Ultrasound probe and device based on high intensity focused ultrasound for skin treatment - Patents.com

Abstract

A high intensity focused ultrasound probe according to an embodiment of the present disclosure includes a transducer module including a plurality of transducer elements that receive an electrical signal and generate ultrasound waves, and a circuit that provides drive signals to the plurality of transducer elements based on a control signal input from a control system, wherein the plurality of transducer elements have a concave shape in a first axis direction that is a focusing direction of ultrasound waves, and are arrayed in a second axis direction perpendicular to the first axis across a kerf, and at least two different elements of the plurality of transducer elements are configured to emit high intensity focused ultrasound waves at different times based on the drive signal.

Description

[Technical field]

[0001] The present disclosure relates to a High Intensive Focused Ultrasound (HIFU) probe and an ultrasound device for skin treatment employing the probe, and more particularly to a High Intensive Focused Ultrasound probe and ultrasound device capable of focusing high intensity ultrasound for skin treatment at multiple points and multiple depths based on the geometric structure and array form of array-type transducer elements without mechanical movement of the transducer elements. [Background technology]

[0002] Recently, there has been much interest in using High Intensive Focused Ultrasound (HIFU) for skin treatments such as skin lifting and skin tightening.

[0003] High-intensity focused ultrasound is a technology that focuses high-intensity acoustic energy on a local area in the body to increase the temperature of the local area at the focal point, causing thermal mutations and treating lesions. When used on the skin, it uses the effect of removing wrinkles and restoring skin elasticity by creating wounds due to thermal mutations at the local area where the fine ultrasound is focused, and regenerating denatured tissue.

[0004] Conventional high intensity focused ultrasound devices use a circular single element ultrasound transducer as a transducer for generating ultrasound to deliver strong ultrasound energy to a treatment area. Since multiple focusing points must be formed to deliver ultrasound energy for skin treatment to a wide area, conventional single element ultrasound transducers use a method of mechanically moving the single element ultrasound transducer so that ultrasound can be focused to various internal body areas.

[0005] Therefore, the conventional high intensity focused ultrasound uses a circular single element ultrasonic transducer, and therefore, when applying the treatment depth (focus point) to different depths, it is necessary to replace the cartridge designed with different ultrasonic frequencies and transducer geometric structures every time. To solve this problem, there was a prior art in which a lever, motor, or scanner was attached to the handpiece tip to adjust the depth of the target area to allow the user to select it manually, semi-automatically, or fully automatically to focus the ultrasound. However, such prior art still requires mechanical movement because the transducer must still be moved using a motor. In addition, this increases the treatment time, and the position of the ultrasonic transducer in the handpiece must be mechanically changed to change the treatment depth, limiting the improvement of the treatment effect.

[0006] On the other hand, in the case of diagnostic ultrasound equipment that generates low energy ultrasound, an ultrasound transducer in the form of an array element is used as shown in Fig. 19. In other words, ultrasound is focused at a desired position by electrically controlling the transmission time of multiple ultrasound transducers in the lateral direction (x direction), and the reflected ultrasound is received and imaged. At this time, in order to improve diagnostic resolution, a focusing technique can be used in the elevation direction (y direction) to deliver high ultrasound energy to the focus, and methods thereof include natural focusing as shown in Fig. 19(a) and lens focusing as shown in Fig. 19(b).

[0007] Conventionally, even in the case of diagnostic ultrasound equipment, geometrical focusing has not been used in array element ultrasound transducers due to difficulties in the manufacturing process, and as mentioned above, high intensity focused ultrasound equipment for therapeutic ultrasound equipment currently uses a single ultrasound transducer element.

[0008] Despite these problems, it is difficult to realize a high-intensity focused ultrasound device using array-type ultrasonic transducer elements. Since natural focusing is not suitable because the energy is dispersed, acoustic lens focusing or geometric focusing is suitable for increasing the temperature of the lesion. However, in the case of acoustic lens focusing, it is difficult to transmit high-intensity energy to the treatment site due to ultrasonic attenuation by the material used as the lens. In addition, geometric focusing has a problem that it is difficult to form the geometric structure of the array-type ultrasonic transducer (at least several tens of ultrasonic transducers having at least a focusable geometric structure must be configured for electrical transmission time control of the array-type ultrasonic transducer). Summary of the Invention [Problem to be solved by the invention]

[0009] An embodiment of the present disclosure provides a high intensity focused ultrasound probe and ultrasound device in which a plurality of transducers are configured in an array configuration, capable of geometric focusing based on a geometric structure.

