Polymeric plate bendable without thermal energy and methods of manufacture

Abstract

An implantable plate for providing support to a bone of a subject when affixed thereto includes a polymeric body of a biocompatible polymer having a desired amount of polymer molecule orientation in a first direction so that the plate can be bent to conform with a contour of the bone of the subject. The polymeric body includes a top surface, a bottom surface, and at least one fastener portion. The fastener portion includes a recess and a fastener hold that is configured for receiving a fastener when affixed to the bone of the subject. A method of manufacturing the implantable plate includes: (1) injection molding a biocompatible polymeric composition into a polymeric body within an injection mold; (2) removing the polymeric body from the injection mold; and (3) forming at least one fastener hole within polymeric body.

1 . A molded body for use in preparing an implantable plate, the molded body comprising:
 a polymeric body comprised of biocompatible polymers having a desired amount of polymer molecule orientation, wherein the desired amount of polymer molecular orientation enables the polymeric body to be capable of bending without heat so as to conform to a contour of a bone of a subject, the polymeric body including a fastener hole template configured for being formed into a fastener hole for receiving a fastener, and the polymeric body being substantially devoid of a joint line.   
     
     
         2 . The molded body as in  claim 1 , wherein the polymeric body further includes at least one plate portion in the form of an implantable plate that can be affixed to a broken bone to provide support thereto during healing, the implantable plate portion including at least one recess in substantially a frustoconical shape with at least one fastener hole template on a bottom portion of the at least one recess. 
     
     
         3 . The molded body as in  claim 2 , wherein the biocompatible polymer is comprised of at least one polymer selected from the group consisting of a poly(alpha-hydroxy esters), polylactic acids, polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones, polyesters, polyanydrides, polyphosphazenes, polyester amides, polyester urethanes, polycarbonates, polytrimethylene carbonates, polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates), polyfumarates, polypropylene fumarate, poly(p-dioxanone), polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines, poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids, high-density polyethylenes, ultra-high-density polyethylenes, low-density polyethylenes, polypropylenes, polyacrylates, polymethylmethacrylates, polyethylmethacrylates, polysulfones, polyetheretherketones, polytetrafluoroethylenes, polyurethanes, polystyrenes, polystyrene-co-butadienes, and combinations thereof. 
     
     
         4 . An implantable plate for providing support to a bone of a subject when affixed thereto, the plate comprising:
 a polymeric body comprised of a biodegradable polymer having a desired amount of polymer molecule orientation in a first direction so that the plate can be bent without heat to conform with a contour of the bone of the subject, the polymeric body including:
 at least one fastener portion including a fastener hole defined by a wall, the fastener hole formed by being drilled through the at least one fastener portion so that the at least one fastener portion is substantially devoid of a joint line. 
   
     
     
         5 . The implantable plate as in  claim 4 , further comprising:
 a recess defined by a recess surface adjacent with the fastener hole, the fastener hole being configured for receiving a fastener when affixed to the bone of the subject.   
     
     
         6 . The implantable plate as in  claim 4 , wherein the desired amount of polymer molecule orientation results in a plate that is configured to shrink less than about 6% of an original dimension after being immersed within a fluid maintained 37° C. for 10 days. 
     
     
         7 . The implantable plate as in  claim 4 , wherein the desired amount of polymer molecule orientation results in a plate that can be bent without heat to an angle of less than or about 90 degrees. 
     
     
         8 . The implantable plate as in  claim 7 , wherein the desired amount of polymer molecule orientation results in a plate that can be bent without heat to an angle of less than or about 30 degrees. 
     
     
         9 . The implantable plate as in  claim 7 , wherein the implantable plate can retain substantially the bent angle after being affixed to the bone of the subject for at least 12 weeks. 
     
     
         10 . The implantable plate as in  claim 9 , wherein the implantable plate can retain substantially the bent angle after being affixed to the bone of the subject for at least 6 weeks. 
     
     
         11 . The implantable plate as in  claim 4 , wherein the desired amount of polymer molecule orientation includes less than 40% of the polymer molecules being oriented in substantially one direction. 
     
     
         12 . The implantable plate as in  claim 11 , wherein the desired amount of polymer molecule orientation is from about 10% to about 30% of the polymer molecules being oriented in substantially one direction. 
     
     
         13 . The implantable plate as in  claim 4 , further comprising at least one of a magnesium fiber, micro-porous silicon fiber, nano-porous silicon fiber, organic fiber, or ceramic fiber.