Compositions and Methods for Hemostasis

Abstract

The present invention relates to water soluble and completely absorbable and/or physiologically degradable hemostatic compositions having a wax or wax-like base effective for use in tamponade hemostasis of bone or cartilage.

1 . A hemostatic composition of putty-like consistency effective for tamponade hemostasis of bone or cartilage comprising a freely water soluble (FWS) non-particulate solid base material and a dissolution retardant or a dispersion accelerant, wherein the time to complete dissolution or dispersion of the composition in vitro is at least 10 times greater than a reference formulation that consists of PEG 1450/PEG 400 90%/10% by weight. 
     
     
         2 . The composition of  claim 1 , comprising as the FWS non-particulate solid base material a surfactant having an HLB less than 20. 
     
     
         3 . The composition of  claim 1 , comprising as the FWS non-particulate solid base material a surfactant having a molecular weight of at least 4000 kilodaltons (kD), and further comprising a softener. 
     
     
         4 . The composition of  claim 1 , further comprising a microporous particulate ceramic material embedded within solid base material and a rapidly hydrating polysaccharide. 
     
     
         5 . The composition of  claim 4 , wherein the microporous particulate ceramic material is present in an amount that is less than 60% by weight of the putty and the polysaccharide is present in an amount that is up to 15% by weight of the putty. 
     
     
         6 . The composition of  claim 1 , further comprising polypropylene oxide. 
     
     
         7 . The composition of  claim 1 , further comprising an absorbent particulate and wherein when the composition is exposed to water the rate of water absorption in the first hour is equal to or exceeds the dissolution of the solid surfactant. 
     
     
         8 . The composition of  claim 1 , further comprising a water absorbing dissolution retardant. 
     
     
         9 . A hemostatic composition of putty-like consistency effective for tamponade hemostasis of bone or cartilage comprising a poorly water soluble (PWS) non-particulate solid base material and a dispersion accelerant, wherein the PWS base material is a water insoluble wax-like material. 
     
     
         10 . A bone substitute composition comprising a rounded, microporous, particulate ceramic suspended in a non-particulate water soluble base. 
     
     
         11 . The composition of  claim 10 , wherein the bone substitute composition is a hand moldable bone substitute comprising a solid surfactant and less than 70% by weight of a biphasic microporous calcium phosphate in the form of rounded granules wherein said granules have a density greater than 2.5 gm/cc.