Fibrinogen-based tissue adhesive patches
Inventors
Laub, Orgad • Cohn, Daniel • Cohen, Eran • ZAREK, Matthew
Assignees
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Publication Number
US-11071805-B2
Publication Date
2021-07-27
Expiration Date
Abstract
A novel fibrinogen-based tissue adhesive patch is disclosed. The patch comprises a backing made from a non-permeable biocompatible polymer film into which a fibrinogen-based sealant is incorporated. In preferred embodiments of the invention, the biocompatible polymer film comprises units of a biocompatible block copolymer such as a polyethylene glycol-polycaprolactone-DL-lactide copolymer connected by urethane linkages, and the fibrinogen-based sealant comprises fibrinogen, thrombin, and CaCl2. In contrast to similar patches known in the art, the polymer backing serves to seal the tissue to which the patch is applied, and the sealant acts only to bind the patch to the affected tissue. The patch does not include any mesh, woven, or non-woven component. Methods of production and use of the patch are also disclosed.
Core Innovation
The invention relates to a fibrinogen-based tissue adhesive patch having a backing made of a biocompatible polymer film and a fibrinogen sealant. The backing has a specified thickness of about 100–200 µm and is characterized by not comprising an interpenetrating network. The patch does not include any mesh or woven component.
The fibrinogen sealant is incorporated into at least one surface of the biocompatible polymer backing by physically pressing the fibrinogen sealant into the polymer backing surface. The incorporated sealant remains partially exposed on the at least one surface, with an incorporation depth between 20 microns and 60 microns. The polymer backing provides primary tissue sealing and occlusion while fibrinogen binds the patch to tissue upon fluid contact.
A method for producing the patch includes casting a biocompatible polymer film of about 100–200 µm thickness, softening the polymer film, placing the fibrinogen sealant on at least one surface, and pressing to incorporate at least a portion of the fibrinogen sealant into the polymer film to a depth between 20 microns and 60 microns. The production is framed to achieve a patch where sealant is partially exposed at the polymer surface rather than distributed throughout the film or present as free powder.
The document addresses sealing leakage of fluid into or out of a body part, including arterial bleeding, organ tissue bleeding, bile anastomosis, cerebrospinal fluid leak, dura leak, and air leak in damaged lung tissue. Documented examples describe sealing perforations and holes in caecum and liver in rat models, including activation with fluid to support attachment and sealing.
Claims Coverage
The partial content provides two independent claims: one for the fibrinogen-based tissue adhesive patch and one for producing the patch. Across these independent claims, the coverage is driven by a small set of inventive features: a biocompatible polymer film backing with a specified thickness and no interpenetrating network, a fibrinogen sealant incorporated into a polymer surface by physical pressing to a defined penetration depth while remaining partially exposed, exclusion of mesh or woven components, and a production sequence that casts, softens, places sealant, and presses to achieve the defined incorporation depth.
Surface incorporation of partially exposed fibrinogen sealant by pressing
A fibrinogen sealant incorporated into at least one surface of a biocompatible polymer backing to a depth between 20 microns and 60 microns by physically pressing the fibrinogen sealant into the at least one surface such that the fibrinogen sealant remains partially exposed on the at least one surface.
Non-interpenetrating network polymer film backing with defined thickness
A backing comprising a film made of a biocompatible polymer, characterized by a thickness of about 100–200 µm, wherein the backing does not comprise an interpenetrating network.
Patch without mesh or woven component
The tissue adhesive patch does not include any mesh or woven component.
Casting-softening-pressing production to incorporate sealant to target depth
A method comprising casting a polymer film made from a biocompatible polymer of about 100–200 µm thickness, softening the polymer film, placing a fibrinogen sealant on at least one surface, and pressing the polymer film until at least a portion of the fibrinogen sealant is incorporated into the at least one surface to a depth between 20 microns and 60 microns.
Overall, independent claim coverage centers on a patch design where a biocompatible polymer film backing (about 100–200 µm, no interpenetrating network, no mesh or woven component) receives a fibrinogen sealant that is physically pressed into the surface to a defined 20–60 µm incorporation depth while remaining partially exposed, and on a corresponding production method that casts, softens, places sealant, and presses to achieve the same incorporation depth.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Sealing leakage of fluid into or out of a body part using the tissue adhesive patch that activates a fibrinogen sealant on contact with the fluid to attach the polymer backing to the body part and thereby seal it.
Treating arterial bleeding.
Treating organ tissue bleeding.
Treating bile anastomosis.
Treating cerebrospinal fluid leak (CSF/dura leak).
Treating dura leak.
Treating air leak in damaged lung tissue.
Sealing caecum perforations in a rat caecum puncture model.
Sealing liver holes in a rat liver puncture model.
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