Energy based devices and methods for treatment of patent foramen ovale

Abstract

Methods and apparatus for treatment of patent foramen ovale (PFO) generally involve use of a catheter having at least one closure device at its distal end. In some embodiments, the catheter also includes one or more energy transmission members for delivering energy to the closure device(s) and to the tissue adjacent the PFO to induce closure of the PFO. Closure devices may comprise, for example, a bioresorbable matrix or a non-resorbable matrix. In some embodiments, the closure device contains particles dispersed within the closure device to increase conductance and/or to reduce resistance and/or impedance. An exemplary method involves advancing a catheter to position its distal end into the tunnel of the PFO and fixing the closure device within the tunnel of the patent foramen PFO.

1 . A system for percutaneous transluminal closure of a cardiac opening, comprising: 
 a balloon for application of an adhesive comprising an outer surface, the balloon transitionable between a deflated state and an inflated state;    a catheter comprising a length between a proximal end and a distal end, wherein said balloon is joined to the distal end of the catheter; and    a first locator joined to said catheter, wherein said locator positions said balloon in said cardiac opening.    
     
     
         2 . The system of  claim 1 , wherein the first locator comprises a disk, a plurality of arms, a rod, a locator balloon, a right atrial locator, or a left atrial locator.  
     
     
         3 . The system of  claim 1  further comprising a second locator coupled to at least one of the catheter and the balloon, the second locator for positioning the closure device in the cardiac opening.  
     
     
         4 . The system of  claim 1  further comprising a second locator.  
     
     
         5 . The system of  claim 1  further comprising an adhesive coated on the first locator, or the second locator, or both the first and second locators.  
     
     
         6 . The system of  claim 1 , wherein the adhesive comprises a cyanoacrylate, a fibrin based adhesive, an albumin adhesive, a light activated adhesive, an irritant, or a tissue growth stimulator.  
     
     
         7 . The system of  claim 1  further comprising a light source coupled to the catheter for activating a light activated adhesive.  
     
     
         8 . The system of  claim 1 , wherein the balloon is tubular-shaped.  
     
     
         9 . The system of  claim 1 , wherein the adhesive is disposed on a surface of the balloon.  
     
     
         10 . The system of  claim 9 , wherein the surface of the balloon is involuted.  
     
     
         11 . The system of  claim 1 , wherein the first locator is attached to the balloon.  
     
     
         12 . A system for percutaneous transvascular closure of an intra-cardiac opening in a patient, comprising: 
 a catheter comprising a distal end;    a patch defining at least one hollow channel, said patch sized and shaped for percutaneous transvascular delivery to an intracardiac anatomical site and releasably joined to the distal end of the catheter; and    an adhesive for adhering said patch over said intracardiac opening.    
     
     
         13 . The system of  claim 12 , wherein the patch comprises a bioresorbable material, or collagen.  
     
     
         14 . The system of  claim 12 , wherein the adhesive comprises a light activated adhesive.  
     
     
         15 . The system of  claim 12 , wherein the hollow channel comprises a conduit for light.  
     
     
         16 . The system of  claim 12  further comprising a frame enclosed within the hollow channel.  
     
     
         17 . The system of  claim 12 , further comprising a housing.  
     
     
         18 . The system of  claim 17  further comprising a light source.  
     
     
         19 . The system of  claim 18 , wherein the light source comprises a light-conducting medium.  
     
     
         20 . The system of  claim 19 , wherein the light source comprises a fiber optic cable.  
     
     
         21 . The system of  claim 12  further comprising a frame wherein at least a portion of the frame is positioned within the hollow channel.  
     
     
         22 . The system of  claim 21 , wherein the frame comprises a shape memory alloy.  
     
     
         23 . A method for percutaneous transvascular closure of a cardiac opening in patient, comprising: 
 providing the system of  claim 12 , and    positioning the patch over the cardiac opening.    
     
     
         24 . The method of  claim 23 , wherein positioning the patch over the cardiac opening comprises adhering the patch to a tissue surface of the patient proximate the cardiac opening.  
     
     
         25 . The method of  claim 23 , wherein adhering the patch to the tissue surface comprises providing light to the hollow channel defined by the patch and activating the adhesive coated on the patch with the provided light.  
     
