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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 refractory or recurrent anastomotic stenosis

Pending Publication Date: 2021-11-30
UROTRONIC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although balloon dilation has been shown to be a safe and effective non-surgical method for managing anastomotic strictures, problems remain, such as the need for repeated balloon dilations due to refractory or recurrent anastomotic strictures

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

[0347] Various embodiments of the present 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.

[0348] Throughout the examples, unless otherwise stated, stretch ratios are calculated as the ratio of the nominal diameter of the balloon to the untreated diameter of the body lumen at the site of treatment. The untreated diameter of the body cavity at the site of treatment is the normal diameter of the body cavity at the site of treatment and can be calculated as the average of the diameters of healthy tissue adjacent to the stricture, stenosis , or lesion, that is, the stenosis or stenosis of the lumen or the proximal and distal ends of the lesion. The inflated balloon diameter is approximately equal to and within 10% of the nominal balloon diameter at the pressure used during the inflation phase.

[0349] Part I: Preclinical and bench trials

Embodiment I-1

[0350] Example I-1. Preparation example of coating solution.

[0351] Formulation 1: Mix 50-150 mg (0.06-0.18 mmol) paclitaxel, 25-300 mg PEG8 caprylic / capric glycerides, and 2-6 mL ethanol.

[0352] Formulation 2: Mix 50-150 mg (0.06-0.18 mmol) paclitaxel, 25-300 mg PEG8 caprylic / capric glycerides, 25-300 mg uracil and 2-6 mL ethanol.

[0353] Formulation 3: Mix 50-150 mg (0.06-0.18 mmol) paclitaxel, 25-300 mg PEG8 caprylic / capric glycerides, 25-300 mg uridine and 2-6 mL ethanol.

[0354] Formulation 4: Mix 50-150 mg (0.06-0.18 mmol) paclitaxel, 25-300 mg PEG8 caprylic / capric glycerides, 25-300 mg sucralose and 2-6 mL ethanol.

[0355] Formulation 4a: mix 50-150mg (0.06-0.18mmol) paclitaxel, 25-300mg PEG8 caprylic / capric glycerides, 25-300mg sucralose and 2-6mL ethanol, paclitaxel: PEG8 caprylic / capric glycerol The mass ratio of ester:sucralose is 1:1:1.

[0356] Formulation 4b: mix 50-150mg (0.06-0.18mmol) paclitaxel, 25-300mg PEG8 caprylic / capric glycerides, 25-300mg suc...

Embodiment I-2

[0377] Example I-2. Preclinical Studies 1 & 2: Prostate, Urethra, and Ureters

[0378] 21 balloon catheters (12 4 mm diameter and 40 mm long, 6 8 mm diameter and 40 mm long, 3 20 mm diameter and 50 mm long) inflated to 1-2 atmospheres and wiped with ethanol wipes to clean balloon surface. Next, the balloons were coated with sufficient coating solution to achieve 2-4 micrograms of paclitaxel per square millimeter of balloon surface using the various formulations (1-6) from Example 1-1. Balloons were then dried, folded, sheathed, packaged in Tyvek bags and ethylene oxide sterilized in preparation for animal testing.

[0379] For this study, male dogs were used. Prior to drug-coated balloon therapy, a baseline urethrogram was taken to measure the inner diameter of the urethra at the treatment site. Non-overlapping treatments were performed in the pelvic (pelvic) urethra, bulbar (bulbar) urethra, and distal urethra immediately adjacent to the penis bone using a drug-coated ba...

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Abstract

A balloon catheter for treating, preventing, or reducing the recurrence of a stricture and / or cancer, or for treating benign prostatic hyperplasia (BPH), in a non-vascular body lumen is disclosed. The ballon catheter comprises: an elongated balloon; a coating layer overlying an exterior surface of the balloon, wherein the coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent; and a length-control mechanism (600) which stretches and elongates the balloon during deflation, giving the balloon a smaller cross-sectional deflated profile for tracking through the body lumen and for removal after treatment.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 809,048, filed February 22, 2019, and U.S. Provisional Patent Application Serial No. 62 / 859,396, filed June 10, 2019, the disclosures of both All of them are hereby incorporated by reference. [0003] The disclosures of each of the following applications are hereby incorporated by reference in their entirety. U.S. Patent Application Serial No. 16 / 135,436, which is a continuation-in-part of International Application No. PCT / US2018 / 03108 filed May 4, 2018, which claims a U.S. Provisional Patent Application filed May 5, 2017 Priority interest in serial number 62 / 502,212. U.S. Patent Application Serial No. 16 / 135,436 is also a continuation-in-part of U.S. Patent Application Serial No. 15 / 568,614, filed October 23, 2017, which is derived from the International Application, filed April 21, 2016 U.S. national phase filing unde...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61L29/08A61L29/16
CPCA61M25/1002A61M25/1018A61L29/08A61L29/16A61M2025/1004A61P31/00A61M25/10A61M2025/105A61M2025/1068A61K31/337A61K31/436A61L2300/416A61M2025/1059A61M2210/105A61M2210/1057A61M2210/106A61M2210/1064A61M2210/1085A61M2210/1089
Inventor 王立筱P·巴奈特D·亨德里克森
Owner UROTRONIC
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