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Method of treating peripheral artery diseases in lower limbs

A medical device, water-insoluble technology, applied in cardiovascular system diseases, balloon catheters, medical science, etc., can solve problems such as peripheral vascular embolism, achieve low toxicity and high inhibitory effect on intravascular stenosis

Inactive Publication Date: 2017-02-22
TERUMO KK
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In particular, although the use of braces in the treatment of the lower extremities is not recommended, there is still a need for DEB
At the same time, when using DEB, there is a risk of downstream peripheral vessel embolism (which is caused by particles)

Method used

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  • Method of treating peripheral artery diseases in lower limbs
  • Method of treating peripheral artery diseases in lower limbs
  • Method of treating peripheral artery diseases in lower limbs

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0126] (1) Preparation of coating solution 1

[0127] Weigh L-serine ethyl ester hydrochloride (CAS No. 26348-61-8) (56 mg) and paclitaxel (CAS No. 33069-62-4) (134.4 mg). Absolute ethanol (1.2 mL), tetrahydrofuran (1.6 mL), and RO (reverse osmosis) membrane-treated water (hereinafter, referred to as RO water) (0.4 mL) were respectively added thereto and dissolved to prepare a coating solution 1 .

[0128] (2) Coating of drug on the balloon

[0129] A balloon catheter (manufactured by Terumo Corp., material of the balloon (widening part) is nylon elastomer) having a size of 3.0 mm in diameter x 20 mm in length (widening part) when widened was prepared. Coating solution 1 was coated on the dilated balloon so that the coating solution evaporated slowly so that the amount of paclitaxel was about 3 μg / mm 2 . That is, the dispensing tube having the opening at the most distal end is moved horizontally in the lateral direction and placed on the surface of the balloon. At least a ...

Embodiment 2

[0132] (1) Preparation of coating solution 2

[0133] Weigh L-serine ethyl ester hydrochloride (70 mg) and paclitaxel (180 mg). Anhydrous ethanol (1.5 mL), acetone (2.0 mL), tetrahydrofuran (0.5 mL), and RO water (1 mL) were respectively added thereto and dissolved, whereby a coating solution 2 was prepared.

[0134] (2) Coating of drug on the balloon

[0135] A balloon catheter (manufactured by Terumo Corp., material of the balloon (widening part) is nylon elastomer) having a size of 3.0 mm in diameter x 20 mm in length (widening part) when widened was prepared. Coating solution 2 was coated on the dilated balloon so that the coating solution evaporated slowly so that the amount of paclitaxel was about 3 μg / mm 2 .

[0136] That is, coating was performed in the same manner as in Example 1 except that the coating solution was dispensed on the surface of the balloon at a rate of 0.088 microliter / second.

[0137] Next, the coated layer was dried to prepare a drug-eluting ball...

Embodiment 3

[0139] (1) Preparation of coating solution 3

[0140] Weigh L-serine ethyl ester hydrochloride (70 mg) and paclitaxel (168 mg). Anhydrous ethanol (1.5 mL), tetrahydrofuran (1.5 mL), and RO water (1 mL) were respectively added thereto and dissolved, thereby preparing coating solution 3 .

[0141] (2) Coating of drug on the balloon

[0142] A balloon catheter (manufactured by Terumo Corp., material of the balloon (widening part) is nylon elastomer) having a size of 3.0 mm in diameter x 20 mm in length (widening part) when widened was prepared. Coating solution 3 was coated on the dilated balloon so that the coating solution evaporated slowly so that the amount of paclitaxel was about 3 μg / mm 2 .

[0143] That is, coating was performed in the same manner as in Example 1 except that the coating solution was dispensed on the surface of the balloon at a rate of 0.101 microliter / second.

[0144] Next, the coated layer was dried to prepare a drug-eluting balloon.

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Abstract

A method of treating peripheral artery diseases in lower limbs by providing a medical device having an expandable member having a drug coating layer which has a crystalline morphological form including a plurality of crystal particles of a water-insoluble drug regularly arranged and uniformly sized on the surface of the medical device, inserting the medical device in peripheral blood vessels, expanding the expandable member, pressing the drug coating layer to a blood vessel wall such that at least part of the plurality of crystals are transferred to the blood vessel wall, and deflating the expandable member such that a pharmacokinetics profile is presented in which a drug concentration in the blood vessels is kept for the inhibition of smooth muscle cell proliferation in a high drug-concentration period of time, and for the non-inhibition of endothelial cell growth in a later low drug-concentration period of time.

Description

technical field [0001] The invention discloses a drug coating of a water-insoluble drug, a drug coating in the form of a specific crystal form of the water-insoluble drug, and a method for treating lower extremity peripheral arterial disease. Background technique [0002] In recent years, development of a drug-eluting balloon (DEB), in which a balloon catheter is coated with a drug, has been actively carried out, and it has been reported that the drug-eluting balloon is effective in the treatment and prevention of restenosis. The balloon is coated with a coating containing the drug and excipients, and when the vessel is dilated, the balloon presses against the vessel wall and delivers the drug to the target tissue. [0003] It has been found in recent years that the morphology of the drug coated on the surface of the balloon affects the releasing property (releasing property) and tissue transferability (tissue transferability) of the drug released from the balloon in the are...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/16A61M25/10
CPCA61M25/10A61L31/16A61M2025/1031A61M2025/105A61L2300/416A61L2300/63A61P9/10A61L29/16A61L29/08
Inventor 山下惠子野泽滋典森本克己
Owner TERUMO KK
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