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Films and methods of manufacture

A rate control, flexible body technology, applied in pharmaceutical formulations, prostheses, fixators, etc., can solve the problems of amplification, supervision, economic and logistics burden, etc., and achieve the effect of improving tactile sensation

Active Publication Date: 2016-05-04
DEPUY SYNTHES PROD INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, given the large number, size and shape of implants and other medical devices, the regulatory, economic and logistical burden of providing a coating for each device is substantial
This problem is magnified when considering the use of additional drugs such as pain relievers, antineoplastic agents and growth promoting substances in the coating

Method used

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  • Films and methods of manufacture
  • Films and methods of manufacture
  • Films and methods of manufacture

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0236] Membrane Preparation: Membranes were prepared from a copolymer comprising approximately: 70% glycolic acid, 17% caprolactone, 5% lactic acid, and 8% trimethylene carbonate (US Surgical, North Haven, CT). The copolymer was dissolved in dimethyl sulfoxide (DMSO) at a concentration of 20% by weight and cast as a film on a 20 cm x 20 cm glass plate, or mixed with 5% or 10% gentamicin sulfuric acid and then cast . The cast films were dried in air at 60 °C for at least 12 hours to remove the solvent, then removed from the glass plate and stored under vacuum for further testing. The finished film has a thickness of 0.06±0.01 mm.

[0237] Tensile test: Tensile break test was performed on 10 mm x 80 mm strips cut from cast film according to ASTM D882 at room temperature on an Instron test stand (type 3342) using a tensile rate of 20 mm / s. The initial yield stress obtained by testing at t=0 is as follows Figure 12 As shown, the elongation of the membrane under yield as Figu...

example 2

[0241] In an exemplary embodiment, the implant is tested by implanting it in a sheep. The implant is a metal plate into which a tubular, thin (0.05-0.08mm), transparent polymer sleeve is carefully slid onto the metal plate just before surgical insertion and attachment to the bone. The sleeves are a tight fit and completely cover the metal plate over the entire length, however the sleeves are open at both ends of the plate. The cannula was constructed of a synthetic copolyester (glycolide, caprolactone, trimethylene carbonate, lactide) with 1.5 mm diameter holes equally spaced throughout the cannula. One set of tubes contained triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether) at a concentration of 1%, one set of tubes contained gentamicin at a concentration of 10%, and one set of Tubes contained a combination of triclosan (1%) and gentamicin (10%). Concentrations of gentamicin and triclosan were chosen based on in vitro testing to determine the therapeutic window of each ...

example 3

[0246] In an exemplary embodiment, membrane 10 is fabricated by the following method:

[0247] Determination of water content of gentamicin:

[0248] The water content of gentamicin sulfate powder was measured by the loss on drying method. About 0.5 g of gentamicin was weighed in a glass jar, then heated to 110° C. under vacuum for 3 hours, and then weighed again. The weight loss was recorded as the moisture content, which was used to calculate the percent moisture.

[0249] Solution mixing:

[0250] Weigh 14.69 grams of Gentamicin Sulfate powder to compensate for the percent water content calculated above. This was mixed into 400 g of DMSO solvent in a 1 liter vessel using a paddle stirrer. The mixture was stirred for 30 minutes until the gentamicin was evenly distributed. 100 g of a copolymer comprising glycolic acid, caprolactone, lactic acid and trimethylene carbonate monomers were added to the suspension and the mixing vessel was heated to 65°C. Mixing was continued...

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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.

Description

[0001] Cross references to related patent applications [0002] This application claims the benefit of US Provisional Patent Application 61 / 837,716, filed June 21, 2013, entitled "Films and Methods of Manufacturing," which is hereby incorporated by reference in its entirety. [0003] incorporated by reference [0004] US Patent Application 12 / 089,574, filed April 8, 2008, is a national phase patent application of PCT / US2006 / 040038, filed October 12, 2006, and both patent applications are incorporated herein by reference in their entirety. U.S. Patent Application 13 / 727,682, filed December 27, 2012, claims the benefit of U.S. Provisional Patent Application 61 / 580,679, filed December 28, 2011, entitled "Films and Methods of Manufacturing," and both patent applications are incorporated by reference in their entirety Incorporated into this article. technical field [0005] The present disclosure relates generally to films (eg, polymeric films) and methods of manufacture, and in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/06A61L31/14A61L31/16B32B3/26A61F2/30
CPCA61L31/06A61L31/14A61L31/16A61F2/30907B32B2535/00A61B17/80A61F2002/30677A61B2017/00526A61F2310/00389A61F2310/0097A61L2430/02C08L67/04B32B3/266A61B17/8057A61B17/8085A61K9/7007A61L24/0015
Inventor D.阿尔姆鲁斯特J.德耶J.乔米恩S.H.科尔
Owner DEPUY SYNTHES PROD INC