Device and method for sealing blood vessels

Abstract

The present invention provides devices, systems, and methods for percutaneously sealing a puncture site in tissue tracts and vessels in human or animal bodies. One system includes a locating assembly that is used to locate the puncture site and can also provide temporary hemostasis when the system is used for closing a vessel puncture. The system also includes a compression assembly comprising a tubular member with a balloon on a distal end thereof. This balloon is at a fixed distance from the locator tip which locates the balloon outside the vessel wall at a predetermined distance. Inflation of this balloon causes forward elongation of the balloon which compresses subcutaneous tissue between the distal tip of the balloon and the vessel wall. This tissue compression against the puncture site is the mechanism that provides hemostasis.

What is claimed is: 
     
         1 . A system for hemostasis of a puncture site in a body lumen, the device comprising:
 a locating member having a proximal end and a distal end and an expansible member disposed on the distal end thereof; and   a compression member at least partially coaxial with the locating member, the compression member having a proximal end and a distal end and an expansible element disposed at the distal end thereof, wherein a distal end of the expansible element is postionable at a predetermined distance away from a wall of the body lumen.   
     
     
         2 . The system of  claim 1 , further comprising deployment means coupleable to the proximal end of the locating member so as to move the expansible member between a contracted configuration and an expanded configuration. 
     
     
         3 . The system of  claim 2 , wherein the expansible member in the expanded configuration has a diameter in a range from about 0.05 inch to about 0.5 inch. 
     
     
         4 . The system of  claim 3 , wherein the expansible member in the expanded configuration has a diameter in a range from about 0.15 inch to about 0.30 inch. 
     
     
         5 . The system of  claim 1 , wherein the expansible member comprises stainless steel, shape memory material, or superelastic material. 
     
     
         6 . The system of  claim 1 , further comprising a temporary hemostasis member coupleable to the distal end of the locating member. 
     
     
         7 . The system of  claim 6 , wherein the expansible element is disposed between the distal end of the compression member and a proximal end of the temporary hemostasis member. 
     
     
         8 . The system of  claim 1 , further comprising a deformable membrane at least partially disposed over the expansible member. 
     
     
         9 . The system of  claim 1 , wherein the locating member and compression member form an integrated catheter assembly. 
     
     
         10 . The system of  claim 1 , wherein the compression member remains proximal a distal end of the expansible member. 
     
     
         11 . The system of  claim 10 , further comprising mechanical or visual means on the locating member or compression member. 
     
     
         12 . The system of  claim 10 , wherein the predetermined distance is in a range from about 0.05 inch to about 0.5 inch. 
     
     
         13 . The system of  claim 12 , wherein the predetermined distance is in a range from about 0.2 inch to about 0.3 inch. 
     
     
         14 . The system of  claim 10 , wherein the compression member is fixed relative to the locating member. 
     
     
         15 . The system of  claim 10 , wherein the compression member is moveable relative to the locating member. 
     
     
         16 . The system of  claim 1 , wherein the locating member is laterally offset from an axis of the compression member. 
     
     
         17 . The system of  claim 1 , wherein the expansible element comprises a balloon. 
     
     
         18 . The system of  claim 17 , wherein the balloon comprises one or more materials selected from the group consisting of polyethylene, polyethylene terephthalate, polytetrafluroethylene, nylon, polyurethane, silicone, latex, polyvinyl chloride, and thermoplastic elastomer. 
     
     
         19 . The system of  claim 17 , wherein the balloon is pre-formed or pre-molded symmetrically or asymmetrically. 
     
     
         20 . The system of  claim 17 , wherein the balloon has a deployed configuration comprising a conical shape. 
     
     
         21 . The system of  claim 17 , wherein the balloon comprises a plurality of concentric folds that are unfolded in a deployed configuration. 
     
     
         22 . The system of  claim 17 , wherein the balloon has a deployed configuration comprising a concave distal end. 
     
     
         23 . The system of  claim 17 , wherein the balloon further comprises a radio-opaque material. 
     
     
         24 . The system of  claim 17 , further comprising a coating on an outer surface of the balloon. 
     
     
         25 . The system of  claim 24 , wherein the coating comprises electrically conductive material for the delivery of energy. 
     
     
         26 . The system of  claim 25 , wherein the energy comprises radio frequency energy or microwave energy. 
     
     
         27 . The system of  claim 24 , wherein the coating comprises a clot promoting or anti-infection agent. 
     
     
         28 . The system of  claim 17 , wherein the balloon comprises a semi-permeable membrane. 
     
     
         29 . The system of  claim 17 , further comprising an inflation assembly coupleable to the proximal end of the compression member and in communication with the balloon. 
     
     
         30 . The system of  claim 29 , wherein the inflation assembly comprises a source of at least air, fluid, clot promoting agent, anti-infection agent, or radio-opaque medium. 
     
     
         31 . A device for hemostasis of a puncture site in a body lumen, the device comprising:
 a first tubular member having a proximal end and a distal end;   a second tubular member having a proximal end and a distal end and at least partially coaxial with the first tubular member so as to define an inflation lumen therebetween;   a balloon disposed at the distal ends of the first and second tubular members and in communication with the inflation lumen, wherein a distal end of the balloon is postionable behind a locator and at a predetermined distance away from a wall of the body lumen.   
     
     
         32 . The device of  claim 31 , wherein the predetermined distance is in a range from about 0.05 inch to about 0.5 inch. 
     
     
         33 . The device of  claim 32 , wherein the predetermined distance is in a range from about 0.2 inch to about 0.3 inch. 
     
     
         34 . The device of  claim 31 , wherein the balloon comprises one or more materials selected from the group consisting of polyethylene, polyethylene terephthalate, polytetrafluroethylene, nylon, polyurethane, silicone, latex, polyvinyl chloride, and thermoplastic elastomer. 
     
     
         35 . The device of  claim 31 , wherein the balloon is pre-formed or pre-molded symmetrically or asymmetrically. 
     
     
         36 . The device of  claim 31 , wherein the balloon has an expanded configuration comprising a conical shape. 
     
     
         37 . The device of  claim 31 , wherein the balloon comprises a plurality of concentric folds that are unfolded in an expanded configuration. 
     
     
         38 . The device of  claim 31 , wherein the balloon has an expanded configuration comprising a concave distal end. 
     
     
         39 . The device of  claim 31 , wherein the balloon further comprises a radio-opaque material. 
     
     
         40 . The device of  claim 31 , further comprising a coating on an outer surface of the balloon. 
     
     
         41 . The device of  claim 40 , wherein the coating comprises electrically conductive material for the delivery of energy. 
     
     
         42 . The device of  claim 41 , wherein the energy comprises radio frequency energy or microwave energy. 
     
     
         43 . The device of  claim 40 , wherein the coating comprises a clot promoting or anti-infection agent. 
     
     
         44 . The device of  claim 31 , wherein the balloon comprises a semi-permeable membrane. 
     
     
         45 . The device of  claim 31 , wherein the balloon comprises an expansible member and a deformable membrane at least partially disposed over the expansible member. 
     
     
         46 . The device of  claim 31 , wherein the balloon is inflatable with air, fluid, clot promoting agent, anti-infection agent, radio-opaque medium or a combination thereof.