Self-retaining sutures of poly-4-hydroxybutyrate and copolymers thereof
Inventors
Rizk, Said • Williams, Simon F.
Assignees
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Publication Number
US-11944709-B2
Publication Date
2024-04-02
Expiration Date
Abstract
Absorbable monofilament fibers and self-retaining sutures with high tensile strengths have been developed. The straight pull tensile strengths of the absorbable self-retaining sutures closely approximate, equal or exceed the average minimum knot-pull tensile standards set by the United States Pharmacopeia (USP). These higher strength absorbable self-retaining sutures can therefore be used either without needing to oversize the suture for a given procedure, or by oversizing the self-retaining suture by no more than 0.1 mm in diameter. In one embodiment, the absorbable self-retaining sutures are made from poly-4-hydroxybutyrate or copolymers thereof.
Core Innovation
The invention relates to an absorbable self-retaining suture comprising a monofilament fiber that includes a sheath-core structure and at least one tissue retainer. The core is composed of the same polymer as the sheath, and the sheath, the core, and the at least one tissue retainer each have an indentation hardness, where the indentation hardness of the sheath is higher than the indentation hardness of the core.
In the disclosed suture, the indentation hardness of the at least one tissue retainer is less than the indentation hardness of the sheath and higher than the indentation hardness of the core. The partial content further characterizes high tensile strength absorbable self-retaining sutures using poly-4-hydroxybutyrate (P4HB) or copolymers of P4HB, designed to meet or approximate USP average minimum knot-pull tensile standards.
The partial content links performance to the pronounced sheath-core structure, in which the harder sheath versus a softer core and retainers supports high strength. It also states that the sutures can require little or no oversizing, enabling smaller suture diameters with reduced tissue tunnel size and improved pliability.
Claims Coverage
The independent claim is centered on an absorbable self-retaining suture having a monofilament sheath-core fiber with polymer identity across sheath and core and a tissue retainer with a specific indentation hardness relationship. Overall, the claim coverage includes one independent claim with several refinement elements provided in dependent claims.
Sheath-core monofilament with polymer identity
An absorbable self-retaining suture comprising a monofilament fiber with a sheath-core structure, wherein the core is composed of the same polymer as the sheath.
Tissue retainer indentation hardness relationship
The sheath, the core and at least one tissue retainer each have an indentation hardness, wherein the indentation hardness of the sheath is higher than the indentation hardness of the core, and the indentation hardness of the at least one tissue retainer is less than the indentation hardness of the sheath and higher than the indentation hardness of the core.
Across the independent claim, the core inventive theme is the combination of a monofilament fiber with a sheath-core structure using the same polymer for sheath and core and a tissue retainer whose indentation hardness is positioned between the sheath and the core. Dependent claims further refine the concept with poly-4-hydroxybutyrate (P4HB) or its copolymers, fiber diameter range, and quantified indentation hardness and conditioning constraints.
Stated Advantages
Provides high tensile strength absorbable self-retaining sutures that approximate or equal and in some cases exceed USP average minimum knot-pull standards.
Requires little or no oversizing, enabling use of smaller suture diameters.
Enables reduced tissue tunnel size.
Improves pliability.
Documented Applications
Surgical applications including plastic surgery/lift procedures.
Surgical applications including wound closure.
Surgical applications including breast reconstruction/mastopexy.
Surgical applications including ligament/tendon repair.
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