Balloon catheter

A balloon catheter and balloon technology are applied in the field of drug-eluting balloon catheters and their preparation, which can solve the problems of drug coating damage, need, life-threatening and the like, achieve good mutual compatibility, reduce drug loss, increase The effect of firmness

Inactive Publication Date: 2015-04-15
SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It uses laser drilling or etching technology to make microholes, which not only requires expensive equipment, but also has a complicated process, which is not suitable for industrial production
In addition, although the density of laser drilling is high, microcracks are likely to be generated around the microholes during the laser high-heat fusion microhole process, thereby affecting the mechanical strength of the balloon; etching technology is easy to ionize molecules around the microholes, thereby breaking the polymer chain
[0005] Chinese patent CN101785900A discloses a drug-eluting balloon catheter and its preparation method. The drug-eluting balloon catheter adopts ultraviolet laser grinding to process the outer surface of the balloon, so that the surface of the balloon forms a convex-concave non-planar structure, thereby improving the performance of the balloon. The adsorption capacity of the capsule to the drug can reduce the loss of the drug on the drug balloon during the delivery process. The preparation process of the drug-eluting balloon designed by this method is complicated, and the surface of the balloon is etched with a laser, which is easy to cause damage to the balloon
However, this patent still has the problem of a large amount of loss during the intervention process. In terms of technology, it chooses to spray the coating and then extract it. The extraction process is complicated, and the solvent used for extraction may also cause damage to the drug coating. After extraction, the organic solvent is in the Residue on the balloon is also a problem to be solved, and the flaky drug coating adhered to the blood vessel wall falls off, which may cause the risk of thrombus and even endanger life

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] like figure 1 As shown, take five 3.0mm*20mm (diameter*long) balloon catheters (material: Pebax, block polyetheramide), the balloon is balloon 1 in the schematic diagram, the surface of the balloon is 2, and the balloon catheter is 75 % ethanol to wipe clean and set aside.

[0049] Dissolve 500 mg of paclitaxel and appropriate amount of polyethylene glycol in ethanol to prepare a solution with a drug concentration of 50 mg / ml, and spray this solution on the surface of the balloon to form a drug loading of 5 μg / mm 2 The first drug-loaded coating 4 has a coating thickness of 5 μm.

[0050] Dissolve 200 mg of paclitaxel and appropriate amount of polyethylene glycol in ethanol to prepare a solution with a drug concentration of 20 mg / ml, and spray this solution on the surface of the balloon to form a drug loading of 2 μg / mm 2 The second drug-loaded coating 5 has a coating thickness of 2.5 μm.

[0051] Dried, folded, and packaged, the resulting drug-eluting balloon cathete...

Embodiment 2

[0053] like figure 2 As shown, take five 3.0mm*20mm (diameter*long) balloon catheters (material: Pebax), the balloon is balloon 1 in the schematic diagram, and the surface of the balloon is 2, wipe it clean with 75% ethanol, spare.

[0054] Dissolve 500 mg of paclitaxel and appropriate amount of polyethylene glycol in ethanol to prepare a solution with a drug concentration of 50 mg / ml, and spray this solution on the surface of the balloon to form a drug loading of 5 μg / mm 2 The first drug-loaded coating 4 has a coating thickness of 5 μm.

[0055] Dissolve 200 mg of paclitaxel and appropriate amount of polyethylene glycol in ethanol to prepare a solution with a drug concentration of 20 mg / ml, and spray this solution on the surface of the balloon to form a drug loading of 2 μg / mm 2 The second drug-loaded coating 5 has a coating thickness of 1 μm.

[0056] Dissolve 100 mg of paclitaxel and appropriate amount of polyethylene glycol in ethanol to prepare a solution with a drug ...

Embodiment 3

[0059] like figure 2 As shown, take five 3.0mm*20mm (diameter*long) balloon catheters (material: nylon), the balloon is balloon 1 in the schematic diagram, and the surface of the balloon is 2, wipe it clean with 75% ethanol, spare.

[0060] Plasma cleaning technology was used to clean the debris on the surface of the balloon, and the plasma cleaning time was 15 minutes. The plasma cleaning technology uses argon as the inert gas, the power is 10KHz-100KHz, and the pressure in the working chamber is 0.01atm-0.3atm during cleaning.

[0061] Dissolve 500 mg of rapamycin and appropriate amount of polyethylene glycol-polycaprolactone in ethanol to prepare a solution with a drug concentration of 50 mg / ml, and spray this solution on the surface of the balloon to form a drug loading of 5 μg / mm 2 The first drug-loaded coating 4 has a coating thickness of 10 μm.

[0062] Dissolve 200 mg of rapamycin and an appropriate amount of polyethylene glycol-polycaprolactone in ethanol to pre...

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Abstract

The invention provides a medicine eluting balloon catheter. The medicine eluting balloon catheter has the characteristics of simple structure, simple production process, less loss of medicines in a conveying process, and less medicine residue amount on a balloon after interventional operation. The medicine eluting balloon catheter has a simple structure and is also suitable for large-scale production.

Description

technical field [0001] The invention relates to a medical device, in particular to a drug-eluting balloon catheter for interventional treatment of cardiovascular diseases and a preparation method thereof. technical background [0002] Drug-eluting balloon catheter is a combination of traditional balloon angioplasty and advanced drug-eluting technology. Drug-eluting balloon catheter can release drugs immediately and quickly when the balloon reaches the lesion during interventional treatment, avoiding metal stents and The side effects caused by the long-term retention of polymer carriers are an effective supplement to metal stent angioplasty. There is also a large loss of drugs on the surface of the balloon during the intervention process, resulting in a low drug loading rate in the diseased tissue, and some drugs still adhere to the surface of the balloon after interventional treatment due to the existence of surface binding force (approximately 10-20%), affecting the releas...

Claims

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Application Information

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IPC IPC(8): A61M25/10A61M31/00
Inventor 刘庄申峰袁玲
Owner SHENZHEN SALUBRIS BIOMEDICAL ENG CO LTD
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