Protease Modulating Wound Interface Layer For Use With Negative Pressure Wound Therapy

Abstract

Systems, methods, and apparatuses for modulating proteases including matrix metalloproteinase (MMP), elastase, and bacterial protease in a negative pressure therapy system are described. A mesh having a sacrificial substrate is included. The sacrificial substrate includes a plurality of collagen fibers reinforced with a supporting material and intersecting with each other to form a network of collagen fibers having a plurality openings. The openings of the plurality of openings have an average area between about 0.5 mm 2 and about 20 mm 2 to permit the flow of negative pressure through the mesh. The sacrificial substrate can also include oxidized regenerated cellulose.

1 .- 101 . (canceled) 
     
     
         102 . A mesh for modulating proteases, comprising:
 a first plurality of fibers comprising collagen; and   a second plurality of fibers comprising oxidized regenerated cellulose;   wherein at least a portion of the first plurality of fibers are positioned to intersect at least a portion of the second plurality of fibers.   
     
     
         103 . The mesh of  claim 102 , wherein at least a portion of the first plurality of fibers and at least a portion of the second plurality of fibers are woven. 
     
     
         104 . The mesh of  claim 102 , wherein the first plurality of fibers and the second plurality of fibers are positioned in an alternating arrangement. 
     
     
         105 . The mesh of  claim 102 , wherein each of the second plurality of fibers comprises a supporting material and oxidized regenerated cellulose. 
     
     
         106 . The mesh of  claim 105 , wherein:
 the supporting material is formed into fibers; and   the oxidized regenerated cellulose is in the form of a powder dispersed on the fibers formed from the supporting material.   
     
     
         107 . The mesh of  claim 102 , wherein each of the second plurality of fibers has a diameter of no greater than 1 mm. 
     
     
         108 . The mesh of  claim 102 , wherein each of the second plurality of fibers comprises a plurality of filaments. 
     
     
         109 . The mesh of  claim 102 , wherein the second plurality of fibers forms between 30% and 70% of the mesh. 
     
     
         110 . The mesh of  claim 102 , further comprising a plurality of openings positioned between the first plurality of fibers and the second plurality of fibers. 
     
     
         111 . The mesh of  claim 110 , wherein the plurality of openings have an average area of between 0.2 mm 2  and 20 mm 2  to permit the flow of negative pressure through the mesh. 
     
     
         112 . The mesh of  claim 110 , wherein the openings are generally circular in shape and have an average diameter between 0.5 mm and 5.0 mm. 
     
     
         113 . The mesh of  claim 110 , wherein the openings are generally circular in shape and have an average diameter between 1 mm and 2.5 mm. 
     
     
         114 . The mesh of  claim 102 , wherein the mesh has a thickness of between 5 microns and 2 millimeters. 
     
     
         115 . A mesh for modulating proteases in a negative pressure therapy system, comprising:
 a plurality of collagen fibers; and   a supporting material adapted to provide structural support to the mesh;   wherein the mesh comprises a plurality of openings positioned between the plurality of collagen fibers and the supporting material, wherein the plurality of openings have an average area between about 0.2 mm 2  and about 20 mm 2  to permit the flow of negative pressure through the mesh.   
     
     
         116 . The mesh of  claim 115 , wherein at least a portion of the supporting material is disposed within the plurality of collagen fibers. 
     
     
         117 . The mesh of  claim 115 , wherein the openings are generally circular in shape and have an average diameter between 1 mm and 2.5 mm. 
     
     
         118 . The mesh of  claim 115 , wherein the plurality of collagen fibers have a diameter of less than 1 millimeter. 
     
     
         119 . The mesh of  claim 115 , wherein the collagen fibers have a collagen content between about 10% and about 50% of the total material of the collagen fiber. 
     
     
         120 . The mesh of  claim 115 , wherein the supporting material comprises supporting fibers. 
     
     
         121 . The mesh of  claim 120 , wherein the supporting fibers are twisted with the plurality of collagen fibers. 
     
     
         122 . The mesh of  claim 120 , wherein at least a portion of the supporting fibers and at least a portion of the plurality of collagen fibers are woven together. 
     
     
         123 . The mesh of  claim 120 , wherein the supporting fibers are water soluble. 
     
     
         124 . The mesh of  claim 120 , wherein the supporting fibers are biodegradable. 
     
     
         125 . The mesh of  claim 120 , wherein the collagen fibers and supporting fibers are non-woven. 
     
     
         126 . The mesh of  claim 115 , wherein the collagen fibers comprise:
 staple fibers formed from collagen; and   staple fibers formed from the supporting material and twisted together with the staple fibers formed of collagen.   
     
     
         127 . The mesh of  claim 126 , wherein the supporting material comprises one or more selected from a group consisting of: polyethylene oxide, alginate, polylactic acid, polyvinyl alcohol, polycaprolactones, and polyamides. 
     
     
         128 . The mesh of  claim 126 , wherein a length of the staple fibers formed from collagen is between about 4 mm and about 6 mm. 
     
     
         129 . The mesh of  claim 115 , further comprising a plurality of oxidized regenerated cellulose fibers intersecting the collagen fibers. 
     
     
         130 . A negative-pressure system for modulating proteases in a tissue site, comprising:
 a modulating layer comprising a plurality of collagen fibers and a supporting material adapted to provide structural support to the modulating layer, wherein the modulating layer comprises a plurality of openings between the plurality of collagen fibers;   a manifold configured to be positioned adjacent the modulating layer; and   a cover configured to be positioned over the manifold and the modulating layer to form a sealed space around the tissue site.   
     
     
         131 . The system of  claim 130 , further comprising a negative-pressure interface adapted to be fluidly coupled to the manifold through the cover. 
     
     
         132 . The system of  claim 130 , further comprising a negative-pressure source configured to be fluidly coupled to the manifold to provide negative pressure to the sealed space. 
     
     
         133 . The system of  claim 130 , wherein the openings of the plurality of openings have an average effective diameter between 0.5 mm and 5 mm to permit the flow of negative pressure through the modulating layer. 
     
     
         134 . The system of  claim 130 , wherein the openings are generally circular in shape and have an average diameter between about 1 mm and about 2.5 mm. 
     
     
         135 . The system of  claim 130 , wherein the collagen fibers have a diameter of less than about 1 millimeter. 
     
     
         136 . The system of  claim 130 , wherein the supporting material comprises supporting fibers. 
     
     
         137 . The system of  claim 136 , wherein at least a portion of the supporting fibers are twisted with at least a portion of the plurality of collagen fibers. 
     
     
         138 . The system of  claim 136 , wherein at least a portion of the plurality of supporting fibers and at least a portion of the plurality of collagen fibers are woven together. 
     
     
         139 . The system of  claim 140 , wherein the collagen fibers and supporting fibers are non-woven. 
     
     
         140 . The system of  claim 130 , wherein the modulating layer further comprises a plurality of oxidized regenerated cellulose fibers intersecting the collagen fibers.