Tissue distraction device

• US 20040220580A1
• Filed: 07/21/2003
• Published: 11/04/2004
• Est. Priority Date: 03/08/2001
• Status: Abandoned Application

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Kieval, Robert, Wales, Larry, Johnson, Wes, Lipschultz, Tyler
• Application Number:
  US10/624,066
• Publication Number:
  US 20040220580A1
• 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. (cancelled).

98. A method for distracting in a given direction two tissue surfaces comprising consecutively introducing a plurality of elements in contact with each other between the tissue surfaces to distract such tissue surfaces generally in the given direction as elements are consecutively introduced.

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 introducing step includes the step of placing an elongated access channel in communication with a space between said tissue surfaces 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 tissue surfaces by stacking one wafer atop another wafer.

104. The method of claim 98, wherein said elements are introduced by sliding one element along a surface of another element.

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. The method of claim 98, wherein said tissue surfaces are superior and inferior surfaces of a damaged or diseased vertebral body in a spine, and wherein the elements are consecutively inserted into the vertebral body to distract said superior and inferior surfaces until the normal height of the vertebral body is substantially attained.

109. The method of claim 98, wherein said tissue surfaces are superior and inferior endplate surfaces of opposing vertebral bodies in a spine, and wherein the elements are consecutively inserted between said vertebral bodies to distract said opposing superior and inferior endplate surfaces until stability of the vertebral bodies is substantially achieved.

110. The method of claim 98, wherein said tissue surfaces are surfaces of a damaged or fractured tibia, and wherein the elements are consecutively inserted between the surfaces to distract such surfaces until the damage or fracture is substantially reduced.

111. A method for supporting in a given direction two tissue surfaces comprising consecutively introducing between the tissue surfaces a plurality of elements in contact with each other generally in the given direction until said tissue surfaces are supported.

112. The method of claim 111, wherein said elements are wafers configured for stacking one atop another.

113. The method of claim 111, wherein said elements are introduced by moving at least one element to a different position in the given direction upon introduction of a subsequent element.

114. The method of claim 113, wherein said elements are introduced by sliding one element along a surface of another element.

115. The method of claim 111, further comprising the step of introducing a bone filler in contact with said plurality of elements.

116. The method of claim 111, wherein said elements are introduced in a manner to simultaneously distract and support said tissue surfaces.

117. An apparatus for the support of tissue surfaces in a given direction, comprising a plurality of elements in cooperative contact forming a structure between said tissue surfaces generally extending in the given direction, said elements being configured for consecutive receipt between said tissue surfaces to thereby form said structure as said elements are received.

118. The apparatus of claim 117, wherein each element has an interface, the interfaces of elements in contact being configured to provide said cooperative contact.

119. The apparatus of claim 118, wherein said interfaces are configured to provide unconstrained degrees of cooperative contact.

120. The apparatus of claim 118, wherein said interfaces are configured to provide semi-constrained selective degrees of cooperative contact.

121. The apparatus of claim 118, wherein said interfaces are configured to provide constrained degrees of cooperative contact.

122. The apparatus of claim 118, wherein said interfaces are arcuate.

123. The apparatus of claim 122, wherein said arcuate surfaces are generally cylindrical.

124. The apparatus of claim 122, wherein said arcuate surfaces are generally spherical.

125. The apparatus of claim 118, wherein said interfaces are generally flat.

126. The apparatus of claim 125, 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.

127. The apparatus of claim 117, wherein said tissue surfaces are superior and inferior surfaces of a damaged or diseased vertebral body in a spine, and wherein said elements are configured for consecutive receipt into said vertebral body to form said structure between said superior and inferior surfaces of said vertebral body.

128. The apparatus of claim 117, wherein said tissue surfaces are superior and inferior endplate surfaces of opposing vertebral bodies in a spine, and wherein said elements are configured for consecutive receipt between said vertebral bodies to form said structure between said superior and inferior endplate surfaces of said opposing vertebral bodies.

129. The apparatus of claim 117, wherein said tissue surfaces are surfaces of a damaged or fractured tibia, and wherein said elements are configured for consecutive receipt between said surfaces to form said column between such surfaces.

130. An apparatus for the distraction and support of tissue surfaces in a given direction, comprising a plurality of stackable wafers cooperatively forming a column generally in the given direction between said tissue surfaces, 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 given direction.

131. The apparatus according to claim 130, wherein a stackable wafer comprises a single wafer.

132. The apparatus according to claim 130, wherein a stackable wafer comprises multiple wafers.

133. The apparatus of claim 130, wherein one or more wafers are curved in a plane generally normal to the direction of the axis of the column.

134. The apparatus of claim 130, wherein one or more wafers are of non-uniform thickness.

135. The apparatus of claim 130, 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.

136. The apparatus of claim 130, wherein the wafer contact surfaces are provided with complementary configurations to restrain the wafers from slipping out of the column.

137. The apparatus of claim 136, wherein the complementary configurations are complementary ridges and grooves.

138. The apparatus of claim 137, wherein the complementary ridges and grooves have dovetail ridge and groove configurations.

139. The apparatus of claim 136, 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.

140. The apparatus of claim 136, wherein the complementary configurations comprise detent configurations so configured as to restrain any lateral movement between adjacent wafers in a column.

