Vascular Sealing Device and Method Using Clot Enhancing Balloon and Electric Field Generation

Abstract

An apparatus and method for closing an opening in a blood vessel wall is disclosed. The apparatus includes at least one member which is extended through a tissue tract formed through the epidermis and subcutaneous layer of skin and through the opening in the blood vessel. The member includes a proximal end and a distal end with the distal end being positionable proximate to the opening in the blood vessel wall. A positive electrode is positioned next to the distal end with a negative electrode being positioned next to the proximal end When the electrodes are energized an electric field is created therebetween, blood cells are attracted to the positive electrode, and a thrombus is formed at the opening in the blood vessel wall. The member may include a balloon at the distal end to temporarily occlude blood flow from the blood vessel to the tissue tract to facilitate formation of the thrombus. In addition, the shape of the balloon may be tailored to facilitate the formation of the thrombus including, but not limited to, the creation of pockets and self-supporting balloons

1 . An apparatus fbi closing an opening in a blood vessel, comprising:
 a balloon catheter having a proximal end positionable at an epidermis of the patient, and a distal end positionable at a blood vessel wall of the patient;   a first electrode positioned on tissue of the patient distant from the opening in the blood vessel; and   a second electrode at the distal end the balloon catheter   
   
   
       2 . The apparatus of  claim 1 , further including a sheath extending from the epidermis of the patient to the blood vessel wall, the sheath having a proximal end positionable at the epidermis of the patient, and a distal end at the blood vessel wall of the patient 
   
   
       3 . The apparatus of  claim 1 , wherein the first electrode is negatively charged and the second electrode is positively charged. 
   
   
       4 . The apparatus of  claim 1 , wherein the balloon catheter includes a balloon at the distal end, the balloon being toroidal in cross-section shape 
   
   
       5 . The apparatus of  claim 4 , wherein the balloon forms a pocket against an interior surface of the blood vessel wall, the pocket facilitating formation of a thrombus. 
   
   
       6 . The apparatus of  claim 1 , further including a second set of positive and negative electrodes. 
   
   
       7 . The apparatus of  claim 3 , further including a second positive electrode, the second positive electrode being positioned on one of the balloon catheter and the sheath at a distance closer to the negative electrode than the first positive electrode 
   
   
       8 . The apparatus at  claim 1 , wherein the balloon catheter includes a balloon at the distal end, the balloon being substantially T-shaped in cross-section 
   
   
       9 . The apparatus of  claim 1 , wherein the balloon catheter includes a balloon at the distal end, the balloon being substantially teardrop-shaped 
   
   
       10 . The apparatus of  claim 1 , wherein the balloon catheter includes a balloon adapted to extend between diametrically opposed interior surfaces of the blood vessel while still allowing perfusion through the blood vessel 
   
   
       11 . The apparatus of  claim 1 , wherein the first and second electrodes are formed by one of coiled wire, metal bands, foil, conductive ink, and gold micro-extrusion 
   
   
       12 . The apparatus of  claim 1 , wherein the balloon is a tolling membrane balloon. 
   
   
       13 . The apparatus of  claim 1 , further including a heat-source at the distal end of one of the sheath and balloon catheter 
   
   
       14 . An apparatus for closing an opening in a blood vessel, comprising:
 a member for extending between an epidermis of a patient and a blood vessel wall of the patient, the member including a proximal end positionable at the epidermis, and a distal end positionable at the blood vessel wall;   a first electrode at the member proximal end; and   a second electrode at the member distal end.   
   
   
       15 . The apparatus of  claim 10 , wherein the first electrode is negatively charged and the second electrode is positively charged. 
   
   
       16 . The apparatus of  claim 10 , further including a backstop at the member distal end. 
   
   
       17 . The apparatus of  claim 16 , wherein the backstop is a balloon. 
   
   
       18 . The apparatus of  claim 16 , wherein the backstop is a membrane covered wall 
   
   
       19 . The apparatus of  claim 17 , wherein the balloon is a lolling membrane balloon. 
   
   
       20 . The apparatus of  claim 17 , wherein the balloon is substantially toroidal in cross-sectional shape. 
   
   
       21 . The apparatus of  claim 17 , wherein the balloon is substantially T-shaped in cross-section. 
   
   
       22 . A method of closing an opening in a blood vessel, comprising:
 inserting a sheath into a tissue tract within a patient extending between an epidermis and a blood vessel wall;   extending a balloon catheter into the sheath, the balloon catheter having a shaft terminating in a balloon, the balloon catheter being inserted until the balloon is fully within the blood vessel, one of the sheath or balloon catheter having a positive electrode thereon, one of the sheath and balloon catheter having a negative electrode thereon;   inflating the balloon;   retracting the balloon catheter until the inflated balloon engages an interior surface of the blood vessel wall; and   creating an electric field between the negative and positive electrodes, blood cells thereby being attracted to the positive electrode and forming a thrombus at the blood vessel wall   
   
   
       23 . The method of  claim 22 , wherein inflating and retracting the balloon causes a pocket to form between the balloon and the blood vessel wall. 
   
   
       24 . The method of  claim 22 , wherein inflating the balloon causes the balloon to engage the blood vessel wall at at least two diametrically opposed points 
   
   
       25 . The method of  claim 22 , wherein the balloon is self-supporting when inflated. 
   
   
       26 . A method of closing an opening in blood vessel, comprising:
 inserting a member between an epidermis of a patient and the opening of the blood vessel wall of the patient, the member having a positive electrode and negative electrode thereon; and   creating an electric field between the negative and positive electrodes, blood cells being attracted to the positive electrode and forming a thrombus at the blood vessel wall.   
   
   
       27 . The method of  claim 26 , wherein the member is a balloon catheter. 
   
   
       28 . The method of  claim 26 , wherein the member is a rolling membrane balloon 
   
   
       29 . The method of  claim 28 , wherein the rolling member is inserted by directing a pressurized fluid into the rolling balloon 
   
   
       30 . The method of  claim 28 , wherein the rolling membrane balloon is inserted and retracted using a mechanical extension and withdrawal rod. 
   
   
       31 . The method of  claim 26 , wherein the member is a working sheath. 
   
   
       32 . The method of  claim 31 , further including extending a balloon catheter through the working sheath until a balloon extending from a shaft of the balloon catheter is fully within the blood vessel, inflating the balloon, and retracting the balloon until it engages an interior surface of the blood vessel wall, before the electric field is created. 
   
   
       33 . The method of  claim 32 , further including forming a pocket between the balloon and the blood vessel wall to facilitate formation of the thrombus. 
   
   
       34 . The method of  claim 32 , further includes inflating the balloon such that it engages at least two diametrically opposed points on the interior surface of the blood vessel wall. 
   
   
       35 . The method of  claim 26 , further including heating the distal end of the member.