Hydrogel bead intervertebral disc nucleus

• US 5,192,326 A
• Filed: 09/09/1991
• Issued: 03/09/1993
• Est. Priority Date: 12/21/1990
• Status: Expired due to Term

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Pfizer Hospital Products Group, Inc. (Pfizer Inc.)
• Inventors: Bao, Qi-Bin, Higham, Paul A.
• Primary Examiner(s): Frinks, Ronald
• Application Number:
  US07/756,957
• Time in Patent Office: 547 Days
• Field of Search: 623/16, 623/17, 623/18, 623/11, 606/60, 606/61
• US Class Current: 623/17.12
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• 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 2002/30133 kidney-shaped or bean-shaped
• 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 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
• CPC Class Codes: C08L 33/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones

Abstract

A prosthetic nucleus for implantation in the disc space after removal of a damaged or degenerated nucleus is formed from a multiplicity of hydrogel beads having a water content of at least 30%. The beads are covered by a semi-permeable membrane. The membrane has porosity less than the size of the beads to thereby retain the beads therein but permit fluids to flow in and out of the prosthetic nucleus.

Claims

1. A prosthetic nucleus for implanting in the disc space after the removal of the degenerated or damaged nucleus of an intervertebral disc comprising:

A multiplicity of hydrogel beads having a water content of at least 30%; and

a flexible semi-permeable cover surrounding said hydrogel beads.

2. The prosthetic nucleus as set forth in claim 1 wherein said hydrated hydrogel beads each have a water content of between 75 and 99%.

3. The prosthetic nucleus as set forth in claim 1 wherein each hydrogel bead when dehydrated has a volume of 2-70% of a hydrated hydrogel bead.

4. The prosthetic nucleus as set forth in claim 1 wherein said hydrated hydrogel beads each have a particle size of at least three times larger than the porosity of the membrane.

5. The prosthetic nucleus as set forth in claim 1 wherein the hydrogel beads are made from crosslinked polysaccharide.

6. The prosthetic nucleus as set forth in claim 1 wherein the hydrogel beads are made from a 5-25% PVA powder mixed with a solvent selected from the group consisting of water, dimethyl sulfoxide, ethylene glycol and a combination thereof.

7. The prosthetic nucleus as set forth in claim 6 wherein the hydrogel beads are prepared by crystallizing a solution of polyvinyl alcohol at a temperature of -10°

C. or below.

8. The prosthetic nucleus as set forth in claim 1 wherein the hydrogel beads are prepared by the polymerization of monomers selected from the group consisting of:

N-vinyl monomer (e.g. N-vinyl-2-pyrrolidone), hydroxy alkyl methacrylate (e.g. 2-hydroxylethyl methacrylate), alkyl methacrylate (e.g. methyl methacrylate), ethylenical unsaturated and or its salt (e.g. methacrylic acid), ethylenically unsaturated base or its salt (e.g. N,N-diethyl-aminoethyl methacrylate and a combination thereof with a cross-linking monomer containing at least two ethylinic sites (e.g. ethylene glycol dimethacrylate).

9. The prosthetic nucleus as set forth in claim 1 wherein the hydrogel beads are made of polyacrylonitrile hydrogel.

10. The prosthetic nucleus as set forth in claim 1 wherein the hydrogel beads are superabsorbents such as sodium carboxymethyl cellulose and poly(acrylic acid) salts.

11. The prosthetic nucleus as set forth in claim 1 wherein the flexible semi-permeable membrane is made of a material selected from the group of polyester, polyolefine and poly(ethylene terephthalate), polytetrafluro ethylene, polysulfone or nylon.

12. The prosthetic nucleus as set forth in claim 1 wherein the membrane structure is woven.

13. The prosthetic nucleus as set forth in claim 1 wherein the membrane has two layers with one layer providing the mechanical strength and another layer providing the necessary porosity for the membrane.

14. The prosthetic nucleus membrane as set forth in claim 13 wherein the membrane is made of a layer of nonwoven nylon for mechanical strength coated with a layer of microporous acrylic copolymer film.

15. The prosthetic nucleus membrane as setforth in claim 13 wherein the membrane is made of a layer of nonwoven polyester for mechanical strength coated with a layer of microporous urethane/fluoropolymer film.

16. The prosthetic nucleus membrane as set forth in claim 13 wherein the membrane is made of a layer of nonwoven nylon for mechanical strength coated with a layer of microporous acrylic copolymer film and a wetting agent.

17. The prosthetic nucleus membrane as set forth in claim 13 wherein the membrane is made of a layer of nonwoven polyester for mechanical strength coated with a layer of microporous polysulfone film.

18. The prosthetic nucleus as set forth in claim 1 wherein the membrane has multiple layers with a microporous layer being sandwiched in-between the two strong backing layers.

19. The prosthetic nucleus membrane as set forth in claim 18 wherein the microporous layer is an ultrafiltration membrane which is made of a member selected from the group consisting of cellulose, cellulose ester or a mixture of cellulose ester, cellulose nitrate and a combination thereof.

20. The prosthetic nucleus as set forth in claim 1 wherein the porosity of the semi-permeable membrane is at least three times smaller than the smallest particle size of the hydrated hydrogel beads.

21. The prosthetic nucleus as set forth in claim 1 wherein the porosity of the semi-permeable membrane is less than 7 μ

m.

22. The prosthetic nucleus as set forth in claim 1 wherein the porosity of the semi-permeable membrane has a molecular weight cut-off of 15,000 daltons.

23. The prosthetic nucleus as set forth in claim 1 wherein the surface of the membrane is treated.

24. The prosthetic nucleus membrane as set forth in claim 23 wherein the membrane is coated with a member selected from the group consisting of hyaluronic acid (HA), polyvinyl alcohol, polyethylene glycol, or polyurethane and a combination thereof.

25. The prosthetic nucleus membrane as set forth in claim 23 wherein the membrane is coated by a method selected from the group consisting of graft polymerization, plasma polymerization, chemical vapor deposition, photolithographic process and a combination thereof.

26. A prosthetic nucleus for implanting in the disc space after the removal of the degenerated or damaged nucleus of an intervertebral disc comprising:

a hydrogel material having, when hydrated in the disc, a water content of at least 30%; and

a semi-permeable membrane surrounding said hydrogel, and, when inflated, having a size and shape generally conforming to a natural nucleus.