Tissue distraction device

• US 20050187558A1
• Filed: 07/21/2003
• Published: 08/25/2005
• Est. Priority Date: 03/08/2001
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Johnson, Wesley D., Kieval, Robert, Wales, Larry, Lipschultz, Tyler
• Granted Patent: US 7,311,713 B2
• Time in Patent Office: Days
• US Class Current: 606/90
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8852 capable of being assembled or enlarged, or changing shape, inside the bone or disc
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/4425 made of articulated components
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30237 partial tubes
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30385 the rib and groove having non-parallel, e.g. conically-tapered, cooperating sides, e.g. having a trapezoidal front cross-section
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30392 Rotation
• CPC Class Codes: A61F 2002/304 with additional means for limiting said sliding
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30449 : the adhesive being cement
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30476 : locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/3049 : using a slidable sleeve covering the connection
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• CPC Class Codes: A61F 2002/4485 : comprising three or more adjacent spinal implants
• 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 2002/4666 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/912 : Radiolucent material
• CPC Class Codes: Y10S 606/914 : Toolkit for installing or removing spinal positioner or stabilizer

Abstract

An apparatus and method for distracting, in a given direction, and supporting two tissue surfaces. A plurality of wafers are consecutively inserted between the two tissue surfaces to create a column of wafers. The column of wafers is oriented between the tissue surfaces so as to expand in the given direction as the wafers are consecutively added to the column.

Claims

1-97. -97. (canceled)

98. A method of providing interbody fusion between two vertebral bodies of the spine, comprising the steps of:

accessing the intradiscal space between two generally opposed vertebral bodies; and

consecutively introducing a plurality of elements in contact with each other generally in the direction of the axis of the spine between the opposed vertebral bodies to distract and support such vertebral bodies along the axis of the spine until stability of the vertebral bodies is substantially achieved.

99. The method of claim 98 wherein said elements are introduced by moving at least one element to a different position upon introduction of a subsequent element.

100. The method of claim 99 wherein said at least one element is moved by contacting a surface thereof with a surface of said subsequent element.

101. The method of claim 100 wherein the accessing step includes the step of placing an elongated access channel in communication with the space between said vertebral bodies and introducing the elements through said channel.

102. The method of claim 101, further including the step of providing a bone filler in contact with the elements.

103. The method of claim 100 wherein said elements are wafers, said wafers being introduced between said vertebral bodies by stacking one wafer atop another wafer.

104. The method of claim 98, wherein said space between said vertebral bodies is accessed by an approach selected from the group of procedures consisting of anterior, posterior, posterior lateral and extrapedicular.

105. The method of claim 98, further including the step of providing an outer member and introducing said elements into said member.

106. The method of claim 98, wherein said elements have arcuate contact surfaces.

107. The method of claim 98, wherein said elements have generally flat contact surfaces.

108. A method of providing interbody fusion between two vertebral bodies of a spine, comprising the steps of:

accessing the intradiscal space between two generally opposed vertebral bodies; and

stacking a plurality of wafers in the direction of the axis of the spine between the opposed vertebral bodies to distract and support such vertebral bodies along the axis of the spine until stability of the vertebral bodies is substantially achieved.

109. The method of claim 108, wherein said wafers are stacked by consecutively inserting said wafers one atop the other to form a column extending in the direction of the axis of the spine.

110. The method of claim 109, wherein said wafers are consecutively inserted in a direction substantially normal to the axis of the spine.

111. The method of claim 110, wherein said wafers are consecutively inserted by slidably moving one wafer along a surface of another wafer.

112. The method of claim 111, including the step of inserting between the vertebral bodies an elongated guide track along which the wafers travel during insertion.

113. The method of claim 112, including the step of inserting each wafer subsequent to the first wafer between the next preceding wafer and a base.

114. The method of claim 113, wherein the base is the guide track.

115. The method of claim 113, wherein the base is a wafer adjacent the next preceding wafer.

116. The method of claim 113, wherein the wafers have leading and trailing beveled ends, the method comprising the step of engaging the leading beveled end of one wafer with the trailing beveled end of the next preceding wafer to enable the one wafer to be inserted between the guide track and the next preceding wafer to thereby urge the preceding wafer away from the guide track in the direction of the spine.

