# US 11,638,649 B2 · Percutaneous implantable nuclear prosthesis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,638,649 B2 - Document ID: US11638649B2 - Status: Granted - Kind: B2 - Application number: 16/396,042 - Filed: 2019-04-26 - Published: 2019-08-15 - Granted: 2023-05-02 - Earliest claimed: 2014-11-04 - Assignees: Spinal Stabilization Technologies LLC - Applicants: Spinal Stabilization Technologies LLC - Inventors: Nadi S. Hibri; James D. Lutz - Web page: https://patentgrep.com/patent/US11638649B2 ## CPC - A61F 2/441: {made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel} - A61F 2/3094: {Designing or manufacturing processes} - 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)} - B29C 41/14: Dipping a core {(B29C41/10 takes precedence)} - B29C 45/14: incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles {(B29C45/1671 takes precedence)} - A61F 2002/30092: {using shape memory or superelastic materials, e.g. nitinol} - A61F 2002/30235: {tubular, e.g. sleeves} - A61F 2002/30242: {spherical} - A61F 2002/30586: {having two or more inflatable pockets or chambers} - A61F 2002/444: {for replacing the nucleus pulposus} - 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) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) ## Abstract A multi-chamber balloon for a nuclear implant has an elastomeric membrane defining inner and outer chambers integral with a valve body. The valve body includes a core portion and sealing membrane for sealing the inner and outer chambers. An assembly for manufacturing the multi-chamber balloon includes a balloon mandrel which may be dip coated in a silicone dispersion to create an elastomeric membrane for the inner and outer chambers integral with the valve body. The elastomeric membrane formed on the mandrel is partially inverted to form a coaxial elastomeric structure with the smaller inner chamber disposed within the larger outer chamber. The valve is incorporated into the inner and outer chambers to form a unitary structure. ## Claims ### Claim 1 An implantable prosthetic device comprising: an inner inflatable enclosure having a first opening and a second opening generally opposite of the first opening; an outer inflatable enclosure having a first opening and a second opening generally opposite of the first opening of the outer inflatable enclosure, the outer inflatable enclosure encapsulating the inner inflatable enclosure; a valve assembly sealingly coupled to the first opening of the outer inflatable enclosure and the first opening of the inner inflatable enclosure, the valve assembly being configured to allow independent inflation of the outer and inner inflatable enclosures; a plug sealingly couples the second opening of the inner inflatable enclosure and the second opening of the outer inflatable enclosure; and a reinforcement band around the periphery of the outer inflatable enclosure. ### Claim 2 (depends on 1) The implantable prosthetic device of claim 1, wherein the inner and outer inflatable enclosures comprise a unitary piece of material. ### Claim 3 (depends on 1) The implantable prosthetic device of claim 1, wherein the plug is coupled to a neck portion of the second opening of the outer inflatable enclosure. ### Claim 4 (depends on 3) The implantable prosthetic device of claim 3, wherein the plug and the neck portion of the second opening of the outer inflatable enclosure are coupled to a neck portion of the second opening of the inner inflatable enclosure. ### Claim 5 (depends on 4) The implantable prosthetic device of claim 4, wherein the reinforcement band is tucked into the second opening of the inner inflatable enclosure. ### Claim 6 (depends on 1) The implantable prosthetic device of claim 1, wherein the reinforcement band is attached only to the plug. ### Claim 7 (depends on 1) The implantable prosthetic device of claim 1, further comprising a fastener for fastening the reinforcement band to the plug. ### Claim 8 (depends on 1) The implantable prosthetic device of claim 1, wherein the reinforcement band includes a shape memory material. ### Claim 9 (depends on 8) The implantable prosthetic device of claim 8, wherein the reinforcement band further comprises a tubular braid enclosing the shape memory material. ### Claim 10 (depends on 1) The implantable prosthetic device of claim 1, wherein the valve assembly comprises: a valve core having an opening from an interior of the valve core to an exterior of the valve core; a valve membrane coupling the first openings of the outer and inner inflatable enclosures, the valve membrane partially enveloping the valve core and having an opening into the outer inflatable enclosure, wherein the opening in the valve membrane and the valve core are separated from one another. ### Claim 11 (depends on 10) The implantable prosthetic device of claim 10, wherein the valve core further comprises a resealable, puncturable membrane for accessing the inner inflatable enclosure. ### Claim 12 (depends on 10) The implantable prosthetic device of claim 10, wherein the valve membrane and the valve core are integrally molded. ### Claim 13 (depends on 10) The implantable prosthetic device of claim 10, wherein the valve core is bonded to the valve membrane with an adhesive. ### Claim 14 (depends on 1) The implantable prosthetic device of claim 1, wherein the inner and outer inflatable enclosures comprise an elastomer. ### Claim 15 (depends on 1) The implantable prosthetic device of claim 1, further comprising: a cured silicone material inflating the outer inflatable enclosure; and a compressible gas inflating the inner inflatable enclosure to allow the cured silicone material to deform. ### Claim 16 (depends on 15) The implantable prosthetic device of claim 15, wherein the cured silicone material substantially surrounds the inner inflatable enclosure. ### Claim 17 (depends on 15) The implantable prosthetic device of claim 15, wherein the cured silicone material further polymerizes with the inner and outer inflatable enclosures to form a solid member. ### Claim 18 A valve assembly for inflating an implantable prosthetic device comprising an inner inflatable enclosure connected to an outer inflatable enclosure; the valve assembly comprising: an elastomeric membrane forming a passageway from an interior of the inner inflatable enclosure to an exterior of the outer inflatable enclosure, the elastomeric membrane having an opening into an interior of the outer inflatable enclosure; a valve core disposed in the passageway so that the elastomeric membrane surrounds the valve core, the valve core comprising a conduit extending from a first end to a second end; a resealable, puncturable membrane at the second end of the conduit of the valve core for providing resealable access to the inner inflatable enclosure; and an opening in the conduit extending from an interior of the conduit to an exterior of the conduit; the opening in the conduit of the valve core being offset from the opening in the elastomeric membrane to form a one way valve allowing material introduced into the interior of the conduit to pass into the interior of the outer inflatable enclosure. ### Claim 19 An implantable prosthetic device comprising: an inner inflatable enclosure having a first opening and filled with a compressible gas; an outer inflatable enclosure having a first opening and filled with a cured silicone material, the outer inflatable enclosure substantially encapsulating the inner inflatable enclosure; a valve assembly sealingly coupled to the first opening of the outer inflatable enclosure and the first opening of the inner inflatable enclosure, the valve assembly comprising: a valve section disposed between a proximal end of the outer inflatable enclosure and a proximal end of the inner inflatable enclosure, wherein the valve section comprises a conduit having a sidewall with at least one opening extending through the sidewall; and, optionally, a reinforcement band around the periphery of the outer inflatable enclosure. ### Claim 20 (depends on 19) The implantable prosthetic device of claim 19, wherein the inner inflatable enclosure has a second opening generally opposite of the first opening of the inner inflatable enclosure; the outer inflatable enclosure has a second opening generally opposite of the first opening of the outer inflatable enclosure; and a plug sealingly couples the second opening of the inner inflatable enclosure and the second opening of the outer inflatable enclosure.