Drug coated balloon catheters for nonvascular strictures
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Publication Number
US-12357732-B2
Publication Date
2025-07-15
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 relates to treating a nonvascular body lumen by contacting a coating on a medical device with the walls of the body lumen. The coating comprises a liquid comprising water, at least one additive, and an initial drug load of a therapeutic agent. The body lumen is a nasal lumen, a sinus lumen, an airway lumen, a bronchial lumen, a bronchiole lumen, a trachea, or combinations thereof.
The coating additive is compatible with an initial drug load of therapeutic agents comprising paclitaxel, paclitaxel analogues, docetaxel, docetaxel analogues, taxol, taxol analogues, rapamycin, rapamycin analogues, everolimus, everolimus analogues, tacrolimus, tacrolimus analogues, or combinations thereof. The disclosed additive classes and examples include polyglyceryl fatty esters, ascorbic acid derivatives, small soluble amino acids and vitamins, and pentaerythritol ethoxylate and pentaerythritol propoxylate derivatives.
A core aspect is using water-soluble coating additives in a water-containing coating to promote rapid hydrophobic drug release during contacting of the coating with lumen walls, including balloon catheter-based contacting in a nonvascular lumen. The document describes that additive-water interactions can displace water and enable interactions that loosen lipid membranes, thereby facilitating release of the hydrophobic drug, with the coating and loading configured for a reported drug release range under bench testing.
Claims Coverage
The document provides three independent claims. Each claim is directed to contacting a water-containing coating on a medical device with walls of a nonvascular body lumen and delivering an initial drug load of specified therapeutic agents, with claim-specific limitations on lumen type and additive identity.
Water-containing coating contacting walls of a nonvascular lumen with an initial drug load
Contacting a coating on a medical device in a body lumen with walls of the body lumen, wherein the coating comprises a liquid comprising water, wherein the body lumen comprises a nasal lumen, a sinus lumen, an airway lumen, a bronchial lumen, a bronchiole lumen, a trachea, or a combination thereof, and wherein the coating comprises at least one additive and an initial drug load of a therapeutic agent comprising paclitaxel, a paclitaxel analogue, docetaxel, a docetaxel analogue, taxol, a taxol analogue, rapamycin, a rapamycin analogue, everolimus, an everolimus analogue, tacrolimus, a tacrolimus analogue, or a combination thereof.
Pentaerythritol ethoxylate additive with paclitaxel initial drug load for nasal/sinus treatment
Contacting a coating on a medical device in a body lumen with walls of the body lumen, wherein the coating comprises a liquid comprising water, wherein the body lumen comprises a nasal lumen, a sinus lumen, or a combination thereof, wherein the coating comprises at least one additive comprising pentaerythritol ethoxylate 15/4 EO/OH and an initial drug load of a therapeutic agent comprising paclitaxel, a paclitaxel analogue, or a combination thereof.
Pentaerythritol ethoxylate additive with paclitaxel initial drug load for airway treatment
Contacting a coating on a medical device in a body lumen with walls of the body lumen, wherein the coating comprises a liquid comprising water, wherein the body lumen comprises an airway lumen, a bronchial lumen, a bronchiole lumen, a trachea, or a combination thereof, wherein the coating comprises at least one additive comprising pentaerythritol ethoxylate 15/4 EO/OH and an initial drug load of a therapeutic agent comprising paclitaxel, a paclitaxel analogue, or a combination thereof.
Across the independent claims, treatment is performed by contacting a water-containing coating on a medical device with walls of a nonvascular body lumen and delivering an initial drug load of paclitaxel and, in one claim, docetaxel, taxol, rapamycin, everolimus, and tacrolimus families. Two independent claims further limit the additive to pentaerythritol ethoxylate 15/4 EO/OH and restrict the lumen type to nasal/sinus or airway/bronchial/trachea.
Stated Advantages
Inhibiting hyperplasia of body-lumen wall tissue.
Relieving symptoms of sinusitis.
Relieving symptoms of asthma.
Enables rapid hydrophobic drug release during contacting in short inflation periods.
Reported drug release range under bench testing.
Documented Applications
Treating strictures in nonvascular body lumens including nasal lumen, sinus lumen, airway lumen, bronchial lumen, bronchiole lumen, and trachea.
Treating benign prostatic hyperplasia (BPH) strictures.
Treating urethral strictures.
Treating ureteral strictures.
Treating esophageal strictures.
Treating sinus strictures.
Treating biliary tract strictures.
Treating airway lumen strictures including bronchial and bronchiole contexts.
Treating a nonvascular body lumen in nasal lumens and/or sinus lumens by contacting device coatings that include water, an additive, and an initial drug load of paclitaxel or paclitaxel analogues.
Treating a nonvascular body lumen in airway lumens, bronchial lumens, bronchiole lumens, and/or a trachea by contacting device coatings that include water, an additive, and an initial drug load of paclitaxel or paclitaxel analogues.
In the broader method claim, treating a nonvascular body lumen in nasal/sinus/airway/bronchial/bronchiole/trachea by contacting a water-containing coating with the lumen walls, with initial drug loads including paclitaxel family and additional therapeutic agent families.
In one dependent context, inhibiting hyperplasia of body-lumen wall tissue contacted by the coating and/or relieving symptoms of sinusitis and asthma.
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