Percutaneous methods for injecting a curable biomaterial into an intervertebral space

• US 7,837,733 B2
• Filed: 06/29/2005
• Issued: 11/23/2010
• Est. Priority Date: 06/29/2004
• Status: Expired due to Fees

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Carter, Andrew, Wilson, Thomas S., Walkenhorst, Jared, LoGuidice, Mark D., Collins, Keith
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/170,588
• Publication Number:
  US 20060009851A1
• Time in Patent Office: 1,973 Days
• Field of Search: 606 92- 94, 623/16.11, 623 1711- 1716
• US Class Current: 623/17.12
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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 17/8827 with filtering, degassing, venting or pressure relief means
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• 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 2002/4663 for measuring volumes or other three-dimensional shapes
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method for treating a spinal disc comprises the steps of: determining the integrity of the annulus by subjecting the annulus to a first pressure applied internally of the annulus; providing access to the nucleus pulposus through the annulus without removing any tissue from the annulus or from the nucleus pulposus; and sealably injecting curable biomaterial through the annulus access directly into the nucleus pulposus at a second pressure correlated with the first pressure. The integrity of the annulus may be determined by a pre-operative discogram using a contrast medium that has a viscosity substantially similar to the viscosity of the biomaterial to be injected. The curable biomaterial may be injected under a pressure sufficient to distract opposing vertebral bodies communicating with the disc space.

Claims

1. A method for treating a spinal disc having an outer relatively intact annulus defining a disc space and an inner defective nucleus pulposus within said disc space, comprising the steps of:

determining the integrity of said annulus by subjecting the annulus to a first pressure applied internally of said annulus;

providing access to said nucleus pulposus through said annulus without removing any tissue from said annulus or from said nucleus pulposus; and

sealably injecting curable biomaterial through said annulus access directly into said nucleus pulposus at a second pressure selected to be correlated with said first pressure, wherein said curable biomaterial is injected at a pressure selected to not cause distraction of said disc space.

2. The method of claim 1, wherein the integrity of said annulus is determined by a discogram.

3. The method of claim 2, wherein said discogram is performed pre-operatively.

4. The method of claim 2, wherein a quantity of contrast medium is injected into said nucleus pulposus through said annulus at said first pressure.

5. The method of claim 4, wherein the flow of said contrast medium within said nucleus pulposus is visualized through an imaging device.

6. The method of claim 5, wherein said imaging device comprises fluoroscopy.

7. The method of claim 4, wherein the viscosity of the contrast medium is selected to be substantially similar to the viscosity of said biomaterial upon injection.

8. The method of claim 7, wherein said second pressure at which said biomaterial is injected is selected to be no greater than the first pressure at which said contrast medium is injected.

9. The method of claim 4, wherein the viscosity of the contrast medium is selected to be less than the viscosity of said biomaterial upon injection.

10. The method of claim 9, wherein said first pressure at which said contrast medium is injected is selected to be less than the second pressure at which said curable material is injected.

11. The method of claim 1, wherein the integrity of said annulus is determined by injection of a saline solution under pressure.

12. The method of claim 11, wherein said saline solution is injected intra-operatively.

13. The method of claim 1, wherein said access to said nucleus pulposus is provided by inserting a needle through said annulus into said nucleus pulposus.

14. The method of claim 13, further comprising the step of introducing directly into said annulus an outer cannula forming a seal with said wall of said annulus, said cannula having an inner surface configured for relatively close fit receipt of said needle.

15. The method of claim 14, wherein said cannula is selected to be in the range of 16-20 cannula gage.

16. The method of claim 14, wherein said cannula is configured to have an anchor portion at its distal tip to anchor said cannula to said annulus and form said seal thereat.

17. The method of claim 16, wherein said anchor portion is defined by threads formed at said distal tip.

18. The method of claim 13, wherein said needle is placed initially within the center of the nucleus pulposus and during injection of said biomaterial said needle is withdrawn to approximately the inner border of the annulus for completion of the injection.