[0010] Another embodiment of the present disclosure provides a high intensity focused ultrasound probe and ultrasound device in which multiple transducers capable of geometric focusing are configured in an array configuration that is inexpensive and easily manufacturable.

[0011] Another embodiment of the present disclosure provides a high intensity focused ultrasound probe and ultrasound device in which multiple transducers are configured in an array configuration capable of geometric focusing that can deliver high energy to a treatment site while reducing grating lobes.

[0012] Another embodiment of the present disclosure provides a high intensity focused ultrasound probe and an ultrasound device in which a plurality of transducers are configured in an array configuration, which allows the ultrasound transmission time of each ultrasound transducer element to be electrically controlled and shortens treatment time without mechanical movement.

[0013] Another embodiment of the present disclosure provides an ultrasound device in which therapeutic ultrasound is focused at multiple points or multiple depths based on multiple transducers configured in an array.

[0014] Another embodiment of the present disclosure provides an ultrasound device that prevents patient burns from ultrasound waves generated from multiple transducers configured in an array. [Means for solving the problem]

[0015] One embodiment of the present disclosure provides a high intensity focused ultrasound probe and ultrasound device.

[0016] A high intensity focused ultrasound probe according to an embodiment of the present disclosure includes a transducer module including a plurality of transducer elements that receive an electrical signal and generate ultrasound waves, and a circuit that provides drive signals to the plurality of transducer elements based on a control signal input from a control system, wherein the plurality of transducer elements have a concave shape in a first axis direction that is a focusing direction of ultrasound waves, and are arrayed in a second axis direction perpendicular to the first axis across a kerf, and at least two different elements of the plurality of transducer elements are configured to emit high intensity focused ultrasound waves at different times based on the drive signal.

[0017] A high intensity focused ultrasound device according to an embodiment of the present disclosure includes a probe that emits high intensity focused ultrasound (HIFU) and a control system that transmits a control signal to the probe, the probe includes a transducer module including a plurality of transducer elements that generate ultrasound based on the control signal, the plurality of transducer elements having a concave shape in a first axis direction that is a focusing direction of the ultrasound are arrayed in a second axis direction perpendicular to the first axis across a kerf, and the control system controls at least two different elements of the plurality of transducer elements to generate high intensity focused ultrasound at different times. Effect of the Invention

[0018] High intensity focused ultrasound probes and ultrasound devices according to embodiments of the present disclosure are capable of geometric focusing of generated ultrasound waves based on the geometric configuration of a plurality of high intensity focused ultrasound transducer elements.

[0019] The high-intensity focused ultrasound probe and ultrasound device according to the embodiments of the present disclosure can inexpensively and easily improve the skin treatment effect while shortening the treatment time by electrically controlling the transmission time of multiple high-intensity focused ultrasound transducer elements.

