Intervertebral disk prosthesis or nucleus replacement prosthesis

• US 20050090901A1
• Filed: 12/05/2001
• Published: 04/28/2005
• Est. Priority Date: 12/05/2001
• Status: Abandoned Application

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Studer, Armin
• Application Number:
  US10/497,712
• Publication Number:
  US 20050090901A1
• Time in Patent Office: Days
• US Class Current: 623/17.12
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• 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 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins

Abstract

An intervertebral disk prosthesis or nucleus replacement prosthesis includes a bio-compatible pouch (1) receiving a curable, flowable material (2). The curable flowable material includes monomers, comonomers, homopolymers, oligomers or mixtures thereof. Curing the curable, flowable material introduced into the pouch (1) takes place in situ after the prosthesis is installed in the intervertebral space between two adjacent vertebras.

Claims

1. An intervertebral disk prosthesis or nucleus replacement prosthesis comprising a bio-compatible pouch (1) receiving a curable, flowable material (2), said curable, flowable material including a material selected from the group consisting of monomers, comonomers, homopolymers, oligomers, and mixtures thereof,

wherein at walls (6, 7) designed to rest against upper plates (13, 14) of adjacent vertebras (11, 12), the pouch (1) is thicker than in remaining wall segments that are not designed to rest against the upper plates of adjacent vertebras.

2. The intervertebral disk prosthesis as claimed in claim 1, wherein the flowable material (2) contains a photo-initiator.

3. The intervertebral disk prosthesis as claimed in claim 2, wherein the photo-initiator absorbs light in the 340 to 420 nm range.

4. The intervertebral disk prosthesis as claimed in claim 2, wherein the photo-initiator is a selected from the group consisting of phosphine oxide and acylphosphine oxide.

5. The intervertebral disk prosthesis as claimed in claim 4, wherein the phosphine oxide is copolymerized with dimethylacryl amide.

6. The intervertebral disk prosthesis as claimed in claim 1, wherein the monomers, comonomers, homopolymers, oligomers or mixtures thereof are selected from the group of

(a) polyethylene glycols, including polyethyleneglycol (di)acrylates;

(b) N-vinylpyrrolidones; and

(c) vinyls, including vinyl alcohols; and

(d) styrenes.

7. The intervertebral disk prosthesis as claimed in claim 1, wherein a weight percent of water of the flowable material (2) is selected from the group of ranges consisting of 30 to 160% water and 40 to 90% water.

8. The intervertebral disk prosthesis as claimed in claim 1, wherein the flowable material (2) contains a hydrogel.

9. The intervertebral disk prosthesis as claimed in claim 1, wherein the pouch (1) has a double-walled structure and the flowable material (2) is introduced between two walls (3, 4) of the double-walled structure whereby a center (5) of the intervertebral disk prosthesis is hollow.

10. The intervertebral disk prosthesis as claimed in claim 1, wherein the pouch (1) is made of a memory-effect substance whereby said pouch shall assume a previously stored geometric shape at body temperature.

11. The intervertebral disk prosthesis as claimed in claim 1, wherein the flowable material (2) further includes a material selected from the group consisting of a polymerization catalyst and a polymerization accelerator.

12. The intervertebral disk prosthesis as claimed in claim 1, wherein the pouch (1) is made of a substance that is chemically identical to the material contained in the pouch.

13. The intervertebral disk prosthesis as claimed in claim 1, wherein, at its walls (6, 7) touching the upper plates (13, 14) of the adjacent vertebras (11, 12), the pouch (1) is made relatively thicker and preferably consists of a material selected from the group consisting of polycarbonate urethane (PCU) and polycarbonate.

14. A method for manufacturing an intervertebral disk prosthesis or a nucleus replacement prosthesis, comprising the steps of:

(a) implanting a bio-compatible pouch (1) in the intervertebral space (10) of two adjacent vertebras (11, 12),

(b) introducing a curable, flowable material (2) inside the implanted, biocompatible pouch (1), said flowable material including materials selected from the group consisting of monomers, comonomers, oligomers and mixtures thereof, the pouch (1) when filled remaining centered in the intervertebral space (10); and

,

(c) curing in situ the curable, flowable material (2) that is disposed within the pouch (1).

15. The method as claimed in claim 14, wherein the material (2) is cured by photo-polymerization using visible or ultraviolet light.

16. The method as claimed in claim 14, wherein the pouch (1) is inflated with air between the steps (a) and (b).

17. The method as claimed in claim 14, wherein, between the steps (a) and (b), the pouch (1) is filled with an x-ray contrast means.

18. The method as claimed in claim 14, wherein the flowable material (2) is cured by auto-polymerization.

19. The method as claimed in claim 14, wherein the material (2) is introduced substantially at no excess pressure into the pouch (1).

20. The method as claimed in claim 14, wherein the material (2) is introduced into the pouch (1) at an excess pressure, said excess pressure being selected from the group of ranges consisting of less than 3 atm and less than 1.1 atm.

21. (canceled)