Hemostatic microspheres

Abstract

Provided herein are hemostatic compositions. In one embodiment, the hemostatic composition includes cross-linked polymer microspheres, such as cross-linked gelatin microspheres with pores. In another embodiment, the hemostatic composition comprises an additive such as a wetting agent, a suspending agent, or both. The hemostatic compositions may also include a hemostatic agent such as thrombin, and may include a high concentration of thrombin. The hemostatic compositions may also include plasma. Also provided herein are devices for dispersing said hemostatic compositions in a diluent, and delivering said dispersed hemostatic composition. The hemostatic compositions may also fabricated with a selected geometry as administration suggests.

1 - 19 . (canceled) 
     
     
         20 . A dry powder hemostatic composition comprising:
 a plurality of porous cross-linked gelatin microspheres;   a wetting agent; and   a suspending agent;   wherein the porous cross-linked gelatin microspheres have a diameter from about 50 μm to about 500 μm, inclusive, when fully hydrated, and wherein the porous cross-linked gelatin microspheres contain pores having a pore diameter from about 15 μm to about 25 μm, inclusive,   wherein the suspending agent is carboxymethylcellulose.   
     
     
         21 . The hemostatic composition of  claim 20 , wherein the porous gelatin microspheres have a diameter from about 110 μm to about 400 μm, inclusive, when fully hydrated. 
     
     
         22 . The hemostatic composition of  claim 20 , further comprising thrombin. 
     
     
         23 . The hemostatic composition of  claim 22 , wherein the thrombin concentration is in a range of about 1,000 IU to about 2,000 IU per ml of rehydrated microsphere gel, inclusive. 
     
     
         24 . The hemostatic composition of  claim 22 , wherein the thrombin concentration is in a range of about 1,000 IU to about 5,000 IU per ml of rehydrated microsphere gel, inclusive. 
     
     
         25 . The hemostatic composition of  claim 22  wherein the thrombin concentration is in a range of about 5,000 IU to about 50,000 IU per ml of rehydrated microsphere gel, inclusive. 
     
     
         26 . The hemostatic composition of  claim 20 , wherein the hemostatic composition, when fully hydrated, remains flowable for at least 90 minutes. 
     
     
         27 . A hemostatic composition delivery device comprising a syringe, wherein the syringe contains the hemostatic composition of  claim 20 . 
     
     
         28 . The hemostatic composition delivery device of  claim 27 , further comprising a second syringe and a diluent. 
     
     
         29 . The hemostatic composition delivery device of  claim 28 , wherein thrombin is present in the diluent. 
     
     
         30 . The hemostatic composition delivery device of  claim 29 , wherein the diluent is or contains plasma. 
     
     
         31 . The hemostatic composition delivery device of  claim 28 , wherein the second syringe and the syringe containing the hemostatic composition are interconnected. 
     
     
         32 . The hemostatic composition delivery device of  claim 31 , wherein the syringes are interconnected by a male/female luer lock system. 
     
     
         33 . The hemostatic composition of  claim 20 , wherein the wetting agent and the suspending agent are present in a ratio of microspheres:the wetting agent and suspending agent of 3:1 to 60:1 (w/w). 
     
     
         34 . A hemostatic composition delivery device comprising a first syringe and a second syringe, wherein the first syringe comprises a dry powder hemostatic composition comprising:
 a plurality of porous cross-linked gelatin microspheres;   a wetting agent; and   a suspending agent;   wherein the porous cross-linked gelatin microspheres have a diameter from about 50 μm to about 500 μm, inclusive, when fully hydrated, and wherein the porous cross-linked gelatin microspheres contain pores having a pore diameter from about 15 μm to about 25 μm, inclusive,   wherein the suspending agent is carboxymethylcellulose.   
     
     
         35 . The hemostatic composition delivery device of  claim 34 , wherein the second syringe comprises a diluent comprising thrombin. 
     
     
         36 . The hemostatic composition delivery device of  claim 35 , wherein
 the thrombin has a concentration in a range of about 1,000 IU to about 5,000 IU per mL of rehydrated microsphere gel and a high level of the thrombin is released from the hemostatic composition to yield a homogenous clot.   
     
     
         37 . The hemostatic composition delivery device of  claim 34 , wherein the hemostatic composition, when fully hydrated, remains flowable for at least 90 minutes. 
     
     
         38 . The hemostatic composition delivery device of  claim 34 , wherein the diluent comprises or is plasma. 
     
     
         39 . The hemostatic composition delivery device of  claim 34 , wherein the second syringe and the first syringe are interconnected. 
     
     
         40 . A kit including a hemostatic composition, the kit comprising:
 a plurality of porous cross-linked gelatin microspheres;   a wetting agent; and   a suspending agent;   wherein the porous cross-linked gelatin microspheres have a diameter from about 50 μm to about 500 μm, inclusive, when fully hydrated, and wherein the porous cross-linked gelatin microspheres contain pores having a pore diameter from about 15 μm to about 25 μm, inclusive,   wherein the suspending agent is carboxymethylcellulose; and   thrombin.