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Drugcoated balloon controllable in drug metabolism and preparation method of drugcoated balloon

A drug and balloon technology, applied in the direction of balloon catheters, coatings, catheters, etc., can solve the problems of limiting the therapeutic effect of drug balloons, and achieve the effect of increasing the action cycle and accelerating drug metabolism

Active Publication Date: 2019-10-29
SHANGHAI HEARTCARE MEDICAL TECH CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method adds a layer of slow-release layer. The initial slow-release layer needs to be dissolved first. During this period, there is no drug metabolism, that is, there is no drug effect in the early postoperative period, which will limit the therapeutic effect of the drug balloon.

Method used

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  • Drugcoated balloon controllable in drug metabolism and preparation method of drugcoated balloon
  • Drugcoated balloon controllable in drug metabolism and preparation method of drugcoated balloon
  • Drugcoated balloon controllable in drug metabolism and preparation method of drugcoated balloon

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Prepare the drug balloon according to the following ratio and method:

[0040] 1. In terms of weight ratio, mix FKBP12 inhibitor drug a: 3%, rapamycin: 1%, water: 5-10%, ethanol: 82-93%, and mix to obtain a rapamycin concentration of 52 mg / ml of liquid medicine;

[0041] 2. Put the liquid medicine into the special ultrasonic spraying equipment, and set the flow rate to 0.01-0.1ml / min;

[0042] 3. Set the speed of the balloon to 5.0rev / s, and use ethanol to wet the surface of the balloon before spraying;

[0043] 4. Adjust the ultrasonic nozzle of the ultrasonic spraying equipment to be 10-30mm away from the balloon, and control the ambient temperature to 18-28°C;

[0044] 5. Turn on the ultrasound, spray back and forth 10 times along the axial direction of the balloon, and finally control the drug-loaded content on the balloon to 4.0ug / mm 2 ;

[0045] 6. The sprayed balloon is placed in an environment of 18-28° C. for 120 minutes to dry.

Embodiment 2

[0047] Prepare the drug balloon according to the following ratio and method:

[0048] 1. In terms of weight ratio, mix FKBP12 inhibitor drug c: 4%, rapamycin: 4%, water: 5-10%, ethanol: 82-93%, and mix to obtain a rapamycin concentration of 52mg / ml of liquid medicine;

[0049] 2. Put the liquid medicine into the special ultrasonic spraying equipment, and set the flow rate to 0.01-0.1ml / min;

[0050] 3. Set the speed of the balloon to 5.0rev / s, and use ethanol to wet the surface of the balloon before spraying;

[0051] 4. Adjust the ultrasonic nozzle of the ultrasonic spraying equipment to be 10-30mm away from the balloon, and control the ambient temperature to 18-28°C;

[0052] 5. Turn on the ultrasound, spray back and forth 10 times along the axial direction of the balloon, and finally control the drug-loaded content on the balloon to 4.0ug / mm 2 ;

[0053] 6. The sprayed balloon is placed in an environment of 18-28° C. for 120 minutes to dry.

Embodiment 3

[0055] Prepare the drug balloon according to the following ratio and method:

[0056] 1. In terms of weight ratio, mix FKBP12 inhibitor drug c: 5%, rapamycin: 1.25%, water: 5-10%, ethanol: 82-93%, and mix to obtain a rapamycin concentration of 52mg / ml of liquid medicine;

[0057] 2. Put the liquid medicine into the special ultrasonic spraying equipment, and set the flow rate to 0.01-0.1ml / min;

[0058] 3. Set the speed of the balloon to 5.0rev / s, and use ethanol to wet the surface of the balloon before spraying;

[0059] 4. Adjust the ultrasonic nozzle of the ultrasonic spraying equipment to be 10-30mm away from the balloon, and control the ambient temperature to 18-28°C;

[0060] 5. Turn on the ultrasound, spray back and forth 10 times along the axial direction of the balloon, and finally control the drug-loaded content on the balloon to 4.0ug / mm 2 ;

[0061] 6. The sprayed balloon is placed in an environment of 18-28° C. for 120 minutes to dry.

[0062] (2) Using drug ...

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Abstract

The invention discloses a drugcoated balloon controllable in drug metabolism and a preparation method of the drugcoated balloon, and relates to the technical field of drugcoated balloons. The drugcoated balloon is prepared through the steps of mixing a drug acceptor protein inhibitor with drugs, water and ethanol to obtain medicinal liquid, spraying the medicinal liquid onto the surface of the balloon back and forth through ultrasonic spraying equipment, and performing drying so as to obtain the drugcoated balloon. The drug acceptor protein inhibitor can also be replaced with a drug metabolismisoenzyme inhibitor, an inducer or a mixture of the drug acceptor protein inhibitor and a drug metabolism isoenzyme inhibitor for preparing the medicinal liquid, and through adjusting the addition quantity of the drug acceptor protein inhibitor and the compounding ratio of the drug acceptor protein inhibitor to drugs further, the drug metabolism period of the drugcoated balloon can be adjusted and controlled. The invention provides the drugcoated balloon controllable in drug metabolism and a simple and efficient preparation method of the drugcoated balloon controllable in drug metabolism, andthe prepared drugcoated balloon has the functions that metabolism can be effectively controllable without destroying the structure of an intima, at the initial stage of using the drugcoated balloon,drug metabolism can be generated to achieve the effect of drug treatment, and the effect period of the drugs can be prolonged through adjusting the formula.

Description

technical field [0001] The invention relates to the technical field of drug balloons, in particular to a drug balloon with controllable drug metabolism and a preparation method thereof. Background technique [0002] Drugcoated Balloon is a drug delivery device sent by a catheter. This concept was proposed by Harvey Wolinsky in 1991 to prevent vascular restenosis after vascular balloon dilation. Its mechanism of action is to inhibit the hyperplasia of the vascular intima by carrying drugs. When the drugs coated on the surface of the balloon reach the lesion, the balloon is pressurized and expanded to expand the lesion. This is sustained release, so that the blood vessel wall can fully absorb the drug, thereby inhibiting the occurrence of restenosis. The drug-balloon approach eliminates the need for radiation therapy, polymers or other sustained-release technologies, and allows drug delivery to all areas within the reach of the balloon. [0003] Drug-coated balloon is a new ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61L29/16
CPCA61M25/1029A61M25/104A61L29/16A61M2025/1031A61M2025/105A61L2300/216A61L2300/606A61L2420/02A61L2300/436
Inventor 王国辉张晨朝王君毅
Owner SHANGHAI HEARTCARE MEDICAL TECH CORP LTD
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