Percutaneous Implantable Nuclear Prosthesis

• US 20100256766A1
• Filed: 04/02/2010
• Published: 10/07/2010
• Est. Priority Date: 04/07/2009
• Status: Active Grant

• Current Assignee: Spinal Stabilization Technologies LLC
• Original Assignee: Spinal Stabilization Technologies LLC
• Inventors: Hibri, Nadi S., Lutz, James D.
• Granted Patent: US 8,636,803 B2
• Time in Patent Office: Days
• US Class Current: 623/17.160
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30006 differing in density or specific weight
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30074 stretchable
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30584 filled with gas
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations

Abstract

An inter-vertebral disc prosthesis intended for percutaneous deployment comprises an expandable annular enclosure and an expandable nuclear enclosure. The expandable annular enclosure incorporates a reinforcing annular band along its periphery and is filled with in-situ curable rubber. The expandable nuclear enclosure is filled with a gas. The nuclear prosthesis further incorporates a novel, integrally molded sealing valve assembly and is stretchable and collapsible into a minimal profile for ease of insertion into a specially designed delivery cannula, and is inflation-assisted expandable into an inter-vertebral disc in which complete percutaneous nuclectomy has been performed.

Claims

1. A nuclear prosthesis for percutaneous implantation into a percutaneously de-nucleated inter-vertebral disc space of a human, said nuclear prosthesis comprising:

an annular enclosing layer substantially discoid in shape and defining an annular enclosure;

an annular reinforcement band adjacent an outer margin of said annular enclosing layer and defining an outer layer of said nuclear prosthesis;

a nuclear enclosing layer adjacent an inner margin of said annular enclosing layer, said nuclear enclosing layer enclosing and defining a nuclear enclosure;

a sealing valve assembly comprising a sealing valve core disposed within said annular enclosure and bonded to said annular enclosing layer, an indwelling catheter partially enclosed within said nuclear enclosure and extending outward through said nuclear enclosing layer, said inner margin of said annular enclosing layer and into said sealing valve core such that the remaining portion of said indwelling catheter is enclosed within said sealing valve core, and a sealing plug insertable within said indwelling catheter; and

wherein said sealing valve assembly conducts compressible fluid into said nuclear enclosure and deformable fluid into said annular enclosure.

2. The nuclear prosthesis as recited in claim 1 wherein said sealing valve assembly further comprises:

an inlet port disposed within said sealing valve core and lateral to said indwelling catheter, said inlet port opening into said annular enclosure for said conduction of said fluid into said annular enclosure; and

wherein said indwelling catheter has a pore for conduction of said fluid into said nuclear enclosure.

3. The nuclear prosthesis as recited in claim 2 wherein said sealing valve core further comprises an outlet port substantially opposite said inlet port and lateral to said indwelling catheter, said outlet port having an opening into said annular enclosure for receiving a return of said fluid that is conducted into said annular enclosure.

4. The nuclear prosthesis as recited in claim 2 wherein said indwelling catheter further comprises a connection terminal for detachably receiving a central tube of an inflation stylus to conduct said fluid into said nuclear enclosure.

5. The nuclear prosthesis as recited in claim 3 wherein said indwelling catheter further comprises a connection terminal for detachably receiving a central tube of an inflation stylus to conduct said fluid into said nuclear enclosure.

6. The nuclear prosthesis as recited in claim 3 further comprising:

a nuclear mounting region having a predefined nuclear slot along a side of said sealing valve core adjacent said inner margin of said annular enclosing layer, said nuclear slot receiving said indwelling catheter and a connector terminal of said nuclear enclosing layer;

wherein said connector terminal comprises a neck portion of said nuclear enclosing layer and a retaining collar encompassing said neck portion of said nuclear enclosing layer, said connector terminal receiving and bonding to said indwelling catheter snugly to create a fluid-tight bond.

7. The nuclear prosthesis as recited in claim 4 further comprising:

a nuclear mounting region having a predefined nuclear slot along a side of said sealing valve core adjacent said inner margin of said annular enclosing layer, said nuclear slot receiving said indwelling catheter and a connector terminal of said nuclear enclosing layer;

wherein said connector terminal comprises a neck portion of said nuclear enclosing layer and a retaining collar encompassing said neck portion of said nuclear enclosing layer, said connector terminal receiving and bonding to said indwelling catheter snugly to create a fluid-tight bond.

