Melt blown dressing with gradient density
The present invention is directed to an absorbable hemostatic nonwoven patch that utilizes a biocompatible substrate comprised of melt-blown microfibers as webbed sheets that are layered and bonded/entangled in descending density and ascending porosity; with the substrate having a high flexibility, strength and porosity that is suitable for coating cross-linkable active molecules and ability for laparoscopic use or trocar deployment, ultimately for functional use as a highly effective hemostat in addressing problematic bleeding during both open and minimally invasive surgical procedures.
1 . A method for preparing a wound dressing comprising a melt-blown multi-layered substrate of a polymeric material having at least two major surfaces and a coated layer that is applied to at least one of the major surfaces of a sealing agent that is selected from the group consisting of co-reactive hydrogel-forming materials, one or more plasma-based hemostatic agents and combinations thereof, wherein the melt-blown substrate has a porosity gradient profile, said method comprising melt blowing microfibers as webbed sheets, layering the melt-blown sheets, and bonding the layers melt-blown sheets.
2 . The method according to claim 1 wherein the substrate is a multi-layered, integrated composite of layers of polymeric materials, each layer having descending density and ascending porosity relative to an adjacent layer.
3 . The method according to claim 2 , wherein the substrate consists essentially 4 to 14 discrete and integrated layers.
4 . The method according to claim 3 , wherein each discrete and integrated layer is about 0.05-0.2 mm thick.
5 . The method according to claim 1 , wherein the substrate has, on an overall basis, a pore size diameter in the range of 0.01-0.5 mm.
6 . The method according to claim 5 , wherein a majority of the pores have a pore size diameter in the range of 0.1-0.3 mm.
7 . The method according to claim 1 , wherein a total open porosity of the substrate is in a range from of 30-90%.
8 . The method according to claim 1 , wherein the bottom-third of the substrate has an open porosity of about 30%, the middle-third of the substrate has an open porosity of about 80% and the top-third of the substrate to the coated major surface has an open porosity of about 85%.
9 . The method according to claim 1 , wherein the coating rests on at least one major surface of the substrate and the overall substrate porosity is greater than 60%.
10 . The wound dressing according to claim 9 , wherein the coating penetrates to a depth greater than 95% penetration.
11 . The method according to claim 1 , wherein the overall substrate porosity is greater than 65%.
12 . The method according to claim 1 , wherein the wound dressing has a mean stiffness of at least 0.50 N/mm.
13 . The method according to claim 1 , wherein the polymeric materials are selected from biodegradable polymers selected from the group consisting of polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), poly(lactic acid) (PLA), (polydioxanone) (PDS), polycaprolactone, caprolactone/glycolide polyesters and combinations thereof.
14 . The method according to claim 1 , wherein the polymeric material is a copolymer of glycolide and epsilon-caprolactone (Monocryl), polyglactin 910 (Vicryl) or combinations thereof.
15 . The method according to claim 1 , wherein the hydrogel-forming materials are each at least two different multifunctional polymers or polymeric precursors that comprise two or more electrophilic or nucleophilic functional groups.
16 . The method according to claim 15 , wherein at least one of the hydrogel-forming materials has two or more nucleophilic functional groups that reacts with an electrophilic functional group on a second hydrogel forming material to form a covalent bond.
17 . The method according to claim 1 , wherein the hydrogel-forming materials are: multi-arm PEG functionalized with multiple NHS groups as a first co-reactive component, and a multifunctional nucleophilic component as a second co-reactive component.
18 . The method according to claim 17 , wherein the multi-arm PEG functionalized with multiple NHS groups has four, six or eight arms and has a molecular weight of from about 5,000 to about 25,000.