Devices and methods for multi-focus ultrasound therapy.
Abstract
Embodiments of a dermatological cosmetic treatment and imaging system and method can include use of transducer to simultaneously or substantially simultaneously produce multiple cosmetic treatment zones in tissue. The system can include a hand wand, a removable transducer module, a control module, and/or graphical user interface. In some embodiments, the cosmetic treatment system may be used in cosmetic procedures, including brow lifts, fat reduction, sweat reduction, and treatment of the décolletage. Skin tightening, lifting and amelioration of wrinkles and stretch marks are provided.

Term
8.9 yearsleft in the term
Expires 20 August 2035.
- Priority
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- Today
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72 claims: 51 independent, 21 dependent
- 1REIVINDICACIONES 1. Una sonda para tratamiento con ultrasonido para crear simultáneamente múltiples zonas focales con un transductor de ultrasonido, que comprende:un transductor de ultrasonido adaptado para aplicar terapia ultrasónica focalizada a un tejido en una pluralidad de locaciones en una o más profundidades focales con al menos uno del grupo que consiste en: modulación de amplitud, polarización y derivación de fase, en donde la polarización comprende diferentes momentos de polarización provistos en una pluralidad de porciones del material piezoeléctrico, en donde la derivación de fase comprende la pluralidad de porciones del material piezoeléctrico que es estimulada mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido;y en donde la pluralidad de locaciones están ubicadas en una secuencia lineal dentro de una zona de tratamiento y el transductor de ultrasonido comprende un elemento de transducción de ultrasonido único, el transductor de ultrasonido estando adaptado para crear múltiples puntos de coagulación termal en el tejido simultáneamente mediante la aplicación del ultrasonido terapéutico, con cada punto de coagulación térmica individuales separado de los puntos de coagulación térmica circundantes por un espacio de tratamiento.
- 2La sonda para tratamiento con ultrasonido de la reivindicación 1, en donde la pluralidad de locaciones está ubicada en una secuencia lineal dentro de la zona de tratamiento, y el transductor de ultrasonido comprende un elemento único de transducción de ultrasonido.
- 3La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones anteriores, en donde un primer juego de locaciones queda ubicado dentro de una primera zona de tratamiento y un segundo juego de locaciones queda ubicado dentro de una segunda zona de tratamiento, la primera zona siendo diferente a la segunda zona.
- 4La sonda para tratamiento con ultrasonido de la reivindicación 3, en donde la primera zona de tratamiento comprende una secuencia lineal del primer juego de locaciones, y la segunda zona de tratamiento comprende una secuencia lineal del segundo juego de locaciones.
- 5La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 1 a 4, en donde el transductor de ultrasonido está adaptado para aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual la pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad acústica, en donde una primera amplitud es diferente a una segunda amplitud.
- 6La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 1 a 4, en donde el transductor de ultrasonido está adaptado para aplicar terapia ultrasónica con derivación de fase, mediante lo cual la pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase.
- 7La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 1 a 4, en donde el cci Rnn/Ri nz/R/Y transductor de ultrasonido está adaptado para:aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual la pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad acústica, en donde una primera amplitud es diferente a una segunda amplitud;y aplicar terapia ultrasónica con derivación de fase, mediante lo cual la pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase.
- 8La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 6 y 7, en donde la pluralidad de fases comprende valores de fase discretos.
- 9La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 5, 7 y 8, en donde el transductor de ultrasonido comprende material piezoeléctrico, y la pluralidad de porciones del transductor de ultrasonido se adapta para crear una pluralidad de variaciones en el material piezoeléctrico correspondiente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido.
- 10La sonda para tratamiento con ultrasonido de la reivindicación 9, en donde la pluralidad de variaciones del material piezoeléctrico comprende al menos una de la expansión del material piezoeléctrico y la contracción del material piezoeléctrico.
- 11La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 5 y 7 a 10, en donde al menos una porción del transductor ultrasónico se adapta para emitir la terapia ultrasónica en dos o más amplitudes de intensidad acústica, y en donde la amplitud de la terapia ultrasónica emitida por la al menos una porción del piezoeléctrico varía con el tiempo.
- 12La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 1 a 11, que además comprende un mecanismo de movimiento adaptado para que sea programado para proporcionar espacio variable entre la pluralidad de zonas de tratamiento individuales.
- 13La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 1 a 11, en donde una secuencia de zonas de tratamiento individuales tiene un espacio de tratamiento en un rango de alrededor de 0.01 mm a alrededor de 25 mm.
- 14La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 1 a 11, en donde el tratamiento ultrasónico es adaptado para al menos uno de un levantamiento facial, un levantamiento de la ceja, un levantamiento de la barbilla, un tratamiento de ojos, una reducción de arrugas, una reducción de cicatriz, un tratamiento por quemadura, una eliminación de tatuaje, un estiramiento de piel, una remoción de vena, una reducción de vena, un tratamiento en una glándula sudorípara, un tratamiento de hiperhidrosis, una remoción de mancha de sol, un tratamiento para gordura, un rejuvenecimiento vaginal y un tratamiento de acné.
- 15La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 1 a 11, en donde el transductor ultrasónico está adaptado para proporcionar una energía acústica de la terapia ultrasónica en un rango entre alrededor de 1W a alrededor de 100W y una frecuencia de alrededor 1 MHz a alrededor de 10 MHz. cci Rnn/Ri Π7/ε/υ
- 16La sonda para tratamiento con ultrasonido para uso en un tratamiento cosmético para crear simultáneamente múltiples puntos focales con un transductor de ultrasonido, el sistema comprendiendo:un mango con un interruptor que controla operativamente una función del tratamiento ultrasónico, para proporcionar un tratamiento ultrasónico;un mecanismo de movimiento adaptado para dirigir tratamiento ultrasónico en al menos una secuencia de zonas de tratamiento térmico individuales;y un módulo transductor adaptado para aplicar terapia ultrasónica con al menos uno del grupo que consiste en modulación de amplitud, polarización y derivación de fase, en donde la polarización comprende diferentes momentos de polarización provistos en una pluralidad de porciones de polarización del material piezoeléctrico, en donde la derivación de fase comprende una pluralidad de porciones del material piezoeléctrico que son estimuladas mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones de fase del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido;en donde el módulo transductor está adaptado para acoplarse al mango, en donde el módulo transductor comprende un transductor de ultrasonido adaptado para aplicar terapia ultrasónica al tejido, en una pluralidad de locaciones a una o más profundidades focales.
- 17La sonda para tratamiento con ultrasonido de la reivindicación 16, en donde la pluralidad de locaciones está ubicada en una secuencia lineal dentro de un tejido.
- 18La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 16-17, en donde un primer juego de locaciones queda ubicado dentro de una primera zona de tratamiento y un segundo juego de locaciones queda ubicado dentro de una segunda zona de tratamiento, la primera zona siendo diferente a la segunda zona.
- 19La sonda para tratamiento con ultrasonido de la reivindicación 18, en donde la primera zona de tratamiento comprende una secuencia lineal del primer juego de locaciones, y la segunda zona de tratamiento comprende una secuencia lineal del segundo juego de locaciones.
- 20La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 16 a 19, en donde el módulo transductor está adaptado para aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual la pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad acústica, en donde una primera amplitud es diferente a una segunda amplitud.
- 21La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 16 a 20, en donde el módulo transductor está adaptado para aplicar terapia ultrasónica con derivación de fase, mediante lo cual la pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase.
- 22La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 16 a 21, en donde el módulo transductor está adaptado para:cci Rnn/Ri nz/R/γ aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual una pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad acústica, en donde una primera amplitud es diferente a una segunda amplitud;y aplicar terapia ultrasónica con derivación de fase, mediante lo cual una pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase.
- 23La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 21 y 22, en donde la pluralidad de fases comprende valores de fase discretos.
- 24La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 20, 22 y 23, en donde el módulo transductor comprende material piezoeléctrico, y la pluralidad de porciones del módulo transductor se adapta para crear una pluralidad de variaciones en el material piezoeléctrico correspondiente en respuesta a un campo eléctrico aplicado al módulo transductor.
- 25La sonda para tratamiento con ultrasonido de la reivindicación 24, en donde la pluralidad de variaciones del material piezoeléctrico comprende al menos una de la expansión del material y la contracción del material.
- 26La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 20 y 22-25, en donde al menos una porción del módulo transductor se adapta para emitir la terapia ultrasónica en dos o más amplitudes de intensidad acústica, y en donde la amplitud de la terapia ultrasónica emitida por la al menos una porción del módulo transductor varía con el tiempo.
- 27La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 16 a 26, en donde el mecanismo de movimiento está adaptado para que sea programado para proporcionar espacio variable entre la pluralidad de zonas de tratamiento térmico individuales.
- 28La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 16 a 26, en donde una secuencia de zonas de tratamiento térmico individuales tiene un espacio de tratamiento en un rango de alrededor de 0.01 mm a alrededor de 25 mm.
- 29La sonda para tratamiento con ultrasonido de acuerdo con cualquiera de las reivindicaciones 16 a 26, en donde los interruptores primero y segundo comprenden botones o teclas operadas por usuario.
- 30La sonda para tratamiento con ultrasonido de acuerdo con cualquiera de las reivindicaciones 16 a 26, en donde al menos uno del primer interruptor y el segundo interruptor es activado manualmente.
- 31La sonda para tratamiento con ultrasonido de acuerdo con cualquiera de las reivindicaciones 16 a 26, en donde la función de tratamiento está adaptada para al menos uno de un levantamiento facial, un levantamiento de la ceja, un levantamiento de la barbilla, un tratamiento de ojos, una reducción de arrugas, una reducción de cicatriz, un tratamiento por quemadura, una eliminación de tatuaje, un estiramiento de piel, una remoción de vena, una reducción de vena, un tratamiento en una glándula sudorípara, una remoción de mancha de sol, un tratamiento para gordura, un rejuvenecimiento vaginal y un tratamiento de acné.
- 32La sonda para tratamiento con ultrasonido de cualquiera de las reivindicaciones 16 a 26, en donde el cci Rnn/Ri nz/R/γ módulo transductor está adaptado para proporcionar una energía acústica de la terapia ultrasónica en un rango entre alrededor de 1W a alrededor de 100W y una frecuencia alrededor de 1 MHz a alrededor de 10 MHz.
- 33Un sistema de tratamiento, el sistema comprendiendo:una varita de mano adaptada para dirigir el tratamiento ultrasónico en una secuencia de zonas de tratamiento térmico individuales, un módulo que comprende un transductor adaptado para aplicar terapia ultrasónica a tejido en una locación en una o más profundidades focales, la locación ubicada dentro de una zona de tratamiento focal, en donde el transductor además está adaptado para aplicar terapia ultrasónica a tejido de manera simultánea en una pluralidad de locaciones en la profundidad focal con polarización, en donde se proporcionan distintos momentos de polarización en una pluralidad de porciones de polarización del material piezoeléctrico, o derivación de fase, en donde una pluralidad de porciones de fase del material piezoeléctrico se estimula mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones de fase del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido.
- 34Un método para enfocar múltiples puntos focales con un solo transductor, el método comprendiendo:acoplar un módulo transductor con una sonda ultrasónica;en donde la sonda ultrasónica comprende un primer interruptor para activar la imagen acústica;en donde la sonda ultrasónica comprende un segundo interruptor para activar la terapia acústica para causar una pluralidad de zonas de tratamiento individuales;en donde la sonda ultrasónica comprende un mecanismo de movimiento para proporcionar espacio deseado entre las zonas de tratamiento individuales;contactar el módulo transductor con una superficie de la piel de un sujeto;activar el primer interruptor en la sonda ultrasónica para acústicamente formar en imagen, con el módulo transductor, una región debajo de la superficie de la piel;y activar el segundo interruptor en la sonda ultrasónica tratar acústicamente, con el módulo transductor, la región debajo de la superficie de la piel en una secuencia deseada de zonas de tratamiento individuales mediante el mecanismo de movimiento, en donde el módulo transductor comprende un transductor de ultrasonido único adaptado para aplicar terapia ultrasónica a tejido en una pluralidad de locaciones en una profundidad focal con al menos uno del grupo que consiste en modulación de amplitud, polarización, en donde se proporcionan diferentes momentos de polarización en una pluralidad de porciones del material piezoeléctrico, y derivación de fase, en donde la pluralidad de porciones del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido.
- 35Una sonda para tratamiento con ultrasonido para crear múltiples puntos focales simultáneos en el tejido con un transductor de ultrasonido, el sistema comprendiendo:una varita de mano adaptada para dirigir el tratamiento ultrasónico en una secuencia de zonas de tratamiento cci Rnn/Ri nz/R/Y térmico individuales, la varita de mano comprendiendo: un transductor único adaptado para aplicar de manera simultánea terapia ultrasónica a tejido en una pluralidad de locaciones a una profundidad focal con al menos uno del grupo que consiste en modulación de amplitud y polarización, en donde se proporcionan diferentes momentos de polarización en una pluralidad de porciones del material piezoeléctrico.
- 36El uso de una sonda para tratamiento con ultrasonido de acuerdo con cualquiera de las reivindicaciones 1 a 33 y 35 para el tratamiento cosmético no invasivo de la piel.
- 37Un sistema de imagen y tratamiento, el sistema comprendiendo:una sonda ultrasónica adaptada para formar imagen ultrasónica y el tratamiento ultrasónico tejido en una pluralidad de locaciones a múltiples profundidades focales, que comprende: un módulo transductor adaptado para acoplarse a la sonda ultrasónica, en donde el módulo transductor comprende un transductor de ultrasonido adaptado para aplicar una terapia ultrasónica al tejido en la pluralidad de locaciones con al menos uno del grupo que consiste en polarización, en donde se proporcionan diferentes momentos de polarización en una pluralidad de porciones del material piezoeléctrico, y derivación de fase, en donde la pluralidad de porciones del material piezoeléctrico es estimulada mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones de material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido, un mecanismo de movimiento adaptado para dirigir el tratamiento ultrasónico en al menos una secuencia de zonas de tratamiento termal individuales.
- 38El sistema de imagen y tratamiento de la reivindicación 37, en donde la pluralidad de locaciones se posiciona en una secuencia lineal dentro de una zona de tratamiento.
- 39El sistema de imagen y tratamiento de la reivindicación 37, en donde un primer juego de locaciones queda ubicado dentro de una primera zona de tratamiento y un segundo juego de locaciones queda ubicado dentro de una segunda zona de tratamiento, la primera zona siendo diferente a la segunda zona.
- 40El sistema de imagen y tratamiento de la reivindicación 39, en donde la primera zona de tratamiento comprende una secuencia lineal del primer juego de locaciones, y la segunda zona de tratamiento comprende una secuencia lineal del segundo juego de locaciones.
- 41El sistema de imagen y tratamiento de la reivindicación 37, en donde el módulo transductor está adaptado para aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual una pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad acústica, en donde una primera amplitud es diferente a una segunda amplitud.
- 42El sistema de imagen y tratamiento de la reivindicación 37, en donde el módulo transductor está adaptado para aplicar terapia ultrasónica con derivación de fase, mediante lo cual una pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase. cci Rnn/Ri nz/R/γ
- 43El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde el módulo transductor está adaptado para:aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual una pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad acústica, en donde una primera amplitud es diferente a una segunda amplitud;y aplicar terapia ultrasónica con derivación de fase, mediante lo cual una pluralidad de porciones del módulo transductor se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase.
- 44El sistema de imagen y tratamiento de la reivindicación 43, en donde la pluralidad de fases comprende valores de fase discretos.
- 45El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde el módulo transductor comprende material piezoeléctrico, y la pluralidad de porciones del módulo transductor se adapta para crear una pluralidad de variaciones en el material piezoeléctrico correspondiente en respuesta a un campo eléctrico aplicado al módulo transductor.
- 46El sistema de imagen y tratamiento de la reivindicación 45, en donde la pluralidad de variaciones del material piezoeléctrico comprende al menos una de la expansión del material y la contracción del material.
- 47El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde al menos una porción del módulo transductor se adapta para emitir la terapia ultrasónica en dos o más amplitudes de intensidad acústica, y en donde la amplitud de la terapia ultrasónica emitida por la al menos una porción del módulo transductor varía con el tiempo.
- 48El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde el mecanismo de movimiento está adaptado para que sea programado para proporcionar espacio variable entre una pluralidad de zonas de tratamiento térmico individuales.
- 49El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde una secuencia de zonas de tratamiento térmico individuales tiene un espacio de tratamiento en un rango de alrededor de 0.01 mm a alrededor de 25 mm.
- 50El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde los interruptores primero y segundo comprenden botones o teclas operadas por usuario.
- 51El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde al menos uno del primer interruptor y el segundo interruptor es activado por manipulación manual.
- 52El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde la función de tratamiento está adaptada para al menos uno de un levantamiento facial, un levantamiento de la ceja, un levantamiento de la barbilla, un tratamiento de ojos, una reducción de arrugas, una reducción de cicatriz, un tratamiento por quemadura, una eliminación de tatuaje, un estiramiento de piel, una remoción de vena, una reducción de vena, un tratamiento en una glándula sudorípara, una remoción de mancha de sol, un tratamiento para gordura, un cci Rnn/Ri nz/R/v rejuvenecimiento vaginal y un tratamiento de acné.
- 53El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 37 a 42, en donde el módulo transductor está adaptado para proporcionar una energía acústica de la terapia ultrasónica en un rango entre alrededor de 1W a alrededor de 100W y una frecuencia alrededor de 1 MHz a alrededor de 10 MHz.
- 54Una sonda para tratamiento con ultrasonido multienfoque simultáneo, que comprende:una varita de mano adaptada para dirigir el tratamiento ultrasónico simultáneo en una secuencia de zonas de tratamiento térmico separadas, la varita de mano comprendiendo un transductor adaptado para aplicar terapia ultrasónica a tejido en una locación a una o más profundidades focales, la locación ubicada dentro de una zona de tratamiento térmico, en donde el transductor además está adaptado para aplicar terapia ultrasónica a tejido de manera simultánea en una pluralidad de locaciones con modulación de amplitud, polarización, en donde se proporcionan diferentes momentos de polarización en una pluralidad de porciones del material piezoeléctrico, y derivación de fase, en donde la pluralidad de porciones del material piezoeléctrico se estimula mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido.
- 55Un sistema de tratamiento multienfoque simultáneo y de imagen, que comprende:un módulo que comprende un transductor de ultrasonido adaptado para aplicar terapia ultrasónica a tejido en una pluralidad de locaciones con al menos uno del grupo que consiste en modulación de amplitud, polarización, en donde se proporcionan diferentes momentos de polarización en una pluralidad de porciones del material piezoeléctrico, y derivación de fase, en donde la pluralidad de porciones del material piezoeléctrico se estimula mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido. en donde el módulo además comprende una guía de interfaz diseñada para acoplarse de modo removible a una varita de mano, para proporcionar comunicación electrónica y energía entre el módulo y la varita de mano.
- 56El sistema de imagen y tratamiento de la reivindicación 55, en donde la pluralidad de locaciones se posiciona en una secuencia lineal dentro de una zona de tratamiento.
- 57El sistema de imagen y tratamiento de la reivindicación 55, en donde un primer juego de locaciones queda ubicado dentro de una primera zona de tratamiento y un segundo juego de locaciones queda ubicado dentro de una segunda zona de tratamiento, la primera zona siendo diferente a la segunda zona.
- 58El sistema de imagen y tratamiento de la reivindicación 57, en donde la primera zona de tratamiento comprende una secuencia lineal del primer juego de locaciones, y la segunda zona de tratamiento comprende una secuencia lineal del segundo juego de locaciones.
- 59El sistema de imagen y tratamiento de la reivindicación 55, en donde el transductor de ultrasonido está adaptado para aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual una pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad cci Rnn/Ri nz/R/v acústica, en donde una primera amplitud es diferente a una segunda amplitud.
- 60El sistema de imagen y tratamiento de la reivindicación 55, en donde el transductor de ultrasonido está adaptado para aplicar terapia ultrasónica con derivación de fase, mediante lo cual una pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase.
- 61El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 55 a 60, en donde el transductor de ultrasonido está adaptado para:aplicar terapia ultrasónica utilizando modulación de amplitud, con lo cual una pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de amplitudes de intensidad acústica, en donde una primera amplitud es diferente a una segunda amplitud;y aplicar terapia ultrasónica con derivación de fase, mediante lo cual una pluralidad de porciones del transductor de ultrasonido se adapta para emitir terapia ultrasónica en una pluralidad de fases de intensidad acústica, en donde una primera fase es diferente a una segunda fase.
- 62El sistema de imagen y tratamiento de la reivindicación 61, en donde la pluralidad de fases comprende valores de fase discretos.
- 63El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 55 a 60, en donde el transductor de ultrasonido comprende material piezoeléctrico, y la pluralidad de porciones del transductor de ultrasonido se adapta para crear una pluralidad de variaciones en el material piezoeléctrico correspondiente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido.
- 64El sistema de imagen y tratamiento de la reivindicación 63, en donde la pluralidad de variaciones del material piezoeléctrico comprende al menos una de la expansión del material piezoeléctrico y la contracción del material piezoeléctrico.
