Balloon insertion apparatus and method of sealing a tissue puncture

Abstract

The present invention provides apparatus and methods of closing internal tissue punctures. The apparatus and method provide for an introducer sheath having at least one side port enabling aspiration of an internal tissue puncture site and injection of a sealant.

What is claimed is: 
     
         1 . An internal tissue puncture sealing apparatus, comprising:
 a first thin, elongated conduit having a first central lumen and first and second ends, the first end being insertable through the internal tissue puncture and having an inflation segment in fluid communication with the central lumen;   an expandable member disposed at the first end, the expandable member being selectively inflatable with a fluid via the central lumen;   a second thin, elongated conduit having a second central lumen receptive of the first thin, elongated conduit and having a distal and a proximal end, the proximal end having at least one valved side-port in fluid communication with an annulus between the first thin, elongated conduit and the second thin, elongated conduit.   
     
     
         2 . An internal tissue puncture sealing apparatus according to  claim 1 , further comprising a volume of sealant in fluid communication with the valved side-port for selective injection of the sealant to a situs of the internal tissue puncture via the annulus. 
     
     
         3 . An internal tissue puncture sealing apparatus according to  claim 1  wherein the valved side-port comprises a vacuum evacuation port. 
     
     
         4 . An internal tissue puncture sealing apparatus according to  claim 1  wherein the valved side-port comprises a vacuum evacuation port and a sealant introduction port. 
     
     
         5 . An internal tissue puncture sealing apparatus according to  claim 1  wherein the valved side-port comprises branches to a vacuum evacuation port and a sealant introduction port; and wherein the vacuum evacuation port is in fluid communication with a vacuum syringe, and the sealant introduction port is in fluid communication with a sealant-containing syringe. 
     
     
         6 . An internal tissue puncture sealing apparatus according to  claim 1  wherein the valved side-port is selectively positionable between a closed position, a position open to an evacuator, and a position open to a sealant. 
     
     
         7 . An internal tissue puncture sealing apparatus according to  claim 1 , further comprising a spacer disposed on the first thin, elongated conduit limiting an insertion distance of the first thin, elongated conduit through the second thin, elongated conduit. 
     
     
         8 . An internal tissue puncture sealing apparatus according to  claim 1 , further comprising a spacer disposed on the first thin, elongated conduit limiting an insertion distance of the first thin, elongated conduit through the second thin, elongated conduit such that the first end thereof extends beyond the distal end of the second thin, elongated conduit by a predetermined distance. 
     
     
         9 . An internal tissue puncture sealing apparatus according to  claim 1  wherein the expandable member is coaxial and flush with the first thin, elongated conduit when uninflated. 
     
     
         10 . An internal tissue puncture sealing apparatus according to  claim 1  wherein the first thin, elongated conduit and expandable member comprise a balloon catheter. 
     
     
         11 . An internal tissue puncture sealing apparatus according to  claim 1  wherein the second thin, elongated conduit comprises a vascular insertion sheath. 
     
     
         12 . A vascular puncture sealing system, comprising:
 a balloon catheter;   an introducer assembly receptive of the balloon catheter;   at least one side port in the introducer assembly for evacuating the introducer assembly.   
     
     
         13 . A vascular puncture sealing system according to  claim 12 , further comprising a volume of sealant in fluid communication with the side port of the introducer assembly. 
     
     
         14 . A vascular puncture sealing system according to  claim 12  wherein the side port comprises a three-way valve. 
     
     
         15 . A vascular puncture sealing system according to  claim 12  wherein the side port comprises a three-way valve operable between a closed position, an first open position fluidly connecting the introducer assembly with a vacuum device, and a second open position fluidly connecting the introducer assembly with a sealant supply. 
     
     
         16 . A vascular puncture sealing system according to  claim 12  wherein the side port comprises a three-way valve operable between a closed position, an first open position fluidly connecting the introducer assembly with a vacuum device, and a second open position fluidly connecting the introducer assembly with a sealant supply;
 wherein the vacuum device comprises a first syringe, and the sealant supply comprises a second syringe containing a volume of sealant. 
 
     
     
         17 . A vascular puncture sealing system according to  claim 12  wherein the side port comprises a translucent valve for providing visual indication of blood flow. 
     
     
         18 . A vascular puncture sealing system according to  claim 12  wherein one of the balloon catheter and introducer assembly comprises a stopper sleeve limiting insertion of the balloon catheter into the introducer assembly. 
     
     
         19 . A vascular puncture sealing system according to  claim 12  wherein the side port comprises a valve operable between a closed position an open position fluidly connecting the introducer assembly with a sealant supply;
 wherein the sealant supply comprises a syringe containing a volume of sealant; 
 wherein the sealant comprises a gel or foam comprising one of: collagen, polyvinyl alcohol, polyethylene glycol, cyanoacrylates, chitosan, or poly-n-acetyl glucosamine. 
 
     
     
         20 . An internal tissue puncture sealing apparatus, comprising:
 a balloon catheter;   an introducer assembly having an introducer lumen receptive of the balloon catheter and at least one side port in flow communication with the introducer lumen, the at least one side port providing a common access point for applying a vacuum force to evacuate the introducer lumen and delivering sealant to the introducer lumen after evacuating the introducer lumen.