Composite spinal nucleus implant with water absorption and swelling capabilities
View Patent ↗Embodiments relate to a spinal nucleus implant with water absorption and swelling capabilities, compositions for producing the spinal nucleus implants, and methods of preparing and using the spinal nucleus implants. The spinal nucleus implant can be created from a composition comprising a mixture of non-hydrogel polymer material and at least one hydrophilic polymer, the weight ratio of non-hydrogel polymer material to the at least one hydrophilic polymer being from about 1:1 to about 19:1.
1. A spinal nucleus implant comprising a heterogeneous mixture of non-hydrogel polymer material and at least one hydrophilic polymer wherein the non-hydrogel polymer material and the at least one hydrophilic polymer are present in a weight ratio from about 1:1 to about 19:1, wherein the implant has a tapered cross-section formed by the ratio of non-hydrogel polymer material to hydrophilic polymer in the posterior side of the implant from about 19:1 to about 10:1 and in the anterior side from about 10:1 to about 1:1, and wherein, upon hydration, said implant occupies at least 50% of evacuated disc space.
2. The spinal nucleus implant of claim 1 , wherein the implant has a shape selected from the group consisting of a substantially “C”-shape, spherical, cylindrical, helixical, ovate, tapered three-dimensional trapezoid, or rod-like shape.
3. The spinal nucleus implant of claim 1 , wherein the implant has a height within the range of from about 3 mm to about 15 mm.
4. The spinal nucleus implant of claim 1 , wherein the implant has a volume within the range of from about 0.5 mL to about 10 mL.
5. The spinal nucleus implant of claim 1 , wherein the implant is substantially deformable in the plane perpendicular to the spine and substantially less deformable in the direction parallel to the spine.
6. The spinal implant of claim 1 , wherein the non-hydrogel polymer and the at least one hydrophilic polymer are present in a weight ratio from about 3:1 to about 19:1.
7. The spinal implant of claim 1 , wherein the non-hydrogel polymer and the at least one hydrophilic polymer are present in a weight ratio from about 4.5:1 to about 19:1.
8. A method of making a spinal nucleus implant comprising: mixing a non-hydrogel polymer material and at least one hydrophilic polymer to form a heterogeneous or homogeneous mixture, wherein the non-hydrogel polymer material and the at least one hydrophilic polymer are present in a weight ratio from about 1:1 to about 19:1; molding the mixture into a nucleus implant wherein the implant has a tapered cross-section formed by the ratio of non-hydrogel polymer material to hydrophilic polymer in the posterior side of the implant from about 19:1 to about 10:1 and in the anterior side from about 10:1 to about 1:1; and curing or solidifying the non-hydrogel polymer to form the spinal nucleus implant.
9. The method of claim 8 , wherein molding comprises injection molding, transfer molding, compression molding, reaction-injection molding, blow molding, insert molding, or extrusion molding.
10. The method of claim 8 , wherein mixing comprises melting the non-hydrogel polymer material and adding the hydrophilic material to the molten non-hydrogel polymer material in an extruder, a blender, a mixer, a container, or a mold.
11. The method of claim 8 , wherein mixing comprises melting the hydrophilic material and adding the non-hydrogel polymer material to the molten hydrophilic material in an extruder, a blender, a mixer, a container, or a mold.
12. The method of claim 8 , wherein the non-hydrogel polymer and the at least one hydrophilic polymer are present in a weight ratio from about 3:1 to about 19:1.
13. The spinal implant of claim 1 , wherein the non-hydrogel polymer and the at least one hydrophilic polymer are present in a weight ratio from about 4.5:1 to about 7:1.
14. A method of treating or preventing a disease or disorder associated with the spine, comprising: surgically evacuating at least a portion of the nucleus pulposus material and any free disc fragments from an intervertebral disc space; producing a spinal nucleus implant as claimed in claim 8 ; and implanting the spinal nucleus implant into the at least partially evacuated intervertebral disc space.
15. The method of claim 14 , further comprising measuring the volume of the at least partially evacuated intervertebral disc space by an injectable balloon prior to implanting the spinal nucleus implant.
16. The method of claim 14 , wherein the disease or disorder is selected from the group consisting of: bulging disc(s); herniated disc(s); spinal injury due to trauma; age-related degeneration or failure of spinal column components; spinal instability; discogenic back pain; intervertebral osteochondrosis; spondylolisthesis; spinal infection; spinal tumors; arthritis of the spine; and combinations thereof.