[0020] A high intensity focused ultrasound probe and ultrasound device according to embodiments of the present disclosure can prevent burns to a patient by providing differential cooling depending on the operation mode of a plurality of high intensity focused ultrasound transducer elements. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 is a diagram illustrating an implementation environment of an array-type high intensity focused ultrasound probe and an ultrasound device according to an embodiment of the present disclosure. [Diagram 2] FIG. 1 is a block diagram illustrating a simplified configuration of an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Diagram 3] 1A and 1B are perspective and plan views illustrating a geometric structure of transducer elements in an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure; [Figure 4] 1A and 1B are perspective and side views illustrating a part of a transducer module in an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure; [Diagram 5] 1 is a block diagram showing a simplified configuration of an array-type high-intensity focused ultrasound device according to an embodiment of the present disclosure. [Figure 6] FIG. 2 is a block diagram illustrating a simplified configuration of a transducer module of an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 7]FIG. 13 is a diagram illustrating a control signal transmitted to an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 8] FIG. 2 is a diagram illustrating an operation mode of an array-type high intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 9] FIG. 2 is a diagram illustrating an operation mode of an array-type high intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 10] 13 is a result of an experiment on the kerf spacing of an array-type high intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 11] 13 is a result of an experiment on the element width of an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 12] FIG. 2 is a perspective view showing a portion of a transducer module in an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 13] 1 is a flowchart illustrating a method for manufacturing an array transducer of an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 14] 1A to 1C are diagrams for explaining a method for manufacturing an array-type transducer of an array-type high-intensity focused ultrasonic probe according to an embodiment of the present disclosure. [Figure 15] 1 is a flowchart illustrating a method for manufacturing an array transducer of an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 16] 1A to 1C are diagrams for explaining a method for manufacturing an array-type transducer of an array-type high-intensity focused ultrasonic probe according to an embodiment of the present disclosure. [Figure 17] 1 is a flowchart illustrating a method for manufacturing an array transducer of an array-type high-intensity focused ultrasound probe according to an embodiment of the present disclosure. [Figure 18] 1A to 1C are diagrams for explaining a method for manufacturing an array-type transducer of an array-type high-intensity focused ultrasonic probe according to an embodiment of the present disclosure. [Figure 19] 1 is a diagram illustrating an ultrasonic focusing method of an ultrasonic probe used in a conventional diagnostic ultrasonic imaging device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Hereinafter, the embodiments disclosed in the present specification will be described in detail with reference to the attached drawings, and the same or similar components are given the same reference numbers regardless of the drawing numbers, and the duplicated description thereof will be omitted. The suffixes "module" and "part" for components used in the following description are given or mixed for the sake of ease of specification writing only, and do not have a meaning or role that is different from each other by themselves. In addition, when describing the embodiments disclosed in the present specification, if it is determined that a detailed description of such known technology may make the gist of the embodiments disclosed in the present specification unclear, the detailed description will be omitted. In addition, the attached drawings are only for making the embodiments disclosed in the present specification easy to understand, and it should be understood that the attached drawings do not limit the technical ideas disclosed in the present specification, and include all modifications, equivalents, or alternatives included in the idea and technical scope of the present invention.

[0023] Terms including ordinal numbers such as first, second, etc. may be used to describe various components, but the components are not limited by the terms. The terms are used only to distinguish one component from another.

[0024] When a component is referred to as being "coupled" or "connected" to another component, it should be understood that the component may be directly coupled or connected to the other component, but that there may be other components in between. In contrast, when a component is referred to as being "directly coupled" or "directly connected" to another component, it should be understood that there are no other components in between.

[0025] An ultrasound device according to an embodiment of the present disclosure includes an array-type high-intensity focused ultrasound probe 100 and a control system 200. An implementation environment of the array-type high-intensity focused ultrasound probe 100 and the control system 200 will be described with reference to FIG.

[0026] Referring to FIG. 1, the ultrasound device according to the embodiment of the present disclosure can transmit acoustic energy to the patient's internal tissue (dermis, SMAS (superficial musculo-aponeurotic system) layer, etc.) by controlling the high intensity focused ultrasound probe 100 with the control system 200 and focusing the ultrasound generated from the high intensity focused ultrasound probe 100 at a specific point inside the body. The control system 200 can electrically control the transmission time of a plurality of array type transducer elements included in the transducer module of the high intensity focused ultrasound probe 100 to change the focal point. The high intensity focused ultrasound probe 100 can transmit high intensity focused ultrasound energy inside the body for non-invasive face lifting treatment, skin tightening treatment, non-invasive subcutaneous fat layer reduction or removal treatment, etc.

[0027] In one embodiment, the control system 200 can control multiple transducer array elements of the high intensity focused ultrasound probe 100 to focus ultrasonic energy at multiple positions at the same depth, and can control multiple transducer array elements of the high intensity focused ultrasound probe 100 to focus ultrasonic energy at different depths.

[0028] The control system 200 may include a control unit including a treatment beamformer for calculating the ultrasound transmission time delay of each transducer element of the high intensity focused ultrasound probe 100 for changing the focal point.

