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-9131874-B2
Publication Date
2015-09-15
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 describes a fluoroscopy-independent thoracic aortic occlusion system designed for rapid deployment in end-stage shock resulting from non-compressible torso hemorrhage or other forms of cardiogenic or neurogenic shock. The system comprises a self-centering endovascular wire with calibration markers, a compliant aortic occlusion balloon mounted on a balloon shaft, and a nomogram correlating external anatomical landmarks to intra-arterial distances, allowing positioning of the occlusion balloon at a desired location within the thoracic aorta inferior to the left subclavian artery without fluoroscopic guidance.
The problem addressed is the lack of effective, minimally invasive procedures to control hemorrhage from torso vascular injuries, which are a leading cause of preventable deaths in trauma settings. Existing methods such as tourniquets are ineffective for torso bleeding, and the accepted method of resuscitative thoracotomy is invasive, requires specialized skills, and has poor survival rates. Current balloon occlusion devices are designed for aneurysm treatment in elderly patients, require large sheaths, fluoroscopic guidance for precise positioning and inflation, and do not have safeguards against over-inflation, limiting their use in emergency or austere environments.
The invention overcomes these limitations by providing a calibrated endovascular system that uses statistical correlation data from CT imaging to determine appropriate insertion lengths based on easily measurable external landmarks of torso extent, such as the distance between the sternal notch and the symphysis pubis. The self-centering wire with thermally expandable nitenol struts keeps the device centered in the arterial lumen, preventing misdirection into side branches. The balloon shaft and occlusion balloon are sized to fit through a smaller sheath and include a multi-port valve assembly with a pressure gauge to prevent over-inflation. This system enables precise, rapid aortic occlusion for hemorrhage control and perfusion support without fluoroscopy.
Claims Coverage
This patent contains two independent claims covering both the aortic occlusion system and a method for deploying the balloon.
Thoracic aortic occlusion system enabling fluoroscopy-independent positioning
A system comprising an endovascular wire, a balloon shaft with aortic occlusion balloon passing over the wire, and a nomogram correlating external anatomical landmarks to intra-arterial distances. This allows calculation of insertion length for positioning the occlusion balloon in the thoracic aorta without fluoroscopy.
Method for deploying and inflating a thoracic aortic balloon without fluoroscopy
A method involving measurement of a distance between external anatomical landmarks (symphysis pubis and sternal notch), comparison to a prediction model from CT imaging data correlating torso extent to arterial distances, calculation of insertion length, and insertion of a calibrated endovascular wire and balloon shaft to position and inflate the balloon independently of fluoroscopy.
The independent claims cover both the apparatus incorporating an endovascular wire, balloon system, and nomogram for fluoroscopy-independent positioning, and the method applying measurement of external landmarks linked to arterial distances to enable guided balloon deployment without fluoroscopy.
Stated Advantages
Enables rapid, accurate deployment of aortic occlusion balloon in trauma patients without the need for fluoroscopy.
Provides a less invasive alternative to resuscitative thoracotomy with reduced morbidity.
Includes a self-centering wire design reducing risk of vessel perforation or misdirection into branches.
Incorporates calibrated length markers and a nomogram facilitating precise insertion length calculation from easily measurable external landmarks.
Features a pressure-monitored inflation system to prevent balloon over-inflation and vessel injury.
Allows use in austere, emergency, and non-operating room environments where fluoroscopy is unavailable.
Documented Applications
Treatment of non-compressible torso hemorrhage in trauma patients for resuscitative aortic occlusion.
Management of profound shock from hemorrhage, cardiac, or neurogenic causes causing severe central hypotension.
Emergency, intensive care unit, or surgical settings lacking fluoroscopy to control hemorrhage and augment perfusion to heart and brain.
Potential applications include civilian trauma, military battlefield care, neurogenic shock, cardiac arrest, and post-partum hemorrhage within operating or delivery rooms.
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