Medical device using bioabsorbable material
Inventors
Biadillah, Youssef • Cox, Martijn Antonius Johannes
Assignees
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Publication Number
US-11510782-B2
Publication Date
2022-11-29
Expiration Date
Abstract
Bioabsorbable medical devices such as vascular closures, mitral chorea replacements, and mitral leaflet extensions are provided.
Core Innovation
The invention provides an electrospun mitral leaflet extension prosthesis that includes a bioabsorbable fibrous network configured to be attached directly to a free edge of a native mitral leaflet to act as an extension of the free edge. The bioabsorbable fibrous network is defined by pores with a pore size in between 1 to 300 micrometers that allows cell infiltration and cell ingrowth throughout the thickness of the bioabsorbable fibrous network. The bioabsorbable fibrous network further includes electrospun polymers or a matrix with one or more supramolecular compounds and has a fiber diameter of 1 micrometer to 50 micrometer.
Upon implantation, the bioabsorbable fibrous network is capable of progressively being absorbed by a body and replaced by new tissue growth to replace the bioabsorbable fibrous network. The system is framed around attachment to the native mitral leaflet free edge to create an extension that contributes to coaptation, while supporting cell infiltration and cell ingrowth through the thickness. The disclosed structure is further defined in terms of electrospun material selection, supramolecular compound inclusion, and fibrous geometry parameters.
The disclosed approach includes configuring functional zones for attachment and extension, where an attachment zone attaches to the native mitral leaflet and an extension zone provides additional coaptation material extending beyond the periphery of the attachment zone and/or the native leaflet. The attachment zone includes at least one anchor for attachment to native leaflet material, and the prosthesis can be configured for a posterior mitral leaflet with the extension zone disposed on a concave edge of the attachment zone. Additional refinements include a coefficient of friction below 0.8 for the bioabsorbable fibrous network.
Claims Coverage
The identified independent claim contains four principal inventive feature areas: an electrospun bioabsorbable mitral leaflet extension prosthesis with direct attachment to a native mitral leaflet free edge; pore characteristics enabling cell infiltration and cell ingrowth through thickness; electrospun polymers or a supramolecular-compound matrix with specified fiber diameter; and progressive absorption with replacement by new tissue growth. The dependent claims further refine attachment and extension zones, anchor presence, posterior/concave configuration, and a quantitative coefficient of friction threshold.
Electrospun mitral leaflet extension prosthesis with direct attachment to native mitral leaflet free edge
An electrospun mitral leaflet extension prosthesis comprising a bioabsorbable fibrous network configured to be attached directly to a free edge of a native mitral leaflet to act as an extension of the free edge of the native mitral leaflet.
Pore size enabling cell infiltration and cell ingrowth through thickness
The bioabsorbable fibrous network has pores with a pore size in between 1 to 300 micrometers allowing cell infiltration and cell ingrowth throughout the thickness of the bioabsorbable fibrous network.
Electrospun polymers or supramolecular-compound matrix with defined fiber diameter
The bioabsorbable fibrous network has electrospun polymers or a matrix with one or more supramolecular compounds with a fiber diameter of 1 micrometer to 50 micrometer.
Progressive absorption and replacement by new tissue growth
Upon implantation the bioabsorbable fibrous network is capable of progressively being absorbed by a body and replaced by new tissue growth to replace the bioabsorbable fibrous network.
Attachment zone and extension zone for additional coaptation material
The attachment zone for attaching to a native mitral leaflet and an extension zone providing additional coaptation material extending beyond the periphery of the attachment zone and/or the native leaflet.
Anchors in the attachment zone
The attachment zone includes at least one anchor for attachment of the prosthesis to native leaflet material.
Posterior mitral leaflet configuration with concave-edge disposed extension zone
The prosthesis is configured for a posterior mitral leaflet, with the extension zone disposed on a concave edge of the attachment zone.
Coefficient of friction below 0.8
The bioabsorbable fibrous network has a coefficient of friction below 0.8.
Across the independent claim and its refinements, the coverage centers on a bioabsorbable, electrospun fibrous network that attaches directly to a native mitral leaflet free edge to provide an extension for coaptation. Claim coverage further requires pore sizes that enable cell infiltration and cell ingrowth through thickness, electrospun polymer or supramolecular-compound matrix materials with specified fiber diameter, and progressive absorption with replacement by new tissue growth. Dependent features add attachment/extension zones, anchors, a posterior/concave disposition, and a friction threshold.
Stated Advantages
Allows cell infiltration and cell ingrowth throughout the thickness of the bioabsorbable fibrous network.
Progressively being absorbed by a body and replaced by new tissue growth to replace the bioabsorbable fibrous network.
Provides additional coaptation material for a mitral leaflet extension prosthesis.
Is configured with an attachment zone and anchors for attachment to native leaflet material.
Has a defined coefficient of friction below 0.8.
Documented Applications
Prosthetic mitral leaflet extensions intended to close leaflet gaps and support coaptation by attaching directly to a native mitral leaflet free edge [context described in provided partial content].
Prosthetic mitral chordae replacements using bioabsorbable, load-bearing materials with similar mechanical/degradation/suture-retention targets and adjustable tension [context described in provided partial content].
Bioabsorbable vascular closure devices (VCDs) with load-bearing integrity during healing and absorption to avoid permanent obstruction, enabling possible re-intervention at the same or adjacent access site [context described in provided partial content].
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