[0029] In one embodiment, the control system 200 may include an input or output for user input.

[0030] The input unit includes a user interface (UI) including a microphone and a touch interface for receiving information from a user, and the UI can include not only a mouse and a keyboard but also mechanical and electronic interfaces implemented in the device, and is not particularly limited in type or form as long as it can input a user's command. The electronic interface includes a display that allows touch input.

[0031] The output unit is for transmitting information to a user by outputting the output of the control system 200 to the outside, and may include a display, an LED, a speaker, etc. for outputting a visual output, an audible output, or a tactile output. If the high intensity focused ultrasound probe 100 includes an imaging transducer element module, the display may display an ultrasound image of an internal body tissue.

[0032] The control system 200 may include a peripheral device interface unit for data transmission with various types of connected external devices, and may include a memory card port, an external device I / O (Input / Output) port, etc.

[0033] The control system 200 can be connected to the high intensity focused ultrasound probe 100 via a cable or wirelessly to control the high intensity focused ultrasound probe 100 .

[0034] In one embodiment, the high intensity focused ultrasound probe 100 can include a hand piece (sometimes called a wand) 100b and a cartridge 100a. In this case, the ultrasound transducer module is realized in the cartridge 100a. In another embodiment, the high intensity focused ultrasound probe 100 can be realized with the hand piece 100b and the cartridge 100a integrated together.

[0035] When the handpiece 100b and the cartridge 100a are realized separately, the handpiece 100b and the cartridge 100a are realized with an electrical connection terminal and a guide portion for physical connection so that the cartridge 100a can be connected to the handpiece 100b. In one embodiment, the guide portion may be realized in the shape of a bar or a protrusion protruding from the front end of the handpiece 100b in the direction in which the cartridge 100a is connected.

[0036] A configuration of a high intensity focused ultrasound probe 100 according to an embodiment of the present disclosure will be described with reference to FIG.

[0037] The high intensity focused ultrasound probe 100 may include a transducer module 110 that receives electrical signals and generates ultrasound waves, and circuitry 120 that inputs the electrical signals to the transducer module 110 .

[0038] In one embodiment, when the transducer elements of the transducer module 110 are configured in an array with a small number of transducer elements, the high intensity focused ultrasound probe 100 may include a stepping motor that can move the transducer module 110 in one dimension in the forward and backward directions, which are the axial directions of the handpiece 100b, to focus ultrasound waves at multiple focal points (i.e., so that the ultrasound focal points form multiple points at regular intervals along the same line).

[0039] In one embodiment, a sensor 130 capable of determining the position of the transducer module 110 may be included. The sensor 130 may be an optical sensor, a roller ball sensor, or the like.

[0040] As another example, an encoder may be connected to a motor for moving the transducer module 110 to calculate the displacement, and the current position of the transducer module 110 may be determined without using the sensor 130 .

[0041] In one embodiment, the sensor 130 is a variety of sensors used for various purposes, such as detecting not only the movement of the transducer module 110, but also detecting the connection between the handpiece 100b and the cartridge 100a (in this case, it may be a pressure sensor or a switch that detects an electrical connection), the angle of the handpiece 100b with respect to the ground, the user's grip on the handpiece 100b, etc.

[0042] In one embodiment, the sensor 130 may be a temperature sensor that measures at least one of the temperature of the transducer element inside the transducer module 110, the temperature of the degassed water in the load space 112 within the transducer module 110, and the temperature of the patient's skin in contact with the high intensity focused ultrasound probe 100.

[0043] As another embodiment, when the transducer elements are configured in a plurality of arrays, the control system 200 can control at least some or all of the plurality of transducer elements based on delay signals determined by the treatment beamformer 210 so that the ultrasound waves are focused simultaneously or sequentially at a plurality of ultrasound focusing positions. The control system 200 can focus the ultrasound waves at a plurality of focusing points in the forward and backward directions, which are the axial direction of the handpiece 100b, or at different skin depths of the patient by varying the delay signals used to control the controlled transducer elements. In this case, the movement of the transducer module 110 is not required. This will be described in detail below with reference to FIGS. 7 to 9.