- 65El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 55 a 60, en donde al menos una porción del transductor de ultrasonido se adapta para emitir la terapia ultrasónica en dos o más amplitudes de intensidad acústica, y en donde la amplitud de la terapia ultrasónica emitida por la al menos una porción del piezoeléctrico varía con el tiempo.
- 66El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 55 a 60, que además comprende un mecanismo de movimiento adaptado para que sea programado para proporcionar espacio entre la pluralidad de zonas de tratamiento individuales.
- 67El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 55 a 60, en donde una secuencia de zonas de tratamiento individuales tiene un espacio de tratamiento en un rango de alrededor de 0.01 mm a alrededor de 25 mm.
- 68El sistema de imagen y tratamiento de acuerdo con cualquiera de las reivindicaciones 55 a 60, en donde el tratamiento ultrasónico es adaptado para al menos uno de un levantamiento facial, un levantamiento de la ceja, un levantamiento de la barbilla, un tratamiento de ojos, una reducción de arrugas, una reducción de cicatriz, un tratamiento cciEnn/Rinz/E/Y por quemadura, una eliminación de tatuaje, un estiramiento de piel, una remoción de vena, una reducción de vena, un tratamiento en una glándula sudorípara, un tratamiento de hiperhidrosis, una remoción de mancha de sol, un tratamiento para gordura, un rejuvenecimiento vaginal y un tratamiento de acné.
- 69El sistema de imagen y tratamiento de cualquiera de las reivindicaciones 55 a 60, en donde el transductor ultrasónico está adaptado para proporcionar una energía acústica de la terapia ultrasónica en un rango entre alrededor de 1W a alrededor de 100W y una frecuencia de alrededor 1 MHz a alrededor de 10 MHz.
- 70Un sistema de tratamiento, el sistema de tratamiento comprendiendo:un módulo transductor adaptado para enfocar simultáneamente ultrasonido en una secuencia de zonas de tratamiento térmico separadas, el módulo transductor comprendiendo: un transductor adaptado para aplicar de manera simultánea terapia ultrasónica a tejido en una pluralidad de locaciones a una profundidad focal con al menos uno del grupo que consiste en modulación de amplitud, polarización, en donde se proporcionan diferentes momentos de polarización en una pluralidad de porciones del material piezoeléctrico, y derivación de fase, en donde la pluralidad de porciones del material piezoeléctrico se estimula mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido.
- 71Un método para enfocar simultáneamente ultrasonido de un transductor de ultrasonido único en múltiples locaciones, el método comprendiendo:un módulo transductor que comprende un transductor de ultrasonido adaptado para aplicar terapia ultrasónica a tejido en una pluralidad de locaciones con al menos uno del grupo que consiste en modulación de amplitud, polarización y derivación de fase, en donde la polarización comprende diferentes momentos de polarización proporcionados en una pluralidad de porciones de polarización del material piezoeléctrico, en donde la derivación de fase comprende una pluralidad de porciones de fase del material piezoeléctrico que es estimulada mediante señales correspondientes con diferentes fases, en donde la pluralidad de porciones de fase del material piezoeléctrico se adapta para crear variaciones respectivamente en respuesta a un campo eléctrico aplicado al transductor de ultrasonido, en donde el módulo transductor comprende un mecanismo de movimiento para proporcionar espacio deseado entre las zonas de tratamiento individuales;y activar la sonda ultrasónica para enfocar acústicamente una secuencia deseada de zonas de tratamiento individuales mediante el mecanismo de movimiento.
- 72El uso de un sistema de imagen y tratamiento de acuerdo con cualquiera de las reivindicaciones 37-42, 5560 y 70 para el tratamiento cosmético no invasivo de la piel.
Independent claims72
285 paragraphs in 4 sections, as filed
DEVICES AND METHODS FOR MULTIFOCAL ULTRASOUND THERAPY
Reference to Related Applications [0001] This application claims the priority benefit of provisional application US No. 61 / 774,785 filed on March 8, 2013, which is incorporated in its entirety by reference herein.
Field of the Invention [0002] Various embodiments of the present invention generally relate to non-invasive energy-based treatments to achieve cosmetic effects. For example, some modalities generally relate to devices, systems, and methods for providing multiple ultrasound treatment points or focus areas to performing various imaging and / or processing treatments safely and effectively. Some modalities refer to dividing an ultrasound therapy beam into two, three, four, or more focal zones to perform various multi-phase and / or modulated phase treatment and / or imaging processes. Some modalities refer to dividing an ultrasound therapy beam into two, three, four, or more focal areas to perform various treatment and / or imaging processes with polarization techniques. In various embodiments, devices and methods are provided to direct ultrasound therapy to multiple focus points in cosmetic and / or medical processing.
Background of the Invention [0003] Many cosmetic procedures comprise invasive procedures that may require invasive surgery. Patients not only have to endure weeks of recovery time, but are also frequently required to undertake risky anesthesia procedures for cosmetic treatments.
Brief Description of the Invention [0004] Although energy-based treatments have been described for cosmetic and medical purposes, no procedures are known to the applicant, other than the applicant's own work, that successfully achieves an aesthetic effect using directed ultrasound and precise to bring about a visible and effective cosmetic result by a thermal route by splitting an ultrasound therapy beam into two, three, four or more focal zones to perform various imaging and / or treatment procedures.
[0005] In various modalities described herein, non-invasive ultrasound is used to achieve one or more of the following effects: a facial lift or rejuvenation, a brow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a tattoo removal, a vein removal, a vein reduction , a treatment in a sweat gland, a hyperhidrosis treatment, a sunspot removal, an acne treatment, a pimple reduction. Neckline treatment is provided in several modalities. In another embodiment, the device can be used on adipose tissue (eg, fat). In another embodiment, the system, device, and / or method can be applied to the genital area (eg, vaginal rejuvenation and / or vaginal tightening, such as to tighten the supporting tissue of the vagina).
[0006] According to various modalities, a cciRnn / Rinz / E / Y ultrasound cosmetic treatment system and / or method can non-invasively produce one or multiple cosmetic treatment zones one or multiple thermal coagulation points where focuses ultrasound on one or more locations in a treatment region in the tissue below the skin's surface. Some systems and methods provide cosmetic treatment at different locations in the tissue, such as at different depths, heights, widths and / or positions. In one embodiment, a system and method comprises a multi-depth transducer system configured to provide ultrasound treatment to more than one region of interest, such as between at least two of a deep treatment region of interest, a surface region of interest, and / or a subcutaneous region of interest. In one embodiment, a method and system comprise a transducer system configured to provide ultrasound treatment to more than one region of interest, such as between at least two points at various locations (eg, at a depth, height, width, fixed orientation or variable, etc.) in a region of interest in the tissue. Some modalities may split a beam to focus on two, three, or four or more focal points (eg, multiple focal points, or multifocal points) for cosmetic treatment areas and / or to image a region of interest in tissue. . The position of the focal points can be placed axially, laterally, or otherwise within the tissue. Some modalities can be configured for spatial control, such as by the location of a focus point, changing the distance of a transducer to a reflection surface, and / or changing focused or non-focused energy angles to the region of interest and / or configured for temporal control, such as controlling changes in frequency, drive amplitude, and transducer timing. In some modalities, the position of multiple treatment zones or focal points with polarization, phasic polarization, biphasic polarization, and / or multiphasic polarization. In some modalities, the position of the multiple treatment zones or focal points with phaging, such as in one modality, electrical phaging. As a result, changes in the location of the treatment region, the number, shape, size and / or volume of treatment areas or lesions in a region of interest can be dynamically controlled over time, as well as thermal conditions.
[0007] According to various modalities, an ultrasound cosmetic treatment system and / or method can create multiple cosmetic treatment zones using one or more phase modulation, polarization, nonlinear acoustics, and / or Fourier transforms to create some periodic spatial pattern with one or multiple portions of ultrasound. In one embodiment, a system simultaneously or sequentially distributes one or multiple treatment zones using polarization at a certain level. In one embodiment, a polarization pattern is a function of local frequency and depth, and the use of odd or even functions. In one embodiment, a process in two or more dimensions can be used to create any spatial periodic pattern. In one embodiment, an ultrasound beam is split axially and laterally to significantly reduce treatment time through the use of nonlinear Fourier transforms and acoustics. In one embodiment, modulation of a system and amplitude modulation of a ceramic product or transducer can be used to place multiple treatment zones on the tissue, either sequentially or simultaneously.
[0008] In one embodiment, an imaging and aesthetic treatment system includes an ultrasonic zone including an ultrasound transducer configured to apply ultrasonic therapy to tissue in a Rnn / Ri nz / R / γ cci plurality of locations at one depth focal with at least one of the group consisting of phase variation and amplitude modulation polarization. In one embodiment, the system includes a control module coupled to the ultrasound zone to control the ultrasound transducer.
[0009] In various embodiments, the plurality of locations are placed in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is placed within a first cosmetic treatment zone and a second set of locations is placed within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence from the first set of locations and the second cosmetic treatment zone includes a substantially linear sequence from the second set of locations. In one embodiment, the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby a plurality of portions of the ultrasound transducer are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, where a first amplitude is different from a second amplitude. In one embodiment, the ultrasound transducer is configured to apply phase variation of ultrasonic therapy whereby a plurality of portions of the ultrasound transducer are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, whereby a first phase it is different from a second phase. In one embodiment, the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby it is configured in a plurality of portions of the ultrasound transducer to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude is different from a second amplitude, and applying phase variation of ultrasonic therapy whereby a plurality of portions of the ultrasound transducer are configured to emit ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the plurality of phases includes discrete phase values. In one embodiment, the ultrasound transducer includes piezoelectric material, and the plurality of portions of the ultrasound transducer is configured to create a plurality of corresponding variations of piezoelectric material in response to an electric field applied to the ultrasound transducer. In one embodiment, the plurality of variations of piezoelectric material includes at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasound transducer is configured to emit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by at least a portion of the piezoelectric material varies with the passage of the weather. In one embodiment, the system also includes a movement mechanism configured to be programmed to provide variable spacing between the plurality of individual cosmetic treatment zones. In one embodiment, a sequence of individual cosmetic treatment zones has a treatment spacing in a range of from about 0.01mm to about 25mm. In various modalities, ultrasonic treatment is at least one of a facial lift or rejuvenation, a brow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a removal of tattooing, a skin tightening, a vein removal, a vein reduction, a treatment on a sweat gland, a cci «nn / Ainz / E / Y hyperhidrosis treatment, a sunspot removal, a fat treatment, a vaginal rejuvenation and an acne treatment. In one embodiment, the ultrasound transducer is configured to provide an acoustic power of the ultrasonic therapy in a range of from about 1W to about 100W and a frequency of about 1MHz to about 10MHz to thermally heat the tissue to cause coagulation.
[00010] In one embodiment, an imaging and cosmetic treatment system for use in cosmetic treatment includes: an ultrasonic zone and a control module. The ultrasonic zone includes a first switch that operably controls an ultrasonic imaging function to provide ultrasonic imaging, a second switch that operably controls an ultrasonic treatment function to provide ultrasonic treatment, and a motion mechanism configured to direct the ultrasonic treatment in at least one sequence of Individual thermal cosmetic treatment zones. In one embodiment, the system also includes a transducer module. In one embodiment, the transducer module is configured for both ultrasonic imaging and ultrasonic treatment. In one embodiment, the transducer module is configured for coupling to the ultrasonic probe. In one embodiment, the transducer module includes an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth. In one embodiment, the transducer module is configured to operably couple at least one of the first switch, the second switch, and the drive mechanism. In one embodiment, the control module includes a processor and display to control the transducer module.
[00011] In various embodiments, the plurality of locations are placed in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is placed within a first cosmetic treatment zone and a second set of locations is placed within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence from the first set of locations and the second cosmetic treatment zone includes a substantially linear sequence from the second set of locations. In one embodiment, the transducer module is configured to apply ultrasonic therapy using amplitude modulation whereby it is configured in a plurality of portions of the transducer module to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, where a first amplitude is different of a second amplitude. In one embodiment, the transducer module is configured to apply phase variation of ultrasonic therapy whereby a plurality of portions of the transducer module are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the transducer module is configured to apply ultrasonic therapy using amplitude modulation whereby it is configured in a plurality of portions of the transducer module to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, where a first amplitude is different of a second amplitude. In one embodiment, the transducer module is configured to apply phase variation of ultrasonic therapy whereby it is configured in a plurality of portions of the transducer module to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different of a second phase. In one embodiment, the plurality of phases includes discrete phase cci Rnn / Ri nz / R / Y values. In one embodiment, the transducer module is configured such that the transducer module includes piezoelectric material and the plurality of portions of the transducer module are configured to create a plurality of corresponding variations of the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of piezoelectric material variations include at least one of material expansion and material contraction. In one embodiment, at least a portion of the transducer module is configured to emit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of ultrasonic therapy emitted by the at least a portion of the transducer module varies with the passage of the weather. In one embodiment, the movement mechanism is configured to be programmed to provide variable spacing between a plurality of individual thermal cosmetic treatment zones. In one embodiment, a sequence of individual thermal cosmetic treatment zones has a treatment spacing in a range of from about 0.01mm to about 25mm. In one embodiment the first and second switches include user operated keys or buttons. In one embodiment, at least one of the first switch and the second switch is activated by the control module. In one modality, the treatment function is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation and acne treatment. In one embodiment, the transducer module is configured to provide acoustic power from the ultrasonic therapy in a range of from about 1W to about 100W and a frequency of about 1MHz to about 10MHz to thermally heat the tissue to cause coagulation.
[00012] In one embodiment, a treatment system includes a control device that operably controls an ultrasonic therapy function to provide ultrasonic treatment and a hand wand configured to direct ultrasonic treatment in a sequence of individual treatment zones cosmetic, thermal. In one embodiment, the hand wand includes a transducer configured to apply ultrasonic therapy to tissue at a location at a focal depth, the location positioned within a thermal, cosmetic treatment zone, where the transducer is further configured to apply ultrasonic therapy to tissue in a plurality of locations at focal depth.
[00013] In one embodiment, a method of performing cosmetic processing includes coupling a transducer module with an ultrasonic probe, wherein the ultrasonic probe includes a first switch to control acoustic imaging, wherein the ultrasonic probe includes a second switch. to control acoustic therapy to trigger a plurality of individual cosmetic treatment zones, wherein the acoustic probe includes a movement mechanism to provide desired spacing between the individual cosmetic treatment areas. In one embodiment, the method includes contacting the transducer module with the surface of a subject's skin. In one embodiment, the method includes activating the first switch on the acoustic probe to acoustically image, with the transducer module, a region below the skin surface. In cci Rnn / Ri Π7 / ε / υ one modality, the method includes activating the second switch on the acoustic probe to acoustically treat, with the transducer module, the region below the skin surface in a desired sequence of individual areas of cosmetic treatment that is controlled by the movement mechanism, wherein the transducer module includes an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth.
[00014] In one embodiment, a treatment system includes a control device that operably controls an ultrasonic treatment function to provide ultrasonic treatment, and a hand wand configured to direct ultrasonic treatment in a sequence of individual zones of cosmetic, thermal treatment. In one embodiment, the hand wand includes a transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth.
[00015] In one embodiment, the use of an aesthetic imaging and treatment system for is for non-invasive cosmetic treatment of the skin.
[00016] According to various modalities, an esthetic ultrasound treatment system for creating multiple focus points with an ultrasound transducer includes an ultrasonic probe comprising an ultrasound transducer includes an ultrasonic probe comprising an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations to a focal depth with at least one of the group consisting of amplitude modulation polarization and phase variation, and a control module coupled to the ultrasonic probe to control the ultrasound transducer.
[00017] In one embodiment, the ultrasound treatment comprises a single ultrasound transduction element. In one embodiment, the plurality of locations are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is positioned within a first cosmetic treatment area and a second set of locations is positioned within a second cosmetic treatment area, the first area being different from the first area. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence from the first set of locations and the second cosmetic treatment zone comprises a substantially linear sequence from the second set of locations.
[00018] In one embodiment, the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby it is configured in a plurality of portions of the ultrasound transducer to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude is different from a second amplitude. In one embodiment, the ultrasound transducer is configured to apply phase variation of ultrasonic therapy whereby it is configured in a plurality of portions of the ultrasound treatment to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase it is different from a second phase. In one embodiment, the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby it is configured on a plurality of portions of the ultrasound transducer to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude A second amplitude is different from cci Rnn / Ri nz / R / γ, and applying phase variation from ultrasonic therapy whereby a plurality of portions of the ultrasound transducer are configured to emit ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the ultrasound transducer comprises piezoelectric material, and the plurality of portions of the ultrasound transducer is configured to create a plurality of corresponding variations of piezoelectric material in response to an electric field applied to the ultrasound transducer. In one embodiment, the plurality of variations of piezoelectric material comprises at least one of expansion of piezoelectric material and contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasound transducer is configured to emit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by at least a portion of the piezoelectric material varies with the passage of the weather.
[00019] In one embodiment, the system further includes a movement mechanism configured to be programmed to provide variable spacing between the plurality of individual cosmetic treatment zones. In one embodiment, a sequence of individual cosmetic treatment zones has a treatment spacing in a range of from about 0.01mm to about 25mm.
[00020] In various modalities, ultrasonic treatment is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment , a tattoo removal, a skin tightening, a vein removal, a vein reduction, a treatment on a sweat gland, a hyperhidrosis treatment, a sunspot removal, a fat treatment, vaginal rejuvenation and acne treatment.
[00021] In one embodiment, the ultrasonic transducer is configured to provide an acoustic power of the ultrasonic therapy in a range of between about 1W to about 100W and a frequency of about 1MHz to about 10MHz to heat treat the tissue to cause coagulation .
[00022] In accordance with various modalities, a cosmetic treatment system for use in cosmetic treatment to create multiple focal points with an ultrasound transducer includes an ultrasonic probe including a first switch that operably controls a formation function ultrasonic imaging to provide ultrasonic imaging, a second switch operably controlling an ultrasonic treatment function to provide an ultrasonic treatment and a movement mechanism configured to direct the ultrasonic treatment in at least one sequence of the individual areas of the cosmetic, thermal treatment. The system includes a transducer module configured to apply ultrasonic therapy with at least one of the group consisting of amplitude modulation polarization and phase variation, where the transducer module is configured for both ultrasonic imaging and ultrasonic treatment, where the transducer module is configured for coupling to the ultrasonic probe, wherein the transducer module comprises an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of cciEnn / Rinz / E / Y locations at a focal depth, where the transducer module is configured to operably couple with the minus one of the first switch, the second switch and the movement mechanism, and a control module, wherein the control module comprises a processor and a display to control the transducer module. [00023] In one embodiment, the plurality of locations are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is positioned within a first cosmetic treatment area and a second set of locations is positioned within a second cosmetic treatment area, the first area being different from the second area. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence from the first set of locations and the second cosmetic treatment zone comprises a substantially linear sequence from the second set of locations.
[00024] In one embodiment, the transducer module is configured to apply ultrasonic therapy using the amplitude module whereby it is configured in a plurality of portions of the transducer module to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude is different from a second amplitude. In one embodiment, the transducer module is configured to apply phase variation of ultrasonic therapy whereby a plurality of portions of the transducer module are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the transducer module is configured to apply ultrasonic therapy using amplitude modulation whereby a plurality of portions of the transducer module are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude is different from a second amplitude and applying phase variation of ultrasonic therapy whereby a plurality of portions of the transducer module are configured to emit ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the transducer module comprises piezoelectric material and the plurality of portions of the transducer module are configured to create a plurality of corresponding variations of the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of piezoelectric material variations comprise at least one of material expansion and material contraction. In one embodiment, at least a portion of the transducer module is configured to emit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by the at least a portion of the transducer module varies with pitch. weather.
[00025] In one embodiment, the movement mechanism is configured to be programmed to provide variable spacing between a plurality of individual thermal, cosmetic treatment zones. In one embodiment, a sequence of individual thermal, cosmetic treatment zones has a treatment spacing in a range of from about 0.01mm to about 25mm. In one embodiment, the first and second switches comprise user operated keys or buttons. In one embodiment, at least one of the first switch and the second switch are activated by the control module.
cci Rnn / Ri nz / R / v [00026] In one modality, the treatment function is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction , a scar reduction, a burn treatment, a tattoo removal, a skin tightening, a vein removal, a vein reduction, a sweat gland treatment, a hyperhidrosis treatment, a sunspot removal, a fat treatment, a vaginal rejuvenation and an acne treatment.
[00027] In one embodiment, the transducer module is configured to provide an acoustic power of ultrasonic therapy in a range of from about 1W to about 100W and a frequency of about 1MHz to about 10MHz to thermally heat the tissue to cause coagulation .
[00028] In accordance with various modalities, a treatment system includes a control device that operably controls a function of acoustic treatment to provide ultrasonic treatment, and a hand wand to direct ultrasonic treatment in a sequence of individual zones for cosmetic, thermal treatment. The hand wand includes a transducer configured to apply ultrasonic therapy to tissue at a location at a focal depth. The location placed within a thermal cosmetic treatment zone, where the transducer is additionally applied to apply ultrasonic therapy to the tissue at a plurality of locations at the focal depth.
