Surgical adhesive material
AssigneeMatrix Pharmaceutical, Inc./Project Hear
InventorsDavid H. Sierra, Edward E. Luck, Dennis M. Brown
Life of this patent
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Abstract
The present invention provides a surgical adhesive comprising, in an aqueous composition, fibrinogen, FXIII, collagen, thrombin, Ca.sup.2+ and optionally, an antifibrinolytic agent. The present adhesive may be formed from the patient's plasma without the use of any added reagents for concentration or isolation of the fibrinogen. Conveniently, the adhesive is formulated as a two-part composition which is mixed together just prior to use.
Claims21
A surgical adhesive useful in treating a patient in need thereof comprising in an aqueous composition:
- (a) fibrinogen and Factor XIII (FXIII);
- (b) collagen in an amount sufficient to enhance the rate of gelatin of the adhesive, said collagen being characterized by being fibrillar, insoluble at a pH greater than about 5, flowable, having substantially the native helical structure of collagen fibrils and capable of causing gelation of the subject adhesive;
- and
- (c) thrombin and Ca.sup.2+ in an amount sufficient to catalyze polymerization of said fibrinogen to produce a clot.
A surgical adhesive useful in treating a patient in need thereof comprising in an aqueous composition:
- (a) fibrinogen and FXIII;
- (b) collagen in an amount sufficient to enhance the rate of gelatin of the adhesive at a concentration of at least about 5 mg/ml, said collagen being characterized by being fibrillar, insoluble at a pH greater than about 5, flowable, having substantially the native helical structure of collagen fibrils and capable of causing gelation of the subject adhesive;
- and
- (c) thrombin and Ca.sup.2+ in an amount in the range of about 1 to 1000 NIHu and sufficient to catalyze polymerization of said fibrinogen to produce a clot.
A surgical adhesive useful in treating a patient in need thereof comprising in an aqueous composition:
- (a) fibrinogen and FXIII;
- (b) from about 10 to 30 mg/ml collagen, said collagen being characterized by being fibrillar, insoluble at a pH greater than about 6, flowable and having substantially the native helical structure of collagen fibrils and capable of enhancing gelation of the subject adhesive;
- (c) about 1 to 500 NIHu/ml thrombin;
- (d) from about 5 to about 30 mg/ml aminocaproic acid;
- and
- (e) Ca.sup.2+ in at least about 5 mM.
A method of making a surgical adhesive for treating a patient in need thereof, said method comprising:
- (a) mixing in an aqueous medium, fibrinogen and Factor XIII with collagen in an amount sufficient to enhance the rate of gelation of said surgical adhesive, said collagen being characterized by being fibrillar, insoluble at a pH greater than about 5, flowable and having substantially the native helical structure of collagen fibrils and capable of enhancing gelation of said medium;
- (b) combining said medium with thrombin and Ca.sup.2+ in an amount sufficient to catalyze polymerization of fibrinogen present in said medium, whereby said fibrinogen is polymerized to form said surgical adhesive.
A kit comprising in a first container, collagen characterized by being fibrillar, insoluble at a pH greater than about 5, flowable and having substantially the native helical structure of collagen fibrils and capable of causing gelation of a surgical adhesive;
- and in a second container, thrombin, optionally combined with an antifibrinolytic agent and Ca.sup.2+.
A surgical adhesive according to claim I, further s comprising alloplastic materials.
Dependencies are inferred from the claim text.