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Drug coating balloon dilatation catheter and preparation method thereof

A technology for dilating catheters and drug coatings, applied in balloon catheters, catheters, coatings, etc., can solve the problems of reducing vascular restenosis, not showing certainty, etc., to improve drug release, improve bioavailability, slow down blood solidified effect

Pending Publication Date: 2016-12-21
恒壹(北京)医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The experimental results showed that the second method did not show a definite and statistically significant effect on reducing vascular restenosis or reducing neointimal thickness and neointimal area, which also shows that the matrix in the drug-coated balloon is very important

Method used

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  • Drug coating balloon dilatation catheter and preparation method thereof
  • Drug coating balloon dilatation catheter and preparation method thereof
  • Drug coating balloon dilatation catheter and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Coating of inner layer coating:

[0035] Put the completed semi-finished product with the balloon into the spraying equipment after weighing and recording the data, and fix it.

[0036] Accurately weigh 0.05g of paclitaxel and 0.05g of citric acid with a one-hundred-thousandth balance, put them into a 10ml volumetric flask, add 10ml of methanol into the volumetric flask, and after the paclitaxel is completely dissolved, put it into an ultrasonic oscillator and vibrate for 20s to prepare Paclitaxel citrate-methanol solution.

[0037] Adjust the parameters of the spraying equipment, spray the prepared paclitaxel citrate-methanol solution evenly on the balloon with the spraying equipment, weigh with a balance after spraying and record the data.

[0038] 2. Coating of outer coating:

[0039] Accurately weigh 0.05g of heparin sodium with a one-hundred-thousandth balance, put it into a 10ml volumetric flask, add 10ml of water for injection into the volumetric flask, and ...

Embodiment 2

[0048] 1. Coating of inner layer coating:

[0049] Weigh and record the data of the completed semi-finished product with the balloon, put it into the spraying equipment, and fix it.

[0050] Accurately weigh 0.05g of paclitaxel and 0.1g of citric acid with a one-hundred-thousandth balance, put them into a 10ml volumetric flask, add 10ml of methanol into the volumetric flask, and after the paclitaxel is completely dissolved, put it into an ultrasonic oscillator and vibrate for 20s to prepare Paclitaxel citrate-methanol solution.

[0051] Adjust the parameters of the spraying equipment, spray the prepared paclitaxel citrate-methanol solution evenly on the balloon with the spraying equipment, weigh with a balance after spraying and record the data.

[0052] 2. The coating of the outer layer coating is the same as that of Example 1.

[0053] 3. The test of inner layer loss and drug release during drug delivery is the same as that of Example 1.

[0054] 4. The solvent residue te...

Embodiment 3

[0056] 1. Coating of inner layer coating:

[0057] Weigh and record the data of the completed semi-finished product with the balloon, put it into the spraying equipment, and fix it.

[0058] Accurately weigh 0.05g of paclitaxel and 0.05g of citric acid with a one-hundred-thousandth balance, put them into a 10ml volumetric flask, add 10ml of methanol into the volumetric flask, and after the paclitaxel is completely dissolved, put it into an ultrasonic oscillator and vibrate for 20s to prepare Paclitaxel citrate-methanol solution.

[0059] Adjust the parameters of the spraying equipment, spray the prepared paclitaxel citrate-methanol solution evenly on the balloon with the spraying equipment, weigh with a balance after spraying and record the data.

[0060] 2. Coating of outer coating:

[0061] Accurately weigh 0.1g of heparin sodium with a one-hundred-thousandth balance, put it into a 10ml volumetric flask, add 10ml of water for injection into the volumetric flask, and after ...

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Abstract

The invention belongs to the technical field of medical apparatuses and instruments, and particularly relates to a drug coating balloon dilatation catheter and a preparation method thereof. The drug coating balloon dilatation catheter comprises a balloon dilatation catheter body and a drug coating. The drug coating coats the surface of the balloon dilatation catheter body. The drug coating includes an outer layer and an inner layer, the outer layer is a water soluble protecting layer, and the inner layer is an effective drug and an excipient, the mass ratio of the effective drug to the excipient is 1:(0.2-2), and the mass ratio of the inner layer to the outer layer is 1:(0.3-3). The preparation method comprises the steps that the balloon dilatation catheter is placed into spraying equipment, after an inner layer coating solution is prepared, inner layer coating is performed, then, outer layer coating is performed, drying and folding are performed, the catheter body is sleeved with a protective cover, and the drug coating balloon dilatation catheter is obtained.

Description

technical field [0001] The invention belongs to the technical field of medical devices, in particular to a drug-coated balloon dilatation catheter and a preparation method thereof. Background technique [0002] In recent years, stent implantation has been widely used in the treatment of vascular stenosis. Early studies have shown that bare metal stents (BMS) have a very high therapeutic effect on coronary stenosis by physically stretching blood vessels, but there will be a certain probability of restenosis. Drug-eluting stents (DES), which appeared later, are coated with antithrombotic drugs on the basis of bare metal stents to further prevent restenosis by inhibiting intimal hyperplasia. However, all interventional treatments for vascular stenosis or occlusion cannot completely eliminate the occurrence of restenosis at the lesion site, and there will still be a 10% restenosis rate after surgery. [0003] As early as 2004, Scheller et al. used drug-coated balloons for the ...

Claims

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Application Information

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IPC IPC(8): A61M25/10A61M29/02A61L29/08A61L29/16A61M25/16
CPCA61L29/08A61L29/16A61M25/0009A61M25/0021A61M25/0045A61M25/10A61M25/1027A61M29/00A61L2300/416A61L2420/02A61M2025/105A61M2025/1031A61M2025/0057A61M2025/1075A61M25/104A61L2300/802A61L2300/602A61L2300/608A61L29/085A61L2420/08C08L5/10
Inventor 张羽马立金
Owner 恒壹(北京)医疗科技有限公司
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