# US 9,005,289 B1 · Tissue engineered nucleus pulposus replacement > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,005,289 B1 - Document ID: US9005289B1 - Status: Granted - Kind: B1 - Application number: 13/530,624 - Filed: 2012-06-22 - Granted: 2015-04-14 - Earliest claimed: 2011-07-01 - Assignees: Clemson University - Applicants: Dan Simionescu; Jeremy Mercuri - Inventors: Dan Simionescu; Jeremy Mercuri - Web page: https://patentgrep.com/patent/US9005289B1 ## CPC - A61F 2/441: {made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel} - A61F 2/44: for the spine, e.g. vertebrae or spinal discs - A61L 27/26: Mixtures of macromolecular compounds - A61L 27/52: Hydrogels or hydrocolloids - A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body} - A61F 2002/30971: {Laminates, i.e. layered products} - A61F 2002/444: {for replacing the nucleus pulposus} - A61F 2310/00371: Collagen - A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs - A61L 2430/40: Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking - 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) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## Abstract A nucleus pulposus replacement is described that includes a containment balloon that can sequester synthetic and/or tissue engineered fill material(s) in the nucleus pulposus region of the IVD thus mitigating migration and expulsion of the fill materials. The containment balloon can be formed of a biocompatible material that includes the structural proteins elastin and collagen. The containment balloon is joined to a closure device that can be used to deliver a fill material, e.g., a hydrogel, to the interior of the containment balloon following implantation of the replacement device in the intervertebral disc area. ## Claims ### Claim 1 A nucleus pulposus replacement comprising: a containment balloon, the containment balloon comprising multiple layered sheets, each of which including elastin and collagen; and a closure device, the closure device being joined to the containment balloon, the closure device including a one-way port for furnishing a fill material to an interior of the containment balloon. ### Claim 2 (depends on 1) The nucleus pulposus replacement of claim 1, wherein the multiple layered sheets comprise fibrous plies, the plies of adjacent sheets being at an angle to one another. ### Claim 3 (depends on 1) The nucleus pulposus replacement of claim 1, wherein the sheets are formed of a source tissue that has been decellularized. ### Claim 4 (depends on 1) The nucleus pulposus replacement of claim 1, wherein the containment balloon is porous. ### Claim 5 (depends on 1) The nucleus pulposus replacement of claim 1, wherein at least one of the elastin and the collagen are cross-linked. ### Claim 6 (depends on 5) The nucleus pulposus replacement of claim 5, wherein the elastin is cross-linked with pentagalloyl glucose. ### Claim 7 (depends on 1) The nucleus pulposus replacement of claim 1, wherein the containment balloon exhibits a compressive stress before failure of greater than about 1 MPa. ### Claim 8 (depends on 1) The nucleus pulposus replacement of claim 1, wherein the sheets of the containment balloon have been loaded with one or more biologically active agents. ### Claim 9 (depends on 1) The nucleus pulposus replacement of claim 1, wherein the closure device comprises multiple components. ### Claim 10 (depends on 9) The nucleus pulposus replacement of claim 9, wherein a portion of the containment balloon is sandwiched between components of the closure device to join the containment balloon to the closure device. ### Claim 11 (depends on 1) The nucleus pulposus replacement of claim 1, wherein at least one of the containment balloon and the closure device is degradable. ### Claim 12 (depends on 11) The nucleus pulposus device of claim 11, wherein both the containment balloon and the closure device are degradable. ### Claim 13 (depends on 1) A method for forming the nucleus pulposus device of claim 1, the method including joining the containment balloon to the closure device. ### Claim 14 (depends on 13) The method according to claim 13, wherein the closure device comprises multiple components, the method comprising locating a portion of the containment balloon between components of the closure device. ### Claim 15 (depends on 13) The method according to claim 13, the method further comprising modifying an outer surface of the containment balloon. ### Claim 16 (depends on 13) The method according to claim 13, further comprising modifying an outer surface of the closure device. ### Claim 17 A method for replacing nucleus pulposus tissue, the method comprising: removing nucleus pulposus tissue from an intervertebral disc to form a void in the intervertebral disc; and inserting a nucleus pulposus replacement into the void, the nucleus pulposus replacement comprising a containment balloon, the containment balloon comprising a sheet that includes elastin and collagen, and a closure device, the closure device being joined to the containment balloon, the closure device including a one-way port for furnishing a fill material to an interior of the containment balloon. ### Claim 18 (depends on 17) The method of claim 17, the method further comprising furnishing the fill material to the interior of the containment balloon via the one-way port. ### Claim 19 (depends on 18) The method of claim 18, wherein the fill material is a gel matrix. ### Claim 20 (depends on 19) The method of claim 19, wherein the gel matrix is furnished to the interior of the containment balloon in final form. ### Claim 21 (depends on 19) The method of claim 19, wherein the gel matrix is finally cross-linked following furnishing of the fill material to the interior of the containment balloon. ### Claim 22 A nucleus pulposus replacement comprising: a containment balloon, the containment balloon comprising a sheet that includes elastin and collagen, the elastin being crosslinked with pentagalloyl glucose; and a closure device, the closure device being joined to the containment balloon, the closure device including a one-way port for furnishing a fill material to an interior of the containment balloon. ### Claim 23 (depends on 22) The nucleus pulposus replacement of claim 22, wherein the containment balloon comprises multiple layered sheets. ### Claim 24 (depends on 23) The nucleus pulposus replacement of claim 23, wherein the multiple layered sheets comprise fibrous plies, the plies of adjacent sheets being at an angle to one another. ### Claim 25 (depends on 22) The nucleus pulposus replacement of claim 22, wherein the sheet is formed of a source tissue that has been decellularized. ### Claim 26 (depends on 22) The nucleus pulposus replacement of claim 22, wherein the sheet of the containment balloon has been loaded with one or more biologically active agents. ### Claim 27 A nucleus pulposus replacement comprising: a containment balloon, the containment balloon comprising a sheet that includes elastin and collagen, wherein the containment balloon exhibits a compressive stress before failure of greater than about 1 MPa; and a closure device, the closure device being joined to the containment balloon, the closure device including a one-way port for furnishing a fill material to an interior of the containment balloon. ### Claim 28 (depends on 27) The nucleus pulposus replacement of claim 27, wherein the containment balloon comprises multiple layered sheets, each of which including elastin and collagen. ### Claim 29 (depends on 28) The nucleus pulposus replacement of claim 28, wherein the multiple layered sheets comprise fibrous plies, the plies of adjacent sheets being at an angle to one another. ### Claim 30 (depends on 27) The nucleus pulposus replacement of claim 27, wherein the sheet is formed of a source tissue that has been decellularized. ### Claim 31 (depends on 27) The nucleus pulposus replacement of claim 27, wherein the sheet of the containment balloon has been loaded with one or more biologically active agents. ### Claim 32 (depends on 27) The nucleus pulposus replacement of claim 27, wherein at least one of the elastin and the collagen are cross-linked.