141. The apparatus of claim 136, wherein the complementary configurations comprise a cylindrical indent.

142. The apparatus of claim 136, wherein the complementary configurations comprise a spherical indent.

143. The apparatus of claim 136, 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.

144. The apparatus of claim 130, wherein the wafers comprise a dovetail and a cylindrical indent to constrain all degrees of freedom.

145. The apparatus of claim 130, 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.

146. The apparatus of claim 130, wherein the wafers have spherical interfaces.

147. The apparatus of claim 130, further including a pin for locking the wafers in place.

148. The apparatus of claim 130, 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.

149. The apparatus of claim 148, wherein the lip extends along all edges of the bottom surface except for the trailing edge.

150. The apparatus of claim 148, wherein the lip extends along the leading edge of the bottom surface.

151. The apparatus of claim 148, wherein the lip extends along the lateral edges of the bottom surface.

152. The apparatus of claim 130, wherein the wafers are marked with a radio-opaque material for observation under fluoroscopy.

153. The apparatus of claim 130 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.

154. The apparatus of claim 130 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.

155. The apparatus of claim 154 wherein said wafer defining said bottom wafer in said column has a length larger than at least one other wafer in said column.

156. The apparatus of claim 130 wherein said wafers comprise implant materials.

157. The apparatus of claim 156, wherein one or more wafers have at least one orifice for receiving a filler material therein.

158. The apparatus of claim 157, wherein said wafers further comprise osteoinductive agents.

159. The apparatus of claim 158, wherein said wafers further comprise a drug therapy.

160. The apparatus of claim 130 further including an outer member covering at least a portion of such wafer column.

161. The apparatus of claim 160, wherein said outer member is permeable.

162. The apparatus of claim 161, wherein said permeable outer member comprises a material of macro-porosity.

163. A kit for use in the distraction of tissue surfaces in a given direction, comprising;

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

an inserter for consecutively inserting a plurality of elements between said tissue surfaces in a manner such that such elements are placed in contact with each other in a direction generally extending in the given direction.

164. The kit of claim 163 further including bone filler.

165. A method of treating a damaged or diseased bone having cancellous bone therein having a reduced volume as a result of damage or disease, comprising the steps of:

accessing the cancellous bone within said damaged or diseased bone;

introducing into said cancellous bone an expandable support configured to be expanded within said cancellous bone;

expanding said expandable support unidirectionally within said cancellous bone to restore volume of said damaged or diseased bone;

filling at least a portion of said cancellous bone adjacent said expandable support with a flowable material capable of setting to a harden condition; and

permanently retaining said expandable support within said restored volume bone in said expandable condition.

166. The method of claim 165 wherein said expandable support comprises a plurality of elements configured to cooperatively contact each other and wherein said expandable support is expanded by consecutively introducing said elements into contact with each other within said damaged or diseased bone.

167. The method of claim 166 wherein said elements are wafers, said wafers being introduced by stacking one wafer atop another wafer.

168. The method of claim 166 wherein said elements are introduced by sliding one element along a surface of another element.

169. The method of claim 166 wherein said damaged or diseased bone is a vertebral body in a spine, said vertebral body having superior and inferior endplates spaced apart at a height less than the natural height as a result of said damage or disease, said elements being consecutively inserted into said vertebral body to distract said superior and inferior endplates until the normal height of said vertebral body is substantially attained.

170. The method of claim 169 wherein said flowable material is injected into said cancellous bone of said vertebral body adjacent said plurality of elements and allowed to harden therein to further stabilize said distracted superior and inferior endplates.

171. The method of claim 170 wherein said plurality of elements define a substantially solid structure and said flowable material interdigitates with cancellous bone adjacent such solid structure and at least partially therearound.

172. The method of claim 170 wherein said plurality of elements define a permeable structure with one or more openings communicating with said cancellous bone and wherein said flowable material interdigitates with said cancellous bone and resides in said openings of said permeable structure.

173. The method of claim 165 wherein said flowable material is injected into said cancellous bone in a step separate from the step of expanding said expendable member.

174. A method of treating a damaged or diseased bone having reduced spacing between opposing tissue surfaces as a result of damage or tissue, comprising the steps of:

accessing the interior of said bone;

introducing into the interior of said bone an expandable support member configured to be expanded within the interior of said bone;

expanding said expandable support unidirectionally within said bone to substantially restore the spacing between opposing tissue surfaces of said bone; and

permanently retaining said expandable support in said restored spacing within said bone in said expanded condition.

175. The method claim 174 wherein said expandable support member comprises a plurality of elements configured to be consecutively introduced into cooperative contact with each other increasing the dimension of said spacing in one direction.

176. The method of claim 175 wherein said elements are wafers adapted to be stacked one wafer atop another wafer to define a stack of wafers in said one direction.

177. The method of claim 174 wherein said damaged or diseased bone is a vertebral body in a spine, said vertebral body having superior and inferior endplates spaced apart at a height less than the natural height as a result of said damage or disease, said expandable support being expanded to distract said superior and inferior endplates until the normal height of said vertebral body is substantially attained.

178. The method of claim 174 wherein said damaged or diseased bone is a tibia and wherein said expandable support is inserted under the articular surface of the tibial condyle to reduce tibial plateau compression fractures.