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Drug-coated balloon catheters for body lumens

A balloon catheter and balloon technology, applied in the field of drug-coated balloon catheters used in body cavities, can solve problems such as asthma that cannot be cured

Active Publication Date: 2019-03-01
UROTRONIC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Currently, there is no cure for asthma

Method used

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  • Drug-coated balloon catheters for body lumens
  • Drug-coated balloon catheters for body lumens
  • Drug-coated balloon catheters for body lumens

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0295] Various embodiments of the invention may be better understood by reference to the following examples, which are provided by way of illustration. The invention is not limited to the examples given herein.

[0296] In all examples, unless otherwise stated, the stretch ratio was calculated as the ratio of the nominal balloon diameter to the standard diameter at the body lumen treatment site. The standard diameter at the treatment site of the body cavity is the standard diameter at the treatment site of the body cavity and can be calculated as the diameter of the healthy tissue adjacent to the stricture (stenosis) or lesion (ie, the proximal and distal ends of the lumen stenosis or lesion) average value. For the pressure used during the inflation phase, the inflated balloon diameter is approximately equal to and within 10% of the nominal balloon diameter.

[0297] Part I.

Embodiment I-1

[0298] Example 1-1. Preparation of coating solution.

[0299] Formulation 1: Mix 50-150 mg (0.06-0.18 mmole) paclitaxel, 25-300 mg PEG8 caprylic / capric glyceride and 2-6 ml ethanol.

[0300] Formulation 2: Mix 50-150 mg (0.06-0.18 mmole) paclitaxel, 25-300 mg PEG8 caprylic / capric glyceride, 25-300 mg uracil and 2-6 ml ethanol.

[0301] Formulation 3: Mix 50-150 mg (0.06-0.18 mmole) paclitaxel, 25-300 mg PEG8 caprylic / capric glycerides, 25-300 mg uridine and 2-6 ml ethanol.

[0302] Formulation 4: Mix 50-150 mg (0.06-0.18 mmole) paclitaxel, 25-300 mg PEG8 caprylic / capric glycerides, 25-300 mg sucralose and 2-6 ml ethanol.

[0303] Formulation 4a: Mix 50-150 mg (0.06-0.18 mmole) of paclitaxel, 25-300 mg of PEG8 caprylic / capric glycerides, 25-300 mg of sucralose and 2-6 ml of ethanol, paclitaxel: PEG8 caprylic / capric glycerides: three The mass ratio of sucralose is 1:1:1.

[0304] Formulation 4b: Mix 50-150mg (0.06-0.18mmole) paclitaxel, 25-300mg PEG8 caprylic / capric glyceri...

Embodiment I-2

[0325] Example 1-2. Clinical study 1 & 2 sample preparation.

[0326] Twenty-one balloon catheters (twelve 4 mm diameter and 40 m long, six 8 mm diameter and 40 mm long, three 20 mm diameter and 50 mm long) were inflated to 1 to 2 atmospheres and wiped with ethanol to clean the balloon surface. Next, the balloon was coated with various formulations (1-6) from Example 1-1, the coating solution was sufficient to achieve 2-4 micrograms of paclitaxel per square millimeter of balloon surface. Balloons were then dried, folded, sheathed, and packaged in Tyvek bags and ethylene oxide sterilized in preparation for animal testing.

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Abstract

Various embodiments disclosed relate to drug-coated balloon catheters for treating strictures in body lumens and methods of using the same. A drug- coated balloon catheter for delivering a therapeuticagent to a target site of a body lumen stricture includes an elongated balloon having a main diameter. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. Thecoating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 502,212, filed May 5, 2017, the disclosure of which is incorporated herein by reference in its entirety. Background of the invention [0003] Benign prostatic hyperplasia is a noncancerous enlargement of the prostate that affects more than 50 percent of men over the age of 60. Early in life the prostate is the size and shape of a walnut and weighs about 20 grams. An enlarged prostate appears to be a normal process. With age, the prostate gradually increases in size to two or more times its normal size. As the prostate grows, it squeezes the urethra and narrows it, causing prostatic urethral extrusion and blockage of the urinary tract, making it difficult or impossible to pass urine. [0004] Male urethral stricture disease affects up to 0.6% of some populations. Urethral stricture disease appears to be more common in the elderly pop...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L29/16A61L29/08A61K31/337A61K31/439A61P31/00A61P37/06
CPCA61L29/16A61L29/08A61M25/1002A61L2300/802A61L2300/416A61L2300/606A61K31/337A61P31/00A61P37/06
Inventor L·王P·巴涅特D·亨德里克森
Owner UROTRONIC
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