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Medicine coating balloon, preparation method and medicine coating balloon dilatation catheter

A technology for drug coating and dilating catheters, applied in balloon catheters, catheters, coatings, etc., can solve the problems of drug balloon inhibition of restenosis and short drug release cycle, and achieve long-term restenosis and drug loss. Fewer and smaller gaps

Inactive Publication Date: 2020-06-19
KOSSEL MEDTECH SUZHOU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stable combination between the drug coating and the surface of the balloon can achieve less loss of the drug coating during the delivery of the balloon catheter and reduce the impact on downstream blood vessels; at the same time, the rapid release of the drug to the vascular tissue can achieve more Proportion of drug transfer and adsorption to the target blood vessels to effectively inhibit the excessive proliferation of smooth muscle cells. Currently, the coating structure and patented coating technology of the marketed products are difficult to achieve both these two key properties. Therefore, it is necessary to research and develop a new type of drug Composite coating to achieve a balance of delivery loss and quick release
In addition, the existing technologies rely on the tissue absorption characteristics and crystallinity of the drug itself to control the release of the drug. Compared with the drug stent, the drug release period of the drug balloon is shorter, which is what causes the drug balloon to inhibit restenosis. one of the reasons for the lack of

Method used

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  • Medicine coating balloon, preparation method and medicine coating balloon dilatation catheter
  • Medicine coating balloon, preparation method and medicine coating balloon dilatation catheter

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] A method for producing a drug-coated balloon, comprising the steps of:

[0064] 1) Dissolve paclitaxel, iopromide and lecithin in acetone and water, ultrasonically dissolve until colorless and transparent, and filter to obtain a spray solution. The volume ratio of acetone to water is 9:1, the mass ratio of iopromide to lecithin is 5:1, the mass ratio of paclitaxel to excipients is 5:2, and the drug concentration is 12.5mg / ml.

[0065] 2) Spray the drug solution on the surface of the bare balloon, wherein the ultrasonic power is 1.0W, the flow rate of the drug solution delivered by the syringe pump is 0.1ml / min, the spray temperature is 30°C, the spray pressure is 0.05MPa, and the spray height is 50mm; spray 20 layers.

[0066] 3) Put the sprayed balloon in a vacuum drying oven and treat it at a constant temperature for 5 hours, wherein the temperature is 40°C.

Embodiment 2

[0068] A method for producing a drug-coated balloon, comprising the steps of:

[0069] 1) Dissolve paclitaxel, iopromide, and acetyl tributyl citrate in methanol, ultrasonically dissolve until colorless and transparent, and filter to obtain a spray solution. The mass ratio of iopromide to acetyl tributyl citrate is 8:1, the mass ratio of paclitaxel to excipients is 5:1, and the drug concentration is 20 mg / ml.

[0070] 2) Spray the drug solution on the surface of the bare balloon, wherein the ultrasonic power is 1.8W, the flow rate of the drug solution delivered by the syringe pump is 0.2ml / min, the spray temperature is 30°C, the spray pressure is 0.04MPa, and the spray height is 30mm; spray 15 layers.

[0071] 3) Put the sprayed balloon into a vacuum drying oven and treat it at a constant temperature for 3 hours, wherein the temperature is 40°C.

Embodiment 3

[0073] A method for preparing a drug-coated balloon, comprising the steps of:

[0074] 1) Dissolve paclitaxel, iohexol, and ethyl cellulose in methanol, ultrasonically dissolve until colorless and transparent, and filter to obtain a spray solution. The mass ratio of iohexol to ethyl cellulose is 2:1, the mass ratio of paclitaxel to excipients is 3:1, and the drug concentration is 15 mg / ml.

[0075] 2) Spray the drug solution on the surface of the bare balloon, wherein the ultrasonic power is 1.5W, the flow rate of the drug solution delivered by the syringe pump is 0.2ml / min, the spray temperature is 40°C, the spray pressure is 0.04MPa, and the spray height is 50mm; spray 15 layers.

[0076] 3) The sprayed balloon is placed in a vacuum drying oven, and treated at a constant temperature for 3 hours, wherein the temperature is 40°C.

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Abstract

The invention discloses a medicine coating balloon. The medicine coating balloon comprises a balloon body and a medicine coating covering the surface of the balloon body, wherein the medicine coatingis formed by spraying a medicine spraying solution to the surface of the balloon body; and the medicine spraying solution is obtained by dissolving medicine, a fat-soluble excipient and a hydrophilicexcipient in a solvent. The invention further discloses a preparation method of the medicine coating balloon and a medicine coating balloon dilatation catheter. According to the medicine coating balloon, the firmness of the medicine coating is higher, the granularity of the medicine is small, the medicine loss can be greatly reduced in the medicine balloon crossing and dilatation process, the tissue absorption rate is high, and the medicine utilization rate is increased.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a drug-coated balloon, a preparation method of the drug-coated balloon, and a balloon dilation catheter comprising the drug-coated balloon. Background technique [0002] In recent years, with the rapid development of neuroimaging, catheter technology, materials, and computers, endovascular interventional technology has become increasingly mature in the treatment of vascular diseases, and has been affirmed by doctors and patients for its minimally invasive, safe, and effective features. At present, it has become one of the important treatment methods for vascular diseases. [0003] Balloon angioplasty is an established method of treating vascular disease by physically dilating areas of atherosclerosis, reduced lumen diameter, or narrowing in diseased vessels. Typically, angioplasty is performed using a catheter that is advanced within the circulatory system to the disease...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61L29/08A61L29/14A61L29/16
CPCA61M25/1002A61M25/1029A61L29/085A61L29/08A61L29/16A61L29/14A61L29/146A61L29/148A61M2025/1031A61M2025/105A61M2205/0238A61M2025/1079A61L2300/416A61L2300/604A61L2300/606A61L2420/02C08L1/02C08L71/02A61L2300/802
Inventor 胡清黄俭汪令生王志高胡堃
Owner KOSSEL MEDTECH SUZHOU
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