Intervertebral disc prosthesis

• US 7,001,431 B2
• Filed: 02/13/2003
• Issued: 02/21/2006
• Est. Priority Date: 05/06/1994
• Status: Expired due to Fees

• Current Assignee: Disc Dynamics, Inc.
• Original Assignee: Disc Dynamics, Inc.
• Inventors: Arsenyev, Alexander, Felt, Jeffrey C., Bao, Qi-Bin, Yuan, Hansen A., Hudgins, Robert Garryl
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/365,868
• Publication Number:
  US 20030220649A1
• Time in Patent Office: 1,104 Days
• Field of Search: 623/17.11, 623/17.12, 623/17.14, 623/17.15, 623/17.16, 623/23.68, 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 device comprising:

a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon 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;

a catheter;

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

a curable biomaterial adapted to be delivered to the balloon through the first lumen;

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

one or more fluid control devices adapted to control the flow of biomaterial from the biomaterial delivery apparatus to the balloon, the fluid control device comprising an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery.

2. The apparatus of claim 1 wherein the endpoint monitor is adapted to monitor delivery pressure of the biomaterial.

3. The apparatus of claim 1 wherein the endpoint monitor is adapted to monitor volume of biomaterial delivered.

4. The apparatus of claim 1 wherein the endpoint monitor is adapted to monitor distraction of the intervertebral disc.

5. The apparatus of claim 1 wherein the fluid control device comprises a fluid control valve.

6. The apparatus according to claim 1 wherein the balloon is fabricated from a substantially non-compliant material.

7. The apparatus according to claim 1 wherein the balloon is fabricated from a substantially compliant material.

8. The apparatus according to claim 7 wherein the material comprises a block copolymer selected from the group consisting of castable thermoplastic polyurethanes.

9. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to adjust the flow rate of the biomaterial.

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

11. The apparatus according to claim 1 comprising an adaptor for use in shunting biomaterial between the biomaterial delivery device and the balloon.

12. The apparatus according to claim 1 wherein the balloon is provided in a collapsed form within a delivery cannula.

13. The apparatus according to claim 12 wherein cannula is provided with a fluted portion adapted to permit the cannula to be secured to tissue within the disc space.

14. The apparatus according to claim 1 wherein delivery of biomaterial provides a delivery pressure within a range of from about 0.2 mPA to about 1.5 mPA.

15. The apparatus according to claim 1 wherein the biomaterial cures with an induction time of between about 5 and about 60 seconds.

16. The apparatus according to claim 1 wherein the biomaterial cures with an induction time of between about 5 and about 30 seconds.

17. The apparatus according to claim 1 wherein the biomaterial cures with an induction time of between about 5 and about 15 seconds.

18. The apparatus according to claim 1 wherein the biomaterial when cured exhibits a compression modulus of between about 0.1 MPa and about 50 Mpa when measured using ASTM method D575A at a physiological strain range between 3–

20%.

19. The apparatus according to claim 1 wherein the biomaterial when cured comprises a compression modulus of between about 1 MPa and about 25 Mpa.

20. The apparatus according to claim 1 wherein the balloon comprises different regions, having compliant and non-compliant properties, respectively.

21. The apparatus according to claim 1 wherein the balloon comprises a lateral wall that is sufficiently non-compliant, and superior and inferior walls that are sufficiently compliant, so as to permit a distraction force generated upon biomaterial delivery to be in a generally vertical direction.

22. The apparatus according to claim 1 wherein the balloon comprises two or more layers of materials having the same or different levels of expandability.

23. The apparatus according to claim 1 wherein the filled balloon provides a semi-flattened ovoid configuration.

24. The apparatus according to claim 1 wherein the balloon is prepared from polymeric materials selected from the group consisting of polyether-based polyurethanes and polycarbonate-based polyurethanes.

25. The apparatus according to claim 1 wherein the expandable balloon includes two or more layers formed, respectively, from different polymeric materials having different physical and functional properties.

26. The apparatus according to claim 1 wherein the balloon comprises:

at least one inner layer formed of a polymeric material that provides exotherm-resistant properties; and

at least one outer layer formed of a polymeric material that provides resistance to physical damage greater than the inner layer.

27. The apparatus according to claim 1 wherein the balloon and biomaterial are adapted to permit the formation of covalent bonds between the curing polymer and balloon.

28. The apparatus according to claim 1 wherein the balloon provides an exterior surface adapted to facilitate tissue in-growth.

29. The apparatus of claim 1 wherein the at least one biomaterial delivery apparatus comprises a plurality of biomaterial delivery apparatuses.

30. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to mix a plurality of biomaterial parts and deliver the flowable biomaterial to the balloon.

31. The apparatus of claim 1 wherein the biomaterial comprises a two-part system and the biomaterial delivery apparatus is adapted to deliver the two parts of the biomaterial at a substantially constant flow rate.

32. The apparatus of claim 1 wherein the biomaterial comprises a two-part system and the biomaterial delivery apparatus is adapted to deliver the two parts of the biomaterial at a substantially continuous flow rate.

33. The apparatus of claim 1 wherein the fluid control device permits the balloon to be inflated less than the entire volume of the intervertebral disc space.