[0044] As another example, when multiple transducer elements are arranged in an array, a motor can be used to rotate multiple transducer elements (transducer modules) through a fixed angle around the longitudinal axis of the handpiece, allowing a larger area to be treated simultaneously.

[0045] As another example, the axis along which the transducer elements are coupled in a one-dimensional array of transducer elements can be perpendicular to the longitudinal axis of handpiece 100b.

[0046] Therefore, in this case, the transducer module can be moved such that the array transducer elements move along the longitudinal axis of the handpiece 100b (i.e., along the third axis direction, referring to FIG. 3), thereby shortening the treatment time by simultaneously transmitting ultrasonic energy to a larger area.

[0047] Referring to FIG. 3, an array-type transducer element included in a transducer module 110 of an array-type high-intensity focused ultrasound probe 100 according to an embodiment of the present disclosure will be described.

[0048] In this specification, the axis toward the point where ultrasonic waves are generated from the multiple transducer elements and focused is referred to as the first axis (also referred to as the height direction or axial direction axis), the direction in which the multiple transducer elements are arranged is referred to as the second axis (also referred to as the lateral direction or side direction axis), and the axis in the longitudinal direction in which each transducer element extends and perpendicular to the first and second axes is referred to as the third axis (also referred to as the elevation direction or altitude direction axis). The first, second, and third axes are mutually orthogonal. The expression "along any one axis" includes being parallel to the axis in question, or being non-parallel but facing in a similar direction to the axis in question while maintaining an angle.

[0049] The transducer elements of the array type high intensity focused ultrasonic transducer module 110 according to an embodiment of the present disclosure may be in a form in which a plurality of transducer elements 111 are arranged in a one-dimensional array form in the second axis direction with a kerf 113 sandwiched therebetween.

[0050] The kerf means the interval between the transducer elements, and includes the width of the kerf and the transducer element 111 in the second axial direction, and is called the element pitch. The size of the grating lobe and the amount of energy transmitted to the inside of the body vary depending on the element pitch and the size of the kerf. Therefore, in the high intensity focused ultrasound transducer of the array element type, it is necessary to select the optimal ultrasound element pitch so that the main lobe size increases and the side lobe size is minimized.

[0051] Each transducer element 111 may have a concave geometric shape in opposite directions in the first axis direction, and this geometric structure is associated with the setting of a focal point of the ultrasound generated from the transducer element 111. That is, the inner surface of each transducer element 111 may have a concave shape in opposite directions in the first axis direction based on a plane formed by the second and third axis directions. The ultrasound generated by each transducer element 111 receiving an electrical signal travels in the first axis direction and is focused at a specific depth point inside the body to transmit energy.

[0052] Each transducer element 111 may be elongated in the third axis direction. Therefore, each transducer element 111 may have a length in the third axis direction longer than its width in the second axis direction.

[0053] The ultrasonic waves generated by each transducer element 111 receiving an electrical signal travel in the first axial direction and are focused and transmitted to a specific depth point inside the body, and the energy (i.e., ultrasonic output energy of the transducer module) may be 0.5 J / cm2 or more at the focused point. Alternatively, the output energy per area of ​​the transducer element 111 may be 500 W / cm2 or more. Therefore, the energy may be transmitted so that the temperature of the focused spot inside the body becomes a certain temperature or higher, thereby generating a thermal mutation at the focused spot inside the body.

[0054] Referring to FIG. 4, an array-type transducer element of an array-type high-intensity focused ultrasonic transducer module 110 according to an embodiment of the present disclosure will be described.

[0055] The array-type high intensity focused ultrasound transducer module 110 according to an embodiment of the present disclosure may include an isolation member 115 disposed in the kerf 113 between the high intensity focused ultrasound transducer elements 111. The isolation member 115 may isolate multiple transducer elements to prevent them from contacting each other.

[0056] In one embodiment, the high intensity focused ultrasonic transducer elements 111 are not directly connected to each other and arranged in an array, but are fixedly coupled to each other via a separating member 115 while being separated from each other.

