# US 9,039,769 B2 · Intervertebral nucleus and annulus implants and method of use thereof

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- Number: US 9,039,769 B2
- Document ID: US9039769B2
- Status: Granted
- Kind: B2
- Application number: 12/725,988
- Filed: 2010-03-17
- Published: 2011-09-22
- Granted: 2015-05-26
- Earliest claimed: 2010-03-17
- Assignees: Globus Medical, Inc.
- Applicants: Damien O'Halloran; Jody L. Seifert; Jeff Bennett; Aditya Ingalhalikar; Sean Suh; Sophia Tetteh
- Inventors: Damien O'Halloran; Jody L. Seifert; Jeff Bennett; Aditya Ingalhalikar; Sean Suh; Sophia Tetteh
- Web page: https://patentgrep.com/patent/US9039769B2

## CPC

- 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)}
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/441: {made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel}
- A61F 2/4611: {of spinal prostheses}
- A61F 2002/30064: {Coating or prosthesis-covering structure made of biodegradable material}
- A61F 2002/30069: {elastomeric}
- A61F 2002/302: {toroidal, e.g. rings}
- A61F 2002/30224: {cylindrical}
- A61F 2002/30291: {spirally-coiled, i.e. having a 2D spiral cross-section}
- A61F 2002/30565: {having spring elements}
- A61F 2002/30586: {having two or more inflatable pockets or chambers}
- A61F 2002/30588: {filled with solid particles}
- A61F 2002/30616: {Sets comprising a plurality of prosthetic parts of different sizes or orientations}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/3082: {Grooves}
- A61F 2002/30841: {Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes}
- A61F 2002/4435: {Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes}
- A61F 2002/444: {for replacing the nucleus pulposus}
- A61F 2002/4622: {having the shape of a forceps or a clamp}
- A61F 2002/4635: {using minimally invasive surgery}
- A61F 2230/0065: toroidal, e.g. ring-shaped, doughnut-shaped
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00029: Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
- A61F 2310/00059: Chromium or Cr-based alloys
- A61F 2310/00071: Nickel or Ni-based alloys
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 1

A nucleus pulposus containment shell comprising:
a. an outer shell comprised of a biocompatible material defining a central fillable cavity having a central cavity and one or more envelope cavities completely surrounding an outer perimeter of the central cavity;
b. an inner surface including a load bearing polymeric or elastomeric material therein, wherein the load bearing material comprises a plurality of beads in a fluid or gel suspension;
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.

### Claim 2 (depends on 1)

The nucleus pulposus containment shell of claim 1, wherein the outer shell is comprised of a metallic foil-like material comprised NiTi alloy, stainless steel, titanium or combinations thereof.

### Claim 3 (depends on 1)

The nucleus pulposus containment shell of claim 1, wherein the outer shell is comprised of a polymeric material, a biodegradable or bioresorbable material, or a combination thereof.

### Claim 4 (depends on 3)

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.

### Claim 5 (depends on 3)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

The nucleus pulposus containment shell of claim 1, wherein the outer shell is porous having pores between about 50 μm and about 500 μm.

### Claim 8 (depends on 7)

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.

### Claim 9 (depends on 8)

The nucleus pulposus containment shell of claim 8, wherein the one or more bioactive agents promote growth or reduce inflammation.

### Claim 10

A nucleus pulposus containment shell comprising:
a. an outer shell including a top surface, a bottom surface, and lateral sides comprised of a biocompatible material;
b. an inner surface including a load bearing polymeric or elastomeric material therein, wherein the load bearing material comprises a plurality of beads in a fluid or gel suspension,
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 comprises a tube forming a ring extending around an opening, wherein a top surface and/or a bottom surface on the ring of the outer shell are textured to provide anchorage with vertebral endplates, and wherein, when inflated with the load bearing material, the top and bottom surfaces and the lateral sides of the ring are rounded so that the nucleus pulposus containment shell can fit firmly to the annulus fibrosus and vertebral endplates.

### Claim 11 (depends on 10)

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.

### Claim 12 (depends on 10)

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.

### Claim 13 (depends on 10)

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.

### Claim 14 (depends on 12)

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.

### Claim 15 (depends on 12)

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.

### Claim 16 (depends on 10)

The nucleus pulposus containment shell of claim 10, wherein the outer shell is porous having pores between about 50 μm and about 500 μm.

### Claim 17 (depends on 16)

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.

### Claim 18 (depends on 17)

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

### Claim 19 (depends on 1)

The nucleus pulposus containment shell of claim 1, wherein the central cavity and the one or more envelope cavities surrounding the central cavity are independently filled with the load bearing polymeric or elastomeric material.

### Claim 20 (depends on 1)

The nucleus pulposus containment shell of claim 1, wherein the load bearing material is configured to bear physiologic loads and mimic the nucleus pulposus of a healthy subject.