Articles of poly(butylene succinate) and copolymers thereof
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.
1. A method of forming an implant comprising the steps of: (a) preparing a polymeric composition
comprising a polymer or copolymer of 1,4-butanediol unit and a succinic acid unit, and a metal catalyst, wherein the metal catalyst comprises scandium, yttrium, titanium, zirconium, vanadium, molybdenum, tungsten, zinc, iron, tin or germanium, and (b) melt processing the polymeric composition to form the implant,
wherein the weight average molecular weight of the polymer or copolymer of 1,4-butanediol unit and the succinic acid unit increases by 1% to 100% during the melt processing of the polymeric composition.
2. The method of claim 1 , wherein the catalyst is present at a level of 0.1 to 1,000 ppm.
3. The method of claim 1 , wherein the implant is formed by a process comprising one of the following melt processing processes: melt extrusion, injection molding, melt foaming, film extrusion, melt blowing, melt spinning, compression molding, lamination, thermoforming, molding, spun-bonding, non-woven fabrication, tube extrusion, fiber extrusion, 3D printing by melt extrusion deposition, fused pellet deposition, fused filament fabrication, and selective laser melting.
4. The method of claim 1 , wherein the polymeric composition is heated to a peak temperature between 150° C. and 250° C. during melt processing.
5. The method of claim 1 , wherein the implant comprises a suture; mesh—including mesh for hernia repair, breast reconstruction, and breast lift; breast implant; tissue scaffold; monofilament fiber; multifilament fiber; non-woven; film; injection molded implant; 3D printed implant; tube; foam screw; pin; clip; clamp; nail; bone plate; bone substitute; tack; suture fastener; rivet; staple; suture anchor; bone anchor; meniscus anchors; meniscal implant; intramedullary rod and nail; joint spacer; interosseous wedge implant; osteochondral repair device; spinal fusion device; spinal fusion cage; bone plug; cranioplasty plug; and plug to fill or cover trephination burr holes.
6. The method of claim 1 , wherein the polymeric composition is melt processed to form a fiber, and wherein the fiber has one or more of the following properties: (i) tensile strength of 400 MPa to 2,000 MPa, (ii) Young's Modulus of 600 MPa to 5 GPa, and (iii) elongation to break of 10% to 150%.
7. The method of claim 6 , wherein the fiber is knitted, woven, braided, or formed into a mesh.
8. The method of claim 1 , wherein the polymeric composition is heated to a temperature between 100° C. and 250° C. during melt processing.
9. The method of claim 1 , wherein the catalyst is present in the polymeric composition at a level of 0.1-1000 ppm.
10. The method of claim 1 , wherein the metal catalyst comprises a titanium alkoxide.
11. The method of claim 1 , wherein the weight average molecular weight increases during melt processing by 2% to 60%.
12. The method of claim 1 , wherein the weight average molecular weight increases during melt processing by 2% to 31%.