Balloon catheter and fluid management system thereof
Inventors
Melsky, Gerald • Estabrook, Brian • Baxter, Lincoln
Assignees
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Publication Number
US-11207505-B2
Publication Date
2021-12-28
Expiration Date
Abstract
A balloon catheter device with a fluid management system includes a source of balloon fill media and a balloon catheter in fluid communication with the source of balloon fill media. A first conduit is provided for delivering the balloon fill media from the source to the balloon catheter for inflation of a balloon of the catheter device. A second conduit is provided for returning the balloon fill media from the balloon catheter to the source for deflating the balloon. A first pump is disposed along one of the first conduit and the second conduit for pumping the balloon fill media through the respective conduits. The fluid management system operates in three states, namely, (1) a first state in which the balloon fill media is delivered to the balloon for inflation thereof, (2) a second state in which the balloon fill media is removed from the balloon for deflation thereof; and (3) a trapped volume mode in which the balloon fill media is circulated through the balloon so as to maintain an at least substantially constant pressure in the balloon. The fluid management system is configured to maintain a pressure of the balloon between 0.2 psi and 1 psi while maintaining adequate fluid flow to cool the balloon.
Core Innovation
The invention describes a balloon catheter configured for seating against a pulmonary vein ostium. The balloon uses compliant material and is maintained at a low inflation pressure to increase tissue contact. Disclosed forms also include a compound taper and balloon materials including urethane, silicone rubber, or polyisoprene.
The fluid-management system uses a reservoir, conduits, a pump, and valves to provide balloon inflation and deflation and to circulate balloon fill media through the balloon in a source-isolated closed loop. This trapped-volume mode maintains substantially constant balloon pressure while allowing fluid flow for cooling.
Claims Coverage
The four independent claims cover a balloon catheter for pulmonary vein ostium seating and fluid-management systems for controlling balloon fill media, comprising four inventive features.
Balloon catheter for pulmonary vein ostium seating
Claim 1 covers a catheter body with a balloon coupled to its distal end, with the balloon maintained at a specific inflation pressure for seating against a pulmonary vein ostium.
Valve-controlled fluid management system
Claim 3 covers a balloon catheter, reservoir, delivery and return conduits, pump, and connected valve circuit. The circuit is configured for inflation, deflation, and purge, as well as maintaining the balloon inflation level through circulation of balloon fill media.
Source-isolated trapped-volume recirculation
Claim 5 covers a source, balloon catheter, delivery and return conduits, and pump. In trapped-volume mode, valves isolate the source and the pump circulates balloon fill media through the balloon in a closed loop to maintain substantially constant balloon pressure.
Trapped-volume recirculation through a branch conduit
Claim 12 covers a source, balloon catheter, delivery and return conduits, and pump, with a branch conduit and valves defining a source-isolated closed recirculation loop. The loop circulates balloon fill media through the balloon to maintain substantially constant balloon pressure.
The independent claims cover balloon seating at a pulmonary vein ostium and fluid-management arrangements that inflate and deflate the balloon or circulate fill media through it in a source-isolated loop.
Stated Advantages
Compliant balloon materials and inflation are described as increasing tissue contact.
The trapped-volume mode maintains balloon size and pressure while allowing adequate fluid flow for cooling.
Documented Applications
Seating a balloon against a pulmonary vein ostium.
Cooling the balloon through circulation of balloon fill media.
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