US2023158119A1PendingUtilityA1

High concentrated protein compositions for preventing tissue adhesion

Assignee: OMRIX BIOPHARMACEUTICALS LTDPriority: Dec 12, 2018Filed: Jan 12, 2023Published: May 25, 2023
Est. expiryDec 12, 2038(~12.4 yrs left)· nominal 20-yr term from priority
A61K 38/363A61K 38/36A61K 47/183A61K 9/08A61K 47/02A61K 9/06A61K 9/0019A61L 2400/06C12Y 304/21005A61K 2300/00A61L 31/047A61P 7/04A61L 31/046A61K 38/38A61K 38/366A61K 38/4833A61L 31/14A61K 33/06A61L 31/145A61K 47/42A61K 38/37A61P 41/00A61K 38/00
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Claims

Abstract

Disclosed herein is an anti-adhesion kit comprised of: (i) a fibrinogen solution component comprising: fibrinogen at a concentration of about 5 to 25 mg/ml; and free calcium ions at a concentration ranging from 0.1 μM to 1 mM; and (ii) a thrombin component containing thrombin. Further disclosed is an anti-adhesion kit comprised of: (i) a fibrinogen solution component containing fibrinogen at a concentration of 8% to 25% of total protein by weight, and optionally free calcium ions at a concentration ranging from 0.1 μM to 1 mM; wherein a total protein concentration ranges from about 80 to 120 mg/ml; and (ii) a thrombin component containing thrombin. Methods of using the kits e.g., to provide anti-adhesion curable compositions are also disclosed.

Claims

exact text as granted — not AI-modified
1 . An anti-adhesion kit comprising:
 (i) a first container comprising a fibrinogen solution component comprising fibrinogen at a concentration of about 8% to about 25% of total protein by weight, and optionally free calcium ions at a concentration ranging from about 0.1 μM to about 1 mM; wherein a total protein concentration ranges from about 80 to about 120 mg/ml; and   (ii) a second container comprising a thrombin component comprising thrombin.   
     
     
         2 . The anti-adhesion kit of  claim 1 , wherein said thrombin component comprises free calcium ions, optionally at a concentration of about 0.1 μM to about 45 mM, or about 35 mM to about 45 mM. 
     
     
         3 . The anti-adhesion kit of  claim 1 , wherein said thrombin component is devoid of chelating agent. 
     
     
         4 . The anti-adhesion kit of  claim 1 , wherein said fibrinogen in said fibrinogen component is present at a concentration of more than about 7.7 to less than about 17 mg/ml. 
     
     
         5 . The anti-adhesion kit of  claim 1 , wherein each of said fibrinogen component and said thrombin component is devoid of: potassium citrate, ethylenediaminetetraacetic acid (EDTA), ethylene glycol-bis(β-aminoethyl ether)-N,N,N′,N′-tetra-acetic acid (EGTA), and PBS. 
     
     
         6 . The anti-adhesion kit of  claim 1 , wherein the fibrinogen solution component comprises albumin at a concentration of at least 20% of the total proteins by weight. 
     
     
         7 . The anti-adhesion kit of  claim 1 , wherein the fibrinogen solution component comprises albumin at a concentration ranging from 60 to 110 mg/ml. 
     
     
         8 . The anti-adhesion kit of  claim 1 , wherein the fibrinogen is derived from plasma concentrated cryo-precipitate, optionally, a viral inactivated plasma cryo-precipitate. 
     
     
         9 . The anti-adhesion kit of  claim 1 , wherein the fibrinogen solution component further comprises factor XIII at a concentration of at least 1 IU/ml. 
     
     
         10 . The anti-adhesion kit of  claim 1 , wherein the fibrinogen is present in said fibrinogen solution component at a concentration of below 14%, of total protein by weight. 
     
     
         11 . The anti-adhesion kit of  claim 1 , wherein the thrombin component is in the form of a liquid solution, optionally at a concentration ranging from 100 to 300 IU/ml. 
     
     
         12 . The anti-adhesion kit of  claim 1 , wherein said fibrinogen component does not comprises tranexamic acid or aprotinin. 
     
     
         13 . The anti-adhesion kit of  claim 1 , for use in producing an anti-adhesive curable composition, optionally for use in preventing tissue adhesion following invasive procedures selected from post-operative procedures, or laparoscopic procedures, e.g., resolving intestinal obstruction, and abdominal or genecology surgery, optionally wherein the composition is used by spraying or dripping the composition onto a site to be treated. 
     
     
         14 . The anti-adhesion kit of  claim 1 , for use in preventing tissue adhesion.

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