[00029] According to various modalities, one method of performing non-invasive cosmetic processing on the skin by creating multiple focal points with a single transducer includes coupling a transducer module with an acoustic probe, wherein the ultrasonic probe comprises a first switch for control ultrasonic imaging, wherein the ultrasonic probe comprises a second switch to control acoustic therapy to cause a plurality of individual cosmetic treatment zones, wherein the ultrasonic probe comprises a movement mechanism to provide desired spacing between the individual cosmetic treatment zones, bringing into contact the transducer module with the subject's skin surface, activating the first switch on the ultrasonic probe to acoustically image, with the transducer module, a region below the skin surface, and activating the second switch on the acoustic probe to acoustically treat, with the module transducer ,, the region below the skin surface in a desired sequence of individual cosmetic treatment areas that is controlled by the movement mechanism, wherein the transducer module comprises an individual ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth.
[00030] In accordance with various modalities, an aesthetic treatment system for creating multiple focal points in tissue with an ultrasound transducer includes a control device that operably controls an ultrasonic treatment function to provide an ultrasonic treatment, and a wand handheld configured to direct ultrasonic treatment into a sequence of individual thermal cosmetic treatment zones. The hand wand includes a transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth. In accordance with various modalities, the use of an aesthetic treatment system is for the non-invasive cosmetic treatment of the skin.
cci Rnn / Ri nz / R / v [00031] According to various modalities, an esthetic ultrasound treatment system for creating multiple focus points with an ultrasound transducer includes an ultrasonic probe comprising an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a local depth with at least one of the group consisting of amplitude modulation and phase variation polarization and a control module coupled to the ultrasonic probe to control the transducer of ultrasound. In one embodiment, the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby a plurality of portions of the ultrasound transducer is configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, where a first amplitude is different from a second amplitude. In one embodiment, the ultrasound transducer is configured to apply phase variation of ultrasonic therapy whereby a plurality of portions of the ultrasound transducer are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby a plurality of portions of the ultrasound transducer are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, where a first amplitude is different from a second amplitude, and applying phase variation of ultrasonic therapy whereby a plurality of portions of the ultrasound transducer are configured to emit ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the ultrasound transducer comprises the piezoelectric material and the plurality of portions of the ultrasound transducer are configured to create a plurality of corresponding variations of piezoelectric material in response to an electric field applied to the ultrasound transducer. In one embodiment, the plurality of variations of piezoelectric material comprise at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasonic transducer is configured to emit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by at least a portion of the piezoelectric material varies over time. . In various modalities, ultrasonic treatment is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a removal tattoo, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation and acne treatment.
[00032] In accordance with various modalities, an aesthetic treatment system for use in cosmetic treatment to create multiple focal points with an ultrasound transducer includes an ultrasonic probe including a first switch that operably controls a formation function ultrasonic imaging to provide ultrasonic imaging, a second switch operably controlling an ultrasonic treatment function to provide ultrasonic treatment, and a movement mechanism configured to direct ultrasonic treatment to the at least one sequence of individual cci Rnn / Ri nz / R / γ cosmetic treatment zones , thermal. The system includes a transducer module configured to apply ultrasonic therapy with at least one of the group consisting of amplitude modulation polarization and phase variation, where the transducer module is configured for both ultrasonic imaging and ultrasonic treatment, where the transducer module is configured for coupling to the ultrasonic zone, wherein the transducer module comprises an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth, wherein the transducer module is configured to operably engage at least one of the first switch, second switch and the movement mechanism, and a control module, wherein the control module comprises a processor and a display to control the transducer module. In one embodiment, the ultrasound module comprises a single ultrasound transducer. In one embodiment, the ultrasound module comprises a single ultrasound transduction element. In one embodiment, the ultrasound module comprises a single ultrasound transducer comprising a single transducer element. In one embodiment, the plurality of locations are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is positioned within a first cosmetic treatment area and a second set of locations is positioned within a second cosmetic treatment area. The first zone that is different from the second zone. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence from the first set of locations and the second cosmetic treatment zone comprises a substantially linear sequence from the second set of locations. In one embodiment, the transducer module is configured to apply ultrasonic therapy using amplitude modulation whereby a plurality of portions of the transducer module are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude is different from a second amplitude. In one embodiment, the transducer module is configured to apply phase variation of ultrasonic therapy whereby a plurality of portions of the transducer module are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the transducer module is configured to apply ultrasonic therapy using amplitude modulation whereby a plurality of portions of the transducer module are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude is different from a second amplitude, and applying phase variation of ultrasonic therapy whereby a plurality of portions of the transducer module are configured to emit ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the transducer module comprises piezoelectric material and the plurality of portions of the transducer module are configured to create a plurality of corresponding variations of piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of piezoelectric material variations comprise at least one of material expansion and material contraction. In one embodiment, at least a portion of the transducer module is configured to allow ultrasonic therapy at two or more amplitudes of acoustic intensity, and wherein the amplitude of the ultrasonic therapy emitted by at least a portion of the transducer module varies over time. .
cci Rnn / Ri nz / R / Y
In one embodiment, the movement mechanism is configured to be programmed to provide variable spacing between a plurality of individual thermal, cosmetic treatment zones. In one embodiment, a sequence of individual thermal, cosmetic treatment zones has a treatment spacing in a range of from about 0.01mm to about 25mm. In one embodiment, the first and second switches comprise user operated keys or buttons. In one embodiment, at least one of the first switch and the second switch is activated by the control module. In one modality, the treatment function is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, a vaginal rejuvenation and acne treatment [00033] In one embodiment, an imaging and cosmetic treatment system for use in cosmetic treatment includes an ultrasonic probe configured for ultrasonic treatment and ultrasonic imaging of tissue in a plurality of locations at a focal depth. In one embodiment, the probe includes a transducer module configured for coupling of the ultrasonic probe, wherein the transducer module comprises an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at the focal depth. In one embodiment, a first switch that operably controls an ultrasonic imaging function to provide ultrasonic imaging. In one embodiment, a second switch operably controls an ultrasonic treatment function to provide ultrasonic therapy. In one embodiment, a movement mechanism is configured to direct the ultrasonic treatment into at least a sequence of individual thermal, cosmetic treatment zones, wherein the transducer module is configured to operably engage at least one of the first switch, the second switch and the movement mechanism. In one embodiment, the control module comprises a processor and a display to control the transducer module. In one embodiment, the module is removable. For example, in some non-limiting modalities the transducers are configured for a tissue depth of 1.5mm, 3mm, 4.5mm, 6mm, less than 3mm, between 1.5mm and 3mm, between 1.5mm and 4.5mm, plus 4.5mm, over 6mm, and anywhere in the 0.1mm-3mm, 0.1mm-4.5mm, 0.1mm-25mm, 0.1mm-100mm intervals, and any depth between them.
[00034] In various embodiments, the plurality of locations are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is positioned within a first cosmetic treatment area and a second set of locations is positioned within a second cosmetic treatment area, the first area being different from the second area. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence from the first set of locations and the second cosmetic treatment zone comprises a substantially linear sequence from the second set of locations. In one embodiment, the transducer module is configured to apply ultrasonic therapy using amplitude modulation whereby the transducer module comprises a plurality of portions cci Rnn / Ri nz / R / Y configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, where a first amplitude is different from a second amplitude. In one embodiment, the transducer module is configured to apply phase shunt of ultrasonic therapy whereby the transducer module comprises a plurality of portions that are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase it is different from a second phase.
[00035] In one embodiment, a movement mechanism is a movement mechanism. In various embodiments, a movement mechanism is configured to move a transducer within a module or probe. In one embodiment, a transducer is supported by a transducer bracket. In one embodiment, the transducer bracket includes a sleeve that moves along motion restriction bearings, such as linear bearings, specifically, a rod (or shaft) to ensure repeatable linear movement of the transducer. In one embodiment, the sleeve is a slot bushing that prevents rotation around a slot shaft, but any guide is appropriate to maintain the path of motion.
[00036] In one embodiment, the transducer holder is actuated by a movement mechanism, which may be located on a hand wand or on a module, or on a probe. In one embodiment, a movement mechanism 400 includes any or one or more of a stop yoke, a movement member, and a magnetic coupling. In one embodiment, the magnetic coupling helps move the transducer. A benefit of a movement mechanism is that it provides a more precious, accurate, and efficient use of an ultrasound transducer, for therapy and / or imaging purposes. An advantage that this type of movement mechanism has over conventional, fixed arrays of multiple transducers fixed in place in one housing is that the fixed arrays are fixed with a separation distance.
[00037] By placing the transducer on a track (such as a linear track) under the control of the controller, the system and device modes provide adaptability and flexibility, as well as efficiency, accuracy and precision. Near-real-time and near-real-time adjustments can be made to imaging and treatment placement throughout movement controlled by the movement mechanism. In addition to the ability to select almost any resolution based on the increasing adjustments made possible by the motion mechanism, adjustments can be made if imaging detects abnormalities or conditions that warrant a change in target selection and treatment spacing. In one embodiment, one or more sensors can be included in the module. In one embodiment, one or more sensors may be included in the module to ensure that a mechanical coupling is actually coupled between the moving member and the transducer bracket. In one embodiment, an encoder can be placed on top of the transducer bracket and a sensor can be placed on a portion of the module, or vice versa (swapped).
[00038] In various modes the sensor is a magnetic sensor, such as a giant magnetoresistive effect (GMR) or Hall effect sensor, and the encoder can be a magnet, a collection of magnets, a multi-pole magnetic strip. The sensor can be placed as a starting position of the transducer module. In one embodiment, the sensor is a contact pressure sensor. In one embodiment, the sensor is a pressure sensor in cci Rnn / Ri nz / R / γ contact on a surface of the device to perceive the position of the device or transducer in the patient. In various embodiments, the sensor can be used to correlate the position of the device or a component on the device in one, two, or three dimensions. In one embodiment, the sensor is configured to perceive the position, tilt angle, orientation, location, elevation, or other relationship between the device (or a component thereof) and the patient. In one embodiment, the sensor comprises an optical sensor. In one embodiment, the sensor comprises a roller ball sensor. In one embodiment, the sensor is configured to correlate a position in one, two and / or three dimensions to compute a distance between treatment areas or lines on the skin or tissue in a patient.
[00039] The movement mechanism can be any movement mechanism that can be found to be useful for the movement of the transducer. Other modalities of movement mechanisms useful herein may include worm gear and the like. In various embodiments, the movement mechanism is located in a module 200. In various embodiments, the motion mechanism can provide linear, rotational, multi-dimensional motion or action, and the motion can include any collection of points and / or orientations in space. Various modes of movement may be used in accordance with various modes, including but not limited to rectilinear, circular, elliptical, arc, spiral, a collection of one or more points in space, or any other modality of positional and attitudinal movement 1-D, 2-D or 3-D. The speed of the movement mechanism can be set or can be controlled adjustable by a user. In one embodiment, the speed of the movement mechanism for an image sequence may be different than for a treatment sequence. In one embodiment, the speed of the movement mechanism is controllable by a controller.
[00040] In various modalities, the transducer module is configured to apply ultrasonic therapy using amplitude modulation whereby the transducer module comprises a plurality of portions that are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein one first amplitude is different from a second amplitude, and applying phase shunt of ultrasonic therapy whereby the transducer module comprises a plurality of portions that are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase.
[00041] In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the transducer module comprises piezoelectric material, and the plurality of portions of the transducer module is configured to create a plurality of corresponding variations of piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of piezoelectric material variations comprise at least one of material expansion and material contraction. In one embodiment, the transducer module comprises at least a portion that is configured to emit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of ultrasonic therapy emitted by the at least one portion of the transducer module varies with the pass of the time.
[00042] In one embodiment, the movement mechanism is configured to be programmed to provide variable spacing between a plurality of individual thermal, cosmetic treatment zones. In one embodiment, a sequence of individual thermal, cosmetic treatment zones has a treatment spacing in a range of cci Rnn / Ri nz / R / γ from about 0.01 mm to about 25 mm (eg, 1 mm, 1.5 mm, 2 mm, 1-5 mm). In one embodiment, the first and second switches comprise user operated keys or buttons. In one embodiment, at least one of the first switch and the second switch is activated by the control module.
[00043] In various modalities, the treatment function is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a treatment of burn, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, a vaginal rejuvenation, and an acne treatment. In one embodiment, the transducer module is configured to provide acoustic power from the ultrasonic therapy in a range of from about 1W to about 100W (eg, 5-40W, 10-50W, 25-35W) and a frequency of about 1 MHz to about 10 MHz to thermally heat the tissue to cause clotting. In one embodiment, the acoustic power may be in the range of 1 W to about 100 W in a frequency range of about 1 MHz to about 12 MHz (eg, 4 MHz, 7 MHz, 10 MHz, 4-10MHz), or from about 10 W to about 50 W at a frequency range of about 3 MHz to about 8 MHz. In one embodiment, the acoustic power and frequencies are from approximately 40 W to approximately 4.3 MHz and approximately 30 W to approximately 7.5 MHz. An acoustic energy produced by this acoustic power may be between approximately 0.01 joules ("J ha approximately 10 J or approximately 2 J to about 5 J. In one embodiment, the acoustic energy is in a range less than about 3 J.
[00044] In various modalities, a multi-focal ultrasound treatment system includes a control device that operably controls an ultrasonic treatment function to provide an ultrasonic treatment and a hand wand configured to direct the ultrasonic treatment in a sequence of individual areas of cosmetic, thermal treatment. The hand wand includes a transducer configured to apply ultrasonic therapy to tissue at a location at a focal depth, the location placed within a thermal, cosmetic treatment zone, where the transducer is further configured to apply ultrasonic therapy to tissue simultaneously in a plurality of locations at the focal depth.
[00045] In various modalities, a multi-focal treatment and aesthetic imaging system includes an ultrasonic probe comprising an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth with at least one of the group consisting of phase shunt and amplitude modulation polarization and a control module coupled to the ultrasonic probe to control the ultrasound transducer. In one embodiment, the plurality of locations is arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is placed within a first cosmetic treatment zone and a second set of locations is placed within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence of the first cci Rnn / Ri nz / R / Y set of locations and the second cosmetic treatment zone comprises a substantially linear sequence of the second set of locations. In a modality , the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby the ultrasound transducer comprises a plurality of portions that are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, wherein a first amplitude is different from a second amplitude. In one embodiment, the ultrasound transducer is configured to apply phase shunt of ultrasonic therapy whereby the ultrasound transducer comprises a plurality of portions that are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the ultrasound transducer is configured to apply ultrasonic therapy using amplitude modulation whereby the ultrasound transducer comprises a plurality of portions that are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, where the first amplitude is different from a second amplitude, and applying phase shunt of ultrasonic therapy whereby the ultrasound transducer comprises a plurality of portions that are configured to deliver ultrasonic therapy to a plurality of phases of acoustic intensity, wherein a first phase is different from a second phase. In one embodiment, the plurality of phases comprises discrete phase values.
[00046] In one embodiment, the ultrasound transducer comprises piezoelectric material and the plurality of portions of the ultrasound transducer is configured to create a plurality of corresponding variations of piezoelectric material in response to an electric field applied to the ultrasound transducer. In one embodiment, the plurality of piezoelectric material variations comprise at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, the ultrasonic transducer comprises at least a portion that is configured to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and wherein the amplitude of the ultrasonic therapy emitted by the at least a portion of the piezoelectric material varies with the pass of the time. In one embodiment, the system also includes a movement mechanism configured to be programmed to provide variable spacing between the plurality of individual cosmetic treatment zones. In one embodiment, a sequence of individual cosmetic treatment zones has a treatment spacing in a range of from about 0.01mm to about 25mm. In one modality, the ultrasonic treatment is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a removal tattoo, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, a vaginal rejuvenation, and an acne treatment. In one embodiment, the ultrasonic transducer is configured to provide an acoustic power of the ultrasonic therapy in a range of from about 1W to about 100W and a frequency of about 1MHz to about 10MHz to thermally heat the tissue to cause coagulation.
[00047] In various modalities, a treatment system includes a control device that operably controls an ultrasonic treatment function to provide ultrasonic treatment, and a hand wand configured to direct ultrasonic treatment in a sequence of individual areas of cci Rnn / Ri nz / R / γ thermal cosmetic treatment. In one embodiment, the hand wand includes a transducer configured to simultaneously apply ultrasonic therapy to tissue at a plurality of locations at a focal depth.
[00048] In various embodiments, a system for performing a cosmetic procedure that is not performed by a doctor includes an ultrasonic probe comprising a transducer module. In one embodiment, the transducer module comprises an ultrasound transducer configured to apply ultrasonic therapy to tissue at a plurality of locations at a focal depth with at least one of the group consisting of phase shunt and amplitude modulation polarization. In one embodiment, the ultrasonic probe comprises a first switch to control acoustic imaging, the ultrasonic probe comprises a second switch to control acoustic therapy by causing a plurality of individual cosmetic treatment areas, and the ultrasonic probe comprises a mechanism for movement to provide desired spacing between individual cosmetic treatment areas. [00049] In various modalities, the aesthetic imaging and treatment system for use in cosmetic treatment includes an ultrasonic probe. In one embodiment, a transducer module includes an ultrasound transducer configured to apply ultrasonic therapy through an opening in an acoustically transparent member to form a thermal coagulation point (TCP) at a focal depth in the tissue. In one embodiment, a first switch operably controls an ultrasonic imaging function to provide ultrasonic imaging, a second switch operably controls an ultrasonic treatment function to provide ultrasonic treatment, and a feedback mechanism is configured. movement to direct the ultrasonic treatment into at least one sequence of individual cosmetic, thermal treatment zones. In various embodiments, the transducer module is configured for both ultrasonic imaging and ultrasonic treatment, the transducer module is configured for coupling to the ultrasonic probe, the transducer module is configured to operably couple to at least one of the first switch, the second switch and the movement mechanism. In one embodiment, a control module comprises a processor and a display to control the transducer module.
[00050] In one embodiment, the plurality of locations are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of locations is placed within a first cosmetic treatment area and a second location area is placed within a second cosmetic treatment area, the first area that is different from the second area. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence of the first set of locations and the second cosmetic treatment zone comprises a substantially linear sequence of the second set of locations. In one embodiment, the movement mechanism is configured to provide fixed spacing between a plurality of individual thermal, cosmetic treatment zones. In one embodiment, a sequence of individual thermal, cosmetic treatment zones has a treatment spacing in a range of from about 0.01mm to about 25mm. In one embodiment, the first and second switches comprise user operated keys or buttons. In one modality, the treatment function is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a cciEnn / Rinz / E / Y wrinkle reduction, scar reduction , a burn treatment, a tattoo removal, a skin tightening, a vein removal, a vein reduction, a sweat gland treatment, a hyperhidrosis treatment, a sunspot removal, a fat treatment, a vaginal rejuvenation, and an acne treatment. In one embodiment, the transducer module is configured to provide acoustic power from ultrasonic therapy in a range of from about 1 W to about 100 W and a frequency of about 1 MHz to about 10 MHz to thermally heat the tissue to cause coagulation.
[00051] In various modalities, a cosmetic treatment system includes a control device that operably controls an ultrasonic treatment function to provide ultrasonic treatment at different depths below the skin surface, and a configured hand wand to direct the ultrasonic treatment at two or more focal depths below the surface of the skin, the hand wand configured to connect at least two interchangeable transducer modules configured to apply ultrasonic treatment to the two or more focal depths below the skin surface, where each of the transducer modules is configured to create one or more Thermal Coagulation Point (TCP) sequences.
[00052] In one embodiment, the system also includes an imaging transducer configured to provide images at least one depth below the skin surface. In one embodiment, the system also includes a movement mechanism to place the sequence of individual discrete lesions in a linear sequence. In one embodiment, the transducer modules comprise at least one transducer module that is configured to provide ultrasound therapy in a range of between about 1 W to about 100 W and a frequency of about 1 MHz to about 10 MHz. In one embodiment, the Transducer modules comprise a transducer module that is configured to provide therapy at a depth of 3mm. In one embodiment, the transducer modules comprise a transducer module that is configured to provide therapy at a depth of 4.5 mm.
[00053] In one embodiment, the at least two interchangeable transducer modules comprise a first interchangeable transducer module that is configured to treat a first focal depth below the skin surface with a first therapeutic transduction element, wherein the at least two interchangeable transducer modules comprise a second interchangeable transducer module that is configured to treat a second focal depth below the skin surface with a second therapeutic transduction element, wherein the hand wand is configured to connect to one of the first interchangeable transducer module and the second interchangeable transducer module at a time, wherein the system further comprises a screen for displaying a first image of the first focal depth below the skin surface and a second image of the second focal depth below the skin surface.
[00054] In one embodiment, the hand wand is configured to connect to one of the at least two interchangeable transducer modules at a time, the at least two interchangeable transducer modules comprise a first module that is configured to treat a first Focal depth below the skin surface with a first individual item of ultrasound therapy, and a second module that is configured to treat a Rnn / Ri Π7 / ε / υ second focal depth below the skin surface with a second individual element of ultrasound therapy. In one embodiment, creating the one or more Thermal Coagulation Point (TCP) sequences comprises creating multiple linear Thermal Coagulation Point (TCP) sequences.
