Ultrasound treatment device including plurality of transducers movable in vertical direction and operating method thereof

Abstract

An ultrasound device according to an embodiment of the present invention may comprise a probe including: a first motor configured to provide a first driving force for moving a first transducer and a second transducer in a first direction; and a second motor configured to provide a second driving force for moving the first transducer and the second transducer in a second direction perpendicular to the first direction. The ultrasound device may comprise: a pulser configured to output a first driving signal and a second driving signal to the first transducer and the second transducer, respectively; and a control circuit configured to generate an ultrasound image on the basis of a reflected ultrasound signal received by the first transducer and to generate a second control signal instructing generation of a high intensity focused ultrasound signal from the second transducer.

Description

Ultrasonic treatment device and method of operation including a plurality of transducers movable in a vertical direction

[0001] The present invention relates to an ultrasonic treatment device. More specifically, the present invention relates to a High Intensity Focused Ultrasound (HIFU) device comprising a plurality of transducers movable in a vertical direction.

[0002] Recently, high-intensity focused ultrasound (HIFU) devices are being used in patient treatment. For example, HIFU devices are utilized in cosmetic dermatology and obesity treatment. In this case, high-intensity focused ultrasound can be delivered to internal human tissues.

[0003] In order to use high-intensity focused ultrasound for human treatment, it is necessary to accurately and safely localize the focal point of the high-intensity focused ultrasound so as not to damage other tissues surrounding the target tissue for treatment. For example, Korean Registered Patent Publication No. 10-1849922 discloses a medical ultrasound device capable of simultaneously confirming the treatment site using ultrasound imaging and performing treatment using high-intensity focused ultrasound.

[0004] However, if the vertical position of the ultrasound imaging transducer for generating ultrasound images is fixed within the device (e.g., cartridge), it is difficult to generate precise ultrasound images. Furthermore, if the vertical position of the ultrasound focusing transducer is fixed within the device (e.g., cartridge), a problem arises in that different cartridges must be used for different treatment depths.

[0005] The object of the present invention is to provide an ultrasonic treatment device capable of moving an ultrasonic imaging transducer and an ultrasonic focusing transducer in a vertical direction along the depth direction of the skin, and a method of operating the same.

[0006] In addition, another objective of the present invention is to provide an ultrasonic treatment device capable of generating precise ultrasonic images using an ultrasonic imaging transducer movable in the horizontal direction, and a method of operating the same.

[0007] In addition, another objective of the present invention is to provide an ultrasonic treatment device and a method of operation thereof that can enhance the therapeutic effect by utilizing an ultrasonic imaging transducer and an ultrasonic focusing transducer movable in vertical and horizontal directions.

[0008] An ultrasonic device according to an embodiment of the present invention comprises a probe including a first transducer and a second transducer that generate ultrasound based on a first driving signal and a second driving signal, respectively different from each other; a control circuit configured to output a first control signal and a second control signal that control the driving of the first transducer and the second transducer; and a pulser configured to output a first driving signal and a second driving signal to each of the first transducer and the second transducer based on the first control signal and the second control signal. The probe further comprises a first motor configured to provide a first driving force to move the first transducer and the second transducer in a first direction, and a second motor configured to provide a second driving force to move the first transducer and the second transducer in a second direction perpendicular to the first direction. The control circuit may be configured to generate an ultrasonic image based on a reflected ultrasonic signal received by the first transducer and to generate the second control signal that directs the generation of a high-intensity focused ultrasonic signal from the second transducer.

[0009] A method of operating an ultrasonic device according to an embodiment of the present invention may include the steps of: a control circuit controlling a first motor configured to provide a first driving force to move a first transducer and a second transducer in a first direction; while the first transducer and the second transducer are moving in the first direction, the first transducer generates a first ultrasonic signal; the control circuit generates an ultrasonic image based on a reflected ultrasonic signal corresponding to the first ultrasonic signal; the control circuit controlling a second motor configured to provide a second driving force to move the first transducer and the second transducer in a second direction perpendicular to the first direction; receiving a user input instructing the generation of a second ultrasonic signal, which is a focused ultrasonic signal of the second transducer; and, in response to the user input, the second transducer generating a second ultrasonic signal, which is a high-intensity focused ultrasonic signal, at a plurality of predetermined first positions along the first direction.

[0010] The ultrasonic treatment device and the method of operation according to the present invention can generate precise ultrasonic images.

[0011] The ultrasonic treatment device and the method of operation according to the present invention can improve the treatment effect.

[0012] FIG. 1 is a drawing illustrating the configuration of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0013] FIG. 2 is a diagram illustrating the configuration of a probe of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0014] FIG. 3 is a drawing illustrating a control circuit and an image processing circuit according to one embodiment of the present disclosure.

[0015] FIGS. 4a and FIGS. 4b are drawings illustrating the operation of an ultrasonic imaging transducer according to one embodiment of the present disclosure.

[0016] FIGS. 5A and 5B are drawings illustrating the operation of an ultrasonic focusing transducer according to one embodiment of the present disclosure.

[0017] FIG. 6 is a diagram illustrating a driving signal transmitted to an ultrasonic focusing transducer according to one embodiment of the present disclosure.

[0018] FIG. 7a is a diagram illustrating a comparison of driving signals transmitted to an ultrasonic focusing transducer according to one embodiment of the present disclosure, and FIG. 7b is an experimental result showing a thermal coagulation area formed by each of the driving signals.

[0019] FIG. 8 is a diagram illustrating the operation of setting the treatment energy level according to the operating frequency of the ultrasonic focusing transducer of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0020] FIG. 9 is a diagram illustrating the operation of setting the treatment energy level according to the depth of the ultrasound focusing point of an ultrasound treatment device according to one embodiment of the present disclosure.

[0021] FIG. 10 is a diagram illustrating the operation of setting the treatment energy level according to the operating frequency and depth of the ultrasonic focusing transducer of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0022] FIG. 11 is a drawing illustrating a graphical user interface of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0023] FIG. 12 is a drawing illustrating a graphical user interface for setting the treatment energy level of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0024] FIG. 13 is a drawing illustrating a graphical user interface related to thermal coagulation of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0025] FIG. 14 is a diagram illustrating the detection operation of internal tissue boundaries of a human body using an ultrasonic treatment device according to one embodiment of the present disclosure.

[0026] FIG. 15 is a drawing illustrating a boundary pattern of internal tissue boundaries of a human body and a graphic user interface for setting the boundary pattern of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0027] FIG. 16 is a drawing illustrating the ultrasonic treatment operation of an ultrasonic treatment device according to one embodiment of the present disclosure, based on a specific boundary pattern.

[0028] FIG. 17 is a flowchart illustrating the operation method of an ultrasonic treatment device according to one embodiment of the present disclosure.

[0029] FIG. 18 is an ultrasound image of a human body in which the skin and the underlying tissue layer are distinguishably shown, generated by an ultrasound treatment device according to one embodiment of the present disclosure.

[0030] FIG. 19 is a flowchart illustrating a treatment method by medical staff according to one embodiment of the present disclosure.

[0031] In the following, embodiments of the present invention will be described clearly and in detail so that a person skilled in the art can easily practice the present invention.

[0032]

[0033] In the embodiments of this specification, parts, units, elements, modules, and blocks, etc., may perform at least one function disclosed in the specification.

[0034] In this specification, parts, units, elements, modules, and blocks, etc., may be realized by hardware, realized by software, or implemented using at least one of hardware and software. Additionally, one part, unit, element, module, and block may be implemented using at least one piece of hardware, and two or more parts, units, elements, modules, and blocks may be implemented by one piece of hardware. Parts, units, elements, modules, and blocks may be implemented by any one of software, hardware, and firmware, or a combination thereof.

[0035] For example, the parts, units, elements, modules, blocks, etc. of the embodiments may be physically separated into two or more separate parts, units, elements, modules, blocks, etc. that interact with one another without departing from the scope of the present disclosure. Additionally, the parts, units, elements, modules, blocks, etc. may be physically combined to be implemented into more complex units, elements, modules, blocks, etc. without departing from the scope of the present disclosure.

[0036] For example, parts, units, elements, modules, blocks, etc., may be physically implemented by analog and / or digital circuits such as logic gates, integrated circuits, microprocessors, microcontrollers, memory circuits, passive electronic components, active electronic components, optical components, hardwired circuits, etc., and may optionally be driven by firmware.

[0037] For example, parts, units, elements, modules, blocks, etc., may be implemented as circuits on one or more semiconductor chips or on a substrate support such as a printed circuit board (PCB). The circuits constituting the parts, units, elements, modules, blocks, etc., may be implemented by dedicated hardware or by a processor (e.g., one or more programmed microprocessors and associated circuits), or may be implemented in a combination form where some functions of the parts, units, elements, modules, blocks, etc., are performed by dedicated hardware and other functions are performed by a processor.

[0038] In this specification, signals may be described as having an on-level and an off-level. The magnitude of the on-level does not necessarily mean that it is greater than the magnitude of the off-level. The on-level may refer to the level of the signal at which the receiving device is activated.

[0039] In order to clearly explain the proposed invention in the drawings, parts unrelated to the description have been omitted, and similar reference numerals have been used for similar parts throughout the specification. Furthermore, where a part is described as "including" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components.

[0040] In each step, identification codes (1st, 2nd, etc.) are used for convenience of explanation and do not describe the order of the operations; rather, the operations may be performed differently from the specified order unless a specific order is clearly indicated in the context. That is, the operations may be performed in the same order as specified, substantially simultaneously, or in the reverse order.

[0041] Furthermore, unless otherwise defined, all technical and scientific terms used in this specification shall have the same meaning as commonly understood by those skilled in the art to which the present invention pertains, and in the event of a conflict, the description in this specification including definitions shall prevail.

[0042]

[0043] FIG. 1 is a drawing illustrating the configuration of an ultrasonic treatment device (10) according to one embodiment of the present disclosure. The configuration of the ultrasonic treatment device (10) of FIG. 1 is exemplary and may include other configurations not shown in FIG. 1 according to the embodiment.

[0044] An ultrasonic treatment device (10) according to an embodiment of the present disclosure may include a control device (100) and a probe (200).

[0045] The control device (100) can transmit driving signals (DS1, DS2) to the probe (200). The first and second transducers (TD1, TD2) of the probe can each generate an ultrasonic signal based on the first driving signal (DS1) and the second driving signal (DS2).

[0046] For example, the first transducer (TD1) is an ultrasonic imaging transducer and can generate an ultrasonic signal for imaging based on a first driving signal (DS1). The second transducer (TD2) is an ultrasonic focusing transducer and can generate a focused ultrasonic signal based on a second driving signal (DS2).

[0047] In one embodiment, the first transducer (TD1) and the second transducer (TD2) may be single-element transducers.

[0048] In one embodiment, the single-element transducer may have a concave shape when viewed from the third direction (DR3). The generated ultrasonic signal may form a focus on the center axis of curvature of the transducer. In one embodiment, the single-element transducer may have a flat or convex shape when viewed from the third direction (DR3), and the shape is not specifically limited. The single-element transducer may further include a lens at the bottom (the direction approaching human tissue along the second direction (DR2)).

[0049] In this specification, the first transducer (TD1) and the second transducer (TD2) are described on the premise that they are, by example, single-element transducers.

