DEVICE FOR DELIVERING A FLOWABLE TISSUE DRESSING MATERIAL AND METHODS OF USE
Devices for delivering a flowable tissue dressing material for treating a tissue site are described. The devices include a first zone including a first reactant, such as a polyol, and a second zone including a second reactant, such as a multi-isocyanate, which can be mixed together to form a flowable tissue dressing material. The device can also include a flowable tissue dressing material including a reacted polymer present in a carrier. Kits and methods including and/or using the devices are also described.
1 . A device for delivering a flowable tissue dressing material, wherein the device comprises:
a first zone comprising a first reactant selected from the group consisting of a polyol, a polyaldehyde, and a polyamine; and
a second zone comprising a second reactant selected from the group consisting of a multi-isocyanate, a multi-isocyanate prepolymer, a polycarbamate, a polycarboxylic acid, and an anhydride; wherein the first zone is physically separate from the second zone.
2 . The device of claim 1 , wherein the first zone is a first container and the second zone is a second container.
3 . The device of claim 1 or claim 2 , wherein the first zone and the second zone are present in a single container having a wall defined therein, which separates the first zone and the second zone, wherein the wall is at least partially removable to allow for mixing between the first reactant and the second reactant to form the flowable tissue dressing material.
4 . The device of any one of the previous claims, further comprising a third zone for mixing the first reactant with the second reactant to form the flowable tissue dressing material and/or for delivering the flowable tissue dressing material, wherein the third zone is physically separate from the first zone and the second zone.
5 . The device of any one of the previous claim, further comprising one or more of:
(i) a cell opener;
(ii) a foaming agent;
(iii) a catalyst;
(iv) water soluble particles;
(v) a propellant;
(vi) an antimicrobial agent;
(vii) collagen;
(viii) oxidized regenerated cellulose (ORC); and
(ix) chitosan.
6 . The device of claim 5 , wherein the cell opener is selected from the group consisting of a silicone, a polyether siloxane, a mineral, and a combination thereof.
7 . The device of claim 5 or claim 6 , wherein the foaming agent is selected from the group consisting of a low boiling point liquid, water, a compressed gas, and a combination thereof.
8 . The device of claim 7 , wherein the low boiling point liquid is a fluorocarbon, a chlorofluorocarbon, or a combination thereof.
9 . The device of claim 7 or claim 8 , wherein the compressed gas comprises carbon dioxide, nitrogen, an alkane, or a combination thereof.
10 . The device of any one of claims 5 to 9 , wherein the water soluble particles comprise a salt, a water soluble polymer, or a combination thereof.
11 . The device of claim 10 , wherein the salt is selected from the group consisting of sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and a combination thereof.
12 . The device of claim 10 or claim 11 , wherein the water soluble polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and a combination thereof.
13 . The device of any one of claims 5 to 12 , wherein the antimicrobial agent is selected from the group consisting of a carboxylic acid, silver, gold, zinc, copper, polyhexamethylene biguanide (PHMB), iodine and a combination thereof.
14 . A device for delivering a flowable tissue dressing material, wherein the device comprises:
the flowable tissue dressing material comprising a reacted polymer present in a carrier,
wherein the reacted polymer is selected from the group consisting of a polyurethane, a polyester, a polyamide, an acrylic polymer, an acrylate polymer, a polyvinyl acetate, a polysiloxane, and a combination thereof,
wherein the carrier is a low boiling point liquid, water, a compressed gas, or a combination thereof.
15 . The device of claim 14 , wherein the low boiling point liquid is a fluorocarbon, a chlorofluorocarbon, or a combination thereof.
16 . The device of claim 14 or claim 15 , wherein the compressed gas comprises carbon dioxide, nitrogen, an alkane, or a combination thereof.
17 . The device of any one of claims 14 to 16 , further comprising one or more of:
(i) a cell opener;
(ii) water soluble particles;
(iii) an alcohol;
(iv) a propellant;
(v) an antimicrobial agent;
(vi) collagen;
(vii) oxidized regenerated cellulose (ORC); and
(viii) chitosan.
18 . The device of claim 17 wherein the cell opener is selected from the group consisting of a silicone, a polyether siloxane, a mineral, and a combination thereof.
19 . The device of claim 17 or 18 , wherein the water soluble particles comprises a salt, a water soluble polymer, or a combination thereof.
20 . The device of claim 19 , wherein the salt is selected from the group consisting of sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and a combination thereof.
21 . The device of claim 19 or claim 20 , wherein the water soluble polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and a combination thereof.
22 . The device of any one of claims 17 to 21 , wherein the antimicrobial agent is selected from the group consisting of a carboxylic acid, silver, gold, zinc, copper, polyhexamethylene biguanide (PHMB), iodine and a combination thereof.
23 . The device of any one of the previous claims, further comprising one or more of:
(i) a photoinitiator;
(ii) an ultraviolet light source for solidifying the flowable tissue dressing material;
(iii) a mixer for mixing the flowable tissue dressing material; and
(iv) a delivery tube for delivering the flowable tissue dressing material.
24 . The device of any one of the previous claims, wherein the flowable tissue dressing material is capable of solidifying to form an open cell foam when applied to a tissue site.
25 . The device of claim 24 , wherein the open cell foam has a moisture vapor transmission rate of about 250 g/m2/24 hours to about 1500 g/m2/24 hours.
26 . The device of claim 24 of claim 25 , wherein the open cell foam has a molecular weight of greater than or equal to about 100,000.
27 . The device of any one of the previous claims, wherein an interior of the device is sterile and/or the device is formed from metal, plastic, or a combination thereof.
