IP Library Granted Patent US 8,157,786
Granted Patent B2
US 8,157,786 · App. 11/616,219 · Granted Apr 17, 2012

Spinal diagnostic methods and apparatus

Assignee: Kyphon SARL
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Quick Facts
Patent No.
US 8,157,786
App. No.
11/616,219
Granted
Apr 17, 2012
Kind
B2
Abstract

Methods, devices and systems facilitate diagnosis, and in some cases treatment, of back pain originating in intervertebral discs. Methods generally involve introducing one or more substances into one or more discs using a catheter device. In one embodiment, a patient assumes a position that causes back pain, and a substance such as an anesthetic or analgesic is introduced into the disc to determine whether the substance relieves the pain. Injections into multiple discs may optionally be performed, to help pinpoint a disc as a source of the patient's pain. In some embodiments, the catheter device is left in place, and possibly coupled with another implantable device, to provide treatment of one or more discs. A catheter device includes at least one anchoring member for maintaining a distal portion of the catheter within a disc.

Claims (37)

1. A method comprising:

inserting an elongate member percutaneously into a spine of a patient, the elongate member comprising a lumen extending from a proximal end to a distal end of the elongate member, the elongate member further comprising an axial slot extending from the proximal end to the distal end in communication with the lumen, wherein the axial slot is at least partially covered by a frangible cover;

inserting a catheter percutaneously into the spine of the patient through the lumen of the elongate member, the catheter including an anchoring member;

deploying the anchoring member to anchor the catheter in the patient's spine;

deforming the frangible cover and removing the elongate member by passing the catheter from the lumen through the axial slot;

delivering a substance via the catheter into the patient through and beyond the anchoring member anchored in the patient's spine, wherein the substance is delivered through the catheter to emerge directly into the intervertebral disc distal to the anchoring member; and

identifying the intervertebral disc which is causing pain after delivering the substance and while the catheter is anchored in the spine.

2. The method according to claim 1 , wherein the substance is an anesthetic and identifying comprises having the patient reposition his or her spine in a manner which would be expected to cause pain in the intervertebral disc.

3. The method according to claim 1 , further comprises: increasing a cross-sectional diameter of the catheter at one or more locations on the catheter to anchor the catheter in the patient's spine.

4. The method according to claim 1 , wherein the catheter is anchored in the intervertebral disc in the patient's spine.

5. The method according to claim 1 , further comprises: inflating an anchoring member on the catheter to anchor the catheter in the intervertebral disc which is located within the patient's spine.

6. The method according to claim 1 wherein removing the elongate member by passing the catheter through the axial slot includes deforming a frangible cover at least partially covering the axial slot prior to passing the catheter through the axial slot.

7. The method according to claim 6 wherein deforming the frangible cover includes one of tearing and shearing the frangible cover.

8. The method according to claim 6 , wherein the frangible sheath is comprised of a material selected from the group consisting of polyester, PET, FEP, PTFE, polyolefins, nylons, PVCs, and neoprenes.

9. The method according to claim 1 wherein the elongate member has a substantially c-shape cross section.

10. The method according to claim 1 , wherein the elongate member is a needled.

11. The method according to claim 1 , wherein the distal end of the elongate member has a sharpened distal tip.

12. The method according to claim 1 , wherein the distal end of the elongate member has a blunt distal tip.

13. The method according to claim 1 , wherein the catheter has a proximal end sized and shaped larger than the proximal end of the elongate member such that the proximal end of the catheter is prevented from entering the lumen of the elongate member.

14. A method for determining a source of pain in a patient's spine:

inserting an elongate member percutaneously into a spine of a patient, the elongate member comprising a lumen extending from a proximal end to a distal end of the elongate member, the elongate member further comprising an axial slot extending from the proximal end to the distal end in communication with the lumen, wherein the axial slot is at least partially covered by a frangible cover;

inserting a catheter into the spine of the patient through the lumen of the elongate member, the catheter including an anchoring member;

deploying the anchoring member to anchor the catheter in an intervertebral disc;

deforming the frangible cover and removing the elongate member by passing the catheter from the lumen through the axial slot; and

injecting an anesthetic into a intervertebral disc through and beyond the anchoring member anchored in the intervertebral disc, wherein the substance is injected through the catheter to emerge directly into the intervertebral disc distal to the anchoring member; and

requesting the patient to relate whether pain is lessened after injecting the anesthetic.

15. The method according to claim 14 , further comprising requesting the patient to reposition his or her spine in a manner which would be expected to cause pain in the intervertebral disc.

16. A method for diagnosing an intervertebral disc in a patient's spine:

inserting an elongate member percutaneously into a spine of a patient, the elongate member comprising a lumen extending from a proximal end to a distal end of the elongate member, the elongate member further comprising an axial slot extending from the proximal end to the distal end in communication with the lumen, wherein the axial slot is at least partially covered by a frangible cover;

inserting a catheter into the spine of the patient through the lumen of the elongate member, the catheter including an anchoring member;

deploying the anchoring member to anchor the catheter in the patient's spine;

deforming the frangible cover and removing the elongate member by passing the catheter from the lumen through the axial slot; and

injecting an anesthetic into a intervertebral disc through and beyond the anchoring member anchored in the intervertebral disc, wherein the substance is injected through the catheter to emerge directly into the intervertebral disc distal to the anchoring member; and

injecting a contrast agent through the catheter either prior to or after the injection of the anesthetic.

17. The method according to claim 16 , wherein the contrast agent comprises a radio-opaque contrast agent.

18. The method according to claim 16 , wherein the contrast agent comprises an ultrasound contrast agent.

19. The method according to claim 16 , further comprising imaging the intervertebral disc after injecting the contrast agent to confirm that the contrast agent has entered the disc.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 28, 2018
From: DISC DIAGNOSTICS, INC.
To: GLOBUS MEDICAL, INC.
Reel/Frame 046231/0792 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 28, 2018
From: KYPHON SARL
To: DISC DIAGNOSTICS, INC.
Reel/Frame 046231/0762 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 9, 2008
From: MEDTRONIC SPINE LLC
To: KYPHON SARL
Reel/Frame 021070/0278 →
CHANGE OF NAME Recorded May 9, 2008
From: KYPHON INC
To: MEDTRONIC SPINE LLC
Reel/Frame 020993/0042 →
TERMINATION/RELEASE OF SECURITY INTEREST Recorded Mar 14, 2008
From: BANK OF AMERICA, N.A.
To: KYPHON, INC.
Reel/Frame 020666/0869 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2007
From: MILLER, DAVID R.; ALAMIN, TODD, M.D.; CAMPBELL, PETER F.
To: KYPHON INC.
Reel/Frame 019868/0675 →
SECURITY AGREEMENT Recorded Feb 5, 2007
From: KYPHON INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 018875/0574 →
Continuity (3)
Continuation In Part 10825961 · Apr 16, 2004
Continuation 11597349
Related Publication 20080009826A1 · Jan 10, 2008