Hemostatic bioabsorbable device with polyethylene glycol binder
A hemostatic pad comprising a bioabsorbable scaffolding material; a lyophilized thrombin powder, a lyophilized fibrinogen powder, and a meltable binder powder, with all powders disposed on the bioabsorbable scaffolding material. A meltable binder such as PEG bonds the lyophilized thrombin powder and the lyophilized fibrinogen powder to the bioabsorbable scaffolding material for improved friability, wettability and performance in a use, such as for hemostatic treatment or sealing at a wound site.
1. A hemostatic pad comprising:
a) a bioabsorbable scaffolding material;
b) a thrombin powder particle,
c) a fibrinogen powder particle, and
d) a meltable binder powder that is a hydrophilic, biocompatible, and bioabsorbable material having a melting point from about 25° C. to about 100° C.,
wherein said thrombin and fibrinogen powder particles are disposed on the bioabsorbable scaffolding material and the meltable binder powder bonds the thrombin powder particles and the fibrinogen powder particles to the bioabsorbable scaffolding material but does not coat or fully envelope the thrombin powder particles and/or the fibrinogen powder particles.
2. The hemostatic pad according to claim 1 wherein the meltable binder comprises a polyethylene glycol polymer having an average molecular weight from about 1500 to about 20,000 Daltons.
3. The hemostatic pad according to claim 1 wherein the meltable binder is composed substantially of polyethylene glycol polymer having an average molecular weight from about 2500 to about 8000 Daltons, more preferably from about 2500 to about 4000 Daltons.
4. The hemostatic pad according to claim 3 wherein average molecular weight of the polyethylene glycol polymer for the binder powder is about 3000 Daltons.
5. The hemostatic pad according to claim 2 wherein the binder particles have a number average particle size of about 45 microns.
6. The hemostatic pad according to claim 2 wherein the weight fraction of the thrombin powder is about 10-15%, the fibrinogen powder is about 55-85%, and the polyethylene glycol is 2-20%, each relative to total weight of the thrombin, fibrinogen and polyethylene glycol powders on the hemostatic pad.
7. The hemostatic pad according to claim 2 wherein the bioabsorbable scaffolding material is a woven or a non-woven synthetic or natural bioabsorbable material or combinations thereof.
8. The hemostatic pad according to claim 2 wherein the bioabsorbable scaffolding material is a bi-layer material comprising a layer of non-woven Polyglactin 910 fibers that has been needle punched into a layer of knitted oxidized regenerated cellulose, wherein said powders are disposed only on said layer of non-woven Polyglactin 910 fibers.
9. The hemostatic pad according to claim 2 wherein said thrombin powder particles and said fibrinogen powder particles are bonded to the bioabsorbable scaffolding material by elevating the temperature of the hemostatic pad to a point above the melting point of the polyethylene glycol polymer.
10. The hemostatic pad according to claim 2 wherein said hemostatic pad contains about 200-600 IU of thrombin per square inch of said hemostatic pad, as measured when applied, contains fibrinogen in the amount of about 20-80 mg per square inch of said hemostatic pad, as measured when applied, and the polyethylene glycol is present in the amount of about 6-25 mg per square inch of said hemostatic pad.
11. The hemostatic pad according to claim 2 further comprising carboxymethyl cellulose powder.
12. The hemostatic pad according to claim 11 wherein said carboxymethyl cellulose powder has a number average particle size of about 20 microns and wherein said carboxymethyl cellulose powder is present in an amount of about 15-20 mg per square inch of said hemostatic pad.