Devices, Systems and Methods for Closure of Cardiac Openings

Abstract

The invention generally relates to devices, systems, and methods for percutaneous closure of cardiac openings and obliteration of the cardiac cul-de-sacs. In one embodiment, a closure device includes a patch with an adhesive and/or a removable frame. The patch may be placed across a cardiac opening, such as a patent foramen ovale, or across a cardiac cul-de-sac, such as a left atrial appendage. In another embodiment, a closure device includes a balloon together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the balloon. The balloon may be inserted into a cardiac opening, such as the patent foramen ovale, or into a cardiac cul-de-sac, such as a left atrial appendage.

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. 
     
     
         3 . The system of  claim 1 , wherein the first locator comprises a plurality of arms. 
     
     
         4 . The system of  claim 1 , wherein the first locator comprises a rod. 
     
     
         5 . The system of  claim 1 , wherein the first locator comprises a locator balloon. 
     
     
         6 . The system of  claim 1 , wherein the first locator comprises a right atrial locator. 
     
     
         7 . The system of  claim 1 , wherein the first locator comprises a left atrial locator. 
     
     
         8 . 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. 
     
     
         9 . The system of  claim 1  further comprising an adhesive coated on the first locator. 
     
     
         10 . The system of  claim 1  further comprising a second locator. 
     
     
         11 . The system of  claim 1 , wherein the adhesive comprises a cyanoacrylate. 
     
     
         12 . The system of  claim 1 , wherein the adhesive comprises a fibrin based adhesive. 
     
     
         13 . The system of  claim 1 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive. 
     
     
         14 . The system of  claim 1  further comprising an adhesive coated on the first locator. 
     
     
         15 . The system of  claim 8  further comprising an adhesive coated on the second locator. 
     
     
         16 . The system of  claim 14 , wherein the adhesive comprises a cyanoacrylate. 
     
     
         17 . The system of  claim 14 , wherein the adhesive comprises a fibrin based adhesive. 
     
     
         18 . The system of  claim 14 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive. 
     
     
         19 . The system of  claim 1 , wherein the adhesive comprises a light activated adhesive. 
     
     
         20 . The system of  claim 1  further comprising a light source coupled to the catheter for activating the light activated adhesive. 
     
     
         21 . The system of  claim 1  further comprising an adhesive coated on an outer surface of the balloon. 
     
     
         22 . The system of  claim 1  further comprising an adhesive coated on an inner surface of the balloon. 
     
     
         23 . The system of  claim 1 , wherein the balloon is tubular-shaped. 
     
     
         24 . The system of  claim 1 , wherein the balloon comprises a plurality of holes. 
     
     
         25 . The system of  claim 24 , wherein the holes comprise slits. 
     
     
         26 . The system of  claim 24 , wherein the adhesive is contained within the balloon. 
     
     
         27 . The system of  claim 1 , wherein the adhesive is disposed on the surface of the balloon. 
     
     
         28 . The system of  claim 27 , wherein the surface of the balloon is involuted. 
     
     
         29 . The system of  claim 1 , wherein the balloon is adapted to deliver the adhesive from the inner lumen of the balloon to the exterior surface of the balloon by capillary action. 
     
     
         30 . The system of  claim 1 , wherein the balloon is detachable from the distal end of the catheter. 
     
     
         31 . The system of  claim 30 , wherein the first locator is attached to the balloon. 
     
     
         32 . The system of  claim 1 , wherein the adhesive comprises an irritant. 
     
     
         33 . The system of  claim 1 , wherein the adhesive comprises a tissue growth stimulator. 
     
     
         34 . A closure device for percutaneous transluminal closure of a cardiac opening, comprising:
 a balloon comprising an outer surface, the balloon inflatable between a deflated state and an inflated state, wherein in the deflated state the outer surface of the balloon involutes to form a cavity, and wherein in the inflated state the cavity unfolds to form the outer surface of the balloon; and   an adhesive, wherein in the deflated state the adhesive is coated on a surface of the cavity, and wherein in the inflated state the adhesive is coated on the outer surface of the balloon.   
     
     
         35 . The device of  claim 34 , wherein the cavity is formed around a mid-portion of the balloon. 
     
     
         36 . The device of  claim 34 , wherein the balloon is tubularly-shaped. 
     
     
         37 . The device of  claim 34 , wherein the adhesive comprises cyanoacrylate. 
     
     
         38 . The device of  claim 34 , wherein the adhesive comprises a fibrin based adhesive. 
     
     
         39 . The device of  claim 34 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive. 
     
     
         40 . The device of  claim 34 , wherein the adhesive comprises a light activated adhesive. 
     
     
         41 . The device of  claim 34  further comprising a substance for stimulating tissue growth, wherein in the deflated state the substance is coated on the surface of the cavity, and wherein in the inflated state the substance is coated on the outer surface of the balloon. 
     
     
         42 . The device of  claim 41 , 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. 
     
     
         43 . 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.   
     
     
         44 . The device of  claim 43 , wherein the porous band encircles a center portion of the balloon. 
     
     
         45 . The device of  claim 43 , wherein the balloon is tubularly-shaped. 
     
     
         46 . The device of  claim 43 , wherein the adhesive comprises cyanoacrylate. 
     
