Percutaneous methods for injecting a curable biomaterial into an intervertebral space

• US 20060009851A1
• Filed: 06/29/2005
• Published: 01/12/2006
• Est. Priority Date: 06/29/2004
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: LoGuidice, Mark D., Carter, Andrew, Wilson, Thomas G., Collins, Keith, Walkenhorst, Jared
• Granted Patent: US 7,837,733 B2
• Time in Patent Office: Days
• US Class Current: 623/17.160
• 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 having an outer relatively intact annulus defining a disc space and an inner defective nucleus pulposus within the disc space, 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 needle is placed initially within the center of the nucleus pulposus and then withdrawn during the injection to approximately the inner border of the annulus. The second pressure is then maintained until the biomaterial is substantially cured. In steps, the curable biomaterial has strong adhesive properties and is capable of injection under pressure to fill fissures in the nucleus pulposus. 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 correlated with said first pressure.

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. The method of claim 1, wherein said second pressure is selected to distract opposing vertebral bodies communicating with said disc space.

23. The method of claim 22, wherein said pressure is selected to be at least 100 psi.

24. The method of claim 23, wherein said second pressure is selected to be at least 160 psi.

25. 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.

26. The method of claim 25, 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.

27. The method of claim 26, 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.

28. The method of claim 25, 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.

29. The method of claim 25, wherein the curable biomaterial is selected to be a curable protein polymer.

30. The method of claim 25, further including the step of determining the integrity of the annulus prior to injecting the biomaterial.

31. The method of claim 30, wherein the integrity of said annulus is determined by a discogram.

32. The method of claim 31, wherein said discogram is performed pre-operatively.

33. The method of claim 31, wherein said discogram includes the step of injecting a contrast medium under a test pressure to determine if there are leaks through said annulus.

34. The method of claim 33, wherein said pressure at which said biomaterial is injected is no greater than the test pressure of said injected contrast medium.

35. The method of claim 30, wherein the integrity of said annulus is determined by injecting a saline solution under pressure.

36. The method of claim 35, wherein said saline solution is injected intra-operatively.

37. The method of claim 25, wherein said curable biomaterial is injected at a pressure selected to cause distraction of opposing vertebral bodies communicating with said disc space.

38. The method of claim 25, wherein said access is provided posteriorly of the spinal disc.

39. The method of claim 38, wherein said access is provided in an extraforaminal location.

40. The method of claim 40, 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.

41. 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.

42. The method of claim 41, wherein said pressure is selected to distract opposing vertebral bodies communicating with said disc space.

43. The method of claim 41, 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.

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

45. The method of claim 41, further including the step of maintaining the pressure at which said biomaterial is introduced into said nucleus pulposus.

46. The method of claim 45, 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.

47. 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;

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.

48. The method of claim 47, wherein said first pressure is selected to cause said biomaterial to fill any fissures in said nucleus pulposus without causing distraction of said disc space.

49. The method of claim 48, wherein said first pressure is selected to be in the range of about 25-40 psi.

50. The method of claim 48, wherein said second pressure is selected to cause distraction of opposing vertebral bodies communicating with said disc space.

51. The method of claim 50, wherein said second pressure is selected to be at least 100 psi.