     
         26 . The method of  claim 25 , wherein adhering the patch to the tissue surface further comprises applying a primer to the tissue surface.  
     
     
         27 . The system of  claim 21 , wherein the frame is capable of transporting radio frequency energy for application to the patch.  
     
     
         28 . The system of  claim 21 , wherein the frame is removable.  
     
     
         29 . The system of  claim 12 , further comprising means for applying radio frequency energy and an adhesive to the patch.  
     
     
         30 . The system of  claim 12 , wherein the adhesive is extrudable into the at least one hollow channel.  
     
     
         31 . A closure device for percutaneous transvascular closure of an intra-cardiac opening in a patient, comprising: 
 a patch sized and shaped for percutaneous transvascular delivery to an intracardiac anatomical site;    an adhesive coated on the patch; and    at least one hollow channel enclosed within the patch.    
     
     
         32 . A closure device for percutaneous transluminal closure of a cardiac opening, comprising: 
 a housing;    a releasable patch coupled to the housing; and    an adhesive coated on the releasable patch.    
     
     
         33 . A closure device for percutaneous transluminal closure of a cardiac opening, comprising: 
 a patch;    at least one hollow channel enclosed within the patch; and    a removable frame enclosed within the hollow channel.    
     
     
         34 . The closure device of  claim 33 , wherein the frame comprises a shape memory alloy.  
     
     
         35 . The closure device of  claim 34 , wherein the shape memory alloy comprises nitinol.  
     
     
         36 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising: 
 inserting the closure device of  claim 31  into a heart of the patient; and    positioning the closure device across the cardiac opening to substantially occlude the cardiac opening.    
     
     
         37 . The method of  claim 36 , wherein positioning the closure device across the cardiac opening comprises coupling the closure device to a tissue surface of the patient proximate the cardiac opening.  
     
     
         38 . The method of  claim 37 , wherein coupling the closure device to the tissue surface comprises providing light to the hollow channel enclosed within the patch and activating the adhesive coated on the patch with the provided light.  
     
     
         39 . The method of  claim 36 , wherein the cardiac opening is a patent foramen ovale.  
     
     
         40 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising: 
 inserting the closure device of  claim 32  into a heart of the patient; and    positioning the releasable patch across the cardiac opening to substantially occlude the cardiac opening.    
     
     
         41 . The method of  claim 40 , wherein positioning the releasable patch across the cardiac opening comprises coupling the releasable patch to a tissue surface of the patient proximate the cardiac opening.  
     
     
         42 . The method of  claim 41 , wherein coupling the releasable patch to the tissue surface comprises providing a light source emitting light within the housing and activating the adhesive coated on the releasable patch with the emitted light.  
     
     
         43 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising: 
 inserting the closure device of  claim 33  into a heart of the patient; and    positioning the closure device across the cardiac opening to substantially occlude the cardiac opening.    
     
     
         44 . The method of  claim 43 , wherein positioning the closure device across the cardiac opening comprises coupling the closure device to a tissue surface of the patient proximate the cardiac opening.  
     
     
         45 . The method of  claim 44 , wherein coupling the closure device to the tissue surface comprises thermally welding the closure device to the tissue surface.  
     
     
         46 . The method of  claim 45 , further comprising removing the frame of the closure device from within the hollow channel after having thermally welded the closure device to the tissue surface.  
     
     
         47 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising: 
 providing a compound, comprising: 
 an adhesive; and  
 a plurality of composite particles disposed within the adhesive, wherein the composite particles are capable of expansion upon contact with at least one of blood and water; and  
   injecting the compound into the cardiac opening to substantially occlude the cardiac opening.    
     
     
         48 . The method of  claim 47 , further comprising positioning a patch across an end of the cardiac opening.  
     
     
         49 . The method of  claim 47 , further comprising positioning a barrier across an end of the cardiac opening.  
     
     
         50 . A closure device for percutaneous transluminal closure of a cardiac opening, comprising: 
 a balloon comprising an outer surface;    a porous band comprising a plurality of openings, the porous band encircling only a portion of the outer surface of the balloon; and    an adhesive disposed between the outer surface of the balloon and the porous band.    
     