     
         47 . The device of  claim 43 , wherein the adhesive comprises a fibrin based adhesive. 
     
     
         48 . The device of  claim 43 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive. 
     
     
         49 . The device of  claim 43 , wherein the adhesive comprises a light activated adhesive. 
     
     
         50 . The device of  claim 43  further comprising a substance for stimulating tissue growth, wherein the substance is disposed between the outer surface of the balloon and the porous band. 
     
     
         51 . The device of  claim 50 , 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. 
     
     
         52 . A closure device for percutaneous transluminal closure of a cardiac opening, comprising:
 an outer balloon comprising a plurality of first holes;   an inner balloon comprising a plurality of second holes, the inner balloon contained within the outer balloon; and   an adhesive contained within the inner balloon.   
     
     
         53 . The device of  claim 52 , wherein at least one of the plurality of first holes and the plurality of second holes comprises pores. 
     
     
         54 . The device of  claim 52 , wherein at least one of the plurality of first holes and the plurality of second holes comprises slits. 
     
     
         55 . The device of  claim 52 , wherein at least one of the inner balloon and the outer balloon is tubularly-shaped. 
     
     
         56 . The device of  claim 52 , wherein the adhesive comprises cyanoacrylate. 
     
     
         57 . The device of  claim 52 , wherein the adhesive comprises a fibrin based adhesive. 
     
     
         58 . The device of  claim 52 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive. 
     
     
         59 . The device of  claim 52 , wherein the adhesive comprises a light activated adhesive. 
     
     
         60 . The device of  claim 52  further comprising a substance for stimulating tissue growth, wherein the substance is contained within the inner balloon. 
     
     
         61 . The device of  claim 60 , 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. 
     
     
         62 . A closure device for percutaneous transluminal closure of a cardiac opening, comprising:
 a balloon comprising a membrane constructed from a wicking material; and   an adhesive contained within the membrane of the balloon.   
     
     
         63 . The device of  claim 62 , wherein the balloon is tubularly-shaped. 
     
     
         64 . The device of  claim 62 , wherein the adhesive comprises cyanoacrylate. 
     
     
         65 . The device of  claim 62 , wherein the adhesive comprises a fibrin based adhesive. 
     
     
         66 . The device of  claim 62 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive. 
     
     
         67 . The device of  claim 62 , wherein the adhesive comprises a light activated adhesive. 
     
     
         68 . The device of  claim 62  further comprising a substance for stimulating tissue growth, wherein the substance is contained within the membrane of the balloon. 
     
     
         69 . The device of  claim 68 , 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. 
     
     
         70 . The device of  claim 62 , wherein at least a portion of the adhesive is absorbed within the membrane of the balloon. 
     
     
         71 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
 inserting a closure device into a heart of the patient, the closure device comprising:   a balloon comprising an outer surface, the balloon inflatable between a deflated state and an inflated state, wherein in the deflated state the outer surface of the balloon involutes to form a cavity, and wherein in the inflated state the cavity unfolds to form the outer surface of the balloon; and   an adhesive, wherein in the deflated state the adhesive is coated on a surface of the cavity, and wherein in the inflated state the adhesive is coated on the outer surface of the balloon.   positioning the closure device within the cardiac opening with the balloon in the deflated state; and   inflating the balloon to expose the adhesive to the cardiac opening.   
     
     
         72 . The method of  claim 71  further comprising removing the balloon of the closure device from the patient after the adhesive is exposed to the cardiac opening. 
     
     
         73 . The method of  claim 71 , wherein the cardiac opening is a patent foramen ovale. 
     
     
         74 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
 inserting a closure device into a heart of the patient, the closure device 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; 
   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.   
     
     
         75 . The method of  claim 74  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. 
     
     
         76 . The method of  claim 74  wherein the cardiac opening is a patent foramen ovale. 
     
     
         77 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
 inserting a closure device into a heart of the patient, the closure device comprising:
 an outer balloon comprising a plurality of first holes; 
 an inner balloon comprising a plurality of second holes, the inner balloon contained within the outer balloon; and 
 an adhesive contained within the inner balloon; 
   positioning the closure device within the cardiac opening;   applying a first pressure to the inner balloon to express the adhesive through the plurality of second holes; and   applying a second pressure to the outer balloon to express the adhesive through the plurality of first holes to the cardiac opening.   
     
     
         78 . The method of  claim 77  further comprising removing the outer balloon and the inner balloon of the closure device from the patient after the adhesive is expressed through the plurality of first holes to the cardiac opening. 
     
     
         79 . The method of  claim 77 , wherein the cardiac opening is a patent foramen ovale. 
     
     
         80 . A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
 inserting a closure device into a heart of the patient, the closure device comprising:
 a balloon comprising a membrane constructed from a wicking material; and 
 an adhesive contained within the membrane of the balloon; 
   positioning the closure device within the cardiac opening; and   contacting a tissue surface of the cardiac opening with the membrane of the balloon to apply-the adhesive to the tissue surface of the cardiac opening.   
     
     
         81 . The method of  claim 80  further comprising removing the balloon of the closure device from the patient after the adhesive is applied to the tissue surface of the cardiac opening. 
     
     
         82 . The method of  claim 80  wherein the cardiac opening is a patent foramen ovale.