Method and Apparatus for Intervertebral Disc Expansion

• US 20080091167A1
• Filed: 10/25/2007
• Published: 04/17/2008
• Est. Priority Date: 12/07/2002
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai
• Application Number:
  US11/924,026
• Publication Number:
  US 20080091167A1
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30205 conical
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30252 quadric-shaped
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4445 Means for culturing intervertebral disc tissue
• CPC Class Codes: A61F 2002/467 for measuring fluid pressure
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0073 : Quadric-shaped
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00377 : Fibrin
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 2210/1003 : Spinal column
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An intervertebral disc is expanded and injected by forming and dilating an opening in the disc annulus and introducing an inflatable member into the disc nucleus pulposus. The inflatable member location within the nucleus pulposus is verified and the inflatable member is gradually inflated for augmenting a space in the nucleus pulposus. The internal pressure and expansion of the inflatable member are monitored. The inflatable member is subsequently deflated and a biomaterial is injected into the augmented space.

Claims

1. A method of treating an intervertebral disc of a patient, the method comprising the steps of:

inserting a balloon into a nucleus pulposus without removing material from the nucleus pulposus, the balloon being connected to a catheter;

inflating the balloon with a biomaterial; and

removing the catheter from the patient while leaving the inflated balloon in the patient.

2. The method of claim 1, wherein inflating the balloon comprises introducing the biomaterial through the catheter.

3. The method of claim 1, further comprising:

providing the biomaterial as a formulation that includes one or more types of cells effective to promote healing, repair, regeneration and/or restoration of the intervertebral disc.

4. The method of claim 1, further comprising:

verifying the location of the balloon within the nucleus pulposus.

5. The method of claim 4, wherein the location of the balloon is verified by fluoroscopy.

6. The method of claim 5, wherein the inflation of the balloon is monitored by fluoroscopy.

7. The method of claim 6, wherein the biomaterial is at least partially radiopaque.

8. A method of augmenting an intervertebral space, the method comprising the steps of:

inserting a balloon into a nucleus pulposus without removing material from nucleus pulposus, the balloon being connected to a catheter;

inflating the balloon with a first material;

allowing the balloon to remain inflated for a period of time;

removing the first material from the balloon;

injecting into the balloon a second material, the second material comprising a biomaterial; and

removing the catheter from the patient while leaving the balloon injected with the second material in the patient.

9. The method of claim 8, wherein inflating the balloon comprises introducing the first material through the catheter.

10. The method of claim 9, wherein removing the first material comprises extracting the first material through the catheter and wherein injecting the second material comprises introducing the second material through the catheter.

11. The method of claim 10, wherein removing the first material and injecting the second material are performed simultaneously.

12. The method of claim 11, wherein the catheter comprises a dual-lumen catheter and the first material is removed through a first lumen of the catheter and the second material is injected through a second lumen of the catheter.

13. The method of claim 12, wherein the balloon has an inflated volume from about 0.1 cc to about 8.0 cc.

14. The method of claim 13, wherein the balloon has an inflated volume sized to at least partially distract the vertebrae adjacent to the nucleus pulposus.

15. A method of treating a patient, comprising the steps of:

inserting a balloon into a nucleus pulposus of an intervertebral disc without removing material from nucleus pulposus, the balloon being connected to a catheter;

inflating the balloon with a first material through the catheter;

allowing the balloon to remain inflated within the nucleus pulposus for a period of time;

removing the first material from the balloon leaving a prepared space within the nucleus pulposus;

removing the balloon from the patient; and

injecting a biomaterial into the prepared space of the nucleus pulposus.

16. The method of claim 15, wherein the biomaterial is selected from the group consisting of collagen, fibrin, albumin, silk, elastin, keratin, and other proteoglycans.

17. The method of claim 16, wherein the biomaterial further comprises a polysaccharide selected from the group consisting of hyaluronic acid, chitosan, cellulose, and agar.

18. The method of claim 15, wherein the biomaterial includes a synthetic material.

19. The method of claim 18, wherein the synthetic material includes an elastomeric material from a group consisting of silicone, polyurethane, silicone-polyurethane copolymers, polyolefin, and combinations thereof.

20. The method of claim 19, wherein the synthetic material includes a hydrogel material from a group consisting of polyester, polyacrylamide, polyacrylic acid, polyvinyl alcohol, polyethylene oxide, polyethylene glycol, and combinations thereof.

21. The method of claim 19, wherein the synthetic material includes a resorbable polymer material from a group consisting of polylactide, polyglycolide, poly(lactide-co-glycolide), poly(dioxanone), poly(ε

-caprolactone), poly(hydroxylbutyrate), poly(hydroxylvalerate), tyrosine-based polycarbonate, polypropylene fumarate, and combinations thereof.

22. A method treating an intervertebral disc of a patient, the method comprising:

forming and dilating an opening in a disc annulus without removing any of the disc annulus;

introducing an inflatable member through the dilated opening in the disc annulus and into a nucleus pulposus of the disc without removing any of the nucleus pulposus;

inflating the inflatable member with a first material to augment a space in the nucleus pulposus;

monitoring the internal pressure and expansion of the inflatable member;

extracting the first material from the inflatable member; and

injecting a biomaterial into the inflatable member.

23. The method of claim 22, wherein injecting the biomaterial comprises injecting the biomaterial through a passage in the inflatable member simultaneously with the extraction of the first material.

24. The method of claim 23, wherein the first material is extracted through a first lumen of a dual-lumen catheter and the biomaterial is injected through a second lumen of the dual-lumen catheter.