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

• US 8,337,557 B2
• Filed: 06/29/2005
• Issued: 12/25/2012
• Est. Priority Date: 06/29/2004
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Collins, Keith, Wilson, Thomas G., Carter, Andrew
• Primary Examiner(s): Truong, Kevin T
• Assistant Examiner(s): ARAJ, MICHAEL J
• Application Number:
  US11/170,657
• Publication Number:
  US 20060004326A1
• Time in Patent Office: 2,736 Days
• Field of Search: 606/53, 606 92- 94, 606/192, 623/17.11, 623/17.12, 623/17.16, 604/60, 604/164.11
• 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 kit of parts is provided that comprises: a cannula, the distal end of the cannula adapted to be inserted through the disc annulus; an injection needle, 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 comprise a quantity of curable biomaterial that is selected to have upon curing strong adhesive properties such as a protein polymer.

Claims

1. 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, a proximal end and an inner opening extending therethrough, the distal end of said cannula adapted to be inserted through said disc annulus;

a sharp-tipped stylet configured to fit within said inner opening and adapted to be removed from said cannula after insertion of said cannula through said 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, said injection needle having a length sufficient so that said distal end is disposed inside the disc annulus when the needle is inserted into said cannula;

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; and

a quantity of curable biomaterial that upon curing emulates the properties of natural nucleus pulposus.

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

3. The kit of claim 2, wherein said cannula is thin-walled, having a substantially constant outer diameter, and said inner opening extending therethrough is of substantially constant inner diameter.

4. The kit of claim 3, wherein said cannula inner diameter is sized for a close sliding fit with the outer diameter of said needle.

5. The kit of claim 4, wherein said cannula has a smooth outer surface.

6. The kit of claim 1, wherein said cannula is in the range of 16-20 hypodermic gage.

7. The kit of claim 6, wherein said needle is in the range of 18-22 hypodermic gage.

8. The kit of claim 1, 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.

9. The kit of claim 8, 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.

10. The kit of claim 1, wherein said cannula has an anchor portion for docking said cannula to said annulus.

11. The kit of claim 10, 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.

12. The kit of claim 11, 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.

13. The kit of claim 12, wherein said flange is expandable from a first dimension to a larger second dimension sized to contact the outer surface of said annulus.

14. The kit of claim 13, 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.

15. The kit of claim 1, wherein said syringe includes a valve coupled thereto between said syringe and said injection needle, 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.

16. The kit of claim 1, wherein said biomaterial is selected to have upon curing strong adhesive properties.

17. The kit of claim 1, wherein said biomaterial is selected to contain a protein polymer.