117. The method of claim 109, wherein one or more of the wafers have filler-receiving orifices, the method including the step of providing the fluent bone filler in the orifices.

118. The method of claim 111, wherein the accessing step includes the step of inserting between the vertebral bodies an elongated access channel through which said wafers are inserted.

119. The method of claim 112, wherein the accessing step includes the step of inserting between the vertebral bodies an elongated access channel having collapsible and expandable configurations, the method including the steps of inserting the access channel in its collapsed configuration between the vertebral bodies and then expanding the access channel between the vertebral bodies laterally of its length and in a direction generally normal to the direction of the spine to enable the access channel to receive the guide track therewithin.

120. The method of claim 117 including the step of providing a membrane around the wafer column to control the flow of filler on and into said wafer column.

121. The method of claim 108, wherein said accessing step includes the step of removing a portion of the disc annulus and at least a portion of the disc nucleus.

122. The method of claim 121, wherein said step of removing a portion of the disc annulus comprises providing an opening through said annulus.

123. The method of claim 109, further comprising the step of preparing the endplates of opposing vertebral bodies to expose bleeding bone.

124. The method of claim 109, wherein said accessing step comprises an anterior approach.

125. The method of claim 109, wherein said accessing step comprises a posterior approach.

126. The method of claim 125, wherein said accessing step further comprises the provision of stacking two columns of wafers side by side.

127. The method of claim 126, wherein wafers are inserted alternatively between the two columns.

128. The method of claim 118, wherein said accessing step comprises a posterior-lateral approach.

129. The method of claim 128, wherein the accessing step further comprises the preparation of an opening in the disc annulus and advancing said access channel to the annulus opening for insertion of the wafers therethrough.

130. The method of claim 118, wherein said accessing step comprises an extra-pedicular approach.

131. The method of claim 130, wherein the accessing step further comprises the preparation of an opening in the disc annulus through the wall of an adjacent vertebral body and advancing said access channel to said opening for insertion of the wafers therethrough.

132. An interbody fusion device for the distraction and support of opposing vertebral bodies in a spine at a selected spacing between said vertebral bodies, comprising a plurality of elements in cooperative contact forming a structure between said opposing vertebral bodies generally extending in the direction of the axis of the spine, said structure being formed by the consecutive receipt of said elements between said opposing vertebral bodies to the selected spacing between said vertebral bodies.

133. The interbody fusion device of claim 132, wherein each element has an interface, the interfaces of elements in contact being configured to provide said cooperative contact.

134. The interbody fusion device of claim 133, wherein said interfaces are configured to provide unconstrained degrees of cooperative contact.

135. The interbody fusion device of claim 133, wherein said interfaces are configured to provide semi-constrained selective degrees of cooperative contact.

136. The interbody fusion device of claim 133, wherein said interfaces are configured to provide constrained degrees of cooperative contact.

137. The interbody fusion device of claim 133, wherein said interfaces are arcuate.

138. The interbody fusion device of claim 137, wherein said arcuate surfaces are generally cylindrical.

139. The interbody fusion device of claim 137, wherein said arcuate surfaces are generally spherical.

140. The interbody fusion device of claim 133, wherein said interfaces are generally flat.

141. The interbody fusion device of claim 140, wherein said structure is defined by a plurality of wafers each having said generally flat interfaces, one wafer being disposed atop another wafer to form said structure.

142. An interbody fusion device for the distraction and support of opposing vertebral bodies in a spine comprising a plurality of stackable wafers cooperatively forming a column generally in the direction of the axis of the spine between said two opposing vertebral bodies, the wafers each having a contact surface, a contact surface of one wafer being slidably receivable on a contact surface of another wafer in a sliding direction generally normal to the axis of the spine.

143. The interbody fusion device according to claim 142, wherein a stackable wafer comprises a single wafer.

144. The interbody fusion device according to claim 142, wherein a stackable wafer comprises multiple wafers.

145. The interbody fusion device of claim 142, wherein one or more wafers are curved in a plane generally normal to the direction of the axis of the column.

146. The interbody fusion device of claim 142, wherein one or more wafers are of non-uniform thickness.

147. The interbody fusion device of claim 142, wherein each wafer has a length and a width and wherein one or more wafers increases in thickness along the wafer length such that the one or more wafers are configured as a wedge.

