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Publication Number
US-10905792-B2
Publication Date
2021-02-02
Expiration Date
Abstract
An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film in which the PEG-CL-LA units are preferably connected by urethane linkages and into a surface of which a fibrinogen-based sealant comprising less than 8 mg/cm2 fibrinogen and less than 10 IU/cm2 thrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.
Core Innovation
The invention is a fibrinogen-based tissue adhesive patch that includes a backing made from a biocompatible polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer (PECALA). The PECALA comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA ratio of 34:2, and PECALA units are connected by isocyanate linkages formed by reaction with hexamethylene diisocyanate.
The tissue adhesive patch further includes a fibrinogen sealant comprising less than 8 mg/cm2 fibrinogen and less than 20 IU/cm2 thrombin incorporated into the PECALA polymer backing. The fibrinogen sealant is incorporated into a surface of the backing to a depth of between 20 μm and 60 μm, and the backing film participates in sealing tissue while the fibrinogen/thrombin primarily attaches the film.
The adhesive patch excludes interpenetrating polymer network, mesh or woven components, non-woven fabric, and any material made by methods of paper-making technology. The described approach includes tuning degradation behavior to obtain a predetermined degradation time of about 10–14 days, with degradation correlated to PECALA formulation parameters such as PEG molecular weight and CL:LA ratio.
Claims Coverage
The document provides one independent claim. It specifies a PECALA-backed fibrinogen sealant tissue adhesive patch with isocyanate-linked PECALA structure, defined fibrinogen and thrombin loading limits, incorporation depth, and exclusions of certain material classes.
PECALA triblock backing with defined PEG and CL:LA and isocyanate linkages
A backing made from a biocompatible polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer (PECALA) comprising PEG having a molecular weight of between 3000 and 3500 and a CL:LA ratio of 34:2, where PECALA units are connected by isocyanate linkages.
Fibrinogen sealant loading incorporated into PECALA backing
A fibrinogen sealant comprising less than 8 mg/cm2 fibrinogen and less than 20 IU/cm2 thrombin incorporated into the biocompatible polymer backing, with the sealant incorporated into a surface of the backing to a depth of between 20 μm and 60 μm.
Exclusion of interpenetrating polymer network, mesh/weave, non-woven fabric, and paper-making materials
The adhesive patch does not include any interpenetrating polymer network; any mesh or woven component; any non-woven fabric; or any material made by methods of paper-making technology.
Isocyanate linkages formed using hexamethylene diisocyanate
The isocyanate linkages are the product of reaction between two biocompatible polymer units and an aliphatic diisocyanate, where the aliphatic diisocyanate is hexamethylene diisocyanate.
Across the independent claim, the coverage centers on a tissue adhesive patch having a PECALA backing with defined PEG molecular weight and CL:LA ratio connected by isocyanate linkages, with a fibrinogen sealant incorporated into the backing surface to a specified depth, while excluding interpenetrating polymer networks and specified fabric/paper-making material categories.
Stated Advantages
Faster degradation behavior described as a predetermined degradation time of about 10–14 days (less than 2 weeks).
Detachment performance is described with a measured detachment force in the range of 1.25–1.75 N/cm2.
Adhesive failure is described as occurring along the interface between the sealant and the substrate.
Documented Applications
Tissue adhesion using a fibrinogen-based tissue adhesive patch for attachment to a substrate and tissue sealing.
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