[0057] In one embodiment, the separating member 115 is made of a material having thermal stability of 300° C. or more, for example, polyimide (PI). Therefore, the separating member 115 is made of a material whose physical properties change little even when exposed to high temperatures for a long time, so that the separating member 115 can be prevented from being thermally deformed when the signal lines 119 are connected to the transducer elements 111 by the soldering 117 method.

[0058] A signal line for applying an electric signal can be connected to the rear surface of each of the transducer elements 111 of the array type high intensity focused ultrasound transducer module according to an embodiment of the present disclosure in the direction opposite to the ultrasonic focusing direction by soldering 117. The high intensity focused ultrasound transducer element applies a high energy signal that causes thermal mutation in a desired lesion, and can instantaneously generate high heat. In order to connect the signal line to the transducer element 111 while preventing separation of the signal line due to high heat, a soldering method 117 having a melting point of about 300° C. or more can be used.

[0059] In one embodiment, the length of the isolating member 115 in the first axial direction may be longer than the length (thickness) of the transducer element 111 in the first axial direction. Therefore, the isolating member 115 can act as a dam to prevent molten lead from being connected to other elements when connecting a signal line to the transducer element 111 by soldering 117.

[0060] With reference to FIG. 5, a configuration of an ultrasonic device control system 200 according to an embodiment of the present disclosure will be described.

[0061] The control system 200 can include a treatment beamformer 210 that generates delay signals such that at least some of the array-type transducer elements of the ultrasound probe 100 receive electrical control signals at different times and emit ultrasound waves at different times.

[0062] In one embodiment, the delay signals generated by the treatment beamformer 210 are transmitted to the probe 100 via a treatment circuit 220 including a pulser, a digital-to-analog converter (DAC) and an amplifier. The treatment circuit 220 may include a digital element section and an analog element section. The delay signals are transmitted to the pulser and converted into high voltage signals (HV signals). The control system 200 may transmit to the probe 100 a drive signal (HV signal) generated based on a delay signal calculated based on a time point at which a signal is input to each transducer element in order to control the position and depth of the focal point of the treatment ultrasound.

[0063] In one embodiment, the processing circuitry 220 can include a multiplexer that can transmit drive signals to different transducer elements 111 of the probe 100 at different times in response to the delay signal through multiplexing.

[0064] In one embodiment, the control system 200 can generate an ultrasound B-mode image based on the received ultrasound that is generated by reflecting the generated ultrasound (ultrasound for treatment or separate ultrasound for imaging) inside the body. In this case, the probe 100 can include an analog front-end circuit for processing an electrical signal (referred to as a received ultrasound signal) converted from an ultrasound signal. The analog front-end circuit can include a low-noise amplifier (LNA) and a depth gain compensation (TGC) for attenuation compensation. The transducer element 111 of the probe 100 converts the received ultrasound into an electrical signal and transmits it to the imaging circuit 250, and the imaging circuit 250 can include an analog digital converter (ADC), a first-input-first-output (FIFO) memory, etc. The digitally processed received ultrasound signal is subjected to receive focusing (Rx focusing) in the imaging beamformer 240 based on the delay signal of the treatment beamformer 2110, and then scan converted in the image processor 260 and displayed on the display 270.

[0065] In one embodiment, the control system 200 can include a controller 230 that controls whether to operate in an ultrasound imaging mode (B-mode) to image received ultrasound signals or in a treatment mode to perform high intensity focused ultrasound treatment on a subject.

[0066] In one embodiment, the control system 200 or a separate external device may include a motor for circulating the degassed water in the load space 112 in the transducer module 110, and a cooling device for cooling the degassed water discharged from the load space 112. The controller 230 may control the circulation rate of the degassed water drawn into or discharged from the load space 112 based on at least one of the temperature of the transducer elements in the transducer module 110 measured by the temperature sensor 130, the temperature of the degassed water in the load space 112 in the transducer module 110, and the temperature of the patient's skin in contact with the high-intensity focused ultrasound probe 100. Thus, burns to the patient due to high-intensity focused ultrasound treatment may be prevented.

[0067] A conceptual configuration of a transducer module 110 of an array-type high intensity focused ultrasonic probe 100 according to an embodiment of the present disclosure will be described with reference to Fig. 6. For convenience of description, Fig. 6 shows a state in which the transducer module 110 is realized in a cartridge 100a.

