Balloon catheter and fluid management system thereof
Inventors
Melsky, Gerald • Estabrook, Brian • Baxter, Lincoln
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11957856-B2
Publication Date
2024-04-16
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 provides a balloon catheter system for atrial fibrillation ablation that uses a balloon configured to increase the balloon-to-tissue contact area. A fluid management system controllably inflates and deflates the inflatable balloon using balloon fill media, and selectively enables a closed loop recirculation that is not in fluid communication with the reservoir.
The balloon material and geometry support the contact-area increase. The balloon is formed of a material selected from urethane, silicone rubber, and polyisoprene, has a durometer between 50 Shore A and 80 Shore A, and includes a distal taper of 15 degrees to 25 degrees and a proximal taper of 30 degrees to 55 degrees.
Fluid-management states maintain substantially constant balloon pressure despite transient axial force changes. Multiple operational modes include inflate, deflate, and a trapped-volume mode, where trapped fill media is circulated through the balloon catheter, and pump and valve arrangements circulate trapped fill media and allow additional pump flow for cooling while maintaining balloon pressure.
Claims Coverage
The disclosed independent claims are clm-00001 and clm-00005. Across these claims, the main inventive features total four core aspects: selective open-flow versus closed-loop recirculation fluid routing using a diverter valve; closed-loop recirculation that prevents backflow to the reservoir; a balloon formed from specified elastomer materials with specified durometer and taper geometry; and a selectable valve enabling either reservoir-based inflation and deflation or a closed-loop mode not in fluid communication with the reservoir.
Diverter valve with open flow mode and closed-loop recirculation that prevents backflow
A balloon catheter system includes a fluid management system with a reservoir, a first conduit between the reservoir and the balloon, a second conduit between the balloon and the reservoir, and a first pump disposed along the first conduit between the diverter valve and the balloon; the diverter valve is configured for placement in a first position and a second position, where in the first position the balloon fill media freely flows from the reservoir to the balloon and from the balloon back to the reservoir, and in the second position the balloon fill media is recirculated through the balloon catheter in a closed loop manner and is prevented from flowing back to the reservoir from the balloon.
Balloon formed from specified materials with specified durometer and compound taper
A balloon catheter system includes a balloon formed of a material selected from urethane, silicone rubber and polyisoprene and having a durometer between 50 Shore A and 80 Shore A, where the balloon has a distal taper of 15 degrees to 25 degrees and a proximal taper of 30 degrees to 55 degrees.
Selectable valve providing reservoir-exchange inflation/deflation and closed-loop recirculation not in fluid communication with the reservoir
A fluid management system includes a selectable valve that permits the balloon to be inflated by delivering the balloon fill media to the balloon, to be deflated by removing the balloon fill media from the balloon, and permits the balloon fill media to be circulated in a closed loop which is not in fluid communication with the reservoir.
Pump configured to circulate balloon fill media along a circuit defined by first and second conduits
A fluid management system includes a reservoir for storing balloon fill media, a first conduit connected between the reservoir and the balloon for delivering the balloon fill media, a second conduit connected between the balloon and the reservoir for returning the balloon fill media from the balloon to the reservoir, and a pump disposed along the first conduit and configured to circulate the balloon fill media along a circuit defined by the first and second conduits.
The independent claims cover a balloon catheter system that combines controlled balloon inflation and deflation with selective switching between open reservoir exchange and closed-loop recirculation modes, including prevention of backflow to the reservoir, and a balloon having defined elastomer material selection, durometer range, and distal and proximal taper geometry. Pump-based circulation along defined conduits and valve selectability for reservoir communication versus non-reservoir closed-loop operation are also central to the claim coverage.
Stated Advantages
Increased balloon-to-tissue contact area.
Documented Applications
Atrial fibrillation ablation using an inflatable balloon catheter, including placement in relation to the pulmonary vein ostium as described in the document context.
Interested in licensing this patent?