Apparatus and methods for sealing a puncture in tissue

Abstract

An occlusion device for sealing a puncture through tissue includes a tubular wire member having a proximal end, a distal end sized for insertion into the puncture, a lumen extending between the proximal and distal ends, a port adjacent the proximal end communicating with the 5 lumen, and a balloon on the distal end. A source of fluid is connectable to the wire member for delivering fluid via the port into the lumen for expanding the balloon. A fluid loading device is disposed on the proximal end of the wire member to receive the source of fluid and to deliver fluid within the lumen into the balloon to expand the balloon.

What is claimed is: 
     
         1 . An occlusion device for sealing a puncture through tissue, comprising:
 an elongate tubular member comprising a proximal end, a distal end sized for insertion into a puncture, a lumen extending at least partially between the proximal and distal ends, and an expandable occlusion element carried on a distal region of the tubular member, the occlusion element having an interior communicating with a distal opening in the lumen, the tubular member having a substantially uniform diameter extending between the proximal end and the distal region; and   a fluid loading device receivable on the proximal end of the elongate tubular member for delivering fluid into, and drawing fluid out of, the interior of the occlusion element to thereby expand and collapse the occlusion element.   
     
     
         2 . The device of  claim 1 , wherein the fluid loading device further comprises a connector to connect a source of fluid to a housing of the fluid loading device. 
     
     
         3 . The device of  claim 2 , wherein the source of fluid is a syringe. 
     
     
         4 . The device of  claim 2 , wherein the housing further comprises a shut-off mechanism having an open and a closed position. 
     
     
         5 . The device of  claim 4 , wherein the open position of the shut-off mechanism allows for the source of fluid to evacuate substantially all the air out of the lumen of the elongate tubular member and/or out of the interior of the occlusion element. 
     
     
         6 . The device of  claim 4 , wherein the closed position of the shut-off mechanism allows for isolating fluid delivered from the source of fluid into the lumen of the elongate tubular member and into the interior of the occlusion element. 
     
     
         7 . The device of  claim 1 , wherein the tubular member further comprises a port in a proximal region of the tubular member communicating with the lumen and communicating with the fluid loading device. 
     
     
         8 . The device of  claim 1 , wherein the tubular member has an outer diameter of not more than about 0.040 inch. 
     
     
         9 . The device of  claim 1 , wherein the tubular member comprises one or more wire coils defining a substantially nonporous wall of the tubular member. 
     
     
         10 . The device of  claim 1 , wherein the tubular member comprises a solid-walled tubular body defining the lumen. 
     
     
         11 . An occlusion device for sealing a puncture through tissue, comprising:
 an elongate tubular member comprising a proximal end, a distal end sized for insertion into a puncture, a lumen extending at least partially between the proximal and distal ends, a port in a proximal region of the tubular member communicating with the lumen, and an expandable occlusion element carried on a distal region of the tubular member, the occlusion element having an interior communicating with a distal opening in the lumen; and   a fluid loading device connectable to the proximal region of the tubular member, such that the fluid loading device seals all sides of the tubular member and the fluid loading device communicates with the port for delivering fluid from the fluid loading device into the lumen of the tubular member; and   a syringe coupled to the fluid loading device to deliver fluid into the lumen to allow expansion and collapse of the occlusion element.   
     
     
         12 . The device of  claim 11 , wherein the fluid loading device further comprises a shut-off mechanism that isolates fluid loaded into the lumen from the fluid loading device when the shut-off mechanism is placed in the closed position. 
     
     
         13 . The device of  claim 12 , wherein fluid is released from the lumen when the shut-off mechanism is placed in the open position. 
     
     
         14 . The device of  claim 11 , wherein the tubular member has an outer diameter of not more than about 0.040 inch between the proximal end and the distal region. 
     
     
         15 . The device of  claim 11 , wherein the tubular member has a substantially uniform outer cross-section such that a delivery sheath may pass easily over the occlusion device when the occlusion device is backloaded into the delivery sheath. 
     
     
         16 . A method for sealing a puncture extending through tissue from a patient's skin to a body lumen, comprising:
 introducing a distal end of an elongate occlusion member into the puncture until an expandable member carried on the distal end is disposed within the body lumen, the occlusion member comprising a substantially uniform diameter lumen extending proximally from the distal end and communicating with an interior of the expandable member;   delivering fluid into the lumen of the elongate occlusion member to the interior of the expandable member to thereby expand the expandable member;   retracting the occlusion member at least partially against a wall of the body lumen to cause the expandable member to substantially seal the body lumen from the puncture;   advancing a sheath over the proximal end of the elongate occlusion member into the puncture; and   delivering sealing compound into the puncture through the sheath.   
     
     
         17 . The method of  claim 16 , further comprising closing a shut-off mechanism to isolate fluid within the lumen and interior of the expandable member. 
     
     
         18 . The method of  claim 17 , further comprising collapsing the expandable member and withdrawing fluid from the interior of the expandable member and body lumen by opening the shut-off mechanism. 
     
     
         19 . The method of  claim 16 , wherein the step of delivering fluid into the lumen further comprises providing a syringe connected to a fluid loading device attached to a proximal end of the elongate occlusion member. 
     
     
         20 . The method of  claim 16 , wherein the elongate occlusion member has substantial uniformity in cross-section such that the sheath passes easily over the elongate occlusion member when the sheath is advanced over the elongate occlusion member.