Drug-eluting self-retaining sutures and methods relating thereto
Inventors
Gross, Jeffrey M. • Drubetsky, Lev • Naimagon, Alexander • Avelar, Rui • D'Agostino, William L. • Nelson, Kevin Don • Crow, Brent B. • Griffin, Nickolas B.
Assignees
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Publication Number
US-11007296-B2
Publication Date
2021-05-18
Expiration Date
Abstract
A drug-eluting self-retaining suture comprises a filament, a plurality of retainers, and a drug impregnated in or coated on the filament. The shape and distribution of retainers modifies the in vivo release kinetics of the drug. The drug release kinetics may be modified uniformly or region by region. The self-retaining suture may for example be used for reattaching severed nerves and release nerve growth factor or other regeneration accelerating agents into the region of the nerve injury.
Core Innovation
The invention relates to a suture comprising a filament with a core and a sheath, where the sheath includes a plurality of triangular-shaped sheath elements angularly spaced apart about a circumference of the core. Each triangular-shaped sheath element has a base connected to the core and a tip narrower than the base, with the tip extending radially outward from the core.
The filament further includes a first end portion, a second end portion, and a middle portion between the first end portion and the second end portion, and the suture includes a plurality of tissue retainers formed in the filament. The suture is configured to include a therapeutic agent associated with the filament and/or integrated into the filament, specifically triclosan associated with the sheath or Nerve Growth Factor (NGF) integrated into the filament.
The distribution of the therapeutic agent is selected such that at least one of the first end portion, the second end portion, and the middle portion has a higher concentration of the therapeutic agent than another of the first end portion, the second end portion, and the middle portion. The kinetics of release of the therapeutic agent is determined by a distribution of the therapeutic agent on the retainers for triclosan or by at least one of a distribution of the retainers, a density of the retainers, a size of the retainers, a surface area of the retainers, or a shape of the retainers.
For the NGF embodiments, the suture includes first order burst in-vitro release kinetics of the NGF such that at least about 80% of the NGF is released from the suture on day 5 after implantation of the suture. In both therapeutic-agent configurations, the suture comprises at least one non-degradable material selected from polyamide, polyester, polytetrafluoroethylenes, polyether-ester, 4-hydroxybutyrate, polyhydroxylalkanoate, polyurethane, metals, metal alloys, polypropylene, polyethylene, silk, cotton and combinations thereof.
Claims Coverage
The document contains two independent claims that define a suture architecture combining a core/sheath filament with angularly spaced triangular-shaped sheath elements and a plurality of tissue retainers, with claim-specific therapeutic-agent integration and release-kinetics control. Across the independent claims, the inventive features are characterized by the filament sheath geometry, therapeutic agent placement or association, selective higher-concentration regions along filament portions, and release kinetics determined by retainer distribution and geometry.
Angularly spaced triangular-shaped sheath elements forming a filament core/sheath
A filament comprising a core and a sheath, where the sheath comprises a plurality of triangular-shaped sheath elements angularly spaced apart from adjacent triangular-shaped sheath elements about a circumference of the core; each triangular-shaped sheath element has a base connected to the core and a tip narrower than the base with the tip extending radially outward from the core.
Therapeutic agent distribution with higher concentration across filament portions
A therapeutic agent configuration in which at least one of the first end portion, the second end portion and the middle portion has a higher concentration of the therapeutic agent than another of the first end portion, the second end portion, and the middle portion.
Triclosan associated with the sheath and release kinetics determined by triclosan distribution on retainers
Triclosan associated with the sheath, where kinetics of release of the triclosan from the suture is determined by a distribution of the triclosan on the retainers, a density of the retainers, a size of the retainers, a surface area of the retainers and a shape of the retainers.
NGF integrated into the filament with in-vitro first order burst release performance
Nerve Growth Factor (NGF) integrated into the filament, where kinetics of release of the NGF from the suture is determined by at least one of a distribution of the retainers, a density of the retainers, a size of the retainers, a surface area of the retainers or a shape of the retainers, and where first order burst in-vitro release kinetics of the NGF is such that at least about 80% of the NGF is released from the suture on day 5 after implantation of the suture.
Non-degradable material selection for the suture
The suture comprises at least one non-degradable material selected from polyamide, polyester, polytetrafluoroethylenes, polyether-ester, 4-hydroxybutyrate, polyhydroxylalkanoate, polyurethane, metals, metal alloys, polypropylene, polyethylene, silk, cotton and combinations thereof.
The claim set covers a suture filament architecture with core/sheath triangular sheath elements and tissue retainers, coupled to controlled release of triclosan or NGF by using selective higher-concentration regions and retainer-geometry-driven release kinetics, with the NGF claim additionally specifying first order burst in-vitro release such that at least about 80% of the NGF is released on day 5 after implantation.
Stated Advantages
Documented Applications
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