[0050] The first transducer (TD1) generates an imaging ultrasound signal (US1) based on a first driving signal (DS1), and the first transducer (TD1) can receive a reflected ultrasound signal (US1_E) that is reflected from within the human tissue (TS) by the imaging ultrasound signal. The interior of the human tissue (TS) may refer to the area below the skin surface (SS) along a second direction (DR2) which is a direction away from the skin surface (SS). The second direction (DR2) may be a direction parallel to the axial direction, which is the direction of propagation of the imaging ultrasound signal and the focused ultrasound signal.

[0051] The reflected ultrasonic signal (US1_E) can be converted into an echo signal (ED), which is an electrical signal, and transmitted to a control device (100). The control device (100) can process the echo signal (ED) to generate an ultrasonic image.

[0052] The second transducer (TD2) can generate a focused ultrasound signal (US2) based on the second driving signal (DS2).

[0053] In one embodiment, the control device (100) may include a first control circuit (110), a pulser (120), a high-voltage power supply circuit (130), a display device (140), and an image processing circuit (150).

[0054] In one embodiment, the probe (200) may include a handpiece (210) and a cartridge (220) that is configured to be mechanically detachable from the handpiece (210) and electrically connected.

[0055] In this specification, the control circuit is exemplarily described as being implemented separately as a first control circuit (110) of the control device (100), a second control circuit (211) of the handpiece (210), and a third control circuit (221) of the cartridge (220). However, the control circuit may otherwise be implemented in the control device (100), or in both the control device (100) and the handpiece (210). It should be interpreted that the control circuit being implemented as a single control circuit and / or multiple control circuits is included within the scope of the present invention. Accordingly, the expression in this specification that a control circuit outputs a specific signal does not exclude the possibility that another control circuit is implemented in a form that outputs said specific signal. For example, although the second control circuit (211) is shown in FIG. 1 as outputting the first motor control signal (MS1), the first control circuit (110) may be implemented to output the first motor control signal (MS1), and the present invention is not limited thereto.

[0056] The first control circuit (110) may be configured to output a first control signal (CS1) and a second control signal (CS2) that control the driving of the first transducer (TD1) and the second transducer (TD2), respectively. The pulser (120) may be configured to output a first driving signal (DS1) and a second driving signal (DS2) based on the first control signal (CS1) and the second control signal (CS2), respectively.

[0057] In one embodiment, the pulser (120) may output a first driving signal (DS1), which is a pulse signal having a preset period, in response to a first control signal (CS1). The pulser (120) may output a second driving signal (DS2), which is a pulse signal having a preset period, in response to a second control signal (CS2).

[0058] In one embodiment, the second control signal (CS2) is a pulse signal, and the pulser (120) outputs a second driving signal (DS2) which is a pulse signal that changes to an on-off level in response to a first level of the second control signal (CS2), and can output a second driving signal (DS2) which maintains an off level in response to a second level of the second control signal (CS2).

[0059] According to an embodiment, in response to a user input signal (e.g., pressing of a treatment button) received by the handpiece (210), the second control circuit (211) of the handpiece (210) outputs a second control signal (CS2), and the first control circuit (110) may again transmit the second control signal (CS2) to the pulser (120).

[0060] The high voltage power circuit (130) can supply a driving voltage (VOL) at which the pulser (120) can operate.

[0061] The image processing circuit (150) can generate an I / Q (In-phase and Quadrature) signal based on an echo signal (ED), process the I / Q signal to generate ultrasound image data (IDT), and then transmit it to a display device (140).

[0062] The probe (200) may include a handpiece (210) and a cartridge (220). The handpiece (210) may be in a form that a user can grip. The cartridge (220) may have a structure that is detachable from the handpiece (210).

[0063] In one embodiment, an electrical connection terminal and a guide portion for physical connection may be implemented in the handpiece (210) so that the cartridge (220) can be connected to the handpiece (210). For example, the guide portion may be implemented in the shape of a bar or a projection protruding in the direction in which the cartridge (220) is connected to the front end of the handpiece (210).

[0064] In one embodiment, the cartridge (220) may include a plurality of transducers (TD1, TD2). The cartridge (220) may include a body portion forming an outer housing, a window that passes ultrasound irradiated from the plurality of transducers (TD1, TD2) to the outside of the body portion, and a cavity portion. The cavity portion may be located inside the body portion, located between the plurality of transducers (TD1, TD2) and the window, and may be filled with a liquid. For example, the cavity portion may be filled with distilled water.

[0065] The probe (200) may include a first motor (M1) and a second motor (M2).

[0066] In one embodiment, the first motor (M1) may be located inside the handpiece (210). The first motor (M1) may provide a first driving force (DP1) to move the first transducer (TD1) and the second transducer (TD2) in a first direction (DR1). In one embodiment, the first motor (M1) may provide a first driving force (DP1) to move a transducer module (223) containing the first transducer (TD1) and the second transducer (TD2) in a first direction (DR1). The transducer module (223) may be a structure (MC) as described in FIG. 2 below. The transducer module (223) may be configured to contain the first transducer (TD1) and the second transducer (TD2) inside and may include a mechanical structure for receiving the first driving force (DP1), and the structure is not particularly limited.

[0067] In one embodiment, the second motor (M2) may be located inside the cartridge (220). The second motor (M2) may provide a second driving force (DP2) that moves the first transducer (TD1) and the second transducer (TD2) in a second direction (DR2). In one embodiment, the first transducer (TD1) and the second transducer (TD2) may be structures mounted on a mechanical structure (224), and the mechanical structure (224) may be the third structure (MC3) of FIG. 2.

[0068] The first motor (M1) can be driven based on the first motor control signal (MS1) transmitted by the second control circuit (211). The second motor (M2) can be driven based on the second motor control signal (MS2) transmitted by the third control circuit (221).

[0069] In one embodiment, the second control circuit (211) can transmit a first motor control signal (MS1) to the first motor (M1) to drive the first motor (M1) in response to a user input signal (e.g., pressing of an imaging button). The first motor (M1) can rotate at a preset speed in response to the first motor control signal (MS1).

[0070] In one embodiment, in imaging mode, the first motor (M1) may provide a first driving force (DP1) to cause the transducer module (223) to perform reciprocating motion along a first direction (DR1) based on a preset time or number of rotations. For example, the first motor (M1) may rotate clockwise (or counterclockwise) for a first number of rotations and then rotate counterclockwise (or clockwise) for a second number of rotations. The transducer module (223) may reciprocate within a certain distance based on the number of rotations of the first motor (M1). Within a certain range during the reciprocating movement of the transducer module (223), the first transducer (TD1) may ultrasonically scan an area (ROI) based on a first driving signal (DS1). In one embodiment, the time or number of rotations may be set based on a preset speed of the motor and a target movement position (distance value from a reference position) of the transducer module (223), and the direction of rotation of the motor may be determined according to the target movement position.

[0071] In one embodiment, in imaging mode, the second control circuit (211) may transmit a first driving request signal (DAS1) to the first control circuit (110) while the transducer module (223) moves within a preset range during the reciprocating movement section. The first control circuit (110) may output a first control signal (CS1) based on the first driving request signal (DAS1). This will be explained in detail below with reference to FIG. 4.

[0072] In one embodiment, in a treatment mode, the first motor (M1) may provide a first driving force (DP1) to cause the transducer module (223) to move along the first direction (DR1) to a plurality of predetermined first positions along the first direction (DR1). For example, the first motor (M1) may rotate based on a rotational speed corresponding to each of the plurality of first positions. The transducer module (223) may stop moving at each of the plurality of first positions based on the rotational speed setting of the first motor (M1). At each of the plurality of first positions, the second control circuit (211) may transmit a second driving request signal (DAS2) to the first control circuit (110). The first control circuit (110) may output a second control signal (CS2) based on the second driving request signal (DAS2). The second transducer (TD2) can irradiate a focused ultrasound signal (US2) based on the second driving signal (DS2).

[0073] In one embodiment, the first control circuit (110) can transmit a depth movement signal (TR_D) to the third control circuit (221). For example, the depth movement signal (TR_D) may be the distance that the transducer module (223) must move along the second direction (DR2). The third control circuit (221) outputs a second motor control signal (MS2) based on the depth movement signal (TR_D), and the second motor (M2) may provide a second driving force (DP2) to move the transducer module (223) in the second direction (DR2) based on the second motor control signal (MS2).

[0074] In one embodiment, the first motor (M1) may be a BLDC (brushless DC) motor and the second motor (M2) may be a piezoelectric motor. The first motor (M1) may be a servo motor that is an integrated motor. The second control circuit (211) may perform closed-loop control of the first motor (M1).

[0075]

[0076] FIG. 2 is a diagram illustrating the configuration of a probe (200) of an ultrasonic treatment device (10) according to one embodiment of the present disclosure. The probe (200) of FIG. 2 may correspond to the probe (200) of FIG. 1. For convenience of explanation, some configurations are omitted in FIG. 2, and only configurations necessary for the features of one embodiment of the present invention are shown.

[0077] The probe (200) includes a handpiece (210) and a cartridge (220) implemented in different separate housings, and the handpiece (210) and the cartridge (220) can be mechanically detachably coupled through a coupling structure (CONN1).

[0078] In one embodiment, the first motor (M1) can be operated in a lead screw manner.

[0079] For example, the first motor (M1) is connected to a threaded lead screw (LS) through a coupling (CPL), and the lead screw (LS) can be coupled to a nut-type lead screw block (LSB). By the rotation of the first motor (M1) and the lead screw (LS), the lead screw block (LSB) can move along a first direction (DR1).

[0080] In one embodiment, the first rod (LDD1) of the handpiece (210) fixed to the lead screw block (LSB) moves along the first direction (DR1) in the same way as the movement of the lead screw block (LSB), and the second rod (LDD2) of the cartridge (220) coupled with the first rod (LDD1) can move along the first direction (DR1). For example, the first rod (LDD1) of the handpiece (210) may be configured to be temporarily coupled by magnetic force to the second rod (LDD2) of the structure (MC) mounted inside the cartridge (220).

[0081] In one embodiment, the structure (MC) of the cartridge (220) may include a second rod (LDD2), a first structure (MC1), and a second structure (MC2). According to an embodiment, the second rod (LDD2), the first structure (MC1), and the second structure (MC2) may be mechanically joined or implemented as a single structure. For example, the first structure (MC1) and the second structure (MC2) may be cases configured to allow a second motor (M2) to be inserted inside, and the cases may be structures joined to the second rod (LDD2). According to an embodiment, the second rod (LDD2), the first structure (MC1), and the second structure (MC2) may be manufactured with a single mold or manufactured with different molds and then mechanically joined.

[0082] The second structure (MC2) can move along the first direction (DR1) based on the first driving force (DP1) along the guide (GUD) fixed inside the cartridge (220).

[0083] In one embodiment, the second motor (M2) inside the second structure (MC2) is coupled to the third rod (LDD3) to provide a second driving force (DP2) that moves the third structure (MC3) within a certain range (R2) along the second direction (DR2).