148. The interbody fusion device of claim 142, wherein the wafer contact surfaces are provided with complementary configurations to restrain the wafers from slipping out of the column.

149. The interbody fusion device of claim 148, wherein the complementary configurations are complementary ridges and grooves.

150. The interbody fusion device of claim 149, wherein the complementary ridges and grooves have dovetail ridge and groove configurations.

151. The interbody fusion device of claim 148, wherein the complementary configurations are configured to enable the wafers to rotate in a plane normal to the given direction while remaining in the column.

152. The interbody fusion device of claim 148, wherein the complementary configurations comprise detent configurations so configured as to restrain any lateral movement between adjacent wafers in a column.

153. The interbody fusion device of claim 148, wherein the complementary configurations comprise a cylindrical indent.

154. The interbody fusion device of claim 148, wherein the complementary configurations comprise a spherical indent.

155. The interbody fusion device of claim 148, wherein the wafer contact surfaces are configured to permit limited rotation of one wafer with respect to another wafer about an axis parallel to the sliding direction.

156. The interbody fusion device of claim 142, wherein the wafers comprise a dovetail and a cylindrical indent to constrain all degrees of freedom.

157. The interbody fusion device of claim 142, wherein the wafer contact surfaces have cylindrical interfaces to provide axial translation along the axis of the cylinder and rotational movement about the radius of the cylinder.

158. The interbody fusion device of claim 142, wherein the wafers have spherical interfaces.

159. The interbody fusion device of claim 142, further including a pin for locking the wafers in place.

160. The interbody fusion device of claim 142, wherein each wafer has a leading edge, a trailing edge, and two lateral edges, the wafer further including a lip formed along a bottom surface for limiting axial travel of a subsequent wafer.

161. The interbody fusion device of claim 160, wherein the lip extends along all edges of the bottom surface except for the trailing edge.

162. The interbody fusion device of claim 160, wherein the lip extends along the leading edge of the bottom surface.

163. The interbody fusion device of claim 160, wherein the lip extends along the lateral edges of the bottom surface.

164. The interbody fusion device of claim 142, wherein the wafers are marked with a radio-opaque material for observation under fluoroscopy.

165. The interbody fusion device of claim 142 wherein each wafer has a length and a width and wherein the wafer defining the bottom wafer in said column has a length larger than at least one other wafer in said column.

166. The interbody fusion device of claim 142 wherein each wafer has a length and a width and wherein the wafer defining the top wafer in said column has a length larger than at least one other wafer in said column.

167. The interbody fusion device of claim 166 wherein said wafer defining said bottom wafer in said column has a length larger than at least one other wafer in said column.

168. The interbody fusion device of claim 142 wherein said wafers comprise implant materials.

169. The interbody fusion device of claim 168, wherein one or more wafers have at least one orifice for receiving a filler material therein.

170. The interbody fusion device of claim 168, wherein said wafers further comprise osteoinductive agents.

171. The interbody fusion device of claim 168, wherein said wafers further comprise a drug therapy.

172. The interbody fusion device of claim 142 further including an outer member covering at least a portion of such wafer column.

173. The interbody fusion device of claim 172, wherein said outer member is permeable

174. The interbody fusion device of claim 173, wherein said permeable outer member comprises a material of macro-porosity.

175. A kit for use in interbody fusion of vertebral bodies in a spine, comprising;

an interbody fusion device adapted to comprise a plurality of insertable wafers of various thickness; and

a wafer inserter for inserting wafers between said vertebral bodies, said wafer inserter being adapted to selectively insert consecutive wafers of the same or different thicknesses between said vertebral bodies to thereby form a column of wafers between said vertebral bodies.

176. The kit of claim 175 wherein a stackable wafer of a given first thickness comprises a single wafer.

177. The kit of claim 175 wherein a stackable wafer of a given second thickness comprises multiple wafers.

178. A method of treating a spine having a plurality of vertebral bodies, comprising consecutively introducing into the spine a plurality of elements in contact with each other generally in the direction of the axis of the spine between two vertebral bodies to support such vertebral bodies along the axis of the spine.

179. The method of claim 178, wherein said elements are wafers configured for stacking one atop another.

180. The method of claim 178, wherein said elements are introduced by moving at least one element to a different position in the direction of the axis of the spine upon introduction of a subsequent element.

181. The method of claim 180, wherein said elements are introduced by sliding one element along a surface of another element.

