Patent US5290552A successfully refreshed from Google Patents.
US5290552A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Surgical adhesive material
Assignee: Novartis Vaccines and Diagnostics Inc
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Filing: 1992-03-23
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Granted: 1994-03-01
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Expires: 2012-03-23
Abstract
Abstract The present invention provides a surgical adhesive comprising, in an aqueous composition, fibrinogen, FXIII, collagen, thrombin, Ca 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.
Inventors
- 👤 David H. Sierra
- 👤 Edward E. Luck
- 👤 Dennis M. Brown
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 16:50
CPC Classifications
A; A61; A61L; A61L24/00; A61L24/04; A61L24/10; A61L24/102; A61L24/0005; A61L24/0047; A61L24/0073; A61L24/0084
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
91 words
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 2+ in an amount sufficient to catalyze polymerization of said fibrinogen to produce a clot.
Claim 2
Dependent Claim
91 words
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 2+ in an amount sufficient to catalyze polymerization of said fibrinogen to produce a clot.
Claim 3
Dependent Claim
22 words
A surgical adhesive according to claim 1, further comprising an antifibrinolytic agent in an amount sufficient to retard degradation of said clot.
Claim 4
Dependent Claim
16 words
A surgical adhesive according to claim 1, further comprising an effective amount of an antimicrobial agent.
Claim 5
Dependent Claim
108 words
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 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.
Claim 6
Dependent Claim
108 words
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 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.
Claim 7
Dependent Claim
21 words
A surgical adhesive according to claim 4, wherein the source of said fibrinogen and FXIII is autologous plasma from said patient.
Claim 8
Dependent Claim
36 words
A surgical adhesive according to claim 4, wherein said collagen is in from about 5 to 50 mg/ml and has at least about a 90% volume content of fibers of a least 5 nm in diameter.
Claim 9
Dependent Claim
38 words
A surgical adhesive according to claim 4, wherein said collagen is in from about 5 to 50 mg/ml and up to about 90% volume content of fibers of from 5 to 10 nm in diameter, and is cross-linked.
Claim 10
Dependent Claim
12 words
A surgical adhesive according to claim 4, further comprising an antifibrinolytic agent.
Claim 11
Dependent Claim
11 words
A surgical adhesive according to claim 4, further comprising a mineral.
Claim 12
Dependent Claim
16 words
A surgical adhesive according to claim 9, wherein said mineral is a naturally occurring calcium phosphate.
Claim 13
Dependent Claim
90 words
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 2+ in at least about 5 mM.
Claim 14
Dependent Claim
90 words
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 2+ in at least about 5 mM.
Claim 15
Dependent Claim
21 words
A surgical adhesive according to claim 11, wherein the source of said fibrinogen and FXIII is autologous plasma from said patient.
Claim 16
Independent Claim
109 words
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 2+ in an amount sufficient to catalyze polymerization of fibrinogen present in said medium, whereby said fibrinogen is polymerized to form said surgical adhesive.
Claim 17
Independent Claim
109 words
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 2+ in an amount sufficient to catalyze polymerization of fibrinogen present in said medium, whereby said fibrinogen is polymerized to form said surgical adhesive.
Claim 18
Dependent Claim
44 words
A method according to claim 13, wherein said collagen is present in from about 10 to 30 mg/ml; said thrombin is present in from about 1 to 500 NIHu/ml, an anti-fibrinolytic agent is present, and said aqueous medium is fibrinogen and Ca 2+ .
Claim 19
Dependent Claim
56 words
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 2+ .
Claim 20
Dependent Claim
56 words
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 2+ .
Claim 21
Dependent Claim
16 words
A kit according to claim 15, wherein said antifibrinolytic agent is present and is ε-amino-n-caproic acid.
Claim 22
Dependent Claim
22 words
A surgical adhesive according to claim 1, further comprising singly or a combination of: (a) growth factors; (b) cytokines; or (c) immunoglobulins.
Claim 23
Dependent Claim
55 words
A surgical adhesive according to claim 1, further comprising singly or a combination of: (a) epithelial, epidemal, fibroblast, osteoblast or mesencymal cells; (b) hepatocytes, pancreatic cells, macrophage, platelets, T-cells, or B-cells; where the cells of groups (a) and (b) are naturally occurring, and (c) cultured modified cells designed to deliver therapeutic or growth enhancing substances.
Claim 24
Dependent Claim
17 words
A surgical adhesive according to claim 1, comprising a biologically active fibrinogen analog in place of fibrinogen.
Claim 25
Dependent Claim
22 words
A surgical adhesive according to claim 1, further comprising in place of thrombin, a biologically active thrombin analog or a reptilase-coagulation catalyst.
Claim 26
Dependent Claim
12 words
A surgical adhesive according to claim I, further s comprising alloplastic materials.
References Cited (Backward Citations)
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