Prosthetic intervertebral discs having balloon-based fillable cores that are implantable by minimally invasive surgical techniques
View Patent ↗The described devices are spinal implants that may be surgically implanted into the spine to replace damaged or diseased discs using a posterior approach. The discs are prosthetic devices that approach or mimic the physiological motion and reaction of the natural disc.
1. A prosthetic intervertebral disc for inserting in an intervertebral space between two adjacent vertebrae in a spine, comprising:
a.) a first end plate;
b.) a second end plate;
c.) at least one core member comprising a fillable noncompliant balloon having a first unfilled configuration and a second filled configuration, positioned between said first and second end plates; and
d.) at least one fiber extending between and engaged with said first and second end plates; and
wherein said end plates and said core member are held together by said at least one fiber and wherein the disc is configured to be insertable into the intervertebral space when the fillable noncompliant balloon is in the unfilled configuration and wherein the fillable noncompliant balloon is configured to be filled to the filled configuration after being inserted in the intervertebral space.
2. The prosthetic intervertebral disc of claim 1 wherein the fibers have been placed to extend between the first end plate and said second end plate in a form including the fillable noncompliant balloon.
3. The prosthetic intervertebral disc of claim 1 further including an amount of at least one curable polymer system, curable within the fillable noncompliant balloon.
4. The prosthetic intervertebral disc of claim 1 further including an amount of at least one hydrogel.
5. The prosthetic intervertebral disc of claim 1 wherein the fillable noncompliant balloon is a pre-formed balloon.
6. The prosthetic intervertebral disc of claim 1 wherein the fillable noncompliant balloon is a pre-shaped balloon.
7. The prosthetic intervertebral disc of claim 1 wherein the fillable noncompliant balloon comprises a balloon wall having a composition selected from the group consisting of polyamides, polyimides, polyolefins, and polyethylene-block amides.
8. A kit for surgically replacing a disc in a spine with a posterior approach, comprising exactly two of the prosthetic discs of claim 1 .
9. The kit of claim 8 further comprising at least one cannula suitable for a posterior approach configured to access a disc to be replaced and to bypass the spinal cord and local nerve roots and further sized for passage of at least one of the prosthetic discs of claim 1 .
10. The kit of claim 9 wherein the first and second end plates of each of the prosthetic discs have a length and a width, and wherein the length is greater than the width.
11. The kit of claim 10 wherein the first and second end plates of each of the prosthetic discs have a length:width aspect ratio range of about 1.5 to 5.0.
12. A kit for surgically replacing multiple discs in a spine with a posterior approach, comprising at least four of the prosthetic discs of claim 1 .
13. The kit of claim 12 further comprising at least one cannula suitable for a posterior approach configured to access a disc to be replaced and to bypass the spinal cord and local nerve roots and further sized for passage of at least one of the at least four of the prosthetic discs of claim 1 .
14. The kit of claim 13 wherein the first and second end plates of each of the at least four of the prosthetic discs have a length and a width, and wherein the length is greater than the width.
15. The kit of claim 14 wherein the first and second end plates of each of the at least four prosthetic discs have a length:width aspect ratio in the range of about 1.5 to 5.0.
16. A prosthetic intervertebral disc for inserting in an intervertebral space between two adjacent vertebrae in a spine, comprising:
a.) a first end plate;
b.) a second end plate;
c.) at least one core member comprising a fillable noncompliant balloon having a pre-form or pre-shape, a first unfilled configuration, and a second filled configuration, the balloon being positioned between said first and second end plates; the pre-form or pre-shape providing a selected lordotic angle between the first end plate and the second end plate when the fillable non-compliant balloon is in the second filled configuration, and
d.) at least one fiber extending between and engaged with said first and second end plates in a form including the fillable noncompliant balloon and placed to allow the fillable noncompliant balloon to form the selected lordotic angle between the first end plate and the second end plate when the fillable noncompliant balloon is in the second filled configuration; and
wherein said end plates and said core member are held together by said at least one fiber and wherein the disc is configured to be insertable into the intervertebral space when the fillable noncompliant balloon is in the first unfilled configuration and wherein the fillable noncompliant balloon is configured to be filled to the second filled configuration after being inserted in the intervertebral space.
17. The prosthetic intervertebral disc of claim 16 further including an amount of at least one curable polymer system, curable within the fillable noncompliant balloon.
18. The prosthetic intervertebral disc of claim 16 further including an amount of at least one hydrogel.
19. The prosthetic intervertebral disc of claim 16 wherein the fillable noncompliant balloon comprises a balloon wall having a composition selected from the group consisting of polyamides, polyimides, polyolefins, and polyethylene-block amides.
20. A kit for surgically replacing a disc in a spine with a posterior approach, comprising exactly two of the prosthetic discs of claim 16 .
21. The kit of claim 20 further comprising at least one cannula suitable for a posterior approach configured to access a disc to be replaced and to bypass the spinal cord and local nerve roots and further sized for passage of at least one of the prosthetic discs of claim 16 .
22. The kit of claim 21 wherein the first and second end plates of each of the prosthetic discs have a length and a width, and wherein the length is greater than the width.
23. The kit of claim 22 wherein the first and second end plates of each of the prosthetic discs have a length:width aspect ratio in the range of about 1.5 to 5.0.
24. A kit for surgically replacing multiple discs in a spine with a posterior approach, comprising at least four of the prosthetic discs of claim 16 .
25. The kit of claim 24 further comprising at least one cannula suitable for a posterior approach Configured to access a disc to be replaced and to bypass the spinal cord and local nerve roots and further sized for passage of at least one of the at least four of the prosthetic discs of claim 16 .
26. The kit of claim 25 wherein the first and second end plates of each of the at least four of the prosthetic discs have a length and a width, and wherein the length is greater than the width.
27. The kit of claim 26 wherein the first and second end plates of each of the at least four prosthetic discs have a length:width aspect ratio in the range of about 1.5 to 5.0.