Apparatus and methods for sealing a vascular puncture

Abstract

Apparatus and methods for sealing a puncture through tissue or otherwise treating a body lumen of a patient. The carrier includes at least one, but not all, of the adherent layer components required to form a tacky or sticky adherent layer on the carrier. The remaining adherent layer precursor(s) are delivered to the carrier in situ to form a sticky and/or tacky adherent layer on the carrier that enhances the attachment and retention of the carrier to tissue surrounding a target treatment location in which the carrier is delivered. The carrier may include hydrogel and/or other porous material, e.g., for releasing one or more agents carried by the carrier at the treatment location.

We claim: 
     
         1 . A system for sealing a puncture extending through tissue, comprising:
 a carrier sized for delivery into the puncture, the carrier carrying at least one adherent layer component;   a delivery device for delivering at least one additional adherent layer component to the carrier in situ; and   wherein contact between the at least one adherent layer component and the at least one additional adherent layer component creates an adherent layer on the carrier.   
     
     
         2 . The system of  claim 1 , wherein the carrier comprises a bioabsorbable mass. 
     
     
         3 . The system of  claim 1 , wherein the at least one adherent layer component comprises at least one of a first hydrogel precursor, a second hydrogel precursor, and an activating agent, and wherein the at least one additional adherent layer component comprises the other of the first hydrogel precursor, the second hydrogel precursor, and the activating agent that are not carried by the carrier, the first and second hydrogel precursors combining to create a hydrogel in the presence of the activating agent. 
     
     
         4 . The system of  claim 3 , wherein the activating agent comprises a pH adjusting agent. 
     
     
         5 . The system of  claim 1 , wherein the at least one adherent layer component comprises at least one of an amine-terminated polymer and an ester-terminated polymer. 
     
     
         6 . The system of  claim 1 , wherein the at least one adherent layer component comprises an amine-terminated polymer. 
     
     
         7 . The system of  claim 6 , wherein the amine-terminated polymer comprises a polypeptide. 
     
     
         8 . The system of  claim 5 , wherein the at least one additional adherent layer component comprises the other of the amine-terminated polymer and the ester-terminated polymer. 
     
     
         9 . The system of  claim 5 , wherein one of the at least one adherent layer component and the at least one of additional adherent layer component further comprises sodium borate. 
     
     
         10 . The system of  claim 1 , wherein the at least one adherent layer component comprises an amine-terminated polymer and the at least one additional adherent component comprises sodium borate. 
     
     
         11 . The system of  claim 4 , wherein one of the at least one adherent layer component and the at least one of additional adherent layer component further comprises ester-terminated polymer. 
     
     
         12 . The system of  claim 1 , wherein the at least one adherent layer component comprises an ester-terminated polymer and the at least one addition adherent layer component comprises sodium borate. 
     
     
         13 . A system for sealing a puncture extending through tissue, comprising:
 a cartridge comprising a tubular member sized for insertion into a puncture and a pusher member slidably disposed within the tubular member;   a carrier disposed within the tubular member distal to the pusher member, the carrier carrying at least one adherent layer component;   a delivery device for delivering at least one additional adherent layer component to the carrier in situ via the cartridge; and   wherein contact between the at least one adherent layer component and the at least one additional adherent layer component creates an adherent layer on the carrier.   
     
     
         14 . The system of  claim 13 , wherein the delivery device comprises a syringe coupled to at least one of the tubular member and the pusher member for delivering the at least one additional adherent layer component to the carrier. 
     
     
         15 . The system of  claim 13 , wherein at least one of the tubular member and the pusher member comprises a port communicating with a lumen, the port configured for connecting a conduit thereto that communicates with the delivery device for delivering the at least one additional adherent layer component via the lumen to the carrier. 
     
     
         16 . The system of  claim 13 , wherein the carrier comprises a bioabsorbable mass. 
     
     
         17 . The system of  claim 13 , wherein the at least one adherent layer component comprises at least one of a first hydrogel precursor, a second hydrogel precursor, and an activating agent, and wherein the at least one additional adherent layer component comprises the other of the first hydrogel precursor, the second hydrogel precursor, and the activating agent that are not carried by the carrier, the first and second hydrogel precursors combining to create a hydrogel in the presence of the activating agent. 
     
     
         18 . The system of  claim 17 , wherein the activating agent comprises a pH adjusting agent. 
     
     
         19 . A method for sealing a puncture extending through tissue to a body lumen, comprising:
 delivering a carrier carrying at least one adherent layer component into the puncture; and   delivering at least one additional adherent layer component to the carrier in situ, wherein contact between the at least one adherent layer component and the at least one additional adherent layer component initiates creation of an adherent layer on the carrier.   
     
     
         20 . The method of  claim 19 , wherein the carrier comprises a hydrogel, the hydrogel expanding within the puncture to enhance hemostasis.