Pharmaceutical 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, high concentration of drugs in local vascular tissue, and apoptosis of vascular tissue cells, so as to reduce the risk of local irritation and cell virus, Guaranteed long-term effectiveness, stable and lasting effect of drug release

Active Publication Date: 2019-07-09
LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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  • Summary
  • 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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  • Pharmaceutical balloon and preparation method thereof
  • Pharmaceutical balloon and preparation method thereof
  • Pharmaceutical balloon and preparation method thereof

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preparation example Construction

[0026] The preparation method of the above-mentioned drug 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 and grooving treatment.

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

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

[0032] It can be understood that step S210 can be omitted.

[0033] S...

Embodiment 1

[0091] Select a peripheral PTA balloon catheter with a balloon size of 4.0×40, and use a plasma machine to perform surface pretreatment on the PTA balloon catheter (diameter 4mm, length 40mm, nylon balloon) in a clean environment of 10,000 grades. It is a mixed gas 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] Select the commercially available silane coupling agent KH-602 to prepare the treatment liquid, the solvent is a mixed solvent of methanol, ethanol and water for injection, the volume percentage of KH-602 in the treatment liquid is 2%, the volume percentage of methanol is 70%, ethanol The volume percentage is 17%, the volume percentage of water for injection is 10%, the volume percentage of glacial acetic acid used as the hydrolysis catalyst of the silane coupling agent is 1%, and the above-mentioned components are mixed uniformly to...

Embodiment 2

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

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

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Abstract

The invention discloses a pharmaceutical balloon and a preparation method thereof. The pharmaceutical balloon comprises a balloon, a hydrophilic layer and a drug layer. The hydrophilic layer is formedon the surface of the balloon, and the drug layer is formed on the surface of the hydrophilic layer. The hydrophilic layer comprises a hydrophilic polymer, and the hydrophilic polymer is selected from at least one of polyvinylpyrrolidone, polyacrylamide, polyethylene glycol and polyvinyl alcohol. The drug layer comprises drug microspheres, and each drug microsphere comprises a drug and a degradable polymer covering the drug. The drug carrying layer of the pharmaceutical balloon can release the drugs stably for a long time.

Description

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

Claims

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Application Information

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Patent Type & Authority Applications(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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