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Drug coating balloon and preparation method thereof

A technology of drug coating and balloon, applied in the direction of coating, balloon catheter, catheter, etc., can solve the problems of ineffective treatment, easy peeling of drug coating, poor release of drugs, etc., to increase adhesion Sexuality and firmness, beneficial to tissue absorption capacity, and the effect of reducing loss

Active Publication Date: 2022-01-28
SHANGHAI SHENQI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

By increasing the drug loading of the balloon coating, the drug absorption can be increased locally, but a large amount of excess drugs flow to the distal end of the blood vessel, affecting the health of patients
Due to the short expansion time of ordinary drug balloon dilation catheters, the drug is not released well, so the problems and difficulties faced by ordinary drug balloon dilation catheters are as follows: (1) While the drug coating is released rapidly, the delivery process will also be affected. The blood washes away a lot of drugs; (2) The drug adheres to the wall for a short time, and it is difficult to be absorbed by the blood vessel wall in large quantities, so that a good therapeutic effect cannot be achieved; (3) The drug coating is easy to fall off and produce particles, which is easy to generate thrombus

Method used

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Examples

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preparation example Construction

[0039] The present invention also provides a method for preparing the drug-coated balloon as described above, comprising the following steps:

[0040] (1) make bottom coat solution, interlayer coat solution and top coat solution respectively;

[0041] (2) Spraying the bottom coating solution, the interlayer coating solution and the top coating solution onto the surface of the balloon body in sequence to form the drug coating.

[0042] Wherein, in the step (1), the raw materials used for preparing the bottom coating, the interlayer coating and the top coating are respectively mixed and dissolved with a solvent to prepare the bottom coating solution, the interlayer coating solution and the top coating solution. Described solvent comprises methanol, ethanol, acetone, isopropanol, dimethyl sulfoxide, ethyl acetate, acetonitrile, tetrahydrofuran, dichloromethane, n-heptane, n-hexane, cyclohexane or any one or at least one in water A combination of the two. The combination of at l...

Embodiment 1

[0046] This embodiment provides a drug-coated balloon and a preparation method thereof. The drug-coated balloon includes a balloon body and a drug coating disposed on the outer surface of the balloon body. The drug coating includes sequentially stacked The bottom coating, the interlayer coating and the top coating, the thicknesses of the bottom coating, the interlayer coating and the top coating are respectively 4 μm, 6 μm, and 4 μm.

[0047] The preparation raw material of the bottom coating is hydroxymethyl cellulose, the preparation raw material of the top coating is butyl hydroxyanisole, and the preparation raw material of the interlayer coating is sirolimus and lipophilic materials (DC-cholesterol, 1,2-di Oleoyl Lecithin, Stearic Acid).

[0048] The mass ratio of DC-cholesterol, 1,2-dioleoyl lecithin, and stearic acid is 2:1:1; the mass ratio of sirolimus to lipophilic material is 1:1; The mass ratio of rolimus is 1:1.5; the mass ratio of butylated hydroxyanisole to siro...

Embodiment 2

[0055] This embodiment provides a drug-coated balloon and a preparation method thereof. The drug-coated balloon includes a balloon body and a drug coating disposed on the outer surface of the balloon body, and the drug coating includes successively stacked bottom layers Coating, interlayer coating and top coating, the thicknesses of the bottom coating, interlayer coating and top coating are respectively 4 μm, 8 μm and 4 μm.

[0056] The preparation raw material of bottom coating is hydroxypropyl cellulose, the preparation raw material of top coating is dibutyl hydroxytoluene, the preparation raw material of interlayer coating is sirolimus and lipophilic material DC-cholesterol, dipalmitate phosphatidyl cholesteryl alkali, lauric acid).

[0057] The mass ratio of DC-cholesterol, dipalmitoylphosphatidylcholine, and lauric acid is 1:1:1; the mass ratio of sirolimus to lipophilic material is 2:1; hydroxypropyl cellulose to sirolimus The mass ratio of dibutyl hydroxytoluene and si...

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Abstract

The invention relates to a drug coating balloon and a preparation method thereof. The drug coating balloon comprises a balloon body and a drug coating arranged on the outer surface of the balloon body. The drug coating comprises a bottom coating, an interlayer coating and a top coating which are sequentially stacked. The bottom coating is used for increasing the adhesion and firmness of the drug coating to the balloon body, so as to reduce the drug loss in the conveying process and increase the utilization rate of a drug. The interlayer coating is used for loading a drug and helping the drug to be better absorbed by tissues. The top coating is used for promoting the attachment of the drug coating and the intima of the vascular wall, so that the tissue absorption capability of the drug is better facilitated.

Description

technical field [0001] The invention belongs to the technical field of medical devices, and in particular relates to a drug-coated balloon and a preparation method thereof. Background technique [0002] Drug-coated balloon is a new therapeutic balloon drug release technology developed on the basis of interventional techniques such as balloon dilatation or balloon angioplasty. It is to coat anti-proliferative drugs, such as paclitaxel, on the balloon On the surface, when the balloon reaches the lesion site, it is stretched and expanded, and when it comes into contact with the intima of the blood vessel wall, the drug is rapidly released and transferred in the local blood vessel wall. Prevention of vascular restenosis after vascular intervention. On the one hand, the drug-coated balloon can effectively inhibit the excessive proliferation of smooth muscle cells and reduce the incidence of restenosis; Dual antiplatelet time reduces the risk of bleeding. In addition, in clinic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61L29/16A61L29/14A61L29/08
CPCA61M25/1029A61L29/08A61L29/085A61L29/14A61L29/16A61M2025/1031A61M2025/105A61L2420/02A61L2420/08A61L2300/606A61L2420/06C08L1/284C08L67/04A61L2300/802A61L2300/416
Inventor 王森于绍兴王占军戴志豪王鼎曦
Owner SHANGHAI SHENQI MEDICAL TECH CO LTD
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