[00055] In one embodiment, an imaging transducer is configured to provide images of at least one depth below the skin surface, where the individual areas of cosmetic, thermal treatment are discrete individual lesions, and further comprising a movement mechanism to place the sequence of individual discrete lesions in a linear sequence, wherein the transducer modules comprise at least one transducer module that is configured to provide ultrasound therapy in a range of between about 1 W to about 100 W and a frequency of about 1 MHz to about 10 MHz, where the transducer modules comprise a transducer module that is configured to provide therapy at a depth of 3mm or 4.5mm, and where the treatment function is at least one of a facial lift or rejuvenation, an eyebrow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a removal tattoo, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, a vaginal rejuvenation, and an acne treatment.
[00056] In several of the modalities described herein, the procedure is completely cosmetic and not a medical act. For example, in one embodiment, the methods described herein need not be performed by a doctor, but at a spa institute or other cosmetic institute. In some modalities, a system can be used for non-invasive cosmetic treatment of the skin.
[00057] The methods outlined above and discussed in detail further below describe certain actions taken by a practitioner; however, it should be understood that they may also include the instruction of these actions by a third party. Thus, actions such as coupling a transducer module with an ultrasonic probe "includes" giving instructions for coupling a transducer module with an ultrasonic probe. "
[00058] Additionally, the areas of applicability will become evident from the description provided herein. It should be noted that the specific description and examples are intended for illustration purposes only and are not intended to limit the scope of the modalities described herein.
Brief Description of the Figures [00059] The figures described herein are for illustration purposes only and are not intended to limit the scope of the present description in any way. The embodiments of the present invention will become more fully understood from the detailed description and the attached figures where:
[00060] Figure 1 is a schematic illustration of an ultrasound system according to various embodiments of the present invention.
[00061] Figure 2 is a schematic illustration of an ultrasound system coupled to a region of interest according to various embodiments of the present invention.
cci Rnn / Ri nz / R / v [00062] Figure 3 is a schematic partial sectional illustration of a portion of a transducer according to various embodiments of the present invention.
[00063] Figure 4 is a partial sectional side view of an ultrasound system according to various embodiments of the present invention.
[00064] Figures 5A-5D are graphs illustrating time delays in reaching a focal point for various transducers according to various embodiments of the present invention.
[00065] Figures 6A-6C are graphs illustrating phase lags to achieve a focal point for various transducers according to various embodiments of the present invention.
[00066] Figures 7A-7C are graphs illustrating qualified phase lags to achieve a focal point for various transducers according to various embodiments of the present invention.
[00067] Figures 8A-8B are graphs illustrating profiles of the quantized phase lags to achieve a focal point for various transducers according to embodiments of the present invention.
[00068] Figure 9 is a schematic illustration of the characteristics of the polarized piezoelectric material according to an embodiment of the present invention.
[00069] Figures 10A-10B are graphs illustrating approximations of amplitude modulation according to various embodiments of the present invention.
[00070] Figures 11A-11H are schematic and graphical illustrations illustrating modulation functions and corresponding intensity distributions according to various embodiments of the present invention.
[00071] Figures 12A-12D are graphs illustrating modulation functions and corresponding intensity distributions according to various embodiments of the present invention.
[00072] Figure 13 is a schematic illustration of a two-phase system according to an embodiment of the present invention.
[00073] Figure 14 is a schematic illustration of a selected four-phase system according to an embodiment of the present invention.
[00074] Figure 15 is a graph illustrating the performance of a discrete phase system according to an embodiment of the present invention.
[00075] Figures 16A-16B are graphs illustrating the performance of discrete phases in various approaches according to various embodiments of the present invention.
[00076] Figures 17A-17D are schematic illustrations of hybrid systems and graphs illustrating their performance according to various embodiments of the present invention.
[00077] Figure 18 is a schematic illustration of a two-phase changeable system according to an embodiment of the present invention.
[00078] Figures 19A-19C are graphs of an intensity distribution before focusing according to an embodiment of the present invention.
[00079] Figures 20A-20C are graphs of a focus intensity distribution according to a cci Rnn / Ri nz / R / v embodiment of the present invention.
[00080] Figure 21 is a schematic illustration of an amplitude modulation aperture pattern according to an embodiment of the present invention.
[00081] Figures 22A-22C are graphs of an intensity distribution of an amplitude modulated aperture before focusing according to an embodiment of the present invention.
[00082] Figures 23A-23C are graphs of an intensity distribution of an amplitude modulated aperture in focus according to an embodiment of the present invention.
[00083] Figure 24 is a schematic illustration of an amplitude modulated aperture pattern with changing states according to an embodiment of the present invention.
[00084] Figures 25A-25D are graphs of an intensity distribution of an amplitude modulated aperture with changing states before focusing according to an embodiment of the present invention.
[00085] Figures 26A-26C are graphs of an intensity distribution of an amplitude modulated aperture with changing states in focus according to an embodiment of the present invention.
[00086] Figure 27A is a schematic illustration of an amplitude modulated aperture with two levels of change according to an embodiment of the present invention.
[00087] Figure 27B is a state transition table of the schematic view of Figure 27A according to an embodiment of the present invention.
[00088] Figure 28A is a schematic illustration of an amplitude modulated aperture with three levels of change according to an embodiment of the present invention.
[00089] Figure 28B is a state transition table of the schematic view of Figure 28A according to an embodiment of the present invention.
[00090] Figure 29A is a schematic illustration of an amplitude modulated aperture with four levels of change according to an embodiment of the present invention.
[00091] Figure 29B is a state transition table of the schematic view of Figure 29A according to an embodiment of the present invention.
Detailed Description of the Invention [00092] The following description sets forth examples of embodiments, and is not intended to limit the present invention or its teachings, applications, or uses thereof. It should be understood that throughout the figures, corresponding reference numbers indicate similar or corresponding parts and characteristics. The description of the specific examples indicated in the various embodiments of the present invention is intended for illustration purposes only and is not intended to limit the scope of the invention described herein. Furthermore, the citation of multiple modalities having the stated characteristics is not intended to exclude other modalities that have additional characteristics, or other modalities that incorporate different combinations of the indicated characteristics. Additionally, features in one modality (such as in a figure) can be combined with descriptions (and figures) of other modalities.
cci Rnn / Ri nz / R / v [00093] In various modalities, systems and methods for tissue ultrasound treatment are configured to provide cosmetic treatment. In various modalities, tissue below or even on the surface of the skin such as the epidermis, dermis, fascia, muscle, fat, and superficial muscular fascia (SMAS) are treated non-invasively with ultrasound energy. Ultrasound energy can be focused on one or more treatment points, it may not be focused and / or be out of focus, and it can be applied to a region of interest that contains at least one of epidermis, dermis, hypodermis, fascia, muscle, fat and SMAS to achieve a cosmetic and / or therapeutic effect. In various modalities, the systems and / or methods provide non-invasive dermatological treatment to tissue through heat treatment, coagulation, ablation, and / or stretching. In various modalities described herein, non-invasive ultrasound is used to achieve one or more of the following effects: a facial lift or rejuvenation, a brow lift, a chin lift, an eye treatment, a wrinkle reduction, a scar reduction, a burn treatment, a tattoo removal, a vein removal, a vein reduction , a sweat gland treatment, hyperhidrosis treatment, sunspot removal, acne treatment, and pimple removal. In one embodiment, fat reduction is achieved. In one embodiment, the cleavage is treated. In some modalities, two, three, or more beneficial effects are achieved during the same treatment session, and can be achieved simultaneously. In another embodiment, the device can be used on adipose tissue (eg, fat). In another embodiment, the system, device, and / or method can be applied to the genital area (eg, a vagina for vaginal rejuvenation and / or vaginal tightening, such as to tighten the supporting tissue of the vagina).
[00094] Various embodiments of the present invention relate to devices or methods for controlling energy distribution to tissue. In various modalities, various forms of energy may include acoustic, ultrasonic, light, laser, radio frequency (RF), microwave, electromagnetic, radiation, thermal, cryogenic, electron beam, photon based, magnetic, magnetic resonance, and / or other forms of energy. The various embodiments of the present invention relate to devices or methods for dividing an ultrasound energy beam into multiple beams. In various modalities, devices or methods can be used to alter the distribution of ultrasound acoustic energy in any of the procedures such as, but not limited to, therapeutic ultrasound, diagnostic ultrasound, non-destructive test (NDT) using ultrasound, ultrasonic welding, any application that involves coupling mechanical waves to an object, and other procedures. In general, with therapeutic ultrasound, a tissue effect is achieved by concentrating acoustic energy using focusing techniques from the opening. In some cases, high intensity focused ultrasound (HIFU) is used for therapeutic purposes in this way. In one embodiment, a tissue effect created by the application of therapeutic ultrasound at a given depth can be referred to as the creation of a thermal coagulation point (TCP). It is through the creation of PCTs in particular positions that the thermal and / or mechanical ablation of the tissue can occur non-invasively or remotely.
[00095] In one embodiment, TCPs can be created in a linear or substantially linear sequence or zone, with each individual TCP separated from its neighboring TCPs by treatment spacing. In one embodiment, cci Rnn / Ri nz / R / Y can create multiple TCP sequences in a treatment region. For example, PCTs can be formed along a first linear sequence and a second linear sequence separated by a treatment distance from the first linear sequence. Although therapeutic ultrasound treatment can be administered through the creation of individual PCTs in a sequence and sequences of individual PCTs, it may be desirable to reduce the treatment time and the corresponding risk of pain and / or discomfort experienced by a patient. Therapy time can be reduced by forming multiple PCTs simultaneously, almost simultaneously, or sequentially. In some modalities, the treatment time can be reduced 10%, 20%, 25%, 30%, 35%, 40%, 4%, 50%, 55%, 60%, 65%, 70%, 75%, 80% or more when creating multiple TCPs.
[00096] Various embodiments of the present invention face potential challenges presented by the administration of ultrasound therapy. In various embodiments, the time to effect TCP formation for a desired cosmetic and / or therapeutic treatment for a desired clinical approach in a target tissue is reduced. In various modalities, the target tissue, but is not limited to, any of the skin, eyelids, eyelashes, eyebrows, caruncle lacrimalis, crow's feet, wrinkles, eye, nose, mouth, tongue, teeth, gums, ears, brain, heart, lungs, ribs, abdomen, stomach, liver, kidneys, uterus, breast, vagina, prostate, testicles, glands, thyroid glands, internal organs, hair, muscles, bones, ligaments, cartilage, fat, labuli fat, adipose tissue, subcutaneous tissue, implanted tissue, an implanted organ, lymphoid, a tumor, a cyst, an abscess, or a portion of a nerve, or any combination of this.
[00097] In some embodiments, discrete phage and / or amplitude modulation techniques can be applied to an aperture configured to emit ultrasonic energy. This can cause the splitting of an ultrasonic beam emitted from the aperture into multiple beams, which can simultaneously, substantially simultaneously, or sequentially distribute ultrasonic energy to multiple locations or focal points. In some embodiments, amplitude modulation can be combined with configured techniques to change the modulation states of an aperture to reduce the intensity of distributed ultrasonic energy to tissues located before and / or after the focal points. In various modalities, the therapy time can be reduced by 1-24%, 1-26%, 1-39%, 1-50%, or more than 50%.
[00098] Various modalities of imaging and ultrasound treatment devices are described in US application No. 12 / 996,616, which was published as US Publication No. 2011-0112405 A1 on May 12, 2011, which is a US National Phase according to 35 USC § 371 of International Application No. PCT / US2009 / 046475, filed on June 5, 2009 and published in English on December 10, 2009, which claims the priority benefit of Provisional US No. 61 / 059,477 filed on June 6, 2008, each of which is incorporated in its entirety by reference herein.
System Overview [00099] Referring to the illustration in Figure 1, one embodiment of an ultrasound system 20 includes a hand wand 100, module 200, and a controller 300. Hand wand 100 can be attached to controller 300 by an interface 130, which can be a wired or wireless interface. Interface 130 can be attached to hand wand 100 by connector 145. The far end of interface 130 can be connected to a Rnn / Ri nz / R / γ controller connector on circuit 345. In one embodiment, interface 130 can transmit controllable power from controller 300 to hand wand 100 .
[000100] In various modes, controller 300 can be configured for operation with hand wand 100 and module 200, as well as functionality of the full ultrasound system 20. In various modes, multiple controllers 300, 300 ', 300 ”etc. can be configured. for operation with multiple hand wands 100, 100 ', 100 ”, etc. and / or multiple modules 200, 200 ', 200 ", etc. Controller 100 may include an interactive graphic display 310, which may include a touch monitor and a graphical user interface (GUI) that allows the user to interact with the ultrasound system 20. As illustrated, graphic display 315 includes a touch interface 315. In various modes, display 310 establishes and displays operating conditions, including equipment activation status, treatment parameters, system messages and warnings, and ultrasound images. In various embodiments, controller 300 can be configured to include, for example, a microprocessor with software and input / output devices, systems and devices for controlling electronics and / or mechanical scanning and / or multiplexing of transducers and / or multiplexing of transducer modules, a system for the distribution of energy or power, systems for monitoring, systems to perceive the spatial opposition of the probe and / or transducers and / or multiplexing of transducer modules, and / or systems to manage user input and record treatment results, among others. In various embodiments, controller 300 may include a system processor and various analog and / or digital control logic, such as one or more microcontrollers, microprocessors, field programmable gate arrays, computer cards, and associated components, including firmware or control software, which may be able to interface user controls and interface circuits as well as input / output circuits and systems for communications, displays, interconnection, storage, documentation and other useful functions. The system software running in the system process can be configured to control all initialization, synchronization, level adjustment, monitoring, safety monitoring functions and all other functions of the ultrasound system to achieve the treatment goals defined by the user. Additionally, controller 300 may include various input / output modules, as well as switches, buttons, etc., which can also be appropriately configured to control the operation of ultrasound system 20.
[000101] As illustrated in Figure 1, in one mode, controller 30 may include one or more 390 data ports. In various modes, data ports 390 may be a USB port, Biuetooth port, IrDA port, parallel port, serial port and the like. Data ports 390 can be located on the front, side and / or back of controller 300, and can be used to access storage devices, printing devices, computing devices, etc. Ultrasound system 20 may include a latch 395. In one embodiment, in order to operate ultrasound system 20, latch 395 must be unlocked so that a power switch 393 can be activated. In one embodiment, the lock 395 can be connected to the controller 300 via a data port 390 (for example, a USB port). Lock 395 can be unlocked by inserting an access key (eg, USB access key), a hardware key, or the like into data port 390. Controller 300 may include an emergency stop button 392, which can be easily accessible for emergency cci Rnn / Ri nz / R / γ deactivation.
[000102] In one embodiment, the hand wand 100 includes one or more finger-activated switches or controllers, such as 150 and 160. In one embodiment, the hand wand 100 may include a removable module 200. In other embodiments, the module 200 may be non-removable. Module 200 can be mechanically coupled to hand wand 100 using a latch or coupler 140. An interface guide 235 can be used to assist in coupling module 200 to hand wand 100. Module 200 can include one or more ultrasound transducers. In some embodiments, an ultrasound transducer includes one or more ultrasound elements. Module 200 can include one or more ultrasound elements. Hand wand 100 may include imaging only modules, treatment only modules, imaging and treatment modules, and the like. In one embodiment, control module 300 can be attached to hand wand 100 via interface 130, and graphical user interface 310 can be configured to control module 200. In one embodiment, control module 300 can provide power to hand wand 100. In one embodiment, hand wand 100 may include a power source. In one embodiment, switch 150 can be configured to control a tissue imaging function and switch 160 can be configured to control a tissue treatment function.
[000103] In one embodiment, module 200 can be coupled to hand wand 100. Module 200 can emit and receive energy, such as ultrasonic energy. Module 200 can be electronically coupled to hand wand 100 and this coupling can include an interface that is in communication with controller 300. In one embodiment, interface guide 235 can be configured to provide electronic communication between module 200 and hand wand 100. Module 200 can comprise various probe and / or transducer configurations. For example, module 200 can be configured for a combined dual-mode imaging / therapy transducer, coupled or co-hosted imaging / therapy transducers, separate imaging and therapy probes, and the like. In one embodiment, when module 200 is inserted into or connected to the hand wand, controller 300 automatically detects it and updates interactive graphic display 310.
[000104] In various modalities, the tissue below still on the surface of the skin such as the epidermis, dermis, hypodermis, facia and superficial muscular fascia ("SIMAS"), and / or muscle are treated non-invasively with ultrasound energy. The tissue can also include blood vessels and / or nerves. The ultrasound energy can be focused, not focused or out of focus and apply a region of interest that contains at least one of epidermis, dermis, hypodermis, facia and SIMAS to achieve a therapeutic effect. Figure 2 is a schematic illustration of the ultrasound system 20 coupled in the region of interest 10. In various embodiments, the tissue layers of the region of interest 10 may be somewhere in the body of a subject. In one embodiment, the tissue layers are in the subject's head and face region. The tissue cross-section portion of the region of interest 10 includes a skin surface 501, an epidermal layer 502, a dermal layer 503, a layer of fat 505, a superficial muscular aponeurotic system 507 (hereinafter "SIMAS 507), and a layer of muscle 509. The tissue may also include the hypodermis 504, which may include any tissue below the dermal layer 503. The combination of these layers in total may be known as subcutaneous tissue 510. Also illustrated in Figure 2 cci Rnn / Ri nz / R / γ is a treatment zone 525 that is below surface 501. In one embodiment, surface 501 may be a surface of the skin of a subject 500. Although a modality targeting therapy to a tissue layer can be used herein as an example, the system can be applied to any tissue in the body. In various modalities, the system and / or method can be used on muscles (or other tissue) of the face, neck, head, arms, legs, or any other location on the body.
[000105] Referring to the illustration in Figure 2, one embodiment of the ultrasound system 20 includes the hand wand 100, the module 200, and the controller 300. In one embodiment, the module 200 includes a transducer 280. Figure 3 illustrates an embodiment of an ultrasound system 20 with a transducer 280 configured to treat tissue at a focal depth 278. In one embodiment, focal depth 278 is a distance between transducer 280 and target tissue for treatment. In one embodiment, a 278 focal depth is set for a given 280 transducer. In one embodiment, a 278 focal depth is variable for a given 280 transducer.
[000106] Referring to the illustration in Figure 4, module 200 may include a transducer 280 that can emit energy through an acoustically transparent member 280. In various embodiments, a depth may refer to focal depth 278. In one In this embodiment, transducer 280 may have a deflected distance 270, which is the distance between transducer 280 and an acoustically transparent member surface 230. In one embodiment, the focal depth 278 of a transducer 280 is a fixed distance from the transducer. In one embodiment, a transducer 280 may have a fixed offset distance 270 from the transducer to the acoustically transparent member 280. In one embodiment, an acoustically transparent member 280 is configured in one position in module 200 or ultrasound system 20 to make contact with skin surface 501. In various embodiments, focal depth 278 exceeds offset distance 270 by an amount corresponding to treatment to a target area located at tissue depth 279 below skin surface 501. In various embodiments, when the ultrasound system 20 placed in physical contact with the skin surface 501, the tissue depth 279 is a distance between the acoustically transparent member 230 and the target area, measured as the distance from the wand portion hand-held 100 or modulo-200 surface that contacts the skin (with or without an acoustic coupling gel, medium, etc.) and the depth in the tissue from the point of contact on the skin surface to the target area. In one embodiment, focal depth 278 may correspond to the sum of a deflected distance 270 (as measured from the surface of the acoustically transparent member 230 in contact with a coupling medium and / or skin 501) in addition to a tissue depth 279 below the skin surface 501 to the target or target region. In various embodiments, the acoustically transparent member 230 is not used.
[000107] Coupling components may comprise various substances, materials and / or devices to facilitate coupling of transducer 280 or module 200 to a region of interest. For example, the coupling components may comprise an acoustic coupling system configured to acoustically couple the ultrasound signals and energy. The acoustic coupling system with possible connections such as collector can be used to couple the sound in the region of interest, to provide fluid or fluid filled lens focus. The coupling system can facilitate this coupling through the use of one or more cci Rnn / Ri nz / R / γ coupling means, including gases, water, liquids, fluids, gels, solids, non-gels, and / or any combination of this, or any other means that allows signals to be transmitted between transducer 280 and a region of interest. In one embodiment, one or more coupling means is provided within a transducer. In one embodiment, a fluid filled module 200 contains one or more coupling means within a housing. In one embodiment, a fluid filler module 200 contains one or more coupling means within a sealed housing, which is detachable from a dry portion of an ultrasound device. In various embodiments, a coupling means is used to transmit ultrasound energy between one or more devices and the tissue with a transmission efficiency of 100%, 99% or more, 98% or more, 95% or more, 90% or more, 80% or more, 75% or more, 60% or more, 50% or more, 40% or more, 30% or more, 25% or more, 20% or more, 10% or more, and / or 5% or more.