[0068] In one embodiment, the transducer module 110 is implemented in a housing separate from the handpiece 100b so as to be detachable therefrom. In another embodiment, the transducer module 110 may be implemented in the same housing as the handpiece 100b. The embodiment described with reference to FIG. 6 will be described as an embodiment in which the transducer module 110 is implemented in a housing separate from the handpiece 100b.

[0069] The transducer module 110 includes an array of transducer elements 111 arranged with a kerf therebetween. In one embodiment, the kerf between the transducer elements 111 may include a separator 115 that prevents the transducer elements 111 from touching each other.

[0070] In one embodiment, the transducer module 110 has two axes (two axes) parallel to the longitudinal axis of the handpiece 100b and the axis along which the multiple transducer elements are arranged, but in other embodiments, they may intersect each other.

[0071] In one embodiment, the transducer module 110 includes a load space 112 in an interior space, which is filled with degassed water or other acoustically transparent material, and the load space 112 is filled with degassed water. In another embodiment, the load space 112 may be left as an empty space without being filled with a separate material.

[0072] In one embodiment, the transducer module 110 may include a circulation passage 116 capable of circulating the degassed water in the load space 112. The circulation passage 116 may include an inlet 116a and an outlet 116b. The degassed water cooled outside the transducer module 110 is drawn into the load space 112 inside the transducer module 110 through the inlet 116a, and the degassed water whose temperature has increased due to heat generation by the transducer elements 111 is discharged from the load space 112 to the outside through the outlet 116b.

[0073] In one embodiment, when the transducer module 110 is implemented in a separate housing that is detachable from the handpiece 100b, the transducer module 110 can include an electrical interface 114 that can be electrically coupled to the control system 200 via the circuitry of the handpiece 100b. The electrical interface 114 can include a PCB that performs the function of an electrical / mechanical connector.

[0074] In one embodiment, the housing of the transducer module 110 is formed with an open window through which ultrasonic waves can pass in the direction (one axis) in which the ultrasonic waves generated from the transducer element 111 are emitted, and when the loading space 112 is filled with a substance with high acoustic transparency such as degassed water, a cover member 118 is formed to prevent the substance from escaping through the window.

[0075] Ultrasonic waves generated from a plurality of transducer elements 111 based on mutually different delays are focused at a specific point 1010 in one axial direction.

[0076] A control method based on a delay signal of a plurality of array-type ultrasonic transducer elements 111 according to another embodiment of the present disclosure will be described with reference to Fig. 7. Fig. 7 will be described on the assumption that the delay elements 211 are separately connected to each of the transducer elements 111, but in another embodiment, the analog front end 210b may include a high-voltage multiplexer (HV multiplexer), in which case the delay elements 211 are not connected to each of the transducer elements 111, and an element to be activated (to generate ultrasonic waves) is selected from among the plurality of transducer elements 111 via the HV multiplexer. Also, the analog front end 210b may be realized inside the control system 200 or inside the handpiece 100b.

[0077] 7, the delay signal is transmitted to the analog front end 210b, and the analog front end 210b performs analog beamforming to control at least two different elements of the plurality of transducer elements 111 to generate high intensity focused ultrasound at different times based on the drive signal of the control system 200. In one embodiment, the analog front end 210b may include a signal generator 213, a delay element 211, a high voltage amplifier, a filter (such as a DAC filter), and an impedance matching transformer. The RF pulse generated by the signal generator 213 is transmitted to the delay element 211. The delay element 211 may supply a drive signal to the plurality of transducer elements 111 according to a delay value referring to a delay table stored in a separate memory.

[0078] With reference to FIG. 8 and FIG. 9, different modes for generating high-intensity focused ultrasound of the array-type transducer element 111 according to one embodiment of the present disclosure will be described.

[0079] 8, a plurality of transducer elements 111 may be exclusively classified to belong to a plurality of different subgroups 1021, 1022, 1023, and 1024. Being exclusively classified means that any one transducer element belongs to only one of the subgroups.

