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Coatings for medical devices
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A technology of coating and therapeutic agent, which can be used in coatings, balloon catheters, anti-tumor drugs, etc., and can solve problems such as difficulty in drug delivery
Inactive Publication Date: 2017-02-22
SPECTRANETICS
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[0003] Efficacy of systemic drug therapy in these diseases may be limited by inadequate drug delivery to diseased tissues and / or dose-limiting histotoxic effects in nondiseased tissues
Local delivery of drugs to diseased tissues in body cavity walls can be difficult
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Embodiment 1
[0111] In short, the ballooncatheter is coated as follows. The balloon catheter is taken out of its packaging, the protective sheath is removed, and the balloon is expanded to approximately 3 atmospheres with air. Optionally, pre-condition the balloon catheter (clean with isopropanol, then air-dry and / or argon-plasma treatment). The balloon catheter was dip-coated at 70°F at a 90° angle into the above coating solution to the nominal paclitaxeldose listed in Table 1 below. The balloon catheter was rotated at 58 ± 2 rpm during the coating process. Allow the balloon catheter to dry for 5 minutes to 24 hours, then inspect the balloon, fold, sheath, and sterilize with ethyleneoxide.
[0112] The coating formulation of the present disclosure is prepared according to the above method. The "A" coating solution was serially diluted with a solvent (azeotrope) to produce a "B-D" formulation (see Table 1 below).
[0113] For each of the 12 coating formulations of this example and the re...
Embodiment 2
[0149] Covidien / ev3 NANOCROSS TM A 0.014" balloon catheter (4×40mm) was used in this study.
[0150] The balloon was dip-coated into the 3B coating formulation described above.
[0151] The effects of plasma treatment, balloon cleaning, wetting, and Fr. size on the appearance, integrity and rapid paclitaxel uptake of the coating into the porcine carotid tissue on the experimental bench model in Example 1 were evaluated.
[0152] The devices are divided into eight (8) groups (see sample matrix in Table 5 below).
[0153] Fifty-eight (58) devices were evaluated, with the following parameters changed:
[0154] ●Small 3.5 (Fr) and large 4.5 (Fr) balloon protective sleeves;
[0158] ●Single expansion is relative to multiple expansions.
[0159] Groups A, B, E, and F were cleaned with 99.5% IPA and soni...
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Abstract
A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a ballooncatheter, is coated with a non-durable coating which includes an amphiphilic polymer or copolymer, in embodiments polyethylene glycol, having a substantially water-insoluble therapeutic agent dispersed therein. In some embodiments, the coating may also include iodine. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.
Description
Technical field [0001] The present disclosure provides coatings for medical devices and the delivery of therapeutic agents therefrom. In embodiments, the present disclosure relates to methods and devices for the local delivery of water-soluble or water-insoluble therapeutic agents to the surface of normal or diseased body cavities. Background technique [0002] Sporadic, genetic, environmental and iatrogenic diseases related to significant morbidity and mortality occur in the body cavity walls of the endothelial cell lining and epithelial cell lining. For example, atherosclerosis and postoperative restenosis occur in the arterial wall. Adenocarcinoma, esophageal varices, and bile ductepithelial cancer occur in the gastrointestinal wall. [0003] The efficacy of systemic drug therapy for these diseases may be limited by insufficient drug delivery from diseased tissues and / or dose-limiting tissue toxicity of non-diseased tissues. The local delivery of drugs to diseased tissues in...
Claims
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