[0084] A first transducer (TD1) and a second transducer (TD2) may be located inside the third structure (MC3). In one embodiment, when viewed from the second direction (DR2), the first transducer (TD1) may be located inside the second transducer (TD2). In another embodiment, when viewed from the second direction (DR2), the first transducer (TD1) may be located outside the second transducer (TD2). For example, as in the third structure (MC3A) according to another embodiment, the first transducer (TD1) may be located next to the second transducer (TD2) along the first direction (DR1). In this case, in one embodiment, the ultrasonic generating surface of the first transducer (TD1) may be located differently from the ultrasonic generating surface of the second transducer (TD2) along the second direction (DR2).

[0085] In one embodiment, the first motor (M1) can be coupled with a position sensor structure (PSM) configured with a position sensor (PS).

[0086] In one embodiment, the handpiece (210) can set the position where the lead screw block (LSB) overlaps with the position sensor structure (PSM) when viewed from the second direction (DR2) as the origin of the movement position of the lead screw block (LSB).

[0087] For example, FIG. 2 shows a partial bottom view (AA) of the position sensor structure (PSM) viewed from a second direction (DR2). When the ultrasonic treatment device (10) starts operating, the first motor (M1) can move the lead screw block (LSB) away from the first motor (M1) and then move the lead screw block (LSB) back towards the first motor (M1). Referring to the partial bottom view (AA), the lead screw block (LSB) can move into the position sensor structure (PSM). When the lead screw block (LSB) blocks the path of light (LGT) between the light-emitting part (PS_E) and the light-receiving part (PS_R) of the position sensor (PS), the first motor (M1) stops operating, and the second control circuit (211) of FIG. 1 can set that position as the origin of the movement position of the lead screw block (LSB). Accordingly, the ultrasonic treatment device (10) can accurately calculate the movement position along the first direction (DR1) of the lead screw block (LSB) using a distance conversion coefficient based on the rotational speed of the first motor (M1) and the screw thread pitch, etc. Alternatively, the position sensor (PS) may be a sensing sensor by magnetic or mechanical methods, and the method is not particularly limited.

[0088]

[0089] FIG. 3 is a drawing illustrating a first control circuit (110) and an image processing circuit (150) according to one embodiment of the present disclosure. FIG. 3 illustrates an exemplary signal processing process according to one embodiment of an ultrasonic treatment device (10), and some blocks of FIG. 3 may be omitted or modified depending on the implementation example.

[0090] The first control circuit (110) can process an echo signal (ED) and output an I / Q signal (I / Q). The image processing circuit (150) can transmit an ultrasound image processed from the I / Q signal (I / Q) to a display device (140).

[0091] The first control circuit (110) may include an analog preprocessing block (AF), an analog-to-digital conversion block (ADC), a high-pass filter block (HPF), a time gain control block (TGC), a quadrature demodulation block (QM), and a low-pass filter block (LPF).

[0092] The Analog-to-Digital Converter (ADC) converts the analog signal output from the Analog Front Processing Block (AF) into a digital signal. The Analog-to-Digital Converter (ADC) can sample the analog signal at a sampling frequency sufficiently higher than the ultrasound center frequency.

[0093] The high-pass filter block (HPF) can perform filtering to remove low-frequency components (DC offset and low-frequency noise) from the digital signal. The time gain control block (TGC) performs gain control to compensate for ultrasonic signals that attenuate over time (i.e., depth) and can uniformly correct the signal strength between shallow and deep regions. The quadrature demodulation block (QM) performs quadrature demodulation to convert the high-frequency RF signal into a baseband signal and can generate an in-phase (I) component and a quadrature (Q) component. The low-pass filter block (LPF) can remove high-frequency components from the I / Q signal generated during the quadrature demodulation process and output an I / Q signal (I / Q) from which only the pure baseband signal has been extracted.

[0094] The image processing circuit (150) may include a magnitude detection block (MD), a log compression block (LC), a scan conversion block (SC), a median filter block (MF), and an image resize block (IR).

[0095] The magnitude detection block (MD) can calculate the magnitude (envelope) of the signal using the I / Q signal (I / Q). For example, the magnitude detection block (MD) can extract amplitude information of the I / Q signal (I / Q). The log compression block (LC) can compress the amplitude information of the I / Q signal (I / Q) on a logarithmic scale. The scan conversion block (SC) can convert ultrasound data acquired in polar coordinate form into Cartesian coordinate form suitable for display. The scan conversion block (SC) can perform interpolation during the coordinate conversion process. The median filter block (MF) can perform non-linear filtering to remove noise within the scan-converted ultrasound image. The image resize block (IR) can adjust the size of the ultrasound image to suit the output of the display device (140).

[0096] In one embodiment, the image processing circuit (150) may include a boundary detection block (LD) configured to determine tissue boundaries within the human body. The boundary detection block (LD) may determine tissue boundaries based on changes in pixel values ​​of the ultrasound image or changes in the intensity of the reflected ultrasound signal.

[0097] For example, the boundary detection block (LD) can determine tissue boundaries in an ultrasound image generated by the image resize block (IR) or in an initial ultrasound image obtained by the scan conversion block (SC) scanning the I / Q data of the reflected ultrasound signal. In one embodiment, the boundary detection block (LD) can perform moving average filtering on the ultrasound image or the initial ultrasound image.

[0098] In one embodiment, the window size used for moving average filtering of the boundary detection block (LD) may be set based on at least one of the wavelength and pulse length of the imaging ultrasonic signal (US1) generated by the first transducer (TD1) of FIG. 1 and FIG. 2.

[0099] For example, the window size can be set to a value closest to n times the wavelength of the imaging ultrasonic signal (US1) (where n is a natural number). For example, the window size can be set to be within the range of 0.5 times or more to 1 times or less the wavelength of the imaging ultrasonic signal (US1). For example, if the wavelength of the imaging ultrasonic signal (US1) is 0.1 mm and the length of one pixel is 0.02 mm, the window size can be set within the range of 3 to 5.

[0100] For example, the window size can be set based on the size of one pixel of the ultrasound image or the initial ultrasound image and the pulse length (i.e., wavelength × number of cycles) of the ultrasound signal for imaging (US1). For example, the window size can be set to be within a range of 0.5 times or more to 1 times or less the pulse length of the ultrasound signal for imaging (US1). For example, if the pulse length of the ultrasound signal for imaging (US1) is 0.2 mm and the length of one pixel is 0.02 mm, the window size can be set within a range of 5 to 10.

[0101]

[0102] FIGS. 4a and 4b are drawings illustrating the operation of an ultrasonic imaging transducer according to an embodiment of the present disclosure. The ultrasonic imaging transducer may correspond to the first transducer (TD1) of FIGS. 1 and 2. The operation of the first transducer (TD1) will be described with reference to FIGS. 1, FIG. 2, FIGS. 4a and 4b.

[0103] As described with reference to FIGS. 1 and 2, in imaging mode, the first transducer (TD1) can perform reciprocating motion along the first direction (DR1) by the first driving force (DP1) of the first motor (M1) of FIGS. 1 and 2.

[0104] FIG. 4a illustrates the movement speed of the first transducer (TD1) over time and the first driving request signal (DAS1) of the second control circuit (211) transmitted to the first control circuit (110). In FIG. 4, a positive sign of the speed indicates a direction moving away from (or closer to) the first motor (M1), and a negative sign indicates a direction moving closer to (or further away from) the first motor (M1).

[0105] The first motor (M1) may have an acceleration / deceleration profile. The acceleration / deceleration profile may define the process by which the first motor (M1) reaches a set speed from a stationary state and returns to a stationary state. In one embodiment, the first motor (M1) may be driven by a trapezoidal acceleration / deceleration profile, or in another embodiment, the first motor (M1) may be driven by a sigmoidal acceleration / deceleration profile. Alternatively, the first motor (M1) may be driven by a different type of acceleration / deceleration profile, but even in this case, the first motor (M1) may be driven by an acceleration / deceleration profile that includes a constant speed section. Although the first motor (M1) is described in this specification on the premise that it is driven by a trapezoidal acceleration / deceleration profile, the present invention does not exclude the first motor (M1) from being driven by a different type of acceleration / deceleration profile.

[0106] Referring to FIG. 4a, in the movement section (R1) following the first direction (DR1), the first motor (M1) can be driven in three movement sections: an acceleration movement section (T1, T4), a constant speed movement section (T2, T5), and a deceleration movement section (T3, T6), based on a trapezoidal acceleration / deceleration profile and a first motor control signal (MS1).

[0107] A control circuit according to an embodiment of the present disclosure can generate a control signal to cause the first transducer (TD1) to generate a first ultrasonic signal while the first transducer (TD1) moves at a constant speed.

[0108] For example, the second control circuit (211) of FIG. 1 can transmit an on-level first drive request signal (DAS1) to the first control circuit (110) during the constant speed movement section (T2, T5) of the first motor (M1). For example, the first control circuit (110) can output a first control signal (CS1) based on the on-level first drive request signal (DAS1). The pulser (120) can output a first drive signal (DS1) that directs the irradiation of an ultrasonic signal for imaging of the first transducer (TD1) based on the first control signal (CS1).

[0109] The second control circuit (211) can receive the rotational speed of the first motor (M1) by communicating with the driving circuit of the first motor (M1). For example, the second control circuit (211) can obtain driving information of the first motor (M1) through communication with the first motor (M1). The driving information may include, for example, the speed of the motor, time information measured from the start of motor driving, the rotational speed of the motor shaft, position information such as the rotational angle or distance traveled of the motor shaft, torque or load information, current / voltage applied to the motor, the heating state of the motor, diagnostic information such as overcurrent, overheating, and communication error.

[0110] The second control circuit (211) can determine the movement position of the first transducer (TD1) based on the rotational speed of the first motor (M1) and the movement distance conversion coefficient. When the first motor (M1) rotates for more than a preset rotational speed, or when the first motor (M1) rotates for more than a preset time, or when the first transducer (TD1) (transducer module (223) of FIG. 1) reaches a preset movement position, the second control circuit (211) can determine that the first motor (M1) has entered a constant speed movement section (T2, T5).

[0111] In one embodiment, the second control circuit (211) can output an on-level first drive request signal (DAS1) to the first control circuit (110) within a constant speed movement section (T2, T5) of the first motor (M1). For example, referring to FIG. 4a, the second control circuit (211) can start outputting the on-level first drive request signal (DAS1) after a certain time (or a certain position determined based on the rotational speed of the first motor (M1), or the rotational speed of the first motor (M1) and the screw pitch, etc.) after the first transducer (TD1) enters a constant speed movement section (T2) while moving from right to left, and can continue outputting the on-level first drive request signal (DAS1) for a certain time (or a certain rotational speed of the first motor (M1)) (D1). Additionally, for the constant speed movement section (T5) while the first transducer (TD1) is moving from left to right, the second control circuit (211) can output an on-level first drive request signal (DAS1) for a certain time (or a certain number of rotations of the first motor (M1)) (D2) in the manner described above. Accordingly, an on-level first drive request signal (DAS1) can be output in the imaging ultrasonic signal generation section (ROI_D), which is a constant speed movement section within a certain margin from the point of change between the constant speed movement section (T2, T5) of the first motor (M1) and the acceleration or deceleration movement section.

[0112] A first transducer (TD1), which is an ultrasonic imaging transducer according to an embodiment of the present disclosure, receives an on-level first driving signal (DS1) while moving at a constant speed, and the first transducer (TD1) can generate an ultrasonic signal for imaging at a preset constant time interval based on the first driving signal (DS1) without stopping movement while moving at a constant speed. Accordingly, the first transducer (TD1) can generate an ultrasonic signal for imaging at precise time intervals and position intervals. As a result, distortion of the ultrasonic image can be reduced and image quality can be improved.

