Method and Apparatus for the Treatment of the Intervertebral Disc Annulus
The present invention provides methods and devices for treating the annulus of an intervertebral disc. The methods and devices can employ an expandable treatment device which is deployed at least partially in the subannular space. Fixation devices and methods are also disclosed, which help to secure the treatment device in place.
1 - 189 . (canceled)
190 . A method of treating an intervertebral disc comprising:
providing a first delivery tool having a proximal portion and a distal portion, the distal portion carrying a treatment device, said treatment device being configured to be attached by compression to the distal portion of the delivery tool during delivery or deployment of the treatment device to the intervertebral disc;
providing at least one second delivery tool having a proximal portion and a distal portion, the distal portion carrying at least one affixation device configured to affix said treatment device to the intervertebral disc tissue;
introducing the distal portion of the first delivery tool at least partially into the intervertebral disc;
introducing the distal portion of said at least one second delivery tool at least partially into intervertebral disc;
deploying at least one affixation device into, or through, a portion of the annulus and portion of the treatment device so as to, at least partially, secure said treatment device to the intervertebral disc;
removing said at least one second delivery tool;
actuating the first delivery tool, said actuating step causing the compressible attachment of the treatment device to the delivery tool to be relieved so as to release said treatment device from the delivery tool; and
removing said first delivery tool.
191 . A method of claim 190 , wherein said affixation device is comprised of one or more bands, filaments, lines, wires, tethers or sutures.
192 . A method of claim 190 , wherein said treatment device comprises material to facilitate regeneration of tissue.
193 . A method of claim 190 , wherein said affixation device comprises material to facilitate regeneration of tissue.
194 . A method of claim 190 , wherein said treatment device comprises a mesh, patch, scaffold, stent, barrier or membrane.
195 . A method of claim 190 , wherein said at least one affixation device comprises at least one anchor portion and at least one band portion.
196 . A method of claim 190 , wherein said at least one affixation device comprises two anchor portions.
197 . A method of claim 196 , wherein one anchor portion is disposed, in use, at the outer surface of the annulus, and the second anchor portion is disposed, in use, within the intervertebral disc.
198 . A method of claim 196 , wherein said anchor portion disposed within the intervertebral disc comprises a t-anchor configuration.
199 . A method of claim 196 , wherein said anchor portion disposed at the outer surface of the annulus comprises a pledget configuration.
200 . A method of claim 196 , wherein said at least one affixation device comprises an assembly connecting said two anchor portions, said assembly being capable of being shortened.
201 . A method of claim 195 , wherein said anchor portion comprises at least one T-anchor.
202 . A method of claim 195 , wherein said anchor portion comprises at least one barb.
203 . A method of claim 195 , wherein said anchor portion comprises at least one element configured as a pledget.
204 . A method of claim 200 , wherein a portion of said connecting assembly is contiguous with said anchor portions and is of a smaller girth than a portion of the connecting assembly disposed between said anchor portions.
205 . A method of claim 195 , wherein said band portion material is comprised of mesh tube.
206 . A method of claim 200 , wherein said affixation device is capable of being secured with a retainer, clip, locking element or knot after the process of being shortened.
207 . A method of claim 190 , wherein said treatment device comprises braided mesh.
208 . A method of claim 190 , wherein said treatment device obtains a deployed configuration by actuating said first delivery tool so as to shorten the treatment device dimension along the axis of the delivery tool.
209 . A method of claim 190 , wherein said treatment device obtains a deployed configuration by actuating said first delivery tool so as to laterally expand the treatment device dimension away from the axis of the delivery tool.
210 . A method of claim 190 , wherein multiple treatment devices and multiple affixation devices are used to treat an intervertebral disc.
211 . A method of claim 209 , wherein said treatment device comprises portions or elements of the device that facilitate non-uniform expansion of the treatment device away from the axis of the delivery tool.
212 . A method of claim 207 , wherein said treatment device comprises multiple braided meshes configured in series or in parallel.
213 . A method of claim 190 , wherein said treatment device comprises a retention element so as to secure the treatment device in a deployed configuration.
214 . A method of claim 190 , wherein said treatment device has a first configuration during delivery or placement of the device in the intervertebral disc and a second, deployed configuration.