[000108] In various modalities, transducer 280 can image and treat a region of interest at any suitable tissue depth 279. In one embodiment, transducer module 280 can provide acoustic power or energy in a range of about 1W or less, between about 1W or about 100W and more than about 100W. In one embodiment, transducer module 280 can provide acoustic power at a frequency of about 1 MHz or less, between about 1 MHz to about 10 MHz, and more than about 10 MHz. In one embodiment, module 200 has a focal depth 278 for treatment at a tissue depth 279 of approximately 4.5 mm below the skin surface 501. Some non-limiting modalities of 280 transducers or 200 modules can be configured to distribute ultrasonic energy at a tissue depth of 3mm, 4.5mm, 6mm, or less than 3mm, between 3mm and 4.5mm, between 4.5mm and 6 mm, more than 4.5 mm, more than 4 mm, etc., and anywhere in the intervals of 0-3 mm, 0.4.5 mm, 0-6 mm, 0-25 mm, 0-100 mm, etc., and any depth in this. In one embodiment, ultrasound system 20 is provided with two or more 280 transducer modules. For example, a first transducer module may apply treatment to a first tissue depth (eg, approximately 4.5 mm), and a second transducer module may apply treatment to a second tissue depth (eg, approximately 3 mm), and a third Transducer module can apply treatment to a third tissue depth (eg approximately 1.5-2mm). In one embodiment, at least some or all of the transducer modules can be configured to apply treatment at substantially equal depths.
[000109] In various modalities, changing the number of focus point locations (for example such as with a tissue depth of 279) for an ultrasonic procedure may be advantageous in that it allows treatment of a patient at various tissue depths even if the focal depth 278 of a transducer 270 is set. This can provide synergistic results and maximize clinical results from an individual treatment session. For example, treatment at multiple depths under a single surface region allows for a greater total volume of tissue treatment, resulting in improved collagen formation and narrowing. Additionally, treatment at different depths affects different tissue types, thereby producing different clinical effects that together provide an improved, total cosmetic result. For example, surface treatment may reduce the visibility of wrinkles, and deeper treatment may induce Rnn / Ri nz / R / cci to form more collagen growth. Similarly, treatment at multiple locations at the same or different depth can improve a treatment.
[000110] Although treating a subject at different locations in one session may be advantageous in some modalities, sequential treatment over time may be beneficial in other modalities. For example, a subject can be treated under the same surface region at one depth once, at a second depth at a second time, etc. In various modes, time can be in the order of nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other periods of time. The new collagen produced by the first treatment may be more sensitive to subsequent treatments, which may be desired for some indications. Alternatively, treatment at multiple depths under the same surface region in a single session may be advantageous because treatment at one depth can synergistically enhance or complement treatment at another depth (due to, for example, blood flow). improved, stimulation of growth factors, hormonal stimulation, etc.). In various modalities, different transducer modules provide treatment at different depths. In one embodiment, an individual transducer module can be adjusted or controlled for varying depths. Safety features can be used to minimize the selection of an incorrect depth, in conjunction with the individual module system.
[000111] In various embodiments, a method is provided for treating an area of the neck or lower face (eg, the submental area). In various embodiments, a method is provided for treating (eg, softening) the mentholabial folds. In other embodiments, a method of treating the eye region is provided. An improvement in the laxity of the upper eyelid and periorbital lines and improvement of the texture will be achieved by various modalities when treating at variable depths. By treating at various locations in an individual treatment session, optimal clinical effects (eg, softening, stretching) can be achieved. In various modalities, the treatment methods described herein are non-invasive cosmetic processing. In some embodiments, the methods can be used in conjunction with invasive procedures such as liposuction or surgical face lifts, where skin tightening is desired. In various modalities, the methods can be applied to any part of the body.
[000112] In one embodiment, a transducer module allows a treatment sequence at a fixed depth at or below the skin surface. In one embodiment, a transducer module allows a treatment sequence at a fixed depth below the dermal layer. In various embodiments, the transducer module comprises a movement mechanism configured to direct ultrasonic treatment in a sequence of individual thermal injuries (hereinafter referred to as thermal coagulation points "or" TCP ") to a fixed focal depth. In one embodiment, the individual TSP linear sequence has a treatment spacing in a range of about 0.01mm to about 25mm. For example, the spacing can be 1.1mm or less, 1.5mm or less, between about 1.1mm and about 1.5mm, etc. In one embodiment, the individual TCPs are discrete. In one embodiment, the individual TCPs are overlapping. In one embodiment, the movement mechanism is configured to be programmed to provide variable spacing between individual TCPs. In various embodiments, the transducer module comprises a motion mechanism configured to direct the ultrasonic treatment in cci Rnn / Ri nz / R / Y a sequence such that TCP is formed in linear or substantially linear sequences separated by a treatment distance. For example, a transducer module can be configured to form TCP along a first linear sequence and a second linear sequence separated by a treatment distance from the first linear sequence. In one embodiment, the treatment distance between the adjacent linear sequences of the individual TCPs is in a range of about 0.01mm to about 25mm. For example, the treatment distance may be 2mm or less, 3mm or less, between about 2mm and about 3mm, etc. In various embodiments, a transducer module may comprise one or more movement mechanisms configured to direct ultrasonic treatment in one sequence such that TCP forms in linear or substantially linear sequences of individual thermal injuries separated by a treatment distance from other sequences linear. In one embodiment, the treatment distance separating the linear or substantially linear sequences of TCP is the same or substantially the same. In one embodiment, the treatment distance separating the linear or substantially linear sequences of TCP is different or substantially different for several adjacent pairs of linear TCP sequences.
[000113] In one embodiment, first and second removable transducer modules are provided. In one embodiment, each of the first and second transducer modules are configured for both ultrasonic treatment and ultrasonic imaging. In one embodiment, a transducer module is configured for treatment only. In one embodiment, an imaging transducer can be attached to a probe handle or a hand wand. The first and second transducer modules are configured for interchangeable coupling to a hand wand. The first transducer module is configured to apply ultrasonic therapy to a first layer of tissue, while the second transducer module is configured to apply ultrasonic therapy to a second layer of tissue. The second layer of tissue is at a different depth than the first layer of tissue.
[000114] As illustrated in Figure 3, in various embodiments, the distribution of emitted energy 50 at a suitable focal depth 278, distribution, timing, and energy level are provided by module 200 through operation controlled by control system 300 to achieve the desired therapeutic effect of controlled thermal injury to treat at least one of epidermal layer 502, dermis layer 503, fat layer 504, SMAS layer 507, muscle layer 509 and / or hypodermis 504. FIG. 3 illustrates a modality of a depth corresponding to a depth for treating muscle. In various modalities, depth can correspond to any tissue, tissue layer, skin, epidermis, dermis, hypodermis, fat, SMAS, muscle, blood vessel, nerve, or other tissue. During operation, module 200 and / or transducer 280 can also be scanned mechanically and / or electronically along surface 501 to treat an extended area. Before, during and after distribution of the ultrasound energy 50 to at least one of the epidermal layer 502, dermis layer 503, and hypodermis 504, fat layer 505, the SMAS layer 507 and / or the muscle 509, monitoring of the treatment area and surrounding structures can be provided to plan and assess the results and / or provide feedback to the controller 300 and the user via a graphical interface 510.
[000115] In one embodiment, the ultrasound system 20 generates ultrasound energy that is directed to and focuses Rnn / Ri nz / R / γ below the surface 501. This controlled and focused ultrasound energy 50 creates the zone or point thermal coagulation (TCP) 550. In one embodiment, ultrasound energy 50 creates a gap in subcutaneous tissue 510. In various embodiments, the emitted energy 50 targets or targets tissue below surface 501 that cuts, ablates, coagulates, micro-ablates, manipulates, and / or causes injury 550 to tissue portion 10 by below surface 501 at a specified focal depth 278. In one embodiment, during the treatment sequence, transducer 280 moves in a direction denoted by arrow marked 290 at specified intervals 295 to create a series of treatment zones 254 each of which receives emitted energy 50 to create one or more TCP 550.
[000116] In various embodiments, the transducer modules comprise one or more transduction elements. The transduction elements may comprise a piezoelectrically active material, such as lead zirconate titanate (PZT), or any other piezoelectrically active material, such as a ceramic, crystalline, plastic, and / or piezoelectric compound material, as well as lithium niobate, lead titanate, barium titanate and / or lead methaniobate. In various embodiments, in addition to, or instead of, a piezoelectrically active material, the transducer modules may comprise any other material configured to generate radiation and / or acoustic energy. In various modes, transducer modules can be configured to operate at different treatment frequencies and depths. Transducer properties can be defined by an outside diameter (OD j and focal length (FL). In one embodiment, a transducer can be configured to have OD = 19mm and FL = 15mm. In other embodiments, other suitable OD and FL values can be used, such as OD less than about 19mm, greater than about 19mm, etc. and FL of less than about 15mm, greater than about 15mm, etc. The transducer modules can be configured to apply ultrasonic energy to different depths of target tissue. As described above, in various embodiments, the transducer modules comprise motion mechanisms configured to direct ultrasonic treatment in a linear or substantially linear sequence of individual TCPs with a treatment spacing between individual TCPs. For example, treatment spacing can be approximately 1.1mm, 1.5mm, etc. In various embodiments, the transducer modules may further comprise motion mechanisms configured to direct the ultrasonic treatment in a sequence such that the TCPs are formed into separate linear or substantially linear sequences with a treatment spacing. For example, a transducer module can be configured to form TCP along a first linear sequence and a second linear sequence separated by the treatment spacing of approximately 2mm to 3mm from the first linear sequence. In one embodiment, a user can manually move the transducer modules across the surface of a treatment area so that adjacent linear TCP sequences are created. In one embodiment, a movement mechanism can automatically enhance the transducer modules across the surface of a treatment area so that adjacent linear sequences of TCP are created.
[000117] In various modalities, the treatment can be advantageously distributed at a faster speed and with improved accuracy. This in turn can reduce the treatment time and decrease the pain experienced by the subject. Additionally, efficiency can be increased by reducing the variation in the treatment spacing between linear or substantially linear TCP sequences. In one embodiment, a system uses a configured transducer to produce an individual focus treatment point. In one embodiment, the transducer can be mechanically moved along a line to create a linear sequence of TCP. For example, Table 1 provides an estimate of the time to create a linear TCP sequence and an estimate of time to move between the linear TCP sequences according to one modality. You can see that the time to create a linear TCP sequence and the time to move between linear TCP sequences are almost equivalent.
cci Rnn / Ri nz / R / v
Table 1
<td>Time metric</td><td>Time (in msec)</td><td>Total percentage of time</td>
<td>Time to create a linear sequence</td><td> 2.9</td><td> 48</td>
<td>Time to move between linear sequences</td><td> 3.2</td><td> 52</td>
<td>Total time</td><td> 6.1</td><td> 100</td>
[000118] In various modalities, the therapeutic treatment can be advantageously delivered at a faster rate and with improved accuracy by using a transducer configured to distribute multiple focus points or TCP. This in turn can reduce the treatment time and decrease the pain experienced by the subject. In various embodiments, treatment time is reduced if the time to create a linear TCP sequence and the time to move between linear TCP sequences are reduced by emitting TCP at multiple locations from an individual transducer.
Distribution of therapy using amplitude modulation
Spatial Frequency Analysis of Aperture and Fourier Transforms [000119] In various modalities, spatial frequency analysis techniques based on Fourier analysis and Fourier optics can be used to increase the efficiency of therapeutic treatment. When a system that has an impulse response h (t) is excited by a stimulus x (t), the relationship between input x (t) and output y (t) is related by the convolution function as follows:
y (í) = x (í) * h (t) = jQ x (r) M> - Jar [000120] In various modalities, Fourier transforms can be applied to compute the convolution of equation (1). The continuous one-dimensional Fourier transform can be defined as:
n /) = nxo = C xo * (2) [000121] Here, f is the frequency, t is the time. It can be shown that the convolution in the time domain is equivalent to the multiplication in the frequency domain:
F (x (i) * h (t)) = X (f) H (f) = ¥ (f) (3) [000122] In various modes, the Fraunhofer approximation can be used to derive a relationship between an opening or transducer aperture and a response resulting from the ultrasonic beam. The derivation of the Fraunhofer approach is described in Joseph Goodman, Introduction to Fouríer Optics (3d ed. 2004), which is incorporated herein by reference in its entirety. According to the Fraunhofer approach, a far-field complex amplitude pattern produced by a complex aperture is equal to a two-dimensional Fourier transform of the phase and amplitude of aperture. In various embodiments, this relationship in optics can be extended to ultrasound since linear wave equations can be used to represent both light propagation and sound propagation. In the case of optics and / or ultrasound, the two-dimensional Fourier transform can be determined from the sound wave pressure amplitude distribution at the focus of a transducer.
[000123] In various modes, a Huygens-Fresnel integral determines a pressure amplitude U (Po) of an aperture by integrating the effect (both amplitude and phase) of each resonator or transducer on a surface 0. It can be expressed how:
= JL (4a) & () = 77 --- cos (n ^ (4b) [000124] where k is a wave number expressed as 2DD0, <sub>ro</sub>i is the distance from an opening to the screen in a field, n is a directional vector from the opening, U (P 1) is the pressure field at the opening, and U (Po) is the pressure field on the screen. .
[000125] In various embodiments, the following assumption is used to lead to an approximation that the amplitude in the pressure field U (Po) is a two-dimensional Fourier transform of U (Pi). First, at small angles, the cosine function of the angle between n and<sub>r</sub>oi is 1. This leads to the following examples:
€ ü.s (n<sub>F</sub>^ T) <sup>1</sup>
-T Λ (χ<sub>0</sub>, χ<sub>0</sub>; χι, η.) * -e * »· [000126] where z represents depth. Second, the Fresnel approximation of distance<sub>r</sub>oi, can be expressed, using a binomial expansion, as:
cciRnn / Rinz / E / Y
<img file="MX2019009155A_D0001.tif" />
[000127] Third, it can be assumed that the observation plane is much larger than the dimensions of the aperture as follows:
[000128] If these assumptions apply to equations (4a) and (4b), then the amplitude in the field can be expressed as:
<img file="MX2019009155A_D0002.tif" />
[000129] Equation (5) includes a quadratic phase term on the outside of the integral that does not affect the total magnitude. Comparing equation (5) to equation (2) reveals a similarity in the arguments within the integral. In particular, instead of a dimensional function y (t) evaluated to sequences f, a two-dimensional function U (x1, y1) is evaluated at spatial frequencies given as:
(5a) (5b) [000130] Because the integral of equation (5) is the two-dimensional Fourier transform, equation (5)
<td>can be rewritten as:</td><td></td>
<td></td><td>~ J.)</td>
[000131] In various modes, the phase and amplitude functions at the opening U (x1, y1) can be separated into two functions, specifically a function of x1 and a function of y1, respectively.
ífeft) = ^ (Λι) & (Χι) (7) [000132]
Applying equation (7) to equation (6) leads to further simplification:
.faith <sup>V</sup>‘<sup>, v-</sup>R £ / (¾. .¾) <sup>w</sup> ~ —Hz: ---- ñ. t? 0q) X, (* (> '1)) i - i (8) [000133] Equation (8) demonstrates that an opening response in the field for a separable three-dimensional function is the multiplication of two transforms of One-dimensional fourier in the x1 and y1 directions. Additionally it can be shown that equations (6) and (8) hold for a focused system with the exception that the spatial frequency arguments change as expressed in equations (9a) and (9b). For a focused system, the variable z representing depth can be replaced with zf which represents a focal length.
<img file="MX2019009155A_D0003.tif" />
(9a) [000134] In various embodiments, the identities of Fourier transforms and Fourier optics (some of which are listed in Table 2, below) can be used for ultrasound transducers to determine the intensity distribution corresponding to a transducer design. For example, the Fourier transform of a rectangle (rect (ax) is a function but. As another example, the Fourier transform of a two-dimensional circle of uniform amplitude is a first-order Bessel function that can be represented as Chi.
Table 2
<td></td><td>Opening function</td><td>Fourier transform</td>
<td> 1</td><td>rect (ax)</td><td>-—- sync í - I</td>
<td> 2</td><td></td><td> 1</td>
<td> 3</td><td>CGS (SEX)</td><td>+ .. z (Μ CtS</td>
<td> 4</td><td>will be</td><td>you + 1 S «1 * one</td>
<td>5 (pair of two-dimensional transforms)</td><td></td><td>4- C<sup>2</sup>) V</td>
<td> 6</td><td>; Ύχ) *</td><td></td>
<td> 7</td><td></td><td>F (a -)</td>
cc i RnniR ι πζ / ε / υιλι [000135] In various modalities, an ultrasound transducer can have a rectangular aperture of adequate dimensions and adequate focal length. In various modalities, an ultrasound transducer can have a circular aperture with adequate dimensions and an adequate focal length. In one embodiment, a transducer can have a circular aperture with an outer radius of about 9.5mm, an inside diameter of about 2mm, and a focal length of about 15mm. The opening of a circular transducer can be described as:
= c'rc ζ-) - (y) (10a) (10b) [000136] For example, a can be approximately 9.5 mm and b can be approximately 2 mm. Applying the Fourier transform (10a) an estimate of the sound wave pressure distribution in focus can be provided.
(11) [000137] where y are the same as fx and fy of equations (9a) and (9b). Equation (11) demonstrates that the sound wave pressure distribution of a transducer with a circular aperture is a function
Bessel of the first order. In one modality, a substantial majority of the energy is concentrated on the focus (eg 15mm away from the aperture). The width of a main ultrasonic beam and the distribution of energy away from the main beam can be expressed as a function of the operating frequency as represented in equations (9a) and (9b).
[000138] In various modes, two identical or nearly identical beams can be created in focus if the aperture was modulated (eg multiplied) by a correct function. In one modality, a cosine function can be applied to a circular opening as follows:
^ (sqy) = eos (ex) (circ J - drc j (12) [000139] An energy distribution or beam response in the modulated aperture approach of equation (12) is the convolution of the Fourier transform of the two functions of the opening:
. / δ; C—— í \ z \ (13) [000140] Equation (13) can be simplified into the sum of two separate functions by applying the Fourier transform identity for a Dirac delta function (for example, identity 2 in Table 2 ):
= (<sup>14</sup>>
[000141] Equation (14) shows that two beams appearing in focus are spatially separated by ± 77 compared to the original unmodulated beam. In various embodiments, one or more of other modulation functions, such as the sine function, can be used to achieve a desired beam response. In various modalities, the aperture can be modulated such that more than two approaches are created. For example, you can create three, four, five, etc., focuses. In various modalities, the aperture can be modulated such that the approaches are created sequentially or substantially sequentially rather than simultaneously.
[000142] In various modalities, therapy transducer modules comprise motion mechanisms configured to direct ultrasonic treatment in a linear or substantially linear sequence of individual TCPs with a treatment spacing between individual TCPs. For example, treatment spacing can be approximately 1.1mm, 1.5mm, etc. In various embodiments, the transducer modules may further comprise motion mechanisms configured to direct ultrasonic treatment in a sequence such that TCP is formed in linear or substantially linear sequences separated by treatment spacing. For example, a transducer module can be configured to form TCP along a first linear sequence and a second linear sequence separated by treatment spacing between approximately 2mm and 3mm from the first linear sequence. According to equation (14), a simultaneous or substantially simultaneous separation in the ultrasonic beam can be achieved in focus (or before focus) if the aperture is modulated by a cosine function and / or cciEnn / Rinz / E / Y sine of a desired spatial frequency. In one embodiment, two simultaneously or nearly simultaneously focused beams, separated by a treatment spacing of approximately 1.1 mm can be created in a linear or substantially linear sequence. At an ultrasound frequency of 7 MHz, the D wavelength of the ultrasound wave in water is approximately 0.220 mm. Therefore, the spatial and focus frequencies are represented as:
cci Rnn / Ri nz / R / Y
<td>Cil | r¿¡ II ¢ 4 in T-í II</td><td>(15a)</td>
<td>15 * a-22S 33</td><td>(15b)</td>
[000143] In order to place two approaches approximately 1.1 mm apart, then the spatial frequency to modulate the aperture is calculated as follows. Using entities 3 and 4 in Table 2, the Fourier transformation of a sine or cosine function is a Di rao delta function with the argument:
- (16a) <3 [000144] In one modality, equation (16a) can be solved for K<sub>x</sub> when the argument is 0:
(16b) [000145] Additionally, xo can be replaced by half the separation distance (for example, 1.1 mm):
-S = -¡y = Í-84- tro<sup>-1</sup> (16c) [000146] In various modes, a circular aperture transducer that emits ultrasonic energy at various operating frequencies can be modulated by sine and / or cosine functions for the spatial frequencies listed in Table 3. The modulated aperture of the transducer can produce a beam simultaneously or substantially simultaneously split with two focuses having different separation distances, as indicated in Table 3. In one embodiment, the transducer can have OD of about 19mm and a focal length of about 15mm.
Table 3
<td></td><td colspan="4">Separation distance between approaches</td>
<td>Ultrasound frequency</td><td>1.1 mm</td><td>1.5 mm</td><td>2 mm</td><td>3 mm</td>
<td>4 MHz</td><td> 0.60</td><td> 0.82</td><td> 1.09</td><td> 1.63</td>
<td>7 MHz</td><td> 1.04</td><td> 1.43</td><td> 1.90</td><td> 2.86</td>
<td>10 MHz</td><td> 1.50</td><td> 2.04</td><td> 2.72</td><td> 3.08</td>
cci Rnn / Ri nz / R / γ [000147] As shown in Table 3, in various modes, a spatial frequency of an aperture modulation function increases as the ultrasonic operating frequency increases for a given separation distance of approaches. Furthermore, the spatial frequency increases as the desired focus separation distance increases.
