Drug balloon and preparation method thereof

A drug and balloon technology, applied in the field of medical devices, can solve the problems of increasing the risk of vascular tissue inflammation and thrombus occlusion, increasing thrombus occlusion, apoptosis of vascular tissue cells, etc.

Active Publication Date: 2022-06-21
LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to maintain the concentration of paclitaxel that can effectively inhibit endothelial cells and smooth muscle cells for a long time, the initial tissue concentration after implantation of the drug balloon is generally high, and the high concentration of paclitaxel can indeed effectively inhibit the endothelial cells and smooth muscle cells in the early stage after DCB implantation. Endothelial and smooth muscle cells proliferate, but at the same time lead to apoptosis of a large number of vascular tissue cells, trigger inflammation of vascular tissue and increase the risk of thrombus occlusion, and delay the later healing of blood vessels
Especially for paclitaxel in crystalline form, the direct contact between paclitaxel crystals and vascular tissue forms an enriched state of paclitaxel in local vascular tissue, resulting in excessive drug concentration in local vascular tissue, increasing the risk of vascular tissue inflammation and thrombosis

Method used

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  • Drug balloon and preparation method thereof
  • Drug balloon and preparation method thereof
  • Drug balloon and preparation method thereof

Examples

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preparation example Construction

[0026] The preparation method of the above-mentioned pharmaceutical balloon comprises the following steps:

[0027] Step S210 , pretreating the surface of the balloon 1 to make the surface of the balloon 1 hydrophilic and rough.

[0028] In one embodiment, the balloon is a nylon balloon.

[0029] In one embodiment, the pretreatment includes at least one of alcoholization treatment, plasma treatment and etching groove treatment.

[0030] Further, the alcoholization treatment is as follows: at 10°C to 70°C, the balloon 1 is immersed in an aqueous solution of ethanol with a volume concentration of 50% to 99.5% for 5 minutes to 120 minutes, taken out and dried.

[0031]The process parameters of the plasma treatment are as follows: the gas used is at least one of nitrogen, oxygen and argon, the output power is 50W to 2000W, the frequency is 10MHz to 100MHz, the treatment time is 5 seconds to 30 minutes, and the air pressure is 1Pa to 100Pa.

[0032] It can be understood that step...

Embodiment 1

[0091] A peripheral PTA balloon catheter with a balloon size of 4.0 × 40 was selected. In a 10,000-level clean environment, a plasma machine was used to pretreat the surface of the PTA balloon catheter (diameter 4mm, length 40mm, nylon balloon), and plasma pretreatment gas It is a mixture of argon and oxygen, the volume ratio V 氩气 : V 氧气 =1:1, the plasma processing power is 500W, the frequency is 30MHz, the processing time is 10min, and the air pressure is 50Pa.

[0092] The commercially available silane coupling agent KH-602 is used to prepare the treatment solution, and the solvent is a mixed solvent of methanol, ethanol and water for injection. The volume percentage is 17%, the volume percentage of water for injection is 10%, and the volume percentage of glacial acetic acid used as a silane coupling agent hydrolysis catalyst is 1%. Soak the balloon part of the plasma-treated balloon catheter into the treatment solution, slowly take out the balloon from the solution after ...

Embodiment 2

[0096] In this example, a peripheral PTA balloon catheter with a balloon size of 4.0×40 is selected. In a 10,000-level clean environment, a plasma machine is used to perform surface pretreatment on the PTA balloon catheter (diameter 4mm, length 40mm, nylon balloon). Plasma The pretreatment gas is a mixture of nitrogen and oxygen, with a volume ratio of V 氮气 : V 氧气 =1:2, the plasma processing power is 50W, the frequency is 100MHz, the processing time is 30min, and the air pressure is 50Pa.

[0097] The commercially available silane coupling agent KH-792 is used to prepare the treatment solution. The solvent is a mixed solvent of ethanol, isopropanol and water for injection. The volume percentage of KH-792 in the treatment solution is 1.5%, and the volume percentage of ethanol is 55%. The volume percentage of isopropanol is 33%, the volume percentage of water for injection is 10%, and the volume percentage of glacial acetic acid as a silane coupling agent hydrolysis catalyst is...

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Abstract

The invention discloses a medicine balloon and a preparation method thereof. A drug balloon, comprising a balloon, further comprising a hydrophilic layer formed on the surface of the balloon and a drug layer formed on the surface of the hydrophilic layer, the hydrophilic layer contains a hydrophilic polymer, and the hydrophilic The water polymer is selected from at least one of polyvinylpyrrolidone, polyacrylamide, polyethylene glycol and polyvinyl alcohol, the drug layer contains drug microspheres, and the drug microspheres include drugs and optional degraded polymers. The drug-loaded layer of the drug balloon can be released continuously and stably.

Description

technical field [0001] The invention relates to medical equipment, in particular to a drug balloon and a preparation method thereof. Background technique [0002] With the change of lifestyle and the aging of the population, cardiovascular disease has gradually become a non-communicable disease that seriously endangers human life and health. According to the World Health Organization (WHO) report, the number of deaths from cardiovascular disease in developed countries will increase by 1 million from 2000 to 2020, from 5 million to 6 million. Deaths from cardiovascular disease in low- and middle-income countries will increase by 9 million over this period, from 10 million to 19 million. Therefore, the prevention and treatment of cardiovascular disease has increasingly become the focus of attention of doctors around the world. [0003] Since Swiss experts successfully completed the first human percutaneous transluminal coronary angioplasty (PTCA) in 1977, significant progres...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L29/08A61L29/16
CPCA61L29/085A61L29/16A61M25/1027A61M25/104A61L2300/216A61L2300/416A61L2300/604A61L2300/606A61L2300/622A61M2025/105C08L39/06C08L33/26C08L71/02C08L29/04
Inventor 卢金华龙汉
Owner LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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