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Drug balloon catheter as well as preparation method and application thereof

A balloon catheter and drug technology, applied in balloon catheters, catheters, coatings and other directions, can solve the problems of reducing the firmness of drug coatings, loosening and loss of drug coatings, etc., so as to improve drug utilization and reduce drug Loss, the effect of increasing the release rate

Pending Publication Date: 2022-08-02
上海畅德医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The drug balloon catheter mainly plays two roles of drug delivery and drug release during use. Among them, during the delivery process of the drug balloon catheter to the vascular lesion, blood flushing and blood vessel wall friction will cause drug loss, and When the balloon is stretched, the drug coating is loosened, which is more likely to be lost with the blood circulation; and when the drug balloon catheter reaches the lesion, the drug cannot be completely released during the short-term expansion of the drug balloon catheter, and at the same time Poor adhesion between drug coating and vessel wall, resulting in poor absorption by vascular tissue and low drug availability
In addition, the size control of drug crystals in the drug coating is difficult and the uniformity is poor, resulting in poor stability of the drug balloon catheter
[0004] CN112535793A discloses a preparation method and application of a drug-coated balloon catheter. The preparation method uses the three-dimensional balloon catheter obtained by inflating treatment as a raw material, and sequentially adopts ultrasonic atomization spraying and fumigation crystallization treatment methods to form The crystal attached to the three-dimensional balloon catheter can obtain a drug-coated balloon catheter to achieve the purpose of improving the utilization rate and release rate of the drug, but the contact between the drug coating and the blood vessel wall only depends on the drug effect, and the viscosity is poor. The absorption rate is not high; and the uniformity of drug crystals obtained by fumigation and purification is poor
Although multi-layer spraying is beneficial to control the supersaturation of the drug solution and the volatilization rate of the solvent, it will reduce the overall firmness of the drug coating; and the solvent vapor treatment under heating will make the drug on the surface of the balloon non-crystallized and then recrystallized Precipitation will completely destroy the binding force between the original drug coating and the balloon body, thus making the drug coating less firm

Method used

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  • Drug balloon catheter as well as preparation method and application thereof
  • Drug balloon catheter as well as preparation method and application thereof
  • Drug balloon catheter as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] This embodiment provides a preparation method of a drug balloon catheter, and the preparation method includes:

[0084] (1) After the balloon catheter 1 is inflated, under ultrasonic conditions, rapamycin and dibutylhydroxytoluene are dissolved in isopropanol to obtain a drug coating solution, wherein the rapamycin in the drug coating solution is The concentration of pyruvate was 25 mg / mL, and the concentration of dibutyl hydroxytoluene was 1.5 mg / mL;

[0085] (2) the drug coating solution obtained in step (1) is applied to the outer surface of the balloon catheter 1 by the method of ultrasonic atomization spraying, and then repeated spraying is carried out after drying, wherein, the process parameters of ultrasonic atomization spraying include: The atomization power is 0.9W, the drainage air flow is 1.0psi, the spraying temperature is 24°C, the spraying humidity is 45%, the spraying flow rate is 0.05mL / min, and the feeding speed of the balloon catheter 1 is 3cm / s , th...

Embodiment 2

[0090] This embodiment provides a preparation method of a drug balloon catheter, and the preparation method includes:

[0091] (1) After the balloon catheter 1 is inflated, under ultrasonic conditions, rapamycin and dibutylhydroxytoluene are dissolved in isopropanol to obtain a drug coating solution, wherein the rapamycin in the drug coating solution is The concentration of pyruvate was 50 mg / mL, and the concentration of dibutyl hydroxytoluene was 5 mg / mL;

[0092] (2) the drug coating solution obtained in step (1) is coated on the outer surface of the balloon catheter 1 by the method of ultrasonic atomization spraying, and then repeated spraying is carried out after drying, wherein, the process parameters of ultrasonic atomization spraying include: The atomization power is 0.8W, the drainage air flow is 0.6psi, the spraying temperature is 30°C, the spraying humidity is 50%, the spraying flow rate is 0.01mL / min, and the feeding speed of the balloon catheter 1 is 0.1cm / s, the...

Embodiment 3

[0097] This embodiment provides a preparation method of a drug balloon catheter, and the preparation method includes:

[0098] (1) After the balloon catheter 1 is inflated, under ultrasonic conditions, rapamycin and dibutylhydroxytoluene are dissolved in isopropanol to obtain a drug coating solution, wherein the rapamycin in the drug coating solution is The concentration of pyruvate was 5 mg / mL, and the concentration of dibutyl hydroxytoluene was 0.05 mg / mL;

[0099] (2) the drug coating solution obtained in step (1) is applied to the outer surface of the balloon catheter 1 by the method of ultrasonic atomization spraying, and then repeated spraying is carried out after drying, wherein, the process parameters of ultrasonic atomization spraying include: The atomization power is 1.2W, the drainage air flow is 1.2psi, the spraying temperature is 20°C, the spraying humidity is 30%, the spraying flow rate is 1mL / min, the feeding speed of the balloon catheter 1 is 5cm / s, The rotati...

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Abstract

The invention provides a medicine balloon catheter as well as a preparation method and application thereof. The medicine balloon catheter comprises a balloon catheter as well as a medicine coating and a phospholipid excipient layer which are sequentially coated on the outer surface of the balloon catheter. The phospholipid excipient layer effectively balances the bonding force among the drug coating, the balloon catheter and the blood vessel wall, drug loss in the conveying process can be reduced, the drug utilization rate can be increased, and the release rate of the drug at the diseased region and the immediate absorption rate of the blood vessel to the drug can be increased; in addition, drug crystals in the drug coating are more uniform in size, and the stability of the drug balloon catheter is higher.

Description

technical field [0001] The invention belongs to the technical field of medical devices, and in particular relates to a drug balloon catheter and a preparation method and application thereof. Background technique [0002] The drug balloon catheter is a rapid exchange PTCA balloon catheter with a drug release balloon system, which is developed on the basis of interventional techniques such as balloon dilatation or balloon angioplasty. The drug balloon catheter is coated with a layer of drugs on the surface of the balloon. After reaching the target lesion site, the drug coating on the surface of the balloon is eluted from the surface of the balloon and released to the blood vessels of the lesion site. At present, methods for coating drug coatings on the surface of balloons include ultrasonic atomization, vacuum spraying, or low-pressure transverse ultrasonic methods. [0003] The drug balloon catheter mainly plays the role of drug delivery and drug release during use. During t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61M25/00A61L29/08A61L29/14A61L29/16
CPCA61M25/10A61M25/1027A61M25/1029A61M25/0009A61M25/0043A61M25/0045A61L29/08A61L29/14A61L29/16A61M2025/105A61L2300/606A61L2420/02A61L2420/08
Inventor 段志邦
Owner 上海畅德医疗科技有限公司
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