[000148] In one embodiment, the higher spatial frequency can result in amplitude transitions at the faster presenting aperture. Due to transducer processing limitations, rapid amplitude variations in the aperture may make the aperture less efficient since there may be a variation in the amount of sound pressure produced by the different parts of the aperture. In one embodiment, using spatial frequencies to divide the beam simultaneously or almost simultaneously can reduce the full focal gain of each beam. As shown in equation (14), a focus field pressure of each beam is reduced by a factor of two compared to an unmodulated beam. In one embodiment, the sound pressure or ultrasound intensity of the aperture can be increased to obtain similar or substantially similar intensities in the focal plane. However, in one embodiment, the increase in opening pressure cannot be limited by the transducer and / or system processing limitations. In one embodiment, an increase in aperture pressure can increase the total intensity in the near field, which can increase the possibility of excessive heating of the tissue in the treatment area that is located before focusing. In one embodiment, the possibility of further heating of the pre-focal tissue can be limited or eliminated by using a lower frequency of ultrasound treatment.
[000149] In one embodiment, application of the aperture modulation function as shown in equation (12) results in two simultaneous or substantially simultaneous ultrasound beams in focus. In various embodiments, the ultrasound beam can be split multiple times, such as three, four, five, etc., times, such that multiple simultaneous or near-simultaneous beams are created. In one embodiment, four equally spaced beams can be generated along one dimension by modulating or multiplying the aperture by two separate spatial frequencies:
i. · z - - / í'Λ \
y) = | cosí ex) T cos (dx)) í circ 1 -1 - eire (-1 “ <sup>v</sup> 'V <sup>w</sup> W (17a)>
M
NC ü cc <£ Ü O [000150] As shown in equation (17b), the unmodulated beam in focus can be created at four different locations along the x axis. In one modality, a constant or DC term, C1, can be added to the amplitude modulation function to maintain energy placement at the original focal location:
and) <sup>=</sup> (cos (cx) -F cos (€ ¿x) 4- «re) - drc (0) gfr _ A * ^ 4. p? ' í 4. A r U 4.
'W'y /.-Íl ·' <sup>4</sup> \ XV <· Sy í ~ <sup>4</sup> Va · V'y /> * 5 (18b) [000151] In one modality, the modulation aperture of equations (17) and (18), whereby the beam can be located at multiple locations simultaneously or almost simultaneously, can have limited applicability due to system, material and / or fabric limitations. In one embodiment, due to the possibility of heating the localized treatment area tissues prior to focusing, the frequency of the ultrasound therapy can be adjusted, such as decreased, in order to limit and / or eliminate this possibility. In one embodiment, non-linear techniques can be applied to the focus in order to limit and / or eliminate the possibility of pre-focal tissue heating. In one embodiment, the sound pressure or ultrasound intensity from the aperture can be increased to obtain similar or substantially similar intensities in the focal plane.
[000152] In various modes, as shown in equation (7), if the amplitude and phase functions at the aperture can be separated, the two-dimensional Fourier transform of a sound pressure function U (xi, yi) is can express as a product of a two-dimensional Fourier transform of x and y, shown in equation (8). In various embodiments, it can be advantageous to create multiple TCPs in a linear or substantially linear sequence, as well as to create multiple linear sequences simultaneously or almost simultaneously. As shown in Table 1, in one embodiment, if two TCPs are created simultaneously or substantially simultaneously in a linear sequence, but linear sequences are created sequentially, the total treatment time can be reduced by approximately 24 %. In one embodiment, if four CTPs are created to handle simultaneously or substantially simultaneously in a linear sequence, but linear sequences are created sequentially, the total treatment time can be reduced by approximately 39%. In one embodiment, if two TCPs are created simultaneously or substantially simultaneously, along with two linear sequences, the total treatment time can be reduced by approximately 50%.
Division of multiple beams in two dimensions [000153] In various modalities, four TCPs, such as two in each, can be created in two linear or substantially linear sequences, using the following aperture amplitude modulation function:
<img file="MX2019009155A_D0004.tif" />
(19a)>
M
NC ü cc <£ Ü O [000154] The Fourier transform of this function is:
sfe-l) - - é-r, -1) - ¿) + f ({, - + ±) +
Φ + έτ '+ έ)') (19b) [000155] As shown in equations (19a) and (19b), the beam can be modulated into two linear sequences, with each sequence having two focuses. In one embodiment, the linear sequences can be orthogonal. In one embodiment, the linear sequences may not be orthogonal. Because the Fourier transform is multiplied by% in equation (19b), the beam width or intensity is reduced compared to the split beam in two approaches (for example, as shown in equation (14)). In one embodiment, due to the possibility of heating the tissues of the treatment area that are located before the focus, the frequency of the ultrasound therapy can be adjusted, such as decrease, in order to limit and / or eliminate the possibility of heating Excessive localized tissue prior to focus. In various embodiments, modulation can be applied such that TCP linear or substantially linear or substantially linear sequences are created sequentially or substantially.
[000156] In various modes, as shown in equations (12) to (14), amplitude modulation by cosine and / or sine through a transducer having a linear aperture creates two separate beams derived by a spatial frequency of the cosine and / or sine modulation function. In various modes, the modulation function can be varied in phase or spatially as follows:
<img file="MX2019009155A_D0005.tif" />
(20a) [000157] In one embodiment, the amplitude caused by the shunt is the same as that in equation (14). In one modality, although the spatial derivation (for example, by the angle Θ) does not change the total amplitude in focus, the phase is modified. In various embodiments, phase modification can be advantageous in reducing a peak intensity prior to focusing. In various embodiments, an aperture can be designed such that pre-focal or near-field heating of the tissue is substantially minimized while the intensity of focus or focal gain is substantially maximized.
Therapy distribution using phase shunt [000158] In various modalities, the beam can be divided axially. It may be advantageous to analyze this axial division through an analysis of time lags and the application of discrete phage. In various embodiments, beam splitting axially in the xy / ody direction can be combined with planar or dimensional amplitude modulation of the aperture (eg, as shown in equations (19a) and (19b)), which can result in splitting the beam into two or three dimensions. In various modalities, the beam can be split by using phase tilt at aperture, which can be substantially equivalent to spatial shunt. In various modes, phase tilt can be performed using the following pair of Fourier transforms:
χ ') 4 / senfax)
V. V. < <sub>(21g)</sub>
JFÍ i - —— |
2π<sup>7</sup> (21b) [000159] In one modality, this function describes an aperture that is only phase modulated since the magnitude of the exponential term is one. In one modality, each spatial location has an element that is under a different phase that can be expressed as the ratio of the imaginary (sine) and real (cosine) parts as follows:
Bt x) ™ tan (-: -: | xcízSUx. (22) [000160] Equation (22) spatially expresses the phase differences.
[000161] In various modalities, the time delays associated with the propagation of ultrasound waves can be used to describe the shunt or phase tilt for beam focusing. In one embodiment, a transducer aperture can be a focused circular bowl that has the following geometry:
X (z - zj = z; (<sub>23a) </sub><sup>r</sup>’ “ <sup>;<</sup>'<sup>2</sup> + (23b) [000162] Equations (23a) and (23b) describe a circular bowl that is centered at the apex of the bowl with a focal length zf. In one mode, the focus can be moved from (0, 0, zf) to a spatial point P0 that is located at (xO, yO, zO). The distance to this new spatial point P0 from any point in the bowl can be expressed as:
<sup>=</sup> V (* i ~ + <sup>—</sup> τ (¾ <sup>—</sup> -¾)<sup>-</sup> (24) cci Rnn / Ri nz / R / γ [000163] where (x1, y 1, z1) are points in the bowl opening that are defined by equations (23a) and (23b).
In one embodiment, in order to determine the actual time to the target or target P0, then the speed of sound c (343.2 m / s) can be divided into a propagation distance d as follows:
<img file="MX2019009155A_D0006.tif" />
cci Rnn / Ri nz / R / Y (25) [000164] In one embodiment, in order to obtain a desired constructive interference associated with the spread of delayed ultrasound waves in focus, equation (25) can be used to calculate the relative time delay to another part of the opening. In one embodiment, this can be accomplished by subtracting equation (25) for the minimum time delay. The remaining time is the additional time for the ultrasound waves emitted by other parts of the opening to arrive at the new spatial point P0.
[000165] In various modes, a focus point of (0.15mm) can be moved to a different focus point P0. Relative time lags to the new focus point P0 relative to the center or apex of the opening bowl (as expressed in radial distance) can be calculated using equation (25) and illustrated in Figures 5A-5D for a transducer having geometry of outside diameter (OD) = 19 mm, inside diameter (ID) = 4 mm, and a distance to focus (El) = 15 mm. Other embodiments may use other dimensions, the present examples illustrate a non-limiting embodiment. Other dimensions are contemplated. Figure 5A illustrates the relative time delay 1002a (in microseconds) for acoustic energy traveling from a spatial point in the aperture to reach a target focus point P0 = (0, 15mm) relative to radial locations. variables in the opening of the bowl according to a modality. As expected, the delay illustrated in Figure 5A is zero since the target target point is the same as the focal point and the focus point has not changed. Figure 5B illustrates the relative time delay 1002b (in microseconds) for acoustic energy traveling from a spatial point in the aperture to reach a target or target focus point P0 = (0, 10mm) relative to to variable radial locations in the bowl opening according to a modality. As illustrated, the radial position starts at 2mm due to a hole in the center of the transducer bowl. In one embodiment, an imaging element can be placed in the hole. The time to the target or target point P0 = (0, 0, 10 mm) increases as the radial position in the bowl increases. Figure 5C illustrates the relative time delay 1002c (in microseconds) for acoustic energy traveling from a spatial point in the aperture to reach a target or target point P0 = (0, 20mm) relative to radial locations. variables in the opening of the bowl according to a modality. As illustrated, if the focus is changed to P0 = (0, 0, 20) mm, the time to the target or target decreases as the radial position in the bowl increases. Figure 5D illustrates the relative time delay 1002d (in microseconds) for acoustic or sonar energy traveling from a spatial point in the aperture to reach a target or target focus point P0 = (2mm, 0.14.7 mm) in relation to variable radial locations in the opening of the bowl according to a modality. In one embodiment, the total distance from the vertex to the target or target point P0 = (2mm, 0.14.7mm) is approximately 15mm. As illustrated, if the focus is derived to P0 = (2mm, 0.14.7mm), the time to target or target is linearly dependent on the x coordinate of the position in the bowl. The time to the target is less for positions that have x positive at the apex and greater for positions that have x negative with respect to the apex. Positions that have x coordinates between about 2mm and about 2mm are displayed outside the inside diameter of the bowl (eg, where an imaging element may be located).
[000166] Figures 5A-5D illustrate time delays for the propagation of sound from various points in the aperture to constructively place the sound energy in focus according to various modalities. A negative time relative to zero implies that it takes less time for energy from that point to reach a new focus point. A positive time relative to zero implies that it takes longer for the energy to reach a new focus point. In one embodiment, if appropriate time lags can be placed at individual points in the bowl, time lags can be controlled to gain constructive interference in the new approach. In one embodiment, for transducers comprising piezoelectrically active material, movement of the focus from a mechanical focus (0, 0, Zf) to a new focus point P0 may change the distances that the resonators must travel in the aperture (due to the expansion and / or contraction of the material) to create constructive interference in the P0 approach. These distances can be converted to time lags by dividing by the distances by the speed of sound. In one embodiment, if the time delays for the resonators at the aperture surface are known, additional time delays in achieving focus P0 can be accounted for such that the desired intensity of pressure in focus P0 can be achieved.
[000167] In various modalities, the ultrasound wave of a variable frequency can be directed to a target or target area. In one embodiment, a transducer comprising piezoelectrically active material can be electrically excited by a continuous wave signal of a suitable operational frequency to achieve a suitable therapy frequency. In various modes of transducers, the operational frequency may be approximately 4 MHz, approximately 7 MHz, approximately 10 MHz, less than approximately 4 MHz (for example, between approximately 20 KHz and approximately 4 MHz), between approximately 4 MHz and approximately 7 MHz, greater than about 10 MHz, etc. In one embodiment, the continuous wave signal can be on or active for a period of between about 20 msec to 30 msec. This in turn may imply that the aperture is excited by between about 80,000 cycles to about 300,000 cycles of the drive signal. In one embodiment, other suitable periods of the excitation signal that are active can be used, such as, for example, less than about 20 msec, greater than about 30 msec, and the like. In one embodiment, a short duration of the drive signal that is active may be unnecessary to obtain constructive interference with focus. This may be the result of time delays for the propagation of an ultrasonic wave for different points of the aperture to a focus point P0 that is longer than the duration of the excitation signal that is active. In one embodiment, it may be sufficient to modify the phases corresponding to the opening locations based on the operational frequency without controlling time delays to obtain constructive interference. In one embodiment, the phases corresponding to the opening locations can be modified, and additionally, time delays can be controlled to obtain constructive interference at a new focus point.
cci Rnn / Ri nz / R / γ [000168] Figures 6A-6C illustrate phase lags associated with sound propagation to focus relative to the apex of an aperture according to various modalities. In one modality, phase delays are associated with time delays. Figure 6A illustrates the relative phase delays 1012a, 1014A, and 1016A (in degrees) for sonar energy traveling from a spatial point in the aperture to reach a target or target focus point P0 = (0, 10mm ) in relation to variable radial locations in the opening of the bowl according to a modality. Curve 1012a corresponds to an excitation signal of approximately 4 MHz, curve 1014A corresponds to an excitation signal of approximately 7 MHz, and curve 1016a corresponds to an excitation signal of approximately 10 MHz. Figure 6B illustrates the relative phase delays 1012b, 1014b, and 1016b (in degrees) for sonar energy traveling from a spatial point in the aperture to reach a focus point or target P0 = (0, 0, 20 mm ) in relation to variable radial locations in the opening of the bowl according to a modality. Curve 1012b corresponds to an excitation signal of approximately 4 MHz, curve 1014b corresponds to an excitation signal of approximately 7 MHz, and curve 1016b corresponds to an excitation signal of approximately 10 MHz. Figure 6C illustrates the relative phase delays 1012c, 1014c, and 1016c (in degrees) for the sonar energy traveling from a spatial point in the aperture to reach a target or target focus point P0 = (2mm, 0, 14.7 mm) in relation to variable radial locations in the opening of the bowl according to one modality. Curve 1012c corresponds to an excitation signal of approximately 4 MHz, curve 1014c corresponds to an excitation signal of approximately 7 MHz, and curve 1016c corresponds to an excitation signal of approximately 10 MHz. As illustrated in the figures 6A-6C, in one embodiment, if the aperture attempts to focus shallow, laterally deep, which can be related to the operational frequency, it is related to a number of discontinuities in phase delay. The number of discontinuities over a given length increases with the operational frequency of the drive signal. In one embodiment, as explained below, manufacturing and system limitations can increase the number of discontinuities. In one embodiment, as illustrated in Figure 6B, the ratio of phase lag transitions increases toward the edge of the transducer (eg, right side of the graph), regardless of whether the transducer is used for deep focusing. or shallow. In one embodiment, as illustrated in Figure 6C, the ratio of phase lag transitions is substantially constant when a transducer is used to tilt the beam. Figures 5B-5D and Figures 6A-6C illustrate additional time and phase to a focus point from a point on a transducer bowl. In one embodiment, the additional time and / or phase can be reduced or eliminated by placing an opposite of the time and / or phase delay at appropriate locations on the transducer.
Therapy distribution using discrete phase shunt [000169] In one modality, quantification of phase and / or delay can affect the precision used to represent time and / or phase delays. In other words, discrete delay and / or discrete phase can be used. In one embodiment, an accuracy of time and / or phase delays can be limited by system parameters, such as the system clock and / or the number of bits available to represent the delay. In one embodiment, other system parameters may instead or additionally limit precision. In one embodiment, the phase lags are equally spaced around the unit circle (360 °). In one embodiment, the phase lags may be aperiodic cci Rnn / Ri nz / R / γ or be unevenly spaced around the unit circle. Table 4 shows the levels of phase quantification according to various modalities. Additional numbers of levels (greater than 8) can be used in various modes. As shown in Table 4 two phases (N = 2), 0<sup>or</sup> and 180 °, it can represent a minimum level of phase control to change the focus point of an ultrasound beam according to a modality.
Table 4 cci Rnn / Ri nz / R / Y
<td>Number of levels (N)</td><td>Phases (degrees)</td>
<td> 2</td><td> 0, 180</td>
<td> 3</td><td> 0, 120, 240</td>
<td> 4</td><td> 0, 90, 180, 270</td>
<td> 5</td><td> 0, 72, 144,216, 288</td>
<td> 6</td><td> 0, 60,120,180, 240,300</td>
<td> 7</td><td> 0, 51,103, 154, 206, 257, 309</td>
<td> 8</td><td> 0, 45, 90,135,180, 225, 270, 315</td>
[000170] Figures 7A-7C illustrate discrete or quantized phase lags for various quantization levels, where phase lags are associated with the propagation of sound to focus relative to the apex of an aperture according to various modalities. Figures 7A-7C illustrate sound propagation at an operational frequency of approximately 7 MHz. Figure 7A illustrates the relative, quantized phase lags 1022a, 1024a and 1026a (in degrees) for sonar energy traveling from a spatial point in the aperture to reach a target or target focus point P0 = (0, 0 , 10 mm) in relation to variable radial locations in the opening of the bowl according to one modality. Curve 1022a corresponds to two levels of phase quantization, curve 1024a corresponds to three levels of phase quantization, and curve 1026a corresponds to four levels of phase quantization. Figure 7B illustrates the quantized, phase relative delays 1022b, 1024b, and 1026b (in degrees) for sound energy traveling from a spatial point in the aperture to reach a target focus point P0 = (0, 0, 20 mm) in relation to variable radial locations in the opening of the bowl according to a modality. Curve 1022b corresponds to two levels of phase quantization, curve 1024b corresponds to three levels of phase quantization, and curve 1026b corresponds to four levels of phase quantization. Figure 7C illustrates the relative quantized phase lags 1022c, 1024c, and 1026c (in degrees) for sound energy traveling from a spatial point in the aperture to reach a target focus point P0 = (2mm, 0, 14.7 mm) in relation to radial variable locations in the opening of the bowl according to a modality. Curve 1022c corresponds to two levels of phase quantization, curve 1024c corresponds to three levels of phase quantization, and curve 1026c corresponds to four levels of phase quantization. In various modes, as the number of quantization levels is increased as shown in Figures 7A-7C (eg, curves 1026a, 1026b, and 1026c), the patterns of quantized phase delay in a modality with a frequency of 7 MHz they become substantially similar to the unquantized phase delay patterns shown in Figures 6A-6C (eg, curves 1014A, 1014b, and 1014c).
[000171] In an embodiment with reference to curve 1022c of Figure 7C (two-level phase quantization), it demonstrates that when a focused beam is directed 2mm and -2mm, a resulting phase delay pattern is substantially similar with transition from 0<sup>or</sup> at 180 ° that occurs at a substantially equal spatial frequency. There is a slight spatial shunt and phase lag pattern. Since the phase lag pattern is substantially similar to 2mm and -2mm, in one embodiment, the acoustic intensity distribution in focus can peak at both focus locations simultaneously. In one modality, if the phase quantization is two levels, a phase solution for a specific focus will also be a solution for another location. In one embodiment, this result may be similar for modifying focus along the beam axis. If the phase quantization is two levels, then a solution for one approach may also be a solution for another approach.
[000172] Figure 8A illustrates discrete or quantized phase delays associated with sound propagation, at an operational frequency of approximately 7 MHz, for focus relative to the apex of an aperture according to various modalities. Figure 8A illustrates the relative phase delays 1032a and 1034a (in degrees) for sound energy traveling from a spatial point in the aperture to achieve objective focus points (2mm, 0.14.7mm) and (- 2 mm, 0, 14.7 mm) respectively. Curves 1032a and 1034a are shown relative to variable radial locations in the bowl opening according to one embodiment. In one embodiment, the quantification level of the two is shown in Figure 8A. As shown in Figure 8A, the phase quantized lag patterns for the two approaches are substantially similar.
[000173] Figure 8B illustrates quantized or discrete phase delays associated with sound propagation, at an operational frequency of approximately 7 MHz, for focus relative to the apex of an aperture according to various modalities. Figure 8B illustrates the relative phase delays 1032b and 1034b (in degrees) for sound energy traveling from a spatial point in the aperture to reach objective focus points (0, 0, 10.25 mm) and (0, 0.27 mm), respectively. Curves 1032b and 1034b are shown in relation to variable radial locations in the bowl opening according to one embodiment. In one embodiment, the level of quantification of the two is shown in Figure 8B. As shown in Figure 8B, the patterns of the quantized phase delay for the two approaches are substantially 180 ° out of phase.
[000174] In various modalities, continuous or discrete amplitude modulation in an aperture and / or continuous or discrete phase delays can be used to focus an ultrasound beam. In one embodiment, it may be advantageous to provide a mechanical focal point instead of using phase control and / or aperture amplitude modulation in a flat aperture because the focal gain associated with mechanical focusing may be preferable. In one embodiment, the complexity of the system design or aperture can be reduced, a mechanical approach can be created, and phase delay and / or modulation techniques can be applied to the mechanical approach. An advantage may be a reduction in the number of discrete phase transitions to focus the beam on a new focal point. Another advantage cci Rnn / Ri nz / R / v may be that a distance between the different discrete phase levels can be increased when the aperture is already mechanically focused, which may result in the use of lower quantization levels, such like two, three, four, etc.
