Temporary aortic occlusion device
Inventors
Greene, Jr., George R. • Sepetka, Ivan • Lei, Cathy • Nguyen, Rupal • Bradley, Matthew J. • Ahlers, Stephen T. • Goforth, Carl S. • Stone, James R.
Assignees
UVA Licensing and Ventures Group • MicroVention Inc • US Department of Navy • University of Virginia UVA
Publication Number
US-11389168-B2
Publication Date
2022-07-19
Expiration Date
2037-08-29
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Abstract
A temporary aortic occlusion device is disclosed, having an expandable locator portion and an expandable occlusion portion. The expandable locator portion assists a user in determining whether the distal end of the device has been advanced within a patient's aorta, and the occlusion portion is expanded to occlude the patient's aorta, preferably below the renal arteries.
Core Innovation
The invention is a temporary aortic occlusion device comprising an expandable locator portion and an expandable occlusion portion. The locator portion assists a user in determining whether the distal end of the device has been correctly advanced within a patient's aorta, and the occlusion portion is radially expanded to occlude the patient's aorta, preferably below the renal arteries. The locator portion typically has a maximum expansion diameter smaller than the occlusion portion and is designed to match or slightly undersize the internal diameter of the patient's aorta to provide minimal resistance when positioned within the aorta.
The problem being solved addresses the challenge of controlling non-compressible torso hemorrhage, which is a leading cause of death in active-duty military personnel due to blast injuries. Current techniques for aortic occlusion require fluoroscopic guidance, specialized operators, and bulky equipment, limiting their use to higher echelons of care. Existing methods are time-consuming, technically complex, and involve risks such as vascular injury requiring surgical repair. This invention seeks to improve temporary hemorrhage control at lower care levels by providing a device that allows for tactile confirmation of placement and controlled occlusion without fluoroscopy.
Claims Coverage
The patent includes two independent claims covering a temporary aortic occlusion device and a method of controlling device expansion and occlusion. There are several inventive features related to the structure and function of the device's locator and occlusion portions, their diameter relationships, control mechanisms, and handle configuration.
Expandable locator portion with controlled radial expansion
The locator portion is near the distal end, radially expandable from the proximal end, and has a maximum expansion diameter less than the aorta's diameter to confirm proper positioning by sensing resistance.
Expandable occlusion portion for aortic blockage
The occlusion portion is near the distal end, radially expandable to a diameter equal to or greater than the aorta's diameter, causing occlusion of the aorta.
Control-member applying axial compressive force to expand locator
A control member extends from the proximal end to the locator portion, configured to apply a compressive axial force that decreases the relative distance between locator sides to radially expand the locator portion.
Locator and occlusion portions composed of braided wires or balloon
The locator and occlusion portions can be formed from braided wires. Alternatively, the occlusion portion can be a balloon inflatable with fluid to control expansion.
Locator positioned proximally or distally relative to occlusion portion
The locator portion can be positioned proximal or distal to the occlusion portion near the distal end of the device body.
Handle with slider members controlling expansions
A handle at the proximal end includes first and second slider members that control radial expansion of the locator portion and occlusion portion, respectively, and may include a fluid connection port for balloon inflation.
Maximum diameter of locator is smaller than occlusion portion
The locator portion's maximum expansion diameter is smaller than that of the occlusion portion, assisting position confirmation without occluding prematurely.
The inventive features collectively provide a device capable of temporary aortic occlusion with improved placement confirmation using a radially expandable locator of smaller diameter, a larger diameter occlusion portion, and user-controlled expansion via proximal handle sliders or fluid inflation, allowing use below the renal arteries without fluoroscopy.
Stated Advantages
Allows users to sense whether resistance is encountered during locator expansion, providing confidence that the device is in the aorta.
The locator portion presents minimal risk of vessel rupture by having a smaller expansion diameter and applying less radial force initially.
Avoids the need for fluoroscopic guidance and bulky equipment, enabling quicker, easier insertion and broader use, including at lower echelons of care.
Atraumatic tip design helps prevent injuring the aorta during insertion.
Expandable occlusion portion can apply sufficient force and seal to occlude the aorta effectively below the renal arteries.
Documented Applications
Hemorrhage control for traumatic non-compressible torso bleeding in battlefield or trauma settings.
Temporary occlusion of the aorta below the renal arteries to stabilize patients with pelvic or intra-abdominal hemorrhage.
Use at forward surgical settings such as Role II or Role I care with non-endovascular specialized providers, including Navy operational medical units like the Navy Afloat Trauma System (NATS) and Navy/Marine Corps Forward Resuscitative Surgical Systems (FRSS).
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