Drug-coated balloon catheters for body lumens

Inventors

Wang, Lixiao • Barnett, Peter • Hendrickson, David

Assignees

Urotronic Inc

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 disclosed subject matter provides methods for treating a body lumen stricture, including a urethral stricture or a benign prostatic hyperplasia (BPH) stricture, using a balloon catheter with a drug coating and an elongated balloon having a main diameter and 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 the neck section is positioned in the bladder neck during inflation. The neck section has an inflated diameter smaller than the main diameter and an area of reduced compliance during inflation relative to the first main section and the second main section.

The disclosed methods include flushing the body lumen stricture or the prostatic urethra with water, saline solution, or a water solution comprising at least one water soluble additive prior to drug-coated balloon catheter delivery. A balloon catheter with an initial drug load of a therapeutic agent is inserted into the body lumen stricture, and the balloon is inflated such that the first main section is in the prostatic urethra, the second main section is in the bladder, and the neck section is in the bladder neck. Inflation proceeds until the stricture is dilated to a desired diameter or until the prostatic urethra tissue yields to create a commissurotomy.

The balloon is kept inflated to release the therapeutic agent into tissue, and then the balloon is deflated and withdrawn. In BPH commissurotomy or splitting, the drug coated balloon catheter is inserted into the prostatic urethra, flushed, and placed near the external sphincter before inflation. The neck section behavior is defined by reduced compliance and by having an inflated diameter smaller than the main diameter during inflation.

Claims Coverage

The provided independent claim set includes three independent methods that share a common drug-coated balloon catheter geometry featuring a reduced-compliance neck section, each aimed at dilating a stricture and delivering a therapeutic agent. Across the independent claims, the coverage includes flushing with water, saline, or a water solution comprising at least one water soluble additive, inserting and inflating a drug-coated balloon catheter with specified main-section and neck-section relationships, releasing the therapeutic agent by keeping the balloon inflated, and then deflating and withdrawing the catheter.

Across the independent methods, the coverage centers on flushing with water, saline, or water-soluble additive, delivering an initial drug load using a drug-coated balloon catheter whose at least one neck section has an inflated diameter smaller than the main diameter, is the smallest diameter during inflation between the main sections, and includes an area of reduced compliance relative to the main sections. The balloon is inflated to dilate a stricture to a desired diameter or to create BPH commissurotomy by yielding tissue, kept inflated to release the therapeutic agent into tissue, then deflated and withdrawn.

Stated Advantages

Documented Applications