Process for making dry and stable hemostatic compositions
US-9084728-B2 · Jul 21, 2015 · US
US9821025B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9821025-B2 |
| Application number | US-201615004520-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jan 22, 2016 |
| Priority date | Oct 11, 2011 |
| Publication date | Nov 21, 2017 |
| Grant date | Nov 21, 2017 |
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The invention discloses a hemostatic composition comprising: a) a biocompatible polymer in particulate form suitable for use in hemostasis, and b) one hydrophilic polymeric component comprising reactive groups.
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What is claimed is: 1. A method for producing a hemostatic composition in mixed dry form for treating a patient, the method comprising: placing, in a container, an amount of hemostatic biocompatible polymer in dry form, wherein the hemostatic biocompatible polymer is cross-linked gelatin, and wherein the cross-linked gelatin is present in particulate form having a median particle diameter within a range from 0.01 mm to 1.5 mm; placing, in the container, an amount of one hydrophilic polymeric component comprising reactive groups in dry form, wherein the reactive groups are electrophilic reactive groups, and wherein the one hydrophilic polymeric component comprising reactive groups is a polyethylene glycol; and mixing, in the container, the amount of the hemostatic biocompatible polymer in dry form and the amount of the one hydrophilic polymeric component comprising reactive groups in dry form to produce the hemostatic composition in mixed dry form, the hemostatic composition comprising a mixture of the amount of the hemostatic biocompatible polymer and the amount of the one hydrophilic polymeric component comprising reactive groups, wherein the amount of the hemostatic biocompatible polymer and the amount of the one hydrophilic polymeric component comprising reactive groups in mixed dry form are present in a ratio, wherein the ratio is of the hemostatic biocompatible polymer to the one hydrophilic polymeric component comprising reactive groups, wherein the ratio is in a range from 0.1% w/w to 50% w/w, and wherein the hemostatic composition does not include a second or further hydrophilic polymeric component with nucleophilic reactive groups. 2. The method according to claim 1 , wherein the polyethylene glycol is pentaerythritolpoly(ethyleneglycol)ether tetrasuccinimidyl glutarate. 3. The method according to claim 1 , wherein the ratio of the hemostatic biocompatible polymer to the one hydrophilic polymer component comprising reactive groups is in a range from 5% w/w to 40% w/w. 4. The method according to claim 1 , further comprising hydrating an amount of the hemostatic composition in mixed dry form with an amount of a diluent to obtain a hydrated product. 5. The method according to claim 4 , further comprising applying the hydrated product to a bleeding wound of the patient. 6. The method according to claim 4 , wherein the diluent is neutral. 7. The method according to claim 6 , wherein the diluent is a saline solution. 8. The method according to claim 6 , further comprising applying the hydrated product to a bleeding wound of the patient. 9. The method according to claim 4 , wherein the diluent is basic. 10. The method according to claim 9 , wherein the diluent has a pH of 9.5. 11. The method according to claim 9 , further comprising applying the hydrated product to a bleeding wound of the patient. 12. The method according to claim 4 , wherein the diluent is acidic. 13. The method according to claim 12 , wherein the diluent has a pH of 1.5. 14. The method according to claim 12 , further comprising applying the hydrated product to a bleeding wound of the patient.
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