[000175] In various embodiments, fabrication methods, including piezoelectric material polarization and / or discrete phaging of the system, can be used to fabricate transducers configured to divide or focus a two and / or three dimensional ultrasound beam from a mechanical focus. The following lists several non-limiting examples of transducer designs. In various embodiments, other transducer designs can be manufactured using the methods described.
Multi-focal energy distribution using transducer polarization [000176] In various modalities, a transducer can comprise piezoelectric material. Piezoelectric material can be polarized at elevated temperatures and high electric fields to create a net dipole moment in the material. A net dipole moment can allow the piezoelectric material to have a piezoelectric effect that causes either contraction or expansion of the material a when an electric field is placed through all or part of the material in the direction of the dipole moment. In one embodiment, parts of a transducer, such as a transduction element, can be treated to have different polarization moment characteristics. In one embodiment, an individual transduction element can be treated to have one, two, or more polarization characteristics. In one embodiment, an individual transduction element can be treated to have a pole. In another embodiment, parts of an element may be treated with one pole, and untreated parts of the element may have a second pole. In one embodiment, the polarization treatment can be painted on a transduction element.
[000177] Figure 9 shows a schematic diagram of a polarized piezoelectric material and the resulting behavior when a voltage is applied according to one modality. In one embodiment, a transducer may comprise the piezoelectric material PZT 1052. The arrow shown in the material PZT 1052 is a net dipole moment. In one embodiment, if a voltage is placed across the PZT 1052 material such that the electric field is in the opposite or substantially opposite direction of the dipole moment (as shown in 1082), then the material contracts. In one embodiment, if a voltage is placed across the PZT 1052 material such that the electric field is in the same or substantially the same direction as the dipole moment (as shown in 1072), then the material expands. In one embodiment, the PZT 1052 material does not expand or contract when no voltage is applied across the material, as shown in 1062.
[000178] In various modalities, the polarization of the piezoelectric material can be used to implement the amplitude modulation of the aperture. In one embodiment, two-level modulation can be equivalent to two-level phase quantization. As shown in Equations (12) - (14), an ultrasonic beam emitted by the opening of a transducer can be modulated to appear at two (or more) locations in a focal plane derived or changed by a distance that is related to the spatial frequency of a modulation function (for example, cosine and / or sine function). In one embodiment, the bias direction can be used to modify the modulation of cci Rnn / Ri nz / R / v amplitude by sine and / or cosine. As the picture shows. 9, in one embodiment, whether the bias or application voltage across all or part of the material can provide three levels of amplitude modulation: -1 (material contraction), 1 (material expansion), and 0 (no change to the shape of the material). Figures 10A-10B illustrate approximations of amplitude modulation using two and three levels of polarization according to various modalities. Figure 10A illustrates approximations of amplitude modulation using a sine function according to one modality. The x-axis represents the relative distance to an apex of the aperture and the Y-axis represents the amplitude of the modulation function. Curve 1092A illustrates the modulation function (eg, sine function), curve 1094a illustrates the approximation using two levels of polarization (eg, ± 1), and curve 1096a illustrates the approximation using three levels of polarization (for example ± 1 and 0). Figure 10B illustrates approximations of amplitude modulation using a sine function with DC deviation of 0.25 according to one modality. The x-axis represents the relative distance to an apex of the aperture and the y-axis represents the amplitude of the modulation function. Curve 1092B illustrates the modulation function (eg, sine function), curve 1094B illustrates the approximation using two levels of polarization (eg, ± 1), and curve 1096b illustrates the approximation using three levels of polarization (for example ± 1 and 0). In one embodiment, as illustrated in Figure 10B, the width of a positive polarized region (having amplitude of 1) is greater than the width of a negative polarized region (having amplitude of -1) so that the amplitude mean is substantially equal to the DC deviation (eg 0.25). Limiting two or three levels limits the achievable C deviation between -1 and 1. In various embodiments, more than three levels of polarization can be used for amplitude modulation.
[000179] In one modality, in order to quantify the energy distribution in focus, then the square wave can be represented in terms of a function that has a related pair of Fourier transforms. The expansion of the Fourier series for a square wave of the period o is:
4- ~ sen (2-ff3ct)% ') ~' (25) [000180] In one modality, a circular aperture with amplitude modulation described in equation (25) can be described as:
<img file="MX2019009155A_D0007.tif" />
cci Rnn / Ri nz / R / γ [000181] The Fourier transform of this function is:
<img file="MX2019009155A_D0008.tif" />
[000182]
Equation (26b) can be simplified as follows:
>
9 ν
C
<img file="MX2019009155A_D0009.tif" />
[000183] In one embodiment, the sound wave pressure in the focal plane includes repetitive patterns of the main beam at multiple spatial locations separated by a distance 2c between each beam. Repetitive patterns may be decreasing in amplitude.
[000184] Figures 11A-11H illustrate some modalities of the apodization or aperture modulation functions (using two-level polarization or three-level polarization) and some corresponding normalized intensity distributions of sound wave pressure in focus or approaches for a transducer excited by a 7 MHz excitation signal according to various modalities. In one embodiment, the transducers illustrated in Figures 11A-11H are configured as circular bowls with OD = 19mm and Fl = 15mm. Figures 11A-11B illustrate the apodization profile without dividing the beam and a corresponding intensity distribution according to one embodiment. Figure 11B illustrates that the intensity is concentrated in focus 1108. Figures 11C-11D illustrate the apodization profile with lateral division of the beam by approximately 1.1 mm between the focus peaks and a corresponding intensity distribution according to one modality. As illustrated by region 1104 in FIG. 11A and region 1114 in FIG. 11C, in various embodiments, part of a transducer aperture has a zero nickname, representing an inner diameter (ID) of the bowl. In some embodiments, these regions 1104 and 1114, which are illustrated as being approximately 4 mm in diameter, may correspond to regions where an imaging element can be located. In one embodiment, the apodization of the imaging element can be represented by region 1106.
[000185] Referring to Figure 11C, in one embodiment, the amplitude modulation for a division of 1.1 mm between the peak approaches is illustrated. In one embodiment, if two levels of polarization or apodization are used, then 8 strips of substantially equal width (except at the edges) are defined on the surface of the aperture. For example, two of these strips are marked 1112 and 1112 '. In one embodiment, the polarization of the strips alternates from -1 to +1 across the transducer surface. The resulting beam pattern is shown in Figure 11D. As expected, the ultrasonic beam appears in both approaches 1120 and 1120 'which is located at approximately -0.55mm and 0.55mm. The highest frequency components of the beam are visible in regions 1122 and 1122 'at a distance of approximately 1.65 mm from the beam axis. In one embodiment, these components are less intense than the focus regions 1120 and 1120 '. The highest frequency components may correspond to the third harmonic that has a lower intensity, as expressed in equation (26c). In various embodiments, as illustrated in Figures 11E-11H, the polarization of portions 1125, 1125 'of the transducer surface may include lines, curves, shapes, waves, patterns, and so on. In one embodiment, the features of the portions 1125,1125 'can be used to maintain a division of focus, and can redistribute energy in a pre-focal and / or post-focal manner for less heating.
[000186] In one embodiment, beam splitting can occur in both the x (azimuth) and y (elevation) dimensions. In one embodiment, divisions on the x and y axes can be handled independently when performing the Fourier transform. In one embodiment, an aperture can be designed to divide the beam in the x dimension by approximately 1.0 mm and in the y dimension by approximately 0.5 mm. The corresponding aperture modulation function can be represented as:
Aperture (|) U * (f) (|) “(;)) [000187] The spatial frequency to toggle amplitude modulation can be calculated as described above in conjunction with equations 26 (a) - (c), with the exception that the calculation is performed for two dimensions. Figures 12A-12D illustrate some modalities of apodization or aperture modulation functions (using two-level polarization) and a corresponding normalized intensity distribution of sound wave pressure in focus or approaches for a transducer excited by a 7 MHz excitation signal according to various modalities. In one embodiment, the transducers illustrated in Figures 12A-12D are configured as circular bowls with OD = 19mm and Fl = 15mm. Figure 12A shows an apodization function for opening according to one embodiment. As illustrated, the checkerboard pattern 1132 and 1136 is alternating in amplitude in both the x and y directions. As illustrated in Figure 12B, the checkerboard pattern produces four substantially different ultrasound beams 1140, 1140, 1142 'and 1142' separated by expected distances, specifically, by about 1.0mm in the x-direction and by about 0.5 mm in the y direction. In one modality, a five-point pattern can be achieved by adding a constant to the apex of the opening, which may have a corresponding intensity distribution at the origin.
[000188] In one embodiment, as illustrated in Figures 12C-12D, a line of four peaks is obtained by placing multiple frequencies along the same dimension (eg, x dimension). The modulation function can be expressed as:
[000189] Figure 12C shows an apodization function for opening according to one modality. As illustrated, pattern 1142 and 1146, for strip polarization alternates from -1 to +1 across the transducer surface. As illustrated in Figure 12D, in one embodiment, the pattern produces four substantially different ultrasound beams 1150, 1152, 1154, and 1156 separated by approximately 1.0mm and 3.0mm in an x direction.
[000190] In one embodiment, an axial beam split or division along one dimension is accomplished such that the beam remains symmetrical to the axis. In one embodiment, splitting the beam axially using two phases of polarization may be more difficult than obtaining lateral direction. This may be due to the difficulty in obtaining the balance of the cci Rnn / Ri nz / R / γ intensity between the two or more peaks. In one modality, two phases can produce two simultaneous peaks of intensity with one shallower than the other. The deepest intensity peak may be less intense than the shallowest peak due to additional attenuation and diffraction in the tissue. In one embodiment, more than two phases can be used to achieve axial division.
[000191] In various modalities, the division of an ultrasonic beam simultaneously, almost simultaneously, or sequentially to the mind in two or more focal points can be achieved through the application of the system's discrete phage. FIG. 13 is an illustration of a two-phase system 1200 according to one embodiment. As illustrated, block 1202 is an AC (or current) voltage source that drives the discrete phase shifters, blocks 1204 and 1206 are discrete phase shifters by 0<sup>or</sup> and 180 °, respectively, and blocks 1208 and 1210 are transducer portions that are phase shunted. In one embodiment, discrete phase shifters 1204 and 1206 can be configured to derive the phase of the AC voltage (or current) signal supplied by source 1202, such that the resulting signals are 180 ° out of phase. In one embodiment, the discrete phase shifters 1204 and 1206 can be configured to drive different portions of the transducer. In one embodiment, the 1200 system is configured to mimic two levels of material bias. In one embodiment, it may be desirable to electrically isolate transducer portions 1208 and 1210. The corresponding connection scheme and electrical isolation can determine a beam pattern resulting in focus according to one embodiment. In one embodiment, electrical isolation cannot be performed. Referring to Figure 1, in some embodiments, discrete phase shifters can be placed in or on the controller 300, hand wand 100, module 200, and / or transducers of the ultrasound system 20. In one embodiment, one can use continuous phase shunt.
[000192] In various modalities, more than two discrete phase shifters can be used (eg as shown in Table 4). Increasing the number of phases can result in an improved approximation of phase delays for beam direction and / or focus. In one embodiment, four discrete phase shifters can be used. FIG. 14 is a schematic illustration of a select, four-phase 1250 system according to one embodiment. As illustrated, blocks 1252, 1254, 1256, and 1258 are AC voltage (or current) sources that drive discrete phase shifters 1262, 1264, 1266, and 1268. Each discrete phase shifter block can be configure to provide four different phases 0<sup>or</sup>, 90 °, 180 ° and 270 °. In one embodiment, multiplexers 1272, 1274, 1276, and 1278 can be included to select a particular phase of a signal. The signal with the selected phase can be applied to portions 1282,1284, 1286, and 1288 of a transducer 1280. In one embodiment, a portion is a part of a single transducer with a single transducer element. In one embodiment, a portion may be a transduction element. As illustrated, each portion 1282, 1284, 1286, and 1288 of the 1280 transducer has a select phase (for example, 0<sup>or</sup>, 90 °, 180 °, or 270 °). In one embodiment, portions 1282, 1284, 1286, and 1288 can be electrically insulated (eg, from each other). In one embodiment, if transducer 1280 is divided or segmented into portions 1282, 1284, 1286, and 1866, the ultrasonic beam can be driven and focused to multiple focus locations.
[000193] In one embodiment, an advantage of providing more discrete phase shifters can be illustrated to the cci Rnn / Ri nz / R / Y by considering a ring transducer or flat disk and an intensity measured on focus compared to an intensity measured in focus from a circular bowl transducer, focused substantially seamlessly. Figure 15 illustrates the performance of a discrete phase system according to one modality. In one embodiment, the bowl transducer can be configured to have OD = 19mm and El = 15mm, and its intensity (in dB) is illustrated by line 1302. The intensity of the flat ring transducer is illustrated by line 1306. As illustrated, the improvement in focal intensity produced by the flat ring transducer increases (eg, exponentially) between approximately two and 5-6 discrete phase levels, but begins to level off after approximately 5-6 discrete phases. In one embodiment, the intensity synthetically approximates approximately -2.3 dB (line 1304). As illustrated in one embodiment, the flat ring transducer (line 1306) produces a smaller focal gain than the bowl transducer (line 1302). As you can see, in one modality, adding additional discrete phase levels can improve focus intensity and thus improve transducer performance.
[000194] In one mode, a difference in intensity between a desired focus point and an ideal focus point can be changed by using a focused bowl. In one embodiment, a single bowl transducer with OD = 19mm and 15mm = Fl can be used initially. Subsequently, in one embodiment, discrete phage techniques can be used to move the focus to a depth of approximately 12mm or 18mm. Figures 16A16B are graphs illustrating the performance of discrete phase systems at various focus points according to various modalities. Figure 16A illustrates the performance 1316 of a bowl transducer (OD = 19mm and Fl = 15mm) when the focus is moved to 12mm using discrete phage compared to the performance 1312 of a bowl transducer (OD = 19 mm bowl and Fl = 12 mm) according to one modality. As illustrated, line 1316 asymptotically approximates approximately -1.3 dB (line 1314). In one embodiment, by comparing line 1316 with the performance of the flat disk transducer, illustrated by line 1306 in Figure 15, the intensity produced by the bowl transducer has been improved. Figure 16B illustrates the performance 1326 of a bowl transducer (OD = 19mm and Fl = 15mm) when the focus is moved to 18mm using discrete phage compared to the performance 1322 of a bowl transducer (OD = 19mm bowl and Fl = 18 mm) according to one modality. As illustrated, line 1326 asymptotically approximates approximately 0.5 dB (line 1324). As illustrated, the performance of the discrete phased bowl transducer (line 1326) can exceed the performance of an ideal transducer (line 1322), such as when the number of discrete phase levels exceeds approximately six. In one modality, it may be advantageous to use discrete phases to move the focus deeper.
Therapy Distribution Using Amplitude Modulation and Discrete Phase Shift [000195] In various modalities, amplitude modulation (eg, performed by material polarization) can be used in addition to discrete phage. In one embodiment, division of an ultrasound beam can cause an increase in transducer power that may be difficult to obtain due to, for example, limitations of the transducer material or system. It may be desirable to phase shift or tilt the ultrasound beam from one focal position to another focal position. In one embodiment, division of the ultrasound beam may be difficult to achieve due to the possibility of excessive heating of the tissue prior to focusing. In one embodiment, cci Rnn / Ri nz / R / v can sequentially or substantially sequentially create linear sequences of TCP without moving a transducer, which can result in reduced therapy time. In one embodiment, the transducer can be moved to further distribute the treatment points. In one embodiment, a transducer can be a circular bowl transducer excited by the 7 MHz drive signal and having OD of about 19mm, ID of about 4mm, and El of about 15mm. Linear TCP sequences can be spaced approximately 1.0 mm apart. It may be desirable to divide the ultrasound beam so that two linear TCP sequences are created simultaneously or substantially simultaneously by approximately 1.0 mm apart. However, in one embodiment, compared to the intensity of a non-dividing beam, each of the divided beams may have an intensity that is approximately 2.4 times less. Due to the potential for excessive heating of the localized tissue prior to focusing, the power delivered to the transducer cannot be increased by approximately 2.4 times to compensate for the reduction in intensity. In one embodiment, quadrature phage can be used to create linear TCP sequences one at a time. Quadrature phage can be achieved by combining material bias with discrete system phage. In one embodiment, the use of quadrature phage can be related to an increase in power of approximately 1.2 times when quadrature phage is applied to a focused bowl transducer. In one embodiment, this slight increase in power may be desirable.
[000196] Figures 17A-17B illustrate the quadrature control of a transducer by combining the polarization and the discrete phase of the system according to one modality. Figure 17A illustrates, in one embodiment, individual strips (eg, 1402, 1404, etc.) defined through a focused circular bowl transducer 1400 at a spacing configured to achieve approximately 1.0 mm in the ultrasonic beam produced by the transducer. . The focus of the transducer is a single beam 1408 in the plane parallel to the face of the transducer. The 1400 transducer is not configured with discrete phage. In one embodiment, as illustrated in FIG. 17B, transducer strips 1410 are polarized by alternating the phage direction. For example, strip 1412 has a phase of 0<sup>or</sup> and strip 1414 has a phase of 180 °. As shown in the intensity graph, two intensity peaks 1418 and 1418 'appear substantially along a line at a focal depth.
[000197] In one embodiment, creating two intensity peaks 1430 and 1432 may be undesirable due to limitations of the system (eg, power supply) and / or transducer materials. For example, it may take more power to the transducer to create two TCPs simultaneously or almost simultaneously. Figure 17C illustrates modulation of an aperture of a transducer 1420 using an additional phase shunt (90 °) according to one embodiment. As illustrated, strip 1422 has a phase of 0<sup>or</sup>, and is further divided into a region or sub-strip 1426 having a phase of 90 ° and sub-strip 1428 having a phase of 0<sup>or</sup>. Additionally, strip 1424 has a phase of 180 ° (eg, alternating phase with respect to strip 1422), and is further divided into a region or sub-strip of 1430 that has a phase of 270 ° and sub-strip 1432 that has a phase of 180 °. In one embodiment, these two additional phases (eg, 1426 and 1428) can be electrically connected to transducer 1420 through a conductive junction and, optionally, a switch or flexible circuit configured to separate the two phases. Similar to the cci Rnn / Ri nz / R / γ modalities illustrated in Figures 17A-17B, transducer 1420 is biased so that the phase alternates between 0<sup>or</sup> and 180 ° between adjacent strips. In one embodiment, half of transducer 1420 is energized with a phase excitation signal of 0<sup>or</sup> and the other half is excited with a 180 ° phase excitation signal. In one embodiment, a phase shift gap is decreased by two with the additional phage (eg, sub-strips 1426 and 1428). In one mode, when discrete phage is combined with polarization (for example, alternating phase between 0<sup>or</sup> and 180 ° between adjacent strips 1422 and 1424), four distinct phases can be provided, specifically, 0<sup>or</sup>, 90 °, 180 °, and 270 °. As illustrated in Figure 17C, the repeating phase pattern applied through transducer 1420 from left to right can be 90 °, 0<sup>or</sup>, 270 ° and 180 °. As illustrated on the intensity graph, in one embodiment, a 1438 peak approximately -1 mm away from a beam axis at a focal depth can be created. In one embodiment, as illustrated in Figure 17D, if the phase pattern has an inverted order of 0<sup>or</sup> (sub-strip 1446), 90 ° (sub-strip 1448), 180 ° (sub-strip 1450), and 270 ° (sub-strip 1452), and then a 1458 peak moves approximately +1 mm away from a beam axis . As illustrated in Figure 17D, strip 1442 has a phase of 0<sup>or</sup> and strip 1444 has a phase of 180 ° (eg, alternating phase with respect to strip 1442).
[000198] Figure 18 is a schematic illustration of a two-phase switchable system 1500 according to one embodiment. As illustrated, system 1500 has an AC voltage (or current) source 1502 that drives discrete phase shifters 1504 (0 phase shifter).<sup>or</sup>) and 1506 (90 ° phase shifter), switches 1508 and 1510, and transducer portions 1512 and 1514. In one embodiment, discrete phase shifters 1504 and 1506 can be configured to phase shift the voltage signal (or AC) current supplied by source 1502, so that the resulting signals are 90 ° out of phase. In one embodiment, discrete phase shifters 1504 and 1506 can be configured to drive different portions (eg, strips) of the transducer. The output of discrete phase shifters 1504 and 1506 can be connected to switches 1508 and 1510 which are connected to different portions 1512 and 1514 of the transducer. In one embodiment, switches 1508 and 1510 can cause the phase of the voltage (or current) signal provided by source 1502 to alternate between 0<sup>or</sup> and 90 ° so that the phase pattern in the transducer reverses the order and causes a focal point to move from one side of the beam axis to the other side of the beam axis, as illustrated in Figures 17C-17D. In one embodiment, phase shifters 1504 and 1506 can derive the phase by any suitable value, such as 30 °, 45 °, 120 °, 145 °, 180 °, and so on.
