Films and methods of manufacture

Abstract

Embodiments of the present disclosure are directed to perforated polymer films and methods of making the same. In some embodiments, the films are for use with implantable medical devices. In one embodiment there is a flexible body including a polymer film having a first surface and an opposing second surface, the film having a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by a one of the plurality of raised lips. In one embodiment, the film comprises a single layer, and in another embodiment, the film can comprise a plurality of layers. In certain embodiments, the film can comprise an adhesive layer. In another embodiment, one or more of the layers may be a drug containing layer and/or a rate controlling layer for drug release.

1 . A flexible body comprising:
 a film having a first surface and an opposing second surface, the film having a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by a one of the plurality of raised lips;   wherein the film comprises a plurality of layers,   wherein at least one of the plurality of layers includes a drug containing layer containing a drug, and,   wherein at least one of the plurality of layers includes an adhesive layer.   
     
     
         2 . The flexible body of  claim 1 , wherein the adhesive layer defines one of the first surface and the second surface. 
     
     
         3 . The flexible body of  claim 1 , wherein at least one of the plurality of layers includes a rate controlling layer configured to control a rate release of the drug. 
     
     
         4 . The flexible body of  claim 1 , wherein the film comprises a biodegradable polymer. 
     
     
         5 . The flexible body of  claim 4 , wherein the drug is at least partially insoluble in the polymer. 
     
     
         6 . The flexible body of  claim 1 , wherein the film further comprises one or more biocompatible particles. 
     
     
         7 . The flexible body of  claim 6 , wherein the particles comprise calcium-containing salt particles. 
     
     
         8 . The flexible body of  claim 1 , wherein the film defines a first region having the apertures and a second region devoid of the apertures. 
     
     
         9 . A method of forming a multi-layered film comprising:
 placing a first polymer solution into a mold having a plurality of protrusions extending from a bottom of the mold;   urging the polymer solution around each of the plurality of protrusions;   placing one or more additional polymer solutions into the mold; and,   solidifying the polymer solution;   wherein a multi-layer film having a plurality of apertures is formed.   
     
     
         10 . The method according to  claim 9 , wherein the step of placing one or more additional polymer solutions into the mold occurs prior to the step of urging, such that urging the polymer solution includes urging the first polymer solution and the one or more polymer solutions. 
     
     
         11 . The method according to  claim 9 , wherein the step of solidifying the polymer solution occurs both prior to and after the step of placing one or more additional polymer solutions into the mold. 
     
     
         12 . The method according to  claim 9 , wherein at least one of the first polymer solution or the one or more additional polymer solutions comprises a drug. 
     
     
         13 . The method according to  claim 9 , wherein at least one of the first polymer solution or the one or more additional polymer solutions comprises an adhesive layer when solidified. 
     
     
         14 . The method according to  claim 9 , wherein at least one of the first polymer solution, or the one or more additional polymer solutions comprises a rate controlling layer for drug release when solidified. 
     
     
         15 . A film storage system, for the storage, packaging and/or shipment of a film comprising:
 the flexible body of  claim 1 ; and   a removable non-adhesive backing material placed over the adhesive layer.   
     
     
         16 . A film storage system, for the storage, packaging and/or shipment of a film comprising:
 the flexible body of  claim 1 ; and   a collector configured to collect the film, wherein the film is separable from the collector.   
     
     
         17 . A system for orthopedic treatment comprising:
 an orthopedic medical device; and,   a film fixation system including the flexible body of  claim 1  and a film fixation element.   
     
     
         18 . The system for orthopedic treatment according to  claim 17 , wherein the orthopedic medical device is a bone plate having a bone fixation hole. 
     
     
         19 . The system for orthopedic treatment according to  claim 18 , further comprising a bone having a threaded shaft configured to align with the bone fixation hole. 
     
     
         20 . The system for orthopedic treatment according to  claim 19 , wherein a diameter of the threaded shaft of the bone screw is greater than both a cross-sectional dimension of at least two adjacent apertures and a gap between the at least two adjacent apertures such that the screw shaft is configured to be driven through a region of the film aligned with the bone fixation hole that includes more than one aperture.