Balloon catheter and fluid management system thereof
Inventors
Babko-Malyi, Sergei • Estabrook, Brian • Melsky, Gerald • Thompson, Richard
Assignees
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Publication Number
US-11484692-B2
Publication Date
2022-11-01
Expiration Date
Abstract
A method for maintaining a balloon of a balloon catheter at a prescribed pressure of between about 0.2 psi and 1 psi comprises the step of: generating a vacuum within a reservoir defined in a burette that is part of a fluid management system that is configured to controllably inflating and deflating the balloon by circulating balloon fill media along a fluid circuit, wherein generating the vacuum results in formation of a pressure differential along the fluid circuit, thereby allowing the balloon to be maintained at the prescribed pressure between about 0.2 psi and about 1 psi.
Core Innovation
The invention relates to a balloon catheter system that includes a balloon catheter with a catheter body and an inflatable balloon and a fluid management system for controllably inflating and deflating the balloon. The fluid management system includes a reservoir for storing balloon fill media, where the reservoir is partitioned into a first compartment and a second compartment, and a vent provides fluid communication between the first compartment and the second compartment. The reservoir is also configured with an inlet port and an inlet valve for selectively permitting air to flow into the first compartment, and an outlet port and an outlet valve for selectively permitting air to exit from the first compartment.
A fluid circuit is provided to deliver the balloon fill media from the second compartment to the balloon and to return the balloon fill media along a return line from the balloon to the second compartment. The fluid management system applies a vacuum that is in selective communication with the first compartment of the reservoir via an applied vacuum valve, where the applied vacuum is configured to generate negative pressure within the reservoir. This creates a pressure differential along the return line of the fluid circuit for controlling an internal pressure within the balloon.
The system further includes a plurality of valves located along the fluid circuit to define a plurality of operating modes depending on the on/off states of the valves. The operating modes include a normal mode in which the fluid circuit is configured such that the balloon fill media can flow along the fluid circuit to the balloon and can flow along the return line to the reservoir, and a trapped volume mode in which the balloon fill media continuously flows along the fluid circuit in a manner in which the balloon fill media is not returned to the second compartment of the reservoir. The document emphasizes that negative pressure and the pressure differential are used to control internal balloon pressure.
Claims Coverage
The independent claim is directed to a balloon catheter system with a reservoir having first and second compartments, air inlet/outlet valving for the first compartment, a fluid circuit with a delivery and return line, and a selectively applied vacuum creating a pressure differential to control internal balloon pressure, with operating modes including a normal mode and a trapped volume mode defined by valve on/off states.
Reservoir partition with vent communication
A reservoir for storing balloon fill media, wherein the reservoir is partitioned into a first compartment and a second compartment configured to store the balloon fill media with a vent providing fluid communication between the first compartment and the second compartment.
Selective air inlet and air outlet for the first compartment
An inlet port in fluid communication with the first compartment and including an inlet valve that selectively permits air to flow into the first compartment, and an outlet port in fluid communication with the first compartment and including an outlet valve that selectively permits air to exit from the first compartment.
Fluid circuit delivering and returning balloon fill media
A fluid circuit for delivering the balloon fill media from the second compartment to the balloon and for returning the balloon fill media along a return line from the balloon to the second compartment.
Applied vacuum to generate negative pressure and return-line pressure differential
An applied vacuum that is in selective communication with the first compartment of the reservoir by virtue of an applied vacuum valve and configured to generate negative pressure within the reservoir and creation of a pressure differential along the return line of the fluid circuit for controlling an internal pressure within the balloon.
Valves defining normal mode and trapped volume mode
A plurality of valves located along the fluid circuit to define a plurality of operating modes depending on on/off states of the plurality of valves, wherein the operating modes includes: (1) a normal mode in which the fluid circuit is configured such that the balloon fill media can flow along the fluid circuit to the balloon and can flow along the return line to the reservoir and (2) a trapped volume mode in which the balloon fill media continuously flows along the fluid circuit in a manner in which the balloon fill media is not returned to the second compartment of the reservoir.
Independent-claim coverage centers on controlling balloon internal pressure using a selectively applied vacuum that generates negative pressure and a pressure differential along the return line, together with a reservoir partition/vent and a valve-defined set of operating modes including normal and trapped volume modes.
Stated Advantages
Enables lower-pressure balloon cooling compatible with soft balloon materials.
Single-operator control.
Documented Applications
Balloon cooling for atrial fibrillation ablation.
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