8. The nuclear prosthesis as recited in claim 5 further comprising:

a nuclear mounting region having a predefined nuclear slot along a side of said sealing valve core adjacent said inner margin of said annular enclosing layer, said nuclear slot receiving said indwelling catheter and a connector terminal of said nuclear enclosing layer;

wherein said connector terminal comprises a neck portion of said nuclear enclosing layer and a retaining collar encompassing said neck portion of said nuclear enclosing layer, said connector terminal receiving and bonding to said indwelling catheter snugly to create a fluid-tight bond.

9. The nuclear prosthesis as recited in claim 8 wherein said inlet port, said outlet port and said indwelling catheter have corresponding pathways terminating with bores for receiving and creating detachable, but fluid tight connections with corresponding tubes of said inflation stylus.

10. The nuclear prosthesis as recited in claim 9 wherein said sealing valve core has:

an outer diameter slightly smaller than the diameter of the annular enclosing layer;

an annular mounting region comprising an annular slot adjacent said outer margin of said annular enclosing layer for receiving a portion of said outer margin, said annular slot extending around a radial circumference of said sealing valve core; and

wherein said nuclear mounting region of said sealing valve core further comprising said annular slot for receiving said a portion of said inner margin of said annular enclosing layer.

11. The nuclear prosthesis as recited in claim 10 wherein said sealing valve core is bonded to said annular enclosing layer by a retaining ring surrounding said sealing valve core, said retaining ring receiving and crimping to said annular slot in said nuclear mounting region and said annular mounting region.

12. The nuclear prosthesis as recited in claim 3 wherein said annular reinforcement band comprises a plurality of at least partially interwoven layers of biocompatible fibers, thereby comprising a three dimensional structure of said annular reinforcement band.

13. The nuclear prosthesis as recited in claim 12 wherein said annular reinforcement band further comprises:

a warp knitted outer layer for enhancing in-growth of soft tissue to said nuclear prosthesis;

at least one intermediate layer formed of a plurality of substantially helical loops of said biocompatible fibers;

an inner layer formed of thin biocompatible fibers; and

wherein said outer layer and said at least one intermediate layer are adjacent and partially interwoven, and said at least one intermediate layer and said inner layer are adjacent and partially interwoven.

14. The nuclear prosthesis as recited in claim 5 wherein said annular reinforcement band comprises a plurality of at least partially interwoven layers of biocompatible fibers, providing a three dimensional structure of said annular reinforcement band.

15. The nuclear prosthesis as recited in claim 14 wherein said annular reinforcement band further comprises:

a warp knitted outer layer for enhancing in-growth of soft tissue to said nuclear prosthesis;

at least one intermediate layer formed of a plurality of substantially helical loops of said biocompatible fibers;

an inner layer formed of thin biocompatible fibers; and

wherein said outer layer and said at least one intermediate layer are adjacent and partially interwoven, and said at least one intermediate layer and said inner layer are adjacent and partially interwoven.

16. The nuclear prosthesis as recited in claim 8 wherein said annular reinforcement band comprises a plurality of at least partially interwoven layers of biocompatible fibers, providing a three dimensional structure of said annular reinforcement band.

17. The nuclear prosthesis as recited in claim 16 wherein said annular reinforcement band further comprises:

a warp knitted outer layer for enhancing in-growth of soft tissue to said nuclear prosthesis;

at least one intermediate layer formed of a plurality of substantially helical loops of said biocompatible fibers;

an inner layer formed of thin biocompatible fibers; and

wherein said outer layer and said at least one intermediate layer are adjacent and partially interwoven, and said at least one intermediate layer and said inner layer are adjacent and partially interwoven.

18. The nuclear prosthesis as recited in claim 11 wherein said annular reinforcement band comprises a plurality of at least partially interwoven layers of biocompatible fibers, providing a three dimensional structure of said annular reinforcement band.

