Tissue substitute multilayer matrix and uses thereof

Inventors

NSEIR MANASSA, Nora • BAHAR, Amir

Assignees

Nurami Medical Ltd

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Publication Number

US-12036330-B2

Patent

Publication Date

2024-07-16

Expiration Date


Abstract

Compositions-of-matter comprising a matrix made of one or more, preferably two or more elastic layers and one or more viscoelastic layer are disclosed. The compositions-of-matter are characterized by high water-impermeability and optionally by self-recovery. Processes of preparing the compositions-of-matter and uses thereof as tissue substitutes or for repairing damaged tissues are also disclosed.

Core Innovation

The invention relates to a composition-of-matter having a multi-layer matrix that includes at least one layer of a viscoelastic polymeric material interposed between two or more layers of an elastic polymeric material. Each of the elastic polymeric material layers is provided in a form of a porous layer of polymeric fibers, and the viscoelastic polymeric material is provided in a form of a continuous polymeric film.

The viscoelastic polymeric material is defined by a glass transition temperature below 0°C and a melting point below 45°C, and each of the polymeric fibers and the viscoelastic polymeric material independently comprises a biocompatible polymer. The elastic and viscoelastic layers are configured in a layered construction where the viscoelastic continuous film is interposed between porous elastic fiber layers.

The layered tissue-substitute compositions are configured to provide tight sealing and water-impermeability while also enabling puncture/suture self-recovery and suturability/stapleability. The layered matrix further includes viscoelastic rheology characterized by loss tangent and shear storage/loss moduli at a specified temperature and frequency, supporting the interposed viscoelastic continuous film function within the multi-layer structure.

Claims Coverage

The partial content provides one independent claim focused on a composition-of-matter multi-layer matrix with an elastic porous-fiber structure and an interposed continuous viscoelastic polymeric film, with temperature-defined viscoelastic polymer parameters and biocompatible polymer requirements.

Multi-layer matrix with interposed continuous viscoelastic film

A composition-of-matter having a multi-layer matrix comprising at least one layer of a viscoelastic polymeric material interposed between two or more layers of an elastic polymeric material, wherein the elastic polymeric layers are porous layers of polymeric fibers and the viscoelastic polymeric material is in a form of a continuous polymeric film.

Viscoelastic polymer temperature limits and biocompatible components

A composition-of-matter wherein the viscoelastic polymeric material has a glass transition temperature below 0°C and a melting point below 45°C, and wherein each polymeric fiber and the viscoelastic polymeric material independently comprises a biocompatible polymer.

Porous elastic polymeric fiber layers

The composition-of-matter wherein each layer of said elastic polymeric material is in a form of a porous layer of polymeric fibers.

Across the independent claim, the key inventive structure is a multi-layer matrix combining porous elastic polymeric-fiber layers with a viscoelastic polymeric material constrained to a continuous polymeric film, with biocompatible polymer composition and specified glass transition and melting point limits.

Stated Advantages

Tight sealing and water-impermeability to prevent water leakage (water-permeability less than 1 ml/hr/cm² at 40 mmHg at the stated conditions).

Puncture/suture self-recovery.

Suturability/stapleability.

Biocompatible multi-layer tissue-substitute configuration for tissue repair.

Documented Applications

Dural repair to prevent cerebrospinal fluid (CSF) leakage.

A medical-device article configured as a patch/tissue substitute for repairing biological tissue by contacting the tissue with the device.

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