Spinal nucleus replacement implants and methods

• US 20050154463A1
• Filed: 01/06/2005
• Published: 07/14/2005
• Est. Priority Date: 08/30/2000
• Status: Abandoned Application

• Current Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Trieu, Hal H.
• Application Number:
  US11/030,337
• Publication Number:
  US 20050154463A1
• Time in Patent Office: Days
• US Class Current: 623/17.160
• CPC Class Codes: A61B 2017/0256 for the spine
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30179 X-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30838 Microstructures
• CPC Class Codes: A61F 2002/30891 Plurality of protrusions
• CPC Class Codes: A61F 2002/30906 shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/30925 : etched
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4415 : elements of the prosthesis being arranged in a chain like manner
• 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 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 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• 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

Abstract

Improved nucleus pulposus implants are provided to better accommodate the disc nucleus space, to provide a modified compressive modulus, to facilitate positioning, to enhance fixation, and to facilitate effective implantation and use. Some implants have sloped upper and/or lower surfaces to provide a “wedge-shaped” implant, while other implants have circumferential grooves, and/or have radiographic markers, and/or are modified by including a material having a compression profile that differs from the compression profile of the predominant material of the implant. Some implants have surface features to enhance fixation to surrounding surfaces.

Claims

1. An intervertebral disc nucleus pulposus implant, comprising a load bearing elastic body sized for introduction into an intervertebral disk space, said body having an anterior portion including an anterior side, and a posterior portion including a posterior side, wherein at least half of said posterior portion tapers to the posterior side of the implant.

2. An intervertebral disc nucleus implant according to claim 1 wherein the entire posterior portion tapers to the posterior side of the implant.

3. An intervertebral disc nucleus implant according to claim 1 wherein at least part of said anterior portion tapers to the posterior side of the implant.

4. An intervertebral disc nucleus implant according to claim 1 wherein substantially all of said anterior portion tapers to the posterior side of the implant.

5. An intervertebral disc nucleus implant according to claim 1 wherein at least part of said anterior portion tapers to the anterior side of the implant, and at least part of said posterior portion tapers to the posterior side of the implant.

6. An intervertebral disc nucleus implant according to claim 1 wherein said implant further includes one or more radiographic markers in the implant to facilitate positioning of the implant.

7. An intervertebral disc nucleus pulposus implant according to claim 1 wherein said implant further includes a flexible peripheral supporting band disposed circumferentially about said elastic body for reducing deformation of said body.

8. An intervertebral disc nucleus pulposus implant according to claim 1 wherein said implant further includes at least one surface feature to enhance fixation of the implant to surrounding surfaces.

9. An intervertebral disc nucleus pulposus implant according to claim 8 wherein said surface feature comprises a three-dimensional porous surface on the implant to enhance fixation of the implant to surrounding surfaces.

10. An intervertebral disc nucleus pulposus implant according to claim 1 wherein said load bearing elastic body has one or more substantially horizontal grooves along a side surface of the implant to reduce the material in the side surface, thereby facilitating deformation of the implant under load and allowing a greater range of motion.

11. An intervertebral disc nucleus implant according to claim 10 wherein said grooves extend substantially completely around the circumference of the implant.

12. An intervertebral disc nucleus pulposus implant according to claim 1 wherein said implant has one or more areas that have a compressive modulus that is different from the compressive modulus of the predominant load bearing portion of the implant, thereby providing an implant with load bearing portions that are more or less stiff than other load bearing portions of the implant.

13. An intervertebral disc nucleus implant according to claim 12 wherein one or more areas of the implant is modified by including in that area a polymeric material having a compressive modulus that is different from the compressive modulus of the predominant load bearing portion of the implant, thereby providing an implant with load bearing portions that are more or less stiff than other load bearing portions of the implant.

14. An intervertebral disc nucleus implant according to claim 12 wherein one or more areas of the implant is modified by including in that area a hydrogel material having a compressive modulus that is different from the compressive modulus of the predominant load bearing portion of the implant, thereby providing an implant with load bearing portions that are more or less stiff than other load bearing portions of the implant.