19. The method of claim 13, wherein said second pressure is maintained until said biomaterial is substantially cured.

20. The method of claim 19 wherein said second pressure is maintained for about five minutes.

21. The method of claim 1, wherein said second pressure is selected to be in the range of 25-40 psi.

22. A method for treating a spinal disc having an outer relatively intact annulus defining a disc space and a defective nucleus pulposus within said disc space, comprising the steps of:

providing access to said nucleus pulposus through said annulus without removing any tissue from said annulus or from said nucleus pulposus; and

sealably injecting under pressure a curable biomaterial having strong adhesive properties directly into said nucleus pulposus, said pressure being selected to fill fissures in said nucleus pulposus, said biomaterial upon curing, augmenting and adhering to said nucleus pulposus, wherein said curable biomaterial is injected at a pressure selected to not cause distraction of said disc space.

23. The method of claim 22, wherein the curable biomaterial is selected to have adhesive properties with a lap shear tensile strength of at least about 200 g/cm² when cured.

24. The method of claim 23, wherein the curable biomaterial has lap shear tensile strength of at least about 300 g/cm² within a cure time of about 5 to about 30 minutes.

25. The method of claim 22, wherein the curable biomaterial is selected to have a lap shear tensile strength of about 100 g/cm² to about 4000 g/cm² when cured.

26. The method of claim 22, wherein the curable biomaterial is selected to be a curable protein polymer.

27. The method of claim 22, further including the step of determining the integrity of the annulus prior to injecting the biomaterial.

28. The method of claim 27, wherein the integrity of said annulus is determined by a discogram.

29. The method of claim 28, wherein said discogram is performed pre-operatively.

30. The method of claim 28, wherein said discogram includes the step of injecting a contrast medium under a test pressure to determine if there are leaks through said annulus.

31. The method of claim 30, wherein said pressure at which said biomaterial is injected is no greater than the test pressure of said injected contrast medium.

32. The method of claim 27, wherein the integrity of said annulus is determined by injecting a saline solution under pressure.

33. The method of claim 32, wherein said saline solution is injected intra-operatively.

34. The method of claim 22, wherein said access is provided posteriorly of the spinal disc.

35. The method of claim 34, wherein said access is provided in an extraforaminal location.

36. The method of claim 22, further including the step of placing the patient in a lordotic posture so as to at least aid in the exposure of the posterior disc.

37. The method of claim 22, wherein said access is provided through said annulus without dilating any portion of said annulus.

38. A method for treating a spinal disc having degenerative disc disease, said disc having an outer relatively intact annulus defining a disc space, and a defective nucleus pulposus within said disc space, comprising the steps of:

providing a cannula having an outer surface and an inner opening extending through said cannula;

inserting said cannula directly into said annulus without an annulotomy and into the nucleus pulposus so as to form a seal between said annulus and said outer surface of said cannula;

inserting a needle through said opening in said cannula and into said nucleus pulposus, said needle being selected to have an outer dimension configured for close sliding fit within said cannula opening; and

without removing nucleus pulposus, introducing under pressure through said needle and into said nucleus pulposus a curable biomaterial, said pressure being selected so as to cause said biomaterial to fill any fissures in said nucleus pulposus.

39. The method of claim 38, wherein said pressure is selected to distract opposing vertebral bodies communicating with said disc space.

40. The method of claim 38, wherein said cannula is selected to be elongate and of predetermined length, said cannula having a distal end extending through said annulus and a proximal end, said predetermined length being selected such that said proximal end extends outside the body of said patient.

41. The method of claim 38, wherein said needle is coupled to a syringe containing said curable biomaterial prior to inserting said needle into said cannula.

42. The method of claim 38, further including the step of maintaining the pressure at which said biomaterial is introduced into said nucleus pulposus.

43. The method of claim 42, wherein said pressure is maintained by providing a valve in communication with said needle and operating said valve in a manner to close said valve and maintain said pressure.

44. A method for treating a spinal disc having an outer relatively intact annulus defining a disc space and a defective nucleus pulposus within said disc space, comprising the steps of:

providing access to said nucleus pulposus through said annulus without removing any tissue from said nucleus pulposus;

introducing directly into said nucleus pulposus through said access a first curable biomaterial at a first pressure selected to cause said first biomaterial to fill any fissures in said nucleus pulposus without causing distraction of said disc space;

allowing said first biomaterial to substantially cure; and

then

introducing directly into said nucleus pulposus through said access a second curable biomaterial at a second pressure greater than said first pressure.

