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Drug eluting balloon catheter and preparation method thereof

A balloon catheter and drug technology, applied in the direction of balloon catheters, catheters, etc., can solve the problems of coating shedding, limiting the use range of devices, and large outer diameters of devices, so as to improve safety, non-toxic safety, and prevent blood washout effect

Pending Publication Date: 2019-03-19
奏申(上海)科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But this method is the same as above, the processing process of the double-layer balloon is very complicated, and after using the double-layer balloon, the outer diameter of the device is bound to be larger than that of the ordinary balloon, and many tortuous lesions may not be able to pass through, which limits the scope of use of the device
At the same time, due to the extremely slow release rate of the polymer coating used, the entire coating needs to be close to the inner wall of the blood vessel for a long time to achieve the therapeutic effect, and the polymer itself is not viscous enough to require the addition of an adhesive, but the adhesive coating itself is Barriers that prevent contact between drugs and the vascular endothelium
At the same time, due to the extremely complex internal environment of the blood vessel, it is difficult to adhere the entire coating to the inner wall of the blood vessel under the continuous washing of the blood flow, and the probability of the coating falling off is extremely high

Method used

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  • Drug eluting balloon catheter and preparation method thereof
  • Drug eluting balloon catheter and preparation method thereof
  • Drug eluting balloon catheter and preparation method thereof

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preparation example Construction

[0027] The second object of the present invention is to provide a method for preparing the above-mentioned drug-eluting balloon catheter, which includes:

[0028] S1. Obtain a coating solution for preparing a dense drug layer.

[0029]In this step, you can directly prepare the coating solution by yourself, or you can directly purchase the prepared coating solution, which is not limited here, but in order to ensure that it meets the above requirements for drug-eluting balloon catheters, the coating solution can be evenly attached On the surface of the balloon body, it is easy to form. In a preferred embodiment of the present invention, the mass concentration of the active drug in the coating solution is 1:500g / ml-1:50g / ml, such as 1:500g / ml, 1: 400g / ml, 1:350g / ml, 1:300g / ml, 1:250g / ml, 1:200g / ml, 1:150g / ml, 1:100g / ml or 1:60g / ml, etc. The mass ratio of the active drug to the carrier in the dense drug layer is 20:1-1:2, for example, the mass ratio of the active drug to the carr...

Embodiment 1

[0041] A drug-eluting balloon catheter made by the following method:

[0042] 100mg of paclitaxel, 40mg of iohexol, and 10ml of absolute ethanol were prepared as a coating solution, and the coating solution was inhaled into an airtight syringe matched with an ultrasonic atomizing sprayer.

[0043] Process 3525 balloon body (diameter 3.5mm, effective length 25mm), the inner diameter is 0.70mm, the outer diameter is the balloon tube of 1.10mm (being the mixture of Pebax and Nylon12, wherein Pebax content is 80%, Nylon12 content is 20%, weight) into the balloon forming machine, and start the multi-stage balloon forming program. The forming machine will automatically use the drawing speed of 1.0-10mm / s and the heating temperature of 50°C-125°C in the 8 programs set in advance. The balloon tube starts the balloon body molding process. Here, the parameters of the balloon molding machine are different from those of common dilatable balloons. The molding temperature is 5°C higher tha...

Embodiment 2

[0047] A drug-eluting balloon catheter made by the following method:

[0048] 80mg of paclitaxel, 40mg of iopamidol and 13ml of tetrahydrofuran were prepared into a coating solution, and the coating solution was inhaled into the airtight syringe matched with the ultrasonic atomizing sprayer.

[0049] The 3512 balloon body (diameter 3.5mm, effective length 12mm) was obtained according to the method of Example 1, the front end of the 3512 balloon body was folded into 3 wings, and the folded balloon body was filled with clean compressed air with a pressure of 2.5Atm and used a micro The hemostatic clip seals the proximal inflation port.

[0050] Use an ultrasonic atomization spraying machine to spray the front end of the balloon body. After each spraying, perform an air-drying process on the front end of the balloon body. After the previous layer is air-dried, perform the next spraying, and repeat the spraying several times until the balloon The concentration of active drug on t...

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Abstract

The invention relates to a drug eluting balloon catheter and a preparation method thereof, and relates to the field of medical instruments. The balloon catheter comprises a balloon catheter body and acompacting drug layer which covers the outer surface of the balloon catheter body, the raw materials of the compacting drug layer comprise an active drug, a carrier and a solvent, the active drug isselected from at least one of the paclitaxel, paclitaxel derivative, rapamycin and rapamycin derivative, the carrier is selected from at least one of the calcium disodium edetate, iohexol, ioversol, iopamidol, anhydrous glucose, sodium chloride, dextran, sodium lactate, calcium chloride and potassium chloride sequentially, the mass ratio of the active drug to the carrier is 20:1-1:2, the catheteris provided with the compacting drug layer with lower releasing rate, and therefore the losing amount of the active drug in the delivery process is effectively reduced. The method has the advantages of being simple to operate and controllable, the catheter is conveniently produced in large batches, and the compacting level of the compacting drug layer of the drug eluting balloon catheter preparedby means of the method is improved.

Description

technical field [0001] The invention relates to the field of medical devices, and in particular to a drug-eluting balloon catheter and a preparation method thereof. Background technique [0002] For drug-eluting balloon catheters, the drug loss before reaching the lesion site is 0%, and the drug release rate after reaching the target site is 100% is the most ideal state. However, in reality, due to the limitation of design, materials and the complex illusion inside the blood vessel, this situation cannot happen. The drug will be lost during the delivery process, and the drug release rate after reaching the target position cannot reach 100%. Under such circumstances, controlling the loss and release rate during the delivery process is a technical problem for current drug-eluting balloon catheters. [0003] Shanghai Shenqi Medical Technology Co., Ltd. has disclosed a utility model patent "A Drug Balloon and Balloon Catheter", CN205041957U. The protection is under the wings t...

Claims

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Application Information

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IPC IPC(8): A61M25/10
CPCA61M25/10A61M25/1027A61M2025/105
Inventor 郭利斌李辉高杰柳飞飞杭晨霞孔洋洋
Owner 奏申(上海)科技有限公司
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