In-situ formed intervertebral fusion device and method

• US 10,376,372 B2
• Filed: 11/29/2017
• Issued: 08/13/2019
• 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: Serhan, Hassan, DiMauro, Thomas M., Malone, John Daniel
• Primary Examiner(s): Harvey, Julianna N
• Assistant Examiner(s): Negrellirodriguez, Christina
• Application Number:
  US15/825,240
• Publication Number:
  US 20180078379A1
• Time in Patent Office: 622 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 expandable spinal fusion device, comprising:

a) an upper endplate having an upper surface configured to engage bone;

b) a first ramp that defines a first ramping surface that extends at an oblique angle with respect to the upper surface of the upper endplate;

c) a lower endplate having a lower surface configured to engage bone;

d) a second ramp having a second ramping surface that extends at an oblique angle with respect to the lower surface of the lower endplate; and

e) a guidewire extending longitudinally through the device such that the device is insertable over the guidewire;

wherein the upper surface of the upper endplate and the lower surface of the lower endplate define a height therebetween;

wherein the height is increased when the first and second ramping surfaces slide along each other;

wherein the upper endplate includes a guide that is received in a track formed in the first ramp to mate the upper endplate to the first ramp;

wherein the upper endplate moves away from the second ramp when the first and second ramping surfaces slide along each other.

2. The device of claim 1, wherein the device has a cross-section substantially in the shape of an I-beam.

3. The device of claim 1, wherein the upper surface of the upper endplate and the lower surface of the lower endplate each include teeth extending therefrom for gripping bone.

4. The device of claim 1, wherein the upper surface of the upper endplate and the lower surface of the lower endplate each include openings to permit bony fusion therethrough.

5. The device of claim 1, wherein the device has an unexpanded configuration and an expanded configuration and wherein the upper surface of the upper endplate and the lower surface of the lower endplate are substantially parallel to one another in each of the unexpanded and expanded configurations.

6. The device of claim 1, wherein the guidewire does not contact either of the upper and lower endplates.

7. The device of claim 1, wherein the upper and lower endplates are modular.

8. The device of claim 1, wherein each of the upper endplate, the lower endplate, the first ramp, and the second ramp has a longitudinal axis and a cross-section transverse to the longitudinal axis, and the cross-sections of the upper and lower endplates are greater in width than the cross-sections of the first and second ramps.

9. The device of claim 1, wherein the device is longitudinally slidable over the guidewire.

10. The device of claim 1, wherein the guidewire extends completely through the device.

11. The device of claim 1, wherein the first ramping surface extends at an oblique angle with respect to the upper surface of the upper endplate and extends at an oblique angle with respect to the lower surface of the lower endplate when the first and second ramping surfaces slide along each other.

12. The device of claim 1, wherein, when the first and second ramping surfaces slide along each other, the first and second ramping surfaces are parallel to one another, the first ramping surface is obliquely angled with respect to the upper surface of the upper endplate and the lower surface of the lower endplate, and the second ramping surface is obliquely angled with respect to the upper surface of the upper endplate and the lower surface of the lower endplate.

13. An expandable spinal fusion device, comprising:

a first component having an upper surface, a first angled wall extending at an oblique angle from the upper surface, and a first opening to permit bony fusion through the first component;

a second component having a lower surface, a second angled wall extending at an oblique angle from the lower surface, and a second opening to permit bony fusion through the second component; and

a guidewire extending through the second component such that the second component can be delivered over the guidewire by first inserting the guidewire into place within the patient and then passing the second component over the guidewire into place within the patient;

wherein the first angled wall of the first component is slidable along the second angled wall of the second component to increase a height of the device, and

wherein the first angled wall extends at an oblique angle with respect to the upper surface of the first component and extends at an oblique angle with respect to the lower surface of the second component when the first and second angled walls slide along each other.

14. The device of claim 13, wherein the device has a cross-section substantially in the shape of an I-beam.

15. The device of claim 13, wherein the upper surface of the first component includes teeth extending therefrom for gripping bone.

16. The device of claim 13, wherein the device has an unexpanded configuration and an expanded configuration and wherein the upper and lower surfaces are substantially parallel to one another in each of the unexpanded and expanded configurations.

17. The device of claim 13, wherein the first and second components mate with each other via a ridge and groove connection.

18. The device of claim 13, wherein the device is longitudinally slidable over the guidewire.

19. The device of claim 13, wherein the guidewire extends completely through the device.

20. The device of claim 13, wherein, when the first and second angled walls slide along each other, the first and second angled walls are parallel to one another, and the second angled wall is obliquely angled with respect to the upper surface of the first component and the lower surface of the second component.

21. An expandable spinal fusion device, comprising:

a first component having an upper surface, a first angled wall extending at an oblique angle from the upper surface, and a first opening to permit bony fusion through the first component;

a second component having a lower surface, a second angled wall extending at an oblique angle from the lower surface, and a second opening to permit bony fusion through the second component; and

a guidewire extending through the second component such that the second component can be delivered over the guidewire by first inserting the guidewire into place within the patient and then passing the second component over the guidewire into place within the patient;

wherein the first angled wall of the first component is slidable along the second angled wall of the second component to increase a height of the device, and

wherein the device has an unexpanded configuration and an expanded configuration and wherein the upper and lower surfaces are substantially parallel to one another in each of the unexpanded and expanded configurations.