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.
1. A tissue sealant comprising:
a) a multi-arm PEG having at least 3 electrophilic groups;
b) albumin;
c) a buffer;
d) water; and
e) entrained gas as bubbles;
wherein when components (a-e) of the tissue sealant are combined produce a compliant soft set foam with closed cell;
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,
wherein gas comprises 65% to 75% of the foam by volume, and
wherein E modulus of the foam in a cured state is above 8.5 kPa and below 110 kPa.
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 multi-arm PEG has molecular weight from about 5 kD to about 20 kD.
4. The tissue sealant of claim 1 , wherein said multi-arm PEG comprises diester linkages.
5. The tissue sealant of claim 1 , wherein said electrophilic groups are hydroxysuccinimide (NHS) or succinimidyl glutarate ester (SG).
6. The tissue sealant of claim 1 , wherein said sealant comprises a foam and is bioresorbable.
7. The tissue sealant of claim 6 , wherein foam flowability is such that the foam requires at least 7 seconds to travel 6 inches on a 30% inclined panel.
8. The tissue sealant of claim 6 , wherein albumin and PEG-SG concentrations in mg/mL of liquid portion of the foam, are selected so that an equation for E Modulus yields values from 8.5 kPa to 110 kPa:
E Modulus ( k Pa)=−2.34−0.168Albumin+0.197 PEG+ 0.000393Albumin{circumflex over ( )}2−0.00462 PEG{circumflex over ( )} 2+0.008318Albumin* PEG.
9. A method of making the tissue sealant of claim 1 , comprising: mixing and foaming a composition comprising multi-arm PEG-SG, albumin, buffer, water, and gas.
10. 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.