Malleable, biodegradable hemostatic agent

Abstract

A malleable, biodegradable hemostatic agent is provided that can be used for mechanical sealing of bleeding bone tissue, as well as a method for forming a malleable, biodegradable hemostatic agent of this type, and a medical implant having a coating that includes a malleable, biodegradable hemostatic agent of this type. The malleable, biodegradable hemostatic agent contains (a) at least one saturated glycerol-1,2,3-tri-fatty acid ester having a melting temperature above 37° C., (b) at least one filling agent present in particulate form, at least in part, and having a melting temperature above 37° C., and (c) at least one compound having a melting temperature not above 37° C. and a solubility at a temperature of 25° C. of less than 50 grams per liter of water.

1 . A malleable, biodegradable hemostatic agent containing the following components:
 (a) at least one saturated glycerol-1,2,3-tri-fatty acid ester having a melting temperature above 37° C.;   (b) at least one filling agent at least partially present in particulate form and having a melting temperature above 37° C.; and   (c) at least one compound having a melting temperature not above 37° C. and a solubility at a temperature of 25° C. of less than 50 grams per liter of water.   
     
     
         2 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein the hemostatic agent has a pH in water at a temperature of 25° C. in a range of 5.0-9.0. 
     
     
         3 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein the hemostatic agent has a pH in water at a temperature of 25° C. in a range of 5.5-8.5. 
     
     
         4 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein component (b) has a solubility at a temperature of 25° C. of less than 50 grams per liter of component (c). 
     
     
         5 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein component (a) is selected from the group consisting of saturated glycerol-1,2,3-tri-fatty acid esters comprising at least one fatty acid residue of 12-28 carbon atoms. 
     
     
         6 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein component (a) is selected from the group consisting of saturated glycerol-1,2,3-tri-fatty acid esters comprising at least one fatty acid residue of 14-24 carbon atoms. 
     
     
         7 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein component (a) is selected from the group consisting of glycerol-1,2,3-tribehenic acid ester, glycerol-1,2,3-tristearic acid ester, and glycerol-1,2,3-tripalmitic acid ester. 
     
     
         8 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein component (b) has a solubility at a temperature of 25° C. of at least 100 grams per liter of water. 
     
     
         9 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein component (b) is selected from the group consisting of polymers of at least one alkylene oxide, copolymers of at least one alkylene oxide, and at lest one calcium compound. 
     
     
         10 . The malleable, biodegradable hemostatic agent according to  claim 9 , wherein component (b) is selected from the group consisting of poloxamers, polyethylene glycols, and poly(propylene glycol-co-ethylene glycol). 
     
     
         11 . The malleable, biodegradable hemostatic agent according to  claim 9 , wherein the calcium compound is selected from the group consisting of calcium carbonate, dolomite, α-tricalcium carbonate, β-tricalcium carbonate, hydroxylapatite, carbonate apatite, octacalcium phosphate, calcium phosphate made amorphous, calcium sulfate dihydrate, and calcium sulfate hemihydrate. 
     
     
         12 . The malleable, biodegradable hemostatic agent according to  claim 1 , wherein component (c) is a saturated fatty acid ester. 
     
     
         13 . The malleable, biodegradable hemostatic agent according to  claim 12 , wherein the saturated fatty acid ester is selected from the group consisting of (i) esters of polyols and at least one fatty acid, (ii) alkyl fatty acid esters, and (iii) esters of polyethers and fatty acids. 
     
     
         14 . The malleable, biodegradable hemostatic agent according to  claim 13 , wherein the saturated fatty acid ester is selected from the group consisting of glycerol-1,2,3-trioctylester, mixed esters of glycerol and caprylic acid and lauric acid, propane-1,2-diol-di-fatty acid esters, and fatty acid esters of 1,3-dihydroxy-2,2-di(hydroxymethyl)propane, lauric acid ethylester, myristic acid methylester, myristic acid ethylester, myristic acid isopropylester, palmitic acid methylester, palmitic acid ethylester, palmitic acid isopropylester, and ethylene glycol fatty acid esters. 
     
     
         15 . The malleable, biodegradable hemostatic agent according to  claim 1 , containing 3-50% by weight of the at least one component (a), 10-80% by weight of the at least one component (b), and 10-50% by weight of the at least one component (c), all % by weight being relative to the total weight of the hemostatic agent. 
     
     
         16 . The malleable, biodegradable hemostatic agent according to  claim 1 , further comprising at least one fibrinolysis inhibitor selected from the group of ε-aminocarbonic acids. 
     
     
         17 . The malleable, biodegradable hemostatic agent according to  claim 1 , further comprising at least one substance selected from the group consisting of antibiotics and antiseptic agents. 
     
     
         18 . A method for forming a malleable, biodegradable hemostatic agent, the method comprising the steps of:
 (a) providing a malleable, biodegradable hemostatic agent according to  claim 1 ;   (b) heating the malleable, biodegradable hemostatic agent to a temperature in a range of 35-40° C.; and   (c) forming the heated malleable, biodegradable hemostatic agent.   
     
     
         19 . The method according to  claim 18 , wherein at least one of the heating and the forming is effected by a hand of a user of the malleable, biodegradable hemostatic agent. 
     
     
         20 . A medical implant having a coating comprising the malleable, biodegradable hemostatic agent according to  claim 1 .