US2016367235A1PendingUtilityA1

Biomaterials for track and puncture closure

Assignee: INCEPT LLCPriority: May 4, 2009Filed: Sep 1, 2016Published: Dec 22, 2016
Est. expiryMay 4, 2029(~2.8 yrs left)· nominal 20-yr term from priority
A61L 31/145A61B 2017/00654A61B 17/0057A61L 31/148A61B 2017/00557A61L 31/06A61B 2017/0065A61B 2017/00004
54
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Claims

Abstract

Embodiments include coatings for adherence of biomaterials to a tissue. Systems and methods for adapting such coated materials to vascular access closure are further proved.

Claims

exact text as granted — not AI-modified
1 . An apparatus for treatment of a track and blood vessel puncture comprising
 an applicator and a plug,   with the applicator comprising a distal sheath portion sized for placement in the track and having a distal opening and a lumen, and a pusher received by the lumen for pushing the plug out of the lumen through the sheath distal opening,   with the plug being sized for placement in the track and comprising
 a coated portion with a substantially dry coating, wherein the coating comprises at least one precursor that dissolves in physiological fluid after placement in the track and undergoes a covalent bonding reaction to form a matrix material that adheres the plug to the track and/or blood vessel, and 
 an uncoated portion that exposes a porous portion of the plug to blood in the track, with the porous portion at least partially dehydrating the blood in the track. 
   
     
     
         2 . The apparatus of  claim 1  wherein a proximal portion of the plug comprises the uncoated portion of the plug and a distal portion of the plug comprises the coated portion of the plug. 
     
     
         3 . The apparatus of  claim 1  wherein the coating comprises a plurality of discrete blebs or discrete stripes separated by the uncoated portion. 
     
     
         4 . The apparatus of  claim 1  wherein the uncoated portion comprises a plurality of discontinuous subportions that are separated from each other by the coating. 
     
     
         5 . The apparatus of  claim 1  wherein the coated portion covers no more than about  60 % of the plug surface area. 
     
     
         6 . The apparatus of  claim 1  wherein the puncture is a vascular access site. 
     
     
         7 . The apparatus of  claim 1  comprising a plurality of the precursors, wherein a first precursor comprises electrophilic functional groups and a second precursor comprises nucleophilic functional groups, wherein both of the precursors are polymers. 
     
     
         8 . The apparatus of  claim 1  wherein the plug comprises a rod, a tube, a rolled-up sheet, a twisted sheet, or a braided sheet. 
     
     
         9 . The apparatus of  claim 1  further comprising a release agent disposed on at least a portion of the coating. 
     
     
         10 . The apparatus of  claim 1  wherein the adherence of the coating to the tissue exceeds the strength of the plug, as testable by the plug failing before disadhering from the tissue. 
     
     
         11 . The apparatus of  claim 1  wherein the plug is readily compressible by manual tamponade. 
     
     
         12 . The apparatus of  claim 1  wherein the plug further comprises an axial lumen. 
     
     
         13 . The apparatus of  claim 1  wherein the plug comprises a dehydrated hydrogel. 
     
     
         14 . The apparatus of  claim 1  wherein the plug comprises a polylactide matrix. 
     
     
         15 . A method for treatment of a track and blood vessel puncture comprising percutaneously introducing a porous plug into the track through an applicator having a lumen terminating in a distal opening, the plug comprising a dry coating on a distal portion of the plug and being free of the coating on a proximal portion of the plug, wherein the coating comprises at least a first precursor that dissolves in physiological fluid after placement in the track and undergoes a covalent bonding reaction to form a matrix material that adheres the plug to tissue of the track and/or blood vessel, with the coating promoting adhesion at or near the puncture and the uncoated portion of the plug at least partially dehydrating blood in the track to reduce flow of blood into the track. 
     
     
         16 . The method of  claim 15  wherein the first precursor comprises electrophilic functional groups and further comprising a second precursor that comprises nucleophilic functional groups, wherein both of the precursors are polymers. 
     
     
         17 . The method of  claim 16  wherein the coating is formed by applying the precursors in a melted state to the plug or by applying the precursors in a liquid solution to the plug and evaporating solvent from the solution.

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