Vascular occlusion catheter for partial occlusion or full occlusion
Inventors
Franklin, Curtis J. • Schmid, Gregory S. • PICKERING, Mathew Charles
Assignees
Publication Number
US-12102330-B2
Publication Date
2024-10-01
Expiration Date
2042-03-17
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Abstract
A vascular occlusion catheter for partial occlusion or full occlusion includes a proximal outer shaft, a distal outer shaft, and an occlusion balloon therebetween. The proximal shaft has first and second internal lumens, the first internal lumen being in fluid communication with the balloon. The distal shaft has a distal internal lumen. A hypotube extends through the first internal lumen, through the balloon and into communication with the distal internal lumen. A first window is formed in the proximal shaft and a proximal sensor is positioned within the second internal lumen at the window. A second window is formed in the distal shaft and a distal sensor is positioned within the distal internal lumen at the window. A display hub is positioned along the proximal shaft and electrically connected with the sensors The uninflated vascular occlusion catheter has a greatest outer diameter of seven French or less.
Core Innovation
The invention is a vascular occlusion catheter designed for at least partial or full occlusion of a target blood vessel, such as the aorta, with a greatest outer diameter of seven French (7 Fr) or less in an uninflated state. The catheter comprises a proximal outer shaft with first and second internal lumens, a distal outer shaft terminating with an atraumatic tip, an occlusion balloon connected between the shafts, and a hypotube extending through the system, serving as the primary load-bearing chassis. The hypotube is in fluid communication with the occlusion balloon, allowing inflation and deflation, and features openings to facilitate fluid connection and minimize stiffness.
The catheter includes sensors housed within each shaft: a proximal sensor facing a window within the second internal lumen of the proximal shaft, and a distal sensor facing a window within the distal lumen of the distal shaft. These sensors, which may be MEMS-based pressure sensors, are connected electrically to a display hub along the proximal shaft. The display hub displays sensor data, such as measured pressures upstream and downstream of the occlusion balloon, and may include data transmission features.
A key problem addressed is the need to achieve vessel occlusion (partial or full) while maintaining minimized catheter size to reduce patient morbidity at the access site. Traditional devices require larger diameters, increasing the risk and complexity of vascular access and recovery. The present catheter achieves its functions and integrates sensor and transmission technology while keeping the maximum uninflated diameter at or below seven French (7 Fr), enabling the use of smaller sheaths and potentially avoiding surgical access site repair.
Claims Coverage
The independent claims set forth three main inventive features for a vascular occlusion catheter system.
Vascular occlusion catheter with dual-lumen proximal section, embedded sensors, and integrated display hub
A vascular occlusion catheter comprises: - A proximal outer section with first and second internal lumens, with the first lumen in fluid communication with an occlusion balloon. - A distal outer section with a distal internal lumen. - A hypotube with an internal hypotube lumen extending through the first internal lumen, the occlusion balloon, and into the distal internal lumen, serving as the primary load-bearing chassis. - A solid distal wire embedded in the distal section, extending toward the tip, with its central axis radially offset from the central axis of the hypotube. - A window in each of the proximal and distal sections, and sensors (proximal and distal) within the respective lumens facing the windows. - A display hub positioned along the proximal outer section, with the second internal lumen and the hypotube extending into the hub. The display hub is electrically connected with the sensors through these lumens.
Vascular occlusion catheter with inflation hub, internal hub frame, and customizable connections
A vascular occlusion catheter includes: - An inflation hub with an inflation shaft. - Proximal and distal outer sections, each with respective internal lumens. - A hypotube operating as the primary load-bearing chassis, extending through the system. - A solid distal wire embedded in the distal section, radially offset from the hypotube. - Proximal and distal sensors facing through windows within their respective lumens. - A display hub with an internal hub frame that: 1. Secures the first internal lumen and hypotube. 2. Secures the inflation shaft and fluidly connects it to the first internal lumen. 3. Allows for electrical connection to the proximal sensor via the second internal lumen and to the distal sensor via the internal hypotube lumen and the distal lumen.
Vascular occlusion catheter with offset distal wire originating beyond balloon neck
A vascular occlusion catheter includes: - Proximal and distal outer sections, a tip, an occlusion balloon, and the specified lumens and hypotube chassis. - A solid distal wire embedded in the distal section, originating distally from the proximal-most end of the balloon neck, radially offset from the hypotube, and extending toward the tip. - Proximal and distal sensors positioned within lumens facing windows, and a display hub electrically connected to these sensors as previously detailed.
In summary, the patent claims cover a low-profile vascular occlusion catheter integrating a hypotube chassis, offset solid distal wire, dual sensors facing through dedicated windows, and a display hub that manages data from the sensors. Configurations include features such as an inflation hub with an internal display hub frame for secure and fluid communication, with a design emphasis on minimizing overall diameter for improved clinical outcomes.
Stated Advantages
The catheter maintains a greatest outer diameter of seven French (7 Fr) or less in an uninflated state, enabling use of smaller insertion sheaths and potentially reducing the need for surgical access site repair.
The hypotube construction provides sufficient structural integrity and bending flexibility, allowing safe balloon inflation and improved maneuverability within tortuous vascular anatomy.
Integrated proximal and distal sensors provide direct measurement of central pressures downstream and upstream of the occlusion balloon for accurate and immediate physiological monitoring.
Display hub allows real-time display of key parameters, including pressure and potentially other physiological data, facilitating user decision-making during procedures.
Configurable features such as sensor types, pressure relief, and data transmission allow for flexible use and adaptation to various clinical scenarios.
Balloon and catheter design (including optional embedded braids and folding features) increase kink resistance and facilitate recapture and deflation through low-profile sheaths.
Documented Applications
The catheter is used for vascular occlusion, including partial or full occlusion of blood vessels such as the aorta for vascular procedures, repairs, or resuscitative endovascular balloon occlusion of the aorta (REBOA).
Medical application involves restricting blood flow upstream or downstream of an occlusion site, with the option for partial occlusion to allow limited downstream perfusion during procedures.
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