Drug-coated balloon catheters for body lumens
Inventors
Wang, Lixiao • Barnett, Peter • Hendrickson, David
Assignees
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Publication Number
US-12383710-B2
Publication Date
2025-08-12
Expiration Date
Abstract
Various embodiments disclosed relate to drug-coated balloon catheters 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 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. In some embodiments, the balloon catheter includes a length-control mechanism which stretches and elongates the balloon when it is in a deflated state, giving the balloon a smaller cross-sectional deflated profile for tracking through the body lumen and for removal after treatment.
Core Innovation
The invention relates to a drug-coated balloon catheter comprising an elongated balloon and a coating layer overlaying an exterior surface of the balloon. The coating layer directly contacts the exterior surface of the balloon and comprises an initial drug load of a therapeutic agent comprising paclitaxel, and at least one additive comprising a sugar derivative, a chemical compound with one or more ester moieties, or a combination thereof.
The disclosed coating is configured so that a soaking procedure or hydration at a target site enables release of the therapeutic agent from the coating layer. A soaking procedure for treating a target site in a body lumen is sufficient for the coating layer to release 37 wt % to 97 wt % of the initial drug load of the therapeutic agent.
Flushing a target site in a body lumen and holding the drug-coated balloon catheter in position to hydrate the coating layer is sufficient for the body lumen tissue at the target site to have a concentration of the therapeutic agent of 0.083 μg/g to 582 μg/g at 1 day, and to release more than 30 wt % of the initial drug load of the therapeutic agent to the target site or 0.1% to 25% of the initial drug load to a body lumen wall at the target site in the body lumen.
Claims Coverage
The consolidated input includes four independent claims. Across these claims, the inventive focus is on a drug-coated balloon catheter with a paclitaxel-containing coating layer that includes specific additive classes and is configured to achieve defined release and/or tissue concentration outcomes upon a soaking procedure or upon flushing and holding to hydrate the coating layer.
Paclitaxel-coated balloon with sugar-derivative and/or ester-moiety additive
An elongated balloon with a coating layer overlaying an exterior surface of the balloon, where the coating layer directly contacts the exterior surface and comprises an initial drug load of a therapeutic agent comprising paclitaxel, and at least one additive comprising a sugar derivative, a chemical compound with one or more ester moieties, or a combination thereof.
Soaking procedure enabling defined paclitaxel release
A soaking procedure for treating a target site in a body lumen is sufficient for the coating layer to release 37 wt % to 97 wt % of the initial drug load of the therapeutic agent from the coating layer.
Hydration by flushing and holding yielding tissue concentration at 1 day
Flushing a target site in a body lumen and holding the drug-coated balloon catheter in position at the target site to hydrate the coating layer is sufficient for the body lumen tissue at the target site to have a concentration of the therapeutic agent of 0.083 μg/g to 582 μg/g at 1 day.
Hydration by flushing and holding yielding release to target site above 30 wt %
Flushing a target site in a body lumen and holding the drug-coated balloon catheter in position at the target site to hydrate the coating layer is sufficient for the coating layer to release more than 30 wt % of the initial drug load of the therapeutic agent from the coating layer to the target site in the body lumen.
Hydration by flushing and holding yielding 0.1% to 25% release to body lumen wall
Flushing a target site in a body lumen and holding the drug-coated balloon catheter in position at the target site to hydrate the coating layer is sufficient for the coating layer to release 0.1% to 25% of the initial drug load of the therapeutic agent from the coating layer to a body lumen wall at the target site in the body lumen.
The independent claims collectively define a drug-coated balloon catheter having a paclitaxel-containing coating layer that directly contacts the balloon exterior and includes a sugar-derivative and/or an ester-moiety-containing additive. The coating is configured so that, upon a soaking procedure or upon flushing and holding to hydrate the coating layer, the catheter achieves specified paclitaxel release and/or tissue concentration ranges at and near the target site.
Stated Advantages
Allows the coating layer to release a defined fraction of the initial paclitaxel drug load under the described soaking or hydration-related handling concepts.
Enables measurement of body lumen tissue concentration of the therapeutic agent at 1 day within a specified range.
Documented Applications
Treatment of a target site in a body lumen using the drug-coated balloon catheter.
Treatment of nonvascular body-lumen strictures, including esophageal, airway, GI tract, urinary/prostate, sinus, achalasia, inflammatory bowel disease strictures, and radiation-induced or surgical anastomotic strictures.
Treatment outcomes for urinary outcomes including Qmax and IPSS as described in the document.
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