Surface opening adhesive sealer

• US 5,653,730 A
• Filed: 09/28/1994
• Issued: 08/05/1997
• Est. Priority Date: 09/28/1993
• Status: Expired due to Fees

• Current Assignee: Hemodynamics, Inc.
• Original Assignee: Hemodynamics, Inc.
• Inventors: Hammerslag, Julius G.
• Primary Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/314,049
• Time in Patent Office: 1,042 Days
• Field of Search: 606/212-214, 606/151, 606/194, 606/92-95, 606/117, 606/191, 128/673, 128/672, 128/748, 128/898, 128/899, 604/118, 604/121, 604/11-18, 604/96, 604/98, 604/310, 604/311, 222/510, 401/263
• US Class Current: 606/214
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen

Abstract

Disclosed is a device for delivering tissue adhesives and/or sealant patches to a surface which covers or surrounds a lumen, cavity or organ, or potential lumen or cavity, within a human or other animal. Also disclosed is a method of delivering tissue adhesives and/or sealant patches to a surface which covers or surrounds a lumen, cavity or organ, or potential lumen or cavity. The method is particularly suited to sealing perforations in vascular walls, such as after arterial access for Percutaneous Transluminal Coronary Angioplasty (PTCA), Percutaneous Coronary Angiography and Percutaneous Coronary Atherectomy and similar diagnostic and therapeutic procedures.

Claims

1. A method of closing a vascular perforation in a vessel wall of the type produced during a percutaneous transluminal catheterization procedure, comprising the steps of:

locating a percutaneous skin entrance site produced for the transluminal catheterization procedure;

introducing a tubular cannula through the skin entrance site and advancing the tubular cannula to bring it into contact with the surface of the wall surrounding the perforation;

providing an applicator which carries a patch;

applying a tissue adhesive to said patch so that said tissue adhesive is positioned between said patch and the surface of the vessel wall;

inserting said applicator carrying said patch and said tissue adhesive into the cannula; and

adhering said patch to the surface of the wall surrounding the perforation to seal the perforation.

2. A method as in claim 1, wherein said adhesive is selected from the group of tissue adhesives consisting of methyl cyanoacrylate, ethyl cyanoacrylate, n-propyl cyanoacrylate, isopropyl cyanoacrylate, n-butyl cyanoacrylate, isobutyl cyanoacrylate, n-amyl cyanoacrylate, isoamyl cyanoacrylate, 3-acetoxypropyl cyanoacrylate, 2-methoxypropyl cyanoacrylate, 3-chloropropyl cyanoacrylate, benzyl cyanoacrylate, phenyl cyanoacrylate, alkenyl cyanoacrylate, butyl-2-cyanoacrylate, alkoxyalkyl 2-cyanoacrylates, fluorinated 2-cyanoacrylates and combinations thereof.

3. A method of closing a vascular perforation of the type produced during a percutaneous transluminal catheterization procedure, comprising the steps of:

locating a subcutaneous perforation in a vessel wall;

exposing the perforation together with the surface of the wall surrounding the perforation; and

adhering a patch to the surface of the wall surrounding the perforation to seal the perforation;

wherein said exposing step further comprises

inserting an introducer sheath through the perforation and into the vessel, said sheath having a pressure sensor thereon;

sensing the pressure within the vessel;

withdrawing the introducer sheath from the vessel while monitoring the pressure within the vessel;

ceasing withdrawal of the introducer sheath once the pressure sensor detects a significant decrease in pressure;

percutaneously inserting a tubular cannula over said introducer sheath and positioning the distal end of the tubular cannula adjacent the vascular wall; and

withdrawing said introducer sheath from said tubular cannula.

4. A method as in claim 3, wherein said percutaneously inserting a tubular cannula step comprises percutaneously inserting the cannula towards the vascular perforation at an angle of about 30°

to the vessel wall.

5. A method as in claim 3, wherein said exposing step comprises exposing a circular area on the surface of the wall.

6. A method as in claim 3, wherein said circle has a diameter of about 3 mm.

7. A method as in claim 3, wherein said inserting an introducer sheath step is accomplished by inserting an introducer sheath over a guidewire.

8. A method as in claim 3, further comprising the step of providing a patch applicator and using the patch applicator to advance a patch to the surface of the wall prior to said adhering step.

9. A method as in claim 8, further comprising the step of applying an adhesive to the patch.

10. A method as in claim 9, wherein the adhesive comprises a cyanoacrylate.

11. A method of closing a vascular perforation of the type produced during a percutaneous transluminal procedure, comprising the steps of:

locating a perforation in a vessel wall;

percutaneously advancing a tubular cannula towards the perforation to expose the perforation together with the surface of the wall adjacent the perforation;

providing a vascular patch and a patch applicator;

advancing the patch along a guidewire and through the tubular cannula using the patch applicator; and

adhering the patch to the surface of the wall to seal the perforation.

12. A method as in claim 11, further comprising the step of applying an adhesive to the patch prior to the advancing the patch step.

13. A method as in claim 12, wherein the applying an adhesive step comprises applying an ethyl cyanoacrylate or a butyl-2-cyanoacrylate based adhesive.

14. A method as in claim 11, further comprising the step of introducing a guidewire through the perforation and into the vessel, prior to the percutaneously advancing the tubular cannula step.

15. A method as in claim 11, wherein the adhering the patch to the surface of the wall step comprises advancing the patch through the tubular cannula until tactile feedback is received indicating that the patch is in contact with the vessel wall.

16. A method as in claim 11, further comprising the step of applying a thrombogenic agent to the patch prior to the advancing the patch step.