Devices and methods for the restoration of a spinal disc

• US 7,004,945 B2
• Filed: 10/29/2002
• Issued: 02/28/2006
• Est. Priority Date: 11/01/2001
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: SpineWave, Inc.
• Inventors: Boyd, Lawrence M., Upton, Maureen L.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US10/282,755
• Publication Number:
  US 20030083642A1
• Time in Patent Office: 1,218 Days
• Field of Search: 606 92- 94, 606/99, 606/61, 606/192, 606/90, 604/500, 604/506, 604/164.11, 424/94.63, 514/12, 128/898
• US Class Current: 606/92
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• 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 2/4675 for cleaning or coating bones, e.g. bone cavities, prior to endoprosthesis implantation or bone cement introduction for cleaning teeth cavities A61C17/00; irrigators A61M3/02
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2002/4677 using a guide wire
• CPC Class Codes: A61P 3/14 for calcium homeostasis vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

A system and method is provided for maintaining a proper intervertebral disc height during the replacement or augmentation of the spinal disc. In one embodiment, a cannulated distractor is used to distract the adjacent vertebrae and maintain a proper disc space height. The cannulated distractor is fluidly connected to a source of fluent material for injection into the disc space. The distraction includes a distraction tip resident within the disc space that includes a central lumen and a number of openings communicating with the lumen to dispense the fluent material within the disc space.

Claims

1. A method for injecting a fluent material into a disc space comprising the steps of:

creating a portal in the annulus fibrosis in communication with the intradiscal space;

impacting a cannulated distractor into the portal, the distractor configured to distract the vertebrae adjacent the intradiscal space and to establish a disc space height between the adjacent vertebrae; and

introducing the fluent material into the intradiscal space through a lumen of the cannulated distractor while the distractor maintains the established disc space height.

2. The method for injecting a fluent material into a disc space according to claim 1, further comprising:

the step of performing a discectomy after the step of creating a portal, the discectomy forming a cavity within the intradiscal space;

wherein the step of impacting a cannulated distractor includes positioning the distractor so that the lumen is in communication with the cavity; and

wherein the step of introducing the fluid includes introducing the fluid into the cavity.

3. The method for injecting a fluent material into a disc space according to claim 2, wherein the discectomy is a total discectomy in which substantially all of the nucleus pulposus is removed from the disc space.

4. The method for injecting a fluent material into a disc space of claim 2, wherein the fluent material is a curable biomaterial and the step of introducing the fluent material includes maintaining the distractor in its impacted position until the biomaterial cures in situ.

5. The method for injecting a fluent material into a disc space of claim 1, wherein the step of introducing the fluent material includes introducing the fluent material under pressure.

6. The method for injecting a fluent material into a disc space of claim 5, wherein the cannulated distractor is sized to seal the portal when the distractor is impacted therein.

7. The method for injecting a fluent material into a disc space of claim 1, further comprising the step of providing a vent in the cannulated distractor, wherein the step of introducing the fluent material includes introducing the material into the intradiscal space until the fluent material seeps from the vent.

8. The method for injecting a fluent material into a disc space of claim 1, wherein the step of introducing the fluent material includes:

fluidly engaging the cannulated distractor to a fluid injector apparatus; and

actuating the apparatus to inject the fluent material through the lumen of the cannulated distractor.

9. The method for injecting a fluent material into a disc space of claim 1, wherein the step of introducing the fluent material includes:

extending a tube through the lumen in the cannulated distractor, the tube fluidly connected to a source of the fluent material; and

introducing the fluent material through the tube into the intradiscal space.

10. The method for injecting a fluent material into a disc space of claim 9, wherein the step of extending the tube through the lumen includes providing a seal between the tube and the lumen.

11. The method for injecting a fluent material into a disc space of claim 9, wherein the step of introducing the fluent material through the tube includes manipulating the tube so that the discharge opening of the tube sweeps through the intradiscal space while the fluent material is introduced through the tube.

12. The method for injecting a fluent material into a disc space of claim 9, wherein the step of introducing the fluent material through the tube includes gradually withdrawing the tube from the lumen while the fluent material is introduced through the tube.

13. The method for injecting a fluent material into a disc space of claim 1, wherein the step of introducing the fluent material includes:

extending a tube through the lumen in the cannulated distractor, the tube fluidly connected to a source of the fluent material; and

introducing the fluent material through the tube into the intradiscal space.

14. The method for injecting a fluent material into a disc space of claim 13, wherein the step of extending the tube through the lumen includes providing a seal between the tube and the lumen.

15. The method for injecting a fluent material into a disc space of claim 13, wherein the step of introducing the fluent material through the tube includes manipulating the tube so that the discharge opening of the tube sweeps through the intradiscal space while the fluent material is introduced through the tube.

16. The method for injecting a fluent material into a disc space of claim 13, wherein the step of introducing the fluent material through the tube includes gradually withdrawing the tube from the lumen while the fluent material is introduced through the tube.

