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Drug-loaded saccule and manufacture method thereof

A manufacturing method and technology of balloons, which are applied in the field of medical devices, can solve problems such as the inability of direct and firm adhesion of drugs, and achieve the effects of preventing mutual aggregation, reducing surface tension, and accelerating release and absorption

Inactive Publication Date: 2016-11-09
HANGZHOU WEIQIANG MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, in the drug-coated balloon, on the one hand, the drug must be firmly adhered to the surface of the balloon without being washed away by the blood; , the drug cannot be released and delivered to the blood vessel wall, and the drug balloons in the prior art cannot overcome the problem of being firmly adhered and at the same time rapidly released and delivered to the blood vessel wall; in addition, due to the drug-coated balloon catheter The drug loaded is generally an active drug, and the balloon is made of nylon, Pebax and other materials. The surface of the balloon is extremely smooth, and the drug cannot be directly and firmly attached to the surface of the balloon.

Method used

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  • Drug-loaded saccule and manufacture method thereof
  • Drug-loaded saccule and manufacture method thereof
  • Drug-loaded saccule and manufacture method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] A. Balloon treatment: Take a 6.0×80mm (produced by Bard Company) balloon catheter, perform wrinkling treatment on the surface of the nylon balloon, and fold it into 5 petals with a flap folding machine (model VBT produced by BLOCKWISE Company).

[0058] B. Composite coating drug solution: prepare solutions with 5 concentration gradient levels: dissolve a certain amount of paclitaxel and PEG2000 in different ratios of ethanol / water (volume ratio), and prepare 5 parts of coating drug solutions in sequence. The total concentration of the coating drug solution is 50%;

[0059] a: Paclitaxel 9.99mg, PEG2000 0.1mg, solvent 20ml (the volume ratio of ethanol / water is 99:1), take 4ml;

[0060] b: Paclitaxel 7.9mg, PEG2000 2.1mg, solvent 20ml (the volume ratio of ethanol / water is 80:20), take 2ml;

[0061] c: Paclitaxel 5.9mg, PEG2000 4.1mg, solvent 20ml (the volume ratio of ethanol / water is 55:45), take 2ml;

[0062] d: Paclitaxel 3.9mg, PEG2000 6.1mg, solvent 20ml (the volume...

Embodiment 2

[0070] A drug-loaded balloon for treating vascular stenosis is prepared by using a nylon balloon.

[0071] A. Balloon treatment: wrinkle the surface of the balloon; take a 6.0×80mm (produced by Bard) balloon catheter, wrinkle the surface of the nylon balloon, and use a flapper (the model produced by BLOCKWISE is VBT), Fold into 3 pieces.

[0072] B. Composite coating drug solution: configure 7 concentration gradient grade solutions: dissolve a certain amount of rapamycin and N-methyl-D-glucose methylamine in different ratios of methanol / water (volume ratio) , and configure 7 solutions in turn. The total concentration of the coating drug solution is 10%;

[0073] a: Rapamycin 9.5mg, N-methyl-D-glucose methylamine 0.5mg, solvent 100ml (the volume ratio of methanol / water is 90:10), take 10ml;

[0074] b: rapamycin 9mg, N-methyl-D-glucose methylamine 1mg, solvent 100ml (the volume ratio of methanol / water is 70:30), take 10ml;

[0075] c: 8mg of rapamycin, 2mg of N-methyl-D-glu...

Embodiment 3

[0086] A drug balloon for treating blood vessel stenosis is prepared by using a nylon balloon.

[0087] A. Balloon treatment: take a 7.0×80mm (produced by Bard Company) balloon catheter, perform wrinkle treatment on the surface of the nylon balloon, and fold it into 4 petals with a flap folding machine (model VBT produced by BLOCKWISE Company).

[0088] B. Composite coating drug solution: configure 2 solutions of concentration gradient levels: dissolve a certain amount of paclitaxel, Tween 80, and acetamide in DMF / water (volume ratio) of different proportions, and configure 2 parts in sequence Apply drug solution. The total concentration of the coating drug solution is 80%;

[0089] a: Paclitaxel 8mg, Tween 80 1.5mg, acetamide 0.5mg, solvent 12.5ml (the volume ratio of DMF / water is 85:15), take 6ml;

[0090] b: Paclitaxel 2mg, Tween 80 5.5mg, acetamide 2.5mg, solvent 12.5ml (the volume ratio of DMF / water is 40:60), take 6ml;

[0091] Label the above two solutions as a and b...

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Abstract

The invention discloses a drug-loaded saccule and a manufacture method thereof. The drug-loaded saccule comprises a saccule with a multivalve structure, wherein a drug-coated crystal layer is adhered to the surface of the saccule, and comprises an active drug and a drug mixture; the content of the active drug in the drug-coated crystal layer is gradually reduced from the surface of the saccule outward, while the content of the drug mixture is gradually increased from the surface of the saccule outward. The manufacture method comprises the following steps: firstly, folding the surface of the saccule; preparing drug-coating solutions with different proportions by using the active drug, the drug mixture and solvent as raw materials; then, sequentially coating the drug-coating solutions to the surface of the saccule according to a decreasing sequence of the content of the active drug, drying and crystallizing to obtain a multi-layer drug-coated crystal layer having the content of the active drug in a gradient descending shape inside-out; and finally, rolling and pressing the saccule to obtain the final drug-loaded saccule. The drug-loaded saccule has an excellent drug-loading performance, strong adhesion soundness and strong washing resistance.

Description

technical field [0001] The invention belongs to the technical field of medical devices, and relates to a method for manufacturing a medical device, in particular to a drug-loaded balloon and a method for manufacturing the drug-loaded balloon. Background technique [0002] Arterial vascular disease refers to primary arterial occlusion, local calcification, plaque, and synthetic vascular restenosis. It is one of the main causes of death in patients with vascular disease. Currently, vascular interventional balloons can be used for this disease. In plastic surgery, an inflatable balloon catheter is used to balloon the diseased blood vessel so that the diseased blood vessel returns to its original lumen diameter. In recent years, a new technology for preventing vascular restenosis after interventional therapy—Drug Coated Balloons (abbreviation: DCB)—has emerged, and has achieved good clinical application results. [0003] Drug-coated balloon is a new treatment technology develop...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61M31/00A61L29/08A61L29/16
Inventor 张庭超陈忠符伟国岳嘉宁李阳
Owner HANGZHOU WEIQIANG MEDICAL TECH CO LTD
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