Method of making an intervertebral disc prosthesis

• US 7,077,865 B2
• Filed: 02/13/2003
• Issued: 07/18/2006
• 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:
  US10/365,842
• Publication Number:
  US 20030195628A1
• Time in Patent Office: 1,251 Days
• Field of Search: 623 1711- 1716, 623/18.11, 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. A method for repairing or resurfacing the site of an injured or diseased articulating joint, the method comprising the steps of:

providing a curable biomaterial; and

performing the surgical steps of;

(a) accessing and preparing the joint site for receipt of the biomaterial;

(b) delivering a quantity of the curable biomaterial to the prepared joint site;

(c) curing the delivered biomaterial in such a manner that the cured biomaterial is permanently retained in apposition to the prepared site; and

contouring the cured, retained biomaterial to achieve a desired conformation approximating that of the natural joint, wherein steps (a) through (c) comprise an intervertebral disc replacement using minimally invasive surgical means.

2. The method according to claim 1 wherein the minimally invasive surgical means are arthroscopic means.

3. The method according to claim 1 wherein the delivery step is performed under arthroscopic visualization using a cannula suitably dimensioned to deliver the curable biomaterial.

4. The method according to claim 1 comprising the further step of coating or modifying the surface of the contoured material with a permanent interface material in order to improve the biocompatability or coefficient of friction of the cured biomaterial, wherein the coating or modifying step is also performed using minimally invasive surgical means.

5. The method according to claim 1 wherein the biomaterial comprises a curable polyurethane polymer.

6. The method according to claim 1 wherein the delivery step is performed using an arthroscopic cannula.

7. The method according to claim 1 wherein the intervertebral disc comprises a mold for retaining the curable biomaterial.

57. The method according to claim 7 comprising providing a mold with elastic properties and non-elastic properties at different regions.

58. The method according to claim 7 wherein at least one lateral wall of the mold comprises a compliance value higher than a delivery pressure of the biomaterial.

59. The method according to claim 7 wherein the mold provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.

60. The method according to claim 7 comprising incorporating a reinforcing material in at least a portion of the mold.

8. A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of:

using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon;

positioning the balloon in the intervertebral disc space using minimally invasive techniques;

providing a biomaterial source comprising a flowable biomaterial;

mixing the flowable biomaterial;

purging a portion of the flowable biomaterial prior to delivery to the intervertebral disc space;

delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space;

allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.

9. The method of claim 8 wherein the biomaterial comprises a polyurethane system.

10. The method of claim 8 wherein the balloon when inflated fills less than the entire volume of the intervertebral disc space.

11. The method of claim 8 comprising locating biomaterial in the intervertebral disc space outside of the balloon.

12. The method of claim 11 wherein the biomaterial located in the intervertebral disc space outside of the balloon is different from the biomaterial located in the balloon.

13. The method of claim 11 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.

14. The method of claim 11 wherein the biomaterial located outside of the balloon is in-situ curable.

15. The method of claim 8 comprising purging a portion of the biomaterial prior to delivery to the balloon.

16. The method of claim 8 comprising purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.

17. The method of claim 8 wherein the delivery of biomaterial is done at a substantially constant flow rate.

18. The method of claim 8 wherein the delivery of biomaterial is done at a substantially continuous flow rate.

61. The method according to claim 8 comprising providing a mold with elastic properties and non-elastic properties at different regions.

62. The method according to claim 8 wherein at least one lateral wall of the balloon comprises a compliance value higher than a delivery pressure of the biomaterial.

63. The method according to claim 8 wherein the balloon provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.

64. The method according to claim 8 comprising incorporating a reinforcing material in at least a portion of the balloon.

19. A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of:

using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon;

positioning the balloon in the intervertebral disc space using minimally invasive techniques;

providing a biomaterial source comprising a flowable biomaterial;

mixing the flowable biomaterial;

withdrawing air from the balloon located in the intervertebral disc space;

delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; and

allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.

20. The method of claim 19 wherein the biomaterial comprises a polyurethane system.

21. The method of claim 19 wherein the balloon when inflated fills less than the entire volume of the intervertebral disc space.

22. The method of claim 19 comprising locating biomaterial in the intervertebral disc space outside of the balloon.

23. The method of claim 22 wherein the biomaterial located in the intervertebral disc space outside of the balloon is different from the biomaterial located in the balloon.

24. The method of claim 22 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.

25. The method of claim 22 wherein the biomaterial located in the annular shell is in-situ curable.

26. The method of claim 19 comprising applying herein mechanical distraction in combination with the pressurized injection of flowable biomaterial to apply a distraction force to the intervertebral disc space.

