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 melt processed implant comprising a polymeric composition comprising a 1,4-butanediol unit and a succinic acid unit, wherein the implant comprises monofilament fiber wherein the monofilament fiber has a tensile strength between 400 to 2,000 MPa, multifilament fiber having a tenacity greater than 4 gram/denier but less than 14 gram/denier, or a combination thereof, wherein the polymeric composition prior to melt processing further comprises a catalyst.
2. The implant of claim 1 , wherein the polymeric composition has a weight average molecular weight between 75,000 and 250,000 Da.
3. The implant of claim 1 , wherein the catalyst comprises one or more of the following metals: scandium, yttrium, titanium, zirconium, vanadium, molybdenum, tungsten, zinc, iron, tin and germanium.
4. The implant of claim 3 , wherein: (a) the catalyst is a titanium alkoxide; and/or (b) the catalyst is present at a level of 0.1 to 1,000 ppm.
5. The implant of claim 3 , wherein the implant comprises monofilament fiber having a tensile strength greater than 700 MPa.
6. The implant of claim 1 , wherein the implant comprises multifilament fiber having a tenacity of at least 8.3 gram/denier.
7. The implant of claim 1 , wherein the polymeric composition is dried prior to melt processing so that the moisture content of the polymeric composition is less than 0.1 wt %, and the monofilament or multifilament fiber is spun by a method comprising heating to a temperature between 150° C. and 250° C. spinning the fiber from the polymeric composition, and hot drawing the spun fiber in a hot conductive liquid chamber.
8. The implant of claim 1 , wherein the fiber is drawn with a draw ratio of 5-14.
9. The implant of claim 1 , wherein the implant is a fiber, 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, bone screw, interference screw, pin, ACL screw, clip, clamp, nail, medullary cavity nail, bone plate, bone substitute, tack, fastener, suture fastener, rivet, staple, fixation device, 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.
10. The implant of claim 1 , wherein the polymeric composition is melt processed to form a fiber, and wherein the fiber has a Young's Modulus of 600 MPa to 5 GPa.
11. The implant of claim 10 , wherein the fiber is knitted, woven or braided.
12. The implant of claim 11 , wherein the implant is a mesh.