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Publication Number
US-12102342-B2
Publication Date
2024-10-01
Expiration Date
Abstract
A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves. The shock waves propagate through the liquid and impinge upon the valve to decalcify and open the valve.
Core Innovation
The invention relates to an apparatus for treating vascular calcifications in a body of a patient using a catheter and a liquid-inflatable balloon containing conductive liquid. The catheter body branches into at least a first body portion and a second body portion, and a balloon at a distal end is fillable with conductive liquid. Within the balloon, a first electrode pair is located at the first body portion and a second electrode pair is located at the second body portion, with the electrode pairs longitudinally spaced within the balloon.
Voltage pulses are applied to the electrode pairs from a power supply, where the pulses have sufficient energy to generate shock waves from each electrode pair. The shock waves propagate through the conductive liquid and through the balloon and impinge on the vascular calcifications to break the vascular calcifications. The power supply is arranged to time the shock waves for treating the vascular calcifications.
In embodiments described for shockwave valvuloplasty of stenotic and calcified aortic valves, the liquid-inflatable balloon is positioned adjacent to valve leaflets or within the valve annulus and contains one or two shockwave-generating arc sources. Coaxially arranged electrode pairs are coupled to a high-voltage power supply to create shock waves in the balloon inflation fluid that impinge on the valve to decalcify and open the valve. The shock waves can be synchronized, including timed synchronization to the heart’s R-wave.
Further balloon configurations described include dual balloon chambers positioned on opposite sides of leaflets sharing an inflation lumen, and an annulus-positioned reduced-diameter balloon portion that additionally applies expansion pressure to soften or remodel the annulus.
Claims Coverage
The partial claims provided include two independent claims, both directed to a catheter-mounted balloon system that uses two longitudinally spaced electrode pairs inside a conductive-liquid balloon to generate timed shock waves that break vascular calcifications. The independent claims share the same core inventive concept, and their claim coverage primarily differs by how explicitly the electrode pair placement and timing are framed.
Branched catheter with distal conductive-liquid balloon
A catheter body that branches into at least a first body portion and a second body portion, and a balloon at a distal end of the catheter body fillable with conductive liquid.
Longitudinally spaced electrode pairs inside the balloon
A first electrode pair located within the balloon at the first body portion and a second electrode pair located within the balloon at the second body portion, the first electrode pair being longitudinally spaced from the second electrode pair within the balloon.
Shock waves propagate through conductive liquid and balloon to break calcifications
The first and second electrode pairs are configured to generate shock waves that propagate through the conductive liquid and through the balloon and impinge on the vascular calcifications to break the vascular calcifications.
Timed voltage pulses from power supply
A power supply for applying voltage pulses to the first and second electrode pairs, the voltage pulses having sufficient energy to generate the shock waves from each electrode pair, the power supply arranged to time the shock waves for treating the vascular calcifications.
Conductor-terminated electrode pairs within the balloon
First and second conductors extending along the catheter body and terminating in a first electrode of a first electrode pair and a second electrode of a second electrode pair, with the first and second electrode pairs located within the balloon at the first and second body portions, respectively.
Across independent claim 1 and independent claim 7, the inventive focus is on a branched catheter with a distal conductive-liquid balloon containing two longitudinally spaced electrode pairs, wherein timed voltage pulses generate shock waves that propagate through the conductive liquid and balloon and impinge on vascular calcifications to break them.
Stated Advantages
Breaks vascular calcifications by impinging shock waves on the vascular calcifications.
Documented Applications
Treating stenotic and calcified aortic valves by decalcifying and opening the valve using shockwave valvuloplasty with a liquid-inflatable balloon adjacent to valve leaflets or within the valve annulus.
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