Intervertebral disc nucleus implants and methods Number:7,520,900 from the United States Patent and Trademark Office (PTO) owispatent Nucleus pulposus implants that are resistant to migration in and/or expulsion from an intervertebral disc space are provided. In one form of the invention, an implant includes a load bearing elastic body surrounded in the disc space by an anchoring, preferably resorbable, outer shell. In certain forms of the invention, the elastic body is surrounded by a supporting member, such as a band or jacket, and the supporting member is surrounded by the outer shell. Kits for forming such implants are also provided. In another form of the invention, an implant is provided that has locking features and optional shape memory characteristics. In yet another aspect of the invention, nucleus pulposus implants are provided that have shape memory characteristics and are configured to allow short-term manual, or other deformation without permanent deformation, cracks, tears, breakage or other damage. Methods of forming and implanting the implants are also described, as are delivery devices and components thereof for delivering the implants.<H Intervertebral, implants, Intervertebral, , 7520900.html, Patent, pto, 7520900

Title: Intervertebral disc nucleus implants and methods

Abstract: Nucleus pulposus implants that are resistant to migration in and/or expulsion from an intervertebral disc space are provided. In one form of the invention, an implant includes a load bearing elastic body surrounded in the disc space by an anchoring, preferably resorbable, outer shell. In certain forms of the invention, the elastic body is surrounded by a supporting member, such as a band or jacket, and the supporting member is surrounded by the outer shell. Kits for forming such implants are also provided. In another form of the invention, an implant is provided that has locking features and optional shape memory characteristics. In yet another aspect of the invention, nucleus pulposus implants are provided that have shape memory characteristics and are configured to allow short-term manual, or other deformation without permanent deformation, cracks, tears, breakage or other damage. Methods of forming and implanting the implants are also described, as are delivery devices and components thereof for delivering the implants.

Patent Number: 7,520,900 Issued on 04/21/2009 to Trieu

Inventors: Trieu; Hai H. (Cordova, TN)
Assignee: Warsaw Orthopedic, Inc. (

Appl. No.: 11/178,945

Filed: July 11, 2005

Related U.S. Patent Documents


Application Number	Filing Date	Patent Number	Issue Date
09943441	Aug., 2001
09650525	Aug., 2000	6620196

Current U.S. Class: 623/17.16

Current International Class: A61F 2/44 (20060101)

Field of Search: 623/17.11-17.16 606/60-63

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Primary Examiner: Stewart; Alvin J
Attorney, Agent or Firm: Haynes and Boone, LLP

Parent Case Text

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation and claims priority from U.S. patent application Ser. No. 09/943,441, filed Aug. 30, 2001 now abandoned, which is a continuation-in-part and claims priority from U.S. patent application Ser. No. 09/650,525, filed Aug. 30, 2000 now U.S. Pat. No. 6,620,196. Both of the above applications are incorporated herein by reference in their entirety.

Claims

What is claimed is:

1. An intervertebral disc nucleus pulposus implant, comprising: a load bearing elastic body having shape memory and sized for placement into an intervertebral disc space, said body having a first end, a second end, and a central portion located between the first and second ends; wherein said shape memory biases said body to a first configuration in which said first end and said second end are folded into contact with the central portion, wherein the first end in contact with the central portion forms a first aperture and the second end in contact with the central portion forms a second aperture; said elastic body configurable into a second, straightened configuration for insertion through an opening in an intervertebral disc annulus fibrosis; wherein said shape memory is effective for returning said body to said first configuration after said insertion.

2. The implant of claim 1, wherein said elastic body is comprised of a hydrogel material.

3. The implant of claim 2, wherein said hydrogel is a member selected from the group consisting of natural hydrogels, hydrogels formed from polyvinyl alcohol, acrylamides, polyacrylic acid, poly(acrylonitrile-acrylic acid), polyurethanes, polyethylene glycol, poly(N-vinyl-2-pyrrolidone), acrylates, poly(2-hydroxy ethyl methacrylate), copolymers of acrylates with N-vinyl pyrrolidone, N-vinyl lactams, acrylamide, polyurethanes and polyacrylonitrile.

