Processes For Mixing Fibrinogen and Thrombin Under Conditions That Minimize Fibrin Formation While Preserving Fibrin-forming Ability, Compositions Produced by These Processes, and the Use Thereof

摘要

Fibrin Sealant products are used for topical hemostasis and tissue adherence. They are composed of two main reagents, fibrinogen and thrombin. When mixed in solution fibrinogen is converted to fibrin upon the addition of activated thrombin. Therefore typically these two components are stored separately in a lyophilized or liquid state, and mixed, upon or immediately before, application to a patient. While effective, these products require significant preparation that must take place immediately before application, thus delaying treatment and limiting the use of these haemostatic products to the treatment of mild forms of low pressure and low volume bleeding. Attempts to eliminate this delay and expand the usefulness and effectiveness of these products have resulted in products produced by processes that require the separation of these components and their deposition in distinct layers within the product. The processes described herein permit the mixing of fibrinogen and thrombin during product manufacture, without excessive fibrin formation. The resulting ‘pre-mixed’ fibrin sealant material can then be stored in either a frozen or dried state, or suspended in a non-aqueous environment. Activation of the material to form therapeutic fibrin sealant is accomplished by permitting the product to thaw (if frozen) or by the addition of water or other aqueous fluid, including blood, or other bodily fluids, if dried or suspended in a non-aqueous environment. The resulting material can be used to make a product in which a pre-mixed form of activatable fibrin sealant is a desired component.

主权项

1. A haemostatic composition comprising a frozen mixture of fibrinogen and thrombin, with or without Factor XIII, which contains insufficient fibrin to prohibit its effective use as a haemostatic agent, and which further retains the ability to convert sufficient fibrinogen to fibrin upon thawing to provide effective hemostasis.