In-situ formed intervertebral fusion device and method

• US 10,405,986 B2
• Filed: 11/08/2017
• Issued: 09/10/2019
• 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: Kelly, James Edward, DiMauro, Thomas M.
• Primary Examiner(s): Harvey, Julianna N
• Assistant Examiner(s): Negrellirodriguez, Christina
• Application Number:
  US15/806,363
• Publication Number:
  US 20180055649A1
• Time in Patent Office: 671 Days
• Field of Search: 606246-249, 623 1711- 1716
• 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. A surgical method, comprising:

inserting an implant into an intervertebral disc space defined between an upper vertebra and a lower vertebra, the implant comprising first and second structural walls and a balloon extending therebetween;

wherein said insertion comprises positioning the first structural wall of the implant in a first lateral portion of the disc space, the first structural wall being positioned such that an upper surface of the first structural wall contacts the upper vertebra and a lower surface of the first structural wall contacts the lower vertebra;

wherein said insertion comprises positioning the second structural wall of the implant in a second lateral portion of the disc space opposite the first lateral portion, the second structural wall being positioned such that an upper surface of the second structural wall contacts the upper vertebra, a lower surface of the second structural wall contacts the lower vertebra, and the second structural wall is spaced a distance apart from the first structural wall;

delivering a flowable material through a cannula and into a cavity of the balloon; and

expanding the balloon such that upper and lower surfaces of the balloon contact the upper and lower vertebrae, respectively, a height dimension defined between said upper and lower surfaces increasing during said expansion.

2. The method of claim 1, further comprising expanding the balloon in an anterior direction.

3. The method of claim 1, wherein the structural walls each have an anterior extent and a posterior extent, and wherein the balloon expands beyond the anterior and posterior extents of the structural walls.

4. The method of claim 1, wherein the balloon comprises a mesh.

5. The method of claim 1, wherein the balloon comprises polyethylene terephthalate.

6. The method of claim 1, wherein the implant includes a titanium rod reinforcement.

7. The method of claim 1, wherein the upper and lower surfaces of the balloon are porous.

8. The method of claim 1, wherein an anterior portion of the first structural wall is greater in height than a posterior portion of the first structural wall.

9. The method of claim 1, wherein the balloon is arcuate.

10. The method of claim 1, wherein the balloon has a pre-deployed state in which it is folded upon itself.

11. The method of claim 1, further comprising distracting the disc space using the implant.

12. The method of claim 1, wherein the flowable material comprises an osteobiologic component.

13. The method of claim 1, wherein a height of the structural walls is at least equal to the height of the natural disc space.

14. The method of claim 1, wherein the structural walls are polymeric.

15. The method of claim 1, wherein the flowable material enters the balloon through an opening in a peripheral side surface of the balloon.

16. The method of claim 15, wherein the opening is closely adjacent to one of the structural walls.

17. A surgical method, comprising:

inserting an implant into an intervertebral disc space defined between an upper vertebra and a lower vertebra, the implant comprising opposed first and second load-bearing lateral portions and a porous inflatable portion connecting the first and second lateral portions, the implant being positioned such that the first and second lateral portions are spaced apart from one another in a lateral direction and in contact with the upper and lower vertebrae; and

delivering a fluid to the implant to expand the inflatable portion such that an upper surface, a lower surface, and a peripheral side surface of the inflatable portion are pushed apart from one another,

wherein the lateral portions each have an anterior extent and a posterior extent, and wherein the inflatable portion expands beyond the anterior and posterior extents of the lateral portions.

18. The method of claim 17, wherein the inflatable portion comprises a mesh.

19. The method of claim 17, wherein the inflatable portion comprises polyethylene terephthalate.

20. The method of claim 17, wherein the implant includes a titanium rod reinforcement.

21. The method of claim 17, wherein the lateral portions are polymeric.