Arteriotomy closure devices and techniques

Abstract

A vascular closure system includes a swellable/bioabsorbable tubular sealing element and a tubular advancement/deployment tool. The sealing element and advancement tool is configured to be attached to the outside of a tubular medical device (such as a vascular introducer, catheter, cannula, trocar, electrode wire, etc.) with the sealing element being advanced distally to a desired area within the body (near or at least partially within an arteriotomy, for example) by the advancement/deployment tool. Once in contact with blood (or other fluid) the sealing element swells, sealing the passageway. The system may include one of several different means to prevent insertion (or over insertion) into the vessel. Additional versions of the system described herein can be used for cardiovascular applications where hemostasis (temporary or permanent) is desired. Additionally, the system can be used with simple modifications for any vessel, area on, in or near any vessel, tissue area, tubular structure, duct, organ, hollow body cavity, chamber, tissue wall, or any other structures or tissues, where temporary or permanent sealing, plugging, reduction of an open space, or reinforcement is needed, or alternatively, where an open conduit or conduit reinforcement is desired. The system could also be used as a reversible sterilization method for women by occluding the fallopian tubes.

1 .- 23 . (canceled)  
   
   
       24 . A vessel closure device comprising a first end, a second end, and an outer wall and a lumen passing between the first end and the second end, wherein the vessel closure device comprises a material being one or more of a swellable, a bioabsorbable, or a biodegradable material.  
   
   
       25 . The vessel closure device of  claim 24 , wherein the material comprises a polymer.  
   
   
       26 . The vessel closure device of  claim 25 , wherein the polymer comprises a polyethylene polymer.  
   
   
       27 . The vessel closure device of  claim 24 , wherein the material swells or expands when exposed to a fluid.  
   
   
       28 . The vessel closure device of  claim 27 , wherein the fluid comprises blood.  
   
   
       29 . The vessel closure device of  claim 24 , wherein the lumen is configured to be open during delivery and for at least a portion of the lumen to close after delivery.  
   
   
       30 . The vessel closure device of  claim 24 , wherein the vessel closure device includes a tissue engagement area configured to contact tissue.  
   
   
       31 . The vessel closure device of  claim 30 , wherein the tissue engagement area comprises an adhesive material.  
   
   
       32 . The vessel closure device of  claim 31 , wherein the adhesive material is configured to adhere to the tissue after blood contacts the adhesive material.  
   
   
       33 . The vessel closure device of  claim 30 , wherein the adhesive includes a radiopaque material.  
   
   
       34 . The vessel closure device of  claim 30 , wherein the tissue engagement area extends outwardly from the outer wall.  
   
   
       35 . The vessel closure device of  claim 24 , wherein the outer wall has a first outer diameter at the first end and a second outer diameter at the second end, the second outer diameter being less than the first outer diameter.  
   
   
       36 . The vessel closure device of  claim 24 , wherein the vessel closure device is removable.  
   
   
       37 . The vessel closure device of  claim 24 , wherein the tubular medical device comprises one or more of a vascular introducer, catheter, guidewire, trocar, cannula, or electrode wire.  
   
   
       38 . The vessel closure device of  claim 36 , wherein the vessel closure device includes one or more of an adhesive and a therapeutic agent configured to affect healing at the site of implantation of the closure device.  
   
   
       39 . The vessel closure device of  claim 24 , wherein the vessel closure device comprises a radiopaque material.  
   
   
       40 . A method of closing an opening in a blood vessel, the method comprising: 
 providing a vessel closure device, the vessel closure device comprising a first end, a second end, and a lumen passing between the first end and the second end, wherein the vessel closure device comprises a material being one or more of a swellable, a bioabsorbable, or a biodegradable material;    introducing a tubular medical device into an opening in a vessel;    advancing the vessel closure device over the tubular medical device until the vessel closure device is near or contacts the vessel, wherein the tubular medical device passes within the lumen of the vessel closure device; and    removing the tubular medical device from the vessel closure device, whereby the vessel closure device seals the opening in the vessel.    
   
   
       41 . The method of  claim 40 , wherein the material comprises a polymer.  
   
   
       42 . The method of  claim 41 , wherein the polymer comprises a polyethylene polymer.  
   
   
       43 . The method of  claim 40 , wherein the material swells or expands when exposed to a fluid.  
   
   
       44 . The method of  claim 43 , wherein the fluid comprises blood.  
   
   
       45 . The method of  claim 40 , further comprising providing a deployment tool to advance the vessel closure device over the tubular medical device.  
   
   
       46 . The method of  claim 45 , further comprising using the deployment tool to advance the vessel closure device over the tubular medical device to the vessel.  
   
   
       47 . The method of  claim 40 , wherein the tubular medical device comprises one or more of a vascular introducer, catheter, guidewire, trocar, cannula, or electrode wire.  
   
   
       48 . The method of  claim 40 , wherein the vessel closure device includes one or more of an adhesive and a therapeutic agent configured to affect healing at the site of implantation of the closure device.