System and method for low-profile occlusion balloon catheter
Inventors
Franklin, Curtis J. • Spencer, David • KRUMMENACHER, Todd J.
Assignees
Publication Number
US-11857737-B2
Publication Date
2024-01-02
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 a low-profile vascular occlusion catheter system designed to facilitate arterial occlusion, especially suited for applications such as resuscitative endovascular balloon occlusion of the aorta (REBOA). The system comprises a proximal hub with an inflation connection port and pathway, a proximal catheter member with an inflation lumen, a stiffener member extending through the lumen and connected at the hub, an occlusion balloon connected between the proximal and distal catheter sections, and an atraumatic tip with a substantially circular relaxed configuration. At least one pressure sensor is positioned distally of the occlusion balloon, wired to a processor.
Conventional balloon catheters often struggle to balance low-profile design with the required proximal segment stiffness and flexible, atraumatic tips for safe navigation through the vasculature, especially for aortic occlusion where trauma avoidance and avoidance of collateral vessel entry are essential. Existing systems may require fluoroscopic guidance, guidewires, or imaging modalities, limiting their use in emergency and field settings. They also lack mechanisms to respond to physiological parameters automatically during potentially dangerous hypertensive or hypotensive states that can occur during or after occlusion procedures.
The described catheter system addresses these shortcomings by providing a low-profile, flexible yet strong catheter shaft, with a compliant occlusion balloon and an atraumatic guiding tip that allows for guidewire- and fluoroscopy-free placement. It enables automatic or computer-controlled inflation and deflation based on monitored physiological parameters such as blood pressure, and features pressure sensors for real-time hemodynamic feedback. Moreover, the design incorporates external length markings for accurate positioning and supports an inflation control system using a flow valve selectively communicating with an inflation device.
Claims Coverage
There is one independent claim in the patent, which defines the main inventive features of the occlusion catheter system.
Low-profile occlusion catheter system with compliant balloon and atraumatic tip
An occlusion catheter system comprising: - A proximal hub; - A flow valve configured to selectively fluidly communicate the proximal hub with an inflation device; - A proximal catheter section in fluid communication with the proximal hub; - A distal catheter section distally terminating with an atraumatic tip; - An intervening compliant occlusion balloon connecting the proximal catheter section with the distal catheter section; - At least one length marking on the exterior of the proximal catheter section to indicate insertion depth; - A lumen extending from the proximal hub through the proximal catheter section into fluid communication with the occlusion balloon; - A solid wire, secured at a proximal-most end within the proximal hub, extending within the proximal catheter section, the occlusion balloon, and into the distal catheter section; - The proximal catheter section, occlusion balloon, and distal catheter section collectively having a greatest outer diameter of less than 6 Fr in an uninflated configuration.
Inflation control system kit including catheter and syringe
An inflation control system kit comprising: - The occlusion catheter system as described above; and - A syringe containing a fluid, configured to fluidly connect with an inlet of the proximal hub.
The independent claim covers a low-profile occlusion catheter system with a compliant balloon, dedicated atraumatic tip, internal solid wire support, length marking for insertion depth, and a flow valve for inflation/deflation control, all within a diameter less than 6 Fr. It additionally extends coverage to a kit including the described catheter and a compatible syringe for inflation.
Stated Advantages
Allows fluoroscopy-free and guidewire-free guidance and placement in vascular procedures, particularly suitable for field, emergency, or trauma settings where imaging is unavailable.
Facilitates rapid deployment and use in pre-hospital, battlefield, or emergency room settings.
The low-profile design enables passage through tortuous vasculature and across severe or remote vascular obstructions.
Balanced stiffness and flexibility of the catheter prevents trauma or perforation while maintaining sufficient column strength.
Atraumatic guiding tip design restricts entry into collateral vessels, minimizing risk of vascular injury.
Pressure sensors and computer control enable automated inflation/deflation in response to physiological parameters, helping mitigate the risks of hypertension and hypotension during and after occlusion.
External length markings on the catheter provide accurate indication of insertion depth.
Documented Applications
Use in resuscitative endovascular balloon occlusion of the aorta (REBOA) procedures for temporary aortic occlusion in trauma, battlefield, and emergency settings.
Vascular pre-conditioning to mitigate ischemia before, during, or after occlusion procedures and to manage hypertension or hypotension.
Arterial and venous occlusion for procedures such as aneurysm repair, hemorrhage control, or vascular exclusion.
Infusion of fluids such as blood, plasma, saline, blood products, or substitutes proximal or distal to the occlusion site.
Use with power injectors for contrast delivery in angiography or arteriography.
Delivery of therapeutic adjuncts (e.g., hypothermia devices, diagnostic or therapeutic tools) through additional lumens.
Applications in combination with extracorporeal membrane oxygenation (ECMO), cryogenic devices, and continuous renal replacement therapy (CRRT) systems.
Partial occlusion or variable flow rates to maintain perfusion as needed, including specialized balloon shapes for controlled occlusion.
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