Intervertebral disc prosthesis

• US 7,713,301 B2
• Filed: 03/29/2006
• Issued: 05/11/2010
• Est. Priority Date: 05/06/1994
• Status: Expired due to Fees

• Current Assignee: Disc Dynamics, Inc.
• Original Assignee: Disc Dynamics, Inc.
• Inventors: Bao, Qi-Bin, Yuan, Hansen A., Arsenyev, Alexander, Felt, Jeffrey C., Hudgins, Robert Garryl
• Primary Examiner(s): Snow; Bruce E
• Application Number:
  US11/277,887
• Publication Number:
  US 20070038300A1
• Time in Patent Office: 1,504 Days
• Field of Search: 623 1711- 1716, 623/18.11, 623/16.11, 433/223, 433/226, 606/61, 606/90
• US Class Current: 623/17.12
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• 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: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3099 for temporo-mandibular [TM, TMJ] joints endoprostheses for mandibular reconstruction A61F2/2803
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/4081 Glenoid components, e.g. cups
• CPC Class Codes: A61F 2/4202 for ankles
• 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 2/4601 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/945 : hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2002/30016 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30024 : differing in coefficient of friction
• CPC Class Codes: A61F 2002/3008 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30578 : having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30929 : having at least two superposed coatings
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4233 : for metatarso-phalangeal joints, i.e. MTP joints
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• 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 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/041 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: B01F 2101/2305 : Mixers of the two-component package type, i.e. where at least two components are separately stored, and are mixed in the moment of application
• CPC Class Codes: C08G 18/10 : Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step
• CPC Class Codes: C08G 18/3206 : aliphatic
• CPC Class Codes: C08G 18/4854 : Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/69 : Polymers of conjugated dienes hydrogenated polymers of conjugated dienes C08G18/6208
• CPC Class Codes: C08L 23/00 : Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 67/02 : Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: C08L 83/04 : Polysiloxanes
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

A system for repairing an intervertebral disc by delivering and curing a biomaterial in situ within the disc. The system includes both a device, having an insertable balloon and related lumen, controls and adapters, as well as an in situ curable biomaterial (and related biomaterial delivery means). The system can allow the doctor to determine a suitable endpoint for biomaterial delivery, by controlling distraction and/or biomaterial delivery pressure, and in turn, to deliver a desired quantity of biomaterial to the balloon in order to achieve improved polymer cure and implant characteristics. Also provided is a related method for repairing an intervertebral disc by using such a system to deliver and cure the biomaterial in situ. The system can be used to implant a prosthetic total disc, or a prosthetic disc nucleus in a manner that leaves the surrounding disc tissue substantially intact.

Claims

1. An apparatus for forming an intervertebral disc prosthesis in situ, the apparatus comprising:

a mold adapted to be delivered to an intervertebral disc space using minimally invasive techniques through an annulus, the mold having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial;

at least first and second lumens fluidly coupled with an interior cavity of the mold, the first lumen adapted to deliver biomaterial, and the second lumen adapted to evacuate fluid from the at least one interior cavity;

a flowable, curable biomaterial deliverable to the mold through at least one lumen;

at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial to the mold through the at least one lumen while the mold is located in the intervertebral disc space; and

an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery.

2. The apparatus of claim 1 wherein the endpoint monitor comprises an indication of at least one of pressure or volume of the biomaterial.

3. The apparatus of claim 1 wherein the endpoint monitor comprises an indication of volume of biomaterial delivered.

4. The apparatus of claim 1 wherein the biomaterial delivery apparatus comprises a manual dispenser gun and the endpoint monitor comprises a tactile sense from the manual dispenser gun provided during the course of biomaterial delivery.

5. The apparatus of claim 1 wherein the endpoint monitor comprises an indication of distraction of the intervertebral disc space.

6. The apparatus of claim 1 wherein the endpoint monitor comprises an indication of working time needed for polymer injection.

7. The apparatus of claim 1 wherein at least a portion of the mold comprises a porous structure.

8. The apparatus of claim 7 wherein the endpoint monitor comprises an indication of biomaterial flowing through the porous structure.

