Temporary aortic occlusion device
Inventors
Greene, Jr., George R. • Sepetka, Ivan • Lei, Cathy • Nguyen, Rupal • Bradley, Matthew J. • Ahlers, Stephen T. • Goforth, Carl W. • Stone, James R.
Assignees
UVA Licensing and Ventures Group • MicroVention Inc • US Department of Navy
Publication Number
US-11389169-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 that includes an expandable locator portion and an expandable occlusion portion. The locator assists the user in determining when the distal end of the device is within the patient's aorta by expanding with little to no resistance when correctly positioned. The occlusion portion is then expanded to block the aorta, preferably below the renal arteries, to control blood flow.
The background identifies the problem of controlling non-compressible torso hemorrhage, a leading cause of death especially from blast injuries in military personnel, which is difficult due to anatomical challenges and the need for specialized, advanced imaging guidance like fluoroscopy to place occlusion devices. Current treatments such as thoracotomy with aortic cross-clamping have high morbidity and mortality. While endovascular balloon occlusion (REBOA) is less invasive, it requires time, skill, fluoroscopy, and trained operators, limiting its use to advanced care facilities. There is a need for a device that allows rapid and safe temporary occlusion without fluoroscopic guidance, suitable for use in lower levels of care by non-specialists.
The invention addresses these needs by providing a device with a locator portion whose expansion diameter approximates the aorta's internal diameter to indicate proper device positioning through tactile feedback or an indicator light. The locator portion's expansion force is controlled to reduce risk of vessel injury. The occlusion portion expands larger than the locator to occlude the vessel effectively. The device is designed to be low profile to allow insertion through a femoral sheath and removal without surgical repair of the artery. It is adapted for rapid deployment in battlefield or emergency situations by non-endovascular specialists, enabling early control of hemorrhage to improve patient survival.
Claims Coverage
The patent contains independent claims directed to methods of occluding vessels using an occlusive device with a locator and occlusion portion, emphasizing positioning confirmation and expansion control.
Method of endovascular vessel occlusion with expanded locator for position confirmation
Provides a method of pushing an elongated device with a locator portion and an occlusion portion through a blood vessel, radially expanding the locator portion to confirm proper positioning based on encountering resistance in smaller diameter regions, and subsequently expanding the occlusion portion to occlude the vessel.
Method of endovascular aortic occlusion using tactile feedback from locator portion
Describes a method of pushing an occlusive device through the aorta, expanding the locator portion to confirm position, including proximally retracting the locator to engage smaller vessel regions to receive resistance, then expanding the occlusion portion to occlude the aorta, possibly seating the locator adjacent to an iliac artery for confirmation.
Method of occluding a parent artery at a bifurcation using a locator to confirm position
Involves pushing the device through a bifurcation into the parent artery, expanding the locator portion, confirming position by retracting until resistance is encountered due to smaller diameter regions at the bifurcation, and expanding the occlusion portion to occlude the parent artery.
The claims focus on using a dual expandable device with a locator portion sized to facilitate tactile or positional confirmation before expanding an occlusion portion to effectively occlude blood flow in targeted vessels, including the aorta and parent arteries at bifurcations.
Stated Advantages
The locator portion provides tactile feedback or an indicator that aids in confirming device position within the aorta or target blood vessel, reducing placement errors without fluoroscopy.
The locator portion has a lower expansion force and smaller diameter than the occlusion portion, minimizing risk of vessel injury during positioning.
The device allows rapid and less invasive insertion and occlusion compared to thoracotomy with aortic cross-clamping, suitable for use by non-specialists in lower care levels.
The design permits temporary occlusion at vessel bifurcations and various vessels, improving versatility for different anatomical regions and injury types.
The occlusion portion’s larger expansion diameter ensures effective occlusion of the vessel to control hemorrhage.
Documented Applications
Controlling torso hemorrhage resulting from trauma such as blast injuries in battlefield scenarios.
Hemorrhage control in pelvic bleeding and non-compressible torso bleeding where advanced care and fluoroscopy are not available.
Use at lower echelons of care such as Role II facilities, forward surgical units, or by first responders including military medics and special operations corpsmen.
Emergency or hospital use to limit blood flow to injured regions in arms or legs as a first step before additional treatment.
Occlusion of parent arteries at vascular bifurcation regions, including aorta-iliac junctions and other arterial branch points in limbs.
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