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Publication Number
US-11369773-B2
Publication Date
2022-06-28
Expiration Date
Abstract
The present invention relates to a targeted cardiac therapy device that can precisely deliver therapeutic compounds to desired locations on, around or within the heart of a patient, and methods of treating conduction system disease, sinus node dysfunction, atrial fibrillation, myocardial infarction, and heart failure, using the described devices to deliver genetically engineered vectors or cells, proteins, stem cells, small molecule pharmaceuticals and biologics.
Core Innovation
A targeted cardiac therapy system uses a steerable catheter with a handle portion, a shaft portion, and a tip portion, where the catheter includes a steering element configured to guide the catheter inside a patient's body. The catheter has an internal conduit running along the longitudinal axis with a fluid pathway disposed within the conduit, and a temperature control element configured to regulate the temperature of a fluid within the fluid pathway, where the temperature control element is an inner rod disposed within the fluid pathway.
The tip portion comprises an actuator configured to allow delivery of fluid through the actuator from the fluid pathway to the exterior of the catheter. The actuator is described as a foam tipped applicator head or a flocked swab applicator head with holes connecting to a hollow lumen rod. The described system further includes optional sensors/markers, electrodes for electrical localization, and video/hemodynamic/data capture for therapy localization and monitoring.
Therapeutic embodiments include delivering locally to treat conduction system disease, sinus node dysfunction, atrial fibrillation, myocardial infarction, and heart failure using gene transfer vectors/cells, proteins, stem cells, small molecules, and biologics. The document describes examples mapping specific transgenes/cell types to sinus node, atrial fibrillation, myocardial infarction, and heart failure, and outlines kit components including a localizing catheter, a sheath, contrast dye, and power/electrical connections.
Claims Coverage
The independent claim contains three inventive features: a steerable catheter architecture with an internal conduit and fluid pathway, a temperature control element implemented as an inner rod, and a tip actuator configured to deliver fluid to the exterior. Dependent claims further specify the therapeutic compound categories, the cardiac disease indications, and additional delivery hardware relationships for actuator actuation and actuator construction.
Temperature-regulated internal conduit for therapeutic fluid delivery
A device includes an internal conduit running along the longitudinal axis, a fluid pathway disposed within the conduit, and a temperature control element configured to regulate the temperature of a fluid within the fluid pathway, wherein the temperature control element is an inner rod disposed within the fluid pathway.
Tip actuator delivering fluid to the exterior from the conduit
The tip portion comprises an actuator configured to allow delivery of fluid through the actuator from the fluid pathway to the exterior of the catheter, wherein the actuator is a foam tipped applicator head or a flocked swab applicator head with holes connecting to a hollow lumen rod.
Steerable catheter for intrabody guidance during treatment
A steering element configured to guide the catheter inside a patient's body, where the catheter comprises a handle portion, a shaft portion, and a tip portion.
Overall claim coverage combines a steerable catheter with an internal conduit, fluid pathway, and inner-rod temperature control element with a tip actuator configured to deliver therapeutic fluid to the exterior of the catheter.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating conduction system disease.
Treating sinus node dysfunction.
Treating atrial fibrillation.
Treating myocardial infarction.
Treating heart failure.
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