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Drug coating layer and method for forming same

A drug coating, drug technology, used in coatings, drug combinations, pharmaceutical formulations, etc.

Pending Publication Date: 2020-04-17
TERUMO KK
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, if the lesion is forcibly expanded, smooth muscle cells may proliferate excessively and new stenosis (restenosis) may occur in the lesion

Method used

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  • Drug coating layer and method for forming same
  • Drug coating layer and method for forming same
  • Drug coating layer and method for forming same

Examples

Experimental program
Comparison scheme
Effect test

no. 1 approach

[0040] The drug coating 40 related to the first embodiment of the present invention is as Figure 1~3 As shown, it is installed on the surface of the balloon 30 of the drug-eluting balloon catheter 10 . In this specification, the side where the balloon catheter 10 is inserted into the lumen of the living body is referred to as the "distal side", and the side where the operation is performed is referred to as the "proximal side".

[0041] First, the structure of the balloon catheter 10 will be described. The balloon catheter 10 has a long catheter body 20 , a balloon 30 disposed on the distal portion of the catheter body 20 , a drug coating 40 disposed on the surface of the balloon 30 , and a hub fixed to the proximal end of the catheter body 20 . Section 26.

[0042] The catheter main body 20 has an outer tube 21 which is a tubular body whose distal end and proximal end are open, and an inner tube 22 which is a tubular body arranged inside the outer tube 21 . The inner tube...

no. 2 approach

[0120] The drug coating 140 related to the second embodiment is as Figure 11 As shown, it differs from the first embodiment in that it has a first additive layer 141 and a second additive layer 142 . In addition, the same code|symbol is attached|subjected to the part which has the same function as 1st Embodiment, and description is abbreviate|omitted.

[0121] The first additive layer 141 and the second additive layer 142 of the drug coating layer 140 according to the second embodiment are formed on the surface of the balloon 30 through different processes. As far as the first additive layer 141 is concerned, as Figure 11 Shown in (A), use aforementioned balloon coating device 60 (referring to Figure 4 ), supplying the first coating solution to the surface of the balloon 30. The first coating solution includes water-insoluble drug, first water-soluble additive, organic solvent and water. The first coating solution may be the same as or different from the coating solutio...

Embodiment 1

[0138] A drug coating having elongated bodies as crystals of a water-insoluble drug having a long axis, a first additive layer, and a second additive layer is formed. The constituent material of the drug-coated balloon in Example 1 is nylon 12, and the water-insoluble drug constituting the elongated body is paclitaxel. As for the water-soluble additive, ethyl serine was used as the first additive layer, and the same ethyl serine as that of the first additive layer was used as the second additive layer. The solvents of the first coating solution are tetrahydrofuran and acetone, and the solvents of the second coating solution are ethanol and water. The amount of the water-soluble low-molecular-weight compound is 500 parts by mass relative to 100 parts by mass of the water-insoluble drug. The photo of the drug coating of embodiment 1 is shown in Figure 14 .

[0139] The surface of the drug coating has a certain degree of undulation. The surface of the drug coating is formed ...

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Abstract

Provided are a drug coating layer and a method for forming the same, the layer being capable of suppressing damage to drug crystals having a long balloon surface, and of maintaining drug crystals in an appropriate shape for having an effect on a living body. A drug coating layer (40) formed on the surface of a balloon (30), the layer comprising: a plurality of long bodies (42), which are crystalsof a water insoluble drug, having a longitudinal axis extending from the surface of the balloon (30) at various lengths and angles; and a water soluble additive layer (41) provided in the space between the surface of the balloon (30) and an outer surface (51) so as to fill the space between the long bodies (42), the outer surface (51) being provided with protrusions and recesses connecting a plurality of tip ends (46) and side surfaces (43) of the long bodies (42), and positioned at an outside of an aggregate (50) of a plurality of the long bodies (42). The side surfaces (43) and / or tip end surfaces (47) of the long bodies (42) are exposed at the surface of the additive layer (41) without the tip ends of the long bodies (42) almost protruding from the additive layer (41).

Description

technical field [0001] The present invention relates to a drug coating provided on the surface of a balloon and a method for forming the same. Background technique [0002] In recent years, balloon catheters have been used to improve lesion (stenosis) in the lumen of a living body. A balloon catheter generally has an elongated shaft and a radially expandable balloon disposed on the distal side of the shaft. The lesion can be expanded by expanding the deflated balloon after reaching the target position in the body through the thin living body lumen. [0003] However, if the lesion is forcibly expanded, smooth muscle cells may proliferate excessively and new stenosis (restenosis) may occur in the lesion. Therefore, recently, a drug eluting balloon (Drug Eluting Balloon: DEB) in which a drug for inhibiting stenosis is coated on the surface of the balloon is used. The drug-eluting balloon instantly releases the drug coated on the surface to the lesion by dilation, thereby sup...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/08A61K31/436A61L29/06A61L29/12A61L29/14A61L29/16A61M25/00A61M25/10A61P9/10A61K31/337
CPCA61K31/337A61K31/436A61L29/08A61L29/14A61L29/16A61M25/00A61M25/10A61P9/10A61L2300/416A61L2300/606A61L2300/608A61L2300/63A61K9/16A61K31/4418A61M25/104A61M2025/105A61M2025/1075A61M2025/1088
Inventor 黑崎靖夫村田悠
Owner TERUMO KK
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