19. The nuclear prosthesis as recited in claim 18 wherein said annular reinforcement band further comprises:

a warp knitted outer layer for enhancing in-growth of soft tissue to said nuclear prosthesis;

at least one intermediate layer formed of a plurality of substantially helical loops of said biocompatible fibers;

an inner layer formed of thin biocompatible fibers; and

wherein said outer layer and said at least one intermediate layer are adjacent and partially interwoven, and said at least one intermediate layer and said inner layer are adjacent and partially interwoven.

20. The nuclear prosthesis as recited in claim 1 wherein said fluid conducted into said nuclear enclosure is a liquid and said fluid conducted into said annular enclosure is a curable rubber.

21. The nuclear prosthesis as recited in claim 1 wherein said fluid conducted into said nuclear enclosure is a gas and said fluid conducted into said annular enclosure is a curable rubber.

22. The nuclear prosthesis as recited in claim 20 wherein said liquid is removed from said nuclear enclosure, and a gas is conducted into said nuclear enclosure.

23. A nuclear prosthesis for implantation into a percutaneously de-nucleated inter-vertebral disc space of a human, said nuclear prosthesis comprising:

a delivery apparatus comprising a delivery cannula and a release cannula, said delivery apparatus being insertable within a percutaneous access apparatus;

a loading apparatus for loading said nuclear prosthesis within said delivery cannula prior to insertion of said delivery cannula into said human;

an inflation stylus for inflating said nuclear prosthesis after delivery into said percutaneously de-nucleated inter-vertebral disc space, said inflation stylus being disposed within said delivery cannula and detachably connected to said nuclear prosthesis;

said nuclear prosthesis comprising an annular enclosing layer substantially discoid in shape and defining an annular enclosure, an annular reinforcement band adjacent an outer margin of said annular enclosing layer and defining an outer layer of said nuclear prosthesis, and a nuclear enclosing layer adjacent an inner margin of said annular enclosing layer, said nuclear enclosing layer enclosing and defining a nuclear enclosure; and

a sealing valve assembly comprising a sealing valve core disposed within said annular enclosure and bonded to said annular enclosing layer, an indwelling catheter partially enclosed within said nuclear enclosure and extending outward through said nuclear enclosing layer and said inner margin of said annular enclosing layer and into said sealing valve core such that the remaining portion of said indwelling catheter is enclosed within said sealing valve core, and a sealing plug insertable within said indwelling catheter.

24. The nuclear prosthesis as recited in claim 23 wherein:

said inflation stylus comprises an annular inlet tube defining a lumen therein, an annular outlet tube defining a lumen therein, and a nuclear access tube defining a lumen therein, each said tube comprising a pore along its distal portion, said annular inlet tube and said annular outlet tube being disposed lateral to said nuclear access tube and substantially opposite one another with respect to said nuclear access tube; and

said indwelling catheter corresponds to said nuclear access tube of said inflation stylus and has a pore for introduction of a fluid into said nuclear enclosure; and

said sealing valve core further comprises;

an outlet port disposed lateral to said indwelling catheter and receiving said annular outlet tube of said inflation stylus; and

an inlet port disposed lateral to said indwelling catheter substantially opposite said outlet port and receiving said annular inlet tube.

25. The nuclear prosthesis as recited in claim 24 further comprising a pathway for receiving said nuclear access tube, said pathway extending from said indwelling catheter through said annular enclosing layer, a retaining ring adjacent said annular enclosing layer, and said annular reinforcement band;

and

wherein said outlet port and said inlet port further comprise pathways extending through said annular enclosing layer, said retaining ring and said annular reinforcement band.

26. The nuclear prosthesis as recited in claim 25 further comprising:

said pore of said annular inlet tube is disposed along a side of said annular inlet tube and aligns with a channel of said inlet port, said channel extending into said annular enclosure;

said pore of said annular outlet tube is disposed along a side of said annular outlet tube and aligns with a channel of said outlet port, said channel extending into said annular enclosure; and

said pore of said nuclear access tube is disposed at the distal end of said nuclear access tube.

27. The nuclear prosthesis as recited in claim 26 wherein said indwelling catheter comprises a connection terminal at its proximal end, and said nuclear access tube comprises a corresponding connection bulb for insertion into said connection terminal, thereby creating a detachable, but fluid tight connection there between.

