Dural sealing needle and method of use

• US 5,053,046 A
• Filed: 09/06/1990
• Issued: 10/01/1991
• Est. Priority Date: 08/22/1988
• Status: Expired due to Term

• Current Assignee: Woodrow W. Janese
• Original Assignee: Woodrow W. Janese
• Inventors: Janese, Woodrow W.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Lewis, Ralph A.
• Application Number:
  US07/579,105
• Time in Patent Office: 390 Days
• Field of Search: 606/213, 606/215, 606/216, 606/228-232, 623/1, 623/11, 604/51, 604/60
• US Class Current: 606/215
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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

Abstract

A spinal needle which has the capability of sealing its opening after withdrawal. A first conventional spinal needle or cannula is used for standard diagnostic or therapeudic use. A second cannula is inserted concentrically into the first needle and includes a dural seal having an absorbable suture extending from the second cannula. A stylet is inserted into the second cannula dislodging the seal into the subarachnoid space. The cannulae are removed and the suture is pulled to set the dural seal in the spinal puncture.

Claims

1. A dural sealing apparatus for spinal puncture and sealing comprising,

a first cannula for performing a spinal puncture,

a second cannula and a stylet, said stylet being telescopically received within said second cannula said second cannula being telescopically insertable into said first cannula,

means for sealing the dura positioned in the distal end of said second cannula including

a dry gelatin product component which softens and swells in the presence of spinal fluid for sealing the spinal puncture,

elastic, initially folded, impact wings for packing the softened gelatin product into the spinal puncture, and

an impact cone for seating in the spinal puncture behind the gelatin product and impact wings, and

seal actuating means connected with said sealing means extending out of the proximal end of said second cannula, said stylet for pushing said sealing means out of said second cannula.

2. The apparatus of claim 1 wherein the gelatin product is slidably positioned on said actuating means.

3. The apparatus of claim 1 wherein said dural seal means includes the impact cone, the gelatin product component slidably positioned on the seal actuating means, and the impact wings connected to the seal actuating means in sequence.

4. The apparatus of claim 1 wherein the gelatin product component is slidably positioned on the seal actuating means.

5. A method of sealing a spinal puncture comprising,

performing a spinal puncture using a first cannula,

telescopically inserting a second cannula into the first cannula in which a dura seal is positioned in the distal end of the second cannula and connected to an absorbable seal actuator line, the seal actuator line having an end extending out of the proximal end of the second cannula, the dura seal including an impact cone slidably connected to the seal actuator line, a swellable sealing component adjusted to the impact cone and slidably connected to the seal actuator line, and a resilient wing assembly adjacent the sealing component and connected to the line, including

after pushing the dura seal through the spinal puncture, allowing the sealing component to absorb spinal fluid and swell and the wing assembly to spread,

thereafter placing the seal actuator line in tension to seat the impact cone in the needle defect resulting from the spinal puncture, and

pulling on the seal actuator line to seat the wing assembly against the impact cone to pack the sealing component against the impact cone to form a seal about the needle defect while holding the extended end of the seal actuator line, and

removing the second cannula and placing the extended end of the seal actuator line in tension to set the dura seal.

6. The method of claim 5 including,

securing the end of the absorbable line to the back of the spine.

7. An apparatus for puncturing the arachnoid/dura mater and sealing the opening resulting therefrom comprising,

a first cannula for penetrating the arachnoid/dura mater and through which operations are conducted in the spinal cavity of a patient,

a second cannula for inserting into the spinal cavity through said first cannula,

a dural seal carried on the end of said second cannula for inserting into the spinal cavity through the first cannula comprised of

a suture,

a plurality of wings attached to the suture and carried on said second cannula in a folded position,

a sealing compound which swells upon contact by an aqueous fluid, and

an impact cone threaded on the suture, the sealing compound being threaded on the suture between the impact cone and the folded wings, and

a stylet for insertion into said second cannula for pushing said dural seal out of said second cannula into the spinal cavity, causing the wings of the dural seal to unfold, the sealing compound to swell, and the impact cone to seat in the opening so that the sealing compound will flatten against the impact cone to seal the opening when the suture is pulled.

8. The apparatus of claim 7 wherein the sealing compound is carried on the end of said second cannula within the impact cone and surrounded by the folded wings of said dural seal.

9. The apparatus of claim 7 wherein the outer parts of the wings of said dural seal are turned inwardly for fitting into said second cannula when folded.

10. The apparatus of claim 7 wherein the wings of said dural seal are comprised of a resilient material.

11. The apparatus of claim 10 wherein the outer part of the wings of said dural seal are turned inwardly for fitting into said second cannula when folded and spring outwardly as a result of the intrinsic elasticity of the resilient material comprising the wings when said dural seal is pushed out of said second cannula by said stylet.

12. A method of sealing an opening made by a first cannula in the arachnoid/dura mater of a patient comprising,

inserting a second cannula into a first cannula, the first cannula having punctured the arachnoid/dura mater of a patient, the second cannula carrying a dural seal on the distal end thereof, the dural seal being comprised of

a suture,

a plurality of folded wings,

a sealing compound which swells in the presence of water, and

an impact cone, the wings, sealing compound and impact cone being threaded onto the suture,

pushing the dural seal off of the distal end of the second cannula into the spinal cavity to seat the impact cone in the opening in the arachnoid/dura mater and to allow the sealing compound to swell,

opening the wings, and

pulling on the suture to flatten the sealing compound against the impact cone with the opened wings.

13. The method of claim 12 wherein the suture is secured to the patient to maintain tension on the suture.

14. An apparatus for sealing a spinal puncture comprising,

a first cannula through which operations are conducted in the spinal cavity of a patent,

a second cannula telescopically insertable into said first cannula,

a wing assembly carried on the end of said second cannula in a first, folded position, said wing assembly being comprised of a resilient elastomer,

a suture attached to said wing assembly,

a sealing compound threaded on said suture, and

a stylet for inserting into said second cannula for pushing said wing assembly and said sealing compound off the end of said second cannula into the spinal cavity, allowing said sealing compound to swell and the wings of said wing assembly to spring outwardly to a second, spread position for engaging the swollen sealing compound to spread the swollen sealing compound over the needle defect left by said first cannula after withdrawal of said first cannula from the spinal cavity and pulling on said suture.

15. The apparatus of claim 14 wherein the ends of the wings of said wing assembly are retained within the end of said second cannula when in said first, folded position.

16. The apparatus of claim 14 additionally comprising an impact cone threaded onto said suture for seating in the needle defect when said suture is pulled.

17. The apparatus of claim 16 wherein said sealing compound is threaded onto said suture between said wing assembly and said impact cone.

18. The apparatus of claim 14 wherein said sealing compound is comprised of a gelatin product.