Drug coated balloon catheters for nonvascular strictures
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Publication Number
US-11484628-B2
Publication Date
2022-11-01
Expiration Date
Abstract
Embodiments of the present invention provide a method of treating a stricture in a nonvascular body lumen such as urethral strictures, benign prostatic hyperplasia (BPH) strictures, ureteral strictures, esophageal strictures, sinus strictures, and biliary tract strictures. Embodiments of the present invention provide a method for treating at least one of benign prostatic hyperplasia (BPH), prostate cancer, asthma, and chronic obstructive pulmonary disease (COPD). The method can include delivering, for example, via drug coated balloon catheters, anti-inflammatory and anti-proliferative drugs (e.g., rapamycin, paclitaxel, and their analogues) and one or more additives.
Core Innovation
The invention describes treating a body lumen stricture by using a balloon catheter with a coating layer overlying external balloon surfaces and comprising at least one additive and an initial drug load of a therapeutic agent. The method includes flushing the body lumen stricture with flushing media comprising water, saline solution, or a water solution comprising at least one water-soluble additive, and exposing the balloon catheter to a liquid comprising the flushing media for a soaking period prior to inflation to hydrate the coating layer.
After hydration, the balloon catheter is inflated in the body lumen stricture to contact walls of the body lumen stricture with the coating layer and continues inflating until the stricture is dilated to a desired diameter. The balloon catheter is then deflated and withdrawn from the body lumen. The disclosure also ties drug release and residual drug to exposure and contacting, including release ranges associated with the soaking period and contact of the coating layer with the stricture.
The coating layer is configured so that water-compatible additives interact with hydrophobic therapeutic agents, including hydrogen-bond and van der Waals interactions, to promote rapid solubilization and release. The disclosure includes additive chemistries and coating layer arrangements such as an adherent layer and an optional top layer to improve coating adhesion and protect against drug loss, including consideration of erosion-release behavior.
Claims Coverage
The independent claim clm-00001 covers a method for treating a body lumen stricture using a drug-loaded balloon catheter coating, with coordinated flushing, soaking to hydrate the coating layer, inflation to dilate the stricture, and deflation and withdrawal. The provided claim content includes four core inventive features, with additional dependent refinements on drug release range, therapeutic agent families, inflation timing, area-normalized drug load, and endoscope scope.
Flushing the body lumen stricture with water or saline comprising a water-soluble additive
The stricture is flushed with flushing media comprising water, saline solution, or a water solution comprising at least one water-soluble additive.
Balloon catheter with a coating layer including an additive and initial drug load
A balloon catheter is inserted into the body lumen stricture, the balloon comprising a coating layer overlying external balloon surfaces, the coating layer comprising at least one additive and an initial drug load of a therapeutic agent.
Soaking in flushing media prior to inflation to hydrate the coating layer
The balloon catheter is exposed to a liquid comprising the flushing media in the body lumen stricture for a soaking period prior to inflation to hydrate the coating layer.
Inflating to dilate the stricture to a desired diameter by contacting the coating layer
The balloon catheter is inflated in the body lumen stricture to contact walls of the body lumen stricture with the coating layer until the stricture in the body lumen is dilated to a desired diameter, then deflated and withdrawn from the body lumen.
Soaking/contact sufficient for a drug release range
The soaking period in combination with contacting of the coating layer with the stricture is sufficient to release 37% to 97% of the initial drug load.
Therapeutic agent selected from specified drug families
The therapeutic agent includes paclitaxel or an analogue, docetaxel or an analogue, taxol or an analogue, rapamycin or an analogue, everolimus or an analogue, tacrolimus or an analogue, or any combination of these.
Holding the balloon inflated for a defined duration before deflation
Keeping a balloon inflated for 0.1 minutes to 10 minutes before deflating it.
Area-normalized initial drug load range on the balloon
The initial drug load of the therapeutic agent on the balloon is between 1 and 20 micrograms per square millimeter.
Endoscope included as part of the method scope
The method scope includes an endoscope.
The claimed approach centers on hydrating a drug-loaded balloon coating by soaking the balloon catheter in flushing media containing water or saline, optionally with water-soluble additives, then inflating to contact stricture walls until dilation to a desired diameter, followed by deflation and withdrawal. The dependent content further specifies drug release range, therapeutic agent families, inflation duration, area-normalized drug load, and endoscope inclusion.
Stated Advantages
Water-compatible additives interact with hydrophobic therapeutic agents, including hydrogen-bond and van der Waals interactions, to promote rapid solubilization and release.
Optional adherent layer and optional top layer features improve coating adhesion and protect against drug loss.
The disclosure considers erosion-release behavior.
Documented Applications
Treatment of a body lumen stricture.
Drug-coated balloons.
Preclinical studies in urethra/ureter contexts.
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