Apparatus and Method for Percutaneous Sealing of Blood Vessel Punctures

Abstract

A device for promoting hemostasis in a blood vessel puncture is employed with an introducer that accesses the puncture through an incision. The introducer has an open distal end positionable at the puncture, an external portion with an open proximal end, and an axial channel therebetween. The device includes a hollow catheter, dimensioned to pass through the introducer channel, having a distal end to which is attached an expansible compression element, which may be an inflatable balloon, a collapsible prong assembly, or a resilient foam pad. The compression element is collapsed when the distal end of the catheter is enclosed within the introducer. When the catheter and the introducer are located the desired distance from the puncture, the introducer is displaced axially relative to the catheter to expose the compression element to the subcutaneous tissue, whereupon the compression element is expanded. Pressure is applied to the compression element through the introducer to promote hemostasis by the compression of subcutaneous tissue adjacent the puncture. The device preferably includes a locator member passing into the blood vessel through the puncture. The locator member may be either a guide wire, or a hollow tube with a locating balloon, disposed near the portion of the tube insertable into the vessel. A dissolvable locating tip element, connected to the distal end of the catheter, may be used to maintain the position of the device while hemostasis takes place after the locator member is removed.

1 - 13 . (canceled)  
   
   
       14 . A locating device for a catheter employed to provide percutaneous sealing of a puncture in a blood vessel, the catheter having a distal end locatable adjacent the puncture, the device comprising: 
 a locating element on the distal end of the catheter so as to extend distally therefrom, the locating element being dimensioned to permit its entry into the puncture, the locating element being formed from a biocompatible material that dissolves in the bloodstream.    
   
   
       15 . The locating device of  claim 14 , wherein the locating element comprises a tubular portion dimensioned to permit its entry into the puncture.  
   
   
       16 . The locating device of  claim 15 , wherein a distal end of the tubular portion is tapered.  
   
   
       17 . The locating device of  claim 14 , wherein the locating element has an axial passage through its length to receive a guidewire.  
   
   
       18 . The locating device of  claim 14 , wherein the locating element comprises: 
 a cylindrical portion; and    a tubular portion extending distally from the cylindrical portion, thereby defining a shoulder at the juncture between the tubular portion and the cylindrical portion, the tubular portion being dimensioned to permit its entry into the puncture.    
   
   
       19 . The locating device of  claim 18 , wherein the distal end of the tubular portion is tapered.  
   
   
       20 . The locating device of  claim 18 , wherein the locating element has an axial passage through its length to receive a guidewire.  
   
   
       21 . The locating device of  claim 14 , wherein the locating element dissolves in the bloodstream during a period of approximately ten to sixty minutes.  
   
   
       22 . The locating device of  claim 21 , wherein the locating element is made of a material selected from the group consisting of methyl cellulose, carboxymethyl cellulose, carbowax, gelatin, polylactic glycolic acids, polyvinyl pyrrolidone, polyvinyl alcohol, polyproline, and polyethylene oxide.  
   
   
       23 . The locating device of  claim 18 , wherein the locating element dissolves in the bloodstream during a period of approximately ten to sixty minutes.  
   
   
       24 . The locating device of  claim 23 , wherein the locating element is made of a material selected from the group consisting of methyl cellulose, carboxymethyl cellulose, carbowax, gelatin, polylactic glycolic acids, polyvinyl pyrrolidone, polyvinyl alcohol, polyproline, and polyethylene oxide.  
   
   
       25 . The locating device of  claim 24 , further comprising an expandable compression member located on the catheter proximal of the locating element for sealing the puncture in the blood vessel.  
   
   
       26 . A device for promoting hemostasis in a blood vessel puncture where the puncture is accessed subcutaneously through a sheath having an axial channel, comprising: 
 a catheter to be received within the axial channel, the catheter having a distal end; and    an expansible compression means coupled to the distal end, the expansible compression means having a collapsed position when enclosed by the sheath, and an expanded position when exposed to the subcutaneous tissue,    wherein the expansible compression means compresses the subcutaneous tissue adjacent the puncture to promote hemostasis at the puncture.    
   
   
       27 . The device of  claim 26  wherein the catheter further comprises an axial lumen, wherein the expansible compression means is in fluid communication with the axial lumen and is inflatable by a fluid introduced through the axial lumen, the expansible compression means having a collapsed position when uninflated and an expanded position when inflated.  
   
   
       28 . The device of  claim 26  wherein the compression means is a foam pad having a distal end.  
   
   
       29 . The device of  claim 29  wherein the foam pad is made of natural a polymer.  
   
   
       30 . The device of  claim 29  further comprising a locating member coupled to the foam pad distal end.  
   
   
       31 . A device for promoting hemostasis in a blood vessel puncture where the puncture is accessed subcutaneously through a sheath having an axial channel, comprising: 
 a catheter to be received within the axial channel, the catheter having a distal end and a lumen; and    a foam pad coupled to the distal end, the foam pad having a collapsed position when enclosed within the sheath, and an expanded position when exposed to the subcutaneous tissue;    wherein the foam pad, in the expanded position, compresses the subcutaneous tissue adjacent the puncture to promote hemostasis at the puncture.    
   
   
       32 . The device of  claim 31  wherein the foam pad further comprises an axial passage to receive a guidewire.  
   
   
       33 . The device of  claim 32  wherein the foam pad is made of a natural polymer.  
   
   
       34 . The device of  claim 33  further comprising a locating member extensible through the catheter lumen, the distal end of the catheter, and the foam pad axial passage, the locating member having a distal portion extensible into the interior of the blood vessel through the puncture.  
   
   
       35 . The device of  claim 34  wherein the locating member further comprises: 
 a hollow tube extensible axially through the catheter lumen, the distal end of the catheter, and the foam pad axial passage; and    a locating balloon coupled to the distal portion of the locating member, the locating balloon inflatable through the hollow tube when positioned in the interior of the blood vessel.    
   
   
       36 . The device of  claim 34  wherein the locating member further comprises a wire extensible axially through the catheter lumen, the catheter distal end, the foam pad axial passage, and into the interior of the blood vessel.  
   
   
       37 . The device of  claim 31  further comprising: 
 a radiopaque marker coupled to the catheter distal end; and    means for introducing a contrast medium into the catheter lumen.    
   
   
       38 . The device of  claim 31  further comprising a pressure applying means coupled to an external portion of the sheath.  
   
   
       39 . The device of  claim 38  wherein the catheter is coupled to the sheath so that the pressure applying means applies downward force to the sheath and catheter when the catheter is diposed within the axial channel.  
   
   
       40 . The device of  claim 38  wherein the pressure applying means comprises: 
 a clamping device secured to the external portion of the sheath; and    a skin patch coupled to the clamping device and adhesively attachable to the surface of the skin.