BALLOON-ASSISTED ANNULUS REPAIR
The present invention is directed to an inflatable annulus repair device ( 10 ) for sealing an annulus defect located in an annulus fibrosis of an intervertebral disc space. In use, the inflatable device is introduced, in a first non-expanded state, preferably via a cannula ( 100 ) into the annulus defect. After the inflatable device has been properly positioned, a filler material ( 11 ) is injected into the inflatable device to expand the device to a second expanded state. In the second expanded state, the inflatable annulus repair device seals the annulus defect, secures its position within the annulus defect to thereby limit or prevent migration, and applies a compression force to a captured portion of the annulus adjacent to the defect. The inflatable device is preferably filled with a liquid that solidifies into an elastic material within the device.
1 . An inflatable annulus repair device for repairing an annulus defect located in an annulus fibrosis surrounding an intervertebral disc space, the annulus defect having side surfaces extending between interior and exterior annular walls, the device comprising:
a central body portion having an external surface and a first diameter in an expanded state;
an intradiscal region having a first disc wall surface and a second diameter in the expanded state; and
an extradiscal region having a second disc wall surface and a third diameter in the expanded state, the central body portion, intradiscal region and extradiscal region insertable into the defect in a first non-expanded state, the external surface being in contact with the side surfaces, the first disc wall in contact with the interior annular wall and the second disc wall in contact with the exterior annular wall in an implanted position in the expanded state, the second and third diameters being larger than the first diameter in the expanded state, the first and second disc walls applying a compression force to a captured portion of the annulus adjacent the defect in the implanted position.
2 . The inflatable annulus repair device of claim 1 , wherein the central body, the intradiscal region and the extradiscal region are integrally formed as a balloon.
3 . The inflatable annulus repair device of claim 1 , wherein the intradiscal region includes one or more laterally expandable elements immediately adjacent to the central body, the expandable elements contacting the interior annular wall in the expanded state.
4 . The inflatable annulus repair device of claim 3 , wherein the extradiscal region includes one or more laterally expandable elements immediately adjacent to the central body, the expandable elements contacting the exterior annular wall in the expanded state.
5 . The inflatable annulus repair device of claim 1 , wherein the inflatable annulus repair device is filled with a fluid in the implanted position in the expanded state, the fluid solidifies into an elastic solid at body temperature.
6 . The inflatable annulus repair device of claim 5 , wherein the fluid is a thermogelling or phase transforming polymer.
7 . The inflatable annulus repair device of claim 1 , further comprising one or more retaining members formed on the external surface of the central body to enhance fixation of the implant to the side surfaces.
8 . The inflatable annulus repair device of claim 7 , wherein the one or more retaining members is selected from one of a projection or a ridge.
9 . The inflatable annulus repair device of claim 1 , further comprising a plurality of pores or holes so that, upon injection, a filler material seeps out of the device.
10 . The inflatable annulus repair device of claim 1 , further comprising one or more deployable secondary fixation members.
11 . The inflatable annulus repair device of claim 10 , wherein the one or more deployable secondary fixation members is located adjacent to the intradiscal region to contact the interior annular wall in the expanded state.
12 . The inflatable annulus repair device of claim 10 , wherein the one or more deployable secondary fixation members is located adjacent to the extradiscal region to contact the exterior annular wall in the expanded state.
13 . The inflatable annulus repair device of claim 10 , wherein the one or more deployable secondary fixation members is in the form of one or more arms.
14 . The inflatable annulus repair device of claim 1 , wherein the intradiscal region of the inflatable annulus repair device is manufactured from a highly compliant material and the extradiscal region of the inflatable annulus repair device is manufactured from a low compliant material.
15 . The inflatable annulus repair device of claim 1 , wherein the intradiscal region of the inflatable annulus repair device is manufactured from a low compliant material and the extradiscal region of the inflatable annulus repair device is manufactured from a high compliant material.
16 . The inflatable annulus repair device of claim 1 , further comprising an inflatable projection formed on the intradiscal region to fill at least a portion of an intradiscal cavity.
17 . The inflatable annulus repair device of claim 1 , further comprising one or more sutures extending from the intradiscal region to the extradiscal region.
18 . The inflatable annulus repair device of claim 17 , wherein the one or more sutures passes through the central body.
19 . The inflatable annulus repair device of claim 17 , wherein the one or more sutures passes through the annulus fibrosis.
20 . A method for repairing an annulus defect located in an annulus fibrosis surrounding an intervertebral disc space using an inflatable annulus repair device having a central body having an external surface and a first diameter in an expanded state, an intradiscal region having a first disc wall surface and a second diameter in the expanded state, and an extradiscal region having a second disc wall surface and a third diameter in the expanded state, the annulus defect having side surfaces extending between interior and exterior annular walls, the method including the steps of:
a) forming an incision;
b) inserting a cannula into the incision so that a distal end of the cannula is positioned adjacent to the annulus defect;
c) inserting the inflatable annulus repair device in a first non-expanded state through the cannula and at least partially into the annulus defect so that the intradiscal region extends through the annulus defect and into the intervertebral disc space; and
d) injecting a filler material into the inflatable annulus repair device so that the external surface contacts the side surfaces, the first disc wall contacts the interior annular wall and the second disc wall contacts the exterior annular wall to seal the annulus defect and to apply a compression force to a captured portion of the annulus adjacent the defect in an implanted position.
21 . The method of claim 20 , further including the step of expanding the second diameter of the intradiscal region to a larger diameter than the first diameter of the central body.
22 . The method of claim 20 , further including the step of expanding the third diameter of the extradiscal region to a larger diameter than the first diameter of the central body.
23 . The method of claim 20 , further comprising the step of performing a discectomy on the intervertebral disc space prior to step (c).
24 . The method of claim 20 , further comprising the step of:
e) inflating one or more deployable secondary fixation members.
25 . The method of claim 20 , further comprising the step of:
e) permitting the filler material to solidify from a liquid at room temperature to an elastic at body temperature.
26 . The method of claim 20 , wherein the filler material is a thermogelling or phase transforming polymer.
27 . The method of claim 20 , further comprising the step of:
e) cutting off any excess length of the inflatable annulus repair device that protrudes beyond the defect so that the inflatable annulus repair device is generally flush with or recessed relative to the exterior annular wall.