28. The nuclear prosthesis as recited in claim 27 wherein said nuclear prosthesis is inflated by:

introduction of a fluid through said pore of nuclear access tube and the pore of the indwelling catheter into said nuclear enclosure;

introduction of a fluid through said pore of said annular inlet tube and said inlet port into said annular enclosure; and

wherein said pore of said annular outlet tube receives a return of said fluid conducted into said annular enclosure through said outlet port.

29. The nuclear prosthesis as recited in claim 28 wherein said delivery apparatus is insertable within said percutaneous access device, and slideably extendable and retractable within said percutaneous access device.

30. The nuclear prosthesis as recited in claim 29 wherein said release cannula of said delivery apparatus is disposed within said delivery cannula of said delivery apparatus and telescopically slideable over said inflation stylus to detach said inflation stylus from said nuclear prosthesis after delivery and inflation thereof.

31. The nuclear prosthesis as recited in claim 30 wherein said release cannula engages said sealing valve core to push said inflation stylus away from said nuclear prosthesis.

32. The nuclear prosthesis as recited in claim 31 wherein said release cannula further comprises a screw drive mechanism threadedly engaged to a proximal end of said inflation stylus and said release cannula, said screw drive mechanism extending said release cannula against said sealing valve core and retracting said inflation stylus.

33. The nuclear prosthesis as recited in claim 32 wherein said loading apparatus further comprises:

a first loading block defining a substantially funnel shaped cavity terminating in a loading port for slideably receiving said delivery apparatus;

a second loading block defining a substantially funnel shaped cavity terminating in a traction port for slideably receiving a traction band, said second loading block being a substantial mirror image of said first loading block, and disposed adjacent thereto such that said loading port of said first loading block and said traction port of said second loading block are opposite one another.

34. The nuclear prosthesis as recited in claim 33 wherein said traction band is detachably wrapped around a portion of said annular band to pull said nuclear prosthesis radially opposite said delivery apparatus to fold said nuclear prosthesis during deflation thereof.

35. The nuclear prosthesis as recited in claim 34 wherein said first loading block and said second loading block are coated with a lubricous hydrophilic substance along inner walls of said funnel shaped cavities.

36. The nuclear prosthesis as recited in claim 35 wherein said sealing valve core further comprises:

a nuclear mounting region having a predefined annular slot and a predefined nuclear slot along a side of said sealing valve core adjacent said inner margin of said annular enclosing layer, said nuclear slot receiving said indwelling catheter and a connector terminal of said nuclear enclosing layer;

wherein said connector terminal comprises a neck portion of said nuclear enclosing layer and a retaining collar encompassing said neck portion of said nuclear enclosing layer, said connector terminal receiving and bonding to said indwelling catheter snugly to create a fluid-tight bond.

37. The nuclear prosthesis as recited in claim 36 wherein:

said annular slot extends around a radial circumference of said sealing valve core, and further defines an annular mounting region along a side of said sealing valve core adjacent said outer margin of said annular enclosing layer; and

said sealing valve core has an outer diameter slightly smaller than the diameter of the annular enclosing layer, and receives a portion of said inner margin of said annular enclosing layer along said nuclear mounting region and a portion of said outer margin of said annular enclosing layer along said annular mounting region, forming a fluid-tight bond between said annular enclosing layer and said sealing valve core.

38. The nuclear prosthesis as recited in claim 37 wherein said sealing valve core is bonded to said annular enclosing layer by a retaining ring surrounding said sealing valve core, said retaining ring receiving and crimping to said annular slot in said nuclear mounting region and said annular mounting region.

39. The nuclear prosthesis as recited in claim 38 wherein said fluid conducted into said nuclear enclosure is a liquid and said fluid conducted into said annular enclosure is a curable rubber.

40. The nuclear prosthesis as recited in claim 38 wherein said fluid conducted into said nuclear enclosure is a gas and said fluid conducted into said annular enclosure is a curable rubber.

41. The nuclear prosthesis as recited in claim 38 wherein said liquid is removed from said nuclear enclosure, and a gas is conducted into said nuclear enclosure.