In-situ formed intervertebral fusion device and method

• US 9,814,589 B2
• Filed: 09/17/2015
• Issued: 11/14/2017
• 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.
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Negrellirodrigue, Christina
• Application Number:
  US14/856,716
• Publication Number:
  US 20160000577A1
• Time in Patent Office: 789 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 for insertion between upper and lower vertebral endplates, the device comprising:

a) upper and lower plates, each plate having an outer bearing surface for bearing against a respective vertebral endplate, an inner surface, and a longitudinal length; and

b) a core disposed between the outer bearing surfaces of the plates and running longitudinally along the length of the plates;

wherein the device has an unexpanded configuration in which the outer bearing surfaces are relatively close and an expanded configuration in which the outer bearing surfaces are relatively distant;

wherein the outer bearing surfaces are substantially parallel to one another in each of the unexpanded and expanded configurations;

wherein at least a portion of each inner surface extends at an oblique angle from its respective outer bearing surface in a longitudinal direction;

wherein the core does not contact either inner surface when the device is in each of the unexpanded configuration and the expanded configuration;

wherein at least a portion of the inner surfaces are parallel to each other; and

wherein the inner surfaces nest with each other in the unexpanded configuration.

2. The device of claim 1, wherein each plate has an opening in its outer bearing surface sized to permit bony fusion therethrough from the upper vertebral endplate to the lower vertebral endplate.

3. The device of claim 1, wherein a proximal portion of each inner surface extends at an angle from its respective outer bearing surface.

4. The device of claim 3, wherein a distal portion of each inner surface extends at an angle from its respective outer bearing surface.

5. The device of claim 1, wherein the core is metallic.

6. The device of claim 1, wherein a maximum height of the upper plate is equal to a maximum height of the device when the device is in the unexpanded configuration.

7. The device of claim 6, wherein a maximum height of the lower plate is equal to a maximum height of the device when the device is in the unexpanded configuration.

8. The device of claim 1, wherein the inner surfaces engage one another when the device is in the unexpanded configuration.

9. The device of claim 1, wherein at least a portion of each inner surface extends at an acute angle from its respective outer bearing surface.

10. An intervertebral implant for insertion between upper and lower vertebrae, the implant comprising:

an upper plate having an outer bearing surface for bearing against an upper vertebra and an inner surface opposite the outer bearing surface;

a lower plate having an outer bearing surface for bearing against a lower vertebra and an inner surface opposite the outer bearing surface; and

a core disposed between the outer bearing surfaces of the plates;

wherein the implant has a first configuration in which the outer bearing surfaces of the upper and lower plates are spaced apart by a first distance and a second configuration in which the outer bearing surfaces of the upper and lower plates are spaced apart by a second distance that is greater than the first distance;

wherein at least a portion of each inner surface extends at an angle from its respective outer bearing surface and wherein said angled portions of each inner surface contact each other when the implant is in the first configuration;

wherein the inner surfaces are parallel to each other; and

wherein at least a portion of the core is disposed between the outer bearing surfaces of the plates when the implant is in the first configuration.

11. The implant of claim 10, wherein the core does not contact either inner surface when the implant is in each of the first configuration and the second configuration.

12. The implant of claim 10, wherein each plate has an opening in its outer bearing surface sized to permit bony fusion therethrough from the upper vertebra to the lower vertebra.

13. The implant of claim 10, wherein a proximal portion of each inner surface extends at an angle from its respective outer bearing surface.

14. The implant of claim 13, wherein a distal portion of each inner surface extends at an angle from its respective outer bearing surface.

15. The implant of claim 10, wherein the core is metallic.

16. The implant of claim 10, wherein a maximum height of the upper plate is equal to a maximum height of the implant when the implant is in the first configuration.

17. The implant of claim 16, wherein a maximum height of the lower plate is equal to a maximum height of the implant when the implant is in the first configuration.

18. The implant of claim 10, wherein at least a portion of each inner surface extends at an acute angle from its respective outer bearing surface.