Epidural needle having a distal flare

• US 6,565,542 B2
• Filed: 06/22/2001
• Issued: 05/20/2003
• Est. Priority Date: 06/22/2001
• Status: Active Grant

• Current Assignee: Minnesota High Tech Resources LLC
• Original Assignee: Minnesota High Tech Resources LLC
• Inventors: Johnson, Larry D., Kumar, Matthew M.
• Primary Examiner(s): Huson, Gregory L.
• Assistant Examiner(s): Ramana, Anuradha
• Application Number:
  US09/887,134
• Publication Number:
  US 20020198501A1
• Time in Patent Office: 697 Days
• Field of Search: 604/500, 604/506-507, 604/512, 604/104, 604/164.01, 604/164.1, 604/164.03, 604/164.06, 604/164.09, 604/264, 604/272-274, 606/167, 606/185
• US Class Current: 604/264
• 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: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2025/0656 having a tip larger than the rest of the body

Abstract

Apparatus and methods for injecting fluid into the epidural space. An improved epidural needle or cannula is provided having a distal bulge or flare located within a few millimeters of the distal tip. The distal flare provides an increased resistance to penetration while the needle is penetrating the ligamentum flavum, and a decrease in resistance to penetration after the distal flare has successfully penetrated the ligamentum flavum. In a preferred embodiment, the distal bulge begins proximally at a distance of less than about 6 millimeters from the distal tip. The epidural needle according to the present invention preferably has the distal bulge or flare beginning proximally at a distance from the distal tip of less than the width of the epidural space. In one method according to the present invention, an epidural needle having a distal flare is advanced to the ligamentum flavum, advanced further through the ligamentum flavum at a perceived higher resistance to travel, until a decrease in resistance to travel is perceived, at which time the distal flare has penetrated the ligamentum flavum into the epidural space, at which time further advancement is stopped.

Claims

1. In a patient having ligamentous structures, a ligamentum flavum ventral to the ligamentous structures, and an epidural space ventral to the ligamentum flavum, a method for injecting a material into the epidural space, the method comprising:

providing an epidural needle having a shaft, a lumen therethrough, a distal tip, and a bulge beginning proximally no more than about 6 millimeters from the distal tip;

advancing the distal tip distally through the ligamentous structures while sensing a first resistance to advancement;

continuing advancing the distal tip as the bulge penetrates the ligamentum flavum while sensing a second resistance to advancement greater than the first resistance to advancement;

stopping further advancement after a decrease in resistance is sensed relative to the second resistance to advancement; and

injecting the material through the lumen and into the epidural space.

2. A method for injecting material into the epidural space as in claim 1, wherein the stopping farther advancement step includes advancing the distal tip a discrete distance after the decrease in resistance is sensed.

3. A method for injecting material into the epidural space as in claim 2, wherein the discrete distance advanced is less than about 2 millimeters.

4. A method for injecting material into the epidural space as in claim 1, wherein the decrease in resistance is sensed as an increased give in the needle.

5. A method for injecting material into the epidural space as in claim 1, wherein the decrease in resistance is sensed as an elastic recoil.

6. A method for injecting material into the epidural space as in claim 1, wherein the material is injected directly through the epidural needle lumen.

7. A method for injecting material into the epidural space as in claim 1, further comprising providing a catheter having a catheter lumen there through, and advancing the catheter through the needle lumen, wherein the injecting step includes injecting the material through the catheter lumen.

8. In a patient having ligamentous structures, a ligamentum flavum ventral to the ligamentous structures, and an epidural space ventral to the ligamentum flavum, a method for disposing a medical device distal tip into the epidural space, the method comprising:

providing the medical device having the distal tip, a shaft, and a bulge beginning proximally within about 6 millimeters from the distal tip;

advancing the distal tip distally through the ligamentous structures while sensing a first resistance to advancement;

continuing advancing the distal tip as the bulge penetrates the ligamentum flavum while sensing a second resistance to advancement greater than the first resistance to advancement;

stopping further advancement after a decrease in resistance is sensed relative to the second resistance to advancement, such that the medical device distal tip is disposed within the epidural space.

9. In a patient having ligamentous structures, a ligamentum flavum ventral to the ligamentous structures, and an epidural space ventral to the ligamentum flavum, a method for injecting a material into the epidural space, the method comprising:

providing an epidural needle having a shaft, a lumen therethrough, a distal portion, a distal tip, and a bulge disposed in the distal portion;

advancing the distal tip distally through the ligamentous structures while sensing a first resistance to advancement;

continuing advancing the distal tip as the bulge penetrates the ligamentum flavum while sensing a second resistance to advancement greater than the first resistance to advancement;

stopping further advancement after a decrease in resistance is sensed relative to the second resistance to advancement; and

injecting the material through the lumen and into the epidural space.