Textile-Based Spinal Implant and Related Methods

• US 20100286778A1
• Filed: 04/18/2008
• Published: 11/11/2010
• Est. Priority Date: 04/18/2007
• Status: Abandoned Application

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Shoshtaev, Eugene, Eisermann, Lukas, McLeod, Alan, Butcher, Peter, Reah, Christopher, Valentine, Keith
• Application Number:
  US12/596,657
• Publication Number:
  US 20100286778A1
• Time in Patent Office: Days
• US Class Current: 623/17.11
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30006 differing in density or specific weight
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30459 stapled
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30481 using a locking clip
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30733 Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property
• CPC Class Codes: A61F 2002/30772 Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30919 Sleeves
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/4628 with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0015 : differing in density or specific weight
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• 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 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00149 : Platinum or Pt-based alloys

Abstract

A textile-based surgical implant that can be inserted through any number of suitable surgical approaches, including but not limited to lateral, anterior, anterior-lateral, posterolateral, and/or posterior approaches. When applied to spine surgery and inserted into an intervertebral disc space, the implant restores the normal height of the intervertebral disc space, while advantageously preserving the natural motion of the spine. The textile construction of the implant is beneficial because it is generally compliant and thereby restores and/or improves spinal motion. The compliant nature of the textile-based implant provides the required flexibility and elasticity to advantageously support physiological movements, as opposed to fusion surgery which forms a boney bridge between adjacent vertebral bodies. In addition, the porosity and biocompatibility of the textile-based implant facilitates tissue ingrowth throughout part or all of the implant, which helps to secure and encapsulate the implant in the intervertebral space.

Claims

1. A textile-based spinal implant dimensioned to be implanted within an intervertebral space, comprising:

a core comprising a plurality of textile layer regions stacked on top of one another to form a spacer element; and

a textile jacket encapsulating the core, the jacket having a pair of opposing vertebral contact surfaces, each vertebral contact surface configured to contact a surface of a vertebral body.

2. The implant of claim 1, wherein the plurality of textile layer regions are formed from at least one of a plurality of individual textile layer elements consecutively stacked on top of one another, a plurality of hingedly connected individual textile layer regions folded on top of one another, and a single continuous textile sheet folded upon itself to form a plurality of stacked textile layer regions.

3. The implant of claim 1, wherein the plurality of stacked textile layer regions are coupled together by at least one of supplemental stitching and adhesives.

4. The implant of claim 1, wherein one or more of the plurality of textile layer regions is contoured such that the spacer element has a cross-section having a pair of opposing non-parallel sides, the non-parallel sides corresponding to the vertebral contact surfaces of the textile jacket.

5. The implant of claim 4, wherein the opposing non-parallel sides are at least one of partially angled relative to one another, generally tapered relative to one another, arranged in a stair step fashion, and curved relative to one another.

6. The implant of claim 4, wherein the one or more textile layer regions is contoured by repeatedly overstitching different sections of the textile layer region using thread of the same thickness to form sections varying in at least one of height and stitch density.

7. The implant of claim 4, wherein the one or more textile layer regions is contoured by stitching different sections of the textile layer region using threads of varying thickness to form sections having varying height.

8. The implant of claim 4, wherein the one or more textile layer regions is contoured by stacking fabric layers having at least one of different sizes and shapes consecutively on top of one another to form sections having different heights.

9. The implant of claim 4, wherein the one or more textile layer regions is contoured by stitching different sections of the textile layer region using sections of different yarn spacing to form sections having different heights.

10. The implant of claim 1, wherein the core is provided with at least one internal radio-opaque marker to enable visualization of the implant after implantation using fluoroscopy.

11. The implant of claim 10, wherein the radio-opaque marker is at least one of an elongated cylinder, a short cylinder, a bead, and an annular ring.

12. The implant of claim 1, wherein the encapsulating jacket has at least one expandable outer cap and a circumferential barrier effective to reinforce the shape of the spacer element.

13. The implant of claim 1, further comprising reinforced stitching throughout the implant, the reinforced stitching effective to prevent bulging of the implant after insertion into an intervertebral space.

14. The implant of claim 1, wherein the implant is dimensioned for insertion into the intervertebral space from at least one of a lateral aspect of a spine and an anterior aspect of a spine.

15. A system for performing spinal surgery, comprising:

a textile-based spinal implant, the implant including a core comprising a plurality of textile layer regions stacked on top of one another to form a spacer element, an encapsulating jacket, and an engagement element dimensioned to facilitate engagement with an insertion device;

an insertion device including a proximal handle portion to allow for user manipulation and a distal engagement region dimensioned to engage with the engagement element of the implant; and

a fixation element configured to securely affix the implant to at least one vertebral body.

20. The system of claim 15, wherein the engagement element comprises at least one pocket provided on the encapsulating jacket.

21. The system of claim 20, wherein the distal engagement region of the insertion device comprises an insertion plate dimensioned to be received within the at least one pocket.

22. The system of claim 15, wherein the engagement element comprises a wireframe provided within the implant, at least a portion of the wireframe at least partially protruding from the implant.

23. The system of claim 22, wherein, wherein the distal engagement region of the insertion device comprises a clamping mechanism configured to engage the portion of the wireframe at least partially protruding from the implant.

24. The system of claim 15, wherein the engagement element comprises an engagement plate positioned at a distal end of the implant and including a threaded aperture, said implant further comprising an aperture extending from a proximal end of the implant to the engagement plate.

25. The system of claim 24, wherein the distal engagement region of the insertion device comprises a threaded engagement feature configured to threadedly engage the threaded aperture of the engagement plate.

26. The system of claim 15, wherein the fixation element comprises at least one of a bone screw, nail, tack, suture, and adhesive.

27. The system of claim 15, wherein the fixation element comprises a fixation buttress and a screw.

28. The system of claim 27, wherein the fixation buttress is at least one of attached and clip-on.

16-19. -19. (canceled)

29. A method for performing spinal surgery, comprising:

providing a textile-based spinal implant the implant including a core comprising a plurality of textile layer regions stacked on top of one another to form a spacer element, an encapsulating jacket, and an engagement element dimensioned to facilitate engagement with an insertion device;

engaging said engagement element to an insertion device; and

inserting said spinal implant into a surgical target site, and thereafter releasing said implant from said insertion device.

30-33. -33. (canceled)