[0113] Referring to FIG. 4b, the first transducer (TD1) can receive a reflected ultrasonic signal (US1_E) without stopping movement while moving at constant velocity.

[0114] Referring to FIG. 4b, the first transducer (TD1) is located at the first position (P1) at the first time within the acceleration movement section (T1, T4) of FIG. 4a, so the first transducer (TD1) does not generate an imaging ultrasonic signal (US1). The first transducer (TD1) is located at the second position (Pk) at the second time within the imaging ultrasonic signal generation section (ROI_D) of the acceleration movement section (T2, T5) of FIG. 4a, and can generate an imaging ultrasonic signal (US1) based on an on-level first driving signal (DS1). The first transducer (TD1), which has moved to the third position (Pk+1) at the third time within the imaging ultrasonic signal generation section (ROI_D), receives a reflected ultrasonic signal (US1_E), and the first transducer (TD1) can convert the reflected ultrasonic signal (US1_E) into an electrical signal. At this time, the influence on the quality of the ultrasound image due to the distance between the second position (Pk) and the third position (Pk+1) is negligible. Again, since the first transducer (TD1) is located at the fourth position (Pn) at the fourth time within the deceleration movement section (T3, T6) of FIG. 4a, the first transducer (TD1) does not generate an ultrasound signal (US1) for imaging.

[0115]

[0116] In one embodiment, the ultrasound treatment device (10) operates in imaging mode when operation is started to display an ultrasound image of the patient on the display device (140) of FIG. 1, and operates in treatment mode according to the user's instructions, and then operates in imaging mode again when the treatment mode is terminated. Accordingly, the ultrasound treatment device (10) can easily check the change in state before and after the formation of thermal coagulation on the focused ultrasound treatment site.

[0117] In one embodiment, the imaging mode after the end of the treatment mode may display information different from the imaging mode prior to the treatment mode on the display device (140). In the imaging mode after the end of the treatment mode, the ultrasound treatment device (10) may include information in the ultrasound image that allows the user (operator) to verify the effect of the treatment.

[0118] In one embodiment, the information may include the height and / or depth of the tissue layer, the size, height, shape, location of the thermal coagulation lesion (coagulation point), the temperature of the treatment site, etc.

[0119] In one embodiment, the ultrasonic treatment device (10) can calculate and display the height and / or depth of the tissue layer based on image data of the treatment target tissue.

[0120] In one embodiment, the ultrasonic treatment device (10) can identify the boundaries of a thermal coagulation lesion based on image data of the treatment target tissue, calculate the size, height, etc., and display them.

[0121] In one embodiment, the ultrasonic treatment device (10) can detect and display the temperature of the treatment site based on image data of the treatment target tissue.

[0122] In one embodiment, the ultrasonic treatment device (10) can generate a temperature image.

[0123] In one embodiment, the ultrasonic treatment device (10) can acquire ultrasound images of the treatment site before and after treatment, respectively, and analyze the ultrasound images to output a comparison result.

[0124] In one embodiment, the ultrasonic treatment device (10) can perform the operation of FIG. 4a at each of a plurality of depths in imaging mode and generate ultrasonic images. The ultrasonic treatment device (10) can alternately display the ultrasonic images generated at each of a plurality of depths on the display device (140), or display an image of blended or averaged ultrasonic images on the display device (140).

[0125]

[0126] FIGS. 5A and 5B are drawings illustrating the operation of an ultrasonic focusing transducer according to an embodiment of the present disclosure. The ultrasonic focusing transducer may correspond to the second transducer (TD2) of FIGS. 1 and 2. The operation of the second transducer (TD2) will be explained with reference to FIGS. 1, 2, FIGS. 5A, and FIGS. 5B.

[0127] As described with reference to FIGS. 1 and 2, in treatment mode, the second transducer (TD2) can move to each of a plurality of predetermined first positions along a first direction (DR1) by the first driving force (DP1) of the first motor (M1) of FIGS. 1 and 2.

[0128] For example, the first motor (M1) can rotate based on a rotational speed corresponding to each of the plurality of first positions. The second transducer (TD2) can stop movement at each of the plurality of first positions based on the rotational speed setting of the first motor (M1). At each of the plurality of first positions, the second control circuit (211) can transmit a second drive request signal (DAS2) to the first control circuit (110). The first control circuit (110) can output a second control signal (CS2) based on the second drive request signal (DAS2). The second transducer (TD1) can irradiate a focused ultrasound signal (US2) based on the second drive signal (DS2).

[0129] Referring to FIG. 5a, the second transducer (TD2) can move along a first direction (DR1) by means of the first driving force (DP1) of the first motor (M1). The second control circuit (211) can stop the movement of the second transducer (TD2) when the second transducer (TD2) reaches a plurality of preset first positions (P2, P3, ..., P7) within a preset treatment section (ROI_T). As described with reference to FIG. 4a and FIG. 4b, the second control circuit (211) can determine that the second transducer (TD2) has reached a plurality of preset first positions (P2, P3, ..., P7) corresponding thereto every time a certain amount of time (or a position determined based on a certain number of rotations of the first motor (M1), or the number of rotations of the first motor (M1) and the screw thread pitch, etc.) has elapsed.

[0130] Subsequently, at each of the multiple preset first positions (P2, P3, ..., P7), the second control circuit (211) can transmit a second driving request signal (DAS2) to the first control circuit (110). The first control circuit (110) outputs a second control signal (CS2) based on the second driving request signal (DAS2), and the pulser (120) can transmit a second driving signal (DS2) to the second transducer (TD2) based on the second control signal (CS2) to instruct the generation of a focused ultrasonic signal of the second transducer (TD2).

[0131] When the second transducer (TD2) reaches a position (e.g., P8) outside the preset treatment section (ROI_T), the first control circuit (110) can determine that the treatment of one treatment line is completed.

[0132] Referring to FIG. 5b, the ultrasonic treatment device (10) can move the second transducer (TD2) to a first depth (D1) and a second depth (D2) among a plurality of second positions along a second direction (DR2) inside human tissue.

[0133] For example, the third control circuit (221) may receive a depth movement signal (TR_D) from the first control circuit (110) and output a second motor control signal (MS2) based on the depth movement signal (TR_D). The second motor (M2) may move the second transducer (TD2) to a first depth (D1) and a second depth (D2) based on the second motor control signal (MS2).

[0134] The ultrasonic treatment device (10) can repeat the operation in the treatment mode of FIG. 5a at each of the first depth (D1) and the second depth (D2).

[0135] For example, the second transducer (TD2) can output a focused ultrasound signal at each of a plurality of preset first positions (P2, P3, ..., P7) within a preset treatment area (ROI_T) at each of the first depth (D1) and the second depth (D2).

[0136] In another embodiment, the second transducer (TD2) may output focused ultrasound signals at different locations along the first direction (DR1) at each of the first depth (D1) and the second depth (D2). This is described below with reference to FIG. 16.

[0137] The second motor (M2) can be controlled so that the second transducer (TD2) can adjust the focal depth of the focused ultrasound signal in units of 0.1 mm through physical movement along the second direction (DR2). Alternatively, the second motor (M2) can be controlled to move the second transducer (TD2) in the second direction (DR2) in units of movement of 0.1 mm or more to 1.5 mm or less. In one embodiment, a plurality of movement units are pre-set in the ultrasound treatment device (10), and one of the movement units can be selected. For example, a user can select a movement unit along the second direction (DR2) of the second transducer (TD2) based on the patient's skin condition.

[0138]

[0139] FIG. 6 is a diagram illustrating a driving signal transmitted to an ultrasonic focusing transducer according to one embodiment of the present disclosure. The ultrasonic focusing transducer may correspond to the second transducer (TD2) of FIG. 1 and FIG. 2. The operation of the second transducer (TD2) will be explained with reference to FIG. 1, FIG. 2, FIG. 5a, FIG. 5b, and FIG. 6.

[0140] In each of the multiple preset first positions (P2, P3, ..., P7) within the preset treatment area (ROI_T) described with reference to FIGS. 5a and 5b, the second transducer (TD2) can repeat the irradiation and irradiation of the focused ultrasound signal.

[0141] In one embodiment, the second transducer (TD2) can irradiate a focused ultrasonic signal in the form of a pulsed wave (PW) including one or more rest periods based on the second driving signal (DS2) at each of the plurality of first positions (P2, P3, ..., P7). For example, the second transducer (TD2) can perform an operation of irradiating a focused ultrasonic signal in the form of a pulsed wave having at least three on-times and two rest periods included between them at each of the plurality of first positions (P2, P3, ..., P7).

[0142] For example, the second transducer (TD2) may receive a second driving signal (DS2), which is a pulse signal with repeating on-level and off-level from the pulser (120). Whenever the second transducer (TD2) stops moving at each of the plurality of first positions (P2, P3, ..., P7), the pulser (120) may transmit a second driving signal (DS2) to the second transducer (TD2), which includes at least two pauses (F1, F2) and at least three on-times (N1, N2, N3). In one embodiment, the pauses may be set to 5 to 10 ms.

[0143] Accordingly, the ultrasonic treatment device (10) according to the present disclosure can transmit a second driving signal (DS2) including a plurality of short pulses to a second transducer (TD2), thereby allowing a focused ultrasonic signal to be applied repeatedly to the same focal position multiple times.

[0144]

[0145] FIG. 7a is a diagram illustrating a comparison of different types of driving signals (CW, PW) that can be applied to an ultrasonic focusing transducer according to the driving mode of an ultrasonic device according to one embodiment of the present disclosure, and FIG. 7b is an experimental result photograph showing a comparison of the thermal coagulation area formed by each driving signal. The first experimental result (710) is the result of irradiating a focused ultrasonic signal having an on-time of 80 ms in the form of a continuous wave (CW). The second experimental result (720) is the result of irradiating a focused ultrasonic signal comprising two pulses consisting of an on-time of 40 ms and a rest period of 10 ms in the form of a pulse wave (PW). The third experimental result (730) is the result of irradiating a focused ultrasonic signal comprising four pulses consisting of an on-time of 20 ms and a rest period of 10 ms in the form of a pulse wave (PW). The result of the fourth experiment (740) is the result of irradiating a focused ultrasound signal comprising eight pulses consisting of a pulse wave (PW) form, an on-time of 10 ms, and a rest period of 2 ms.

[0146] Referring to FIG. 7a, the second transducer (TD2) may irradiate a focused ultrasound signal in the form of a continuous wave (CW) based on a second driving signal (DS2) at each of the plurality of first positions (P2, P3, ..., P7) of FIG. 5a. For example, the ultrasound treatment device (10) according to the present disclosure may transmit a second driving signal (DS2) that is continuously output for a certain period of time without rest to the second transducer (TD2), thereby allowing the focused ultrasound signal to be continuously applied to the same focal position.

[0147] However, referring to FIG. 7b, when a focused ultrasound signal is applied to a treatment target tissue by a continuous wave (CW) driving signal, thermal coagulation spreads to the surroundings and forms in a shape with indistinct boundaries (710), which may cause unintended thermal damage to surrounding tissues. On the other hand, when a focused ultrasound signal is applied to a treatment target tissue by a pulse wave (PW) driving signal, thermal coagulation may form in a shape close to spherical (720, 730, 740).

