Percutaneous prosthetic spinal disc nucleus and method of manufacture

• US 6,022,376 A
• Filed: 03/16/1998
• Issued: 02/08/2000
• Est. Priority Date: 06/06/1997
• Status: Expired due to Fees

• Current Assignee: Raymedica, Inc.
• Original Assignee: Raymedica, Inc.
• Inventors: Assell, Robert L., Ray, Charles D.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/039,582
• Time in Patent Office: 694 Days
• Field of Search: 623/8, 623/17, 606/61, 606/71
• US Class Current: 623/17.16
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30293 Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/448 comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres
• 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 2230/0023 triangular
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A capsule-shaped prosthetic spinal disc nucleus for implantation into a human intradiscal space, made of a substantially inelastic constraining jacket surrounding an amorphous polymer core. The constraining jacket has a generally fixed maximum volume and defines a height. The amorphous polymer core fills an initial volume of the constraining jacket and develops an internal pressure. In response to the internal pressure, the constraining jacket transitions toward the maximum volume, increasing substantially in height.

Claims

1. A prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc, the nucleus cavity defined by an opposing pair of vertebral bodies, forming opposing end plates, and an anulus, the prosthetic spinal disc nucleus comprising:

a substantially inelastic constraining jacket having a generally fixed maximum volume determined by a generally fixed circumference and length, the maximum volume being less than a volume of the nucleus cavity, wherein the constraining jacket defines a height corresponding to a plane substantially perpendicular to the opposing end plates, and further wherein, upon implantation, the constraining jacket is configured such that the opposing end plates force the constraining jacket to an initial implant volume in which the constraining jacket is oval in cross-section; and

an amorphous polymer core inserted into the constraining jacket, the polymer core configured to be flowable in at least a first state such that upon insertion, the amorphous polymer core fills the initial implant volume of the constraining jacket and creates an internal pressure within the constraining jacket, the constraining jacket being configured to transition from the initial implant volume toward the maximum volume, increasing substantially in height in response to the internal pressure.

2. The prosthetic spinal disc nucleus of claim 1, wherein the amorphous polymer core is configured to conform to a contour of the disc space.

3. The prosthetic spinal disc nucleus of claim 1, wherein the amorphous polymer core is a non-hydrophilic polymer, and wherein the internal pressure is a filling pressure of the amorphous polymer core upon insertion into the constraining jacket.

4. The prosthetic spinal disc nucleus of claim 1, wherein the amorphous polymer core is a hydrogel configured to expand from an unhydrated state to a hydrated state.

5. The prosthetic spinal disc nucleus of claim 4, wherein the maximum volume of the constraining jacket is greater than a volume of the amorphous polymer core in the unhydrated state, but less than a volume of the amorphous polymer core in the hydrated state, and wherein the internal pressure is a swelling pressure of the amorphous polymer core transitioning from the unhydrated state to the hydrated state.

6. The prosthetic spinal disc nucleus of claim 4, wherein the hydrogel is a hydrogel powder.

7. The prosthetic spinal disc nucleus of claim 6, wherein the hydrogel powder consists of a plurality of irregularly shaped granules.

8. The prosthetic spinal disc nucleus of claim 7, wherein each of the plurality of irregularly shaped granules is flattened, having a height less than a width or a length.

9. The prosthetic spinal disc nucleus of claim 7, wherein the plurality of irregularly shaped granules is coated with a low friction material.

10. The prosthetic spinal disc nucleus of claim 6 wherein the hydrogel powder includes a plurality of non-spherical granules.

11. The prosthetic spinal disc nucleus of claim 6, wherein the hydrogel powder is suspended in a viscous liquid.

12. The prosthetic spinal disc nucleus of claim 4, wherein the hydrogel is a fluid hydrogel.

13. The prosthetic spinal disc nucleus of claim 12, wherein the fluid hydrogel is configured to congeal upon contact with water.

14. The prosthetic spinal disc nucleus of claim 13, wherein the fluid hydrogel is non-thixotropic.

15. The prosthetic spinal disc nucleus of claim 1, wherein the amorphous polymer core comprises a plurality of hydrogel microchips.

16. The prosthetic spinal disc nucleus of claim 15, wherein at least a portion of an outer surface of each of the plurality of hydrogel microchips is flattened.

17. A method of manufacturing a prosthetic spinal disc nucleus implanted into a nucleus cavity of a spinal disc, the method comprising:

providing a substantially inelastic constraining jacket having a generally fixed maximum volume determined by a generally fixed circumference and length, the maximum volume being less than a volume of the nucleus cavity, and wherein the constraining jacket defines a height corresponding to a transverse plane of the nucleus cavity, and further wherein the constraining jacket is configured such that upon implantation, the constraining jacket is forceable to an initial implant volume in which the constraining jacket is oval in cross-section;

providing an amorphous polymer core that is flowable in at least a first state;

inserting the amorphous polymer core in the first state into the constraining jacket such that the amorphous polymer core fills the initial implant volume of the constraining jacket; and

generating an internal pressure within the constraining jacket, wherein the constraining jacket transitions from the initial implant volume toward the maximum volume, increasing substantially in height in response to the internal pressure.

18. The method of claim 17, wherein providing an amorphous polymer core includes forming a hydrogel configured to expand from an unhydrated state to a hydrated state.

19. The method of claim 18, wherein the amorphous polymer core is inserted into the constraining jacket in the unhydrated state, and wherein generating an internal pressure includes hydrating the amorphous polymer core to the hydrated state.

20. The method of claim 17, wherein the amorphous polymer core is a non-hydrophilic polymer and wherein generating an internal pressure includes injecting a volume of the non-hydrophilic polymer into the constraining jacket greater than the initial implant volume of the constraining jacket to develop a filling pressure.

21. The method of claim 17, wherein providing an amorphous polymer core includes providing a hydrogel powder.

22. The method of claim 21, wherein providing an amorphous polymer core further includes:

coating individual grains of the hydrogel powder with a low friction material.

23. The method of claim 17, wherein providing an amorphous polymer core includes suspending a hydrogel powder in a viscous liquid.

24. The method of claim 17, wherein providing an amorphous polymer core includes providing a fluid hydrogel.

25. The method of claim 24, wherein providing a fluid hydrogel includes dissolving a hydrogel powder in a solvent such that the fluid hydrogel will congeal upon hydration.

26. The method of claim 17, wherein providing an amorphous polymer core includes forming a plurality of hydrogel microchips.