Manifolding Apparatus Or Dressing Exhibiting Low Tissue Ingrowth And Negative-Pressure Treatment Method

Abstract

An apparatus for filling a wound can include an array of at least four truncated ellipsoids interconnected to define at least one fluid path through, for example perpendicular to, the array. The longest principal axis of each ellipsoid may be perpendicular to the array. Each truncated ellipsoid may be a spheroid and/or may include an approximately elliptical contact surface at each contact surface between two interconnected ellipsoids. Each fluid pathway may have four continuously-curved concave sides and may have a parallelogram-shaped cross-section with continuously-curved concave edges. A dressing may include the apparatus, a dressing layer coupled to the apparatus, a backing layer disposed over a surface of the dressing layer opposite the apparatus, and an attachment device disposed on at least a margin of the backing layer. Methods of treating various tissue sites using the apparatus or dressing with negative-pressure therapy are also disclosed.

What is claimed is: 
     
         1 . An apparatus for filling a wound, the apparatus comprising:
 an array of at least four truncated ellipsoids interconnected to define at least one fluid path through the array;   wherein the interconnected ellipsoids are comprised of a polyolefin, a polyester, a polyamide, a polystyrene, a polydiolefin, a polyacrylonitrile, a polysiloxane, or a copolymer or combination thereof; and   wherein each of the interconnected ellipsoids has a surface hardness from about 0 Shore A to about 25 Shore A.   
     
     
         2 . The apparatus of  claim 1 , further comprising a coating disposed on each of the ellipsoids that yields a surface hardness of at least 55 Shore A. 
     
     
         3 . The apparatus of  claim 2 , wherein the coating is comprised of a cellulosic material, a polyester, a polyamide, a polycarbonate, a perhalogenated polyolefin, an aramid, a polybenzimidazole, a polysulfone, or a copolymer, combination, or cross-linked gel thereof. 
     
     
         4 . The apparatus of any one of  claims 1 - 3 , wherein each of the truncated ellipsoids has a principal axis oriented substantially perpendicular to the array. 
     
     
         5 . The apparatus of any one of  claims 1 - 3 , wherein each of the truncated ellipsoids is a truncated spheroid having a principal axis oriented substantially perpendicular to the array. 
     
     
         6 . The apparatus of any one of  claims 4 - 5 , wherein the interconnected ellipsoids are truncated only at each surface where the ellipsoids are interconnected. 
     
     
         7 . An apparatus for filling a wound, the apparatus comprising:
 an array of interconnected polymeric ovules having a truncated ellipsoidal shape, wherein:
 each set of four interconnected ovules defines a fluid pathway extending perpendicularly through the array; 
 each truncated ellipsoidal shape comprises an approximately elliptical contact surface at each contact surface between two interconnected ovules; and 
 each interconnected polymeric ovule has its longest principal axis oriented substantially perpendicular to the array. 
   
     
     
         8 . The apparatus of  claim 7 , wherein the array comprises:
 at least three columns comprising two edge columns and at least one central column; and   at least three rows comprising two edge rows and at least one central row, and   wherein each set of four interconnected ovules is arranged in two of the at least three rows and two of the at least three columns.   
     
     
         9 . The apparatus of  claim 7  or  claim 8 , wherein the array comprises four corner ovules, at least four edge ovules, at least one central ovule, and at least four fluid pathways interstitially therebetween, each central ovule having a truncated ellipsoidal shape with four elliptical contact surfaces, each edge ovule having a truncated ellipsoidal shape with three elliptical contact surfaces, and each corner ovule having a truncated ellipsoidal shape with two elliptical contact surfaces. 
     
     
         10 . The apparatus of any one of  claims 7 - 9 , wherein the interconnected ovules are comprised of a polyolefin, a polyester, a polyamide, a polystyrene, a polydiolefin, a polyacrylonitrile, a polysiloxane, or a copolymer or combination thereof. 
     
     
         11 . The apparatus of any of  claims 7 - 10 , wherein each interconnected ovule has its two principal axes other than the longest principal axis, respectively, oriented at approximately a 45° angle to a row direction of the array and at approximately a 45° angle to a column direction of the array. 
     
     
         12 . The apparatus of any of  claims 7 - 11 , wherein each of the interconnected ovules are truncated only at one end of the longest principal axis and at each surface where the ovules are interconnected. 
     
     
         13 . The apparatus of any one of  claims 1 - 12 , wherein the array of interconnected ellipsoids or interconnected ovules has an upper surface and a lower surface, and wherein the upper surface or the lower surface or both has a hardness from about 0 Shore A to about 25 Shore A. 
     
     
         14 . The apparatus of  claim 13 , wherein the upper surface or the lower surface or both has a coating disposed thereon that exhibits a hardness of at least 55 Shore A. 
     
     
         15 . The apparatus of  claim 14 , wherein the coating is comprised of a cellulosic material, a polyester, a polyamide, a polycarbonate, a perhalogenated polyolefin, an aramid, a polybenzimidazole, a polysulfone, or a copolymer, combination, or cross-linked gel thereof. 
     
     
         16 . The apparatus of any of  claims 1 - 15 , wherein at least a portion of the interconnected ellipsoids or at least a portion of the interconnected ovules comprise one or more grooves on an outer surface of each ellipsoid or of each ovule that extend at least partially in a direction of its longest principal axis. 
     
     
         17 . The apparatus of  claim 16 , wherein each groove has an average depth no more than 30% of a diameter of each interconnected ovule or of each interconnected ellipsoid along a principal axis direction other than the longest principal axis. 
     
     
         18 . The apparatus of any of  claims 1 - 17 , wherein a longest principal axis of each interconnected ellipsoid or each interconnected ovule is from about 3 mm to about 6 mm. 
     
