electrical charge to at least a portion of the adjacent bone masses.

19. The device of claim 18 in which said energizing means delivers positive electrical charge to a second portion of said implant, said second portion being electrically conductive for delivering said positive electrical charge.

20. The device of claim 1 in which said energizing means comprises a surgically implantable battery.

21. The device of claim 20 in which said battery is rechargeable.

22. The device of claim 1 in which said implant has a coil wrapped around said implant, said coil being electrically conductive.

23. The device of claim 22 in which said coil comprises a plurality of external threads on said outer surface of said implant.

24. The device of claim 23 in which said plurality of external threads are electrically coupled to said energizing means.

25. The device of claim 24 in which said implant has a hollow chamber, said plurality of external threads having means for conducting electrical current to said hollow chamber.

26. The device of claim 1 in which said implant has a passage between at least two of said openings such that said passage communicates with each of the adjacent bone masses to be joined;

and

a conductive coil disposed proximate said passage, said coil being coupled to said energizing means.

27. The device of claim 26 in which said implant has a hollow chamber in communication with said passage and said coil.

28. The device of claim 27 in which said energizing means is contained within said implant.

29. The device of claim 28 in which said energizing means is a power supply delivering an electric charge and further including a control means for controlling delivery of said electrical charge, said control means being contained within said implant.

30. The device of claim 1 in which said implant is formed of a material which is stronger than the adjacent bone masses to be joined so as to support the adjacent bone masses.

31. The device of claim 1 in which said implant is for bone healing of a fractured large bone.

32. The device of claim 1 in which said implant is for fusion of a joint in the body.

33. The device of claim 1 in which said implant has a passage between a first of said openings in contact with one of the adjacent bone masses to be joined and a second of said openings in contact with another one of the adjacent bone masses to be joined;

and

a conductive coil disposed proximate said passage, said coil being coupled to said energizing means and creating an electromagnetic field at said passage to promote bone growth through said passage.

34. The device of claim 1 in which said implant comprises a fusion promoting substance.

35. The device of claim 1 in which at least one of said openings of said implant contains fusion promoting materials for promoting bone ingrowth in continuity through said implant from one of the adjacent bone masses to the other of the adjacent bone masses.

36. The device of claim 1 in which said adjacent bone masses are vertebral bodies.

37. The device of claim 1 in which said openings of said implant allow bone growth to occur through said implant from the adjacent bone masses.

38. The device of claim 1 further comprising fusion promoting substances for promoting bone growth.

39. The device of claim 38, in which said implant permits bone growth to occur through said implant from one of the adjacent bone masses to the other of the adjacent bone masses.

40. The device of claim 1 in which said implant is an interbody spinal implant.

41. The device of claim 40 in which said implant is a fusion implant permitting bone growth around and through said implant.

42. The device of claim 1 in which said implant fits entirely between the adjacent bone masses.

43. The device of claim 1 in which said energizing means includes an electromagnetic wave generator.

44. The device of claim 1 in which said energizing means includes an electromagnetic energy generator.

45. The device of claim 1 in which said energizing means includes a magnetic field generator.

46. The device of claim 1 in which said source includes an electromagnetic wave generator.

47. The device of claim 1 in which said source includes an electromagnetic energy generator.

48. The device of claim 1 in which said source includes a magnetic field generator.

49. An assembly for delivering electric current to promote bone growth between adjacent vertebral bodies of a human spine, said assembly comprising:

an implant having an outer surface sized for placement between and in contact with the adjacent vertebral bodies, said implant having openings in said outer surface into which bone from the adjacent vertebral bodies grows; and

means for energizing said implant from a point external to a patient'"'"'s body.

50. The assembly of claim 49 including means for delivering a charge of predetermined polarity to an area of bone adjacent to said implant.

51. The assembly of claim 49 further including means for storing electrical current generated by said energizing means within said implant.

52. The assembly of claim 49 wherein said outer surface of said implant has a length and a width, said length being less than the depth of the adjacent vertebral bodies and the width of said outer surface being less than the width of the adjacent vertebral bodies.

53. The assembly of claim 49 in which said implant is energized with and emits an electromagnetic field.

54. The assembly of claim 49 including a cathode lead integral with said implant.

55. The assembly of claim 49 in which said implant comprises a fusion promoting substance.

56. The assembly of claim 49 in which at least one of said openings of said implant contains fusion promoting materials for promoting bone ingrowth in continuity through said implant from one of the adjacent vertebral bodies to the other of the adjacent vertebral bodies.

57. The assembly of claim 49 in which said openings of said implant allow bone growth to occur through the interior of said implant.

58. The assembly of claim 49 further comprising fusion promoting substances for promoting bone growth.

59. The assembly of claim 58, in which said implant permits bone growth to occur through said implant from one of the adjacent vertebral bodies to the other of the adjacent vertebral bodies.

60. The assembly of claim 49 in which said implant fits entirely between the adjacent vertebral bodies.

61. The assembly of claim 49 in which said energizing means includes an electromagnetic wave generator.

62. The assembly of claim 49 in which said energizing means includes an electromagnetic energy generator.

63. The assembly of claim 49 in which said energizing means includes a magnetic field generator.

64. A method for promoting bone growth with an implant surgically implanted into the area of bone to be joined, comprising the steps of:

placing said implant between adjacent bone masses and in contact with the adjacent bone masses to be joined by bone growth; and

energizing said implant to promote bone growth in the adjacent bone masses and into said implant.

65. The method of claim 64 wherein the energizing step includes the step of negatively charging a first portion of said implant.

66. The medical device of claim 64 in which the adjacent bone masses are vertebral bodies.

67. The method of claim 65 further including the step of providing positive charge to a second portion of said implant to inhibit bone growth in an area adjacent to said second portion.

68. The method of claim 64 in which the placing step includes placing said implant having an outer surface with openings therein to allow bone growth to occur through said implant such that at least some of said openings are in contact with each of the adjacent bone masses.

69. The method of claim 68 further comprising the step of placing said implant comprising a fusion promoting substance to promote bone growth.

70. The method of claim 68 further comprising the step of loading at least one of said openings with fusion promoting substances to promote bone growth into said implant from one of the adjacent bone masses to the other of the adjacent bone masses.

71. The method of claim 64 in which the placing step includes placing an interbody spinal fusion implant.

72. The method of claim 64 in which the placing step includes the step of fitting said implant entirely between the adjacent bone masses.

73. The method of claim 64 in which said step of energizing includes the step of generating an electromagnetic wave.

74. The method of claim 64 in which said step of energizing includes the step of generating electromagnetic energy.

75. The method of claim 64 in which said step of energizing includes the step of generating a magnetic field.

76. A self contained implantable medical device for promoting bone growth between bone masses, the medical device including:

an implant having an outer surface sized to be placed between and into contact with the bone masses;

a source of electrical charge contained within said implant; and

means for delivering charge from said source to the bone masses to promote bone growth into said implant.

77. The medical device of claim 76 wherein said delivering means includes means to deliver negative charge to a first location of bone mass and positive charge to a second location of bone mass.

78. The medical device of claim 76 in which said implant comprises a fusion promoting substance.

79. The medical device of claim 76 in which said implant has at least one opening containing fusion promoting materials for promoting bone ingrowth in continuity through said implant from one of the bone masses to the other of the bone masses.

80. The device of claim 76 in which said implant has an outer surface having openings therein to allow bone growth to occur through said implant from the bone masses.

81. The device of claim 80 further comprising fusion promoting substances for promoting bone growth.

82. The device of claim 80 in which said implant permits bone growth to occur through said implant from one of the bone masses to the other of the bone masses.

83. The device of claim 76 in which said implant is an interbody spinal fusion implant.

84. The device of claim 76 in which said implant fits entirely between the adjacent bone masses.

85. A self contained implantable medical device for placement between adjacent bone masses for promoting bone growth, comprising:

an implant for placement between and in contact with the adjacent bone masses, said implant having a first portion being electrically conductive for delivering electrical charge to at least a portion of the adjacent bone masses;

charge means contained within said implant for providing electrical charge at a predetermined polarity; and

means interposed between said charge means and said first portion for transferring charge from said charge means to said first portion, thereby promoting bone growth into said implant.

86. The medical device of claim 85 wherein said implant is generally cylindrical and has a substantially hollow chamber, said chamber having at least one access opening for receiving said charge means.

87. The device of claim 85 in which said implant is placed within a large bone.

88. The medical device of claim 85 in which the adjacent bone masses are vertebral bodies.

89. The medical device of claim 85 in which said implant comprises a fusion promoting substance.

90. The device of claim 85 in which said implant has at least one opening containing fusion promoting materials for promoting bone ingrowth in continuity through said implant from one of the adjacent bone masses to the other of the adjacent bone masses.

91. The device of claim 85 in which said implant does not extend substantially beyond the outer surface of the adjacent bone masses.

92. A device for promoting bone growth comprising:

an implant sized for placement between and in contact with adjacent bone masses along a contacting surface for each of the adjacent bone masses, said implant having exterior dimensions sized to be contained substantially between said contacting surfaces of the adjacent bone masses; and

means for energizing said implant to promote bone growth, said energizing means contained within said implant.

93. The device of claim 92 in which the adjacent bone masses are vertebral bodies.

94. The device of claim 92 in which said energizing means is a power supply delivering an electric charge.

95. The device of claim 92 in which said energizing means delivers negative electrical charge to a first portion of said implant, said first portion being electrically conductive for delivering said electrical charge to at least a portion of the adjacent bone masses.