4. The implant of claim 1, wherein said elastic body is comprised of an elastomer.

5. The implant of claim 4, wherein said elastomer is selected from the group consisting of silicone, polyurethane, copolymers of silicone and polyurethane, polyolefins, nitrile and combinations thereof.

6. The implant of claim 1, wherein said body further includes an inner surface with projections extending therefrom, said projections extending into said first aperture.

7. The implant of claim 1, wherein said elastic body has an outer surface, said outer surface having projections extending therefrom, said projections configured for enhancing fixation of said body in said intervertebral disc space.

8. The implant of claim 1, wherein said elastic body includes an outer surface, the outer surface of said elastic body is microtexturized.

9. The implant of claim 1, wherein said body further comprises a reinforcing material at said inner fold surface.

10. The implant of claim 9, wherein said reinforcing material comprises fibers.

11. The implant of claim 1, wherein said elastic body is comprised of a hydrogel material, said material having at least one growth factor dispersed therein.

12. The implant of claim 11, wherein said growth factor is selected from the group consisting of transforming growth factor .beta., bone morphogenetic proteins, fibroblast growth factors, platelet-derived growth factors, insulin-like growth factors and combinations thereof.

13. The implant of claim 11, wherein said growth factor comprises a recombinant protein.

14. The implant of claim 13, wherein said recombinant protein is a human protein.

15. The implant of claim 1, wherein said body has at least one surface depression in its second configuration, said first aperture formed from said surface depression.

16. The implant of claim 1 wherein said first end is formed from a first arm, said second end is formed from a second arm and one of said arms of said implant has a length greater than the other of said arms.

17. The implant of claim 1, wherein said first aperture has a cross-sectional shape selected from the group consisting of annular-shaped, elliptical-shaped, and star-shaped.

18. The implant of claim 1, wherein said body is substantially elliptical- or ring-shaped in its folded configuration.

19. The implant of claim 1 wherein said body has a top surface for contacting an upper vertebral endplate of an intervertebral disc and a bottom surface for contacting a lower vertebral endplate of an intervertebral disc; said top and bottom surface configured to be complementary to the endplate they are in contact with.

20. The implant of claim 19, wherein said top and bottom surface of said body are convex.

21. The implant of claim 1, wherein said first end and said second end each have an inner edge and an outer edge, at least one of said inner edges having a rounded configuration.

22. The implant of claim 21, wherein said rounded edge may be an inner edge or an outer edge.

23. The implant of claim 1, wherein said body has a top surface for contacting an upper vertebral endplate of an intervertebral disc; a bottom surface for contacting a lower vertebral endplate of an intervertebral disc, and an external side surface, said body having at least one groove on said side surface, said groove extending between said top surface and said bottom surface.

24. The implant of claim 1, wherein said load bearing elastic body conforms to and substantially fills the space that is vacated by removal of the disc nucleus pulposus.

25. The implant of claim 1, wherein said load bearing elastic body further includes metal beads or wires embedded therein to facilitate x-ray identification.

26. The implant of claim 25 wherein said pharmacological agent is a member selected from the group consisting of antibiotics, analgesics, anti-inflammatories, steroids, and combinations thereof.

27. The implant of claim 25, wherein said pharmacological agent is chemically attached to the surface of the implant.

28. The implant of claim 27, wherein said hydrogel is cross-linked to provide further strength to the implant.

29. The implant of claim 1, wherein said load bearing elastic body further includes at least one pharmacological agent.

30. The implant of claim 1, wherein said load bearing elastic body comprises a hydrophilic polymer.

31. The implant of claim 1, wherein said load bearing elastic body comprises a member selected from the group consisting of silicone, polyurethane, copolymers of silicone and polyurethane, polyolefins, neoprene, nitrile, vulcanized rubber and combinations thereof.

32. The implant of claim 31, wherein said polyurethane is a member selected from the group consisting of thermoplastic polyurethanes, aliphatic polyurethanes, segmented polyurethanes, hydrophilic polyurethanes, polyether-urethane, polycarbonate-urethane and silicone polyether-urethane.

33. The implant of claim 1, wherein said load bearing elastic body comprises a member selected from the group consisting of glucomannan gel.

