Percutaneous cervical disc reconstruction

Abstract

Methods and devices for fixing a defect in a vertebral disc of a patient. One method includes inserting a guide wire into a disc using an anterior approach to create a path. At least a portion of the herniated nucleus pulposus is removed. A disc reconstruction device is then advanced into the disc and fastened to the disc or at least one of the surrounding vertebrae. Alternatively, a passage could be formed in the cranial or caudal vertebra using an angled anterior approach that terminates in a region of the disc containing the herniated nucleus pulposus. At least a portion of the herniated nucleus pulposus is removed. A disc reconstruction device that has a bone in-growth component and a soft tissue in-growth component is then implanted in the passage. Devices having bone and soft tissue in-growth components and having a flexible spine with a plurality of ribs are also described.

Description

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is an axial cross section through a portion of the cervical spine.

FIG. 1B is an anterior view of a portion of the cervical spine.

FIG. 2A is an axial cross section of a portion of the cervical spine and an interbody bone graft.

FIG. 2B is an anterior view of a portion of the cervical spine with a bone graft.

FIG. 2C is an anterior view of a portion of the cervical spine with a plate attached with screws to the surrounding vertebrae.

FIG. 2D is a partial sagittal cross section of a portion of the cervical spine and the fusion system of FIG. 2C.

FIG. 3A is an axial cross section of the neck with a guide wire inserted into the disc.

FIG. 3B is a sagittal cross section of a portion of the neck depicted in FIG. 3A.

FIG. 3C is an axial cross section of the neck with a tissue dilator passed over the guide wire.

FIG. 3D is a sagittal cross section of a portion of the spine and the embodiment of the invention drawn in FIG. 3C.

FIG. 3E is an axial cross section of the neck with a sleeve passed over the tissue dilator.

FIG. 3F is an axial cross section of the neck with a guide wire disposed within the passageway created by the sleeve.

FIG. 3G illustrates an alternative embodiment of the invention with a grasping tool inserted into the disc space.

FIG. 3H illustrates an alternative embodiment of the invention wherein a flexible tip guide wire is inserted into the disc space.

FIG. 3I illustrates an alternative embodiment of the invention wherein a suture anchor has been inserted into a surrounding vertebra.

FIG. 3J illustrates an anterior view of the embodiment of FIG. 3I.

FIG. 3K illustrates a sagittal cross section of a disc reconstruction device being inserted between two vertebrae.

FIG. 3L is a sagittal cross section showing the disc reconstruction device placed into the disc.

FIG. 3M illustrates a suture from the anchor fastened across the anterior position of the discs reconstruction device.

FIG. 3N is an axial cross section of the neck with the disc reconstruction device in position.

FIG. 3O is an anterior view of a portion of the spine illustrating how two ends of a suture, from the suture anchor, have been fastened to each other.

FIG. 3P shows an alternative embodiment wherein the disc reconstruction device has been fastened to the disc.

FIG. 4A is a lateral view of a disc reconstruction device.

FIG. 4B is an axial cross section of the embodiment of the invention drawn in FIG. 4A.

FIG. 4C is a lateral view of an alternative embodiment of the disc reconstruction device which is generally cylindrical in shape.

FIG. 4D is an axial cross section of an alternative embodiment of a disc reconstruction device.

FIG. 4E is an axial cross section of an alternative embodiment in the form of a sheet of mesh which has been folded and fastened to increase the surface area of the device.

FIG. 4F is an axial cross section of an alternative embodiment including a lumen.

4G is an axial cross section of an alternative embodiment in the form of a hollow device that has a larger surface area.

FIG. 5A is an axial cross section of the spine and an alternative embodiment of the invention including an instrument used to remove bone spurs.

FIG. 5B is an oblique view of the end of a cutting tool.

FIG. 5C is an axial cross section of the spine with a reconstructed disc.

FIG. 6 is an oblique view of the tip of a tool that may be used to extract disc tissue.

FIG. 7A is a lateral view of an alternative embodiment of a tool that may be used to extract disc tissue.

FIG. 7B is a lateral view of the embodiment of the invention drawn in FIG. 7A, with the tips of the device depicted in a bent configuration.

FIG. 7C is a lateral view of an embodiment of the invention, wherein the tips of the pinching component have been forced together by advancing the sleeve.