45. The method of claim 44, wherein said first pressure is selected to be in the range of about 25-40 psi.

46. A method of introducing fluent biomaterial directly into the nucleus pulposus of a spinal disc through the annulus fibrosis of the disc, comprising the steps of:

introducing a sharp cannulated instrument through body tissue and into and through the annulus fibrosis without removing any tissue from said annulus fibrosis and into the nucleus pulposus without removing nucleus pulposus, said sharp instrument being selected to be of size and configuration to form with the elastic properties of said annulus fibrosis a seal between said sharp cannulated instrument and said annulus fibrosis;

injecting under pressure a fluent curable biomaterial in liquid form through said sharp cannulated instrument directly into said nucleus pulposus at a pressure selected to fill fissures in said nucleus pulposus, said material having properties when cured substantially emulating the natural nucleus pulposus; and

maintaining said seal and said pressure until said material is substantially cured.

47. The method of claim 46, wherein said sharp cannulated instrument comprises an elongate cannula having an outer surface and an inner opening extending through said cannula.

48. The method of claim 47, wherein said injecting step comprises the step of providing a needle selected to have an outer dimension configured for close sliding fit within said cannula opening.

49. The method of claim 48, wherein said needle is coupled to a syringe containing said curable biomaterial prior to inserting said needle into said cannula.

50. The method of claim 47, wherein said sharp cannulated instrument comprises as sharp-tipped stylet configured to fit within the inner opening of the cannula, and to be removed therefrom after introduction of the sharp cannulated instrument into the spinal disc.

51. The method of claim 46, wherein said sharp cannulated instrument is a needle coupled to a container containing said curable biomaterial.

52. The method of claim 46, wherein said cannulated instrument is provided with an anchoring element at the interface between said instrument and a surface of said annulus fibrosis.

53. The method of claim 46, wherein said pressure is applied manually.

54. The method of claim 46, wherein said pressure is maintained by providing a valve associated with the step of injecting said biomaterial and operating said valve in a manner to close said valve and maintain said pressure.

55. The method of claim 46, wherein said pressure is selected to cause said biomaterial to fill said fissures is said nucleus pulposus without causing distraction of said disc space.

56. The method of claim 55, wherein said pressure is selected to be at least about 25 psi.

57. The method of claim 46, wherein said pressure is selected to cause distraction of opposing vertebral bodies communicating with the disc space.

58. The method of claim 57, wherein said pressure is selected to be greater than about 25 psi.

59. The method of claim 46, wherein said biomaterial is selected to have strong adhesive properties such that upon curing said biomaterial adheres to said nucleus pulposus.

60. The method of claim 59, wherein said biomaterial is selected to have adhesive properties with a lap shear tensile strength of at least 100 g/cm².

61. The method of claim 59, wherein said biomaterial is selected to comprise a protein polymer.

62. The method of claim 46, further including the step of determining the integrity of the annulus fibrosis prior to injecting said biomaterial.

63. The method of claim 62, wherein the integrity of said annulus fibrosis is determined by subjecting said annulus fibrosis to a test pressure internally of the disc.

64. The method of claim 63, wherein the pressure at which said biomaterial is injected into said disc space is no greater than said test pressure.

65. The method of claim 46, wherein said sharp cannulated instrument is introduced through said body tissue without a separate incision.

66. A method of introducing fluent biomaterial directly into the nucleus pulposus of a spinal disc through the annulus fibrosis of the disc, comprising the steps of:

creating an opening through the annulus fibrosis in communication with said nucleus pulposus without dilating said opening;

introducing a sharp cannulated instrument into said disc through said opening and into the nucleus pulposus without removing nucleus pulposus, said sharp instrument being selected to be of size and configuration to form with the elastic properties of said annulus fibrosis a seal between said sharp cannulated instrument and said annulus fibrosis;

injecting under pressure a fluent curable biomaterial in liquid form through said sharp cannulated instrument directly into said nucleus pulposus at a pressure selected to fill fissures in said nucleus pulposus, said material having properties when cured substantially emulating the natural nucleus pulposus; and

maintaining said seal and said pressure until said material is substantially cured.

67. The method of claim 66, wherein said opening is formed by removing tissue from said annulus fibrosis.

68. The method of claim 66, wherein said opening is formed upon the introduction of said sharp cannulated instrument into said disc.