27. The method of claim 19 comprising purging a portion of the biomaterial prior to delivery to the balloon.

28. The method of claim 19 comprising purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.

29. The method of claim 19 wherein the delivery of biomaterial is done at a substantially constant flow rate.

30. The method of claim 19 wherein the delivery of biomaterial is done at a substantially continuous flow rate.

56. The method according to claim 19 wherein air is withdrawn from the balloon at the same time the flowable biomaterial is delivered into the balloon.

65. The method according to claim 19 comprising providing a mold with elastic properties and non-elastic properties at different regions.

66. The method according to claim 19 wherein at least one lateral wall of the balloon comprises a compliance value higher than a delivery pressure of the biomaterial.

67. The method according to claim 19 wherein the balloon provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.

68. The method according to claim 19 comprising incorporating a reinforcing material in at least a portion of the balloon.

31. A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of:

using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon;

positioning the balloon in the intervertebral disc space using minimally invasive techniques;

providing a biomaterial source comprising a flowable biomaterial;

mixing the flowable biomaterial;

delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; and

allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus, 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.

32. The method of claim 31 wherein the injection of pressurized biomaterial is sufficient to distract the intervertebral disc space from constricted dimensions of on the order of 3 mm to 4 mm to dimensions of on the order of 8 mm to 12 mm.

33. The method of claim 31 wherein the biomaterial comprises a polyurethane system.

34. The method of claim 31 wherein the balloon when inflated fills less than the entire volume of the intervertebral disc space.

35. The method of claim 31 comprising locating biomaterial in the intervertebral disc space outside of the balloon.

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

37. The method of claim 35 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.

38. The method of claim 31 wherein the biomaterial located in the annular shell is in-situ curable.

39. The method of claim 31 comprising applying mechanical distraction in combination with the pressurized injection of flowable biomaterial to apply a distraction force to the intervertebral disc space.

40. The method of claim 31 comprising purging a portion of the biomaterial prior to delivery to the balloon.

41. The method of claim 31 comprising purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.

42. The method of claim 31 wherein the delivery of biomaterial is done at a substantially constant flow rate.

43. The method of claim 31 wherein the delivery of biomaterial is done at a substantially continuous flow rate.

44. A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of:

using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon;

positioning the balloon in the intervertebral disc space using minimally invasive techniques;

providing a biomaterial source comprising a flowable biomaterial;

mixing the flowable biomaterial;

purging a portion of the biomaterial prior to delivery to the balloon;

delivering the flowable biomaterial into the balloon using minimally invasive techniques; and

allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.

45. The method of claim 44 wherein the step of purging comprises purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.

46. The method of claim 44 wherein the delivery of biomaterial is done at a substantially constant flow rate.

47. The method of claim 44 wherein the delivery of biomaterial is done at a substantially continuous flow rate.

69. The method according to claim 44 comprising providing a mold with elastic properties and non-elastic properties at different regions.

70. The method according to claim 44 wherein at least one lateral wall of the balloon comprises a compliance value higher than a delivery pressure of the biomaterial.

71. The method according to claim 44 wherein the balloon provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.

72. The method according to claim 44 comprising incorporating a reinforcing material in at least a portion of the balloon.

48. A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of:

using minimally invasive techniques to remove damaged or diseased nucleus from the disc;

providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon;

positioning the balloon in the intervertebral disc space using minimally invasive techniques;

providing a biomaterial source comprising a flowable biomaterial;

mixing the flowable biomaterial;

delivering the flowable biomaterial into the balloon located in the intervertebral disc space while applying a vacuum to the balloon using minimally invasive techniques;

terminating the flow of biomaterial in response to an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery; and

allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.

49. The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by delivery pressure of the biomaterial.

50. The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by volume of biomaterial delivered.

51. The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by the amount of distraction of the intervertebral disc.

52. A method for repairing or resurfacing the site of an injured or diseased articulating joint, the method comprising the steps of:

providing a curable biomaterial; and

performing the surgical steps of;

(a) accessing and preparing the joint site for receipt of the biomaterial;

(b) purging a portion of the biomaterial prior to delivery into the prepared joint site;

(c) delivering a quantity of the curable biomaterial to the prepared joint site;

(d) curing the delivered biomaterial in such a manner that the cured biomaterial is permanently retained in apposition to the prepared site; and

contouring the retained biomaterial to achieve a desired conformation approximating that of the natural joint, wherein steps (a) through (d) comprise an intervertebral disc replacement using minimally invasive surgical means.

53. The method according to claim 52 wherein the biomaterial comprises a curable polyurethane polymer.

54. The method according to claim 52 wherein the delivery step is performed using an arthroscopic cannula.

55. The method according to claim 52 wherein the intervertebral disc site comprises a mold for retaining the curable biomaterial.