96. The device of claim 95 in which said energizing means delivers positive electrical charge to a second portion of said implant.

97. The device of claim 92 in which said implant comprises a fusion promoting substance.

98. The device of claim 92 in which said openings of said implant allow bone growth to occur through said implant from the adjacent bone masses.

99. A method for promoting bone growth with an implant surgically implanted into the area of bone to be joined, comprising the steps of:

placing said implant between adjacent bone masses and in contact with the adjacent bone masses along a contacting surface for each of the adjacent bone masses, said implant having exterior dimensions sized to be contained substantially between said contacting surfaces of the adjacent bone masses; and

energizing said implant with a source contained within said implant to promote bone growth in the area of bone adjacent to said implant.

100. The method of claim 99 wherein the energizing step includes the step of negatively charging a first portion of said implant.

101. The method of claim 99 in which the placing step includes placing said implant having an outer surface with openings therein to allow bone growth to occur through said implant such that at least some of said openings are in contact with each of the adjacent bone masses.

102. The method of claim 101 further comprising the step of placing said implant comprising a fusion promoting substance to promote bone growth.

103. The method of claim 99 in which the placing step includes the step of fitting said implant entirely between the adjacent bone masses.

104. The method of claim 99 in which said step of energizing includes the step of generating electromagnetic energy.

105. A self contained implantable medical device for promoting bone growth between bone masses, the medical device including:

an implant sized to be placed between and into contact with the bone masses along a contacting surface for each of the bone masses, said implant having exterior dimensions sized to be contained substantially between said contacting surfaces of the bone masses;

a source of electrical charge contained within said implant; and

means for delivering charge from said source to the bone masses to promote growth.

106. The medical device of claim 105 wherein said delivering means includes means to deliver negative charge to a first location of bone mass and positive charge to a second location of bone mass.

107. The medical device of claim 105 in which said implant comprises a fusion promoting substance.

108. The medical device of claim 105 in which said implant has an outer surface with openings therein to allow bone growth to occur through said implant from the bone masses.

109. The device of claim 105 in which said implant fits entirely between the adjacent bone masses.

110. A device for promoting bone growth comprising:

an implant sized for placement between and in contact with adjacent bone masses along a contacting surface for each of the adjacent bone masses, said implant having exterior dimensions sized to be contained substantially between said contacting surfaces of the adjacent bone masses; and

means for energizing said implant from a point external to a patient'"'"'s body to promote bone growth.

111. The device of claim 110 in which said energizing means includes a wave form generator.

112. The device of claim 110 in which said energizing means comprises an electromagnetic field generator positioned external to the patient'"'"'s body inductively coupled to said implant.

113. The device of claim 112 further including means for storing electrical current generated by said generator.

114. The device of claim 110 in which said implant comprises a fusion promoting substance.

115. The device of claim 110 in which said adjacent bone masses are vertebral bodies.

116. The device of claim 110 in which said openings of said implant allow bone growth to occur through said implant from the adjacent bone masses.

117. An assembly for delivering electric current to promote bone growth between adjacent vertebral bodies of a human spine, said assembly comprising:

an implant sized for placement between and in contact with each of the adjacent vertebral bodies, said implant having exterior dimensions sized to be contained substantially within the depth and width of the vertebral bodies; and

means for energizing said implant from a point external to a patient'"'"'s body.

118. The assembly of claim 117 in which said implant is energized with and emits an electromagnetic field.

119. The assembly of claim 117 in which said implant comprises a fusion promoting substance.

120. The assembly of claim 117 in which said openings of said implant allow bone growth to occur through the interior of said implant.

121. The assembly of claim 117 further comprising fusion promoting substances for promoting bone growth.

122. The assembly of claim 117 in which said implant fits entirely between the adjacent vertebral bodies.

123. A method for promoting bone growth with an implant surgically implanted into the area of bone masses to be joined, comprising the steps of:

placing said implant between adjacent bone masses and in contact with the adjacent bone masses along a contacting surface for each of the adjacent bone masses, said implant having exterior dimensions sized to be contained substantially between said contacting surfaces of the adjacent bone masses; and

energizing said implant from a point external to a patient'"'"'s body to promote bone growth in the area of bone adjacent to said implant, so as promote the joining of the bone masses by bone growth.

124. The method of claim 123 wherein the energizing step includes the step of negatively charging a first portion of said implant.

125. The method of claim 123 in which the placing step includes placing said implant having an outer surface with openings therein to allow bone growth to occur through said implant such that at least some of said openings are in contact with each of the adjacent bone masses.

126. The method of claim 125 further comprising the step of placing said implant comprising a fusion promoting substance to promote bone growth.

127. The method of claim 123 in which the placing step includes the step of fitting said implant entirely between the adjacent bone masses.

128. The method of claim 123 in which said step of energizing includes the step of generating electromagnetic energy.