Bioadhesive delivery catheter manifold with mixing fixture and methods

Abstract

A bioadhesive delivery catheter includes a manifold, a dual lumen tube, and a mixing member. The manifold includes a delivery device passage and an injection port. The tube is insertable into the delivery device passage and includes first and second lumens positioned side-by-side. The first lumen extends proximal of the second lumen within the delivery device passage, and the second lumen is in flow communication with the injection port. The mixing member is positioned between a proximal inlet of the injection port and the second lumen and is configured to help mix a bioadhesive material that is delivered through the injection port into the second lumen.

What is claimed is: 
     
         1 . A bioadhesive delivery catheter apparatus comprising:
 a delivery tube comprising:
 a first lumen in fluid communication with an interior of a balloon and configured to deliver inflation fluid to inflate the balloon; and 
 a second lumen configured to deliver a bioadhesive material to a tissue tract and a vessel puncture, the bioadhesive material configured to at least partially solidify; 
   wherein the balloon is configured to be inserted through the tissue tract, through the vessel puncture, and into a vessel lumen, the balloon further configured to be inflated upon being positioned in the vessel lumen to seal the vessel puncture to prevent the bioadhesive material from entering the vessel lumen.   
     
     
         2 . The apparatus of  claim 1 , wherein the balloon upon inflation contacts an inner surface of the vessel lumen as the balloon is inflated to create a seal between the vessel puncture and the vessel lumen. 
     
     
         3 . The apparatus of  claim 1 , wherein the delivery tube is partially retracted once the balloon is inflated, causing the balloon to contact an inner surface of the vessel lumen to seal the vessel puncture. 
     
     
         4 . The apparatus of  claim 1 , wherein after the bioadhesive material is at least partially solidified, the balloon is deflated such that the delivery tube can be withdrawn from the tissue tract. 
     
     
         5 . The apparatus of  claim 1 , wherein the balloon upon inflation is configured to prevent contents of the vessel lumen from entering the tissue tract through the vessel puncture. 
     
     
         6 . The apparatus of  claim 1  further comprising an inner tube disposed in the first lumen and configured to deliver a second bioadhesive material to seal a bioadhesive plug tract left in the solidified bioadhesive material after removing the delivery tube. 
     
     
         7 . The apparatus of  claim 1  further comprising a sealing tip that is releasably attached to an inner tube disposed in the first lumen, the sealing tip being configured to lodge within a bioadhesive plug tract left in the bioadhesive material after removing the delivery tube. 
     
     
         8 . The apparatus of  claim 1 , wherein the balloon is deflated by applying a vacuum pressure to withdraw the inflation fluid out of the balloon. 
     
     
         9 . The apparatus of  claim 1 , wherein upon partially solidifying, the bioadhesive material maintains its shape and position in the tissue tract and vessel puncture. 
     
     
         10 . The apparatus of  claim 1  further comprising an indicator member that indicates pressure conditions of the balloon. 
     
     
         11 . A bioadhesive delivery catheter apparatus comprising:
 an expandable member configured to be inserted through a tissue tract into a vessel lumen and expanded to create a seal between the vessel lumen and a vessel puncture; and   a delivery tube configured to deliver a bioadhesive material to be cured in the tissue tract to seal the vessel puncture;   wherein the expandable member is configured to maintain the bioadhesive material in the tissue tract and prevent the bioadhesive material from entering the vessel lumen.   
     
     
         12 . The apparatus of  claim 11  further configured to deliver a second bioadhesive material to seal a tract left in the solidified bioadhesive material after removing the delivery tube. 
     
     
         13 . The apparatus of  claim 11 , wherein the delivery tube is partially retracted once the expandable member is expanded, causing the expandable member to contact an inner surface of the vessel lumen to seal the vessel puncture. 
     
     
         14 . The apparatus of  claim 11  further comprising a sealing tip that is releasably attached to an inner tube disposed in the delivery tube, the sealing tip being configured to lodge within a bioadhesive plug tract left in the bioadhesive material after removing the delivery tube. 
     
     
         15 . A method of delivering a bioadhesive material comprising:
 providing a tube comprising first and second lumens positioned side-by-side, an end of the tube being inserted through a tissue tract and into a vessel lumen through a vessel puncture;   inflating a balloon disposed proximate the end of the tube until the balloon contacts an inner surface of the vessel lumen and seals the vessel puncture;   introducing bioadhesive material through the second lumen and into the tissue tract;   the seal preventing the bioadhesive material from entering into the vessel lumen through the vessel puncture;   allowing the bioadhesive material to at least partially cure in the tissue tract to seal the vessel puncture; and   removing the balloon from the vessel lumen through the tissue track while preventing bioadhesive material from entering into the vessel lumen.   
     
     
         16 . The method of  claim 15  comprising partially retracting the balloon upon inflation to contact the inner surface of the vessel lumen to seal the vessel puncture. 
     
     
         17 . The method of  claim 15  further comprising an inner tube disposed in the first lumen and configured to deliver a second bioadhesive material to seal a tract left in the solidified bioadhesive material after removing the delivery tube. 
     
     
         18 . The method of  claim 15  further comprising detaching a sealing tip in a tract left in the bioadhesive material after removing the delivery tube.