Manifold With Biological Actives For Negative-Pressure Therapy
A system for use in treating a tissue site with negative pressure, which may comprise a dressing or tissue interface and a plurality of standoffs for storing and releasing a biocompatible polymer to the tissue site. The standoff may be cells or closed-end cells. In some examples, the biocompatible polymer may comprise collagen, oxidized regenerated cellulose, or a combination thereof. Method for using and manufacturing the dressing or tissue interface may also be disclosed.
1 . A system for treating a tissue site, comprising:
a tissue interface comprising:
a film, and
a plurality of standoffs on the first film, wherein at least some of the standoffs enclose a composition comprising a biocompatible polymer;
a cover configured to be disposed adjacent to the tissue interface and to form a seal around the tissue site; and
a negative-pressure source fluidly coupled to the tissue interface through the cover.
2 . The system of claim 1 , further comprising a fluid control layer having a smooth surface adjacent to the plurality of standoffs.
3 . The system of claim 1 or 2 , wherein the tissue interface comprises apertures disposed between the standoffs and configured to allow fluid flow through the tissue interface.
4 . The system of any of claims 1 - 3 , wherein the standoffs are cells having a closed end.
5 . The system of claim 4 , wherein the cells have walls with a thickness of between 0.5 mm to 4.5 cm.
6 . The system of claim 4 or 5 , wherein at least some of the cells have a shape that is spherical, circular, polygonal or any combination thereof.
7 . The system of any of claims 4 - 6 , wherein the cells have a diameter of between 0.5 mm and 10 mm.
8 . The system of any of claims 4 - 7 , wherein the cells have a depth of between 0.5 mm and 10 mm.
9 . The system of any of claims 4 - 8 , wherein at least some of the cells have a spacing between two adjacent protrusions ranging from 2.0 mm to 10 mm apart.
10 . The system of any of claims 4 - 9 , wherein the cells are regularly spaced.
11 . The system of any of claims 4 - 10 , wherein the cells are irregularly spaced.
12 . The system of any of claims 4 - 11 , wherein at least some of the cells have perforations.
13 . The system of claim 12 , wherein the perforations comprise slits of between 0.5 to 2 mm in width or crosshatches.
14 . The system of any of claims 1 - 13 , wherein the tissue interface comprises thermoplastic elastomers, polyurethane, polyethylene, silicone, silicone-like materials, polyamide, polypropylene, polyethylene, polyvinyl chloride, ethylene vinyl acetate copolymers, polyvinyl alcohol, polyether block amide (PEBAX) polymers, or any combination thereof.
15 . The system of any of claims 1 - 14 , wherein the biocompatible polymer comprises a biologically-active polymer.
16 . The system of any of claims 1 - 15 , wherein the biocompatible polymer is biosorbable.
17 . The system of any of claims 1 - 16 , wherein the biocompatible polymer comprises anti-inflammatory, matrix metalloproteinases (MMP)-mitigating or antimicrobial polymers.
18 . The system of any of claims 1 - 17 , wherein the biocompatible polymer comprises collagen.
19 . The system of any of claims 1 - 18 , wherein the biocompatible polymer comprises oxidized regenerated cellulose.
20 . The system of any of claims 1 - 19 , wherein the biocompatible polymer comprises cross-linked collagen.
21 . The system of any of claims 1 - 20 , wherein the biocompatible comprises hyaluronic acid, chitosan, heparin, alginate, cellulose, fibrin, gelatin, chondroitin sulfate, agarose, dextran, carrageenan, silk, poly(ethylene glycol), poly(vinyl alcohol), polycaprolactone, polyphophazene, polyglycolic acid, rosin, lactose, sucrose, tapioca starch, and polyvinylpyrrolidone, or any combination thereof.
22 . The system of any of claims 1 - 21 , wherein the tissue interface is pliable.
23 . The system of any of claims 1 - 22 , wherein the tissue interface has a thickness of between 0.5 mm to 5 cm.
24 . The system of any of claims 1 - 23 , wherein the tissue interface has a thickness of between 0.5 mm to 1 cm.
25 . The system of any of claims 1 - 24 , wherein at least some of the standoffs form protrusions on one side of the tissue interface.
26 . The system of any of claims 1 - 24 , wherein at least some of the standoffs form protrusions on two sides of the tissue interface.
27 . The system of claim 25 or 26 , wherein the protrusions have walls with a thickness of between 0.5 mm to 4.5 cm.
28 . The system of any of claims 25 - 27 , wherein at least some of the protrusions have a shape that is spherical, circular, polygonal or any combination thereof.
29 . The system of any of claims 25 - 28 , wherein the protrusions have a width of between 0.5 mm and 10 mm.
30 . The system of any of claims 25 - 29 , wherein the protrusions have a length of between 0.5 mm and 10 mm.
31 . The system of any of claims 25 - 30 , wherein at least some of the protrusions have a spacing between two adjacent protrusions ranging from 2.0 mm to 10 mm apart.
32 . The system of any of claims 25 - 31 , wherein the protrusions are regularly spaced.
33 . The system of any of claims 25 - 32 , wherein the protrusions are irregularly spaced.
34 . The system of any of claims 25 - 33 , wherein at least some of the protrusions have perforations.
35 . The system of claim 34 , wherein the perforations comprise slits of between 0.5 to 2 mm in width or crosshatches.
36 . The system of any of claims 1 - 35 , wherein the biocompatible polymer is in a form of a liquid slurry.
37 . The system of any of claims 1 - 35 , wherein the biocompatible polymer is in a powder form.
38 . A dressing, comprising:
a manifold comprising:
a film,
a first side and a second side,
a plurality of standoffs on at least the first side, wherein at least some of the standoffs enclose a composition comprising a biocompatible polymer; and
a cover configured to be adjacent to the second side of the manifold.
39 . A manifold for treating a tissue site with negative pressure, the manifold comprising:
a polymer film; and
a plurality of standoffs enclosing a composition comprising a biocompatible polymer.
40 . A method for treating a tissue site, comprising:
positioning a manifold adjacent to the tissue site, the manifold comprising a polymeric film having a plurality of cells, at least some of the cells enclosing a composition comprising a biocompatible polymer;
covering the manifold and the tissue site with a cover to form a sealed therapeutic environment; and
providing negative pressure from a negative-pressure source to the tissue site through the manifold.
41 . The method of claim 40 , wherein the cells are configured to not to block negative pressure to the tissue site.
42 . The method of claim 40 , wherein the cells are configured to release the biocompatible polymer over a time period of at least seven days.
43 . The method of claim 40 , wherein the cells are configured to release the biocompatible polymer over a time period of at least 14 days.
44 . A method for manufacturing a manifold, comprising:
providing a polymeric film having a plurality of cells,
incorporating a composition comprising a biocompatible polymer into at least some of the cells; and
sealing the cells to encapsulate the composition.
45 . The method of claim 44 , wherein the composition comprise a liquid slurry.
46 . The method of claim 45 , further comprising freeze-drying the liquid composition.
47 . The method of claim 44 , wherein incorporating the composition into at least some of the cells comprises injecting the composition into at least some of the cells.
48 . A method for manufacturing a manifold, comprising:
providing a polymeric film,
wrapping at least some portions of the polymeric film around a composition comprising a biocompatible polymer; and
sealing the portions of the polymeric film to create cells to encapsulate the composition.
49 . The method of claim 48 , wherein sealing the portions comprises sealing with heat.
50 . The systems, apparatuses, and methods substantially as described herein.