Intervertebral Nucleus and Annulus Implants and Method of Use Thereof

• US 20110230967A1
• Filed: 03/17/2010
• Published: 09/22/2011
• Est. Priority Date: 03/17/2010
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: Tetteh, Sophia, Ingalhalikar, Aditya, Suh, Sean, Seifert, Jody L., Bennett, Jeff, O'Halloran, Damien
• Granted Patent: US 9,039,769 B2
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• 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 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30069 elastomeric
• 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 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3082 Grooves
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2002/4622 having the shape of a forceps or a clamp
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• 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 2310/00059 : Chromium or Cr-based alloys
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys

Abstract

The invention encompasses devices and methods for treating one or more damaged, diseased, or traumatized intervertebral discs to reduce or eliminate associated back pain. Specifically, the invention encompasses intervertebral nucleus and annulus implants that are resistant to migration in and/or expulsion from an intervertebral disc space. The invention further encompasses kits including the implantable devices of the invention and associated delivery tools to treat annular and nuclear tissue.

Claims

1. A nucleus pulposus containment shell comprising:

a. an outer shell comprised of a biocompatible material;

b. an inner surface capable of receiving a load bearing polymeric or elastomeric material,

c. a unidirectional valve to allow filling of the inner surface; and

d. a sealing crimp to prevent leakage of the load bearing polymeric or elastomeric material filling the inner surface.

wherein the outer shell has an cylindrical-like shape,

wherein a top surface and/or a bottom surface of the outer shell are textured to provide anchorage with one or more vertebral endplates.

6. The nucleus pulposus containment shell of claim 1, wherein the load bearing polymeric or elastomeric material is thermoplastic polyurethane elastomer, polysiloxane modified styrene-ethylene/butylene block copolymer, polycarbonate-urethane, polycarbonate-urethane cross-linked by a polyol, silicone rubber, silicone elastomer, polyether urethane, polyester urethane, a polyether polyester copolymer, polypropylene oxide, silicone, urethane, silicone-urethane copolymer, polycarbonate-urethane copolymer, polyethylene terephthalate, saline, beta-glucan, hyaluronic acid and derivatives thereof, polyvinyl pyrrolidone or a hydrogel derivative thereof, dextrans or a hydrogel derivative thereof, glycerol, polyethylene glycol, succinaylated collagen, liquid collagen, and other polysaccharides or biocompatible polymers or combinations thereof.

7. The nucleus pulposus containment shell of claim 1, wherein the composition is porous.

8. The nucleus pulposus containment shell of claim 7, wherein the porous composition further comprises one or more bioactive agents, which slowly diffuse into the surrounding tissue after implantation.

9. The nucleus pulposus containment shell of claim 7, wherein the one or more bioactive agents promote growth or reduce inflammation.

2. The nucleus pulposus containment shell of claim 2, wherein the outer shell is comprised of a metallic foil-like material comprised NiTi alloy, stainless steel, titanium or combinations thereof.

3. The nucleus pulposus containment shell of claim 2, wherein the outer shell is comprised of a polymeric material, a biodegradable or bioresorbable material, or a combination thereof.

4. The nucleus pulposus containment shell of claim 3, wherein the polymeric material is polypropylene, polyethylene, polyurethane, polycarbonate urethane, Polyetheretherketone (PEEK), polyester, PET, poly olefin copolymer, polypropylene, polyethylene or a combination thereof.

5. The nucleus pulposus containment shell of claim 3, wherein the biodegradable or bioresorbable material is collagen, cellulose, polysaccharide, polylactic acid, polyglycolic acid (PGA), polylactic acid/polyglycolic acid, a polylevolactic acid (PPLA), a polydioxanone (PDA), polylactic acid (PDLLA) or a combination thereof.

10. A nucleus pulposus containment shell comprising:

a. an outer shell comprised of a biocompatible material;

b. an inner surface capable of receiving a load bearing polymeric or elastomeric material,

c. a unidirectional valve for filling the inner surface; and

d. a sealing crimp to prevent leakage of the load bearing polymeric or elastomeric material filling the inner surface.

wherein the outer shell has an tubular ring-like shape, wherein a top surface and/or a bottom surface of the outer shell are textured to provide anchorage with vertebral endplates.

11. The nucleus pulposus containment shell of claim 10, wherein the outer shell is comprised of a metallic foil-like material comprised NiTi alloy, stainless steel, titanium or combinations thereof.

12. The nucleus pulposus containment shell of claim 10, wherein the outer shell is comprised of a polymeric material, a biodegradable or bioresorbable material, or a combination thereof.

13. The nucleus pulposus containment shell of claim 10, wherein the polymeric material is polypropylene, polyethylene, polyurethane, polycarbonate urethane, Polyetheretherketone (PEEK), polyester, PET, poly olefin copolymer, polypropylene, polyethylene or a combination thereof.

14. The nucleus pulposus containment shell of claim 12, wherein the biodegradable or bioresorbable material is collagen, cellulose, polysaccharide, polyglycolic acid (PGA), a polylevolactic acid (PPLA), a polydioxanone (PDA), polylactic acid (PDLLA) or a combination thereof.

15. The nucleus pulposus containment shell of claim 12, wherein the load bearing polymeric or elastomeric material is thermoplastic polyurethane elastomer, polysiloxane modified styrene-ethylene/butylene block copolymer, polycarbonate-urethane, polycarbonate-urethane cross-linked by a polyol, silicone rubber, silicone elastomer, polyether urethane, polyester urethane, a polyether polyester copolymer, polypropylene oxide, silicone, urethane, silicone-urethane copolymer, polycarbonate-urethane copolymer, polyethylene terephthalate, saline, beta-glucan, hyaluronic acid and derivatives thereof, polyvinyl pyrrolidone or a hydrogel derivative thereof, dextrans or a hydrogel derivative thereof, glycerol, polyethylene glycol, succinaylated collagen, liquid collagen, and other polysaccharides or biocompatible polymers or combinations thereof.

16. The nucleus pulposus containment shell of claim 10, wherein the composition is porous.

17. The nucleus pulposus containment shell of claim 16, wherein the porous composition further comprises one or more bioactive agents, which slowly diffuse into the surrounding tissue after implantation.

18. The nucleus pulposus containment shell of claim 17, wherein the one or more bioactive agents promote growth or reduce inflammation.

19. A method of replacing a nucleus pulposus comprising:

a. removing the nucleus pulposus through an opening in the annulus fibrosus to create a nucleus cavity;

b. inserting a nucleus pulposus replacement composition comprising a finable central cavity into the nucleus cavity;

c. filling elastomeric beads suspended in a biocompatible fluid or gel into the nucleus pulposus replacement composition; and

d. plugging the annulus fibrosus.

20. The method of claim 19, wherein the nucleus pulposus replacement composition is comprised of one or more biocompatible elastomers comprised of thermoplastic polyurethane elastomer, polysiloxane modified styrene-ethylene/butylene block copolymer, polycarbonate-urethane, polycarbonate-urethane cross-linked by a polyol, silicone rubber, silicone elastomer, polyether urethane, polyester urethane, a polyether polyester copolymer, polypropylene oxide, and combinations thereof.