Medicine elution balloon device

A drug and balloon technology, applied in balloon catheters, dilators, catheters, etc., can solve problems such as drugs that do not effectively prevent blood from scouring blood vessel walls.

Active Publication Date: 2014-08-20
SHANGHAI VASOLUTIONS MEDTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The application focuses on the properties that the polymer needs to meet, but there is no effective way to prevent the blood from washing out the drug on the blood vessel wall

Method used

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  • Medicine elution balloon device
  • Medicine elution balloon device
  • Medicine elution balloon device

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Take 5 balloons of 3.0*20 (material: Pebax), the balloon is the balloon 8 in the schematic diagram, the surface of the balloon is 10, scrub it with 75% ethanol, and set aside;

[0057] Dissolve 20mg of PVP (Wm=10000) in isopropanol to prepare a 25wt% solution, soak the above-mentioned balloon in the above-mentioned solution for 1 second, take it out, and dry it by ultraviolet curing to form a dissolvable and releasable bottom layer 12;

[0058] Dissolving 5 mg of PLGA in THF solution to form a solution with a concentration of 50 wt%, soaking the above-mentioned balloon in the solution for 3 seconds, taking it out, curing it with ultraviolet rays and drying it to form the polymer layer 14;

[0059] Soak the above-mentioned balloon again in pure water at 45°C for half an hour until the bottom layer 12 is completely dissolved and "extracted";

[0060] Dissolve 80mg of paclitaxel in 5:1 (volume ratio) acetone and ethanol solution, the prepared concentration is

[0061] 20m...

Embodiment 2

[0063] Take 5 3.0*20 balloons (material: nylon 12), the balloon is the balloon 8 in the schematic diagram, the surface of the balloon is 10, scrub with 75% ethanol, and set aside;

[0064] Dissolve 1g of sodium alginate in water to form a solution with a concentration of 1wt%, immerse the above-mentioned balloon in the above-mentioned solution for 1 second, take it out, and immerse the balloon in 5wt% of CaCl 2 In aqueous solution, Ca 2+ with Na + For exchange, the balloon is taken out, rinsed with deionized water, and dried to form a calcium alginate layer 14;

[0065] Dissolve 80mg of paclitaxel in 5:1 (volume ratio) acetone and ethanol solution, the prepared concentration is

[0066] 20mg / ml solution, spray this solution on the surface of the above-mentioned balloon to form 1μg / mm 2 coated, dried, folded, and packaged, and the resulting balloon was called DEB2.

Embodiment 3

[0068] Take 5 3.0*20 balloons (material: nylon 12), the balloon is the balloon 8 in the schematic diagram, the surface of the balloon is 10, scrub with 75% ethanol, and set aside;

[0069] Dissolving 2mg of polyhexanediol and 0.2mg of propylene glycol in a mixed solution of 10ml of isopropanol and water to form a solution with a concentration of 10-80wt%;

[0070] 8 mg of polyhydroxybutyrate was dissolved in the above solution to form a latex solution;

[0071] Dissolve 40 mg of paclitaxel in the above solution to form a "core-shell" structure;

[0072] Soak the balloon in the above solution to form 3μg / mm 2 coated, dried, folded, and packaged, and the resulting balloon was called DEB3.

[0073] In order to verify the drug loss of the drug balloon during the delivery process, the above-mentioned balloon that was folded and pressed was delivered into the arteries of New Zealand white rabbits weighing about 2.5 kg for flushing. Measure the remaining drug residue rate on the b...

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PUM

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Abstract

A drug-eluting balloon apparatus comprises a balloon surface (10), a polymer layer (14) that comprises drugs or both drugs and additives, and one or multiple drug layers or drug-and-additive layers (16). When a balloon (8) expands at a target lesion, the polymer layer (14) and the drug layers or the drug-and-additive layers (16) fall off the balloon surface (10) and bond on a blood vessel wall. The polymer layer (14) of the drug-eluting balloon apparatus can prevent a great loss of drugs during a pushing process of the balloon (8), and can also protect the drugs bond on the blood vessel wall from being brushed by blood, thus improving a drug utilization rate.

Description

technical field [0001] The invention relates to the field of medical instruments. More specifically, the present invention relates to a drug eluting balloon device. Background technique [0002] Since the 1970s, the treatment of various diseases by introducing interventional medical devices into the vasculature or other lumens (such as esophagus, bile duct, colon or urinary tract, etc.) of human or vertebrate patients has become more and more important. more common. And it has experienced three milestone rapid developments: pure balloon dilatation (PTCA), bare metal stent (BMS) and drug-eluting stent (DES). In particular, the emergence of drug-coated stents has achieved great success in the treatment of vascular stenosis, showing the potential of DES in the treatment of stenosis. However, analysis of clinical results over the years has found that drug-eluting stents may have some adverse effects, such as delayed thrombosis that can lead to death of patients and chronic in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10
CPCA61M29/02A61M25/10A61L29/14A61L29/085A61L29/148A61L29/16A61M25/104A61M2025/105A61M2025/1075C08L5/00
Inventor 郭芳张琳琳张鹏赵林立桂流峰
Owner SHANGHAI VASOLUTIONS MEDTECH CO LTD
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