Method and apparatus for occluding a physiological opening

Abstract

A method and apparatus for suture-less placement of an occluding patch in which release of the device can be accelerated. In one embodiment, an inactive form of an adhesive is applied on the area of the patch that will come into contact with cardiac tissue; this allows for the introduction and necessary manipulation of the catheter system until activation of the adhesive occurs. In accordance with one aspect of the invention, the adhesive properties of certain polymeric materials are relied upon rather than their ability to cure or harden into a specific shape. In another embodiment, the patch is immediately released utilizing a detaching mechanism on the balloon or the balloon catheter which supports the patch; the patch along with the inflated balloon remain on the cardiac structure occluding the opening.

1 . A method of placing a patch at the site of a physiological opening comprising:
 (a) providing a patch of a polymeric material having an adhesive applied to an outer portion thereof;   (b) placing said patch on an uninflated distal balloon;   (c) placing said patch and said balloon proximate to the physiological opening;   (d) inflating said balloon;   (e) forcing said balloon and said patch firmly against the physiological opening; and   (f) deflating and removing said balloon leaving said patch affixed to said physiological opening.   
     
     
         2 . A method in accordance with  claim 1 , wherein said adhesive applied to said patch is in an inactive form. 
     
     
         3 . A method in accordance with  claim 2 , further comprising activation of said adhesive prior to said step (f) of deflating and removing said balloon. 
     
     
         4 . A method in accordance with  claim 2 , wherein said adhesive is a two-stage adhesive with a transition that is sensitive to pH. 
     
     
         5 . A method in accordance with  claim 2 , further comprising injecting an adhesive initiator around said physiological opening prior to said step (e) of forcing said balloon and said patch firmly against the physiological opening. 
     
     
         6 . A method in accordance with  claim 3 , wherein said step of activating said adhesive comprises applying electromagnetic energy to said adhesive. 
     
     
         7 . A method in accordance with  claim 6 , wherein said electromagnetic energy comprises radiation in a group consisting of the ultraviolet, visible, and infrared spectrums. 
     
     
         8 . A method in accordance with  claim 3 , wherein said step of activating said adhesive comprises exposing said adhesive to ambient or applied thermal energy. 
     
     
         9 . A method of placing a patch at the site of a physiological opening comprising:
 (a) providing a patch of a polymeric material placed on an uninflated distal balloon to create a balloon/patch assembly;   (b) providing a catheter, detachably coupled to said balloon;   (c) utilizing said catheter to place said patch and said balloon proximate to the physiological opening;   (d) inflating said balloon to bring said balloon/patch assembly in contact with said physiological opening; and   (e) detaching said catheter from said inflated balloon/patch assembly and withdrawing said catheter.   
     
     
         10 . A method in accordance with  claim 9 , further comprising:
 (f) deflating said balloon following a coagulation/endothelialization period.   
     
     
         11 . A method in accordance with  claim 9 , further comprising:
 (f) providing an elongate support mechanism for immobilizing said balloon/patch assembly following step (e) of detachment of said catheter.   
     
     
         12 . A method in accordance with  claim 11 , wherein said support mechanism comprises a thread extending from said balloon/patch assembly to percutaneous opening. 
     
     
         13 . A method in accordance with  claim 11 , further comprising:
 (g) attaching a proximal end of said support mechanism to tissue surrounding said percutaneous opening.   
     
     
         14 . A method in accordance with  claim 13 , further comprising an anchor for attachment of said proximal end of said support mechanism to said percutaneous opening. 
     
     
         15 . An occlusive device for placement about a physiological opening, comprising:
 a catheter having a proximal and a distal end;   a distal uninflated balloon in said catheter adjacent said distal end thereof;   an inflation tube extending in said catheter from said balloon to and beyond said proximal end;   a patch of polymeric material at least partially surrounding said balloon; and   an adhesive applied to said patch.   
     
     
         16 . A device in accordance with  claim 14 , wherein said adhesive is inactive. 
     
     
         17 . An occlusive device for placement about a physiological opening, comprising:
 a catheter having a proximal and a distal end;   a distal uninflated balloon, detachably coupled to said sheath;   an polymeric patch disposed over said uninflated balloon to form a balloon/patch assembly;   at least one elastic element for preventing deflation of said balloon upon inflation of said balloon and detachment of said catheter.   
     
     
         18 . An occlusive device in accordance with  claim 17 , further comprising:
 an elongate supporting mechanism, coupled to said balloon/patch assembly, for maintaining placement of said balloon/patch assembly proximate to said physiological opening.   
     
     
         19 . An occlusive device in accordance with  claim 18 , further comprising:
 an anchor, for securing a proximal end of said elongate supporting mechanism in a percutaneous opening.