Vascular sealing device and method of use

Abstract

A collapsible medical device for use, e.g., as a vascular sealer. The device includes a sheath adapted to be positioned such that a distal end thereof is adjacent the opening. A mandrel is disposed within a lumen of the sheath and is adapted to be positioned such that a distal length thereof is adjacent the distal end of the sheath. A collapsible sealing member comprises a fluid-impervious film carried by a plurality of wires. The wires are attached to the mandrel and expand radially outward therefrom. In one method of using such a device, the sealing member is held in a collapsed position within the sheath. The sealing member is advanced through the sheath and beyond the distal end thereof, whereby the sealing member resiliently expands. The sealing member is positioned against the inner wall of the blood vessel adjacent the opening, thereby effecting a temporary seal of the opening. The sealant is introduced into the tissue tract. After hardening, the sealing member is collapsed within the sheath. The sheath the sealing member collapsed therein (together with any existing introducer) are then withdrawn proximally from the patient.

What is claimed is:  
     
         1 . A method for closing an opening in a blood vessel of a patient, comprising: 
 a) providing a collapsible sealing member mounted on a mandrel, the collapsible sealing member having a fluid impermeable body with a naturally expanded configuration;    b) providing a sheath having a distal end adjacent the opening, the sheath having a lumen smaller than an exterior dimension of the sealing member's expanded configuration such that the sealing member is held in a collapsed position when inside the sheath;    c) advancing the collapsed sealing member through the sheath and beyond the distal end thereof whereby the sealing member resiliently expands toward said expanded configuration;    d) positioning the sealing member against an inner wall of the blood vessel adjacent the opening, thereby affecting a temporary seal of the opening;    e) introducing a sealant to an area adjacent the opening;    f) collapsing the sealing member within the sheath; and    g) withdrawing the sheath with the collapsed sealing member therein proximally from the patient.    
     
     
         2 . The method of  claim 1  wherein the sealant is introduced by flowing it into said area adjacent the opening.  
     
     
         3 . The method of  claim 1  wherein the sealant is introduced by syringe injecting it into said area adjacent the opening.  
     
     
         4 . The method of  claim 1  wherein the sealant comprises a procoagulant, thereby promoting clotting to form a hemostatic seal.  
     
     
         5 . The method of  claim 1  wherein the sealant comprises a thermally reversible material with a gelation temperature no higher than 37° Celsius, the method further comprising allowing the sealant to warm to body temperature to promote hardening of the sealant.  
     
     
         6 . The method of  claim 1  wherein the sealant comprises a photo-initiated material, the method further comprising directing an activating light onto the sealant to initiate polymerization.  
     
     
         7 . The method of  claim 1  wherein the sealant comprises a photo-initiated material, the method further comprising directing an activating light onto the sealant to initiate a crosslink reaction.  
     
     
         8 . The method of  claim 1  further comprising bringing a second material into contact with the sealant to cause an in situ crosslink reaction in said area adjacent the blood vessel, causing solidification of the sealant and the second material.  
     
     
         9 . The method of  claim 1  wherein the sealant comprises a therapeutic agent, thereby promoting release of the agent into the patient.  
     
     
         10 . The method of  claim 1  further comprising waiting a predetermined time for the sealant to harden before withdrawing the sheath and the sealing member from the patient.  
     
     
         11 . The method of  claim 1  further comprising suturing an area of tissue adjacent the opening.  
     
     
         12 . A vascular sealing assembly for closing an opening in a blood vessel comprising: 
 a) a sheath adapted to be positioned such that a distal end thereof is adjacent the opening;    b) a mandrel disposed within a lumen of the sheath, the mandrel being adapted to be positioned such that a distal length thereof is adjacent the distal end of the sheath; and    c) a collapsible sealing member comprising a fluid-impervious film carried by a plurality of wires, the wires being attached to the mandrel and expanding radially outward therefrom.    
     
     
         13 . The vascular sealing assembly of  claim 12  further including an introducer disposed around the sheath through which a sealant is adapted to be delivered to an area adjacent the opening.  
     
     
         14 . The vascular sealing assembly of  claim 12  further including a sealant adapted to be injected with a syringe to an area adjacent the opening.  
     
     
         15 . The vascular sealing assembly of  claim 12  wherein the wires comprise stainless steel.  
     
     
         16 . The vascular sealing assembly of  claim 12  wherein the wires comprise nitinol.  
     
     
         17 . The vascular sealing assembly of  claim 12  wherein the wires comprise elgiloy.  
     
     
         18 . The vascular sealing assembly of  claim 12  wherein the wires comprise polymeric fiber.  
     
     
         19 . The vascular sealing assembly of  claim 12  wherein the wires comprise carbon fiber.  
     
     
         20 . The vascular sealing assembly of  claim 12  wherein the film comprises a flexible material selected from the group consisting of urethane, silicone, rubber, and polyvinyl chloride.