System and method for low-profile occlusion balloon catheter
Inventors
Franklin, Curtis J. • Spencer, David • KRUMMENACHER, Todd J.
Assignees
Publication Number
US-10149962-B2
Publication Date
2018-12-11
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 for vascular intervention, particularly for occlusion of relatively large vessels. The system comprises a proximal hub with an inflation connection port, an inflation catheter member with an inflation lumen, an occlusion balloon (having proximal and distal ends), a distal catheter member, and an atraumatic tip positioned at the distal end of the distal catheter member. The atraumatic tip features a substantially circular profile when relaxed and includes a tip shaft with a guide lumen and an exit port designed for guide wire movement.
A key design aspect of the invention is its low-profile structure, allowing passage through small-diameter percutaneous sheaths, and its consideration for use in tortuous vasculature without compromising column strength or flexibility. The system is constructed to provide sufficient pushability and pullability for navigation but includes a distal atraumatic tip to reduce trauma and avoid entry into collateral vessels. The atraumatic tip design permits both guidewire-free and guidewire-assisted navigation.
The patent addresses the challenges present in conventional balloon catheters used for aortic occlusion, such as inadequate balance between proximal stiffness and distal flexibility, large profiles preventing use in emergent or field situations without imaging guidance, and the risk of trauma or misdirections into collateral vessels. By integrating a combination of polymeric or reinforced materials for different catheter segments, the invention supports flexibility, manufacturability, and safer navigation.
The problem being solved includes the need for a balloon catheter system that can be rapidly deployed in emergency, trauma, or austere environments, often without fluoroscopic imaging, while minimizing vascular trauma and the risk of entering incorrect vessels. The invention further provides the capacity for various functional enhancements, such as accommodating sensors, infusion, and power injection, through its multi-lumen and low-profile structure.
Claims Coverage
The independent claim covers an occlusion catheter system with multiple structural and functional features enabling vascular occlusion, atraumatic navigation, and guidewire compatibility.
Integrated low-profile occlusion catheter system with atraumatic tip and guidewire compatibility
The system comprises: - A proximal hub with an inflation connection port and inflation pathway. - An inflation catheter member with an inflation lumen extending to a first port near the distal end, aligned along a longitudinal axis. - An occlusion balloon affixed at its proximal end to the distal end of the inflation catheter, where the first port opens into the internal space of the balloon. - A distal catheter member aligned on the longitudinal axis, connected to the distal balloon end. - An atraumatic tip situated at the distal end of the distal catheter member, exhibiting a substantially circular profile in a relaxed state, with an unconnected end proximate to the longitudinal axis. - The atraumatic tip includes a tip shaft with a guide lumen and a flattened distal section that has a solid, substantially circular profile. The guide lumen features an exit port near the distal end, positioned proximate to the longitudinal axis. - A guide wire is configured for slidable movement within the guide lumen and can extend out of the exit port beyond the atraumatic tip. These features are claimed exactly as presented in the patent claim, delineating both the low-profile structural arrangement and the functional elements combining vascular occlusion, atraumatic navigation, and guidewire capability.
The claim coverage focuses on a highly structured, low-profile occlusion catheter system that combines an atraumatic tip for safe vascular navigation and guidewire compatibility, offering improved flexibility and safety for vascular occlusion procedures.
Stated Advantages
Provides a low-profile balloon catheter that can be used in tortuous vasculature and passed through small percutaneous sheaths, facilitating access and navigation.
Eliminates or reduces the need for a guide wire and imaging guidance (e.g., fluoroscopy), enabling use in field operations or emergency situations.
Reduces trauma or perforation of blood vessels through the use of an atraumatic guiding tip.
The distal tip design inhibits entry into collateral vessels and maintains the intended track through the vasculature.
Enables rapid deployment and easier use during vascular occlusion procedures, including in resource-constrained or non-hospital environments.
Documented Applications
Emergency or trauma endovascular use for procedures such as REBOA to occlude non-compressible hemorrhage in field, battlefield, or emergency room settings.
Vascular pre-conditioning, such as mitigating ischemia before, during, or after a vascular occlusion procedure.
Augmenting and maintaining cerebral perfusion in patients suffering from global or focal ischemia.
Infusing fluids such as blood, plasma, saline, or blood products proximal or distal to the occlusion site.
Accommodating other medical devices or therapies (e.g., flow wires, imaging catheters, atherectomy, drug delivery, hypothermia catheters) through accessory lumens.
Partial vessel occlusion to control hypertension or hypotension during vascular procedures and enabling perfusion past the occlusion member in response to physiological parameters.
Power injection of contrast medium for angiography or arteriography procedures.
Use in combination with extra corporeal membrane oxygenation (ECMO), cryogenic devices, or continuous renal replacement therapy (CRRT).
Applications in prevention of cerebral ischemia during coronary catheterization or surgery, treating shock, or preventing hypotensive neurological damage during carotid stenting.
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