28 . A kit comprising the device of any one of the previous claims and a cover.
29 . A method for treating a tissue site, the method comprising:
applying a flowable tissue dressing material from a device to a tissue site, wherein the flowable tissue dressing material is formed in the device by mixing a first reactant with a second reactant to form the flowable tissue dressing material, wherein the first reactant is selected from the group consisting of a polyol, polyaldehyde, and a polyamine; and the second reactant is selected from the group consisting of a multi-isocyanate, a multi-isocyanate prepolymer, a polycarbamate, a polycarboxylic acid, and an anhydride; and wherein, prior to mixing, the first reactant is present in a first zone and the second reactant is present in a second zone in the device; wherein the first zone is physically separate from the second zone; and
solidifying the flowable tissue dressing material to form an open cell foam adjacent to the tissue site.
30 . The method of claim 29 , wherein the first zone is a first container and the second zone is a second container.
31 . The method of claim 29 or claim 30 , wherein the first zone and the second zone are present in a single container having a wall defined therein, which separates the first zone and the second zone, wherein the wall is at least partially removable to allow for mixing between the first reactant and the second reactant to form the flowable tissue dressing material.
32 . The method of any one of claims 29 to 31 , wherein the device further comprises a third zone for mixing the first reactant with the second reactant to form the flowable tissue dressing material and/or for delivering the flowable tissue dressing material, wherein the third zone is physically separate from the first zone and the second zone.
33 . The method of any one of claims 29 to 32 , wherein the device further comprises one or more of:
(i) a cell opener;
(ii) a foaming agent;
(iii) a catalyst;
(iv) water soluble particles;
(v) a propellant
(vi) an antimicrobial agent;
(vii) collagen;
(viii) oxidized regenerated cellulose (ORC); and
(ix) chitosan.
34 . The method of claim 33 , wherein the cell opener is selected from the group consisting of a silicone, a polyether siloxane, a mineral, and a combination thereof.
35 . The method of claim 33 or claim 34 , wherein the foaming agent is selected from the group consisting of a low boiling point liquid, water, a compressed gas, and a combination thereof.
36 . The method of claim 35 , wherein the low boiling point liquid is a fluorocarbon, a chlorofluorocarbon, or a combination thereof.
37 . The method of claim 35 or claim 36 , wherein the compressed gas comprises carbon dioxide, nitrogen, an alkane, or a combination thereof.
38 . The method of any one of claims 33 to 37 , wherein the water soluble particles comprises a salt, a water soluble polymer, or a combination thereof.
39 . The method of claim 38 , wherein the salt is selected from the group consisting of sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and a combination thereof.
40 . The method of claim 38 or claim 39 , wherein the water soluble polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and a combination thereof.
41 . The method of any one of claims 33 to 40 , wherein the antimicrobial agent is selected from the group consisting of a carboxylic acid, silver, gold, zinc, copper, polyhexamethylene biguanide (PHMB), iodine and a combination thereof.
42 . A method for treating a tissue site, the method comprising:
applying a flowable tissue dressing material from a device to a tissue site, wherein the flowable tissue dressing material comprises a reacted polymer present in a carrier, wherein the reacted polymer is selected from the group consisting of a polyurethane, a polyester, a polyamide, an acrylic polymer, an acrylate polymer, a polyvinyl acetate, a polysiloxane, and a combination thereof, and wherein the carrier is a low boiling point liquid, water, a compressed gas, or a combination thereof; and
solidifying the flowable tissue dressing material to form an open cell foam adjacent to the tissue site.
43 . The method of claim 42 , wherein the low boiling point liquid is a fluorocarbon, a chlorofluorocarbon, or a combination thereof.
44 . The method of claim 42 or claim 43 , wherein the compressed gas comprises carbon dioxide, nitrogen, an alkane, or a combination thereof.
45 . The method of any one of claims 42 to 44 , wherein the device further comprising one or more of:
(i) a cell opener;
(ii) water soluble particles;
(iii) an alcohol;
(iv) a propellant;
(v) an antimicrobial agent;
(vi) collagen;
(vii) oxidized regenerated cellulose (ORC); and
(viii) chitosan.
46 . The method of claim 45 , wherein the cell opener is selected from the group consisting of a silicone, a polyether siloxane, a mineral, and a combination thereof.
47 . The method of claim 45 or claim 46 , wherein the water soluble particles comprises a salt, a water soluble polymer, or a combination thereof.
48 . The method of claim 47 , wherein the salt is selected from the group consisting of sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and a combination thereof.
49 . The method of claim 47 or claim 48 , wherein the water soluble polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and a combination thereof.
50 . The method of any one of claims 45 to 49 , wherein the antimicrobial agent is selected from the group consisting of a carboxylic acid, silver, gold, zinc, copper, polyhexamethylene biguanide (PHMB), iodine and a combination thereof.
51 . The method of any one of claims 29 to 50 , wherein the device further comprises one or more of:
(i) a photoinitiator;
(ii) an ultraviolet light source for solidifying the flowable tissue dressing material;
(iii) a mixer for mixing the flowable tissue dressing material; and
(iv) a delivery tube for delivering the flowable tissue dressing material.
52 . The method of any one of claims 29 to 51 , wherein the open cell foam has a moisture vapor transmission rate of about 250 g/m2/24 hours to about 1500 g/m2/24 hours.
53 . The method of any one of claims 29 to 52 , wherein the open cell foam has a molecular weight of greater than or equal to about 100,000.
54 . The method of any one of claims 29 to 53 , wherein an interior of the device is sterile and/or the device is formed from metal, plastic, or a combination thereof.