IP Library › Granted Patent US 12,376,824
Granted Patent B2
US 12,376,824 · App. 17/770,431 · Granted Aug 5, 2025

Methods, systems, and computer readable media for utilizing a therapeutic ultrasound device to perform mitral valve decalcification

Inventors: Austin A. Robinson (Charlottesville, VA); Christopher M. Kramer (Charlottesville, VA); John A. Hossack (Charlottesville, VA); Patricia Fiorella Rodriguez Lozano (Charlottesville, VA)
Assignee: University of Virginia Patent Foundation
A61B8/0883A61B8/488A61B34/10A61B2017/00044
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Quick Facts
Patent No.
US 12,376,824
App. No.
17/770,431
Granted
Aug 5, 2025
Kind
B2
Abstract

Methods, systems, and computer readable media for utilizing a therapeutic ultrasound device to perform mitral valve decalcification are disclosed. One method includes acquiring, via an ultrasound imaging component, imaging data of a mitral valve in real-time, defining a therapeutic region of interest corresponding to the mitral valve, and utilizing, by a system controller engine, imaging data from the ultrasound imaging component to determine an interval period of minimal mitral annular movement. The method further includes defining a sequence of therapeutic targets within the region of interest of the mitral valve, utilizing the imaging data acquired in real-time by the ultrasound imaging component to provide a therapeutic ultrasound transducer array with a location and depth of an intra-annular focal zone within the mitral valve, and emitting a high intensity focused ultrasound (HIFU) pulse wave from the therapeutic ultrasound transducer array to each of the therapeutic targets of the mitral valve during the determined interval period and in accordance with the defined sequence.

Claims (34)

1. A therapeutic ultrasound system comprising:

a therapeutic ultrasound (TU) transducer array comprising a plurality of therapeutic transducer elements configured to generate a high-intensity focused ultrasound (HIFU) pulse wave that is directed to a mitral valve of a target patient;

an ultrasound imaging component configured for capturing images corresponding to the mitral valve and for providing real-time steering guidance for the therapeutic ultrasound transducer array; and

a system controller engine for determining an interval period of minimal annular movement exhibited by the mitral valve, coordinating an alternating operation of the ultrasound imaging component and the therapeutic ultrasound transducer array with respect to annular movement exhibited by the mitral valve, and coordinating emission of the high intensity focused ultrasound (HIFU) pulse wave by the therapeutic ultrasound transducer array to the mitral valve only during the determined interval period of minimal annular movement.

2. The therapeutic ultrasound system of claim 1 , wherein the imaging component and the therapeutic ultrasound transducer array are synchronized by the system controller engine in such a manner that the ultrasound imaging component and the therapeutic ultrasound transducer array are prevented from operating simultaneously.

3. The therapeutic ultrasound system of claim 1 , wherein the system controller engine is configured to determine cardiac phases associated with at least the annular movement exhibited by the mitral valve and to subsequently select a timing of TU application based on the determined cardiac phases.

4. The therapeutic ultrasound system of claim 1 , wherein the therapeutic ultrasound transducer array is configured to be located external to the body of the target patient.

5. The therapeutic ultrasound system of claim 1 , wherein the ultrasound imaging component is configured to generate two-dimensional echocardiographic views of the mitral valve.

6. The therapeutic ultrasound system of claim 1 , wherein the ultrasound imaging component is configured to determine a foci of calcification within the mitral valve.

7. A method comprising:

acquiring, via an ultrasound imaging component, imaging data of a mitral valve in real-time;

defining a therapeutic region of interest corresponding to the mitral valve;

utilizing, by a system controller engine, imaging data from the ultrasound imaging component to determine an interval period of minimal mitral annular movement;

defining a sequence of therapeutic targets within the region of interest of the mitral valve;

utilizing the imaging data acquired in real-time by the ultrasound imaging component to provide a therapeutic ultrasound transducer array with a location and depth of an intra-annular focal zone within the mitral valve; and

emitting a high intensity focused ultrasound (HIFU) pulse wave from the therapeutic ultrasound transducer array to each of the therapeutic targets of the mitral valve only during the determined interval period of minimal mitral annular movement and in accordance with the defined sequence.

8. The method of claim 7 , wherein the imaging component and the therapeutic ultrasound transducer array are synchronized by the system controller engine in such a manner that the ultrasound imaging component and the therapeutic ultrasound transducer array are prevented from operating simultaneously.

9. The method of claim 7 , wherein the system controller engine is configured to determine cardiac phases associated with at least an annular movement exhibited by the mitral valve and to subsequently select a timing of a therapeutic ultrasound application based on the determined cardiac phases.

10. The method of claim 7 , wherein the therapeutic ultrasound transducer array is configured to be located externally to a patient body.

11. The method of claim 7 , wherein the ultrasound imaging component is configured to generate two-dimensional echocardiographic views of the mitral valve.

12. The method of claim 7 , wherein the ultrasound imaging component is configured to determine a foci of calcification within an annular sheath of the mitral valve.

13. The method of claim 7 further comprising utilizing the ultrasound imaging component to identify regions of intra-annular and extra-annular calcification in the mitral valve.

14. The method of claim 7 , wherein defining a sequence of therapeutic targets within the region of interest of the mitral valve further includes selecting intra-annular calcium foci as the therapeutic targets and avoiding extra-annular calcium.

15. The method of claim 7 further comprising utilizing the ultrasound imaging component to confirm a presence and location of cavitation in the mitral valve, maintain annular sheath integrity in the mitral valve, and monitor for potential calcific emboli.

16. A non-transitory computer readable medium having stored thereon executable instructions that when executed by a processor of a computer control the computer to perform steps comprising:

acquiring, via an ultrasound imaging component, imaging data of a mitral valve in real-time;

defining a therapeutic region of interest corresponding to the mitral valve;

utilizing, by a system controller engine, imaging data from the ultrasound imaging component to determine an interval period of minimal mitral annular movement;

defining a sequence of therapeutic targets within the region of interest of the mitral valve;

utilizing the imaging data acquired in real-time by the ultrasound imaging component to provide a therapeutic ultrasound transducer array with a location and depth of an intra-annular focal zone within the mitral valve; and

emitting a high intensity focused ultrasound (HIFU) pulse wave from the therapeutic ultrasound transducer array to each of the therapeutic targets of the mitral valve only during the determined interval period of minimal mitral annular movement and in accordance with the defined sequence.

17. The non-transitory computer readable medium of claim 16 further comprising utilizing the ultrasound imaging component to identify regions of intra-annular and extra-annular calcification in the mitral valve.

18. The non-transitory computer readable medium of claim 16 , wherein defining a sequence of therapeutic targets within the region of interest of the mitral valve further includes selecting intra-annular calcium foci as the therapeutic targets and avoiding extra-annular calcium.

19. The non-transitory computer readable medium of claim 16 further comprising utilizing the ultrasound imaging component to confirm a presence and location of cavitation in the mitral valve, maintain annular sheath integrity in the mitral valve, and monitor for potential calcific emboli.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 11, 2025
From: ROBINSON, AUSTIN A.; KRAMER, CHRISTOPHER M.; HOSSACK, JOHN A.; RODRIGUEZ LOZANO, PATRICIA FIORELLA
To: UNIVERSITY OF VIRGINIA
Reel/Frame 070818/0460 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 11, 2025
From: UNIVERSITY OF VIRGINIA
To: UNIVERSITY OF VIRGINIA PATENT FOUNDATION
Reel/Frame 070818/0550 →
Continuity (2)
Provisional Application 62923776 · Oct 21, 2019
Related Publication 20220409169A1 · Dec 29, 2022
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