FIG. 8A is a longitudinal cross section of the tip of an alternative embodiment of the invention that includes a cutting tool located within a sleeve.

FIG. 8B is an end view of the tip of the embodiment of the invention drawn in FIG. 8A.

FIG. 9A is a partial sagittal cross section of the spine and an alternative embodiment of the invention showing a guide wire placed through a portion of a vertebra and into a disc.

FIG. 9B is a partial sagittal cross section of the spine that has been reconstructed with a device that promotes bone in-growth into one portion of the device and soft tissue in-growth into another portion of the device.

FIG. 9C is a lateral view of the device that was inserted into the reconstructed spine drawn in FIG. 9B.

FIG. 9D is a sagittal cross section of an alternative embodiment of the invention wherein a mesh material surrounds a dowel-shaped piece of bone and disc component.

FIG. 10A is an anterior view of a portion of the spine with radiopaque markers embedded in a vertebra.

FIG. 10B is a lateral view of a portion of the spine with radiopaque markers embedded in a vertebra.

FIG. 10C is an anterior view of a portion of the spine with in instrument being inserted between the radiopaque markers.

FIG. 10D is a lateral view of a portion of the spine and the embodiment of the invention drawn in FIG. 10D.

FIG. 11A is a lateral view of partial sagittal cross section of a portion of the spine and an alternative implant.

FIG. 11B is an exploded lateral view of the implant pictured in FIG. 11A.

FIG. 11C is a longitudinal cross section of the implant drawn in FIG. 11A.

FIG. 11D is an end view of the implant pictured in FIG. 11A.

FIG. 12A is a lateral view of a partial sagittal cross section of the spine having a hole drilled though the vertebra.

FIG. 12B is a lateral view of a partial sagittal cross section of the spine with the soft tissue and attached elongate member disposed in the hole in the vertebra.

FIG. 12C is a lateral view of a partial sagittal cross section of the spine with the soft tissue and attached elongate member disposed in the hole in the vertebra, with the elongate threaded member disposed about the elongate member.

FIG. 12D is a lateral view of a partial sagittal cross section of the spine and the embodiment of the invention drawn in FIG. 11C.

FIG. 13A is a lateral view of a partial sagittal cross section of the spine having a tunnel extending through the vertebra and ending in the spinal canal.

FIG. 13B is a lateral view of a partial sagittal cross section of the spine having a tunnel extending through the vertebra and a portion of the anulus fibrosus and ending in the spinal canal.

FIG. 14A is a lateral view of a partial sagittal cross section of the spine and an alternative embodiment of the invention having a distal end that radially expands.

FIG. 14B is an exploded lateral view of the embodiment of the invention drawn in FIG. 14A.

FIG. 14C is a view of distal end 442 of the elastic/shape memory component drawn in FIG. 14B.

FIG. 14D is a view of the distal end 442 of the elastic/shape memory component drawn in FIG. 14C.

FIG. 14E is a lateral view of the elastic/shape memory component drawn in FIG. 14B and a sleeve.

FIG. 14F is a lateral view of the embodiment of the invention drawn in FIG. 14E.

FIG. 14G is a lateral view of a partial sagittal cross section the spine and the embodiment of the invention drawn in FIG. 14A inserted into a tunnel in a vertebra.

FIG. 14H is a lateral view of a partial sagittal cross section of the spine and the embodiment of the invention drawn in FIG. 14G with the sleeve retracted.

FIG. 14I is a lateral view of a partial sagittal cross section of the spine and the embodiment of the invention drawn in FIG. 14H with a clamp about the elongate member to secure the elongate threaded members.

FIG. 14J is a lateral view of a partial sagittal cross section of the spine and an alternative embodiment of the invention drawn in FIG. 14A.

FIG. 15A is a lateral view of a partial sagittal cross section of the spine having an alternative implant having a covering over the expandable distal end.

FIG. 15B is an exploded lateral view of the embodiment of the invention drawn in FIG. 15A.

FIG. 15C is a lateral view of a longitudinal cross section of the embodiment of the invention drawn in FIG. 15A.

FIG. 16A is a lateral view of a partial sagittal cross section of the spine having an alternative implant, wherein the distal end has an expandable spiral or coil.

FIG. 16B is a view of the distal end of the embodiment of the invention drawn in FIG. 16A.

FIG. 16C is a view of the end of the distal end of the embodiment of the invention drawn in FIG. 16B. The end of the device has expanded radially.

