Occlusion catheter system for full or partial occlusion
Inventors
Franklin, Curtis J. • REYNOLDS, Jeremy • POINTER, Eric • Garland, Matthew • KRUMMENACHER, Todd J.
Assignees
Publication Number
US-12011172-B2
Publication Date
2024-06-18
Expiration Date
2039-08-06
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Abstract
An occlusion catheter system for full or partial occlusion of a vessel includes an occlusion balloon. The balloon is positioned in a folded, uninflated configuration around a central shaft, a proximal shaft, and a distal shaft of the occlusion catheter system, having an outer diameter less than seven French. The balloon is constructed of a semi-compliant or non-compliant material and is sized to have a blown diameter between approximately ten percent to sixty percent greater than the inner diameter of the vessel, whereby an outer surface of the balloon comes into full diametric contact with an inner surface of the vessel upon partial inflation of the balloon and folds are formed in the outer surface of the balloon. The folds define flow channels with inner surfaces of the vessel or with portions of the outer surface of the balloon that allow partial blood flow past the balloon.
Core Innovation
The invention provides an occlusion catheter system intended for full or partial occlusion of a vessel, particularly the aorta. The system features an occlusion balloon constructed from a semi-compliant or non-compliant material, positioned in a folded, uninflated configuration around a central shaft, a proximal shaft, and a distal shaft. This configuration enables the system, including the folded balloon, to have an outer diameter less than seven French, making it suitable for use with smaller introducer sheaths. Upon inflation, the balloon is designed to have a blown diameter approximately ten to sixty percent greater than the inner diameter of the targeted vessel, ensuring its outer surface comes into diametric contact with the vessel's inner surface during partial inflation.
During partial inflation, the balloon forms folds in its outer surface. These folds act as flow channels, defined either with the inner surface of the vessel or with other portions of the balloon, allowing controlled partial blood flow past the occlusion. This structure maintains engagement between the balloon and vessel wall even during partial occlusion, reducing the likelihood of balloon movement, vibration, or loss of occlusive positioning that can occur with conventional systems during partial perfusion. The design aims to allow both partial and full occlusion, enabling gradual transitions in flow and occlusion states.
The problem addressed by this invention is the difficulty in achieving safe, controlled partial perfusion during occlusion procedures, particularly in the aorta, using existing balloon catheter systems. Prior systems tended to lose contact with the vessel wall during partial deflation, causing unwanted movement, instability, or rapid, uncontrolled changes between full and partial occlusion. This instability could lead to complications such as hypertension during occlusion or hypotension upon reperfusion. The presented occlusion catheter system directly solves these problems by allowing for controlled blood flow while retaining continuous, stable contact with the vessel lumen, and by maintaining a low system profile for ease of introduction.
Claims Coverage
The claims define a set of inventive features focused on an occlusion catheter system with a unique balloon construction and deployment profile, specifically configured for both partial and full aortic occlusion.
Occlusion catheter system with semi-compliant or non-compliant balloon forming flow channels
The occlusion catheter system comprises: - A proximal catheter shaft with a proximal lumen. - A central shaft partially positioned within and spaced from the proximal catheter shaft. - A distal catheter shaft attached to a distal end of the central shaft. - An occlusion balloon, constructed of semi-compliant or non-compliant material, attached at the proximal and distal ends to the respective shafts. The balloon is positioned in a folded, uninflated configuration around the system's shafts and maintains an outer diameter less than seven French in this state. The balloon is sized to have a blown diameter approximately ten to sixty percent greater than the vessel's inner diameter (specifically the aorta), so that upon partial inflation, its outer surface comes into diametric contact with the vessel wall and forms folds. These folds define flow channels either with the vessel's inner surface or with the balloon's outer surface itself, allowing partial blood flow past the balloon.
The claim coverage centers on the structure of a low-profile, semi-compliant or non-compliant balloon occlusion catheter system, in which the balloon's folding during partial inflation allows controlled partial perfusion while preserving stable contact with the vessel wall.
Stated Advantages
Allows both full and partial occlusion of a vessel, with gradual and controllable transitions between occlusion states.
Maintains engagement between the occlusion balloon and vessel wall during partial occlusion, reducing vibration and undesired movement.
Enables fine control of pressure ratio between proximal and distal sides of the balloon, supporting precise management of blood flow.
Minimizes catheter shaft thickness at the balloon connection area, allowing for a low-profile system suitable for introducer sheaths of seven French or less.
Increases procedural safety by reducing the risks of hypertension during occlusion and hypotension upon reperfusion.
Documented Applications
Partial and full occlusion of the aorta in vascular pre-conditioning, REBOA (resuscitative endovascular balloon occlusion of the aorta), or other vascular occlusion procedures to control perfusion and manage hemodynamic parameters.
Use in both arterial and venous systems, particularly for large vessels such as the thoracic and abdominal aorta.
Mitigating ischemia, managing transient hypertension during occlusion, and ameliorating hypotension post-occlusion in vascular repair procedures.
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