     
         19 . The apparatus of  claim 18 , wherein each principal axis other than the longest principal axis of each interconnected ellipsoid or each interconnected ovule is from about 2 mm to about 4 mm. 
     
     
         20 . The apparatus of any of  claims 1 - 19 , wherein each fluid pathway has a minimum width dimension from about 500 microns to about 1500 microns. 
     
     
         21 . The apparatus of any of  claims 1 - 20 , wherein the apparatus is translucent. 
     
     
         22 . The apparatus of any of  claims 1 - 21 , further comprising a wound healing agent in or on the array, the wound healing agent comprising a non-steroidal anti-inflammatory drug, a steroid, an anti-inflammatory cytokine, an anaesthetic, an antiseptic, an antimicrobial agent, a growth factor, a peptide, a microRNA, an antioxidant, or a combination thereof. 
     
     
         23 . The apparatus of  claim 22 , wherein the antimicrobial agent comprises silver, a silver salt, a tetracycline, a beta-lactam, a macrolide, an aminoglycoside, a fluoroquinolone, a cellulose ethyl sulfonate, or a combination thereof. 
     
     
         24 . An apparatus for filling a wound, the apparatus comprising:
 a layer having a plurality of fluid pathways through the layer from a first surface to a second surface, wherein:
 an array of connected polymeric protrusions extends through the layer connecting the first and second surfaces; 
 each set of four connected polymeric protrusions from each of the first and second surfaces defines one fluid pathway extending perpendicularly through the array; and 
 each fluid pathway has four continuously-curved concave sides and has a parallelogram-shaped cross-section with continuously-curved concave edges. 
   
     
     
         25 . A dressing for treating a tissue site, the dressing comprising:
 an apparatus according to any of  claims 1 - 24 ;   a dressing layer coupled to the apparatus;   a backing layer disposed over a surface of the dressing layer opposite from the apparatus; and   an attachment device disposed on at least a margin of the backing layer.   
     
     
         26 . The dressing of  claim 25 , wherein the attachment device is configured to form a seal with a tissue site, and wherein the dressing layer is coupled to the apparatus on a surface opposite the protrusions, or on a surface formed by truncation of the ovules or of the ellipsoids on one end of a principal axis oriented substantially perpendicular to the array. 
     
     
         27 . The dressing of  claim 25  or  claim 26 , wherein the dressing layer comprises an absorbent layer containing from about 45% to about 90% carboxymethyl cellulose fibers and from about 10% to about 55% reinforcing fibers. 
     
     
         28 . The dressing of any of  claims 25 - 27 , wherein the dressing layer comprises a manifolding layer configured to allow both fluid removal and fluid instillation therethrough. 
     
     
         29 . A system for treating a tissue site with negative pressure, the system comprising:
 an apparatus according to any of  claims 1 - 24  or a dressing according to any of  claims 25 - 28 ; and   a negative-pressure source fluidly coupled to the dressing and configured to enable fluid removal through the dressing.   
     
     
         30 . The system of  claim 29 , further comprising:
 a negative-pressure conduit; and   a negative-pressure connector subsystem for fluidly coupling the negative-pressure source to the apparatus or the dressing for fluid removal.   
     
     
         31 . The system of  claim 30 , further comprising a container fluidly coupled to the negative-pressure source and to the apparatus or to the dressing and adapted to collect fluid. 
     
     
         32 . A method for treating a compartmented wound site, the method comprising:
 deploying within a compartmented wound site the apparatus of any of  claims 1 - 24 , the dressing of any of  claims 25 - 28 , or at least a portion of the system for treating a tissue site according to any of  claims 29 - 31 ;   deploying a negative-pressure connector subsystem;   deploying a sealing member to form a fluid seal over the open cavity;   fluidly coupling the negative-pressure connector subsystem to a negative-pressure source; and   activating the negative-pressure source.   
     
     
         33 . The method of  claim 32 , wherein the compartmented wound site comprises a peritoneal or abdominal cavity. 
     
     
         34 . A method for treating a surface wound site, the method comprising:
 deploying over the surface wound site the apparatus of any of  claims 1 - 24 , the dressing of any of  claims 25 - 28 , or at least a portion of the system for treating a tissue site according to any of  claims 29 - 31 ;   deploying a negative-pressure connector subsystem;   deploying a sealing member to form a fluid seal over the surface wound site;   fluidly coupling the negative-pressure connector subsystem to a negative-pressure source; and   activating the negative-pressure source.   
     
     
         35 . The method of  claim 34 , wherein the surface wound site comprises a burn, a graft, an overhang wound, a contusion, or a post-operative wound. 
     
     
         36 . A method for treating a tunnel wound site, the method comprising:
 deploying within the tunnel wound site the apparatus of any of  claims 1 - 24 , the dressing of any of  claims 25 - 28 , or at least a portion of the system for treating a tissue site according to any of  claims 29 - 31 , the dressing substrate comprising a cylinder or tube;   deploying a negative-pressure connector subsystem;   deploying a sealing member to form a fluid seal over the tunnel wound;   fluidly coupling the negative-pressure connector subsystem to a negative-pressure source; and   activating the negative-pressure source.   
     
     
         37 . The method of  claim 36 , wherein the tunnel wound site comprises a puncture or a fistula. 
     
     
         38 . A method of reducing edema for a tissue site, the method comprising positioning an apparatus of any of  claims 1 - 24 , a dressing of any of  claims 25 - 28 , or at least a portion of a system for treating a tissue site according to any of  claims 29 - 31  over the tissue site. 
     
     
         39 . The systems, apparatuses, dressings, compositions, and methods substantially as described herein.