METHOD OF MAKING AN INTERVERTEBRAL DISC PROSTHESIS

• US 20060253200A1
• Filed: 06/30/2006
• Published: 11/09/2006
• Est. Priority Date: 05/06/1994
• Status: Active Grant

• Current Assignee: Disc Dynamics, Inc.
• Original Assignee: Disc Dynamics, Inc.
• Inventors: Arsenyev, Alexander, Felt, Jeffrey C., Bao, Qi-Bin, Hudgins, Robert Garryl, Yuan, Hansen A.
• Granted Patent: US 7,766,965 B2
• Time in Patent Office: Days
• US Class Current: 623/17.120
• 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 method of treating a diseased or damaged intervertebral disc having a nucleus pulposus and an annulus. The method includes the steps of accessing and preparing the intervertebral disc for receipt of the biomaterial by removing at least a portion of the nucleus pulposus to create a nuclear cavity. A quantity of the curable biomaterial is delivered under pressure to the nuclear cavity. The delivered biomaterial is at least partially cured in such a manner to retain it in the nuclear cavity. The at least partially cured biomaterial is contoured to achieve a desired conformation approximating that of the nuclear cavity.

Claims

1. A method of treating a damaged or diseased intervertebral disc, the method comprising the steps of:

providing a curable biomaterial; and

performing the surgical steps of;

(a) accessing and preparing a site in the intervertebral disc for receipt of the biomaterial;

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

(c) at least partially curing the delivered biomaterial in such a manner that the at least partially cured biomaterial is retained in the prepared site to comprise an intervertebral prosthesis, and contouring the at least partially cured, retained biomaterial to achieve a desired conformation approximating that of the prepared site, wherein the steps of curing and contouring are accomplished substantially simultaneously by the use of a mold that retains the biomaterial in the prepared site during the step of curing.

2. The method of claim 1 wherein steps (a) and (b) are performed using minimally invasive surgical means.

3. The method of claim 1 wherein the step of accessing and preparing the intervertebral disc comprises providing access to a nucleus pulposus through an annular wall.

4. The method of claim 1 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial from the intervertebral prosthesis.

5. The method of claim 1 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial from the prepared site.

6. The method of claim 1 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial exterior to the prepared site.

7. The method of claim 1 wherein the step of selecting the mold comprises the step of selecting a mold with one or more of a porous structure, biodegradable properties, radiopaque properties, or a predetermined shape.

8. The method of claim 1 comprising the step of selecting the mold comprising regions with compliant properties and regions with non-compliant properties.

9. The method of claim 1 comprising the step of selecting the mold comprising elastic properties and non-elastic properties at different regions.

10. The method of claim 1 comprising the step of locating a reinforcing material at the prepared site.

11. The method of claim 1 comprising the step of using at least a portion of the prepared site as the mold.

12. The method of claim 1 wherein the prepared site comprises the mold.

13. The method of claim 1 comprising the step of distracting the intervertebral disc space before the step of delivering the curable biomaterial.

14. The method of claim 1 comprising the steps of:

locating a mold in the intervertebral disc space before the step of delivering the curable biomaterial;

delivering a suitable fluid into a mold in order to exert a force sufficient to distract the intervertebral joint to the desired extent; and

removing the fluid and the mold after a period of time.

15. The method of claim 14 wherein the fluid comprises a contrast solution.

16. The method of claim 1 comprising the step of determining one or more of the size, shape, volume or position of the prepared site.

17. The method of claim 1 comprising the step of venting a region proximate the prepared site with a region external to the prepared site.

18. The method of claim 1 comprising the steps of:

delivering the quantity of curable biomaterial to the prepared site under pressure through a first lumen; and

venting though a second lumen a region proximate a distal end of the first lumen to a region exterior to the prepared site.

19. The method of claim 1 comprising the step of closing one or more valves to substantially retain the biomaterial at the prepared site during the step of curing.

20. The method of claim 1 comprising the step of bonding the biomaterial to the intervertebral disc during the step of curing.

21. The method of claim 1 comprising the step of purging a portion of the curable biomaterial during the step of delivering.

22. The method of claim 1 comprising the step of terminating the flow of biomaterial in response to an endpoint monitor providing an indication of an endpoint for biomaterial delivery.

23. The method of claim 1 wherein the intervertebral prosthesis comprises at least a partial nucleus prosthesis.

24. The method of claim 1 wherein the intervertebral prosthesis comprises a total disc prosthesis.

25. The method of claim 1 wherein the intervertebral prosthesis comprises a combination at least a partial nucleus prosthesis and at least partial annulus prosthesis.

26. A method of treating a diseased or damaged intervertebral disc having a nucleus pulposus and an annulus, the method comprising the steps of:

(a) accessing and preparing the intervertebral disc for receipt of the biomaterial by removing at least a portion of the nucleus pulposus to create a nuclear cavity;

(b) delivering under pressure a quantity of the curable biomaterial to the nuclear cavity; and

(c) at least partially curing the delivered biomaterial in such a manner that the at least partially cured biomaterial is retained in the nuclear cavity to comprise an intervertebral prosthesis, and contouring the at least partially cured, retained biomaterial to achieve a desired conformation approximating that of the nuclear cavity.

27. The method of claim 26 wherein steps (a) and (b) are performed using minimally invasive surgical means.

28. The method of claim 26 wherein the step of accessing and preparing the intervertebral disc comprises providing access to a nucleus pulposus through an annular wall.

29. The method of claim 26 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial from the intervertebral prosthesis.

30. The method of claim 26 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial from the nuclear cavity.

31. The method of claim 26 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial exterior to the nuclear cavity.

32. The method of claim 26 wherein the steps of curing and contouring are accomplished substantially simultaneously by the use of a mold that retains the biomaterial in a desired shape during curing.