34. An intervertebral disc nucleus pulposus implant comprising a load bearing body sized for placement into an intervertebral disc space, said body having a first end, a second end, and a central portion; wherein said body assumes a first, folded configuration in which said first end and said second end are positioned adjacent to said central portion to provide an implant having a substantially solid center when the implant is not subjected to straightening forces, and wherein said body assumes a second, straightened configuration in which said central portion is between said first end and said second end to provide an implant having a substantially linear shape when said body is subjected to straightening forces; wherein said first end and said second end are each approximately one half the length of said central portion so that the first end and the second end abut near the middle of said central portion when the body assumes its first, folded configuration; and wherein said body includes a plurality of grooves to prevent cracking or tearing of the implant when the implant is manipulated to its straightened configuration.

Description

BACKGROUND OF THE INVENTION

The present invention relates to nucleus pulposus implants and methods for their implantation.

The intervertebral disc functions to stabilize the spine and to distribute forces between vertebral bodies. A normal disc includes a gelatinous nucleus pulposus, an annulus fibrosis and two vertebral end plates. The nucleus pulposus is surrounded and confined by the annulus fibrosis.

lntervertebral discs may be displaced or damaged due to trauma or disease. Disruption of the annulus fibrosis may allow the nucleus pulposus to protrude into the vertebral canal, a condition commonly referred to as a herniated or ruptured disc. The extruded nucleus pulposus may press on a spinal nerve, which may result in nerve damage, pain, numbness, muscle weakness and paralysis. Intervertebral discs may also deteriorate due to the normal aging process. As a disc dehydrates and hardens, the disc space height will be reduced, leading to instability of the spine, decreased mobility and pain.

One way to relieve the symptoms of these conditions is by surgical removal of a portion or all of the intervertebral disc. The removal of the damaged or unhealthy disc may allow the disc space to collapse, which would lead to instability of the spine, abnormal joint mechanics, nerve damage, as well as severe pain. Therefore, after removal of the disc, adjacent vertebrae are typically fused to preserve the disc space. Several devices exist to fill an intervertebral space following removal of all or part of the intervertebral disc in order to prevent disc space collapse and to promote fusion of adjacent vertebrae surrounding the disc space. Even though a certain degree of success with these devices has been achieved, full motion is typically never regained after such vertebral fusions. Attempts to overcome these problems have led to the development of disc replacements. Many of these devices are complicated, bulky and made of a combination of metallic and elastomeric components. Thus, such devices require invasive surgical procedures and typically never fully return the full range of motion desired.

More recently, efforts have been directed to replacing the nucleus pulposus of the disc with a similar gelatinous material, such as a hydrogel. However, there exists a possibility of tearing or otherwise damaging the hydrogel implant during implantation. Moreover, once positioned in the disc space, many hydrogel implants may migrate in the disc space and/or may be expelled from the disc space through an annular defect, or other annular opening. A need therefore exists for more durable implants, as well as implants that are resistant to migration and/or expulsion through an opening in the annulus fibrosis. The present invention addresses these needs.

SUMMARY OF THE INVENTION

Nucleus pulposus implants that are resistant to migration in and/or expulsion from an intervertebral disc space are provided. Accordingly, in one aspect of the invention, nucleus pulposus implants are provided that include a load bearing elastic body sized for introduction into an intervertebral disc space and surrounded by a resorbable shell that provides the initial fixation for the elastic body within the disc space. The implant may include various surface features on its outer surface, including surface configurations or chemical modifications, that enhance the bonding between the outer surface of the implants and the resorbable shell. Kits for forming such implants are also provided. In other forms of the invention, the elastic body may be surrounded by a supporting member wherein the supporting member is surrounded by the resorbable shell.

In yet another aspect of the invention, nucleus pulposus implants are provided that have shape memory and are configured to allow extensive short-term deformation without permanent deformation, cracks, tears or other breakage. In one form of the invention, an implant includes a load bearing elastic body sized for placement into an intervertebral disc space. The body includes a first end, a second end and a central portion wherein the first end and second end are positioned, in a folded, relaxed configuration, adjacent to the central portion to form at least one inner fold. The inner fold preferably defines an aperture. The elastic body is deformable into a second, straightened, non-relaxed, unfolded configuration for insertion through an opening in an intervertebral disc annulus fibrosis. The elastic body is deformable automatically back into a folded conf