Drug-coated balloon catheters for body lumens
Inventors
Wang, Lixiao • Barnett, Peter • Hendrickson, David
Assignees
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Publication Number
US-12280226-B2
Publication Date
2025-04-22
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
A method of treating a target site in a body lumen is provided using a balloon catheter inserted into the target site, wherein the balloon catheter includes an elongated balloon comprising at least one neck section. The balloon includes a first main section and a second main section on opposite sides of the neck section, and when the balloon is inflated the neck section has an inflated diameter smaller than the inflated main diameter of the first and second sections, so that the inflated diameter of the neck section is the smallest diameter of the balloon catheter between the first main section and the second main section.
The method further includes inflating the balloon catheter to treat the target site, deflating the balloon catheter, and withdrawing the balloon catheter from the body lumen. The disclosed embodiments encompass selecting the target site from vascular lumen and nonvascular lumen, including coronary artery, peripheral artery, urethra and prostatic urethra, ureteral stricture sites, esophagus, biliary tract, stomach, small intestine, duodenum, jejunum, ileum, colon, rectum, sinus, and airway.
Additional embodiments describe a drug-coated balloon catheter and coating layer containing a therapeutic agent and water-soluble additives, including paclitaxel and related taxanes. Further refinements include a neck section with reduced compliance during inflation or reinforcing material around a circumference of the neck section, and coating layer configurations for the balloon catheter.
Claims Coverage
The provided independent claim coverage centers on 3 inventive features: a balloon catheter geometry with a neck section forming the smallest inflated diameter between first and second main sections, a treating method including inserting, inflating, deflating, and withdrawing the catheter, and dependent refinements for target site selection and coating or neck structure.
Elongated balloon with main sections separated by a neck section
The balloon catheter comprises an elongated balloon comprising at least one neck section, with a first main section and a second main section on opposite sides of the neck section.
Neck section forms the smallest inflated diameter
When the balloon is inflated, the at least one neck section has an inflated diameter smaller than the inflated main diameter of the first and second sections, and the inflated diameter of the neck section is the smallest diameter of the balloon catheter between the first main section and the second main section.
Treating the target site by inserting, inflating, deflating, and withdrawing
The method treats a target site in a body lumen by inserting a balloon catheter into the target site, inflating the balloon catheter, deflating the balloon catheter, and withdrawing the balloon catheter from the body lumen.
Selected body lumen locations
The target site is selected from vascular lumen and nonvascular lumen, including urethra, prostatic urethra, ureteral stricture sites, esophagus, biliary tract, stomach, small intestine, duodenum, jejunum, ileum, colon, rectum, sinus, airway, coronary artery, and peripheral artery.
Neck section reduced compliance or reinforcement
The neck section comprises an area of reduced compliance during inflation or reinforcing material around a circumference of the neck section.
Drug-coated balloon catheter with water-soluble additives
The balloon catheter includes a coating layer containing a therapeutic agent and water-soluble additives, including paclitaxel and related taxanes.
Overall, the claim coverage centers on a balloon catheter geometry in which a neck section has the smallest inflated diameter between first and second main balloon sections, combined with a method of treating a target site by inserting, inflating, deflating, and withdrawing the catheter. Dependent coverage further includes selected body lumen locations, neck structure refinements, and drug-coated balloon catheter coating concepts with water-soluble additives.
Stated Advantages
Supports rapid drug release and tissue uptake during brief balloon deployment.
Helps prevent premature drug loss during transit.
Documented Applications
Treating urethral strictures.
Treating esophageal strictures.
Treating sinus strictures.
Treating benign prostatic hyperplasia (BPH) by using a drug-coated balloon catheter positioned under cystoscopy relative to the external sphincter, bladder neck, and anterior commissure, with outcomes reported using maximum urine flow rate (Qmax) and IPSS over follow-up days.
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