Drug-coated balloon catheters for body lumens
Inventors
Wang, Lixiao • Barnett, Peter • Hendrickson, David
Assignees
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Publication Number
US-11504450-B2
Publication Date
2022-11-22
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 method for treatment of an anastomotic stricture. The method includes flushing the anastomotic stricture with a flushing media comprising water, saline solution, or a water solution comprising at least one water-soluble additive, and inserting a balloon catheter into a target site in a body lumen comprising the anastomotic stricture.
The balloon catheter includes an elongated balloon with a coating layer overlying an exterior surface of the balloon, and the coating layer comprises an initial drug load of a therapeutic agent. Prior to inflation, the balloon catheter is exposed to a liquid comprising the flushing media in the anastomotic stricture for a soaking period to hydrate the coating layer.
After hydration, the balloon is inflated at the target site to contact the coating layer with walls of the body lumen at the location of the anastomotic stricture until the balloon achieves an inflated balloon diameter for an inflation period, then deflated after the inflation period and withdrawn from the body lumen.
Claims Coverage
The provided material identifies one independent claim with dependent refinements. The inventive coverage focuses on a flushing-and-hydration drug-coated balloon catheter method for treating an anastomotic stricture, with three core inventive features and additional dependent limitations.
Flushing anastomotic stricture with water or saline media
Flushing the anastomotic stricture with a flushing media comprising water, saline solution, or a water solution comprising at least one water-soluble additive.
Hydrating a drug-coated balloon by soaking in flushing media prior to inflation
Inserting a balloon catheter into a target site in a body lumen comprising the anastomotic stricture, where the balloon catheter comprises an elongated balloon and a coating layer overlying an exterior surface of the balloon, and the coating layer comprises an initial drug load of a therapeutic agent; exposing the balloon catheter to a liquid comprising the flushing media in the anastomotic stricture for a soaking period prior to inflation to hydrate the coating layer.
Inflating the hydrated coating to contact lumen walls at the stricture location
Inflating the balloon at the target site to contact the coating layer with walls of the body lumen at the location of the anastomotic stricture until the balloon achieves an inflated balloon diameter for an inflation period; deflating after the inflation period; and withdrawing the balloon catheter from the body lumen.
Soaking-period release of a portion of the initial drug load
The soaking period such that contacting the coating layer with the stricture releases 37% to 97% of the initial drug load.
Residual drug retention after withdrawal
The balloon retains a residual drug amount after withdrawal that is 70% or less of the initial drug load.
Neck section reduced compliance with smaller inflated diameter relative to main diameter
Inflating the balloon such that the neck section has an inflated diameter smaller than the main diameter and is the smallest between main sections, greater than the neck’s pre-inflation diameter, with reduced compliance during inflation relative to the main sections.
Neck reinforcement using selected filament or suture polymers
The reinforcing material includes a suture or monofilament/multifilament made from nylon, polyamide, including aromatic polyamide, UHMWPE, polyester, including aromatic polyester, PET, or combinations thereof.
Therapeutic agent selection for the balloon coating
The therapeutic agent is chosen from paclitaxel, docetaxel, taxol, rapamycin, sirolimus, zotarolimus, everolimus, tacrolimus, mTOR inhibitors, analogues thereof, and combinations thereof.
Across the provided claim coverage, the central inventive concept is hydrating a drug-coated balloon coating layer by soaking with flushing media in an anastomotic stricture prior to inflation, followed by contact during inflation and then withdrawal. Dependent features narrow performance and structure by specifying release and residual drug thresholds, a reduced-compliance neck geometry with selected reinforcement materials, and therapeutic agent options.
Stated Advantages
Documented Applications
No documented applications found
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