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Protection-sleeve-carrying paclitaxel drug balloon and preparation method thereof

A technology for protecting sleeves and paclitaxel, which is applied in the fields of drug devices, medical science, and other medical devices, can solve problems such as hidden dangers in safety, toxicity of paclitaxel, and few applications, so as to reduce medical costs, facilitate industrial production, The effect of inhibiting vascular restenosis

Active Publication Date: 2014-12-17
BIOVAS (WUHAN) MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] (1) Simple balloon dilation, which limits its use due to the high restenosis rate (39%-67%);
[0005] (2) Intravascular brachytherapy, although it can effectively treat in-stent restenosis, still has a restenosis rate of 16% to 23%, and there are potential problems, such as edge effects, aneurysm-like changes, and operator protection etc. Currently, there are not many applications in China;
[0010] However, when the existing drug balloon is temporarily implanted, 10-20% of the drug will be lost before reaching the lesion. Therefore, in order to obtain a certain drug concentration on the inner wall of the blood vessel at the lesion to ensure the effectiveness of the treatment, the only way to improve the effect of the balloon is to increase the drug concentration. initial drug load
However, the study found that paclitaxel has certain toxicity and there are hidden dangers in its safety.

Method used

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  • Protection-sleeve-carrying paclitaxel drug balloon and preparation method thereof
  • Protection-sleeve-carrying paclitaxel drug balloon and preparation method thereof
  • Protection-sleeve-carrying paclitaxel drug balloon and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Such as figure 1 As shown, the balloon of the drug balloon provided in this implementation is coated with a degradable drug coating containing paclitaxel, and a protective sleeve 8 is arranged on the outside of the drug coating, and the protective sleeve 8 covers from the working section of the balloon to the Proximal push rod, the length of the protective sleeve is 130 mm to 138 mm, the inner diameter is 1.3 mm to 1.4 mm, the wall thickness is 0.20 mm to 0.25 mm, and the guide wire opening 10 is arranged longitudinally in the middle, and the size is 0.40 mm (width) × 400 mm (length) .

[0047] The drug balloon comprises a head end 1, a distal push rod 2, a transition section 3, a proximal push rod 4 and a HUB sheath handle 5, the distal push rod 2 includes a balloon 6, and the transition section 3 contains guide wire outlet 9. The push rod 4 at the proximal end of the drug balloon is made of 304L stainless steel tubing, and the push rod 2 at the far end is made of ny...

Embodiment 2

[0068] The difference between this embodiment and the embodiment 1 is that the drug coating includes a solution of paclitaxel and a contrast agent in a ratio of 1 g / 20-35 ml by weight, and the contrast agent is iodobenzene hexitol.

[0069] The preparation method of the paclitaxel drug balloon, its production steps are as follows:

[0070] (1) The nylon tubing is formed into a balloon body, the length of which is 18mm;

[0071] (2) cleaning the balloon body;

[0072] (3) Coating solution configuration and balloon loading drug:

[0073] ①A solution in which paclitaxel and iodobenzene are mixed in a ratio of 1g / 20ml by weight;

[0074] ② Coat the above-mentioned coating solution on the surface of the balloon body, solidify simultaneously with high-purity nitrogen, and keep the pressure at 1.0Psi until the drug loading reaches 320μg / cm 2 ;

[0075] (4) Place the above-mentioned coated balloon body in a vacuum drying oven, and dry it for 12 hours at a vacuum degree of -0.2Mpa ...

Embodiment 3

[0082] The difference between this embodiment and Example 1 is that the drug coating includes paclitaxel, lactide, glycolide copolymer PLGA and 70 parts of acetone in a ratio of 1 part by weight: 1.3 parts ; The preparation method of the paclitaxel drug balloon, its production steps are as follows:

[0083] (1) The nylon tubing is formed into a balloon body, the length of which is 23mm;

[0084] (2) cleaning the balloon body;

[0085] (3) Coating solution configuration and balloon loading drug:

[0086] ① Weigh paclitaxel and PLGA according to the ratio of 1 part: 1.3 parts for preparation;

[0087] ②Add 1.3 parts of PLGA to 70 parts of acetone, and shake it with a vibrating incubator at room temperature until it dissolves and disperses evenly, then add 1 part of paclitaxel to prepare a coating solution;

[0088] ③ Coat the above-mentioned coating solution on the surface of the balloon body, solidify simultaneously with high-purity nitrogen, and keep the pressure at 1.2Psi ...

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Abstract

The invention relates to a protection-sleeve-carrying paclitaxel drug balloon and a preparation method thereof. The protection-sleeve-carrying paclitaxel drug balloon comprises a drug balloon and a paclitaxel-containing degradable drug coating which is coated on a balloon work section. The drug balloon can be used as a pre-expansion balloon, a conveying balloon and a post-expansion balloon and the drug balloon comprises a HUB protection-sleeve handle, a near-end push rod, a transition section, a far-end push rod and a head end. The coating, which is configured by the paclitaxel and a contrast agent, or which includes the paclitaxel, a degradable polymer and a solvent of trichloroethane, acetone or tetrahydrofuran, can be layeredly coated on the balloon work section. Through the arrangement of a protection sleeve, the drug balloon is, during conveying processes from entering blood vessels to reaching diseased regions, in a protection state, so that drugs on the drug balloon may not be scoured, ineffective loss is avoided, initial drug loading capacity of the drug balloon can be reduced, the treatment effect can be meet and at the same time safety of the drug balloon is greatly improved.

Description

technical field [0001] The invention belongs to the field of biomedical devices, and in particular relates to a paclitaxel drug balloon with a protective sleeve and a preparation method thereof. Background technique [0002] Atherosclerosis and its resulting coronary heart disease and stroke are the main diseases that endanger human health today. Angioplasty is one of the main treatments for atherosclerosis. However, restenosis of the lumen caused by intimal neogenesis after arterial injury is the main reason for the failure of angioplasty and arterial stenting. In-stent restenosis is one of the main factors affecting the long-term efficacy of percutaneous coronary intervention (PCI). The incidence of in-stent restenosis after PCI ranges from 5% to 35%. Higher, and the implantation of drug stents also has a certain incidence. [0003] At present, there are three main methods for the treatment of in-stent restenosis: [0004] (1) Simple balloon dilation, which limits its ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/14A61M31/00A61L31/16A61M29/02A61L31/10
Inventor 张金萍
Owner BIOVAS (WUHAN) MEDICAL TECH CO LTD
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