Collagen hemostatic foam
AssigneeC. R. Bard, Inc.
InventorsFrancis B. Maddalo, Mark V. Iampietro, Stephen N. Eldridge, Robert D. Torgerson
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Abstract
A hemostatic device formed of collagen particles and methods for producing and using the hemostatic device to control bleeding are provided. The collagen particles of the hemostatic device have a hemostatic activity that is equivalent to the hemostatic activity of the collagen particles from which the hemostatic device is formed. More preferably, the hemostatic devices are formed of Avitene® flour and the collagen particles of the hemostatic devices of the invention have a hemostatic activity equivalent to the hemostatic activity of Avitene® flour. The hemostatic devices optionally include hemostatic agents and/or therapeutic agents, to further promote hemostasis and wound healing.
Claims45
A process for preparing a hemostatic device, comprising:
- (a) suspending a plurality of collagen particles in water to form a collagen slurry, wherein the collagen particles have a bulk density sufficient to form a suspension in water and wherein the collagen slurry has a collagen concentration in the range of about 1% to about 2% (weight/volume);
- and
- (b) lyophilizing the collagen slurry to form a hemostatic device.
A hemostatic device prepared by the process comprising:
- (a) suspending a plurality of collagen particles in water to form a collagen slurry, wherein the collagen particles have a bulk density sufficient to form a suspension in water and wherein the collagen slurry has a collagen concentration in the range of about 1% to about 2% (weight/volume);
- and
- (b) lyophilizing the collagen slurry to form a hemostatic device.
A hemostatic device, wherein the collagen particles of the hemostatic device have a hemostatic activity that is equivalent to the hemostatic activity of the collagen particles from which the hemostatic device is formed.
A hemostatic device comprising collagen, wherein the hemostatic device has a hemostatic activity in a pig spleen animal model of hemostasis that corresponds to one tamponade for a hemostatic device having a thickness of ⅜ inch, a length of ½ inch, and a width of ½ inch.
A hemostatic device comprising collagen, wherein the hemostatic device is dry and sufficiently flexible to conform to the contours of a biological surface and absorb exudants present at the biological surface, and wherein the collagen has not been subjected to acid dissolution.
A process for preparing a hemostatic device, comprising:
- (a) suspending a plurality of collagen particles in water to form a collagen slurry, wherein the collagen particles have a bulk density sufficient to form a suspension in water and wherein the collagen slurry has a collagen concentration in the range of about 1% to about 2% (weight/volume);
- (b) introducing the collagen slurry into a mold;
- and
- (c) lyophilizing the collagen slurry to form a hemostatic device.
A process for preparing a hemostatic device, comprising:
- (a) suspending a plurality of collagen particles in water to form a collagen slurry, wherein the collagen particles have a bulk density sufficient to form a suspension in water and wherein the collagen slurry has a collagen concentration in the range of about 1% to about 2% (weight/volume);
- (b) lyophilizing the collagen slurry to form a hemostatic device;
- and
- (c) removing a surface layer of the hemostatic device.
A hemostatic device prepared by the process comprising:
- (a) suspending a plurality of collagen particles in water to form a collagen slurry, wherein the collagen particles have a bulk density sufficient to form a suspension in water and wherein the collagen slurry has a collagen concentration in the range of about 1% to about 2% (weight/volume);
- (b) introducing the collagen slurry into a mold;
- and
- (c) lyophilizing the collagen slurry to form a hemostatic device.
A hemostatic device prepared by the process comprising:
- (a) suspending a plurality of collagen particles in water to form a collagen slurry, wherein the collagen particles have a bulk density sufficient to form a suspension in water and wherein the collagen slurry has a collagen concentration in the range of about 1% to about 2% (weight/volume);
- (b) lyophilizing the collagen slurry to form a hemostatic device;
- and
- (c) removing a surface layer of the hemostatic device.
A hemostatic device, wherein the collagen particles of the hemostatic device have a hemostatic activity that is equivalent to the hemostatic activity of the collagen particles from which the hemostatic device is formed,
- wherein the hemostatic device does not contain thrombin and the hemostatic device has a hemostatic activity in a pig spleen animal model that is greater than that of Gelfoam® with thrombin.
A hemostatic device, wherein the collagen particles of the hemostatic device have a hemostatic activity that is equivalent to the hemostatic activity of the collagen particles from which the hemostatic device is formed,
- wherein the hemostatic device has a wettability index of less than or equal to 1 minute in distilled water at room temperature.
Dependencies are inferred from the claim text.