Apparatus and kit for injecting a curable biomaterial into into an intervertebral space

• US 20060004326A1
• Filed: 06/29/2005
• Published: 01/05/2006
• Est. Priority Date: 06/29/2004
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Carter, Andrew, Wilson, Thomas G., Collins, Keith
• Granted Patent: US 8,337,557 B2
• Time in Patent Office: Days
• US Class Current: 604/57
• 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

An apparatus for introducing a curable biomaterial into a spinal disc nucleus pulposus, comprises: an injection needle sized for introduction into the nucleus pulposus; a syringe operable to inject a curable biomaterial contained in the syringe under fluid pressure through the injection needle; and a valve coupled between the injection needle and the syringe. The valve is operable in an open position to permit passage of the biomaterial from the syringe into the needle under fluid pressure, and in a closed position to maintain the fluid pressure of the injected biomaterial within the nucleus. In certain embodiments, the needle has a relatively smooth outer surface and a substantially constant outer diameter over its length. An outer docking cannula may also be provided that is sized and configured for piercing through the disc annulus and for docking thereto. A kit of parts is provided that comprises: a cannula having a distal end and a proximal end, the distal end of the cannula adapted to be inserted through the disc annulus; an injection needle having a distal end and a proximal end, the distal end adapted to be inserted into the proximal end of the cannula and configured for relatively close sliding fit therewithin; and a syringe for containing a quantity of curable biomaterial, the syringe adapted to be coupled to the proximal end of the needle and to inject the biomaterial into the needle under pressure. The kit may further comprises a quantity of curable biomaterial that is selected to have upon curing strong adhesive properties such as a protein polymer.

Claims

1. An apparatus for introducing a curable biomaterial into a spinal disc nucleus pulposus, comprising:

an injection needle sized for introduction into the nucleus pulposus;

a syringe operable to inject a curable biomaterial contained in the syringe under fluid pressure through the injection needle; and

a valve coupled between the injection needle and the syringe and operable in an open position to permit passage of the biomaterial from the syringe into the needle under fluid pressure, and in a closed position to maintain the fluid pressure of the injected biomaterial within the nucleus.

2. The apparatus of claim 1, wherein said needle has a relatively smooth outer surface and a substantially constant outer diameter over its length.

3. The apparatus of claim 2, further including an outer docking cannula, said cannula being sized and configured for piercing through the disc annulus and for docking thereto.

4. The apparatus of claim 3, wherein said cannula is relatively thin-walled, having a substantially constant outer diameter and an inner opening extending therethrough of substantially constant inner diameter.

5. The apparatus of claim 4, wherein said cannula inner diameter is sized for relatively close sliding fit with the outer diameter of said needle.

6. The apparatus of claim 5, wherein said cannula has a relatively smooth outer surface.

7. The apparatus of claim 6, wherein said cannula is in the range of 16-20 hypodermic gage.

8. The apparatus of claim 7, wherein said needle is in the range of 18-22 hypodermic gage.

9. The apparatus of claim 5, wherein said cannula has a predetermined length from its distal end which is adapted to pierce through said annulus and its proximal end which is adapted to receive said needle.

10. The apparatus of claim 9, wherein said predetermined length is selected to allow the proximal end of said cannula to reside outside the body of a patient when the distal end extends through said annulus.

11. The apparatus of claim 3, wherein said cannula has an anchor portion for docking said cannula to said annulus.

12. The apparatus of claim 11, wherein said anchor portion comprises threads on the outer surface of said cannula along an extent of said cannula at its distal end for threadably engaging said disc annulus.

13. The apparatus of claim 12, further including a flange disposed on said cannula adjacent said threads, said flange being sized and configured to contact the outer surface of said annulus when said cannula is docked thereto for providing and maintaining a seal between said annulus and said flange.

14. The apparatus of claim 13, wherein said flange is expandable from a first dimension to a larger second dimension sized to contact the outer surface of said annulus.

15. The apparatus of claim 14, wherein said flange includes an elastomeric sleeve mounted on said cannula and configured to expand from said first dimension to said second dimension upon application of a force along the longitudinal axis of said cannula.

16. A kit of parts for use in treating a damaged or diseased spinal disc having an outer annulus and an inner nucleus pulposus, comprising:

a cannula having a distal end and a proximal end, the distal end of said cannula adapted to be inserted through said disc annulus;

an injection needle having a distal end and a proximal end, said distal end adapted to be inserted into said proximal end of said cannula and configured for relatively close sliding fit therewithin; and

a syringe for containing a quantity of curable biomaterial, said syringe adapted to be coupled to the proximal end of said needle and to inject said biomaterial into said needle under pressure.

17. The kit of claim 16, wherein said syringe includes a valve coupled thereto, said valve being operable in an open position to permit passage of said biomaterial from the syringe under pressure, and in a closed position to maintain the pressure of the injected material into said needle.

18. The kit of claim 17, further including a quantity of curable biomaterial.

19. The kit of claim 18, wherein said biomaterial is selected to have upon curing strong adhesive properties.

20. The kit of claim 18, wherein said biomaterial contains a protein polymer.