SEALANT FOAM COMPOSITIONS FOR LUNG APPLICATIONS
The present invention is directed to tissue sealant compositions comprising: a multi-arm reactive polyethylene glycol polymer having at least 3 electrophilic groups; albumin; a buffer; water; and entrained gas as bubbles; wherein concentration of albumin in a liquid component of the sealant is within range of 50-200 mg/ml; and wherein concentration of multi-arm PEG in said liquid component of the sealant is within range of 25-100 mg/mL and wherein PEG-SG portion is composed of a blend of 2 PEG-SG different in arm number or arm lengths.
1 . A tissue sealant comprising:
a) A liquid component containing
a. At least two different multi-arm poly(ethylene glycol) succinimidyl glutarate (PEG-SG) components, each having at least 3 electrophilic groups;
b. albumin;
c. a buffering agent;
d. water; and
b) entrained gas as bubbles;
wherein a combination of (a-d) produces a compliant soft set foam with closed cell;
wherein the liquid component has an albumin concentration in range of 50 to 200 mg/ml;
wherein a first PEG-SG component is a four-arm poly(ethylene glycol) succinimidyl glutarate having an average molecular weight 20,000 Dalton (PEG-SG4-20K) having a liquid concentration of between 20 to 45 mg/ml and a second PEG-SG component is a two-arm poly(ethylene glycol) succinimidyl glutarate having an average molecular weight of 10,000 Dalton (PEG-SG2-10K) having a liquid concentration of between 5 to 30 mg/ml, and
wherein the sum of the liquid concentrations for both PEG-SG components is 50 mg/ml, and
wherein gas space comprises 55% to 75% of the foam by volume.
2 . The tissue sealant of claim 1 , wherein said gas is air, nitrogen, argon, carbon dioxide, or mixtures thereof.
3 . The tissue sealant of claim 1 , wherein said first multi-arm PEG component and said second multi-arm PEG component comprises di-ester linkages.
4 . The tissue sealant of claim 1 , wherein said sealant is a foam and is bioresorbable.
5 . (canceled)
6 . The tissue sealant of claim 1 , wherein foam flowability is such that the foam requires at least 7 seconds to travel 6 inches on a 30% inclined panel.
7 . The tissue sealant of claim 1 , wherein E modulus of the cured foam is above 8.5 kPa and below 110 kPa.
8 . A method of making the tissue sealant comprising: mixing and foaming a composition comprising a blend of multi-arm PEG-SGs, albumin, buffer, water, and gas according to claim 1 .
9 . A method of using the tissue sealant of claim 1 , comprising:
rapidly mixing and foaming a composition comprising multi-arm PEG-SG, albumin, buffer, water, and gas, forming a foam;
immediately thereafter applying the foam onto a tissue;
allowing the foam to cure on said tissue.