Devices and method for augmenting a vertebral disc

• US 20040024465A1
• Filed: 05/07/2003
• Published: 02/05/2004
• Est. Priority Date: 08/18/1999
• Status: Abandoned Application

• Current Assignee: Gregory Lambrecht, Jacob Einhorn, Jason Partin, Sean Kavanaugh
• Original Assignee: Gregory Lambrecht, Jacob Einhorn, Jason Partin, Sean Kavanaugh
• Inventors: Einhorn, Jacob, Lambrecht, Gregory, Kavanaugh, Sean, Partin, Jason
• Application Number:
  US10/431,633
• Publication Number:
  US 20040024465A1
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4514 Cartilage
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30723 Plugs or restrictors for sealing a cement-receiving space tools for inserting plugs A61F2/4614; sealing collars for use during cementing A61B17/8808
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• 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 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30571 : Leaf springs
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• 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 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4661 : for measuring thickness
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-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
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Abstract

A vertebral disc prosthesis, a method of implanting a prosthesis and a deployment device is provided. The prosthesis may be implanted into the interior region of the vertebral disc so as to displace existing vertebral tissue, such as NP. The size or amount of the prosthesis inserted into the interior region of the vertebral disc may be a characteristic of the disc or the prosthesis. For example, the amount or size of prosthesis inserted into the disc may be dependent upon restoring the functionality of the disc (e.g., the ability of the disc to transfer nutrients or otherwise survive, the ability of the disc to carry the required loads and absorb stress or the reduction of pain). Restoring disc function may be determined by the resulting disc height desired, the resulting disc pressure desired or the resulting disc volume desired. The prosthesis may be sized or positioned within the interior of the vertebral disc such that it is spaced from at least one of the end plates of the vertebral disc. The prosthesis may be formed of a material having a compression strength that is less than 4 mn/m². A deployment device may be used to facilitate placement of the prosthesis within the vertebral disc. The prosthesis may include a grouping of multiple components that can be deployed as group.

Claims

1. A vertebral disc prosthesis for displacing nucleus, annulus, or vertebral body endplate tissue of a vertebral disc, the prosthesis comprising:

a grouping of at least two discrete components, the grouping constructed and configured to be inserted together as a group into the interior region of a vertebral disc to displace at least a portion of the nucleus, annulus, or vertebral body endplate tissue.

2. The prosthesis according to claim 1, wherein each component is formed of a mass of material having a compressive strength of less than 4 MN/m².

3. The prosthesis according to claim 1, wherein at least one component comprises a hydrogel material.

4. The prosthesis according to claim 1, wherein at least one component is isotropic.

5. The prosthesis according to claim 1, wherein at least one component is constructed to selectively absorb or release fluid.

6. The prosthesis according to claim 1, wherein at least one component comprises a viscoelastic material.

7. The prosthesis according to claim 1, wherein at least one component comprises a spherical shape.

8. The prosthesis according to claim 1, wherein at least one component comprises a rod or spiral shape.

9. The prosthesis according to claim 1, wherein at least one component comprises a therapeutic amount of a desired substance and is constructed to deliver the therapeutic amount of the desired substance to the vertebral disc.

10. The prosthesis according to claim 1, wherein at least one component comprises a Poisson'"'"'s ratio between a range of approximately 0.30 and approximately 0.49.

11. The prosthesis according to claim 1, wherein at least one component has a compressive strength between a range of approximately 2.5 MN/m² and approximately 3.5 MN/m².

12. The prosthesis according to claim 1, wherein at least one component is adapted to absorb approximately 50% to approximately 100% of its volume within approximately 1 hour to approximately 8 hours under a compressive stress between a range of approximately 0.2 MN/m² and 0.8 MN/m².

13. The prosthesis according to claim 1, in combination with a barrier that is constructed to cover an opening in the annulus of the vertebral disc.

14. The prosthesis according to claim 1, wherein the grouping comprises at least three discrete components.

15. A method of restoring function of an vertebral disc, the vertebral disc having vertebral disc tissue comprising a nucleus, an annulus, and vertebral body endplate tissue, the method comprising:

locating an access site on the vertebral disc; and

inserting, at one time, a prosthesis comprising a grouping of at least two discrete components through the access site and into an interior region of the vertebral disc to displace at least a portion of the vertebral disc tissue without removing a substantial amount of nucleus tissue.

16. The method according to claim 15, wherein locating an access site comprises forming an opening in the annulus tissue.

17. The method according to claim 15, wherein locating an access site comprises locating a defect in the annulus tissue.

18. The method according to claim 15, wherein inserting the grouping of component prostheses into the interior region of the vertebral disc comprises inserting at least one grouping of component prostheses into the interior region of the vertebral disc that is of a sufficient size to achieve a desired disc height.

19. The method according to claim 15, wherein inserting the grouping of component prostheses into the interior region of the vertebral disc comprises inserting at least one grouping of component prostheses into the interior region of the vertebral disc that is of a sufficient size to achieve a desired augmentation volume.

20. The method according to claim 15, wherein inserting the grouping of component prostheses into the interior region of the vertebral disc comprises inserting at least one grouping of component prostheses into the interior region of the vertebral disc that is of a sufficient size to achieve a desired disc pressure.

21. The method according to claim 15, wherein inserting the grouping of component prostheses into the interior region of the vertebral disc comprises inserting a grouping of component prostheses, with at least one component prosthesis being formed of a hydrogel material.

22. The method according to claim 15, wherein inserting the grouping of component prostheses into the interior region of the vertebral disc comprises inserting a grouping of component prostheses, with at least one component prosthesis being formed as an isotropic mass of material.

23. The method according to claim 15, further comprising forming at least one component prosthesis with a therapeutic amount of a desired substance.

24. The method according to claim 15, wherein further comprising forming at least one component prosthesis so as to exhibit a compressive strength that is less than 4 MN/m².

25. The method according to claim 15, further comprising inserting a barrier into the vertebral disc so as to cover an opening in the annulus tissue.

26. The method according to claim 15, further comprising locating the grouping of component prostheses within the interior region of the vertebral disc so as to be surrounded by nucleus tissue within the interior region of the vertebral disc.

27. The method according to claim 15, wherein inserting a grouping of component prostheses into the interior region of the disc comprises inserting a grouping of component prostheses having at least one component prosthesis shaped substantially as a sphere.

28. The method according to claim 15, wherein inserting a grouping of component prostheses into the interior region of the disc comprises inserting a grouping of component prostheses having at least one component prosthesis shaped substantially as a rod or spiral.