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Compound drug coated balloon catheter and preparation method thereof

A drug coating and balloon catheter technology, applied in balloon catheters, catheters, coatings, etc., can solve the problems of drug balloon inhibition of restenosis and short drug release cycle, and achieve less drug loss, inhibition of proliferation, The effect of reducing toxic side effects

Active Publication Date: 2019-09-06
科睿驰(深圳)医疗科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stable combination between the drug coating and the surface of the balloon can achieve less loss of the drug coating during the delivery of the balloon catheter and reduce the impact on downstream blood vessels; at the same time, the rapid release of the drug to the vascular tissue can achieve more Proportion of drug transfer and adsorption to the target blood vessels to effectively inhibit the excessive proliferation of smooth muscle cells. Currently, the coating structure and patented coating technology of the marketed products are difficult to achieve both these two key properties. Therefore, it is necessary to research and develop a new type of drug Composite coating to achieve a balance of delivery loss and quick release
In addition, the existing technologies rely on the tissue absorption characteristics and crystallinity of the drug itself to control the release of the drug. Compared with the drug stent, the drug release period of the drug balloon is shorter, which is what causes the drug balloon to inhibit restenosis. one of the reasons for the lack of

Method used

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  • Compound drug coated balloon catheter and preparation method thereof
  • Compound drug coated balloon catheter and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] 1. Raw materials:

[0064] 1. Drugs: Paclitaxel;

[0065] 2. Low molecular weight carrier: mannitol, molecular weight 182;

[0066] 3. High molecular weight carrier: PEG600, molecular weight 600;

[0067] 4. Purified water, medical grade ethanol.

[0068] 2. Preparation method

[0069] 1. Prepare an ethanol solution of high molecular weight carrier PEG600 and paclitaxel at a concentration of 21 mg / ml, wherein the mass ratio of paclitaxel and PEG600 is 20:1, and mix thoroughly to obtain solution 1;

[0070] 2. Prepare an aqueous solution of low-molecular-weight carrier mannitol with a concentration of 10 mg / ml, and mix thoroughly to obtain solution 2;

[0071] 3. Mix 10ml of solution 1 and 1ml of solution 2 to obtain a coating solution, wherein the mass ratio of paclitaxel to high molecular weight carrier to low molecular weight carrier is 20:1:1;

[0072] 4. Spray the coating solution onto the outer surface of the balloon by ultrasonic atomization;

[0073] 5. Aft...

Embodiment 2

[0075] 1. Raw materials:

[0076] 1. Drug: rapamycin;

[0077] 2. Low molecular weight carrier: phosphatidylcholine, molecular weight 759;

[0078] 3. High molecular weight carrier: polylactic acid-glycolic acid copolymer (PLGA), molecular weight 20000;

[0079] 4. Purified water, medical grade ethyl acetate, medical grade ethanol.

[0080] 2. Preparation method

[0081] 1. Dissolve the high molecular weight carrier PLGA and rapamycin in ethyl acetate at a concentration of 20 mg / ml, wherein the mass ratio of rapamycin to PLGA is 1:1, and mix thoroughly to obtain solution 3;

[0082] 2. Dissolve the low-molecular-weight carrier phosphatidylcholine in ethanol at a concentration of 10 mg / ml, and mix thoroughly to obtain solution 4;

[0083] 3. Dissolve polyvinyl alcohol in water to obtain 1 mg / ml polyvinyl alcohol solution 5;

[0084] 4. Spray the solution 3 into the high-speed stirring solution 5 by ultrasonic atomization, continue to stir for 2 hours, and then filter, wash...

Embodiment 3

[0089] 1. Raw materials:

[0090] 1. Drug: zotarolimus;

[0091] 2. Low molecular weight carrier: PEG400, molecular weight 400;

[0092] 3. High molecular weight carrier: poloxamer, molecular weight 3000;

[0093] 4. Medical grade ethanol.

[0094] 2. Preparation method

[0095] 1. Prepare an ethanol solution of high molecular weight carrier poloxamer and zotarolimus, the concentration is 12 mg / ml, wherein the mass ratio of zotarolimus to poloxamer is 1:5, and mix well to obtain solution 1;

[0096]2. Prepare an ethanol solution of low molecular weight carrier PEG400 at a concentration of 10 mg / ml, and mix thoroughly to obtain solution 2;

[0097] 3. Mix 10ml of solution 1 and 5ml of solution 2 to obtain a coating solution, wherein the mass ratio of zotarolimus to high molecular weight carrier to low molecular weight carrier is 2:10:5;

[0098] 4. Spray the coating solution onto the outer surface of the balloon by ultrasonic atomization;

[0099] 5. After the coating is ...

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Abstract

The invention belongs to the technical field of medical apparatuses and instruments and relates to a compound drug coated balloon catheter and a preparation method thereof. The compound drug coated balloon catheter comprises a balloon and a drug coating which covers the surface of the balloon. The drug coating comprises an active drug and a carrier in a mass ratio of 0.2-20, the carrier comprisesa low-molecular-weight carrier and a high-molecular-weight carrier in a mass ratio of 0.5-10, and the drug loading capacity is 0.5-10microgram / mm<2>. The compound drug coated balloon catheter and thepreparation method thereof have advantages that fast drug transferring and reduction of loss in a delivery process are both realized, and integrality of the coating of the drug balloon is guaranteed;after the drug is transferred to the vascular tissue, part of the drug is temporarily fixed in the carrier and cannot be released, and along with degradation and / or dissolution of the high-molecular-weight carrier, the drug is released step by step, so that retention time of the drug in the tissue is prolonged, long-time inhibition of tissue hyperplasia can be realized, and the intravascular stenosis rate is decreased.

Description

technical field [0001] The invention relates to a composite drug-coated balloon catheter and a preparation method thereof, belonging to the technical field of medical devices. Background technique [0002] Percutaneous transluminal angioplasty (PTA) has gone through the stages of bare balloon, bare metal stent, drug-eluting stent, and drug-coated balloon since the 1970s. Among them, Drug Coated Balloon (DCB), on the one hand, drugs can effectively inhibit the excessive proliferation of smooth muscle cells to reduce the incidence of restenosis; The risk of stent thrombosis is reduced, the time of dual antiplatelet is shortened, and the risk of bleeding is reduced. In addition, in clinical studies of coronary artery disease, DCB has shown better efficacy and safety in the treatment of in-stent restenosis, small vessel disease, bifurcation disease, and DCB is also suitable for patients with high bleeding risk, taking oral Patients on anticoagulant drugs or who have recently u...

Claims

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Application Information

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IPC IPC(8): A61L29/08A61L29/16A61M25/10
CPCA61L29/08A61L29/085A61L29/16A61L2300/416A61L2300/43A61L2300/606A61M25/1002A61M25/1036A61M2025/1031A61M2025/105A61M2205/0238C08L71/02C08L67/04
Inventor 胡军卢金华孙宏涛孙蓬车海波
Owner 科睿驰(深圳)医疗科技发展有限公司
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