Systems and methods for closing a hole in cardiac tissue

Abstract

Systems and methods for closing a hold in cardiac tissue. In at least one embodiment of a system for closing a hole in cardiac tissue, the system comprises an engagement catheter having a first and second lumen extending therethrough, an elongated wire capable of insertion into the second lumen of the engagement catheter, a plug capable of insertion into the second lumen of the engagement catheter; an elongated shaft capable of insertion into the second lumen of the engagement catheter, wherein the elongated wire is sized for slidable insertion through the lumen of the shaft and the hole of the plug.

1 . A system for closing a hole in cardiac tissue, the system comprising:
 an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port;   an elongated wire capable of insertion into the second lumen of the engagement catheter;   a plug having a first end, a second end, and a hole extending from the first end to the second end, the plug being capable of insertion into the second lumen of the engagement catheter; and   an elongated shaft having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, the elongated shaft being capable of insertion into the second lumen of the engagement catheter;   wherein the elongated wire is sized for slidable insertion through the lumen of the shaft and the hole of the plug.   
     
     
         2 . The system of  claim 1 , wherein:
 the first end of the plug is radiopaque.   
     
     
         3 . The system of  claim 2 , wherein:
 the first end of the plug has a smaller diameter than the second end of the plug.   
     
     
         4 . The system of  claim 3 , wherein:
 the plug comprises an external surface that has a screw-shaped ridge.   
     
     
         5 . The system of  claim 1 , wherein:
 the elongated wire comprises an elongated guide wire; and   the hole in the plug is self-sealing,   
     
     
         6 . A system for closing a hole in cardiac tissue, the system comprising:
 an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port;   a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the hollow tube is capable of insertion into the second lumen of the engagement catheter;   an elongated delivery wire having a proximal end and a distal end, the distal end of the delivery wire being, capable of insertion through the hollow tube of the delivery catheter; and   a closure member having a first face and a second face, the closure member being capable of transitioning from a folded configuration within the hollow tube of the delivery catheter to an expanded configuration outside of the hollow tube of the delivery catheter;   wherein the first face of the closure member is configured for reversible attachment to the distal end of the delivery wire.   
     
     
         7 . The system of  claim 6 , wherein:
 the closure member comprises an external cover and an internal cover;   the first face of the closure member comprises an outside face of the internal cover; and   the second face of the closure member comprises an outside face of the external cover.   
     
     
         8 . The system of  claim 7 , wherein:
 the internal cover further comprises a first inside face;   the external cover further comprises a second inside face; and   at least one of the first inside face and the second inside face of the external cover comprises a magnet.   
     
     
         9 . The system of  claim 7 , wherein:
 the internal cover further comprises a first inside face;   the external cover further comprises a second inside face; and   an adhesive is attached to the first inside face and the second inside face.   
     
     
         10 . The system of  claim 9 , wherein:
 the closure member comprises a biodegradable substance.   
     
     
         11 . The system of  claim 7 , wherein:
 the external cover is attached to the internal cover.   
     
     
         12 . The system of  claim 11 , wherein:
 the closure member comprises nitinol.   
     
     
         13 . A method for closing a hole in a targeted tissue of a heart, the method comprising the steps of:
 contacting a targeted tissue in the interior of a heart with a distal end of an elongated tube, the elongated tube having a first lumen and a second lumen;   aspirating the targeted tissue such that the targeted tissue is retracted away from a pericardial sac surrounding the heart and a pericardial space between the pericardial sac and the targeted tissue is enlarged;   inserting through the first lumen of the elongated tube a delivery catheter having a lumen;   inserting an elongated delivery wire through the lumen of the delivery catheter, the elongated delivery wire having an external cover that is capable of transitioning from a folded configuration within the lumen of the delivery catheter to an expanded configuration outside of the lumen of the delivery catheter, the external cover being reversibly attached to a distal end of the delivery wire;   delivering the external cover through the hole in the targeted tissue into the pericardial space;   placing the external cover onto the targeted tissue from the pericardial space;   releasing the external cover from the delivery wire; and   withdrawing the delivery wire from the targeted tissue.   
     
     
         14 . The method of  claim 13 , further comprising the steps of:
 reversibly attaching an internal cover to the distal end of the delivery wire, the internal cover being capable of transitioning from a folded configuration within the lumen of the delivery catheter to an expanded configuration outside of the lumen of the delivery catheter;   delivering the internal cover to the targeted tissue in the interior of the heart;   placing the internal cover onto the targeted tissue from the interior of the heart;   releasing the internal cover from the delivery wire; and   withdrawing the delivery wire from the interior of the heart.   
     
     
         15 . A method for closing a hole in a targeted tissue of a heart, the method comprising the steps of:
 inserting a wire through a lumen of an elongated tube and through a hole in a targeted tissue, the elongated tube having a proximal end and a distal end adjacent to the targeted tissue;   inserting into the lumen of the elongated tube and over the wire a plug having a first end, a second end, and a hole extending from the first end to the second end;   inserting into the lumen of the elongated tube and over the wire an elongated shaft having a proximal end, a distal end, and a hole extending from the proximal end to the distal end;   sliding the elongated shaft toward the distal end of the elongated tube until the plug approaches the hole in the targeted tissue;   inserting the plug into the hole in the targeted tissue; and   withdrawing the elongated shaft from the elongated tube,   
     
     
         16 . The method of  claim 15 , wherein:
 the first end of the plug has a diameter that is smaller than the diameter of the second end of the plug.   
     
     
         17 . The method of  claim 16 , wherein:
 at least a portion of the first end of the plug is radiopaque,   
     
     
         18 . The method of  claim 17 , further comprising the step of:
 confirming the location of the plug using radiographic imaging.   
     
     
         19 . The method of  claim 15 , wherein:
 the wire comprises a guide wire; and   the hole of the plug closes after the guide wire is withdrawn from the hole of the plug.   
     
     
         20 . A system for closing a hole in a targeted tissue, comprising:
 a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position; and   a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position.   
     
     
         21 . The system of  claim 20 , further comprising:
 an engagement catheter comprising a proximal end, a distal end, a first lumen extending between the proximal end and the distal end, and a vacuum port operatively connected to the first lumen of the engagement catheter at the proximal end of the engagement catheter, the vacuum port being capable of operative connection to a vacuum source, wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when a vacuum source is operatively attached to the vacuum port;   wherein the delivery catheter is configured for inserted into the first lumen of the engagement catheter.   
     
     
         22 . The system of  claim 21 , wherein:
 the plurality of arms of the closure member comprise nitinol.   
     
     
         23 . The system of  claim 22 , wherein:
 the plurality of arms of the closure member comprise four arms,   
     
     
         24 . A method for closing a hole in a targeted tissue of a heart, the method comprising the steps of:
 providing a closure member having a head and a plurality of arms extending from the head, the closure member capable of transitioning between an open position and a closed position;   delivering the closure member to a heart through a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the closure member is capable of insertion into the hollow tube when the closure member is in the open position;   deploying the closure member such that the closure member contacts a targeted tissue of the heart and transitions to the closed position.   
     
     
         25 . The method of  claim 24 , wherein:
 the plurality of arms comprise four arms.   
     
     
         26 . The method of  claim 25 , wherein:
 the step of delivery the closure member to the heart comprises advancing the closure member through the delivery catheter by pushing on the head of the closure member using a rod inserted into the hollow tube.