     
         51 . The device of  claim 50 , wherein the porous band encircles a center portion of the balloon.  
     
     
         52 . The device of  claim 50  further comprising a substance for stimulating tissue growth, wherein the substance is selected from the group consisting of a growth factor, a pharmacological agent for stimulating tissue growth, an irritant for encouraging an inflammatory response, a cell, and a gene.  
     
     
         53 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising: 
 inserting the closure device of  claim 50  into a heart of the patient;    positioning the closure device within the cardiac opening; and    applying a pressure to the balloon of the closure device to expose the adhesive through the plurality of openings of the porous band to the cardiac opening.    
     
     
         54 . The method of  claim 53  further comprising removing the balloon and the porous band of the closure device from the patient after the adhesive is exposed through the plurality of openings of the porous band to the cardiac opening.  
     
     
         55 . A percutaneous transluminal system for closing a cardiac opening, comprising: 
 a first catheter comprising a proximal end, a distal end, and a lumen extending from the proximal end to the distal end;    a second catheter at least partially enclosed within the lumen of the first catheter, the second catheter movable between a retracted state and a deployed state; and    a lining coupled to the first and second catheters, wherein in the retracted state of the second catheter the lining is positioned within the lumen of the first catheter, and wherein in the deployed state of the second catheter the lining inverts and is positioned outside the lumen of the first catheter.    
     
     
         56 . The system of  claim 55  further comprising an adhesive coated on a surface of the lining or contained within the lining.  
     
     
         57 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising: 
 inserting, into a heart of the patient, the system of  claim 55;     positioning the system proximate the cardiac opening with the second catheter in the retracted state; and    deploying the second catheter to invert the lining and position the lining within the cardiac opening.    
     
     
         58 . The method of  claim 57 , wherein the system further comprises an adhesive.  
     
     
         59 . The method of  claim 58  further comprising removing the system from the patient after the adhesive is exposed to the cardiac opening.  
     
     
         60 . A percutaneous transluminal system for positioning a closure device in a cardiac opening, comprising: 
 a catheter;    a closure device coupled to the catheter; and    a first locator coupled to at least one of the catheter and the closure device, the first locator for positioning the closure device in the cardiac opening.    
     
     
         61 . The system of  claim 60  further comprising a second locator coupled to at least one of the catheter and the closure device, the second locator for positioning the closure device in the cardiac opening.  
     
     
         62 . The system of  claim 60  further comprising an adhesive.  
     
     
         63 . The system of  claim 62  further comprising a light source coupled to the catheter for activating a light activated adhesive.  
     
     
         64 . A closure device for percutaneous transluminal closure of a cardiac opening, comprising: 
 a balloon comprising an outer surface;    a first adhesive coated on the outer surface of the balloon; and    a light source located within the balloon.    
     
     
         65 . The system of  claim 64 , further comprising a second adhesive.  
     
     
         66 . The device of  claim 65 , wherein at least one of the first adhesive and the second adhesive comprises a light activated adhesive.  
     
     
         67 . A method for delivering a closure device to a cardiac opening in a patient, comprising: 
 inserting, into a heart of the patient, a system for positioning the closure device within the cardiac opening, the system comprising: 
 a catheter;  
 a closure device coupled to the catheter; and  
 a first locator coupled to at least one of the catheter and the closure device, the first locator for positioning the closure device within the cardiac opening;  
   using the first locator to locate the cardiac opening; and    using the first locator to position the closure device within the cardiac opening.    
     
     
         68 . The method of  claim 67  further comprising coupling the closure device to the cardiac opening to substantially occlude the cardiac opening.  
     
     
         69 . The method of  claim 67  further comprising coupling the first locator to a tissue surface of the patient proximate the cardiac opening.  
     
     
         70 . The method of  claim 67 , wherein the cardiac opening is a patent foramen ovale.  
     
     
         71 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising: 
 inserting the closure device of  claim 64  into a heart of the patient;    positioning the closure device within the cardiac opening; and    coupling the closure device to the cardiac opening to substantially occlude the cardiac opening.