17. A method for injecting a fluent material into a disc space comprising the steps of:

creating a portal in the annulus fibrosis in communication with the intradiscal space;

placing a cannulated distractor into the portal, the distractor configured after placement to distract the vertebrae adjacent the intradiscal space and to establish a disc space height between the adjacent vertebrae; and

introducing the fluent material into the intradiscal space through a lumen of the cannulated distractor while the distractor maintains the established disc space height.

18. The method for injecting a fluent material into a disc space according to claim 17, further comprising:

the step of performing a discectomy after the step of creating a portal, the discectomy forming a cavity within the intradiscal space;

wherein the step of placing a cannulated distractor includes positioning the distractor so that the lumen is in communication with the cavity; and

wherein the step of introducing the fluid includes introducing the fluid into the cavity.

19. The method for injecting a fluent material into a disc space of claim 18, wherein the fluent material is a curable biomaterial and the step of introducing the fluent material includes maintaining the distractor in its position until the biomaterial cures in situ.

20. The method for injecting a fluent material into a disc space of claim 17, wherein the step of introducing the fluent material includes introducing the fluent material under pressure.

21. The method for injecting a fluent material into a disc space of claim 17, further comprising the step of providing a vent in the cannulated distractor, wherein the step of introducing the fluent material includes introducing the material into the intradiscal space until the fluent material seeps from the vent.

22. A device for injecting a fluent material into a disc space comprising:

a distraction member having opposite surfaces configured to distract adjacent vertebrae to the disc space, the distraction member having a proximal end and a distal end portion, at least the distal end portion configured to be disposed within the disc space;

a fluid passageway defined between said proximal end and said distal end portion, said fluid passageway defining an opening at said proximal end and at said distal end portion; and

said proximal end of said distraction member being configured for fluidly connecting said distraction member to a source of the fluent material.

23. The device for injecting a fluent material into a disc space according to claim 22, wherein at least said distal end portion of said distraction member is bullet-shaped.

24. The device for injecting a fluent material into a disc space according to claim 22, wherein at least said distal end portion of said distraction member is wedge-shaped with opposite substantially flat sides.

25. The device for injecting a fluent material into a disc space according to claim 22, wherein at least said distal end portion of said distraction member is cruciate-shaped.

26. The device for injecting a fluent material into a disc space according to claim 22, wherein at least said distal end portion of said distraction member is I-beam shaped.

27. The device for injecting a fluent material into a disc space according to claim 22, wherein at least said distal end portion of said distraction member is C-shaped.

28. The device for injecting a fluent material into a disc space according to claim 22, wherein said fluid passageway defines a plurality of openings at said distal end portion of said distraction member.

29. The device for injecting a fluent material into a disc space according to claim 28, wherein:

said fluid passageway is an elongated passageway extending from said proximal end to said distal end portion of said distraction member; and

said plurality of openings includes an opening along the length of said elongated passageway and a plurality of openings transverse to said elongated passageway.

30. The device for injecting a fluent material into a disc space according to claim 22, wherein said distraction member defines a vent opening separate from said fluid passageway.

31. The device for injecting a fluent material into a disc space according to claim 22, further comprising an injection tube sized to extend through said fluid passageway in said distraction member, said injection tube having a proximal end configured for fluidly connecting to a source of the fluent material and a discharge opening at an opposite distal end, said distal end configured to be disposed within the disc space when extending through said fluid passageway.

32. The device for injecting a fluent material into a disc space according to claim 31, further comprising a seal disposed between said passageway in said distraction member and said injection tube.

33. The device for injecting a fluent material into a disc space according to claim 31, wherein said injection tube is sized relative to said fluid passageway so that said distal end of said injection tube can be manipulated within the disc space when said injection tube extends through said fluid passageway.

34. The device for injecting a fluent material into a disc space according to claim 31, wherein said distraction member defines a vent opening separate from said fluid passageway.

35. The device for injecting a fluent material into a disc space according to claim 22, wherein said distraction member is formed of a bioresorbable material.

36. The device for injecting a fluent material into a disc space according to claim 22, wherein said distraction member includes a sealing element associated with a proximal portion of said distal end portion, said sealing element configured to provide a substantially fluid-tight seal within the disc space.

37. The device for injecting a fluent material into a disc space according to claim 36, wherein said sealing element includes a number of seal rings disposed on said distal end portion.

38. The device for injecting a fluent material into a disc space according to claim 37, wherein said seal rings are integral with said distal end portion.

39. The device for injecting a fluent material into a disc space according to claim 38, wherein said seal rings are elastomeric rings mounted on said distal end portion.

40. The device for injecting a fluent material into a disc space according to claim 22, wherein said proximal end of said distraction member includes a fitting for fluidly connecting said distraction member to the source of the fluent material.

41. The device for injecting a fluent material into a disc space according to claim 40, further comprising an elongated cannula defining a lumen therethrough, said cannula having a first fitting at one end thereof configured for fluid tight connection to said fitting of said distraction member and a second fitting at an opposite end thereof configured for fluid connection to a source of the fluent material.

42. The device for injecting a fluent material into a disc space according to claim 41, wherein said distraction member is integral with said cannula and said second fitting is said fitting associated with said proximal end of said distraction member.