Implantable sealable member with mesh layer

Abstract

The provided technologies provide an implant closure device having a mesh layer formed on a flexible substrate, collectively forming a sealable member, that improves a seal formed over an aperture in a body lumen. The mesh facilitates a faster and more secure adherence of the sealable member to the surrounding edges at the puncture site. Furthermore, the provided technology may promote platelet-capture and encourage localized platelet aggregation at the exposed collagen in the wound edges on the mesh layer. The platelet impregnated mesh layer can facilitate cellular adhesion, enabling the sealable member that is local to the wound opening to act, in essence, as a “biological glue.”

What is claimed is: 
     
         1 . An implantable device for sealing an aperture in a tissue of a body lumen, the implantable device comprising:
 a sealable member, comprising
 a flexible substrate; and 
 a mesh layer on the flexible substrate; 
   wherein, when the implantable device is an a sealing position, the sealable member is disposed against an internal surface of the tissue adjacent to the aperture such that the mesh layer is in contact with the internal surface.   
     
     
         2 . The implantable device of  claim 1 , wherein the flexible substrate comprises an extruded layer comprising a thickness in a range from about 5 μm and about 4000 μm. 
     
     
         3 . The implantable device of  claim 2 , wherein the extruded layer comprises a thickness in a range from about 60 μm and about 120 μm. 
     
     
         4 . The implantable device of  claim 1 , wherein the sealable member comprises a bioabsorbable polymer film, wherein the bioabsorbable polymer film, when introduced into cells, is broken down by cellular machinery. 
     
     
         5 . The implantable device of  claim 4 , wherein the bioabsorbable polymer film is broken down via enzymatic degradation. 
     
     
         6 . The implantable device of  claim 4 , wherein bioabsorbable polymer film is broken down via hydrolysis. 
     
     
         7 . The implantable device of  claim 4 , wherein the cells either reuse, reabsorb, or dispose of the bioabsorbable polymer film without significant toxic effects to the cells, and
 wherein breakdown of the bioabsorbable polymer film does not induce inflammation of the cells.   
     
     
         8 . The implantable device of  claim 4 , wherein breakdown of the bioabsorbable polymer film comprises at least one of: (i) breakdown of the bioabsorbable polymer film into component polymers, monomers, or both polymers and monomers, (ii) hydrolysis of ester bonds, and (iii) cleavage of urethane linkages. 
     
     
         9 . The implantable device of  claim 1 , wherein both the mesh layer and the flexible substrate comprise at least one material selected from the group consisting of Poly-L-lactide, Poly-D-lactide, Poly-DL-lactide, Polyglycolide, ε-Caprolactone, Polyethylene glycol, and a copolymer thereof. 
     
     
         10 . The device according to  claim 1 , wherein at least one of the mesh layer and the flexible substrate is formed at least in part of a material having an inherent viscosity in a range from 0.5 to 7.0 dl/g. 
     
     
         11 . The implantable device of  claim 1 , wherein the sealable member is structured to flexibly roll when in a delivery configuration such that a delivery cross-sectional area of the rolled sealable member has a diameter smaller than that of the aperture. 
     
     
         12 . The implantable device of  claim 1 , wherein a thickness of the mesh layer is equal to a thickness of the flexible substrate. 
     
     
         13 . The implantable device of  claim 1 , wherein thicknesses of each of the mesh layer and the flexible substrate are less than 50% of a diameter of the aperture. 
     
     
         14 . The implantable device of  claim 1 , wherein a thickness of the sealable member is at least one (1) mm smaller than a diameter of the aperture, and
 wherein a minimum thickness of the mesh layer is smaller than a minimum thickness of the flexible substrate.   
     
     
         15 . The implantable device of  claim 1 , wherein a maximum thickness of the mesh layer is at least 100 times greater than a minimum thickness of the mesh layer, and
 wherein a maximum thickness of the flexible substrate is at least 10 times greater than a minimum thickness of the flexible substrate.   
     
     
         16 . The implantable device of  claim 1 , wherein the mesh layer comprises a plurality of fibers each having a diameter in a range from 0.3 μm to 8 μm,
 wherein a first portion of the plurality of fibers comprises a random orientation, 
 wherein a second portion of the plurality of fibers comprises a patterned orientation, and 
 wherein at least one of the flexible substrate and the mesh layer comprises biocompatible material, the biocompatible material, when added to cells in vitro, results in less than or equal to 20% cell death. 
 
     
     
         17 . The implantable device of  claim 1 , wherein the mesh layer comprises a product of activated platelets. 
     
     
         18 . The implantable device of  claim 17 , wherein the mesh layer comprises a copolymer. 
     
     
         19 . The implantable device of  claim 1 , wherein the mesh layer comprises a plurality of fibers each shaped and sized to promote platelet capture, and
 wherein, when in contact with collagen from an exposed wound, one or more captured platelets encourages localized platelet activation.   
     
     
         20 . The implantable device of  claim 19 , wherein one or more activated platelets adhere to a surface of the collagen creating fibrins. 
     
     
         21 . The implantable device of  claim 1 , wherein the mesh layer comprises a material with low thrombogenicity, and
 wherein the mesh layer comprises a non-thrombogenic surface.