In-situ formed intervertebral fusion device and method

• US 10,639,164 B2
• Filed: 10/24/2016
• Issued: 05/05/2020
• Est. Priority Date: 02/14/2003
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: DiMauro, Thomas M., Slivka, Michael Andrew
• Primary Examiner(s): Harvey, Julianna N
• Assistant Examiner(s): NegrelliRodriguez, Christina
• Application Number:
  US15/331,978
• Publication Number:
  US 20170035578A1
• Time in Patent Office: 1,289 Days
• Field of Search: 623 1711- 1716, 606246-249
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2/4425 made of articulated components
• 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 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/3023 wedge-shaped cylinders
• CPC Class Codes: A61F 2002/30308 : banana-shaped
• CPC Class Codes: A61F 2002/30383 : made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30622 : Implant for fusing a joint or bone material
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30953 : using a remote computer network, e.g. Internet
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• 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 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0065 : telescopic
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61K 49/006 : Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
• CPC Class Codes: A61K 9/0024 : Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/252 : Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/256 : Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/404 : Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/43 : Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/64 : Animal cells
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/06 : Titanium or titanium alloys
• CPC Class Codes: A61L 27/12 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3821 : Bone-forming cells, e.g. osteoblasts, osteocytes, osteoprogenitor cells
• CPC Class Codes: A61L 27/3839 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3847 : Bones
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges

Abstract

An orthopedic device for implanting between adjacent vertebrae comprising: an arcuate balloon and a hardenable material within said balloon.

In some embodiments, the balloon has a footprint that substantially corresponds to a perimeter of a vertebral endplate. An inflatable device is inserted through a cannula into an intervertebral space and oriented so that, upon expansion, a natural angle between vertebrae will be at least partially restored. At least one component selected from the group consisting of a load-bearing component and an osteobiologic component is directed into the inflatable device through a fluid communication means.

Claims

1. An intervertebral fusion device, comprising:

a) an implant having a proximal end portion, a free distal end portion, and a lumen extending therethrough, the implant disposed in a curved shape in which the free distal end portion is disposed adjacent to the proximal end portion, the curved shape defining a central cavity that is external to the implant and substantially circumscribing a perimeter thereof; and

b) an osteobiologic component contained in the central cavity;

wherein the implant is deformable into a relatively elongated shape for delivery to a disc space through a cannula, wherein the proximal end portion is not adjacent to the free distal end portion when the implant is in the relatively elongated shape, and wherein the implant is configured to assume the curved shape without guidance from an external force.

2. The device of claim 1, wherein the implant comprises PEEK.

3. The device of claim 1, wherein the implant includes a plurality of titanium rods.

4. The device of claim 1, wherein the implant has upper and lower surfaces configured to engage upper and lower vertebral endplates, the upper and lower surfaces having surface features to prevent excessive movement of the implant after implantation in a disc space.

5. The device of claim 1, wherein the implant in the curved shape describes an arc of at least 270 degrees about a disc space.

6. The device of claim 1, wherein the implant in the curved shape describes an arc of at least 350 degrees about a disc space.

7. The device of claim 1, wherein the cavity is defined by an inner wall of the implant and wherein the osteobiologic component contacts the inner wall.

8. The device of claim 1, wherein the implant has a footprint that represents substantially equal arcs of two concentric circumferences.

9. The device of claim 1, further comprising a posterior fixation system.

10. The device of claim 9, wherein the posterior fixation system comprises at least one pedicle screw.

11. The device of claim 1, wherein the osteobiologic component comprises at least one of cancellous chips and demineralized bone matrix (DBM).

12. The device of claim 1, wherein the osteobiologic component comprises an osteoinductive scaffold.

13. The device of claim 1, wherein the osteobiologic component comprises a matrix having an open porosity.

14. A method of making an intervertebral fusion device, comprising:

a) inserting a cannula into an intervertebral disc space between upper and lower vertebral endplates;

b) passing an implant through the cannula and into the disc space, the implant having a proximal end portion, a free distal end portion, and a lumen extending therethrough, the implant assuming a substantially linear shape in which the free distal end portion is not adjacent to the proximal end portion as it passes through the cannula;

c) passing materials or devices through the lumen;

d) forming the implant into a curved shape in the intervertebral disc space by positioning the free distal end portion adjacent to the proximal end portion, the curved shape defining a central cavity that is external to the implant, the implant in the curved shape an arc of no more than 360 degrees about the disc space; and

e) inserting an osteobiologic component into the central cavity of the implant such that the osteobiologic component contacts an inner wall of the implant and the upper and lower vertebral endplates.

15. The method of claim 14, wherein the osteobiologic component comprises autograft.

16. The method of claim 14, wherein the curved shape is a generally toroidal shape.

17. The method of claim 14, wherein the implant is inserted into the disc space via a transforaminal approach.

18. The method of claim 14, wherein the implant comprises PEEK.

19. The method of claim 14, wherein the implant includes a plurality of titanium rods.

20. The method of claim 14, wherein the implant has upper and lower surfaces configured to engage the upper and lower vertebral endplates, the upper and lower surfaces having surface features to prevent excessive movement of the implant after implantation.

21. The method of claim 14, wherein the implant in the curved shape describes an arc of at least 270 degrees about the disc space.

22. The method of claim 14, wherein the implant in the curved shape describes an arc of at least 350 degrees about the disc space.

23. The method of claim 14, wherein the implant has a footprint that

24. The method of claim 14, further comprising stabilizing the disc space with a posterior fixation system comprising at least one pedicle screw.

25. The method of claim 14, wherein the osteobiologic component comprises at least one of cancellous chips and demineralized bone matrix (DBM).

26. The method of claim 14, wherein the osteobiologic component comprises an osteoinductive scaffold.

27. The method of claim 14, wherein the osteobiologic component comprises a matrix having an open porosity.

28. An intervertebral fusion device, comprising:

a) an implant having a proximal end portion and a free distal end portion, the implant disposed in a curved shape in which the free distal end portion is disposed adjacent to the proximal end portion, the curved shape defining a central cavity that is external to the implant, the implant in the curved shape an arc of no more than 360 degrees about the disc space; and

b) an osteobiologic component contained in the central cavity;

wherein the implant includes a plurality of titanium rods,

wherein the implant is deformable into a relatively elongated shape for delivery to a disc space through a cannula, wherein the proximal end portion is not adjacent to the free distal end portion when the implant is in the relatively elongated shape, and

wherein the implant is configured to assume the curved shape without guidance from an external force.