9. The apparatus of claim 1 wherein at least a portion of the mold comprises a biodegradable material.

10. The apparatus of claim 1 wherein the mold comprises radiopaque portions.

11. The apparatus of claim 1 wherein at least one lumen comprises radiopaque portions.

12. The apparatus of claim 1 wherein the mold is fabricated from a substantially non-compliant material.

13. The apparatus of claim 1 wherein the mold is fabricated from a substantially compliant material.

14. The apparatus of claim 1 wherein the mold comprises regions with compliant properties and regions with non-compliant properties.

15. The apparatus of claim 1 wherein the mold is fabricated from a substantially elastic material.

16. The apparatus of claim 1 wherein the mold is fabricated from a substantially non-elastic material.

17. The apparatus of claim 1 wherein the mold comprises elastic properties and non-elastic properties at different regions.

18. The apparatus of claim 1 wherein the mold comprises a reinforcing mesh.

19. The apparatus of claim 1 wherein the mold comprises a lateral portion that is sufficiently non-compliant, and superior and inferior portions that are sufficiently compliant so as to permit a distraction force generated upon biomaterial delivery to be generally along an axis of the spine.

20. The apparatus of claim 1 wherein the mold comprises two or more layers of materials having the same or different levels of expandability.

21. The apparatus of claim 1 wherein the mold comprises a predetermined shape.

22. The apparatus of claim 1 wherein the filled mold comprises a cross-sectional area substantially larger than an opening formed to deliver the mold through an annulus into an intervertebral disc space using minimally invasive techniques.

23. The apparatus of claim 1 wherein the expandable mold includes two or more layers formed from materials having different properties.

24. The apparatus of claim 1 wherein the mold provides an exterior surface adapted to facilitate tissue in-growth.

25. The apparatus of claim 1 comprising bioactive agents located in the intervertebral disc space.

26. The apparatus of claim 25 wherein the bioactive agents are selected from the group consisting of growth factors, angiogenic factors and immune system suppressors.

27. The apparatus of claim 1 wherein the biomaterial delivery apparatus delivers the biomaterial at an initial delivery pressure at the mold greater than a subsequent delivery pressure.

28. The apparatus of claim 1 wherein the flowable biomaterial comprises a plurality of components.

29. The apparatus of claim 1 wherein the biomaterial comprises a plurality of biomaterial components and the biomaterial delivery apparatus is adapted to mix a plurality of biomaterial components.

30. The apparatus of claim 1 wherein the biomaterial delivery apparatus permits the mold to be inflated more than or less than the entire volume of a nuclear cavity in the intervertebral disc space.

31. The apparatus of claim 1 comprising at least one lumen adapted to deliver a curable biomaterial in the intervertebral disc space outside of the mold.

32. The apparatus of claim 31 wherein the biomaterial located in the intervertebral disc space outside of the mold is different from the biomaterial located in the mold.

33. The apparatus of claim 31 wherein the biomaterial located in the mold is more flexible than the biomaterial located in the intervertebral disc space outside of the mold.

34. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to purge a volume of biomaterial prior to delivery to the mold.

35. The apparatus of claim 1 wherein the second lumen extends out of the intervertebral disc space through the annulus.

36. The apparatus of claim 1 comprising a valve adapted to control the evacuation of fluid from the at least one interior cavity.

37. The apparatus of claim 1 wherein the intervertebral disc prosthesis comprises a prosthesis disc nucleus.

38. The apparatus of claim 1 wherein the intervertebral disc prosthesis comprises a total disc prosthesis.

39. The apparatus of claim 1 wherein the intervertebral disc prosthesis comprises a combination of nucleus prosthesis and at least a portion annulus prosthesis.

41. The apparatus of claim 1 comprising a mesh incorporated into the mold.

42. The apparatus of claim 1 comprising a mesh extending around a perimeter of the mold.

40. An apparatus for forming a total disc prosthesis in situ, the apparatus comprising:

a mold adapted to be delivered to an intervertebral disc space, the mold having one or more exterior surfaces and one or more interior cavities, at least one of the interior cavities being adapted to receive a curable biomaterial;

at least first and second lumens fluidly coupled with an interior cavity of the mold, the first lumen adapted to deliver biomaterial, and the second lumen adapted to evacuate fluid from the at least one interior cavity;

a flowable, curable biomaterial deliverable to the mold through at least one lumen;

at least one biomaterial delivery apparatus adapted to deliver at least one flowable biomaterial to the mold through the at least one lumen while the mold is located in the intervertebral disc space; and

an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery.