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Coated medical devices comprising a water-insoluble therapeutic agent and an additive

A medical device, water-insoluble technology, applied in the field of medical substances and devices, which can solve the problems of complex, inability to deliver therapeutic agents, etc.

Inactive Publication Date: 2015-02-18
COOK MEDICAL TECH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The delivery of therapeutic agents from coatings in these and other minimally invasive procedures is complicated by the need to have a coating that is durable during delivery and that effectively delivers the therapeutic agent when implanted in an area requiring local treatment
Because the natural biological environment is aqueous, it may happen that a coating containing a water-insoluble therapeutic agent is sufficiently durable during transfer to the intended delivery site, but subsequently fails to deliver the therapeutic agent optimally at that site

Method used

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  • Coated medical devices comprising a water-insoluble therapeutic agent and an additive
  • Coated medical devices comprising a water-insoluble therapeutic agent and an additive
  • Coated medical devices comprising a water-insoluble therapeutic agent and an additive

Examples

Experimental program
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Effect test

preparation example Construction

[0060] In a particular preparation method, an amount of a liquid coating medium as described herein is applied to the surface of an implantable structure of a medical device using a suitable application method (e.g., as discussed above), and removed The solvent, usually by evaporation, forms a TA-releasing layer on the surface. To this end, the solvent may be evaporated under any suitable conditions, including temperature conditions that may be heated, cooled, or ambient (room temperature), and / or pressures that may be atmospheric (i.e., one atmosphere), superatmospheric, or subatmospheric conditions, and / or under different humidity conditions, including reduced humidity conditions (eg, below 30%, or below 20% humidity).

[0061] In other preparation methods, the aqueous solution of the H / D additive and the organic solvent solution of the water-insoluble therapeutic agent can be applied to the surface of the implantable structure of the medical device to be coated shortly befo...

Embodiment 1

[0078] paclitaxel / heparin coated balloon catheter

[0079] Group A : 10.2 mL of water was added to 0.714 g of sodium heparin, and the mixture was placed in a vortex mixing device until the sodium heparin was dissolved. This solution was added dropwise to a solution of 6 g of paclitaxel dissolved in 500 mL of ethanol on a shaking table. The resulting solution was a 2% aqueous ethanol solution containing paclitaxel and sodium heparin in a weight ratio of about 10:1. The solution was added to a Sonotek ultrasonic coating device and spray applied to a cell with a balloon length of 4 cm and an inflated diameter of 7 mm. The outer surface of the 18LP balloon catheter inflates the angioplasty balloon. The coating nozzle was moved relative to the balloon to apply a uniform layer of a mixture of paclitaxel and heparin sodium sulfate having a weight ratio of dry solid paclitaxel:heparin sodium of about 10:1 to the balloon and the solvent was evaporated to form a solid. Continue ...

Embodiment 2

[0082] Dissolution Test of Paclitaxel / Heparin Sodium Coated Balloon Catheters

[0083] Balloon catheters prepared according to Group A in Example 1 were subjected to a paclitaxel dissolution test, compared to similarly prepared balloon catheters, which differed by having a concentration of about 3 μg / mm 2 Paclitaxel-only coating of paclitaxel. Specifically, the coated balloon of the balloon catheter was immersed in a 0.2% w / v solution of hepta(2,6-bis-O-methyl)-β-cyclodextrin under resting conditions at approximately 37°C middle. Samples of the dissolution medium were taken at different exposure times and analyzed to determine the percentage of paclitaxel initially present on the balloon that had been released. The results show faster paclitaxel release from the balloon in the catheter prepared according to Example 1 Group A. After 5 minutes of immersion at rest, the balloons prepared according to Example 1 Group A (10:1 paclitaxel:heparin sodium by weight) released an av...

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Abstract

A medical device includes an implantable structure and a coating layer including a water-insoluble therapeutic agent and one or more additives selected from heparin, heparan sulfate, dextran and dextran sulfate, and physiologically-acceptable salts thereof. The one or more additives can be present in an amount effective to increase the rate of release of the water-insoluble therapeutic agent from the coating layer. The implantable medical device structure can be an expandable structure such as a balloon or stent. Also described are methods of making and using such implantable medical devices and coating layers.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application No. 61 / 644,720, filed May 9, 2012, and US Application No. 13 / 834,339, filed March 15, 2013, both of which are incorporated herein by reference. field of invention [0003] The present invention relates generally to medical substances and devices, and methods of making and using the same. In a particular aspect thereof, the invention relates to a medical device having an implantable structure and a coating comprising a water-insoluble therapeutic agent and one or more agents selected from the group consisting of heparin, heparan sulfate, dextran and sulfuric acid. Additive of dextran and its physiologically acceptable salts. Background of the invention [0004] Local delivery of therapeutic agents is useful in the treatment of many medical conditions. Illustratively, localized delivery of a therapeutic agent within a body vessel and / or to selected porti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61F2/915A61F2/958A61M25/10A61K31/337A61K31/715A61K31/727
CPCA61M2025/109A61M25/1002A61L31/16A61K31/337A61M2025/1004A61L29/085A61M2025/1086A61K9/0019A61K31/727A61F2/915A61L2300/416A61F2/958A61L31/10A61M2025/105A61K31/4523A61L29/16A61P35/00A61P37/06A61P9/10C08L5/02C08L5/10
Inventor J·E·巴比克G·B·雪莉A·R·萨拉萨姆C·格拉贝里A·R·巴内特
Owner COOK MEDICAL TECH LLC
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