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Drug releasing coatings for medical devices

A medical device and device technology, applied in arterial pulsation system, coated balloon catheter, rapid delivery of therapeutic agents to specific tissues or body cavities to treat diseases, can solve the problems of easy hydrolysis or oxidation, moisture sensitivity, and complications And other issues

Active Publication Date: 2013-01-16
路通医疗股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is further complicated by the large surface area of ​​drug-coated medical devices and exposure to heat, humidity and oxidative states during sterilization
These are especially problematic if the therapeutic drug is moisture sensitive or prone to hydrolysis or oxidation

Method used

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  • Drug releasing coatings for medical devices
  • Drug releasing coatings for medical devices
  • Drug releasing coatings for medical devices

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0284] Preparation of coating solution (if necessary, add not more than 10% by volume of a small amount of water sufficient to dissolve all solutes):

[0285] Formulation 1.1 - Mix 30-90mg rapamycin, 1-2% (based on the weight of rapamycin) butylated hydroxytoluene (BHT), 15-90mg Tween 80, 30-90mg docusate sodium (sulfonate diethylhexyl succinate) and 1-3ml ethanol.

[0286] Formulation 1.2 - Combine 30-90mg rapamycin, 1-2% (based on weight of rapamycin) butylated hydroxyanisole (BHA), 15-90mg Tween 80, 30-90mg docusate sodium (Sodium diethylhexyl sulfosuccinate) and 1-3ml ethanol were mixed.

[0287] Formulation 1.3 - Mix 30-90 mg rapamycin without added BHT or BHA, 15-90 mg Tween 80, 30-90 mg docusate sodium (diethylhexyl sodium sulfosuccinate) and 1-3 ml ethanol .

[0288] Formulation 1.4 - Combine 30-90mg rapamycin, 1-2% (based on the weight of rapamycin) BHA or BHT, 15-90mg Solutol HS 15, 5-30mg sodium lauryl sulfate and 1-3ml ethanol mix.

[0289] Formulation 1.5 - C...

Embodiment B

[0311] Five PTCA balloon catheters (3 mm in diameter and 20 mm in length) were coated using the method described in US Patent Application Publication No. 2010-0055294-A1 , which is hereby incorporated by reference in its entirety. Inflate the PTCA balloon catheter at 1-3 atmospheres. Inflated balloons were loaded, sprayed or dipped into the formulations of Example A (1.1-1.3). Then, the balloons were dried, drug-loaded, sprayed or dipped again until balloons with sufficient amount of drug (3 μg / mm) were obtained. The coated balloons are folded, then repackaged and sterilized for analytical testing. For Formulation 1.1 containing BHT, 79% of rapamycin was recovered; for Formulation 1.2 containing BHA, 100% was recovered; and for Formulation 1.3 without BHT or BHA, 14%-50% was recovered. Antioxidants (BHT or BHA) prevent rapamycin from being oxidized or degraded.

Embodiment C

[0313] Six PTCA balloon catheters (3.5 and 3.0 mm in diameter and 20 mm in length) were inflated at 1-3 atmospheres. The inflated balloons were loaded with formulations 1.1-1.25 in Example A. A sufficient amount of drug (3-4 μg / mm2) was obtained on the balloon. The inflated balloon is folded and allowed to dry. The coated folded balloon is then repackaged, sterilized, and optionally vacuum dried for animal testing.

[0314] step : Insertion of coated PTCA balloon catheters into target sites (LAD, LCX, and RCA) in the coronary vessels of 25-45 lb pigs. The balloon is inflated to about 12 atmospheres of pressure. The overdraw ratio (the ratio of balloon diameter to tube diameter) is about 1.15-1.40. During 30-60 seconds of inflation, the drug is delivered to the target tissue. Then, the balloon catheter is deflated and recovered from the animal. Target vessels were harvested 0.25-24 hours after the procedure. The drug content in the target tissue and the residual drug r...

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Abstract

The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, an antioxidant, and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In some embodiments, the additive is a liquid. In other embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide or ester groups.

Description

[0001] Cross References to Related Applications [0002] This application is a continuation-in-part of Application No. 12 / 121,986, filed May 16, 2008, which is a continuation-in-part of Application No. 11 / 942,452, filed November 19, 2007, claimed on November 20, 2006 U.S. Provisional Application No. 60 / 860,084 filed on January 17, 2007, U.S. Provisional Application No. 60 / 880,742 filed on January 17, 2007, U.S. Provisional Application No. 60 / 897,427 filed on January 25, 2007, February 2007 U.S. Provisional Application No. 60 / 903,529 filed on 26th, U.S. Provisional Application No. 60 / 904,473 filed on March 2, 2007, U.S. Provisional Application No. 60 / 926,850 filed on April 30, 2007, US Provisional Application No. 60 / 981,380, filed October 19, and US Provisional Application No. 60 / 981,384, filed October 19, 2007, the disclosures of which are hereby incorporated by reference. field of invention [0003] Particular embodiments of the present invention relate to coated medical dev...

Claims

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Application Information

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IPC IPC(8): A61L29/14A61L29/16A61L31/14A61L31/16
CPCA61L27/34A61L31/10A61L31/16A61L29/16A61L29/085A61L27/54
Inventor L·王
Owner 路通医疗股份有限公司
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