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Drug eluting stone-dissolving bile duct stent and preparation method thereof

A bile duct stent and drug coating technology, which is applied in the field of biomedicine and biopolymer materials, can solve the problems of inability to carry out long-term and continuous treatment, and achieve the maintenance of biliary tract patency, good biocompatibility, and good radial support performance Effect

Inactive Publication Date: 2012-10-17
上海交通大学附属第一人民医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, at present, the above-mentioned drugs can only be administered through local perfusion, and can only be used in surgical operations or postoperative drainage tubes, and cannot be used for long-term continuous treatment.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Drug-coated litholytic biliary stents were prepared by the following steps:

[0027] (1) Place the titanium alloy engraved bracket in acetone, ethanol and distilled water for ultrasonic vibration cleaning for 15 minutes, and dry in a vacuum drying oven at 75°C for 24 hours;

[0028] (2) Dissolve polycaprolactone in acetone at a ratio of 20mg: 1ml to make a solution, and uniformly disperse sodium cholate and disodium edetate with a mass ratio of 1mol: 1mol in the polycaprolactone solution, by spraying, placed on the surface of the titanium alloy engraved stent in the above step (1), to make a drug-coated litholytic bile duct stent;

[0029] (3) After the drug coating of the bile duct stent is prepared, it is placed in a vacuum drying oven, dried at 35° C., sterilized with ethylene oxide, and packaged.

Embodiment 2

[0031] preparation of drug-coated litholytic biliary stents,

[0032] (1) The titanium alloy braided stent was placed in acetone, ethanol and distilled water for ultrasonic cleaning for 18 minutes, and dried in a vacuum drying oven at 63°C for 24 hours;

[0033] (2) Dissolve polylactic acid in methylene chloride at a ratio of 30mg: 1ml to make a solution, and uniformly disperse sodium cholate and disodium edetate with a mass ratio of 1mol: 2mol in the polylactic acid solution , through soaking treatment, placed on the surface of the titanium alloy braided stent in the above step (1), to make a drug-coated litholytic bile duct stent;

[0034] (3) The drug-coated litholytic bile duct stent prepared in step (2) was placed in a vacuum drying oven, dried at 42° C., sterilized with ethylene oxide, and packaged.

Embodiment 3

[0036] Preparation of drug-coated litholytic biliary stent:

[0037] Place the titanium alloy engraved stents in acetone, ethanol and distilled water for ultrasonic cleaning for 18 minutes, then dry them in a vacuum oven at 70°C for 24 hours; dissolve polyglycolic acid in chloroform at a ratio of 40mg:1ml Prepare a solution, uniformly disperse sodium cholate and disodium edetate with a mass ratio of 2mol:1mol in the polyhexanoic acid solution, and place it on the surface of the titanium alloy engraved stent by spraying to form Drug-coated litholytic bile duct stent: place the above-mentioned drug-coated litholytic bile duct stent in a vacuum drying oven, dry at 40° C., sterilize with ethylene oxide, and package.

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PUM

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Abstract

The invention, belonging to the field of biomedicine and physical polymer material, particularly relates to a drug eluting stone-dissolving bile duct stent and a preparation method thereof. The stent is prepared by coating a biodegradable polymer layer containing stone-dissolving drug sodium cholate or / and edetate disodium on the inner surface and outer surface of the uncoated stent, wherein the ratio of sodium cholate to edetate disodium is 0-1mol:0-1mol. Clinical outcomes show that the stone-dissolving bile duct stent of the invention has good radial supporting performance, can keep the bile duct open, has good biocompatibility, and lets almost no internal inflammation generate. Simultaneously, sodium cholate or / and edetate disodium slowly released by the polymer layer containing drugs can dissolve the formed stones and can prevent the re-formation of stones.

Description

technical field [0001] The invention belongs to the fields of biomedicine and biopolymer materials, and in particular relates to a drug-coated litholytic bile duct stent and a preparation method thereof. Background technique [0002] According to clinical medical statistics, bile duct stones have a very high incidence rate. The traditional treatment method mainly adopts surgery, but the trauma is large, the complications are many, and the recurrence rate is high; Other diseases and cannot tolerate surgical treatment. In recent years, with the development of endoscopic technology, endoscopic pancreaticobiliary interventional stone removal technology (ERCP technology) has gradually become the main treatment method for bile duct stones, and has achieved good therapeutic effects. However, for some patients with difficult to remove bile duct stones (such as multiple, huge, hard or special bile duct stones), or patients who cannot tolerate long-term endoscopic operation, the only...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/16A61L31/10
Inventor 宛新建杨庆张佩华戚晓升张伟星时翠红甄慧英
Owner 上海交通大学附属第一人民医院
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