Tissue substitute multilayer matrix and uses thereof

Inventors

NSEIR MANASSA, Nora • BAHAR, Amir

Assignees

Nurami Medical Ltd

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Publication Number

US-11406730-B2

Patent

Publication Date

2022-08-09

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 an article-of-manufacture comprising a multi-layer, suturable and/or stapleable matrix for tissue sealing and repair. The matrix comprises at least one layer of an elastic polymeric material and at least one layer of a viscoelastic polymeric material, and is characterized as providing high water-impermeability, suturability/stapleability, and self-recovery that seals punctures.

The multi-layer architecture places the viscoelastic polymeric layer in relation to the elastic polymeric layers to achieve puncture sealing and recovery. The viscoelastic polymeric layer is characterized by viscoelastic rheology and/or thermal transitions, including a storage shear modulus, a loss shear modulus, a loss tangent, and/or a glass transition temperature and/or melting point below 40°C.

The elastic polymeric layer is characterized by elastic modulus, elongation at failure, and/or a glass transition temperature and/or melting point above 40°C, and by recovery of at least 75%. The elastic polymeric layers are described as porous fiber structures and the viscoelastic polymeric layer is described as less porous or continuous films.

The layered construction is described as integral and includes examples of multi-layer patch fabrication and resulting performance including water-permeability/leakage under pressure, including around sutures, and mechanical properties with suture retention.

Claims Coverage

The partial content provides one independent claim. The independent claim focuses on a multi-layer suturable and/or stapleable matrix defined by elastic and viscoelastic polymer layers, with recovery and quantified viscoelastic/elastic property ranges.

Multi-layer suturable and/or stapleable matrix with elastic and viscoelastic polymeric layers

An article-of-manufacture comprising a multi-layer, suturable and/or stapleable matrix comprising at least one elastic polymeric material layer characterized by a recovery of at least 75% and at least one viscoelastic polymeric material layer.

Viscoelastic layer characterized by rheology and/or thermal transition below 40°C

A layer of viscoelastic polymeric material characterized by at least one of: a storage shear modulus, a loss shear modulus, a glass transition temperature and/or melting point below 40°C, and a loss tangent.

Elastic layer characterized by modulus, elongation, and thermal transition above 40°C

A layer of elastic polymeric material characterized by at least one of: an elastic modulus, an elongation at failure of at least 100%, and a glass transition temperature and/or melting point above 40°C.

Across the independent claim, the inventive concept is a multi-layer suturable and/or stapleable matrix that combines an elastic polymeric layer and a viscoelastic polymeric layer with defined property criteria.

Stated Advantages

High water-impermeability.

Suturability and/or stapleability.

Self-recovery that seals punctures.

Documented Applications

Dural repair.

Hernia repair.

Wound closure and/or repair, including internal and/or topical wound closure.

Skin closure and/or repair.

Tissue and/or organ sealing to contain bodily fluids or air.

Anastomosis sealing.

Inhibition of post-surgical adhesions between tissues.

Promotion of hemostasis.

Administration of a therapeutically effective agent.

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