[0148] Accordingly, the ultrasonic treatment device (10) according to the present disclosure can locally form a spherical thermal coagulation without damaging other tissues surrounding the treatment target tissue by using a second driving signal (DS2) in the form of a pulse wave (PW) including a plurality of short pulses.

[0149]

[0150] FIG. 8 is a diagram illustrating the operation of setting the treatment energy level according to the operating frequency of the ultrasonic focusing transducer of an ultrasonic treatment device according to one embodiment of the present disclosure. The operation of setting the treatment energy level described with reference to FIG. 8 can be performed in the ultrasonic treatment device (10) of FIG. 1. The operation of setting the treatment energy level according to the operating frequency of the ultrasonic focusing transducer is described with reference to FIG. 1 and FIG. 8.

[0151] The ultrasonic treatment device (10) of FIG. 1 according to an embodiment of the present disclosure can control the energy band of the focused ultrasonic signal generated by the second transducer (TD2) based on the operating frequency of the second transducer (TD2).

[0152] For example, if the second transducer (TD2) has a first operating frequency, the ultrasonic treatment device (10) can control the pulser (120) so that the second transducer irradiates a focused ultrasonic signal within the first energy band. If the second transducer (TD2) has a second operating frequency, the ultrasonic treatment device (10) can control the pulser (120) so that the second transducer irradiates a focused ultrasonic signal within the second energy band. The first energy band and the second energy band may not overlap at least partially.

[0153] In one embodiment, when a cartridge is coupled, the operating frequency of the second transducer (TD2) or the type of the cartridge can be determined. The type of the cartridge may be set according to the operating frequency of the second transducer (TD2).

[0154] For example, referring to FIG. 8, the first type, second type, and third type cartridges may each include a second transducer (TD2) operating at different first, second, and third operating frequencies.

[0155] The first control circuit (110) can output a second driving signal (DS2) such that when each of the first type, second type, and third type cartridges is combined, a focused ultrasonic signal of the first, second, and third energy bands (ER1, ER2, ER3) with an energy level lower than or equal to the first, second, and third maximum energy levels (EM1, EM2, EM3) is applied to each of the second transducers (TD2) operating at the first, second, and third operating frequencies. For example, the first control circuit (110) and / or the pulser (120) can control the duty cycle, on-time, pulse duration time, and pulse repetition frequency (PRF), etc., such that a focused ultrasonic signal having an energy lower than or equal to the first, second, and third maximum energy levels (EM1, EM2, EM3) is applied to each of the second transducers (TD2) operating at the first, second, and third operating frequencies. In addition, the range that can be set by the user through the user interface for setting parameters (treatment parameters) of the focused ultrasound signal can also be set differently for each operating frequency of the second transducer (TD2).

[0156] FIG. 8 illustrates, by example, first, second, and third energy bands (ER1, ER2, ER3) having the same minimum energy level and different maximum energy levels, which are set according to cartridge type; however, alternatively, each of the energy bands set in the cartridge may have different minimum energy levels and maximum energy levels.

[0157]

[0158] FIG. 9 is a diagram illustrating the operation of setting the treatment energy level according to the depth from the skin surface of the ultrasound focusing point of an ultrasound treatment device according to one embodiment of the present disclosure. The operation of setting the treatment energy level described with reference to FIG. 9 can be performed in the ultrasound treatment device (10) of FIG. 1. The operation of setting the treatment energy level according to the depth of the ultrasound focusing point is described with reference to FIG. 1 and FIG. 9. Detailed description of parts that overlap with FIG. 8 is omitted.

[0159] The ultrasonic treatment device (10) of FIG. 1 according to an embodiment of the present disclosure can control the energy band of the focused ultrasonic signal generated by the second transducer (TD2) based on the depth of the focusing point of the second transducer (TD2).

[0160] For example, referring to FIG. 9, when the second transducer (TD2) is configured to irradiate a focused ultrasound signal focused at first, second, and third depths (D1, D2, D3) inside human tissue, the ultrasound treatment device (10) can control the pulser (120) so that the second transducer irradiates a focused ultrasound signal within the first, second, and third energy bands (ER1, ER2, ER3). Any two of the first, second, and third energy bands (ER1, ER2, ER3) may not overlap at least partially with each other.

[0161] In one embodiment, as the depth of the focusing point is formed shallower (closer to the skin surface), the duty cycle, on-time, pulse duration time, and pulse repetition frequency (PRF) can be controlled so that the settable energy band of the focused ultrasound signal is smaller or the maximum energy level is lower. In addition, the range that can be set by the user through a user interface for setting parameters (treatment parameters) of the focused ultrasound signal can also be set differently depending on the depth of the focusing point of the focused ultrasound signal.

[0162]

[0163] FIG. 10 is a diagram illustrating the operation of setting a treatment energy level according to the operating frequency of an ultrasonic focusing transducer and the depth of the focusing point, respectively, of an ultrasonic treatment device according to one embodiment of the present disclosure. The operation of setting a treatment energy level described with reference to FIG. 10 can be performed in the ultrasonic treatment device (10) of FIG. 1. The operation of setting a treatment energy level according to the operating frequency of an ultrasonic focusing transducer and the depth of the focusing point of a focused ultrasonic signal is described with reference to FIG. 1 and FIG. 10. Detailed descriptions of parts that overlap with FIG. 8 and FIG. 9 are omitted.

[0164] FIG. 10 illustrates, exemplarily, the maximum energy levels that can be set at each of the 12 depth-direction focusing point positions (D1, D2, ..., D12) of three types of cartridges (1, 2, 3). FIG. 10 exemplarily assumes that the energy levels of the focused ultrasound signal are divided into 1 to 15 steps.

[0165] As described in FIGS. 8 and 9, based on the location (depth) of the focusing point of the second transducer (TD2) and the operating frequency of the second transducer (TD2), the ultrasonic treatment device (10) of FIG. 1 can control the energy band of the focused ultrasonic signal generated by the second transducer (TD2).

[0166] Referring to FIG. 10, for example, when the first type and second type cartridges have a focusing point set at the sixth position (D6), the ultrasonic treatment device (10) can control the user interface so that the maximum energy level of the focused ultrasonic signal can be set to 8 levels or less. The third type cartridge cannot be set to a focusing point lower than the sixth position (D6). Likewise, the first type cartridge cannot be set to a focusing point higher than the eighth position (D8).

[0167] Through the energy setting operation of FIGS. 8 to 10, the ultrasonic treatment device (10) can perform treatment of the target tissue more efficiently and safely. In addition, user convenience can also be improved.

[0168]

[0169] FIG. 11 is a drawing illustrating a graphical user interface of an ultrasonic treatment device according to one embodiment of the present disclosure. The graphical user interface of FIG. 11 may be displayed on a display device (140) of the ultrasonic treatment device (10) of FIG. 1.

[0170] Referring to FIG. 11, the ultrasound treatment device (10) provides information related to treatment using focused ultrasound signals to the user and can receive parameters necessary for treatment using focused ultrasound signals from the user.

[0171] The first interface (GUI1) can display patient information of the treatment target.

[0172] The second interface (GUI2) can display an ultrasound image generated based on a reflected ultrasound signal (US1_E) received from the first transducer (TD1) of FIG. 1.

[0173] Through the third interface (GUI3), the user can set the depth of the focusing point of the focused ultrasound signal.

[0174] Through the fourth interface (GUI4), the user can set the energy level of the focused ultrasound signal. The energy level that the user can set may be set within the energy level band described with reference to FIGS. 8 through 10. The fourth interface (GUI4) can display an absolute energy value corresponding to the energy level set by the user. The fourth interface (GUI4) is further described below with reference to FIG. 12.

[0175] Through the fifth interface (GUI5), the user can set the length of the treatment line treated by the focused ultrasound signal (e.g., the treatment section (ROI_T) in FIGS. 5 and 6). Additionally, the user can set the spacing between the thermal coagulations generated by the focused ultrasound signal. Based on the length of the treatment line and the spacing between the thermal coagulations, the number of thermal coagulations (COAG's number) can be calculated.

[0176] Through the 6th interface (GUI6), the user can set the irradiation time interval of the focused ultrasound signal. FIG. 11 illustrates, for example, a setting in which the focused ultrasound signal is automatically irradiated every 3 seconds.

[0177] The seventh interface (GUI7) displays the simulation results of the expected thermal coagulation based on parameters set through the third interface (GUI3) to the fifth interface (GUI5). For example, the seventh interface (GUI7) of FIG. 11 displays the expected result of a thermal lesion formed by a 10-level focused ultrasound signal set through the fourth interface (GUI4) at a depth of 4.5 mm input through the third interface (GUI3). When viewing the figure from the front, the dots formed at a depth of 4.5 mm may correspond to the length of the treatment line and the spacing between the thermal coagulations set through the fifth interface (GUI5). This is explained again below with reference to FIG. 13.

[0178] Through the eighth interface (GUI8), the user can select the area to be treated.

[0179] The ninth interface (GUI9) can display depth information of the skin and its underlying tissue layers referenced for the area selected through the eighth interface (GUI8), separated by layer. Additionally, the ninth interface (GUI9) can display each layer identified from the ultrasound image of the skin and its underlying tissue layers displayed in the second interface (GUI2), separated by depth.

[0180] The 10th interface (GUI10) can display the absolute depth of the ultrasound image displayed on the 2nd interface (GUI2).

[0181] The 11th interface (GUI11) can display information about the cartridge currently connected to the handpiece. For example, it can display the type of cartridge, the operating frequency of the ultrasonic focusing transducer, the number of uses, etc.

[0182] In one embodiment, the absolute depth referenced in relation to the area selected by the user through the eighth interface (GUI8) and the corresponding relationship between the skin and the underlying tissue layer may be pre-set in the ultrasonic treatment device (10). The ultrasonic treatment device (10) may display the skin and the underlying tissue layer within the ultrasound image displayed on the ninth interface (GUI9) by distinguishing them by depth, corresponding to the area selected by the user through the eighth interface (GUI8).

[0183] In one embodiment, the ultrasonic treatment device (10) detects the boundaries between the skin and the underlying tissue layer within the ultrasonic image and, based on the detected boundaries, can distinguish and display each tissue layer within the ultrasonic image on the ninth interface (GUI9). This is further explained below with reference to FIG. 14.

[0184]

[0185] FIG. 12 is a drawing illustrating a graphical user interface for setting the treatment energy level of an ultrasonic treatment device according to one embodiment of the present disclosure. The interface of FIG. 12 may correspond to the fourth interface (GUI4) of FIG. 11.

[0186] The user can set the energy level of the focused ultrasound signal through the first interface element (EL1) of the fourth interface (GUI4).

[0187] Referring to FIG. 12, graphical information of the energy level set through the first interface element (EL1) can be displayed through the second interface element (EL2). Along with the second interface element (EL2), graphical information of the maximum energy level described with reference to FIG. 8 through 10 can be displayed through the third interface element (EL3). The second interface element (EL2) and the third interface element (EL3) are displayed together with a band of all energy levels that can be set in the ultrasound treatment device (10) (e.g., FIG. 12 is exemplarily levels 0 to 15), thereby allowing the user to conveniently set the energy level of the focused ultrasound signal.

