In-situ formed intervertebral fusion device and method

• US 9,788,963 B2
• Filed: 10/19/2015
• Issued: 10/17/2017
• 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: Aquino Shluzas, Lauren, DiMauro, Thomas M.
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Negrellirodrigue, Christina
• Application Number:
  US14/886,302
• Publication Number:
  US 20160038304A1
• Time in Patent Office: 729 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. An intervertebral fusion device, comprising an anterior endportion, a posterior endportion, an upper surface adapted for gripping a vertebral endplate, and a lower surface adapted for gripping a vertebral endplate, the upper and lower surfaces defining an anterior height at the anterior endportion and a posterior height at the posterior endportion, a pair of sidewalls connecting the two endportions and defining a vertical throughhole extending from the upper surface to the lower surface, wherein the device has:

i) a collapsed configuration in which the anterior height is less than the posterior height, and

ii) an expanded configuration in which the anterior height is greater than the posterior height;

wherein the posterior height is greater in the expanded configuration than in the collapsed configuration.

2. The device of claim 1, further comprising a longitudinal element detachably connected to the posterior endportion, actuation of the longitudinal element being effective to move the fusion device from the collapsed configuration to the expanded configuration.

3. The device of claim 1, wherein the device has a first width in the collapsed configuration and a second width in the expanded configuration, and wherein the second width is greater than the first width.

4. The device of claim 1, wherein the anterior height is greater in the expanded configuration than in the collapsed configuration.

5. The device of claim 1, wherein the upper and lower surfaces define a natural angle between adjacent vertebrae when the device is in the expanded configuration.

6. The device of claim 1, further comprising a plurality of outward projections formed on at least one of the upper and lower surfaces.

7. The device of claim 1, further comprising an osteogenic component disposed in the vertical throughhole.

8. A spinal assembly comprising:

i) an intervertebral fusion device comprising a medial endportion, a lateral endportion, an upper surface adapted for gripping a vertebral endplate, and a lower surface adapted for gripping a vertebral endplate, the device having a medial height at the medial endportion and a lateral height at the lateral endportion, the lateral height being defined by the upper and lower surfaces, a pair of sidewalls extending between the two endportions and defining a throughhole extending from the upper surface to the lower surface, wherein the device extends from the medial endportion to the lateral endportion in a lateral direction, and wherein the device has;

a) a collapsed configuration in which the lateral height is less than the medial height, and

b) an expanded configuration in which the lateral height is greater than the medial height; and

ii) a longitudinal element extending in a first direction and detachably connected to the medial endportion of the intervertebral fusion device;

wherein the extension of the fusion device in the lateral direction is substantially perpendicular to the first direction.

9. The assembly of claim 8, wherein actuation of the longitudinal element is effective to move the fusion device from the collapsed configuration to the expanded configuration.

10. The assembly of claim 8, wherein the lateral height is greater in the expanded configuration than in the collapsed configuration.

11. The assembly of claim 8, wherein the upper and lower surfaces define a natural angle between adjacent vertebrae when the device is in the expanded configuration.

12. The assembly of claim 8, further comprising a plurality of outward projections formed on at least one of the upper and lower surfaces.

13. The assembly of claim 8, further comprising an osteogenic component disposed in the throughhole.

14. A spinal assembly comprising:

a) an intervertebral fusion device comprising a medial endportion, a lateral endportion, an upper surface adapted for gripping a vertebral endplate, and a lower surface adapted for gripping a vertebral endplate, the device having a medial height at the medial endportion and a lateral height at the lateral endportion, the lateral height being defined by the upper and lower surfaces, a pair of sidewalls extending between the two endportions and defining a throughhole extending from the upper surface to the lower surface, wherein the device extends from the medial endportion to the lateral endportion in a lateral direction, and wherein the device has a collapsed configuration and an expanded configuration; and

b) a longitudinal element extending in a first direction and detachably connected to the medial endportion of the intervertebral fusion device;

wherein, during expansion from the collapsed configuration to the expanded configuration, the upper surface moves in a direction along a medial-lateral axis that is substantially perpendicular to the first direction.

15. The assembly of claim 14, wherein, during said expansion, the upper surface moves relative to the longitudinal element in the direction along the medial-lateral axis.

16. The assembly of claim 14, wherein, during said expansion, the upper surface moves relative to the medial endportion in the direction along the medial-lateral axis.

17. The assembly of claim 14, wherein actuation of the longitudinal element is effective to move the fusion device from the collapsed configuration to the expanded configuration.

18. The assembly of claim 14, wherein the lateral height is greater in the expanded configuration than in the collapsed configuration.

19. The assembly of claim 14, wherein the upper and lower surfaces define a natural angle between adjacent vertebrae when the device is in the expanded configuration.

20. The assembly of claim 14, further comprising a plurality of outward projections formed on at least one of the upper and lower surfaces.

21. The assembly of claim 14, further comprising an osteogenic component disposed in the throughhole.

22. An intervertebral fusion device, comprising:

a first frame having upper and lower rims; and

a second frame having upper and lower rims;

wherein the upper and lower rims of the first frame have teeth configured to engage vertebral endplates;

wherein the upper rim of the first frame is coupled to the upper rim of the second frame;

wherein the lower rim of the first frame is coupled to the lower rim of the second frame;

wherein the device has;

i) a collapsed configuration in which an anterior end of the upper rim of the first frame is positioned below at least a portion of the upper rim of the second frame and in which the anterior end of the upper rim of the first frame and an anterior end of the lower rim of the first frame are separated by a first height; and

ii) an expanded configuration in which the anterior end of the upper rim of the first frame is positioned above at least a portion of the upper rim of the second frame and in which the anterior end of the upper rim of the first frame and the anterior end of the lower rim of the first frame are separated by a second height that is greater than the first height.

23. The device of claim 22, wherein, when the device is in the expanded configuration:

the upper rim of the first frame and the upper rim of the second frame define an upper surface;

the lower rim of the first frame and the lower rim of the second frame define a lower surface; and

the upper and lower surfaces define a natural angle between adjacent vertebrae.

24. The device of claim 22, further comprising an osteogenic component disposed in a central cavity of the device disposed between the upper rim of the first frame, the lower rim of the first frame, the upper rim of the second frame, and the lower rim of the second frame.