In-situ formed intervertebral fusion device and method

• US 9,801,729 B2
• Filed: 03/25/2015
• Issued: 10/31/2017
• Est. Priority Date: 02/14/2003
• Status: Expired due to Term

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: DiMauro, Thomas M., Slivka, Michael Andrew, Aquino Shluzas, Lauren
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Negrellirodrigue, Christina
• Application Number:
  US14/668,576
• Publication Number:
  US 20150196401A1
• Time in Patent Office: 951 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:

first and second vertically-disposed telescopically expandable supporting elements, each supporting element having an upper end and a lower end;

a first rigid bar connecting the upper ends of the telescopically expandable supporting elements;

a second rigid bar connecting the lower ends of the telescopically expandable supporting elements;

an upper surface comprising the first rigid bar and defining a first opening; and

a lower surface comprising the second rigid bar and defining a second opening.

2. The device of claim 1, wherein the upper and lower surfaces define a natural angle between adjacent vertebrae.

3. The device of claim 1, wherein the upper and lower surfaces and the supporting elements at least partially define an open cavity.

4. The device of claim 1, wherein a window is disposed between the first and second rigid bars and between the upper and lower surfaces.

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

6. The device of claim 1, further comprising:

a first fluid communication means configured to direct a fluid under pressure into the first and second telescopically expandable supporting elements to increase a height of the first and second telescopically expandable supporting elements; and

a second fluid communication means containing an osteobiologic.

7. An intervertebral fusion device comprising:

a first telescopically expandable component; and

a second telescopically expandable component;

wherein the first and second telescopically expandable components are coupled to one another by upper and lower bars such that the first telescopically expandable component, the second telescopically expandable component, the upper bar, and the lower bar define an opening therebetween;

wherein the fusion device is configured to move from a collapsed to an expanded configuration by injection of fluid into the first and second telescopically expandable components.

8. The device of claim 7, wherein an anterior height of the fusion device differs from a posterior height of the fusion device when the fusion device is in the expanded configuration.

9. The device of claim 8, wherein the anterior and posterior heights are selected to restore a natural angle between adjacent vertebrae.

10. The device of claim 7, further comprising at least one fluid communication means configured to direct a fluid under pressure into the first and second telescopically expandable components to move the fusion device from the collapsed to the expanded configuration.

11. The device of claim 7, wherein the first and second telescopically expandable components at least partially define an open cavity when the fusion device is in the expanded configuration.

12. The device of claim 7, further comprising:

a first fluid communication means configured to direct a fluid under pressure into the first and second telescopically expandable components to move the fusion device from the collapsed to the expanded configuration; and

a second fluid communication means containing an osteobiologic.

13. A spacer for insertion into an intervertebral disc space, the spacer comprising:

an outer wall comprising a metal and defining a cranial margin and a caudal margin, the outer wall being arcuate along its length;

an inner wall comprising a metal and defining a cranial margin and a caudal margin, the inner wall being arcuate along its length; and

an intermediate expandable compartment,

wherein filling of the intermediate expandable compartment with a fluid causes the compartment to expand in a cranial direction away from the cranial margins of the inner and outer walls, thereby providing distraction of the disc space.

14. The spacer of claim 13, wherein the spacer is configured to expand to a wedge shape to thereby restore a natural angle between adjacent vertebrae.

15. The spacer of claim 13, further comprising a syringe pump configured to inject fluid into the expandable compartment.

16. The spacer of claim 13, wherein a thickness of the spacer remains constant as the expandable compartment is filled with fluid to increase a height of the spacer.

17. The spacer of claim 13, wherein the footprints of the inner and outer walls represent substantially equal arcs of two concentric circumferences.

21. The method of claim 16, wherein rigid upper and lower rims extending between the first and second telescopically expandable components engage vertebral endplates adjacent to the intervertebral space when the fusion device is in the expanded configuration.

18. A method for intervertebral fusion comprising:

inserting a fusion device into an intervertebral space in a collapsed configuration in which the fusion device has a first height; and

after inserting the fusion device, distracting the intervertebral space by injecting fluid into first and second telescopically expandable components of the fusion device, the first and second telescopically expandable components being disposed within the intervertebral space, to cause the device to expand to an expanded configuration in which the fusion device has a second height that is greater than the first height.

19. The method of claim 18, wherein the fusion device restores a natural angle between adjacent vertebrae when in the expanded configuration.

20. The method of claim 18, further comprising injecting an osteogenic component into an open cavity defined by the expanded fusion device.

22. The method of claim 18, wherein the fluid is injected through a first fluid communication means and wherein the method further comprises injecting an osteobiologic through a second fluid communication means.