[0188] The fourth interface element (EL4) can display the magnitude of absolute energy corresponding to the energy level set through the first interface element (EL1).

[0189]

[0190] FIG. 13 is a drawing illustrating a graphical user interface related to thermal coagulation of an ultrasonic treatment device according to one embodiment of the present disclosure. The interface of FIG. 13 may correspond to the seventh interface (GUI7) of FIG. 11. FIG. 13 exemplarily illustrates the seventh interface (GUI7A) before treatment by a focused ultrasound signal and the seventh interface (GUI7B) after treatment.

[0191] Referring to FIG. 13, the seventh interface (GUI7A) prior to treatment by focused ultrasound signal can display the simulation result of expected thermal coagulation based on parameters set through the first interface element (SCOG). The simulation result of thermal coagulation may be a thermal coagulation area within the skin and the underlying tissue layer presumed to be formed by irradiation with the focused ultrasound signal. The thermal coagulation area may be automatically derived by the ultrasound treatment device (10) according to the parameter values ​​of the set focused ultrasound signal.

[0192] The second interface element (RCOG) can display a treatment area that varies according to set parameter values. The treatment area may include an upper boundary (COG_U) and a lower boundary (COG_D).

[0193] The third interface element (FC) can indicate the center location of the expected solidification point.

[0194] Therefore, the user can set the parameters of the focused ultrasound signal suitable for the condition of the patient through simulation results prior to treatment.

[0195] Referring to FIG. 13, the seventh interface (GUI7B) after treatment with a focused ultrasound signal can distinguish and display thermal coagulations that have been treated by irradiation with the focused ultrasound signal and thermal coagulations scheduled for irradiation. The user can intuitively understand the progress of the treatment.

[0196]

[0197] FIG. 14 is a diagram illustrating the detection operation of an internal tissue boundary of a human body in an ultrasonic treatment device according to one embodiment of the present disclosure. The detection operation of FIG. 14 can be performed by an image processing circuit (150) of the ultrasonic treatment device (10) of FIG. 1. The changes in the ultrasonic image and pixel values ​​shown in FIG. 14 are exemplary, and the changes in pixel values ​​may differ depending on the ultrasonic image.

[0198] In one embodiment, the image processing circuit (150) of the ultrasonic treatment device (10) can detect the boundaries of human tissues in the ultrasonic image.

[0199] For example, the image processing circuit (150) can determine tissue boundaries in an ultrasound image generated by the image resize block (IR) of FIG. 3 or in an initial ultrasound image in which the scan conversion block (SC) scan-converts the I / Q data of the reflected ultrasound signal. An example of boundary detection operation is described with respect to an ultrasound image.

[0200] In one embodiment, the boundary detection block (LD) of the image processing circuit (150) can detect boundaries for each human tissue by an image processing method.

[0201] The image processing circuit (150) can remove high-frequency noise by performing moving average filtering on the ultrasound image. For example, the moving average filtering block (LD1) of the image processing circuit (150) can perform moving average filtering. The statistical analysis block (LD2) can calculate a statistical average or median value of the pixel values ​​(intensity values ​​in the case of an initial ultrasound image) of the smoothed ultrasound image for each row.

[0202] When the level change detection block (LD3) determines that the degree of change in the average pixel value that changes according to the row is greater than or equal to a preset reference value, the image processing circuit (150) can determine that point is a boundary of the internal tissue of the human body. The reference values ​​compared with the degree of change in the pixel value can be set differently for each boundary of the internal tissue (IFL1, IFL2, IFL3, IFL4). For example, the first reference value for determining the boundary between the dermis and the epidermis may be different from the second reference value for determining the boundary between the epidermis and the dense subcutaneous layer (dense SQ). The ultrasound treatment device (10) can sequentially divide the internal tissues between each detected boundary into the dermis, epidermis, dense subcutaneous layer, loose subcutaneous layer (loose SQ), and SMAS (Superficial Musculo-Aponeurotic System) layer. In this case, specific rows can be determined as boundaries for each internal organization.

[0203] In one embodiment, the ultrasonic treatment device (10) may not calculate a statistical average or median value of the pixel values ​​of the ultrasonic image on a row-by-row basis. For example, the level change detection block (LD3) may determine the boundaries of internal human tissues for each column by comparing the degree of change of pixel values ​​that change according to row on a column-by-row basis with a reference value. In this case, pixels located in different rows for each column may be determined as the boundaries of each internal tissue.

[0204] In one embodiment, the ultrasound treatment device (10) can detect boundaries of human tissues through a deep learning-based discrimination model trained with training data in which each pixel of an ultrasound image is labeled by human tissue. In this case, the ultrasound treatment device (10) may include a deep learning inference block that performs on-device inference. The deep learning inference block may include a neural processing unit (NPU), a graphical processing unit (GPU), and a digital signal processing unit (DSP).

[0205] In one embodiment, the ultrasonic treatment device (10) displays a list of treatment target areas corresponding to each of the tissues of the human body on a display device (140) and can receive a treatment target area from a user. For example, the list of treatment target areas may include the dermis layer, the subcutaneous layer, and the SMAS layer. Based on the boundaries detected from the ultrasound image of the patient, the ultrasonic treatment device (10) can move the first transducer (TD1) and the second transducer (TD2) to a depth corresponding to the selected treatment target area in correspondence with the treatment target area selected by the user.

[0206] In one embodiment, the subcutaneous layer of the treatment target area list may be indicated as a dense subcutaneous layer. When a user selects a dense subcutaneous layer, the ultrasound treatment device (10) may move the first transducer (TD1) and the second transducer (TD2) along the second direction (DR2) of FIG. 1 to a depth in which a focal point of the focused ultrasound signal is formed in the dense subcutaneous layer detected from the ultrasound image.

[0207]

[0208] FIG. 15 is a drawing illustrating a boundary pattern of internal tissue boundaries of a human body and a graphical user interface for setting the boundary pattern of an ultrasonic treatment device according to one embodiment of the present disclosure. An embodiment is described with reference to FIG. 1, FIG. 14 and FIG. 15.

[0209] In one embodiment, the ultrasound treatment device (10) may determine the internal tissue boundary of each column of the human body by comparing the degree of change in pixel values ​​that change according to row for each column of the ultrasound image with a reference value, as described in FIG. 14. In this case, the shape of the internal tissue boundary of each column may be determined as one of preset patterns (PTN1, PTN2, PTN3, PTN4, PTN5).

[0210] For example, if the user selects a dense subcutaneous layer as the treatment area, the ultrasonic treatment device (10) can compare the shape following the row direction of the pixels determined as the dense subcutaneous layer for each column with preset tissue boundary patterns (PTN1, PTN2, PTN3, PTN4, PTN5) and determine the most similar shape pattern.

[0211] Alternatively, for example, the ultrasonic treatment device (10) may display a 12th interface (GUI12) on a display device (140) that displays a list of tissue boundary patterns including a plurality of preset tissue boundary patterns, and receive a selection of one pattern from the user.

[0212]

[0213] FIG. 16 is a drawing illustrating an ultrasonic treatment operation of an ultrasonic treatment device according to one embodiment of the present disclosure, based on a specific tissue boundary pattern. The treatment operation according to the embodiment of FIG. 16 can be performed in the ultrasonic treatment device (10) of FIG. 1.

[0214] In one embodiment, the ultrasonic treatment device (10) can perform treatment using a focused ultrasound signal based on a tissue boundary pattern determined by the user or the ultrasonic treatment device (10) according to the embodiment of FIG. 15.

[0215] An embodiment of FIG. 16 exemplarily illustrates a treatment operation of an ultrasonic treatment device (10) based on the fifth tissue boundary pattern (PTN5) among the tissue boundary patterns (PTN1, PTN2, PTN3, PTN4, PTN5) of FIG. 15.

[0216] Referring to FIG. 16, the ultrasonic treatment device (10) can divide the treatment section (ROI_T) into a preset number of partial treatment sections (ROI_T1, ROI_T2, ROI_T3). The number of partial treatment sections can be preset in correspondence with each tissue boundary pattern.

[0217] In one embodiment, the ultrasound treatment device (10) can determine the depth of the focal point of the focused ultrasound signal suitable for treatment for each partial treatment section (ROI_T1, ROI_T2, ROI_T3).

[0218] For example, among the pixels corresponding to the internal tissue boundaries of the human body (or pixels corresponding to the internal tissue located between the boundaries) for each column of the ultrasound image determined by the ultrasound treatment device (10) in FIG. 15, representative pixels located in the center in the second direction (DR2) can be determined for each column. The ultrasound treatment device (10) can determine the focal point at a location that minimizes the distance along the second direction (DR2) between the representative pixels and a plurality of depths. For example, the ultrasound treatment device (10) can calculate the variance or standard deviation of the distances along the second direction (DR2) between each of the plurality of depths and the representative pixels, and then determine the depth with the smallest value as the optimal treatment depth.

[0219] In one embodiment, the depths of the focal points can be pre-set for each of the partial treatment sections (ROI_T1, ROI_T2, ROI_T3) corresponding to each of the tissue boundary patterns (PTN1, PTN2, PTN3, PTN4, PTN5).

[0220] The ultrasonic treatment device (10) can divide each of the tissue boundary patterns into at least two partial treatment sections. The ultrasonic treatment device (10) can determine at least two depths of focusing points suitable for treating the partial treatment sections.

[0221] FIG. 16 illustrates, by example, that the depth of the focal point suitable for partial treatment sections (ROI_T1, ROI_T2, ROI_T3) is determined as a first depth (D1) and a second depth (D2).

[0222] Referring to FIG. 16, the ultrasound treatment device (10) can move the first transducer (TD1) and the second transducer (TD2) so that the focal point of the focused ultrasound signal is formed at the first depth (D1). The ultrasound treatment device (10) can treat the treatment target tissues at the first depth (D1) in the first partial treatment section (ROI_T1), and treat the treatment target tissues at the first depth (D1) in the third partial treatment section (ROI_T3) without treating the second partial treatment section (ROI_T2). Afterward, the ultrasound treatment device (10) can move the first transducer (TD1) and the second transducer (TD2) so that the focal point of the focused ultrasound signal is formed at the second depth (D2), and treat the treatment target tissues at the second depth (D2) in the second partial treatment section (ROI_T2). The ultrasonic treatment device (10) can operate similarly for other tissue boundary patterns.

[0223] According to the embodiment of FIG. 16, even when the internal tissue boundary is not uniform and is inclined, convex, or concave, accurate treatment can be performed by moving the ultrasound focusing transducer so that a focusing point is formed at a position corresponding to a plurality of depths.

[0224]

[0225] FIG. 17 is a flowchart illustrating a method of operation of an ultrasonic treatment device according to one embodiment of the present disclosure. The operation of FIG. 17 can be performed in the ultrasonic treatment device (10) of FIG. 1. A method of operation of the ultrasonic treatment device (10) is described with reference to FIG. 17. Detailed descriptions of parts that overlap with the embodiments described with reference to FIG. 1 to FIG. 16 are omitted.

[0226] Referring to FIG. 17, the ultrasonic treatment device (10) can operate in imaging mode in steps S110 to S130.

