Drug-coated balloon catheters for body lumens
Inventors
Wang, Lixiao • Barnett, Peter • Hendrickson, David
Assignees
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Publication Number
US-10987451-B2
Publication Date
2021-04-27
Expiration Date
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 therapeutic agent 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. The coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent.
Core Innovation
The invention relates to a drug-coated balloon catheter for treating body-lumen strictures, including vascular strictures and nonvascular strictures. The disclosed examples include benign prostatic hyperplasia (BPH), urethral strictures, ureteral strictures, esophageal strictures, achalasia strictures, biliary tract strictures, stent-related strictures, and airway conditions.
The catheter includes an elongated balloon with a coating layer overlaying an exterior surface of the balloon. The coating layer includes an initial drug load of a therapeutic agent comprising paclitaxel and one or more water-soluble additives comprising pentaerythritol ethoxylate (15/4) and pentaerythritol ethoxylate (3/4).
The paclitaxel to pentaerythritol ethoxylate (15/4) and pentaerythritol ethoxylate (3/4) mass ratio is constrained to 1:5.5 to 10:1. The elongated balloon geometry includes a main inflated diameter and at least one neck section having a smaller inflated diameter than the main inflated diameter, dividing the balloon into at least two main sections.
The disclosure associates the drug coating and necked balloon structure with balloon catheter-based treatment of luminal strictures. It further states that the additive selection and mass ratio constraints are connected with therapeutic delivery, and that the neck geometry reduces migration while supporting coated surface contact during deployment.
Claims Coverage
The independent claims cover two main inventive aspects: a paclitaxel drug-coated balloon formulation with specific water-soluble additives and a constrained paclitaxel-to-additive mass ratio, and a necked elongated balloon geometry that divides the balloon into main sections with a smaller inflated-diameter neck section, combined with the same paclitaxel and pentaerythritol ethoxylate additive coating layer.
Paclitaxel coating with pentaerythritol ethoxylate mass-ratio constraint
A drug-coated balloon catheter including an elongated balloon with a coating layer overlaying an exterior surface of the balloon, where the coating layer comprises an initial drug load of a therapeutic agent comprising paclitaxel and one or more water-soluble additives comprising pentaerythritol ethoxylate (15/4) and pentaerythritol ethoxylate (3/4), with a mass ratio of the paclitaxel to the pentaerythritol ethoxylate (15/4) and the pentaerythritol ethoxylate (3/4) of 1:5.5 to 10:1.
Necked elongated balloon with smaller neck inflated diameter and paclitaxel additive coating
A drug-coated balloon catheter comprising an elongated balloon having a main inflated diameter and at least one neck section on the balloon comprising a smaller inflated diameter than the main inflated diameter, the at least one neck section dividing the balloon into at least two main sections, and a coating layer overlaying an exterior surface of the balloon that includes an initial drug load of a therapeutic agent comprising paclitaxel and one or more water-soluble additives comprising pentaerythritol ethoxylate (15/4) and pentaerythritol ethoxylate (3/4).
Across the independent claims, coverage is centered on a paclitaxel-containing drug-coated balloon coating that uses pentaerythritol ethoxylate (15/4) and pentaerythritol ethoxylate (3/4), with one claim additionally requiring a paclitaxel-to-additive mass ratio of 1:5.5 to 10:1, and the other claim requiring a necked balloon geometry with at least one smaller inflated-diameter neck section dividing the balloon into main sections.
Stated Advantages
Enables rapid drug elution and improved tissue permeation.
Improved tissue permeation without an oil/lipid dependency.
Mechanically anchors the balloon and reduces migration via neck geometry.
Documented Applications
Treating body-lumen strictures, including vascular strictures and nonvascular strictures.
Treating benign prostatic hyperplasia (BPH) and urethral strictures.
Treating ureteral strictures, esophageal strictures, achalasia strictures, biliary tract strictures, stent-related strictures.
Treating airway conditions including asthma and COPD.
Balloon catheter-based treatment of luminal strictures including urethral stricture, esophageal stricture, and sinus stricture.
Treatment of benign prostatic hyperplasia (BPH), including sequential dilation with paclitaxel drug-coated balloon catheters and reported changes in Qmax and IPSS.
Comparative use of uncoated balloon catheter versus paclitaxel drug-coated balloon catheter in the described clinical examples for BPH.
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