33. The method of claim 26 wherein the step of contouring comprises the step of retaining the biomaterial in a mold located in the nuclear cavity.

34. The method of claim 33 wherein the step of selecting the mold comprises the step of selecting a mold with one or more of a porous structure, biodegradable properties, radiopaque properties, or a predetermined shape.

35. The method of claim 26 comprising the step of locating a reinforcing material in the nuclear cavity.

36. The method of claim 26 comprising the step of using at least a portion of the nuclear cavity as the mold.

37. The method of claim 26 wherein the step of contouring comprises the step of retaining the biomaterial in the nuclear cavity during curing so the intervertebral prosthesis comprises the desired shape.

38. The method of claim 26 comprising the step of distracting the intervertebral disc space before the step of delivering the curable biomaterial.

39. The method of claim 26 comprising the steps of:

locating a mold in the nuclear cavity before the step of delivering the curable biomaterial;

delivering a suitable fluid into a mold in order to exert a force sufficient to distract the intervertebral disc to the desired extent; and

removing the fluid and the mold after a period of time.

40. The method of claim 39 wherein the fluid comprises a contrast solution.

41. The method of claim 26 comprising the step of determining one or more of the size, shape, volume or position of the nuclear cavity.

42. The method of claim 26 comprising the step of venting the nuclear cavity to a region external to the nuclear cavity.

43. The method of claim 26 comprising the steps of:

delivering under pressure the quantity of the curable biomaterial to the nuclear cavity through a first lumen; and

venting though a second lumen a region proximate a distal end of the first lumen to a region exterior to the nuclear cavity.

44. The method of claim 26 comprising the step of closing one or more valves to substantially retain the biomaterial at the nuclear cavity during the step of curing.

45. The method of claim 26 comprising the step of bonding the biomaterial bonding to the intervertebral disc during the step of curing.

46. The method of claim 26 comprising the step of purging a portion of the curable biomaterial during the step of delivering.

47. The method of claim 26 comprising the step of terminating the flow of biomaterial in response to an endpoint monitor providing an indication of an endpoint for biomaterial delivery.

48. The method of claim 26 wherein the intervertebral prosthesis comprises an at least partial nucleus prosthesis.

49. The method of claim 26 wherein the intervertebral prosthesis comprises a combination at least partial nucleus prosthesis and at least partial annulus prosthesis.

50. A method of treating a diseased or damaged intervertebral disc, the method comprising the steps of:

(a) accessing and preparing a site in the intervertebral disc for receipt of the biomaterial;

(b) delivering under pressure through a first lumen a quantity of the curable biomaterial to the intervertebral disc; and

(c) venting though a second lumen a region proximate a distal end of the first lumen to a region exterior to the intervertebral disc, and at least partially curing the delivered biomaterial while retained in the intervertebral disc in such a manner that the at least partially cured biomaterial is contoured to comprise an intervertebral prosthesis.

51. The method of claim 50 wherein steps (a) and (c) are performed using minimally invasive surgical means.

52. The method of claim 50 wherein the step of accessing and preparing the intervertebral disc comprises providing access to a nucleus pulposus through an annular wall.

53. The method of claim 50 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial from the intervertebral prosthesis.

54. The method of claim 50 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial from the prepared site.

55. The method of claim 50 wherein the step of contouring comprises the step of removing at least a portion of the at least partially cured biomaterial exterior to the prepared site.

56. The method of claim 50 wherein the step of contouring comprises the step of retaining the biomaterial in a mold located in the prepared site.

57. The method of claim 56 comprising the step of using at least a portion of the prepared site as the mold.

58. The method of claim 50 wherein the step of delivering the biomaterial to a mold positioned at the prepared site comprises the step of distracting the intervertebral disc space.

59. The method of claim 50 comprising the step of distracting the intervertebral disc space before the step of delivering the curable biomaterial.

60. The method of claim 50 comprising the steps of:

locating a mold in the intervertebral disc space before the step of delivering the curable biomaterial;

delivering a suitable fluid into a mold in order to exert a force sufficient to distract the intervertebral joint to the desired extent; and

removing the fluid and the mold after a period of time.

61. The method of claim 60 wherein the fluid comprises a contrast solution.

62. The method of claim 50 comprising the step of closing one or more valves to substantially retain the biomaterial in the intervertebral disc during the step of curing.

63. The method of claim 50 comprising the step of bonding the biomaterial bonding to the intervertebral disc during the step of curing.

64. The method of claim 50 comprising the step of purging a portion of the curable biomaterial during the step of delivering.

65. The method of claim 50 comprising the step of terminating the flow of biomaterial in response to an endpoint monitor providing an indication of an endpoint for biomaterial delivery.

66. The method of claim 50 wherein the intervertebral prosthesis comprises an at least partial nucleus prosthesis.

67. The method of claim 50 wherein the intervertebral prosthesis comprises a total disc prosthesis.

68. The method of claim 50 wherein the intervertebral prosthesis comprises a combination an at least partial nucleus prosthesis and at least partial annulus prosthesis.

69. A method of treating a damaged or diseased intervertebral disc, the method comprising the steps of:

providing a curable biomaterial; and

performing the surgical steps of;

(a) accessing and preparing a site in the intervertebral disc for receipt of the biomaterial;

(b) delivering a quantity of the curable biomaterial to a mold located at the prepared site; and

(c) at least partially curing the delivered biomaterial in such a manner that the at least partially cured biomaterial is retained in the mold at the prepared site to comprise an intervertebral prosthesis, the mold and prepared site cooperating to contour the at least partially cured biomaterial to achieve a desired shape of the intervertebral prosthesis.