Hemostatic Devices with Improved Properties and Methods of Making Same
AssigneeCore Scientific Creations Ltd.
InventorsShani ELIYAHU-GROSS, Yuval YASKIL
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Abstract
Hemostatic devices and methods of making same are disclosed. Disclosed hemostatic devices include biocompatible non-oxidized regenerated cellulose. The disclosed hemostatic devices are effective in providing and maintaining hemostasis in cases of moderate to severe bleeding caused by non-compressional and/or non-tourniquetable injuries, among other things. The disclosed methods enable manufacture of a bioabsorbable, biocompatible, biodegradable carboxymethyl cellulose having high stability and high adherence.
Claims29
A method of making non-oxidized, non-regenerated sodium carboxymethyl cellulose (Na-CMC) comprising:
- alkali treating non-oxidized, non-regenerated Na-CMC by exposing the non-oxidized, non-regenerated Na-CMC to an alkalization agent solution at a first temperature, wherein the alkalization agent solution comprises an alkalization agent, water, and an organic solvent;
- forming an acid solution comprising a monohaloacetic acid;
- forming a saturated solution comprising the alkali-treated non-oxidized, non-regenerated Na-CMC, the alkalization solution, and the acid solution, wherein the saturated solution further comprises sedimentary salt, and has a water to organic solvent ratio up to about 22%;
- dissolving the sedimentary salt by mixing the saturation solution at a second temperature of about 40° C. to about 60° C. for about four hours to about seven hours to form an etherfication solution, wherein the second temperature is higher than the first temperature;
- and
- forming the non-oxidized, non-regenerated Na-CMC in the saturated solution for about two to about twenty four hours at a temperature of about 40° C. to about 60° C., wherein the saturated solution has a water to ethanol ratio up to about 22%.
A hemostatic device comprising:
- non-oxidized, non-regenerated sodium carboxymethyl cellulose (Na-CMC) wherein the non-oxidized, non-regenerated Na-CMC is configured to interact with blood through a hydration process wherein the polymer interacts with a water component of the blood upon dissociation of the at least one counter ion;
- and
- wherein the non-oxidized, non-regenerated Na-CMC has a level of carboxymethyl group substitution of about 0.88;
- and
- wherein the non-oxidized polysaccharide derivative composition comprises at least one carrier form selected from a group consisting of a fabric, sponge, a film, or a foam.
A hemostatic device, comprising:
- non-oxidized, non-regenerated sodium carboxymethyl cellulose (Na-CMC) having a level of carboxymethyl group substitution of about 0.88;
- wherein:
- the non-oxidized, non-regenerated Na-CMC forms a hemodynamic gel when it contacts blood, wherein the Na-CMC is formed by a process comprising:
- an alkali treatment comprising exposing the non-oxidized, non-regenerated Na-CMC to an alkalization agent solution at a first temperature, wherein the alkalization agent solution comprises an alkalization agent, water, and an organic solvent;
- forming an acid solution comprising a monohaloacetic acid;
- forming a saturated solution comprising the alkali-treated non-oxidized, non-regenerated cellulose, the sodium hydroxide solution, and the acid solution, wherein the saturated solution comprises sedimentary salt, and has a water to ethanol ratio up to about 22%;
- dissolving the sedimentary salt by mixing the saturated solution at a second temperature of about 40° C. to about 60° C. for about four hours to about seven hours to form a solution for etherification, wherein the second temperature is higher than the first temperature;
- and
- forming the non-oxidized, non-regenerated Na-CMC in the saturated solution for about two to about twenty four hours at a temperature of about 40° C. to about 60° C., the saturated solution having a water to ethanol ratio up to about 22%.
A hemostatic device comprising:
- non-oxidized, non-regenerated sodium carboxymethyl cellulose (Na-CMC) in the form of a fabric wherein the non-oxidized, non-regenerated Na-CMC is formed from alkali treated, nonoxidized, non-regenerated cellulose washed and adjusted to a neutral pH in a neutralization solution having an adjusted pH between about 4 to about 4.5.
Dependencies are inferred from the claim text.