Prosthetic disc and method of implanting

• US 4,772,287 A
• Filed: 08/20/1987
• Issued: 09/20/1988
• Est. Priority Date: 08/20/1987
• Status: Expired due to Term

• Current Assignee: Raymedica, Inc.
• Original Assignee: Cedar Surgical Incorporated
• Inventors: Ray, Charles D., Corbin, Terry P.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Bender, David J.
• Application Number:
  US07/087,424
• Time in Patent Office: 397 Days
• Field of Search: 623/10, 623/12, 623/16, 623/17, 128/92 R, 128/92 YM, 128/DIG. 20, 128/69
• US Class Current: 623/17.12
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• 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 2002/4627 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/44 having a macromolecular matrix
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin
• CPC Class Codes: Y10S 128/20 Inflatable splint
• CPC Class Codes: Y10S 424/07 Microporous membranes

Abstract

By implanting two prosthetic disc capsules side-by-side into a damaged disc of a human spine, both height and motion, including front-to-back bending, can be maintained. The prosthetic disc capsules have an outer layer of strong, inert fibers intermingled with a bioresorbable material which attracts tissue ingrowth, a bladder enveloped by the layer, and a thixotropic gel filling the bladder. The prosthetic disc capsules can be surgically implanted by (1) jacking apart the vertebrae adjacent a damaged disc, (2) forming a substantially sagital bore in the damaged disc near each of its lateral edges, and (3) inserting one of the capsules axially into each bore.

Claims

1. An elongated cylindrical prosthetic intervertebral disc capsule adapted to be inserted in a sagittal direction within the nucleus of a damaged disc, said capsule having a diameter approximating the height of a human disc space and a length approximating the sagittal diameter of the nucleus of the disc, and said capsule comprising:

an outer layer of strong, inert fibers intermingled with a bioresorbable material which attracts tissue ingrowth, and

a fluid-filled bladder, such that when two of these capsules are inserted side-by-side into the nucleus of the anulus of a damaged disc, each lying near one of the lateral edges of the disc and spaced from the other capsule, they will maintain both height and motion, including front-to-back bending, at the disc space, but will limit rotation.

2. A prosthetic disc capsule as defined in claim 1 wherein the fluid filling the bladder is a thixotropic gel having a viscosity and velocity-shear behavior imitating the natural rheology of intradiscal nuclear tissue.

3. A prosthetic disc capsule as defined in claim 2 wherein said thixotropic gel has a Brookfield viscosity between 100 and 10,000 cps. at 6 rpm.

4. A prosthetic disc capsule as defined in claim 1 having strong, inert fibers woven into the outer layer and extending transversely through the bladder to limit lateral bulging.

5. A prosthetic disc capsule as defined in claim 1 having external ridges or longitudinal vanes attached to the outside of the capsule to inhibit rotation of the capsule within the disc space.

6. A prosthetic disc capsule as defined in claim 1 wherein the ends of the capsule are invaginated.

7. A prosthetic disc capsule as defined in claim 1 wherein said bioresorbable material comprises fibers which are interwoven with said inert fibers.

8. A prosthetic disc capsule as defined in claim 1 wherein said bioresorbable material is coated on the inert fibers.

9. A prosthetic disc capsule as defined in claim 1 wherein said bioresorbable material is selected from polylactic acid, polyglycolic acid, and collagen.

10. A prosthetic disc capsule as defined in claim 1 and including a hollow tubing communicating with said bladder and an external chamber, and means for injecting or withdrawing fluid into or from the chamber.

11. A prosthetic disc capsule as defined in claim 10 wherein said chamber consists of a needle-puncturable, self-sealing membrane.

12. A surgical procedure involving the implantation of two prosthetic disc capsules side-by-side into the nucleus of the anulus of a damaged disc, said procedure comprising the steps of:

15. A surgical procedure as defined in claim 12 and involving the added step of opening a window to the damaged disc through a vertebral facet joint at each side of the spine, and step (2) involves drilling via each window a bore in the damaged disc.

18. A surgical procedure as defined in claim 12 wherein step (3) is followed by the step of inflating the prosthetic disc capsule.

13. (1) jacking apart the vertebrae adjacent to a damaged disc,

16. A surgical procedure as defined in claim 13 wherein each of the bores drilled in the damaged disc in step (2) is angulated about 10°

from the sagittal direction toward the other bore.

14. (2) forming a substantially sagittal bore in the damaged disc near each of its lateral edges and spaced from the other bore, and

(3) inserting an elongated inflatable cylindrical disc capsule axially into each bore.

17. A surgical procedure as defined in claim 14 wherein step (4) involves inserting the prosthetic disc capsules through said windows.