34. The apparatus of claim 1 comprising a lumen adapted to deliver a curable biomaterial in the intervertebral disc space outside of the balloon.

35. The apparatus of claim 34 wherein the biomaterial located in the intervertebral disc space outside of the balloon is different from the biomaterial located in the balloon.

36. The apparatus of claim 34 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.

37. The apparatus of claim 1 comprising one or more endplates and fixation components adapted to be located in the intervertebral disc space.

38. The apparatus of claim 1 wherein the biomaterial comprises a curable polyurethane composition comprising a plurality of parts capable of being aseptically processed or sterilized, stably stored, and mixed at the time of use in order to provide a flowable composition and initiate cure, the parts including:

(1) a quasi-prepolymer component comprising the reaction product of one or more polyols, and one or more diisocyanates, and optionally, hydrophobic additives, and (2) a curative component comprising one or more polyols, one or more chain extenders, one or more catalysts, and optionally, other ingredients such as antioxidants, and dyes.

39. The apparatus of claim 1 wherein the biomaterial comprises an aromatic diisocyanate.

40. The apparatus of claim 1 wherein the biomaterial comprises diphenylmethane diisocyanates.

41. The apparatus of claim 1 wherein the biomaterial comprises toluene di-isocyanate.

42. The apparatus of claim 1 wherein the biomaterial comprises paraphenylenediisocyanate.

43. The apparatus of claim 1 wherein the biomaterial comprises aliphatic diisocyanates.

44. The apparatus of claim 1 wherein the biomaterial comprises hard segments of about 20%–

70% by weight.

45. The apparatus of claim 1 wherein the biomaterial comprises a chain extender selected from the group consisting of short chain diols, short chain triols, short diamines, or combinations thereof.

46. The apparatus of claim 1 wherein the biomaterial comprises soft segments of polytetramethylene oxide, polyhexamethylene oxide.

47. The apparatus of claim 1 wherein the biomaterial comprises a mixture of MWs and polytetramethylene oxide.

48. The apparatus of claim 1 wherein the biomaterial comprises a cross-linking agent of trimethylol propane.

49. The apparatus of claim 1 wherein the biomaterial comprises a silicone modified polyurethane.

50. The apparatus of claim 1 wherein the biomaterial comprises a catalyst of 1–

1% by weight of the total composition.

51. The apparatus of claim 1 wherein the biomaterial comprises a catalyst of 0.01–

0.1% by weight of the total composition.

52. The apparatus of claim 1 wherein the biomaterial comprises a molar ratio of NCO:

OH of about 0.8;

1 to about 1.2;

1.

53. The apparatus of claim 1 wherein the biomaterial comprises a molar ratio of NCO:

OH ratio of about 0.9;

1 to about 1.1;

1.

54. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to deliver the biomaterial at a substantially constant flow rate.

55. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to deliver the biomaterial at a substantially continuous flow rate.

56. The apparatus of claim 1 wherein the biomaterial delivery apparatus comprises a mixer with about 45 to about 65 mixing elements.

57. The apparatus of claim 1 wherein the biomaterial delivery apparatus comprises a mixer with about 50 to about 60 mixing elements.

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

59. The apparatus of claim 1 wherein the biomaterial delivery apparatus is adapted to purge a volume of biomaterial equal to about 1 to about 4 times a volume of a mixer prior to delivery of the biomaterial to the balloon.

60. The apparatus of claim 1 wherein the balloon is constructed from a porous material.

61. The apparatus of claim 1 wherein the balloon is constructed from a porous material with pore sizes of about 50 micrometers to about 1000 micrometers.

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

63. The apparatus of claim 1 comprising a reinforcing material in at least a portion of the balloon.

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

a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon 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;

a catheter;

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

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

one or more fluid control devices adapted to control the flow of biomaterial from the biomaterial delivery apparatus to the balloon, the fluid control device comprising an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery.

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

a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon 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;

a first lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon;

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

a second lumen adapted to deflate the balloon as the biomaterial is delivered.

66. The apparatus of claim 65 wherein the balloon comprises elastic properties and non-elastic properties at different regions.

67. The apparatus of claim 65 comprising a reinforcing material in at least a portion of the balloon.

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

a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon 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;

a catheter;

at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon;

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

a plurality of compositions of curable biomaterials adapted to be delivered to the intervertebral disc space through the at least one biomaterial delivery apparatus; and

one or more fluid control devices adapted to control the flow of biomaterial from the biomaterial delivery apparatus to the balloon, wherein the cured biomaterial provides a heterogeneous implant having a plurality of regions with a more rigid outer region and a more flexible inner region.

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

a collapsed balloon adapted to be positioned within an intervertebral disc space using minimally invasive techniques, the balloon 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;

a catheter;

at least one lumen having a proximal end and a distal end, the proximal end fluidly coupled with an interior cavity of the balloon;

a purge mechanism adapted to purge a volume of biomaterial prior to delivery to the balloon; and

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

70. The apparatus of claim 69 wherein the balloon comprises elastic properties and non-elastic properties at different regions.

71. The apparatus of claim 69 comprising a reinforcing material in at least a portion of the balloon.