FIG. 17A is a lateral view of an alternative embodiment of the invention having an alternative implant positioned in the vertebra and disc, wherein the distal end can expand radially.

FIG. 17B is a lateral view of the embodiment of the invention drawn in FIG. 17A with expandable distal end 462 of the soft tissue in-growth component drawn in its expanded configuration.

FIG. 17C is a lateral view of an alternative embodiment of the invention drawn in FIG. 17A.

FIG. 17D is a lateral view of the embodiment of the invention drawn in FIG. 17C, with distal end 462 drawn in its expanded configuration.

FIG. 18A is a lateral view of a portion of the spine wherein the disc is herniated or protrudes posterior to the vertebrae into the spinal canal.

FIG. 18B is a lateral view of a partial sagittal cross section of a portion of the spine and a drill bit.

FIG. 18C is a lateral view of a partial sagittal cross section of a portion of the spine and an alternative embodiment of the invention having a cannulated drill bit advanced over a guidewire.

FIG. 18D is a lateral view of a partial sagittal cross section of a portion of the spine and an alternative embodiment of the invention wherein a mill tip is used to create a tunnel.

FIG. 18E is an axial cross section through a disc with a drill bit sitting within the anulus fibrosus and protruding into the spinal canal.

FIG. 18F is an axial cross section through a disc and a mill tip sitting within a tunnel.

FIG. 19A is a lateral view of a partial sagittal cross section of the spine and an alternative embodiment.

FIG. 19B is an oblique view of the proximal end of the device drawn in FIG. 19A.

FIG. 19C is an axial cross section of cranial vertebra 120 with device 472 located within the vertebra.

FIG. 19D is an axial cross section of a disc and the device, which lies along the edge of the surgically treated disc.

FIG. 19E is an oblique view of the distal end of the device of FIG. 19A.

FIG. 20A is a lateral view of an alternative embodiment of the invention that can be inserted into a vertebra and a disc.

FIG. 20B is a view of the proximal end of the embodiment of the invention drawn in FIG. 20A.

FIG. 20C is a view of the inferior surface of the embodiment of the invention drawn in FIG. 20A.

FIG. 20D is a view of the proximal end of the embodiment of the invention drawn in FIG. 20B and a balloon in a deflated configuration.

FIG. 20E is a view of the proximal end of the embodiment of the invention drawn in FIG. 20D and a balloon in an expanded configuration.

FIG. 20F is a lateral view of a sagittal cross section through a portion of the spine and a lateral view of the embodiment of the invention drawn in FIG. 20A.

FIG. 20G is a lateral view of a partial sagittal cross section of a portion of the spine and a lateral view of the embodiment of the invention drawn in FIG. 20F with the spine drawn in a flexed position.

FIG. 20H is an axial cross section through a disc and the embodiment of the invention drawn in FIG. 20G.

FIG. 20I is an axial cross section of cranial vertebra 120 and the device drawn in FIG. 20G.

FIG. 20J is an axial cross section of a vertebra and an alternative embodiment of the device.

FIG. 20K is an axial cross section of a vertebra having a tunnel with a different cross section and the device of FIG. 20K.

FIG. 20L is an axial cross section of a vertebra and an alternative embodiment of the invention having a curved spine.

FIG. 20M is an axial cross section of a vertebra having a tunnel with a rectangular cross-section and an alternative embodiment of the invention.

FIG. 20N is an axial cross section of a vertebra having a tunnel with a circular cross-section and the device depicted in FIG. 20M in its contracted configuration.

FIG. 20O is an axial cross section of a vertebra having a tunnel with a circular cross-section and the device depicted in FIG. 20M in its expanded configuration.

FIG. 21 is a view of the proximal end of an alternative embodiment of the invention drawn in FIG. 20A.

Claims

1. A method of repairing a disc having herniated nucleus pulposus, wherein the disc is situated between a cranial and caudal vertebra, comprising the steps of: inserting a guide wire into a disc using an anterior lateral approach to create a path;removing at least a portion of the herniated nucleus pulposus;attaching a suture to at least one of the cranial and caudal vertebra;advancing a disc reconstruction device along the path into the disc; andfastening the disc reconstruction device to at least one of the cranial and caudal vertebra with the suture.

2-25. (canceled)

26. A method for repairing a disc having a herniated nucleus pulposus, wherein the disc is situated between cranial and caudal vertebra, comprising the steps of: forming a passage in the cranial or caudal vertebra that extends into the disc using an angled anterior approach that enters the cranial or caudal vertebra and terminates at a posterior region of the disc that includes the herniated nucleus pulposus;removing at least a portion of the herniated nucleus pulposus; andimplanting a disc reconstruction device into the passage, wherein the disc reconstruction device has a bone in-growth component and a tissue in-growth component, and wherein the bone in-growth component is located in the cranial or caudal vertebra and the tissue in-growth component is located in the disc.

27-41. (canceled)

42. A method for removing a bone spur from a vertebra, comprising the steps of: inserting a guide wire into a disc located adjacent to the vertebra using an anterior lateral approach to create a path;advancing a cutting tool to the bone spur along the path;removing at least a portion of the bone spur from the vertebra using the cutting tool;advancing a disc reconstruction device along the path into the disc; andfastening the disc reconstruction device to at least one of the disc or the vertebra.

43-56. (canceled)

57. A medical device for implantation into a spine of a patient, comprising: a soft tissue in-growth component made from a material selected from the group consisting of porous mesh, allograft tissue, autograft tissue, xenograft tissue, and combinations thereof; anda hard tissue in-growth component associated with the soft tissue in-growth component, and wherein the hard tissue in-growth component is made from a material selected from the group consisting of titanium, ceramic, and tantalum.

58-60. (canceled)

61. A medical device for implantation into a spine of a patient, comprising: a mesh sleeve having a chamber and a closed distal end,a soft tissue in-growth component comprising at least one of anulus fibrosus or nucleus pulposus obtained from the patient, wherein the soft tissue in-growth component is located in the chamber of the mesh sleeve; anda hard tissue in-growth component comprising bone obtained from the patient, wherein the hard tissue in-growth component is located in the chamber of the mesh sleeve and is located proximal of the soft tissue in-growth component.

62-64. (canceled)

65. A medical device for implantation into a spine of a patient, comprising: a soft tissue in-growth component comprising porous mesh;an elongate member extending proximally from the soft tissue in-growth component;an elongate threaded member having a lumen adapted to receive the elongate member; anda fastener releasably attached at a distal end of the elongate member.

66-75. (canceled)

76. A medical device for implantation into a spine of a patient, comprising: a soft tissue in-growth component comprising porous mesh;an elongate member extending proximally from the soft tissue in-growth component; andan elongate threaded member adapted to frictionally engage the elongate member at a position along a circumference of the elongate threaded member.

77-85. (canceled)

86. A medical device for implantation into a spine of a patient, comprising: an expandable implant composed of an elastic or shape-memory material;an elongate member extending proximally from the expandable implant; andan elongate threaded member having a lumen adapted to receive the elongate member; anda fastener releasably attached at a distal end of the elongate member.

87-94. (canceled)

95. A medical device for implantation into a spine of a patient, comprising: an expandable implant composed of an elastic or shape-memory material;an elongate member extending proximally from the expandable implant; andan elongate threaded member adapted to frictionally engage the elongate member at a position along a circumference of the elongate threaded member.

96-99. (canceled)

100. A medical device for implantation into a spine of a patient, comprising: an elongate tubular structure having a proximal end, a distal tapered end, and a lumen therebetween,wherein the elongate tubular structure is composed of a porous mesh made from a shape memory metal.

101-102. (canceled)

103. A method for repairing a disc having a herniated nucleus pulposus, wherein the disc is situated between a cranial and caudal vertebra, comprising the steps of: forming a passage in the cranial vertebra that extends into the disc using an angled anterior approach that enters the cranial vertebra and terminates at a posterior region of the disc that includes the herniated nucleus pulposus;removing a portion of the herniated nucleus pulposus;locating an elongate tubular structure in the passage, wherein the elongate tubular structure has a proximal end, a distal tapered end, and a lumen therebetween, and wherein the elongate tubular structure is composed of a porous mesh; andexpanding the elongate tubular structure to frictionally engage the vertebral surface of the passage.

104-107. (canceled)

108. A medical device for implantation into a spine of a patient, comprising: a generally rectangular member having first and second longitudinal edges; anda plurality of ribs extending from the first and second longitudinal edges,wherein the generally rectangular member and plurality of ribs are composed of an elastic or shape-memory material, and wherein the device is expandable from a contracted state to an expanded state.

109. The device of claim 108, wherein each of the plurality of ribs further comprises at least one projection at a free end of each of the plurality of ribs.

110. The device of claim 109, wherein the projection is a tine or barb.

111. The device of claim 108, wherein the plurality of ribs are composed of nitinol.

112. The device of claim 108, wherein the generally rectangular member and each of the plurality of ribs each have a thickness, and wherein the thickness of the generally rectangular member is larger than the thickness of each of the plurality of ribs.

113. The device of claim 108, wherein a distance between a free end of a rib on the first longitudinal edge and a free end of a corresponding rib on the second longitudinal edge is smaller in the contracted state than in the expanded state.

114. The device of claim 108, wherein the generally rectangular member and the plurality of ribs define a volume, and wherein the defined volume is smaller in the contracted state than in the expanded state.

115. The device of claim 108, wherein the plurality of ribs are expandable from the contracted state to the expanded state.

116. The device of claim 108, wherein the generally rectangular member is expandable from the contracted state to the expanded state.

117. The device of claim 116, wherein the generally rectangular member is curved in the contracted state.

118. The device of claim 108, further comprising an additional generally rectangular member having first and second longitudinal edges, and wherein the plurality of ribs connect the first and second longitudinal edges of the generally rectangular member and the additional generally rectangular member.

119. The device of claim 118, wherein the additional generally rectangular member is curved.

120. A method for repairing a disc having herniated nucleus pulposus, wherein the disc is situated between a cranial and caudal vertebra, comprising the steps of: forming a passage in the cranial vertebra that extends into the disc using an angled anterior approach that enters the cranial vertebra and terminates at a posterior region of the disc that includes the herniated nucleus pulposus;placing a device having a generally rectangular member having first and second longitudinal edges and a plurality of ribs extending from the first and second longitudinal edges into the passage; andexpanding the device to frictionally engage the vertebral surface of the passage.

121. The method of claim 120, wherein the device comprises a shape memory material and wherein the device expands as a result of a temperature change after it is located in the passage.

122. The method of claim 120, wherein the device expands as a result of expanding a balloon located between the plurality of ribs and along a longitudinal axis of the generally rectangular member.

123. The method of claim 120, wherein the passage has a circular cross-section.

124. The method of claim 120, wherein the passage has a rectangular cross-section.

125. The method of claim 120, wherein the generally rectangular member is curved and wherein the device expands by straightening the generally rectangular member.

126. The method of claim 125, wherein the plurality of ribs frictionally engage the vertebral surface as the generally rectangular member straightens.

127. The method of claim 125, wherein the generally rectangular member frictionally engage the vertebral surface as the generally rectangular member straightens.

128. The method of claim 120, wherein the device is placed into the passage using a visualization technique selected from the group consisting of MRI, CT, and fluoroscopy

129. A medical device for implantation into a spine of a patient, comprising: first and second generally rectangular members each having first and second longitudinal edges; anda plurality of ribs extending between the first and second longitudinal edges of the first and second generally rectangular members,wherein the first and second generally rectangular members and the plurality of ribs are composed of an elastic or shape-memory material, and wherein the device is expandable from a contracted state to an expanded state.

130-138. (canceled)

139. A method for repairing a disc having herniated nucleus pulposus, wherein the disc is situated between a cranial and caudal vertebra, comprising the steps of: forming a passage in the cranial vertebra that extends into the disc using an angled anterior approach that enters the cranial vertebra and terminates at a posterior region of the disc that includes the herniated nucleus pulposus;placing a device into the passage having first and second generally rectangular members each having first and second longitudinal edges and a plurality of ribs extending between the first and second longitudinal edges of the first and second generally rectangular members; andexpanding the device to frictionally engage the vertebral surface of the passage.

140-147. (canceled)

148. A method for repairing a disc having a herniated nucleus pulposus, wherein the disc is situated between a cranial and caudal vertebra, comprising the steps of: forming a passage in the cranial vertebra extending into the disc using an angled anterior approach that enters the cranial vertebra and terminates at a posterior region of the disc that includes the herniated nucleus pulposus;placing a disc reconstruction device in the passage, wherein the disc reconstruction device has an expandable implant and an elongate member extending proximally from the expandable implant; andplacing the elongate threaded member at least partially fills the passage in the vertebra.

149-159. (canceled)