Angulated rings and bonded foils for use with balloons for fusion and dynamic stabilization
An inflatable and implantable balloon for treatment of degenerative disc disease, bones, lesions, spinal deformities and spinal motion segment instabilities. The balloon is comprised of adjustable and expandable volumes. Further disclosed are methods of forming, inserting, expanding, and implanting the multi-volume balloon for proper placement and stabilization of the spinal lesion or disease. Still further disclosed are kits for aligning and stabilizing elements of the spine.
1. A method of angling a single-volume balloon to create a multi-volume balloon, the method comprising:
inserting a single-volume balloon into at least one ring, wherein the ring has a first end portion that defines a first opening, a second end portion that defines a second opening, and a central axis that extends through the first and second openings, wherein the first and second end portions are disposed at an oblique angle with respect to the central axis to define a predetermined angle of the end portions of the at least one ring;
inserting the ring containing the single-volume balloon into a cavity of a vertebral column, wherein the cavity is selected from the group consisting of an intervertebral disc space and a space in a vertebral body; and
expanding the single-volume balloon, wherein the expansion of the single-volume balloon within the ring forms a multi-volume balloon having at least two compartments, with the predetermined angle of the ring determining the angulation of a longitudinal axis of each compartment of the multi-volume balloon with respect to the central axis.
2. The method according to claim 1 , the method further comprising bonding the ring to the multi-volume balloon, wherein the bonding is selected from the group consisting of: ultrasonic welding, thermal welding using a light source, thermal welding using a heat source, pressure welding, swaging, joining, gluing, and stitching.
3. The method according to claim 1 , further comprising determining an amount of contents in each compartment of the multi-volume balloon by varying the location of the ring along a length of the single-volume balloon and the predetermined angle of the end portions of the ring.
4. The method according to claim 1 , further comprising inflating the single-volume balloon by connecting one end of the balloon to an inflation device.
5. The method according to claim 1 , wherein the single volume balloon is formed from at least two pieces of foil bonded together, wherein the bonding is selected from the group consisting of: ultrasonic welding, thermal welding using a light source, thermal welding using a heat source, pressure welding, swaging, joining, gluing, and stitching.
6. The method according to claim 1 , further comprising inflating the single-volume balloon with at least one of polymethyl methacrylate (PMMA), hydroxylapatide-based materials, calciumphosphate-based materials, and other bone cements.
7. The method according to claim 1 , further comprising inflating the single-volume balloon with at least one of water, saline solution, contrast medium solution, and gel.
8. The method according to claim 1 , further comprising inflating the single-volume balloon with at least one of elastomers, silicone-based elastomers, hydrogels, and silicone.
9. The method according to claim 1 , further comprising inflating the single-volume balloon with particles selected from the group consisting of: bone, polymers, and bone chips in a liquid.
10. The method according to claim 1 , further comprising inflating the single-volume balloon with bio-absorbable materials.
11. The method according to claim 1 , further comprising sealing an end of the balloon with a valve to prevent contents from being released from the multi-volume balloon.
12. The method according to claim 1 , further comprising filling the balloon with a solidifying material, wherein the solidifying material is selected from the group consisting of: polymer, crystalline solid, elastomer, and glass.
13. The method according to claim 1 , the method further comprising selecting a single-volume balloon made of an inflatable material selected from the group consisting of: foil, mesh, silicone rubber, elastomeric rubber, polyether ether ketone (or PEEK), polyether ketone ketone (or PEKK), polyethylene (or PE), polyurethane (or PU), polycarbonate urethane (or PCU), polyethylene terephthalate (or PET), and thermoplastic polyurethane (or TPU).
14. The method according to claim 1 , wherein the multi-volume balloon has two compartments, the two compartments being individually adjustable and expandable such that (a) each compartment can contain a variable volume of contents, and (b) each of the compartments can contain the same, or a different, volume of contents relative to another compartment.
15. The method according to claim 1 , wherein the multi-volume balloon has a first compartment and a second compartment, wherein the first compartment and the second compartment are expanded to different heights.
16. The method according to claim 15 , wherein the expansion of the first compartment is to provide a cushioning effect, and wherein the first compartment is expanded to a height greater than the second compartment.