Tissue substitute multilayer matrix and uses thereof
Inventors
NSEIR MANASSA, Nora • BAHAR, Amir
Assignees
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Publication Number
US-10478519-B2
Publication Date
2019-11-19
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 tissue-substitute multilayer composition-of-matter configured as a suturable and/or stapleable matrix comprising at least one elastic polymeric material layer and at least one viscoelastic polymeric material layer. The elastic polymeric material is characterized by recovery and, in at least one arrangement, by being in a form of a porous layer of polymeric fibers. The viscoelastic polymeric material layer is characterized by viscoelastic behavior defined using a loss tangent (G3/G2) and/or rheological parameters measured at 10 C and 0.1 Hz.
The matrix targets controlled water-impermeability and thin-sheet construction, including a water-permeability threshold and a thin sheet geometry. The elastic and viscoelastic polymeric layers are selected and characterized using glass transition temperature and/or melting point criteria relative to 40 C, together with quantified viscoelastic parameters at 10 C and 0.1 Hz.
The multilayer structure supports closure-related performance, including self-recovery to close puncture holes while maintaining suturable or stapleable functionality. The disclosure additionally describes medical-device articles-of-manufacture formed from the multilayer composition, and optional surface/additive layers providing adhesion, anti-adhesion, cell growth, and drug-eluting functions.
Claims Coverage
The independent claims cover three main configurations of a multi-layer composition-of-matter. Across the independent claims, the key inventive features are: (i) an elastic porous polymeric-fiber layer combined with a viscoelastic polymeric layer defined by viscoelastic loss tangent and temperature criteria; (ii) a suturable and/or stapleable multilayer matrix with quantified elastic recovery and a specified loss tangent range; and (iii) a suturable and/or stapleable multilayer matrix further constrained by specific rheological and mechanical ranges for elastic and viscoelastic layers, including modulus, elongation, and thermal transitions.
Elastic porous fiber layer combined with viscoelastic loss tangent and temperature criteria
A composition-of-matter comprising a multi-layer matrix having at least one layer of an elastic polymeric material and at least one layer of a viscoelastic polymeric material, where at least one elastic layer is a porous layer of polymeric fibers; the viscoelastic polymeric material comprises a polymer characterized by a glass transition temperature and/or melting point below 40 C; the elastic polymeric material comprises a polymer characterized by a glass transition temperature and/or melting point above 40 C; and the viscoelastic polymeric layer is characterized by a loss tangent (G3/G2) at 10 C and 0.1 Hz in the range 0.01 to 4.
Suturable and/or stapleable multilayer matrix with elastic recovery and constrained viscoelastic loss tangent
A composition-of-matter comprising a multi-layer, suturable and/or stapleable matrix including at least one layer of an elastic polymeric material characterized by a recovery of at least 75% and at least one layer of a viscoelastic polymeric material characterized by a loss tangent (G3/G2) at 10 C and 0.1 Hz in the range 0.02 to 1.
Suturable and/or stapleable multilayer matrix with quantified viscoelastic and elastic mechanical/thermal parameters
A composition-of-matter comprising a multi-layer, suturable and/or stapleable matrix including at least one layer of an elastic polymeric material characterized by a recovery of at least 75% and at least one layer of a viscoelastic polymeric material, where the viscoelastic layer is characterized by at least one of: (a) storage shear modulus (G2) 0.01 to 10 MPa at 10 C and 0.1 Hz; (b) loss shear modulus (G3) 0.0001 to 2 MPa at 10 C and 0.1 Hz; (c) glass transition temperature and/or melting point below 40 C; and (d) loss tangent (G3/G2) at 10 C and 0.1 Hz in the range 0.02 to 1; and where the elastic layer is characterized by at least one of: (a) elastic modulus 1 kPa to 10 MPa as determined in accordance with ASTM international standard D882-12; (b) elongation at failure at least 100%; and (c) glass transition temperature and/or melting point above 40 C.
Across the independent claims, the claimed inventive subject matter is a suturable and/or stapleable multilayer polymeric composition in which elastic and viscoelastic polymeric layers are distinguished by recovery and quantified viscoelastic loss tangent and/or rheological parameters measured at 10 C and 0.1 Hz, together with glass transition and/or melting point criteria relative to 40 C. Additional independent-claim coverage further limits viscoelastic and elastic layers with modulus, elongation at failure, and/or specified storage/loss shear modulus ranges.
Stated Advantages
Provides water-impermeability, including a water-permeability of less than 1 ml·h−1·cm−2 upon exposure to an aqueous liquid at a pressure of 40 mmHg.
Supports closure-related performance, including self-recovery to close puncture holes.
Enables suturable and/or stapleable use via the elastic recovery and recovery-related matrix properties.
Documented Applications
Dura mater repair to prevent cerebrospinal fluid (CSF) leakage, infection, and adhesion.
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