Tissue substitute multilayer matrix and uses thereof

Inventors

NSEIR MANASSA, Nora • BAHAR, Amir

Assignees

Nurami Medical Ltd

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Publication Number

US-11638774-B2

Patent

Publication Date

2023-05-02

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 provides a multi-layer matrix for tissue substitute. The matrix includes at least one layer of a viscoelastic polymeric material interposed between two or more layers of an elastic polymeric material. Each elastic polymeric material layer is in a form of a porous layer of polymeric fibers.

The viscoelastic polymeric material is characterized by at least one of a glass transition temperature below 0°C and a melting point at a temperature below 45°C. The polymeric fibers comprise poly(lactic acid-co-ε-caprolactone), and the viscoelastic polymeric material comprises poly(lactic acid-co-ε-caprolactone).

The described multi-layer tissue-substitute matrix is suturable/staple puncture compatible and is described as optionally having self-recovery after punctures. The matrix is characterized by high water-impermeability, including reduced leakage around suture holes, while providing balanced mechanical properties for suturing and stapling. The document emphasizes performance such as water-permeability less than 1 mL/hr/cm2 at 40 mmHg and leakage reduction even around suture punctures.

Claims Coverage

The independent claim defines a composition-of-matter for a multi-layer matrix. Its inventive features include a viscoelastic polymeric material layer interposed between porous elastic polymeric fiber layers, both using poly(lactic acid-co-ε-caprolactone), and defined thermal and material-form characteristics that further support suturing/stapling puncture performance.

Interposed viscoelastic layer between porous elastic fiber layers

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 each elastic polymeric material layer is in a form of a porous layer of polymeric fibers.

Poly(lactic acid-co-ε-caprolactone) elastic fibers and viscoelastic material

The polymeric fibers comprise poly(lactic acid-co-ε-caprolactone) and the viscoelastic polymeric material comprises poly(lactic acid-co-ε-caprolactone.

Thermal-characterized viscoelastic polymeric material

The viscoelastic polymeric material is characterized by at least one of a glass transition temperature below 0°C and a melting point at a temperature below 45°C.

Overall, the claim coverage centers on a multi-layer matrix where a viscoelastic poly(lactic acid-co-ε-caprolactone) material layer is interposed between two or more porous elastic poly(lactic acid-co-ε-caprolactone) fiber layers, with the viscoelastic layer meeting defined thermal constraints.

Stated Advantages

High water-impermeability, including reduced leakage around suture holes.

Suturing/stapling puncture performance with reduced leakage even around puncture sites.

Balanced mechanical properties for suturing and stapling.

Optionally self-recovery after suturing or staple punctures.

Documented Applications

Dural substitute to prevent cerebrospinal fluid (CSF) leakage.

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