Methods and devices for treating tissue

• US 8,088,119 B2
• Filed: 08/14/2007
• Issued: 01/03/2012
• Est. Priority Date: 02/01/2007
• Status: Expired due to Fees

• Current Assignee: Laurimed, LLC
• Original Assignee: Laurimed, LLC
• Inventors: Saal, Jeffrey Alan, Saal, Joel Stuart, DuBois, Brian Robert
• Primary Examiner(s): Ho, Jackie
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US11/838,692
• Publication Number:
  US 20080188827A1
• Time in Patent Office: 1,603 Days
• Field of Search: 604/117, 604/158, 604/164.01, 604/164.07, 604/164.12, 604/170.03, 604/500, 604/506, 604/512, 604/93.01, 604/164.06, 604/170.01
• US Class Current: 604/506
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61M 2025/0007 Epidural catheters

Abstract

Device and method are provided for diagnosing and treating diseases and injuries to the spine by injecting drugs into the diseased or injured area. The device and method of the subject invention provide improvements to patient and operator safety, along with ease-of-use and convenience improvements over conventional techniques.

Claims

1. A method of performing a transforaminal epidural injection to deliver substances into an injection site in an epidural space of a patient, the method comprising:

providing a needle cannula having a needle lumen and an injection tubing having a distal portion with a blunt tip and extending through the needle lumen, where the injection tubing comprises an injection lumen where the injection tubing comprises a flexible material that deflects away from structures in the body such as blood vessels, nerves, or bone;

fluidly coupling a source of a radiopaque material to the injection lumen;

inserting a distal end of the needle cannula so that it is spaced a distance from the intended injection site, such that the needle cannula is spaced from the epidural space;

advancing the blunt tip of the injection tubing from the needle cannula and distally through a vertebral foramen into the epidural space while the needle cannula is proximally spaced from the epidural space, to advance the blunt tip into the epidural space;

delivering the radiopaque material through the injection lumen to the epidural space to verify placement of the blunt tip of the injection tubing; and

delivering a first therapeutic substance through the injection lumen to the epidural space.

2. The method of claim 1, where a distal portion of the injection tubing is shaped such that advancing the blunt tip of the injection tubing from the needle cannula and distally through the vertebral foramen while the needle cannula is proximally spaced from the epidural space causes the tip of the injection tubing to move away from an axis of the needle cannula.

3. The method of claim 1, where the injection tubing is coupled to a plunger member having a limited range of movement within the needle cannula, where advancing the injection tubing through the needle cannula comprises advancing the plunger member within the needle cannula.

4. The method of claim 1, further comprising fluidly coupling a source of a second therapeutic substance to the injection lumen and delivering the second therapeutic substance to the epidural space without disconnecting the source of the radiopaque material or the first therapeutic substance from the injection lumen.

5. The method of claim 4, where delivering the second therapeutic substance occurs after observing the patient for adverse reactions from delivering the first therapeutic substance.

6. The method of claim 4, where the first therapeutic substance comprises an anesthetic and the second therapeutic substance comprises a corticosteroid.

7. The method of claim 1, where fluidly coupling the source of the radiopaque material to the injection lumen comprises placing the source outside of a surgical field of the patient.

8. The method of claim 1, where the injection lumen is fluidly coupled to a manifold having a plurality of extension lumens.

9. A method of performing a transforaminal injection to deliver a substance at an injection site near a vertebral body in a patient, the method comprising:

providing an injection system including a needle cannula having a needle lumen extending therethrough and an injection tubing having a curved shape at a distal portion, where the injection tubing is slidably located in the needle lumen to move between a retracted position and a deployed position, where in the retracted position the injection tubing remains within the needle lumen and in the deployed position, the injection tubing extends out of a far end of the needle cannula;

advancing a tip of the needle cannula into the patient so that the tip is positioned adjacent to the vertebral body so that the tip is proximally spaced a distance from the epidural space; and

advancing the distal portion of the injection tubing from the tip of the needle cannula through a vertebral foramen and into the epidural space by advancing the injection tubing within the needle cannula such that the distal portion exits the needle cannula along a curved path to bias towards a posterior aspect of the foramen and assumes the curved shape.

10. The method of claim 9, where advancing the tip of the needle cannula into the patient comprises advancing the tip of the needle cannula through a vertebral foramen.

11. The method of claim 9, further comprising fluidly coupling a plurality of fluid sources to an injection lumen in the injection tubing prior to advancing the tip of the needle cannula into the patient.

12. The method of claim 11, where fluidly coupling the plurality of fluid sources comprises placing the fluid sources away from the immediate vicinity of the patient.

13. The method of claim 11, further comprising sequentially delivering fluid in each fluid source through the injection tubing without de-coupling the respective fluid source from the injection lumen.

14. The method of claim 11, where the plurality of fluid sources each comprises at least a radiopaque substance, an anesthetic, and an anti-inflammatory substance.

15. The method of claim 11, where the injection lumen is fluidly coupled to a manifold having a plurality of extension lumens, where fluidly coupling the plurality of fluid sources to the injection lumen comprises fluidly coupling each source to one of the extension lumens.

16. The method of claim 9, where the injection tubing is coupled to a plunger member having a limited range of movement within the needle cannula, where advancing the distal portion of the injection tubing comprises advancing the plunger member within the needle cannula.

17. The method of claim 9, where advancing the tip of the needle cannula into the patient so that the tip is positioned adjacent to the vertebral body comprises spacing the tip of the needle cannula from the vertebral foramen of the patient.