System and method for low-profile occlusion balloon catheter
Inventors
Franklin, Curtis J. • Spencer, David • KRUMMENACHER, Todd J.
Assignees
Publication Number
US-11672951-B2
Publication Date
2023-06-13
Expiration Date
2036-03-18
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Abstract
An occlusion catheter system includes a proximal hub having an inflation connection port and an inflation pathway. An inflation catheter member is connected to the proximal hub and has an inflation lumen. A stiffener member defines a longitudinal axis. The proximal end of the stiffener member is connected to the proximal hub. The stiffener member extends through a portion of the inflation lumen. An occlusion balloon has a proximal balloon end and a distal balloon end. A distal catheter member is positioned substantially on the longitudinal axis and is connected to the distal end of the stiffener member. An atraumatic tip is positioned on a distal end of the distal catheter member. The atraumatic tip has a substantially circular profile in a relaxed configuration. A pressure sensor is connected to the occlusion catheter system distally relative to the occlusion balloon and is connected to a processor by electrical wiring.
Core Innovation
The invention provides an occlusion catheter system designed for full or partial vessel occlusion, particularly suited for aortic and vascular applications. The system includes a first catheter member, a second catheter member with a lumen spaced from the first, a third catheter member attached distally, a proximal hub, and an occlusion balloon defining an inflation space. The balloon features both radially projecting members and intervening landing areas that form fluid flow channels when partially inflated, allowing for controlled blood flow past the occlusion site. The system also includes a pressure relief valve in the fluid pathway to enhance safety by releasing pressure at a level below the balloon's burst pressure.
This invention addresses the problem in the background where conventional occlusion catheters, especially those for aortic occlusion, fail to balance proximal stiffness with distal flexibility and low profile. Existing solutions do not allow for easy navigation through tortuous vasculature or prevent unintended entry into collateral vessels, nor do they provide automatic, physiological feedback-controlled occlusion and perfusion management. Additionally, traditional REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) approaches often require imaging guidance and do not support rapid, field-appropriate deployment or intermittent, parameter-triggered occlusion release.
The catheter system introduces a smart design, featuring an atraumatic tip with a circular relaxed profile for safer vessel navigation, optional sensors for physiological monitoring, and the ability to channel fluid past the balloon during partial occlusion. The system can be coupled to a controller and pump, with distal pressure measurement enabling real-time adjustment of inflation volume based on preset pressure setpoints. The pressure relief feature further prevents over-inflation. The design supports both guidewire-free operation, for rapid deployment in emergency and field settings, and traditional guidewire compatibility.
Claims Coverage
The patent includes one independent claim that outlines several inventive features centered on the configuration and control of a low-profile occlusion catheter system.
Occlusion catheter system with fluid flow channels and landing areas
The system comprises a first, second, and third catheter member and a proximal hub with a fluid pathway. The occlusion balloon is configured to, upon partial inflation, define both radially projecting members and intervening radially projecting landing areas. These elements sit in apposition with the vessel's inner surface, with the landing areas forming fluid flow channels in a curvilinear manner along the balloon's length, allowing channeling of fluid from the distal to the proximal side during partial occlusion.
Pressure relief valve configured for safety
The system integrates a pressure relief valve on the fluid pathway of the proximal hub, designed to open and release pressure at a predetermined value below the balloon's burst pressure. This feature is meant to prevent balloon over-inflation and protect vessel integrity.
Extension of first catheter member into the third catheter member
The first catheter member is constructed to extend distally beyond the distal end of the occlusion balloon and into the third catheter member, forming a specific configuration supporting the unique structure and function of the system.
The inventive features together define a low-profile occlusion catheter system with a pressure-relieving safety mechanism, a balloon that provides controllable partial occlusion with fluid flow pathways, and a specialized multi-catheter structure. These elements collectively address previously unmet clinical needs in vascular occlusion procedures.
Stated Advantages
The atraumatic guiding tip eliminates the need for a guide wire, allowing for guidewire and fluoroscopy-free placement and enabling use in emergency or field operations.
The system can intermittently and automatically allow perfusion past the occluding member in response to physiological parameters, then re-establish occlusion as needed, thereby controlling hypertension and hypotension during or after vascular procedures.
The pressure relief valve prevents over-inflation and potential vessel injury by releasing pressure before reaching the balloon's burst threshold.
The low-profile, flexible distal segment improves trackability through tortuous vasculature and reduces the risk of trauma or perforation.
Computer-controlled monitoring and adjustment of occlusion based on real-time physiological data enhances patient safety and care.
The system can be operated without imaging technology, making it suitable for field use or environments lacking advanced medical infrastructure.
Documented Applications
Temporary aortic occlusion for resuscitative endovascular balloon occlusion of the aorta (REBOA) procedures, especially in trauma settings.
Providing variable partial occlusion of a vessel to augment and maintain cerebral perfusion in patients with global or focal ischemia.
Prophylactic use by interventional radiologists, neuroradiologists, or cardiologists during angiogram or fluoroscopy procedures.
Treating shock to reduce or eliminate the use of systemic vasoconstrictors.
Prevention of cerebral ischemia during procedures with risk of reduced cardiac output, such as coronary catheterization or surgery.
Prevention of hypotensive neurologic damage during carotid stenting.
Infusion of fluids, blood products, or medications proximal or distal to the occlusion site during vascular procedures.
Power injection of contrast media for angiography or arteriography distal to the occlusion balloon.
Use as part of hemorrhage exclusion and flow restoration systems in vascular trauma repair.
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