# US 10,500,304 B2 · Films and methods of manufacture > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,304 B2 - Document ID: US10500304B2 - Status: Granted - Kind: B2 - Application number: 15/725,586 - Filed: 2017-10-05 - Published: 2018-02-01 - Granted: 2019-12-10 - Earliest claimed: 2013-06-21 - Assignees: DePuy Synthes Products, Inc. - Applicants: DePuy Synthes Products, Inc. - Inventors: David A. Armbruster; James Dwyer; Jeffrey Chomyn; Sean H. Kerr - Web page: https://patentgrep.com/patent/US10500304B2 ## CPC - A61L 24/0015: {Medicaments; Biocides} - A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates} - A61B 17/8057: {the interlocking form comprising a thread} - A61B 17/8085: {with pliable or malleable elements or having a mesh-like structure, e.g. small strips (A61B17/8071, A61B17/8076 take precedence)} - A61F 2/30907: {Nets or sleeves applied to surface of prostheses or in cement} - A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)} - A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} - A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - B32B 3/266: {characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12} - A61B 2017/00526: {Methods of manufacturing} - A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body} - A61F 2310/00389: The prosthesis being coated or covered with a particular material - A61F 2310/0097: Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics - A61L 2430/02: for reconstruction of bones; weight-bearing implants - B32B 2535/00: Medical equipment, e.g. bandage, prostheses or catheter - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM ## 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. ## Claims ### Claim 1 A method of forming a biocompatible and implantable multi-layer film for drug delivery comprising: placing a first polymer solution comprising a biodegradable polymer into a mold having a plurality of protrusions extending from a bottom of the mold; urging the first polymer solution around each of the plurality of protrusions such that a meniscus of polymer solution is formed around the plurality of protrusions; placing one or more additional polymer solutions into the mold, the one or more additional polymer solutions comprising a biodegradable polymer, wherein at least one of the first polymer solution or the one or more additional polymer solutions further comprises a drug; and, solidifying the first polymer solution and the one or more additional polymer solutions so as to form a biocompatible and biodegradable multi-layer film configured for implantation, wherein the drug is incorporated within film; wherein the step of solidifying comprises solidifying the meniscus of polymer solution so as form a plurality of raised lips around the plurality of protrusions; wherein a plurality of apertures is formed in the multi-layer film from the protrusions, the plurality of apertures extending completely through the multi-layer film from a first surface to a second surface and wherein each of plurality of the raised lips surrounds a respective aperture of the plurality of apertures. ### Claim 2 (depends on 1) The method of claim 1, 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. ### Claim 3 (depends on 1) The method of claim 1, 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. ### Claim 4 (depends on 1) The method of claim 1, wherein at least one of the first polymer solution or the one or more additional polymer solutions comprises an adhesive layer when solidified. ### Claim 5 (depends on 1) The method of claim 1, 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. ### Claim 6 (depends on 1) The method of claim 1, wherein the drug is dissolved within the multi-layer film. ### Claim 7 (depends on 1) The method of claim 1, wherein the drug is disposed as discrete units within the multi-layer film. ### Claim 8 (depends on 7) The method of claim 7, wherein the drug particles have an average particle diameter under 20 microns. ### Claim 9 (depends on 7) The method of claim 7, wherein the drug particles have an average particle diameter under 10 microns. ### Claim 10 (depends on 1) The method of claim 1, wherein the drug is contained within the first polymer solution. ### Claim 11 (depends on 10) The method of claim 10, wherein the one or more additional polymer solutions form an adhesive layer or a drug controlling layer of the multi-layer film. ### Claim 12 (depends on 1) The method of claim 1, wherein at least one of the first polymer solution or the one or more additional polymer solutions comprises a plurality of drugs. ### Claim 13 (depends on 12) The method of claim 12, wherein the first polymer solution includes a dissolved drug and insoluble drug particles. ### Claim 14 (depends on 1) The method of claim 1, wherein the drug concentration is between about 0.1% to about 13% by weight of the multi-layer film after solidifying. ### Claim 15 (depends on 1) The method of claim 1, wherein the plurality of apertures provide porosity to the multi-layer film in the range of about 5% to about 25% of the total surface area of the multi-layer film; and, wherein the drug comprises an antimicrobial agent.