Therapy distribution using amplitude modulation with displacement [000199] In one embodiment, modulation or division of an ultrasound beam axially and / or laterally, for example so that multiple linear TCP sequences are created simultaneously, from substantially simultaneously, or sequentially you may need to supply additional power to a transducer in order to achieve substantially equal intensity at focal points as an unmodulated beam. In one embodiment, this increase in power may cause the possibility of excessive heating of the tissue proximal (pre-focal) and / or distant (post-focal) to the focus. For example, for a given transducer configuration, dividing the ultrasound beam from a focal position of approximately (0.015mm) to focal positions of approximately (-0.55mm, 0.15mm) and (0.55mm, 0.15 mm) may need to increase the cci Rnn / Ri nz / R / γ power supply by approximately 2.2 times in order to produce substantially the same intensity in the two focal positions as the intensity in the unmodulated focal position. In one embodiment, this increase in power may be undesirable. In various modalities, amplitude modulation can be combined with displacement opening techniques in order to reduce the possibility of excessive heating of the tissues in pre-focal and post-focal regions. For example, the maximum intensity measured in the pre-focal and post-focal regions can be reduced.
[000200] Figures 19A-19C are graphs of a 1600 intensity distribution in an xy plane at approximately 2mm before focusing according to one modality. Modulation has not been applied to a transducer. Graph 1600 illustrates that the distribution of acoustic intensity is symmetrical to the axis around an axis of the beam. In one embodiment, symmetry is caused by a circular opening of the transducer (eg, a focused circular bowl transducer). The highest intensity regions 1601, 1602, and 1604 occur along the beam axis at a radius of approximately 0 mm (region 1601), 0.75 mm (region 1602), and 1.0 mm (region 1604). In one modality, the maximum intensity is approximately 101 W / cm<sup>2</sup> in the plane with the condition that the intensity at the opening is approximately 1 W / cm<sup>2</sup>.
[000201] Figures 20A-20C are graphs of an intensity distribution 1620 in an xy plane at a focal depth according to one modality. In one embodiment, the focal depth may be approximately 15mm. Figures 20A-20C show a significant concentration 1622 in acoustic intensity in a focal plane. In one embodiment, the diameter of the acoustic distribution has decreased from an OD of about 3mm in Figures 20A-20C to a diameter of less than about 0.3mm at a focal depth. The maximum intensity has been increased to approximately 7.73 kW / cm<sup>2</sup>, which is approximately 77.3 times greater than the maximum intensity of approximately 2 mm before focusing.
[000202] Figure 21 is a schematic illustration of an amplitude modulation opening pattern 1630 according to one embodiment. The 1630 amplitude modulation pattern can be placed through an aperture. The groups of strips or transducer portions 1632 may represent an amplitude of +1 (eg, due to expansion of the transducer material). The groups of strips or portions of transducer 1634 may represent an amplitude of -1 (eg, due to contraction of the transducer material). As shown, groups 1632 and 1634 can toggle through the opening. The separation distance 1640 may correspond to a spatial period of transitions between +1 and -1 of the transducer material through the aperture. In one embodiment, the separation distance 1640 together with a local depth and operating frequency can determine the distance of the split beams in the focal plane. In one embodiment, any number of transducer portions can be grouped into groups 1632 and 1634. In one embodiment, the number of portions in groups 1632 and 1634 can be the same. In one embodiment, the number of servings in groups 1632 and 1634 may be different. In one embodiment, amplitude modulation can include more than two levels, such as three (0 and ± 1) or more levels.
[000203] Figures 22A-22C are graphs of an intensity distribution 1650 in an x-plane and of an amplitude modulated aperture pattern of Figure 21 approximately 2 mm before focusing according to one embodiment. In one embodiment, the separation distance is approximately 6 mm for a cci Rnn / Ri nz / R / Y excitation signal frequency of approximately 7 MHz. In one embodiment, the 1630 amplitude modulation pattern is placed along the y axis to divide the beam by approximately 1.1 mm, as demonstrated by focus points 1652 and 1654. In one embodiment, although the energy distribution has an OD of about 3mm in the x direction increases in the ya direction by about 4mm. Compared to Figures 19A-19C, the maximum intensity of the 1650 intensity distribution is increased by approximately 20% at 112 W / cm<sup>2</sup>, with the condition that 1 W / cm is placed<sup>2</sup> intensity at the unmodulated focal point. In one embodiment, the amount of power from a split aperture may need to be increased by a factor of approximately 2.2 to achieve substantially similar intensity at two focus points. At a depth of about 2mm before focus, the maximum intensity can be about 246 W / cm<sup>2</sup> due to the increase in power. However, because in one embodiment the temperature increases in a tissue are proportional to the increases in intensity, the temperature increase in a pre-focal region may be more than double for a split beam design.
[000204] Figures 23A-23C are graphs of an intensity distribution 1670 in an xy plane of an amplitude modulated aperture pattern of Figure 21 at a focal depth according to one embodiment. In one embodiment, the focal depth may be approximately 15mm. In one embodiment, the intensity of each of the 1672 and 1674 approaches can be approximately 3.45 kW / cm<sup>2</sup>, with the condition that 1 W / cm is placed<sup>2</sup> at the unmodulated focal point. As illustrated, two symmetrical beams are presented at focal positions 1672 (0.55mm, 0.15mm) and 1674 (-0.55mm, 0.15mm). In one embodiment, the intensity distribution at focal positions 1672 and 1674 is substantially similar to the intensity distribution illustrated in Figure 20A-20C.
[000205] Figure 24 is a schematic illustration of a 1680 amplitude modulation opening pattern with displaced or changing states according to one embodiment. In one embodiment, pattern 1680 is the same as the amplitude modulation function 1630 illustrated in FIG. 21 with the exception of state changes. In one embodiment, the 1680 amplitude modulation pattern can be placed through an aperture as follows. The separation distance 1688 can comprise a plurality of transducer portions or strips. Although eight of these portions are shown in Figure 24, the number of portions may be any suitable number, such as less than eight or more than eight. The transducer portions can be individually steerable and can be configured to represent an amplitude state of -1 and / or +1. As voltage or current is supplied to the transducer, the aperture changes state (or shifts) from S1 to S2, then from S2 to S3, then from S3 to S4, and so on. As illustrated, in state S1 the plurality of portions across separation distance 1688 are divided into two groups 1682 (modulation of +1) and 1684 (modulation of -1). When transitioning from S1 state to S2 state, the plurality of portions across separation distance 1688 are divided into groups 1692 (modulation of +1) and 1690 and 1694 (modulation of -1). As illustrated, portion 1681 in state S1 corresponds to +1 and in state S2 corresponds to -1. When transitioning from state S2 to state S3, the plurality of portions across separation distance 1688 is divided into groups 1702 (modulation of +1) and 1700 and 1704 (modulation of -1). When transitioning from the S3 state to the S4 state, the plurality of portions across the cci Rnn / Ri nz / R / γ separation distance 1688 are divided into groups 1712 (modulation of +1) and 1710 and 1711 ( modulation of -1). Consequently, the modulation pattern changes (or shifts) through the aperture over time. In one mode, there are eight unique states if the aperture moves with the same amplitude modulation pattern through the aperture. In one embodiment, the effective intensity can be determined as a time-weighted average of the acoustic intensity distribution of each state of the opening. In one embodiment, the aperture changes state (or travels) at a speed sufficient to reduce the possibility of overheating of the tissues in a pre-focal and / or post-focal manner. In one embodiment, the separation distance 1688 can include any suitable number of transducer portions. In one embodiment, the number of portions in the groups that correspond to the modulation of +1 and -1 can be the same. In one embodiment, the number of portions in the groups that correspond to the modulation of +1 and -1 may be different. In one embodiment, amplitude modulation can include more than two levels, such as three (0 and ± 1) or more levels.
[000206] Figures 25A-25D are graphs of an intensity distribution 1730 in an x-plane and of an amplitude-modulated aperture pattern with displacement of Figure 24 approximately 2 mm before focusing according to one embodiment. In one modality, the maximum intensity is approximately 71 W / cm<sup>2</sup> which is approximately 37% less than the maximum intensity of an amplitude modulated aperture pattern without displacement (eg, shown in Figure 22A-22C). In one embodiment, this reduction can be significant. Figures 25A-25D illustrate that the number and area of regions experiencing high intensity has been reduced compared to Figure 22A-22C. Regions that receive significant amounts of energy are located in approximately six locations 1731-1736. The intensity distribution graph 1730 illustrates that the degree of energy distribution is reduced, compared to Figure 22A-22C, to about 2mm OD in the x dimension and about 3mm OD in the y dimension. In one embodiment, this reduction can be significant. In one embodiment, the intensity distribution 1730 appears as the acoustic power emanating from two openings as the intensity distribution 1730 appears to be a spatially off-centered sum of the 1600 distribution in Figure 19A-19C. In one embodiment, as illustrated in Figure 25A-25D, the possibility of excessive heating of localized tissues before and after focusing is significantly reduced.
[000207] Figures 26A-26C are graphs of an intensity distribution 1750 in an xy plane of an amplitude modulated aperture pattern with displacement of Figure 24 at focal depth according to one embodiment. In one embodiment, the focal depth may be approximately 15mm. In one embodiment, although the intensity distribution before focus changes substantially (compare Figure 25A-25D with Figure 22A22C), the intensity distribution 1750 at the focal point is substantially similar to the intensity distribution 1670 at the focal depth for the amplitude modulated opening pattern without displacement illustrated in Figure 23A-23C. In one modality, the peak intensity of the intensity distribution is reduced by 1750 (for example, compare 334 W / cm<sup>2</sup>, with 345 W / cm<sup>2</sup>). In one modality, in order to obtain the same intensity at the focal depth, the power supplied may need to be increased by a factor of 2.3. The maximum intensity about 2mm before focusing will be 163W / cm<sup>2</sup>which is a substantial reduction from the prediction of 246 W / cm<sup>2</sup> (Figure 22A cci Rnn / Ri nz / R / v
22C) if the amplitude modulation pattern does not move through the aperture. In one embodiment, the acoustic intensity maxima in approaches 1752 and 1754 are substantially concentrated compared to the intensity distribution 1650 in Figure 22A-22C.
[000208] Figure 27A is a schematic illustration of an amplitude modulated aperture with displacement (two levels ± 1) 1800 according to one embodiment. In one embodiment, the schematic 1800 corresponds to the pattern 1680 illustrated in FIG. 24. FIG. 27B is a state transition table 1850 of the two-state schematic 1800 according to one embodiment.
[000209] Figure 28A is a schematic illustration of an amplitude modulated aperture with displacement (three levels) 1900 according to one embodiment. Schematic 1900 includes a level 0 1952. In one embodiment, level 0 1952 can be achieved by using a ground terminal or connecting a resistor to the ground terminal. In one embodiment, level 0 1952 can reduce the number of high-frequency spatial components in a focal area (for example, these components may correspond to grid lobes). In one modality, level 0 1952 can reduce spatial frequency transitions in the pre-focal and post-focal zones. FIG. 28B is a 1950 state transition table of the 1900 three-state schematic according to one embodiment.
[000210] Figure 29A is a schematic illustration of an amplitude modulated aperture with displacement (four levels) 2000 according to one embodiment. Schematic 2000 includes two additional levels +0.5 2002 and -0.5 2004. In one modality, doing this can provide similar advantages as adding a level 0. In one embodiment, amplitude modulation through the aperture provided by the 2000 schematic can best approximate a sine wave, such that high-frequency spatial components are not presented in the focal plan. FIG. 29B is a state transition table 2050 of the three-state schematic 1900 according to one embodiment.
[000211] In various embodiments, the number of strips and / or transducer portions in a separation distance may be less than or greater than eight. The number of portions selected may depend on the amount of heating reduction desired for localized tissues before and / or after focusing. In various modes, the number of amplitude modulation levels can be greater than four, such as six, eight, ten, and so on.
[000212] There are several advantages to using the modalities of the systems and methods described herein. In one embodiment, amplitude modulation, particularly with displacement, and / or phase shunting techniques can reduce the possibility of excessive pre-focal and post-focal heating. In one embodiment, amplitude modulation, particularly with displacement, and / or phase shunting techniques can allow an ultrasound beam to be divided into two or more beams. In one embodiment, amplitude modulation, particularly with displacement and / or phase shifting techniques, can bring two or more sources of ultrasound closer together by placing ultrasonic energy at two or more focus locations. In one embodiment, amplitude modulation, particularly with shifting and / or phase shunting techniques, can reduce pain or discomfort experienced by a patient during ultrasound therapy by redistributing acoustic energy away from a focal point. In one embodiment, amplitude modulation, particularly with shift and / or phase shunt techniques, can reduce therapy time due to the cciEnn / Rinz / E / Y production of multiple TCPs.
Imaging systems [000213] In one embodiment, a receiving ultrasound beamformer can be used as part of an ultrasound imaging system. In one embodiment, an ultrasound imaging system uses a transmit and receive event to create a line from an ultrasound image. Transmission is typically focused on one location, and then focus system receive processing is focused on the same location. In this case, the response of the imaging system is described as:
h (t) = Tx (t) * Rx (t) (29) [000214] where h (t) is the spatial response of both the transmission and reception openings, Tx (t) is the response of the opening of transmission, and Rx (t) is the response of the reception opening.
[000215] In one embodiment, an ultrasound imaging system uses dynamic reception approach. In this case, although the transmitting ultrasound beam is focused on a spatial location, the transmission system can dynamically change the focus along the axis beam so that each spatial location is focused in depth. This system response is represented as:
h (t-ó) = Tx (t) * Rx (t-5) (30) [000216] The δ represents the time delay between the received signals which suggests how the focus may change for the reception aperture according to the signals they come from deeper depths.
[000217] In one embodiment, a technique for splitting a transmission therapy beam into multiple approaches through aperture amplitude manipulation may include receiving beams as well. In one embodiment, a system can include two transmit focuses (or more), and it is possible to focus on any spatial aperture using a receive aperture such as a line array where delays can be used to direct and focus the received beam along of different axes. This method allows the system to obtain two receive beams with only one transmit beam. This reduces the time required to visually observe the two beam axes from the receiving aperture. This system is described as:
hi (t-δ) = Tx (t) * Rxi (t-6) (31a) h<sub>2</sub>(t-ó) = Tx (t) * Rx<sub>2</sub> (t-δ) (31b) [000218] For example, assuming that the system produces two approaches, at a distance 1.0 mm away from the central axis of the therapy transducer and another -1.0 mm away from the central axis of the therapy transducer of each one at a depth of 15 mm. The ultrasound receiver will be able to create two receiving lines, one focused cci Rnn / Ri nz / R / v constant on the 1.0mm peak and one focused consistently on the -1.0mm peak. In one embodiment, a receiver can create two receive lines, one constantly focused on the 1.0mm peak and one constantly focused on the -1.0mm peak simultaneously.
[000219] In one embodiment, a method 2100 comprises the steps of:
[000220] transmit multiple approaches with one therapy opening [000221] obtain a signal from each portion of a reception aperture arrangement [000222] create multiple reception vectors based on the multiple approaches, and [000223] use the vectors reception to speed up an algorithm for imaging.
[000224] In some modalities, the transmission of multiple approaches can be simultaneous or sequential. In some embodiments, the reception vectors can be used simultaneously or sequentially.
[000225] Some embodiments and examples described herein are examples and are not intended to be limiting in describing the full scope of the compositions and methods of this description. Equivalent changes, modifications and variations of some embodiments, materials, compositions and methods can be made within the scope of the present invention, with substantially similar results.
[000226] While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the figures and are described in detail herein. However, it will be understood that the invention is not limited to the particular forms or particular methods described, but on the contrary, the invention will cover all these modifications, equivalents and alternatives that fall within the spirit and scope of the various described modalities and the appended claims. Any of the methods described herein may not need to be performed in the order listed. The methods described herein include certain actions taken by a practitioner; however, they may also include any third-party instruction in those actions, either expressly or by implication. For example, actions such as coupling a transducer module with an ultrasonic probe ”include“ instructing the coupling of a transducer module with an ultrasonic probe ”. The ranges described herein also encompass any and all overlaps, sub-ranges, and combinations thereof. Text such as "up to," "at least," "greater than," "less than," "between," and the like include the cited number. Numbers preceded by a term such as "about" or "near" include the cited numbers. For example, "approximately 25mm" includes "25mm".
Contents4
50 sheets
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90 members in 19 offices
Priority claims2
| Document | Office | Kind | Date |
|---|---|---|---|
| 61774785 | United States of America | – | |
| 201361774785 | United States of America | P |
Members90
| Document | Office | Kind | |
|---|---|---|---|
| CN104027893A | China | A | |
| US2014257145A1 | United States of America | A1 | |
| CA2902063A1 | Canada | A1 | |
| CA3177433A1 | Canada | A1 | |
| WO2014137835A1 | World Intellectual Property Organization (WIPO) | A1 | |
| TW201440721A | Taiwan Province of China | A | |
| CN204017181U | China | U | |
| CN204637350U | China | U | |
| AU2014226239A1 | Australia | A1 | |
| SG11201506925XA | Singapore | A | |
| KR20150126933A | Republic of Korea | A | |
| IL241222A0 | Israel | A0 | |
| IL241222D0 | Israel | D0 | |
| PH12015501999A1 | Philippines | A1 | |
| PH12015501999B1 | Philippines | B1 | |
| EP2964327A1 | European Patent Office (EPO) | A1 | |
| MX2015010778A | Mexico | A | |
| JP2016512451A | Japan | A | |
| EP2964327A4 | European Patent Office (EPO) | A4 | |
| BR112015020975A2 | Brazil | A2 | |
| SG10201707463UA | Singapore | A | |
| JP6364030B2 | Japan | B2 | |
| TWI640290B | Taiwan Province of China | B | |
| JP2018198937A | Japan | A | |
| TW201900117A | Taiwan Province of China | A | |
| AU2014226239B2 | Australia | B2 | |
| AU2019203187A1 | Australia | A1 | |
| MX367011B | Mexico | B | |
| US10420960B2 | United States of America | B2 | |
| MX2019009155AThis record | Mexico | A | |
| US2019366127A1 | United States of America | A1 | |
| JP6655130B2 | Japan | B2 | |
| IL241222A | Israel | A | |
| IL241222B | Israel | B | |
| JP2020096868A | Japan | A | |
| IL274174D0 | Israel | D0 | |
| TWI707658B | Taiwan Province of China | B | |
| AU2019203187B2 | Australia | B2 | |
| PH12020550200A1 | Philippines | A1 | |
| KR102221798B1 | Republic of Korea | B1 | |
| KR20210024672A | Republic of Korea | A | |
| AU2021200937A1 | Australia | A1 | |
| IL274174A | Israel | A | |
| IL274174B | Israel | B | |
| IL280974D0 | Israel | D0 | |
| TW202118459A | Taiwan Province of China | A | |
| CN104027893B | China | B | |
| EP2964327B1 | European Patent Office (EPO) | B1 | |
| CN113648551A | China | A | |
| CN113648552A | China | A | |
| DK2964327T3 | Denmark | T3 | |
| PT2964327T | Portugal | T | |
| IL280974A | Israel | A | |
| IL280974B | Israel | B | |
| PL2964327T3 | Poland | T3 | |
| KR102368369B1 | Republic of Korea | B1 | |
| KR20220028167A | Republic of Korea | A | |
| ES2900626T3 | Spain | T3 | |
| EP3988168A1 | European Patent Office (EPO) | A1 | |
| AU2021200937B2 | Australia | B2 | |
| JP2022109978A | Japan | A | |
| TWI776239B | Taiwan Province of China | B | |
| TW202245707A | Taiwan Province of China | A | |
| US11517772B2 | United States of America | B2 | |
| CA2902063C | Canada | C | |
| MX2023001674A | Mexico | A | |
| US2023158337A1 | United States of America | A1 | |
| KR102586994B1 | Republic of Korea | B1 | |
| KR20230145528A | Republic of Korea | A | |
| TWI832354B | Taiwan Province of China | B | |
| US11969609B2 | United States of America | B2 | |
| JP2024088731A | Japan | A | |
| TW202434176A | Taiwan Province of China | A | |
| US2024416150A1 | United States of America | A1 | |
| TWI877984B | Taiwan Province of China | B | |
| CN113648551B | China | B | |
| CN113648552B | China | B | |
| EP3988168B1 | European Patent Office (EPO) | B1 | |
| US2025161719A1 | United States of America | A1 | |
| PT3988168T | Portugal | T | |
| ES3031261T3 | Spain | T3 | |
| EP4582039A2 | European Patent Office (EPO) | A2 | |
| FI3988168T3 | Finland | T3 | |
| DK3988168T3 | Denmark | T3 | |
| PL3988168T3 | Poland | T3 | |
| EP4582039A3 | European Patent Office (EPO) | A3 | |
| US12478807B2 | United States of America | B2 | |
| KR102921533B1 | Republic of Korea | B1 | |
| KR20260021088A | Republic of Korea | A | |
| JP2026120764A | Japan | A |
Numbers
- Publication
- 2019009155
- Application
- 2019009155
Titles2
- Spanish
- DISPOSITIVOS Y MÉTODOS PARA TERAPIA DE ULTRASONIDO MULTIFOCAL
- English
- DEVICES AND METHODS FOR MULTI-FOCUS ULTRASOUND THERAPY.
Classification
- CPC, 9
- A61N7/02
- A61B8/4209
- A61N7/00
- A61N2007/0008
- A61N2007/0034
- A61N2007/0052
- A61N2007/027
- A61B2090/378
- A61N2007/0095
- IPC, 3
- A61N7 00
- A61B8 00
- A61B18 00