[0227] In step S110, the ultrasonic treatment device (10) can move the first transducer and the second transducer in a first direction by controlling a first motor configured to provide a first driving force through a control circuit. The first direction may correspond to the first direction (DR1) of FIG. 1.

[0228] In step S120, while the ultrasonic treatment device (10) is moving in a first direction of the first transducer and the second transducer, the first transducer may generate a first ultrasonic signal. For example, the pulser (120) of FIG. 1 may output a first driving signal to cause the first transducer to generate a first ultrasonic signal during the constant velocity movement section of the first transducer.

[0229] In step S130, the control circuit of the ultrasonic treatment device (10) can generate an ultrasonic image based on a reflected ultrasonic signal corresponding to a first ultrasonic signal. The reflected ultrasonic signal can be received during constant velocity movement of the first transducer.

[0230] The ultrasonic treatment device (10) can operate in a treatment mode in steps S140 to S160.

[0231] In step S140, the ultrasonic treatment device (10) can move the first transducer and the second transducer in a second direction perpendicular to the first direction by controlling a second motor configured to provide a second driving force. The second direction may correspond to the second direction (DR2) of FIG. 1. The ultrasonic treatment device (10) can move the first transducer and the second transducer to a position where a focal point of the focused ultrasonic signal is formed at a depth set through the third interface (GUI3) in FIG. 11.

[0232] In step S150, the ultrasonic treatment device (10) may receive user input instructing the generation of a second ultrasonic signal, which is a focused ultrasonic signal of the second transducer. For example, the handpiece of the ultrasonic treatment device (10) may determine the pressing of a button instructing the irradiation of the focused ultrasonic signal.

[0233] In step S160, the ultrasonic treatment device (10) can move the second transducer along a first direction in response to user input. The ultrasonic treatment device (10) stops the movement of the second transducer at each of a plurality of predetermined first positions along the first direction, and the pulser (120) of FIG. 1 can output a driving signal so that the second transducer generates a second ultrasonic signal, which is a focused ultrasonic signal.

[0234]

[0235] FIG. 18 is an ultrasound image of the human body generated by an ultrasound treatment device according to one embodiment of the present disclosure, illustrating the skin and the underlying tissue layer.

[0236] The skin and its underlying tissue layers may include one or more of the epidermis, dermis, subcutaneous layer, superficial musculoaponeurotic system (SMAS) layer, muscle layer, and fat layer.

[0237] The subcutaneous layer can be divided into a dense subcutaneous layer (dense SQ) and a loose subcutaneous layer (loose SQ) depending on the case. The dense subcutaneous layer is characterized by dense fibrous tissue and prominent strong connective tissues such as collagen fibers, whereas the loose subcutaneous layer is composed of loose connective tissue, adipocytes, and abundant interstitial fluid, resulting in more flexible tissue characteristics. In other words, the dense subcutaneous layer has more fibrous components than adipocytes, making the tissue firm and dense; thus, it provides strong mechanical support and is responsible for shock absorption and rigid connections. On the other hand, the loose subcutaneous layer has relatively fewer collagen fibers, resulting in wider (loose) spacing between tissues, which facilitates smooth movement between the skin and underlying tissues. Its high flexibility allows for the movement and distribution of soft tissues, and it also performs metabolic roles such as fat storage and body temperature maintenance. Due to these differences, each of the aforementioned layers can be distinguished in ultrasound imaging. For example, a dense subcutaneous layer can be represented as a high-echo or high-signal region, and a sparse subcutaneous layer can be represented as a low-echo or low-signal region.

[0238]

[0239] FIG. 19 is a flowchart illustrating a treatment method by medical staff according to one embodiment of the present disclosure.

[0240] Referring to FIG. 19, an exemplary treatment method according to one embodiment of the present disclosure may, in step S210, drive an ultrasound system; in step S220, operate an image generation function of the ultrasound system; in step S230, set the focal depth of a high-intensity focused ultrasound signal of the ultrasound system to a dense subcutaneous layer; and in step S240, instruct the generation of a high-intensity focused ultrasound signal. In step S220, the user may acquire ultrasound images of the skin and the underlying tissue layer and diagnose the tissue structure and condition of the region of interest (ROI). For example, the region of interest includes fibrous connective tissue distributed in the subcutaneous layer or a dense subcutaneous layer. In this specification, “dense subcutaneous layer” refers to an area within the subcutaneous layer where relatively high-density fibrous connective tissue is concentrated.

[0241] In one embodiment, the user can set the focal depth of the ultrasound signal for imaging to a depth corresponding to the area of ​​interest for accurate diagnosis of the area of ​​interest. In this specification, “focal depth” refers to the axial distance from the surface of the skin to the focal point. For example, the focal depth can be set in units of 0.1 mm or in any one of units from 0.1 mm or more to 1.5 mm or less.

[0242] Generally, an ultrasound diagnostic device using a single-element transducer has the characteristic of not forming a focus or, if it does form a focus, having a fixed depth of focus, and the image is best viewed at the fixed depth of focus. However, the resolution of the image obtained from this is low, so compared to an ultrasound diagnostic device with an array structure in which multiple transducers are arranged, the image is generally coarse, and there is a problem that the image of the surrounding area outside the depth of focus region is blurry and difficult to see. On the other hand, in an ultrasound treatment method according to one embodiment of the present disclosure, by using an ultrasound device equipped with a single-element transducer capable of moving in the axial direction as well as the lateral direction, the depth of focus is physically shifted in the axial direction even when using a single-element transducer, thereby solving the above problem and enabling the acquisition of an image with high resolution for the region of interest.

[0243] In one embodiment, step S220 may include the step of a user identifying a dense subcutaneous layer from an ultrasound image. For example, the user may confirm the location of the subcutaneous layer by identifying each boundary area of ​​the skin and the underlying tissue layer.

[0244] In step S230, the user can set the focal depth of the focused ultrasound signal by considering the condition, density, and spatial distribution of the dense subcutaneous layer identified from the ultrasound image information. For example, the focal depth can be set in units of 0.1 mm or in any one of units from 0.1 mm or more to 1.5 mm or less.

[0245] In one embodiment, the user may set a first focal depth targeting a dense subcutaneous layer as the first target, and set a second focal depth targeting an area of ​​the skin and its underlying tissue layer different from the first target. In one embodiment, the second target may be selected from among the boundary areas of the skin and its underlying tissue layer. For example, the second target may include the boundary layer between the dermis and the subcutaneous layer, the SMAS layer, or the boundary area between the SMAS layer and the subcutaneous layer. In conventional focused ultrasound devices for skin procedures, only a skin lifting effect could be obtained by primarily targeting the SMAS layer with focused ultrasound; however, if the dense subcutaneous layer is included as the target for focused ultrasound treatment as described above, it is more effective for skin lifting and tightening, and the improvement effect can be significantly enhanced. Furthermore, when focused ultrasound energy is delivered simultaneously or continuously to the upper (i.e., dense subcutaneous layer) and lower (i.e., SMAS layer or the boundary between the SMAS layer and the subcutaneous layer) parts of the subcutaneous layer as described above, the microenvironment surrounding the subcutaneous adipocytes located between them may be altered by localized thermal coagulation lesions formed in both areas and a rise in temperature. By inducing the remodeling of fibrous connective tissue surrounding adipocytes, changes in the extracellular matrix (ECM), increased metabolic activity of adipocytes, and activation of preadipocytes through the aforementioned thermal stimulation, the improvement of subcutaneous adipose tissue function and tissue regeneration responses can be promoted.

[0246] In one embodiment, the user can set treatment parameters of the ultrasound system. For example, the frequency, intensity, energy, power, voltage, current, resistance, pulse duration, pulse repetition period, number of irradiations, interval, focal area size, treatment length (i.e., lateral distance of the area where the focused ultrasound is irradiated), spacing between focal points, irradiation interval, irradiation time, irradiation angle, target temperature of the target location, etc., of the focused ultrasound signal can be set.

[0247] In step S240, the user can set the treatment parameter conditions of the ultrasound system so that focused ultrasound is continuously irradiated to multiple focal positions (focus points) in a lateral direction from the focal depth set in step S230.

[0248] In one embodiment, the user may set one or more treatment parameters to form a spherical or near-spherical thermal coagulation lesion within the treatment area and instruct a signal to irradiate focused ultrasound under the set conditions. For example, the spherical thermal coagulation lesion may have a diameter of 0.5 to 1.2 mm. For example, the spherical thermal coagulation lesion may have a diameter of about 1 mm.

[0249] In one embodiment, the user may instruct the application of a focused ultrasound signal in the form of a pulsed wave having one or more resting periods. For example, the focused ultrasound signal may be applied in the form of a pulsed wave having two to four resting periods. For example, the resting period of the pulsed wave may be set to 5 to 10 ms. In conventional focused ultrasound devices for skin aesthetics, a single pulse with a pulse duration of typically 50 ms to 200 ms was applied to form thermal coagulation lesions in the dermis or SMAS layer. However, in this case, since the delivered energy is maintained for a relatively long period, the formed lesions take on a longitudinally elongated oval (cigar-shaped) form and become non-uniform; consequently, it is difficult to precisely control heat locally in the target area, and there was a problem of high potential for pain and damage to surrounding tissues during the procedure. In contrast, the treatment method according to one embodiment of the present invention, unlike the conventional single long pulse method, can form uniform thermal coagulation lesions by repeatedly applying short pulses. Due to this uniformization of the lesions, the local concentration of thermal energy is enhanced, and unnecessary thermal damage to surrounding tissues can be suppressed, thereby increasing the effectiveness of the procedure and significantly reducing side effects such as cheek hollowing. Furthermore, through the uniform arrangement of lesions at the micro-unit level, precision and reproducibility of the procedure are ensured, allowing for appropriate response to various skin types and differences in thickness. Additionally, by using pulse waves to form thermal coagulation at a relatively safe temperature compared to conventional focused ultrasound devices, pain occurring during the focused ultrasound procedure can be alleviated.

[0250] A treatment method according to one embodiment of the present disclosure may include, after step S240, a step of acquiring an ultrasound image of a treatment area irradiated with focused ultrasound by an automated method by the user operating an image generation function of an ultrasound system or by the user’s settings, and comparing ultrasound images before and after irradiation to confirm a change in the tissue condition.

[0251] A treatment method according to one embodiment of the present disclosure is a method for accurately identifying the structure of the subcutaneous layer, which has not been conventionally utilized as a treatment target in skin cosmetic treatment using ultrasound equipment, based on ultrasound imaging, and delivering focused ultrasound energy according to the structural characteristics thereof.

[0252] For example, a method for treating the skin and underlying tissues using focused ultrasound includes the step of delivering focused ultrasound energy to fibrous connective tissue present in the subcutaneous layer of a subject.

[0253] Fibrous connective tissue may include the retinacula cutis. The “retinacula cutis” is a collagenous fibrous network present within the subcutaneous layer. The retinacula cutis is believed to play a role in maintaining the structural stability of the subcutaneous layer by connecting the skin to deep supporting structures (SMAS or muscle layer) through a bi-terminal connecting structure that starts in the lower dermis, penetrates the subcutaneous layer, and extends to the SMAS or muscle layer, and by responding to gravity and tension and contributing to the maintenance of a three-dimensional fibrous structure. In this specification, the expression “including the retinacula cutis” may be used to mean including the entire retinacula cutis structure, as well as including only a part or a specific region of the structure depending on the context.

