A drug eluting balloon

A technology of balloons and medicines, applied in the direction of medicine equipment, stents, and other medical equipment, etc., can solve the problems of small applicable population, toxicity, and large limitations, and achieve the effect of firm coating, easy absorption, and prevention of thrombosis

Active Publication Date: 2017-03-29
DONGZHIMEN HOSPITAL OF BEIJING UNIV OF CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the compound drug-eluting balloon of paclitaxel and Uvitamin has been clinically marketed, but there are the following defects: first, as a contrast agent, Uvitamin has certain toxicity and may cause relatively large side effects when used. Yes, when using Uvism, the applicable population is relatively small, especially patients with hyperthyroidism, patients allergic to iodine contrast medium, patients with severe liver and kidney damage, and patients with cardiac insufficiency. The clinical application of capsule is relatively limited

Method used

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  • A drug eluting balloon
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The invention provides a drug-eluting balloon, the surface of the balloon body has a drug coating, and the drug coating composition includes paclitaxel and hirudin with a mass ratio of 1:1. The medicine coating weight of described balloon is 3ug / mm 2 .

[0028] The preparation method of the drug-eluting balloon of the present invention comprises the following steps:

[0029] Step 1, taking paclitaxel and hirudin with a mass ratio of 1:1, adding the hirudin dry powder into methanol at a ratio of 6-8 mg / ml for dissolving, adding paclitaxel in a formula amount after dissolving to prepare a paclitaxel and hirudin solution;

[0030] Step 2: Spray paclitaxel and hirudin solution on the surface of the eluting balloon by vacuum spraying combined with ultrasonic atomization technology. The specific operation is as follows: first spray paclitaxel and hirudin solution to the specified weight range, and then air dry naturally for 10-30 minutes. The drug coating weight of the bal...

Embodiment 2

[0032] The invention provides a drug-eluting balloon, the surface of the balloon body has a drug coating, and the drug coating composition includes paclitaxel and hirudin with a mass ratio of 2:1. The medicine coating weight of described balloon is 3ug / mm 2 .

[0033] The preparation method of the drug-eluting balloon of the present invention comprises the following steps:

[0034] Step 1, take paclitaxel and hirudin with a mass ratio of 2:1, add paclitaxel to methanol at a ratio of 18-20 mg / ml to prepare a paclitaxel solution; add hirudin dry powder to methanol at a ratio of 6-8 mg / ml to dissolve and prepare Hirudin solution; the hirudin solution is prepared by dissolving hirudin dry powder in methanol;

[0035] Step 2: Spray paclitaxel solution and hirudin solution on the surface of the eluting balloon by vacuum spraying combined with ultrasonic atomization technology. The specific operation is as follows: first spray the paclitaxel solution to reach the specified weight ra...

Embodiment 3

[0037] The invention provides a drug-eluting balloon, the surface of the balloon body has a drug coating, and the drug coating composition includes paclitaxel and hirudin with a mass ratio of 3:1. The medicine coating weight of described balloon is 8ug / mm 2 .

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PUM

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Abstract

The invention provides a medicine elution balloon. The surface of the balloon is coated with medicine; the medicine coating comprises a medicine capable of inhibiting endotheliosis and a first medicine in a mass ratio of (0.5 to 20): 1, and the first medicine is one or more of hirudin and hirudin derivatives. Two or more components are smeared on the medicine elution balloon, by utilizing the traditional Chinese medicine compatibility toxicity reducing and efficacy enhancing theory, the blood vessel smooth muscle cell proliferation can be maximally inhibited, the blood vessel endothelialization process is minimally inhibited, and a purpose of effectively treating stenotic pathologic change as well as acute thrombosis, sub-acute thrombosis or late stent thrombosis can be finally achieved.

Description

technical field [0001] The present invention relates to composite drug-eluting balloons. More specifically, the present invention relates to a paclitaxel and hirudin composite drug-eluting balloon. Background technique [0002] Percutaneous coronary intervention (PCI) has become the standard treatment for stenotic coronary artery disease. However, the incidence of short-term and mid-term restenosis after balloon dilatation and traditional stenting is as high as 5%- 60%, which seriously limits the development of PCI. With the in-depth study on the mechanism of restenosis after coronary intervention and the successful development of drug-coated stent (DES), it is possible to prevent restenosis with DES. Even so, there is still a restenosis rate of 10%-20% after DES implantation, and some DES have not even reduced the incidence of major cardiovascular adverse events, and delayed stent thrombosis has become the focus of attention. Drug-eluting balloon (DEB) has the characteri...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F2/82A61M31/00
Inventor 王显
Owner DONGZHIMEN HOSPITAL OF BEIJING UNIV OF CHINESE MEDICINE
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