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drug coated balloon

A drug coating and balloon technology, applied in coatings, catheters, etc., can solve problems such as the inability to ensure rapid drug absorption, and achieve the effect of prolonging the duration of action and inhibiting the curative effect.

Active Publication Date: 2020-09-25
LIFETECH SCI (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these carriers and additives can usually only ensure that the active drug is released to the vessel wall of the lesion as quickly as possible in a short period of time when the balloon is in contact with the lesion target vessel, and cannot guarantee that the drug released to the inner wall of the vessel is quickly absorbed by the vessel tissue. Not be lost by blood washing; In addition, since there is not enough active drug to penetrate the intima into the media of the vessel, there must not be enough drug to remain in the media of the vessel for a long time to continue to exert its drug effect and inhibit long-term vascular restenosis

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] 11 mg of paclitaxel as the active drug, 17 mg of lauric acid as a penetration enhancer, and 5 mg of hydroxypropyl methylcellulose as a dispersant were mixed with 7 mL of ethanol and 4 mL of purified water to prepare a drug solution. Fold the PTA balloon catheter (size: 4mm in diameter, 40mm in length) into three folds in a class 10,000 clean environment, then drip the drug solution onto the folded wings with a precision syringe in a class 100 clean environment On the surface of the balloon and dry, repeat the drop coating until the drug concentration on the balloon surface reaches 3 μg / mm 2 , dried at room temperature for 24 hours, packaged, and ethylene oxide sterilized to obtain the drug-coated balloon of this embodiment. In this embodiment, the total weight of the carrier is 22 mg, the mass ratio of the active drug to the carrier is 0.5, and the mass ratio of the dispersant to the penetration enhancer in the carrier is 0.29.

Embodiment 2

[0043] 495mg of paclitaxel was used as the active drug, 10mg of isooctyl palmitate was used as a penetration enhancer, and 0.1mg of sodium citrate was used as a dispersant, which was mixed with 20mL of isopropanol to prepare a drug solution. After the balloon of the PTA balloon catheter (4mm in diameter and 40mm in length) was folded into three in a class 10,000 clean environment, the drug solution was drip-coated on the surface of the balloon after the flaps were folded in a class 100 clean environment And dry, repeat drop coating until the drug concentration on the surface of the balloon reaches 0.5 μg / mm 2 , dried at room temperature for 24 hours, packaged, and ethylene oxide sterilized to obtain the drug-coated balloon of this embodiment. In this example, the total weight of the carrier is 10.1 mg, the mass ratio of the active drug to the carrier is 49, and the mass ratio of the dispersant to the penetration enhancer in the carrier is 0.01.

Embodiment 3

[0045] 120mg of paclitaxel as the active drug, 36mg of sodium benzoate as a penetration enhancer, mixed with 10mL of ethanol and 4mL of purified water to prepare a drug solution. Fold the PTA balloon catheter (diameter 4mm, length 40mm) into three folds in a class 10,000 clean environment, and spray the drug solution on the surface of the balloon after the flaps in a class 100 clean environment , so that the drug concentration on the surface of the balloon reaches 2 μg / mm 2 , dried at room temperature for 24 hours, packaged, and ethylene oxide sterilized to obtain the drug-coated balloon of this embodiment. The mass ratio of the active drug to the carrier in this example is 3.33.

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Abstract

A drug-coated balloon, comprising a balloon body and a drug coating covering the surface of the balloon body. The drug coating comprises an active drug and a carrier, the active drug comprising an anti-proliferative drug and the carrier comprising a transdermal enhancer. By using the transdermal enhancer which can promote rapid permeation and absorption of drugs as the carrier, the drug rapidly permeates into tissues at diseased locations after being released, so that the absorption rate of the drug in diseased tissues of vascular systems or other body lumens is improved. The defects that in clinical use, after the drug-coated balloon is placed into a human body, the permeation of the drug to a target lesion location is too slow, and the drug flows away due to high-speed blood flow scouring before being absorbed by blood vessels can be solved. Moreover, due to the fact that the drug quantity absorbed by tissues is improved, a large quantity of drugs can be retained in the tunica media, and the drug can take effect continuously to inhibit long-term restenosis.

Description

technical field [0001] The invention relates to an interventional medical device, in particular to a drug-coated balloon. Background technique [0002] The drug-coated balloon is an interventional device. Its principle is to load the active drug on the surface of the ordinary balloon and deliver it to the target lesion of the blood vessel. After the balloon is inflated and inflated, the drug can fully contact the blood vessel wall, thereby eliminating the target lesion. Long-term stenosis of the site. [0003] In addition to capillaries and lymphatic capillaries, the vessel wall is generally divided into intima, media and adventitia from the lumen to the outside. The intima is the innermost layer of the vessel wall and consists of endothelium and subendothelium. Endothelial cells and placode form a dense, permeable barrier through which fluids, gases, and macromolecules selectively pass through to enter the media. The thickness and composition of the media vary with the t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L29/08A61L29/16
CPCA61L29/08A61L29/16A61L2300/416A61L2300/606A61L2300/802A61L2420/06
Inventor 宋精忠谢琦宗
Owner LIFETECH SCI (SHENZHEN) CO LTD