Medical devices containing compositions of poly(butylene succinate) and copolymers thereof
Inventors
Williams, Simon F. • Rizk, Said • Martin, David P. • Limem, Skander • Guo, Kai • Ganatra, Amit • Lopez, German Oswaldo Hohl
Assignees
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Publication Number
US-12151050-B2
Publication Date
2024-11-26
Expiration Date
Abstract
Resorbable implants, coverings and receptacles 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 molding, pultrusion or other melt or solvent processing method. The implants, or the fibers preset therein, may be oriented. These coverings and receptacles may be used to hold, or partially/fully cover, devices such as pacemakers and neurostimulators. The coverings, receptacles and implants described herein, may be made from meshes, webs, lattices, non-wovens, films, fibers, foams, molded, pultruded, machined and 3D printed forms.
Core Innovation
The invention relates to an implant comprising a polymeric composition comprising a 1,4-butanediol unit and a succinic acid unit, characterized by a defined weight average molecular weight. The implant is formed at least in part by melt processing and is a mesh, with mesh forms and textile constructions including monofilament or multifilament fibers and mesh structures such as woven, non-woven, knitted, braid, and mesh configurations.
The disclosure further defines ranges for mechanical and structural properties, including tensile strength, Young’s modulus, elongation, burst strength, suture pullout strength, areal density, thickness, pore size and average pore diameter, Taber stiffness, and tear resistance, in connection with the implant structures. A second aspect provides an implant comprising the same 1,4-butanediol unit and succinic acid unit polymeric composition, further characterized by a weight average molecular weight range and explicitly not being oriented during processing.
The technology emphasizes prolonged strength retention in resorbable implants by using oriented fibers/meshes and oriented films, including porous films, to maintain strength during incubation and implantation. The described implants also maintain low endotoxin content, sterility, and reduced toxicity by avoiding isocyanate-derived polymers and crosslinking agents that could release toxic metabolites.
Claims Coverage
Two independent claims are present, each defining a resorbable polymeric implant based on a succinic acid unit and a 1,4-butanediol unit. Across the independent claims, the coverage focuses on molecular weight constraints, mesh and orientation status, and formation by melt processing.
Polymeric composition with 1,4-butanediol and succinic acid units for a melt-processed mesh implant
An implant comprising a polymeric composition comprising a 1,4-butanediol unit and a succinic acid unit, wherein the polymeric composition has a weight average molecular weight of 75,000 to 250,000 Da, the implant has been formed at least in part by melt processing of the polymeric composition, and the implant is a mesh.
Non-oriented 1,4-butanediol and succinic acid polymeric composition implant
An implant comprising a polymeric composition comprising a 1,4-butanediol unit and a succinic acid unit, wherein the polymeric composition has a weight average molecular weight of 20,000 to 250,000 Da and the polymeric composition has not been oriented during processing of the implant.
Across the two independent claims, the inventive coverage centers on implants made from a polymeric composition defined by 1,4-butanediol and succinic acid units with specified weight average molecular weight ranges, combined with either melt-processing into a mesh implant or an explicit limitation that the polymeric composition has not been oriented during processing.
Stated Advantages
Prolonged strength retention in resorbable implants enabled by oriented fibers, meshes, and oriented films, including porous films.
Oriented fibers retain a high molecular weight fraction after incubation and implantation.
Oriented fibers do not curl and show no pitting or decreased local erosion.
Low endotoxin content, less than about 20 EU/device by LAL, and sterility.
Reduced toxicity by avoiding isocyanate-derived polymers and crosslinking agents that could release toxic metabolites.
High tensile strength and improved degradation and strength retention performance.
Dimensional stability, burst strength retention, stiffness and tissue ingrowth effects, and degradation by weight average molecular weight retention, together with biocompatibility.
Documented Applications
Surgical meshes for repairs, including hernia repair.
Pelvic floor reconstruction, including stress urinary incontinence slings.
Breast reconstruction and mastopexy.
Orthopedic fixation devices, including screws, anchors, and plates.
Cardiac rhythm-management device coverings for pacemakers and neurostimulators.
Optionally antimicrobial or bioactive agent-loaded devices for infection risk reduction.
Surgical mesh use, including hernia repair device, breast reconstruction device, mastopexy implant, sling, ligament or tendon repair device, cardiovascular patch, and a device for lifting tissues.
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