182. The method of claim 178, further comprising the step of introducing a bone filler material between the opposing endplates in contact with said plurality of elements.

183. The method of claim 182, wherein the step of introducing said bone filler material includes introducing the material between adjacent ones of said plurality of elements.

184. The method of claim 182, wherein the step of introducing said bone filler material includes introducing the material about the plurality of elements.

185. The method of claim 178, wherein said elements are introduced in a manner to simultaneously distract and support said vertebral bodies.

186. The method of claim 178, further comprising the step of providing a bone filler in contact with elements and said vertebral bodies to promote fusion between said vertebral bodies.

187. A kit for use in interbody fusion of vertebral bodies in a spine, comprising;

a plurality of wafer stacks of various thicknesses adapted to form a column between opposing vertebral bodies; and

a wafer inserter for inserting said plurality of wafer stacks between said vertebral bodies, said wafer inserter being adapted to selectively insert consecutive wafer stacks of the same or different thicknesses between said opposing vertebral bodies of the vertebral bodies to thereby form said column of wafers between said vertebral bodies.

188. The kit of claim 187, wherein at least a number of said plurality of wafer stacks include only one wafer.

189. The kit of claim 187, wherein at least a number of said plurality of wafer stacks include more than one wafer.

190. A kit for use in interbody fusion of vertebral bodies in a spine, comprising;

a plurality of elements adapted for contact with each other; and

an inserter for consecutively inserting a plurality of elements between said vertebral bodies in a manner such that such elements are placed in contact with each other in a direction generally extending along the axis of the spine.

191. The kit of claim 190, further including bone filler.

192. A method of providing spinal interbody fusion, comprising the steps of:

accessing the intradiscal space between two generally opposed upper and lower vertebral bodies;

providing an expandable structure comprising a top element, a bottom element and an intermediate element, said top element being configured to contact the upper vertebral body, said bottom element being configured to contact the lower vertebral body, and said intermediate element configured to reside between said top element and said bottom element;

introducing said top element and said bottom element into said intradiscal space; and

, introducing said intermediate element between and in contact with said top element and said bottom element to relatively move said top element and said bottom element apart generally along the axis of the spine as said intermediate element is introduced to thereby distract and support said upper and lower vertebral bodies.

193. The method of claim 192, wherein said intermediate element is introduced by sliding between said top element and said bottom element.

194. The method of claim 192, wherein the intermediate element is configured for interlocking coupling with at least said top element.

195. The method of claim 192, wherein the intermediate element is configured for interlocking with said bottom element.

196. The method of claim 192, wherein the top element has an area greater than the intermediate element.

197. The method of claim 196, wherein the bottom element has an area greater than the intermediate element.

198. The method of claim 192, wherein the step of introducing said intermediate element includes sliding a plurality of intermediate elements between the top element and the bottom element.

199. An expandable device for use in spinal interbody fusion, said device being configured for insertion in the disc space between two opposing vertebral bodies comprising:

a top element for contacting an upper vertebral body;

a bottom element for contacting an opposing lower vertebral body; and

an intermediate element having a configuration for sliding insertion between said top element and said bottom element in a first direction and for causing said top element and said bottom element to be relatively spaced apart in a direction generally transverse to said first direction, whereby said top element is adapted to contact said upper vertebral body and said bottom element is adapted to contact said lower vertebral body to distract and support said opposing vertebral bodies.

200. The expandable device of claim 199, wherein said intermediate element comprises an interlock for coupling with said top element.

201. The expandable device of claim 200, where said intermediate element comprises an interlock for coupling with said bottom element.

202. The expandable device of claim 199, wherein said intermediate element includes an angled insertion end.

203. The expandable device of claim 199, wherein said top element has an area greater than the intermediate element.

204. The expandable device of claim 203, wherein said bottom element has an area greater than the intermediate element.

205. The expandable device of claim 199, wherein said intermediate element comprises a plurality of intermediate elements.

206. The expandable device of claim 199, wherein said intermediate element comprises a generally flat wafer.

207. The expandable device of claim 206, wherein said intermediate element comprises plurality of flat wafers, each said wafer being configured for forming a stack of wafers between said top element and said bottom element.

208. The expandable device of claim 207, wherein said plurality of wafers and said top element and said bottom element are all configured to be substantially the same size.