Surgical mesh implants containing poly(butylene succinate) and copolymers thereof

Inventors

Williams, Simon F. • Rizk, Said • Martin, David P.

Assignees

Tepha Inc

Abstract

Resorbable implants comprising poly(butylene succinate) and copolymers thereof have been developed. The implants are preferably sterilized, and contain less than 20 endotoxin units per device as determined by the limulus amebocyte lysate (LAL) assay, and are particularly suitable for use in procedures where prolonged strength retention is necessary, and can include one or more bioactive agents. The implants may be made from fibers and meshes of poly(butylene succinate) and copolymers thereof, or by 3d printing, and the fibers may be oriented. Coverings and receptacles made from forms of poly(butylene succinate) and copolymers thereof have also been developed for use with cardiac rhythm management devices and other implantable devices. These coverings and receptacles may be used to hold, or partially/fully cover, devices such as pacemakers and neurostimulators. The coverings and receptacles are made from meshes, webs, lattices, non-wovens, films, fibers, and foams, and contain antibiotics such as rifampin and minocycline.

Core Innovation

The invention is directed to resorbable, sterilizable surgical implant constructs, including a sterile surgical mesh implant. The constructs are made from a polymeric composition comprising a 1,4-butanediol unit and a succinic acid unit, and the polymeric composition is configured to degrade under physiological conditions in vivo while retaining mechanical integrity.

Under physiological conditions, the weight average molecular weight decreases 3% to 15% over a 4-week time period, decreases 20% to 35% over a 12-week time period, or the percent mass loss of the surgical mesh implant is between 0% and 5% over a 12-week period. Alternatively, the burst strength decreases less than 20% at 4 weeks or less than 35% at 12 weeks.

The polymeric composition and implant are further characterized by specific polymer chemistry and structural retention criteria. The mesh includes fibers, and the implant is configured such that mesh dimensions and/or mesh area are retained after in vivo implantation, with shrinkage and/or decrease limited to specified percentages over a defined implantation period.

Claims Coverage

The independent claims are directed to a sterile surgical mesh implant based on a 1,4-butanediol unit and succinic acid unit polymeric composition with specified in vivo degradation and strength-retention criteria, and to a surgical mesh implant where fibers are produced by spinning and drawn at a specified orientation ratio over specified temperatures. Across the independent claims, the inventive features focus on polymer composition chemistry and in vivo performance metrics and sterility, and on fiber production and multi-stage drawing conditions using an orientation ratio in a specified temperature range.

Taken together, the claims define sterile surgical mesh implants based on a 1,4-butanediol/succinic-acid polymeric composition with specified in vivo degradation and strength-retention performance, and further specify that at least some embodiments form mesh fibers by spinning and drawing at an orientation ratio of 6 to 8 across one or more stages within a 50°C to 80°C temperature range.

Stated Advantages

Documented Applications