Drug eluting balloon

A technology of balloons and medicaments, applied in the direction of drug combination, drug delivery, drug devices, etc.

Active Publication Date: 2018-09-28
ORBUSNEICH MEDICAL PTE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although drug-eluting stents have been shown to be very effective in treating coronary occlusions, there is still a small but measurable incidence of serious complications resulting from stent thrombosis following stent implantation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Example 1: Balloon Coating (Paclitaxel)

[0118] (a) 90% paclitaxel / % Mpeg-PLGA in chloroform: Paclitaxel was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The polymer was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The two solutions were then mixed in a ratio of 90:10, respectively.

[0119] (b) 90% Paclitaxel / 10% Mpeg-PDLA in chloroform: Paclitaxel was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The polymer was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The two solutions were then mixed in a ratio of 90:10, respectively.

[0120] (c) 90% Paclitaxel / 10% Iohexol in distilled (DI (deionized water)) water: Paclitaxel was mixed in acetone to a w / v concentration of 1.5% (15 mg / mL). Iohexol was mixed in deionized water to a w / v concentration of 1.5% (15 mg / mL). The two solutions were then combined in a 90:10 or 95:5 ratio (if applicable).

[0121] (d) 90% Paclitaxel / 10% Urea in DI water: Paclita...

Embodiment 2

[0124] Example 2: Balloon Coating (Sirolimus)

[0125] (a) 90% Sirolimus / 10% Mpeg-PLGA in chloroform: Sirolimus was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The polymer was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The two solutions were then mixed in a ratio of 90:10, respectively.

[0126] (b) 90% sirolimus / 10% Mpeg-PDLA in chloroform: Sirolimus was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The polymer was mixed in chloroform to a w / v concentration of 1.5% (15 mg / mL). The two solutions were then mixed in a ratio of 90:10, respectively.

[0127] (c) 90% sirolimus / 10% iohexol in distilled (DI) water: Sirolimus was mixed in acetone to a w / v concentration of 1.5% (15 mg / mL). Iohexol was mixed in deionized water to a w / v concentration of 1.5% (15 mg / mL). The two solutions were then combined in a 90:10 or 95:5 ratio (if applicable).

[0128] (d) 90% sirolimus / 10% urea in DI water: Sirolimus was mixed in chlorofo...

Embodiment 3

[0131] Example 3: Elution Profile

[0132] (a) Kinetics of the elution profile: Coated balloons were stored in different 1 mL PBS aliquots at 37°C for a series of defined times with and without the expandable cover , such as 30 seconds, 1, 2, 3, 4, 5, 10, 15, 30, 60, and 120 minutes, to generate an elution profile over time. Aliquots of PBS were then analyzed by high pressure liquid chromatography (HPLC) to establish the concentration of sirolimus in solution at each time point. Calibration standards containing known amounts of sirolimus will be used to determine the amount of sirolimus eluted. The multiple peaks present for sirolimus (also present in the calibration standards) were summed to give the amount of sirolimus eluted over that time period (in absolute amounts and as eluted cumulative amounts). High pressure liquid chromatography (HPLC) analysis was then performed using a Waters HPLC system.

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Abstract

The present invention is an inflatable balloon which is enclosed by an expandable cover which becomes increasingly porous / permeable during expansion. The balloon is coated or enclosed with a matrix which contains a pharmaceutically active agent. During expansion of the balloon, the pharmaceutically active agent is released or extruded through the expandable coyer into a body cavity such as an artery or vein. The present invention also provides for a method of treating a disease or condition by delivering the inflatable balloon to a particular body cavity.

Description

technical field [0001] The present invention is an inflatable balloon closed by an expandable cover which becomes more porous / permeable during expansion. The balloon is coated or sealed with a matrix containing the pharmaceutically active agent. During expansion of the balloon, the pharmaceutically active agent is released or squeezed through the expandable covering (eg, membrane) into a body cavity such as an artery or vein. The present invention also provides methods of delivering the inflatable balloon and the pharmaceutically active agent to a body cavity. Background technique [0002] Atherosclerosis involves thickening of the walls of the arteries. Pathologically, atherosclerosis is caused by the invasion and accumulation of white blood cells (also known as foam cells) and the proliferation of intimal smooth muscle cells that form fibrolipid plaques in the artery wall. Potential pool, atherosclerosis can affect any arterial vessel, either centrally or peripherally, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61L29/08A61L29/12A61L29/16A61L29/14
CPCA61L29/085A61L29/146A61L29/16A61L29/14A61M25/104A61L2300/416A61L2400/12A61L2300/62A61M2025/105A61L29/145A61M25/0045A61L2300/204A61L2300/626A61L2300/624A61P29/00A61P35/00A61P35/02A61K9/1652A61K31/337A61K31/436A61M25/10A61M2205/0238A61M2210/1032A61M2210/1035A61M2210/105A61M2210/1053A61M2210/1064A61M2210/1085A61M2210/1089A61M2210/12
Inventor 罗伯特·J·科顿斯蒂芬·罗兰
Owner ORBUSNEICH MEDICAL PTE LTD
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