Method and apparatus for treating valvular disease
Inventors
Messas, Emmanuel • Pernot, Mathieu • Tanter, Mickael • VILLEMAIN, Olivier
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10736603-B2
Publication Date
2020-08-11
Expiration Date
Abstract
An apparatus for treating or preventing a valvular disease comprises: a ultrasound probe located externally to a heart of patient, able to produce ultrasound waves focused inside the heart and suitable to generate, at a focal spot, a pressure sufficient to result in cavitation, an imaging device for mapping in real time a treatment region of a cardiac valve of the patient, the treatment region comprising at least one leaflet of the cardiac valve, a controller configured for driving the ultrasound probe to emit a sequence of focused ultrasound waves, the controller being further configured for steering the focused ultrasound waves so as to scan the entire treatment region to soften the tissues of the treatment region. A method for treating or preventing valvular disease, carried out using the apparatus is also provided.
Core Innovation
The invention relates to treating or preventing valvular stenosis using an apparatus with an ultrasound probe located externally to a heart of a patient. The probe produces ultrasound waves focused inside the heart and is configured to generate, at a focal spot, a pressure sufficient to result in cavitation. A real-time imaging device maps a treatment region of a cardiac valve, wherein the treatment region comprises at least one leaflet of the cardiac valve.
The controller drives the probe to emit a sequence of focused ultrasound waves and is configured to estimate in real time a motion of the treatment region from images acquired by the imaging device. The controller steers the focused ultrasound waves in function of the estimated motion to scan the entire treatment region. The ultrasound emission is constrained such that the duration of a pressure pulse generated by each focused ultrasound wave is less than 80 microseconds.
Each focused ultrasound wave generates at a focal spot a peak negative pressure half-cycle that exceeds 5 MPa and/or a peak positive pressure half-cycle that exceeds 10 MPa. The apparatus further includes a measuring device suitable for measuring an index of valvular stenosis after controlling the ultrasound probe to emit the sequence of N focused ultrasound waves, and the controller reiterates controlling the ultrasound probe and measuring the index until the index crosses a predefined threshold.
Claims Coverage
The document includes two independent claims: an apparatus claim and a method claim. The independent claims share the same core inventive concept: externally located focused ultrasound producing cavitation at a focal spot, combined with real-time mapping and steering of a valve treatment region and, in one claim, measurement-driven reiteration until a stenosis index reaches a predefined threshold. The independent claims additionally define quantitative ultrasound pulse constraints.
Externally located focused ultrasound for cavitation at a valve leaflet treatment region
An ultrasound probe located externally to a heart of a patient, able to produce ultrasound waves focused inside the heart, and suitable to generate at a focal spot a pressure sufficient to result in cavitation at a treatment region of a cardiac valve comprising at least one leaflet.
Real-time mapping of a cardiac valve treatment region
An imaging device for mapping in real time a treatment region of a cardiac valve of the patient, wherein the treatment region comprises at least one leaflet of the cardiac valve.
Motion-estimation and steering to scan the entire treatment region
A controller configured for estimating in real time a motion of the treatment region from images acquired by the imaging device and for steering the focused ultrasound waves emitted by the ultrasound probe in function of said motion of the treatment region to scan the entire treatment region.
Cavitation-producing pulse constraints
Controlling the ultrasound probe to emit a sequence of focused ultrasound waves such that the duration of a pressure pulse generated by each focused ultrasound wave is less than 80 microseconds, and such that each generates at a focal spot a peak negative pressure half-cycle that exceeds 5 MPa and/or a peak positive pressure half-cycle that exceeds 10 MPa.
Measuring an index of valvular stenosis with iterative reiteration until a predefined threshold
A measuring device suitable for measuring an index of valvular stenosis after having controlled the ultrasound probe to emit the sequence of N focused ultrasound waves, with reiteration of controlling the ultrasound probe and measuring the index until said index crosses a predefined threshold.
Across the two independent claims, the principal inventive coverage centers on externally located focused ultrasound that generates cavitation at a focal spot to soften valve treatment-region tissues, combined with real-time mapping and motion-based steering to scan the entire treatment region, and ultrasound pulse constraints defined by pressure pulse duration and peak negative/positive pressure half-cycles. The apparatus claim further covers measuring an index of valvular stenosis and iterating ultrasound emission and index measurement until a predefined threshold is crossed.
Stated Advantages
Treating or preventing valvular stenosis.
Softening tissues of the treatment region by scanning with cavitation-producing focused ultrasound.
Scanning of the entire treatment region while accounting for motion of the treatment region.
Reiterating treatment based on an index of valvular stenosis until the index crosses a predefined threshold.
Documented Applications
Treating or preventing valvular stenosis in a patient using an apparatus with an externally located ultrasound probe and real-time imaging to map and scan a cardiac valve treatment region comprising at least one leaflet.
Interested in licensing this patent?