[0254] In one embodiment, the fibrous connective tissue may form a dense subcutaneous layer. The dense subcutaneous layer may include an aggregate structure of retinacula cutis or fibrous septa, and its thickness and distribution may vary depending on anatomical differences in areas such as the face and neck.

[0255] As described above, irradiating the dense subcutaneous layer with focused ultrasound can promote thermal denaturation and remodeling of fibrous connective tissue, thereby increasing mechanical strength, and induce collagen contraction in the fibrous connective tissue and the production of new collagen due to increased fibroblast activity. Additionally, applying thermal stimulation to adipocytes distributed in the subcutaneous layer can induce improvement in adipocyte function and / or regeneration. The improvement in adipocyte function may include, for example, enhancement of metabolic activity of adipocytes, regulation of adipokine secretion, improvement of mitochondrial function, promotion of cell repair and remodeling, adipogenesis, and adipocyte proliferation.

[0256] Adipocytes distributed in the subcutaneous layer not only perform the function of storing and releasing energy in the form of triglycerides, but also contribute to the regulation of metabolism and immune responses in the body by secreting various bioactive substances such as leptin and adiponectin. Furthermore, subcutaneous adipose tissue plays a role in maintaining the structural stability of the skin and underlying tissues by providing heat preservation and buffering functions against external shocks. Meanwhile, applying thermal stimulation to subcutaneous adipose tissue can induce the improvement of function and / or regeneration of the said adipocytes through changes in the microenvironment surrounding the adipocytes, fibrous connective tissue remodeling, extracellular matrix (ECM) remodeling, activation of preadipocytes, alleviation of cellular stress responses, and activation of metabolic pathways. However, since heating adipocytes by directly delivering high-intensity energy can cause cell membrane denaturation and apoptosis or necrosis, it is necessary to induce the improvement of function or regeneration of adipocytes through thermal stimulation while preventing direct damage to the adipocytes. In one embodiment, the method of applying thermal stimulation to the fat cells may include a method of indirectly delivering thermal stimulation to adjacent fat cells through a localized thermal coagulation lesion or partial thermal elevation formed by irradiating a fibrous network-dense area containing the retinacula cutis with focused ultrasound.

[0257] In one embodiment, the treatment method may be performed using an ultrasonic treatment device according to one embodiment of the present disclosure.

[0258]

[0259] Meanwhile, the above descriptions are specific embodiments for implementing the present invention. In addition to the embodiments described above, the present invention may also include embodiments that can be simply modified or easily modified. Furthermore, the present invention may also include technologies that can be easily modified and implemented using the embodiments. Accordingly, the scope of the present invention should not be limited to the embodiments described above, but should be defined by the claims set forth below as well as equivalents to the claims of this invention.

Claims

1. A probe comprising a first transducer and a second transducer that generate ultrasound based on a first driving signal and a second driving signal, respectively, which are different from each other; A control circuit configured to output a first control signal and a second control signal for controlling the driving of the first transducer and the second transducer; and It includes a pulser configured to output a first driving signal and a second driving signal to each of the first transducer and the second transducer based on the first control signal and the second control signal, and The above probe is, A first motor configured to provide a first driving force for moving the first transducer and the second transducer in a first direction; and It further includes a second motor configured to provide a second driving force that moves the first transducer and the second transducer in a second direction perpendicular to the first direction, and The above control circuit is, An ultrasonic device configured to generate an ultrasonic image based on a reflected ultrasonic signal received by the first transducer and to generate a second control signal that directs the generation of a high-intensity focused ultrasonic signal from the second transducer.

2. In Paragraph 1, The above control circuit is configured to output a first motor control signal that controls the first motor, and The above control circuit is configured to generate a first control signal that causes the first transducer to generate a first ultrasonic signal while the first transducer moves at a constant speed, or to generate a second control signal that causes the second transducer to generate a second ultrasonic signal, which is a high-intensity focused ultrasonic signal, at a plurality of predetermined first positions along the first direction.

3. In Paragraph 2, An ultrasonic device configured such that the pulser does not generate the first driving signal that generates the first ultrasonic signal during the acceleration or deceleration movement of the first transducer and the second transducer, respectively.

4. In Paragraph 2, The above control circuit is an ultrasonic device configured to generate the first control signal that generates the first ultrasonic signal in a preset first time interval after a preset first time interval from the start of operation of the first motor.

5. In Paragraph 2, The above control circuit is configured to generate the first control signal that generates the first ultrasonic signal in a preset first rotation interval after a preset first rotation number from the start of operation of the first motor, based on the rotational speed of the first motor.

6. In Paragraph 2, The pulser is configured to transmit the second driving signal, comprising a plurality of pulses, to the second transducer at each of the first positions, and An ultrasonic device in which the second driving signal is a pulsed wave.

7. In Paragraph 2, The first transducer and the second transducer are single-element transducers, and An ultrasonic device in which the second direction is parallel to the axial direction, which is the direction of propagation of the first ultrasonic signal and the second ultrasonic signal.

8. In Paragraph 2, The above control circuit is configured to output a second motor control signal that controls the second motor, and The above control circuit is configured to generate a second motor control signal for moving the first transducer and the second transducer to either a first depth and a second depth among a plurality of second positions along the second direction, output a first motor control signal for controlling the first motor at either the first depth and the second depth, and generate a second control signal for the second transducer to generate the second ultrasonic signal at the plurality of first positions among the first depth and the second depth.

9. In Paragraph 2, The above control circuit is configured to output a second motor control signal that controls the second motor, and The above control circuit is configured to generate a second motor control signal that moves the first transducer and the second transducer to a first depth and a second depth at different times among a plurality of second positions along the second direction, output a first motor control signal that controls the first motor at each of the first depth and the second depth, and generate a second control signal that causes the second transducer to generate the second ultrasonic signal at each of the plurality of first positions at each of the first depth and the second depth.

10. In Paragraph 8, The pulser is configured such that at the first depth, the second transducer generates the second driving signal that generates the second ultrasonic signal of the first energy band, and at the second depth, the second transducer generates the second driving signal that generates the second ultrasonic signal of the second energy band. An ultrasonic device in which the first energy band and the second energy band are different.

11. In Paragraph 10, The first maximum energy size of the first energy band is smaller than the second maximum energy size of the second energy band, and An ultrasonic device in which the first depth is closer to the skin surface than the second depth.

12. In Paragraph 8, It further includes a display device that outputs a user input and output interface, The above control circuit is configured to display a user input interface on the display device that allows the user to set treatment energy in each of the first energy band and the second energy band, wherein at least a portion of the first energy band and the second energy band have different energy bands, corresponding to each of the user's first control input and second control input corresponding to each of the first depth and the second depth, respectively.

13. In Paragraph 12, The above control circuit is, In response to the first control input of the user corresponding to the first depth, the user input interface capable of setting the treatment energy in the first energy band of the first maximum energy level is configured to be displayed on the display device, and In response to the second control input of the user corresponding to the second depth, the user input interface capable of setting the treatment energy in the second energy band of the second maximum energy level is configured to be displayed on the display device, and An ultrasonic device in which the first maximum energy level is an energy level smaller than the second maximum energy level.

14. In Paragraph 8, It further includes a display device that outputs a user input and output interface, The above control circuit is configured to display a list of treatment target sites corresponding to each of the tissues of the human body on the display device, and to generate a second motor control signal that moves the first transducer and the second transducer to a depth corresponding to a treatment target site selected by the user from the list of treatment target sites among the plurality of second positions.

15. In Paragraph 14, The subcutaneous layer of the above list of treatment target sites includes a dense subcutaneous layer, and An ultrasonic device configured such that, in response to an input signal in which the user selects the dense subcutaneous layer from the list of treatment target areas, the control circuit generates the second motor control signal that moves the first transducer and the second transducer to a preset depth corresponding to the dense subcutaneous layer.

16. In Paragraph 8, It further includes a display device that outputs a user input and output interface, The above control circuit is configured to display the ultrasound image and tissue labels by depth on the display device, and The above-deep tissue labels include an epidermal layer, a dermal layer, a dense subcutaneous layer, a loose subcutaneous layer, and a SMAS layer, in an ultrasound device.

17. In Paragraph 8, The above control circuit is configured to generate the ultrasonic image based on the reflected ultrasonic signal based on the first ultrasonic signal generated by the first transducer while the first transducer moves at a constant speed at each of the first depth and the second depth.

18. In Paragraph 1, The above control circuit is configured to output a first motor control signal for controlling the first motor and a second motor control signal for controlling the second motor, and The control circuit is configured to output a second motor control signal that moves the second transducer to a first depth and a second depth following the second direction based on a tissue boundary pattern, and to output a first motor control signal that controls the first motor at each of the first depth and the second depth. The control circuit is configured to generate a second control signal in which the second transducer generates a high-intensity focused ultrasound signal at a plurality of predetermined first positions along the first direction at the first depth, and to generate a second control signal in which the second transducer generates the focused ultrasound signal at a plurality of predetermined second positions along the first direction at the second depth. An ultrasonic device in which at least some of the first positions are different from the second positions when viewed from the second direction.

19. In Paragraph 18, An ultrasound device further comprising an image processing circuit that determines a tissue boundary based on a change in pixel value of the ultrasound image or a change in intensity of the reflected ultrasound signal, and determines the tissue boundary pattern based on the tissue boundary.

20. In Paragraph 18, The above image processing circuit is, It is configured to perform moving average filtering on an initial ultrasound image obtained by scanning and converting the I / Q data of the ultrasound image or the reflected ultrasound signal, and An ultrasonic device, wherein the window size used for the above moving average filtering is set based on at least one of the wavelength and pulse length of the first ultrasonic signal.

21. In Paragraph 18, The above image processing circuit is configured to display a preset list of tissue boundary patterns on a display device, and An ultrasonic device, wherein the above control circuit is configured to control the first motor and the second motor based on the tissue boundary pattern selected by the user from the list of tissue boundary patterns.

22. In Paragraph 1, Ultrasonic device characterized by treating a dense subcutaneous layer.

23. A step of controlling a first motor configured to provide a first driving force by a control circuit to move a first transducer and a second transducer in a first direction; A step in which the first transducer generates a first ultrasonic signal while the first transducer and the second transducer are moving in the first direction; The step of the above control circuit generating an ultrasonic image based on a reflected ultrasonic signal corresponding to the first ultrasonic signal; A step of controlling a second motor configured such that the above control circuit provides a second driving force to move the first transducer and the second transducer in a second direction perpendicular to the first direction; A step of receiving a user input instructing the generation of a second ultrasonic signal, which is a focused ultrasonic signal of the second transducer; and A method of operating an ultrasonic device comprising the step of, in response to the above user input, generating a second ultrasonic signal, which is a high-intensity focused ultrasonic signal, at a plurality of predetermined first positions along the above first direction, by the second transducer.

24. In Paragraph 23, The step of moving the first transducer and the second transducer in the second direction is A method of operating an ultrasound device comprising the step of moving the first transducer and the second transducer in the second direction so that the focal depth of a high-intensity focused ultrasound signal is formed at the boundary between the dermis and the subcutaneous layer, or at the boundary between the dense subcutaneous layer or the SMAS (Superficial Musculo-Aponeurotic System) layer and the subcutaneous layer.

Images