Fluoroscopy-independent, endovascular aortic occlusion system
Inventors
Eliason, Jonathan L. • Rasmussen, Todd E.
Assignees
Government Of United States Represented By Director Of Defense Health Agency AS • US Department of Veterans Affairs • University of Michigan Ann Arbor
Publication Number
US-10111669-B2
Publication Date
2018-10-30
Expiration Date
2031-04-21
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Abstract
A system for deploying and selectively inflating a thoracic aortic balloon at a desired location within the thoracic aorta for resuscitative aortic occlusion, inferior to the left subclavian artery, without the aid of fluoroscopy is described. Using CT imaging data, a distance between readily identifiable and consistently located external landmarks of torso extent is measured. Next, using the same data, a second distance from the femoral artery to a desired aortic occlusion location inferior to the left subclavian artery is determined. A correlation between the external measure of torso extent and the desired intra-arterial (i.e. endovascular) distance within the torso is made. Using a nomogram, a calibrated endovascular resuscitative thoracic aortic occlusion system can be positioned to this desired location on any injured individual with end-stage shock and impending cardiovascular collapse or death without the aid of fluoroscopy for delivery or balloon inflation.
Core Innovation
The invention provides a system for deploying and selectively inflating a thoracic aortic balloon at a desired location within the thoracic aorta, specifically inferior to the left subclavian artery, for resuscitative aortic occlusion without the use of fluoroscopy. This system employs a nomogram derived from CT imaging data correlating external torso landmarks to internal arterial distances, enabling accurate insertion and placement of an endovascular wire and aortic occlusion balloon from the femoral artery to the thoracic aorta.
The problem addressed is the limitation and risks associated with current methods of controlling non-compressible torso hemorrhage, especially the reliance on highly invasive resuscitative thoracotomy or balloon occlusion systems that require fluoroscopy for precise positioning and inflation. Existing balloons are designed for elderly patients with aneurysms, require large sheaths, lack fixation, dangers of over-inflation, and depend on specialized imaging, restricting their use to equipped medical facilities away from trauma sites.
The invention solves this by enabling fluoroscopy-independent endovascular resuscitative thoracic aortic occlusion through a calibrated system including a self-centering endovascular wire with a thermally-activated, self-expanding nitenol wire strut mechanism for centering and stabilization, an occlusion balloon of appropriate diameter and length for young adults, and calibrated indicia for insertion distance. The system uses measurable external landmarks to calculate insertion lengths, allowing use in semi-austere or emergency environments without fluoroscopic guidance.
Claims Coverage
The claims include two main independent claims focusing on a vessel occlusion system and a thoracic aortic occlusion system, covering key inventive features related to balloon shaft design, positioning method without fluoroscopy, and self-centering wire configurations.
Balloon shaft with pre-calibrated length indicia and port for inflation
A balloon shaft having a distal end with an occlusion balloon connected thereto and a proximal end including a port for inflation, with pre-calibrated length markings on its external surface to indicate insertion distance.
Nomogram correlating external torso landmarks to insertion length for fluoroscopy-independent placement
A nomogram correlating measurable external boney landmarks (e.g., from symphysis pubis to sternal notch) to internal vascular distances from an insertion puncture to a predetermined thoracic aorta location, enabling insertion and positioning of the occlusion balloon without fluoroscopy, including a listing of aortic diameters.
Self-centering endovascular wire with thermally activated wire struts
An endovascular wire featuring a curved J tip to limit vessel perforation and a plurality of self-expanding wire struts made of nitenol that expand upon exiting a percutaneous sheath to center the wire in the arterial lumen and prevent unintended branch entry, secured by anchoring beads thereby preventing balloon migration.
Percutaneous sheath sized for minimally invasive femoral artery insertion
A 6 French percutaneous sheath approximately ten centimeters in length, configured to receive and allow passage of the self-centering wire, balloon shaft, and occlusion balloon into the femoral artery.
Multi-port and valve assembly with pressure monitoring for controlled balloon inflation
A multi-port valve assembly at the proximal end of the balloon shaft including a one-way valve and pressure monitoring device calibrated to inform when sufficient pressure is reached to avoid over-inflation.
The independent claims collectively cover a fluoroscopy-independent thoracic aortic occlusion system comprising a pre-calibrated balloon catheter, a calibrated nomogram for insertion length determination using external landmarks, a self-centering endovascular wire with thermally expanding wire struts for accurate placement, a percutaneous sheath for access, and an inflation system with pressure monitoring to ensure safe balloon deployment.
Stated Advantages
Enables rapid aortic occlusion without reliance on fluoroscopy, facilitating use in emergency and semi-austere environments lacking advanced imaging.
Minimally invasive alternative to highly invasive resuscitative thoracotomy, reducing patient morbidity and complications such as lung injury and post-operative pain.
Self-centering wire design prevents inadvertent entry into arterial branches, improving safety and accuracy of balloon placement.
Calibrated length markings and nomogram allow precise positioning based on external measurements, eliminating need for real-time imaging.
Pressure-monitored inflation reduces risk of over-inflation and potential aortic rupture, enhancing patient safety.
Documented Applications
Treatment of non-compressible torso hemorrhage from trauma in young adult trauma victims in both battlefield and civilian emergency settings.
Resuscitative aortic occlusion to augment perfusion pressure to the heart and brain during end-stage shock from hemorrhage, cardiogenic, or neurogenic causes leading to cardiovascular collapse.
Use in emergency, intensive care unit, or surgical environments where fluoroscopy is not readily available, enabling wide margin endovascular procedures.
Management of cardiac arrest, neurogenic shock, or post-partum hemorrhage in operating or delivery rooms.
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