EXPANDABLE COIL SPINAL IMPLANT

• US 20140277464A1
• Filed: 03/14/2013
• Published: 09/18/2014
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Richter, Joern, Teisen, Jacques
• Granted Patent: US 9,358,120 B2
• Time in Patent Office: Days
• US Class Current: 623/17.12
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: 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
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30019 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2002/30056 differing in radiographic density
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30263 cubical
• CPC Class Codes: A61F 2002/30289 : helically-coiled
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30331 : made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30484 : Mechanically expandable devices located on the first prosthetic part for locking into or onto the second prosthetic part
• CPC Class Codes: A61F 2002/3052 : unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30584 : filled with gas
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30588 : filled with solid particles
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30594 : slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30784 : Plurality of holes
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4683 : by applying ultrasonic vibrations
• CPC Class Codes: A61F 2002/4688 : having operating or control means
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00047 : Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys

Abstract

Coiled spinal implants for disc, vertebral body, and spinal motion segment replacement or reconstruction comprise a plurality of loops and spaces between the loops, with the loops formed of a hollow material and having a plurality of apertures or a longitudinal gap that extend(s) through the sidewalls of the loops and into the hollow center. The coiled implants include one or more balloons within the hollow center, the spaces between the coil loops, and/or within the central void that the coil surrounds. Filling the balloon expands the loops and thereby increases the height of the coil. Bone graft material or bone cement may be deployed from the apertures or gap.

Claims

1. A spinal implant, comprising:

an expandable coil comprising a hollow tube having a first end, a second end, side walls defining a lumen, and a plurality of apertures through the sidewalls, the hollow tube formed into a plurality of loops having a space between the lower and upper sidewalls of vertically adjacent loops, and at least one balloon present in at least some of the spaces between vertically adjacent loops, wherein the implant, when the coil is expanded, has a height that approximates the height of an intervertebral disc, the height of a vertebral body, or the height of a spinal motion segment.

2. The spinal implant of claim 1, wherein the hollow tube comprises nickel, titanium, steel, aluminum, or alloy thereof.

3. The spinal implant of claim 2, wherein the alloy comprises nitinol.

4. The spinal implant of claim 1, wherein the at least one balloon comprises a single chamber.

5. The spinal implant of claim 1, wherein the at least one balloon comprises a plurality of chambers.

6. The spinal implant of claim 4, wherein the chamber comprises a fluid selected from the group consisting of water, a physiologic saline solution, a radiopaque contrast medium, a hydrogel, and a bone cement.

7. The spinal implant of claim 5, wherein the plurality of chambers comprises a fluid selected from the group consisting of water, a physiologic saline solution, a radiopaque contrast medium, a hydrogel, and a bone cement.

8. The spinal implant of claim 1, wherein the at least one balloon is a compliant or semi-compliant balloon.

9. The spinal implant of claim 1, wherein the at least one balloon is a non-compliant balloon.

19. A method for reconstructing a vertebral body, comprising implanting the implant of claim 1 into a vertebral body, filling the at least one balloon with an amount of a fluid sufficient to expand the coil and increase the height of the implant, optionally, deploying a bone graft material or bone cement from the plurality of apertures into the vertebral body, and optionally, removing the expandable coil from the vertebral body.

20. A method for replacing an intervertebral disc, comprising implanting the implant of claim 1 into an intervertebral space from which at least a portion of the intervertebral disc has been removed, filling the at least one balloon with an amount of a fluid sufficient to expand the coil and increase the height of the implant, optionally, deploying a bone graft material or bone cement from the plurality of apertures into the intervertebral space, and optionally, removing the expandable coil from the intervertebral.

23. A method for reconstructing a spinal motion segment, comprising implanting the implant of claim 1 into void formerly occupied by at least a portion of two vertebral bodies and at least one intervertebral disc, filling the at least one balloon with an amount of a fluid sufficient to expand the coil and increase the height of the implant, optionally, deploying a bone graft material or bone cement from the gap into the void, and optionally, removing the expandable coil from the void.

10. A spinal implant, comprising:

an expandable coil comprising a hollow tube having a first end, a second end, side walls defining a lumen, and a gap through the sidewalls extending from the first end to the second end, the hollow tube formed into a plurality of loops having a space between the lower and upper sidewalls of vertically adjacent loops, and at least one balloon present in the lumen, wherein the implant, when the coil is expanded, has a height that approximates the height of an intervertebral disc, the height of a vertebral body, or the height of a spinal motion segment.

11. The spinal implant of claim 10, wherein the hollow tube comprises titanium, steel, aluminum, or alloy thereof.

12. The spinal implant of claim 11, wherein the alloy comprises nitinol.

13. The spinal implant of claim 10, wherein the at least one balloon comprises a single chamber.

14. The spinal implant of claim 10, wherein the at least one balloon comprises a plurality of chambers.

15. The spinal implant of claim 13, wherein the chamber comprises a fluid selected from the group consisting of water, a physiologic saline solution, a radiopaque contrast medium, a hydrogel, and a bone cement.

16. The spinal implant of claim 14, wherein the plurality of chambers comprises a fluid selected from the group consisting of water, a physiologic saline solution, a radiopaque contrast medium, a hydrogel, and a bone cement.

17. The spinal implant of claim 10, wherein the at least one balloon is a compliant or semi-compliant balloon.

18. The spinal implant of claim 10, wherein the at least one balloon is a non-compliant balloon.

21. A method for reconstructing a vertebral body, comprising implanting the implant of claim 10 into a vertebral body, filling the at least one balloon with an amount of a fluid sufficient to deploy the at least one balloon from the gap and into the spaces between the lower and upper sidewalls of vertically adjacent loops and thereby expand the coil and increase the height of the implant, optionally, deploying a bone graft material or bone cement from the gap into the vertebral body, and optionally, removing the expandable coil from the vertebral body.

22. A method for replacing an intervertebral disc, comprising implanting the implant of claim 10 into an intervertebral space from which at least a portion of the intervertebral disc has been removed, filling the at least one balloon with an amount of a fluid sufficient to deploy the at least one balloon from the gap and into the spaces between the lower and upper sidewalls of vertically adjacent loops and thereby expand the coil and increase the height of the implant, optionally, deploying a bone graft material or bone cement from the gap into the intervertebral space, and optionally, removing the expandable coil from the intervertebral space.

24. A method for reconstructing a spinal motion segment, comprising implanting the implant of claim 10 into void formerly occupied by at least a portion of two vertebral bodies and at least one intervertebral disc, filling the at least one balloon with an amount of a fluid sufficient to deploy the at least one balloon from the gap and into the spaces between the lower and upper sidewalls of vertically adjacent loops and thereby expand the coil and increase the height of the implant, optionally, deploying a bone graft material or bone cement from the gap into the void, and optionally, removing the expandable coil from the void.