System and method for low profile occlusion balloon catheter
Inventors
Franklin, Curtis J. • KRUMMENACHER, Todd J. • REYNOLDS, Jeremy • Spencer, David • FISHER, Luke William
Assignees
Publication Number
US-11253264-B2
Publication Date
2022-02-22
Expiration Date
2037-06-02
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Abstract
An occlusion catheter system includes an inflation catheter member and an occlusion balloon. The proximal and distal balloon ends are connected to the inflation catheter between the proximal and distal catheter ends. A distal pressure sensor is attached to the inflation catheter member between the proximal balloon end and the atraumatic tip. An inflatable spine is connected to the inflation catheter. The proximal spine end is connected to the inflation catheter near the proximal balloon end and the distal spine end is connected to the inflation catheter near the distal balloon end. The occlusion balloon and the inflatable spine are configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in a partially inflated configuration.
Core Innovation
The invention is an occlusion catheter system designed for occlusion or partial occlusion of relatively large vessels. It features an inflation catheter member with a first inflation lumen, stiffener member, proximal and distal ends, and an atraumatic tip. An occlusion balloon with internal and external surfaces is centered along the catheter axis, and the system can include a proximal and/or distal pressure sensor, a control hub, a pump, and a controller for managing inflation based on sensed pressure.
The problem addressed by this invention is the lack of precise control during vascular occlusion procedures, especially in managing hypertension during occlusion and hypotension upon withdrawal in scenarios such as aortic occlusion. Existing occlusion balloon technology often results in abrupt changes in blood flow during partial occlusion, loss of balloon-vessel wall contact, balloon vibration and movement, and difficulty in finely controlling pressure ratios across the balloon.
The core innovation of the present invention lies in the integration of sensing, control, and specifically designed balloon and spine geometries. The occlusion balloon and, in some embodiments, an inflatable or solid spine create controllable blood flow channels between the vessel wall, balloon, and spine during partial inflation. The control hub and pressure sensors enable automated or semi-automated regulation of balloon inflation or deflation in response to real-time physiological parameters, providing for gradual, stable, and precise modulation of blood flow and vessel occlusion.
Claims Coverage
The patent contains three independent claims, each addressing a different configuration of the occlusion catheter system. These claims focus on inventive features related to catheter structure, pressure sensing, automated control, and blood flow management.
Automated controlled occlusion catheter system with proximal pressure sensing
An occlusion catheter system comprising: - An inflation catheter member with a stiffener member, a first inflation lumen, distal catheter end, proximal portion, and an atraumatic tip defining a longitudinal axis. - An occlusion balloon with internal balloon space and external balloon surface, connected along the longitudinal axis, with the first inflation lumen in fluid communication with the balloon. - A proximal pressure sensor attached to the proximal portion. - A control hub electronically linked with the proximal pressure sensor. - A pump associated with the catheter to introduce or withdraw pressurized fluid from the balloon space. - A controller that receives proximal pressure signals and controls the pump to adjust balloon inflation or deflation based on the proximal pressure readings.
Automated controlled occlusion catheter system with distal pressure sensing
An occlusion catheter system comprising: - An inflation catheter member with a stiffener member, a first inflation lumen, distal catheter end, proximal portion, and an atraumatic tip. - An occlusion balloon with specified features, and the lumen in fluid communication with the balloon. - A distal pressure sensor attached on the catheter between the distal balloon end and the atraumatic tip. - A control hub in communication with the distal pressure sensor. - A pump for introducing or withdrawing pressurized fluid from the balloon space. - A controller programmed to receive distal pressure signals and control the pump to adjust balloon inflation or deflation based on the distal pressure signals.
Automated occlusion catheter system with both distal and proximal pressure sensing and control hub
An occlusion catheter system comprising: - An inflation catheter member with a stiffener member, first inflation lumen, distal catheter end, proximal portion, and an atraumatic tip. - An occlusion balloon attached as described, with the first inflation lumen in fluid communication with the balloon. - A distal pressure sensor attached between the distal balloon end and the atraumatic tip. - A proximal pressure sensor attached to the proximal portion. - A control hub mounted to the proximal portion of the catheter. - A pump for fluid introduction/withdrawal. - A controller configured to receive both distal and proximal pressure signals and control the pump to introduce or withdraw pressurized fluid from the balloon based on both sets of signals.
The inventive features focus on catheter systems integrating mechanical balloon occlusion with automated, sensor-driven control. Configurations include use of proximal and/or distal pressure sensors, a control hub, and a controller managing inflation or deflation based on real-time physiological feedback to provide controlled, stable partial or full vascular occlusion.
Stated Advantages
Provides smooth and controlled transition between full and partial vascular occlusion, allowing precise control over blood flow across the occlusion balloon.
Maintains stable engagement of the occlusion balloon with the vessel wall during partial perfusion, reducing vibration, movement, and the risk of balloon displacement.
Enables more gradual and fine control of proximal and distal pressure ratios, mitigating abrupt changes in blood pressure and improving physiological management during procedures.
Allows for targeted blood flow to upstream organs (brain, heart, lungs) during occlusion and permits partial perfusion to downstream organs, potentially extending safe device implantation time.
Integrates electronic pressure sensors and automated control, facilitating quick adjustments and providing real-time feedback to the medical practitioner.
Documented Applications
Vascular occlusion and partial occlusion in large vessels, including the aorta, for endoarterial procedures to manage blood flow during vascular procedures or repair.
Use in pre-conditioning procedures to mitigate ischemia before, during, or after vascular occlusion, and to manage hypertension during occlusion or hypotension after occlusion.
Temporary aortic occlusion to increase proximal or central perfusion to the heart and brain in cases of shock due to major trauma.
Resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma management.
Provision for selective partial perfusion to downstream organs such as the liver, digestive tract, kidneys, and legs during an occlusion procedure.
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