15. An intervertebral disc nucleus implant according to claim 12 wherein one or more areas of the implant is modified by including in that area a metalic material having a compressive modulus that is different from the compressive modulus of the predominant load bearing portion of the implant, thereby providing an implant with load bearing portions that are more or less stiff than other load bearing portions of the implant.

16. An intervertebral disc nucleus implant according to claim 12 wherein one or more areas of the implant is modified by including in that area a ceramic material having a compressive modulus that is different from the compressive modulus of the predominant load bearing portion of the implant, thereby providing an implant with load bearing portions that are more or less stiff than other load bearing portions of the implant.

17. An intervertebral disc nucleus pulposus implant according to claim 12 wherein said implant is modified by including one or more voids in the implant to provide at least one load bearing portion having a compression resistance that is different from the compression resistance of other load bearing portions of the implant.

18. An intervertebral disc nucleus pulposus implant according to claim 1 wherein implant comprises a load bearing elastic body sized for placement into an intervertebral disc space, said body having a first end, a second end, a central portion, and a first configuration wherein said first end and said second end are positioned adjacent to said central portion to form at least one inner fold, said elastic body configurable into a second, straightened configuration for insertion through an opening in an intervertebral disc annulus fibrosis, said body configurable back into said first configuration after said insertion.

19. An intervertebral disc nucleus implant according to claim 1 wherein said load bearing elastic body is made of an elastomeric material or a hydrogel.

20. An intervertebral disc nucleus implant according to claim 19 wherein said elastomeric material is a silicone, polyurethane, polyolefin, neoprene, nitrile, or vulcanized rubber, or a mixture of one or more of said materials.

21. An intervertebral disc nucleus implant according to claim 19 wherein said hydrogel is a natural hydrogel or a hydrogel formed from one of more members of the group consisting of polyvinyl alcohols, acrylamide-based hydrogels, polyurethanes, polyethylene glycol, poly(N-vinyl-2-pyrrolidone), acrylate-based hydrogels, N-vinyl lactams, and polyacrylonitriles.

22. An intervertebral disc nucleus implant according to claim 19 wherein said load bearing elastic body is covered by an amount of biocompatible material sufficient to substantially or completely cover the load bearing elastic body.

23. An intervertebral disc nucleus implant according to claim 19 wherein said wherein said biocompatible material comprises a material selected from the group consisting of fibrin, albumin, collagen, elastin, silk, polyethylene oxide, cyanoacrylate, polylactic acid, polyglycolic acid, polypropylene fumarate, tyrosine-based polycarbonate, and demineralized bone matrix.

24. A method of treating a medical patient, said method comprising implanting in an intervertebral disc space of the patient an intervertebral disc nucleus pulposus implant, wherein said intervertebral disc implant comprises a load bearing elastic body sized for introduction into an intervertebral disk space, said body having an anterior portion including an anterior side, and a posterior portion including a posterior side, wherein at least half of said posterior portion tapers to the posterior side of the implant.

25. A method according to claim 24 wherein a stem cell material is additionally added to the intervertebral disc space.

26. A method according to claim 24 wherein a collagen-rich tissue material is additionally added to the intervertebral disc space.

27. A method according to claim 24 wherein a second agent is additionally added to the intervertebral disc space;

wherein said second agent is selected from the group consisting of analgesics, antibiotics, radiocontrast materials, growth factors, crosslinking agents, polysaccharides, hormones, proteoglycans, and agents effective for treating degenerative disc disease.

28. An intervertebral disc nucleus pulposus implant, comprising a load bearing elastic body sized for introduction into an intervertebral disk space, said body having one or more substantially horizontal grooves along a side surface of the implant to reduce the material in the side surface, thereby facilitating deformation of the implant under load and allowing a greater range of motion.

29. An intervertebral disc nucleus pulposus implant, comprising a load bearing elastic body sized for introduction into an intervertebral disk space, wherein one or more areas in the implant have a compressive modulus that is different from the compressive modulus of the predominant load bearing portion of the implant, thereby providing an implant with load bearing portions that are more or less stiff than other load bearing portions of the implant.