System and method for low profile occlusion balloon catheter
Inventors
Franklin, Curtis J. • KRUMMENACHER, Todd J. • REYNOLDS, Jeremy • Spencer, David • FISHER, Luke William
Assignees
Publication Number
US-10368872-B2
Publication Date
2019-08-06
Expiration Date
2037-06-02
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Abstract
An occlusion catheter system includes an inflation catheter member and an occlusion balloon. The proximal and distal balloon ends are connected to the inflation catheter between the proximal and distal catheter ends. A distal pressure sensor is attached to the inflation catheter member between the proximal balloon end and the atraumatic tip. An inflatable spine is connected to the inflation catheter. The proximal spine end is connected to the inflation catheter near the proximal balloon end and the distal spine end is connected to the inflation catheter near the distal balloon end. The occlusion balloon and the inflatable spine are configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in a partially inflated configuration.
Core Innovation
The invention relates to an occlusion catheter system intended for occlusion or partial occlusion of relatively large blood vessels. The system features an inflation catheter member with a stiffener member, at least one inflation lumen, an atraumatic tip, an occlusion balloon, an inflatable spine, and a distal pressure sensor. The occlusion balloon is attached along a section of the catheter and is substantially centered on the longitudinal axis when inflated. Both the occlusion balloon and the inflatable spine can be inflated, creating a controlled occlusion within the vessel.
The problem addressed is the inability of prior occlusion balloon catheters to provide stable, controllable partial occlusion with minimal risk of undesirable balloon movement and abrupt changes in blood flow. Existing systems tend to cause balloon disengagement or vibration during partial perfusion and lack a means to finely control the pressure ratio between the proximal and distal sides of the balloon. This can lead to sudden shifts from full occlusion to high blood flow, complicating pressure management and potentially resulting in the device shifting out of position.
The solution provided by the invention is a novel occlusion catheter system in which the occlusion balloon is combined with an inflatable spine, each having defined lumens for precise inflation. When partially inflated, the system forms distinct blood flow channels between the vessel wall, the external balloon surface, and the external spine surface, permitting controlled partial perfusion. The structure maintains engagement with the vessel wall, reducing vibration and movement during partial occlusion. An integrated distal pressure sensor between the balloon and the atraumatic tip further enables feedback for refined pressure or flow management during vascular procedures.
Claims Coverage
There are two main independent claims in the patent, each presenting inventive features relating to the design and operation of an occlusion catheter system for controlled vessel occlusion.
Inflation catheter member with occlusion balloon and inflatable spine defining blood flow channels
An inflation catheter member is provided with a stiffener member, at least one inflation lumen, proximal and distal catheter ends, and an atraumatic tip. An occlusion balloon, having internal and external surfaces and proximal/distal ends, is mounted substantially centered along the longitudinal axis. Both balloon ends are connected to the inflation catheter. An inflatable spine, with internal space and proximal/distal ends, is also connected to the catheter and is positioned so its external surface contacts the external balloon surface in an inflated state. When the occlusion balloon and inflatable spine are in a partially inflated configuration within a vessel, they are arranged to create blood flow channels defined by the internal vessel surface and the external balloon surface. The inflatable spine maintains a substantially constant diameter between its ends in both partially and fully inflated states.
Inclusion of a distal pressure sensor between balloon and atraumatic tip
The system includes a distal pressure sensor—either an electronic sensor or a distal side port in fluid communication with a stiffener member lumen—mounted between the distal balloon end and the atraumatic tip. This sensor provides means to monitor pressures distal to the occlusion site, which can be used for feedback or monitoring during use.
Alternative configuration with separate inflation lumens for balloon and spine
A variant configuration features first and second inflation lumens, allowing separate inflation of the internal balloon space and the internal spine space. The internal spine space is in fluid communication with the second inflation lumen, enabling individualized or concurrent inflation control over the balloon and the spine for precise occlusion adjustments.
Optional compliant and non-compliant materials for balloon and spine
The occlusion balloon is formed from a compliant polymeric material, while the inflatable spine is constructed from a non-compliant material, such as polyurethane with different durometers. This facilitates predictable expansion of the balloon and spine, enabling fine control over partial or full vessel occlusion.
Optional pressure monitoring and closed-loop control via proximal and distal sensors and control hub
An arrangement may include both proximal and distal pressure sensors, a control hub with display and power source mounted near the catheter's proximal end, and a controller and pump. The controller can introduce or withdraw fluid from the balloon and spine based on measured pressures, allowing pressure or occlusion level to be maintained automatically or displayed to the operator.
In summary, the claims cover an occlusion catheter system with integrated balloon and inflatable spine to create and control blood flow channels for precise perfusion management, pressure sensing close to the occlusion site, and accommodating both manual and automated inflation options, all designed to address and mitigate previous limitations in partial vessel occlusion.
Stated Advantages
Provides smooth-controlled partial occlusion by forming flow channels for blood, allowing more precise control of flow by simply adjusting inflation volume.
Maintains constant contact between the occlusion balloon and the vessel wall during partial occlusion, reducing vibration, movement, and pulsing effects common with prior occlusion balloons.
Reduces or eliminates sudden increases in blood flow across the balloon during transition from full to partial occlusion, overcoming abrupt step-changes found in conventional devices.
Permits fine control of the pressure ratio between proximal and distal sides of the occlusion balloon, enabling gradual and more precise blood flow control through the vessel.
Decreases sensitivity to minor pressure changes in the occlusion balloon, allowing for a more gradual change in blood flow and minimizing the risk of unintentional vessel opening.
Allows intermittent and automatic adjustment of occlusion in response to physiological parameters, improving management of hypertension and hypotension during and after vascular procedures.
Documented Applications
Occlusion or partial occlusion of relatively large vessels, such as the aorta, during endovascular procedures or surgical interventions.
Vascular pre-conditioning to mitigate ischemia before, during, and after occlusion procedures, as well as to ameliorate onset of hypertension or hypotension associated with vessel occlusion or reperfusion.
Resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma management, particularly in cases of shock due to major trauma.
Controlling blood flow in the arterial or venous system to focus perfusion on critical organs (brain, heart, lungs) while allowing partial perfusion to downstream organs (liver, digestive tract, kidneys, legs).
Providing a means of full occlusion and precise partial occlusion during vascular repair procedures to manage and balance proximal and distal pressures.
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