[0080] In one embodiment, the depths of the focal points 1011, 1012, 1013, 1014 of each subgroup 1021, 1022, 1023, 1024 of the plurality of transducer elements 111 may be the same, but may be different from each other. Thus, the delays imparted to each subgroup 1021, 1022, 1023, 1024 may be the same from each other.

[0081] In one embodiment, the control system 200 can control each subgroup 1021, 1022, 1023, 1024 of the plurality of transducer elements 111 to simultaneously focus high intensity focused ultrasound to multiple focal points 1011, 1012, 1013, 1014. Thus, high intensity focused ultrasound treatment can be performed simultaneously on multiple locations within the patient's tissue, thereby reducing the treatment time for the patient.

[0082] 9, a plurality of transducer elements 111 may be mutually divided and belong to a plurality of different subgroups 1041 and 1042. Being mutually divided means that any one transducer element does not belong to only one subgroup 1041, but also belongs to another subgroup 1042.

[0083] In one embodiment, each subgroup 1041, 1042 of the plurality of transducer elements 111 may have a focal point 1031, 1032 at the same depth but at a different position for each subgroup 1041, 1042. Thus, the form of delay delivered to each subgroup 1041, 1042 may be the same.

[0084] In one embodiment, the control system 200 can control each subgroup 1041, 1042 of the plurality of transducer elements 111 to focus high intensity focused ultrasound at multiple focal points 1031, 1032 at different times, thereby enabling high intensity focused ultrasound treatment to be performed on multiple locations within the patient's tissue without mechanical movement of the transducer elements, thereby reducing the treatment time for the patient.

[0085] In one embodiment, the control system 200 can be operated in a first mode in which the plurality of transducer elements 111 are exclusively divided into a plurality of different subgroups and controlled, and a second mode in which the plurality of transducer elements 111 are mutually divided into a plurality of different subgroups and controlled, and the plurality of transducer elements 111 can be controlled in the corresponding mode according to the practitioner's selection.

[0086] In one embodiment, the control system 200 can control the multiple transducer elements 111 so that the spacing between the points at which the high-intensity focused ultrasound is focused in the first mode is greater than the spacing between the points at which the high-intensity focused ultrasound is focused in the second mode.

[0087] Therefore, high intensity focused ultrasound treatment can be performed in different ways depending on the patient's condition.

[0088] In one embodiment, the control system 200 may control the plurality of transducer elements 111 so that the energy (i.e., ultrasonic output energy of the transducer module) delivered to the focal point in the first mode and the second mode is different from each other. For example, the plurality of transducer elements 111 may be controlled so that the energy delivered to the focal point in the second mode, in which the intervals between the points where the high-intensity focused ultrasound is focused, are finer, is lower.

[0089] In one embodiment, the control system 200 can control the operating speed of the circulation motor that circulates the degassed water in the load space 112 inside the transducer module 110 so that the circulation speed of the degassed water in the first mode and the second mode is different, and can control the cooling speed of the degassed water to be different from each other.

[0090] With reference to FIG. 10, the kerf width (size) and the width of the transducer elements of an array-type high intensity focused ultrasonic transducer module according to an embodiment of the present disclosure will be described.

[0091] Figure 10 shows the results of a simulation of the grating lobe magnitude as a function of the kerf width. The width of the transducer element was fixed at about 460 μm, and the simulation was performed with the kerf width varying from 20 μm to 160 μm in 20 μm intervals. At this time, the grating lobe magnitude was set within the range of the kerf width to be less than about -15 dB relative to the maximum energy.

[0092] FIG. 10(a) shows the beam profile when the kerf width is 40 μm, and FIG. 10(b) shows the beam profile when the kerf width is 160 μm. FIG. 10(c) shows the line plot when the kerf width is 40 μm and 160 μm. FIG. 10(d) shows the relative magnitude of the grating lobe according to the change in the kerf width in a graph. It can be confirmed that the relative magnitude of the grating lobe is about -15.34 dB when the kerf width is 100 μm, and is -14.74 dB when the kerf width is 120 μm, which is larger than -15 dB. Therefore, it can be seen that the kerf width can be increased to about 100 μm under the above conditions.

[0093] In FIG. 11, the simulation was carried out while fixing the kerf width at 40 μm and varying the element width from 400 μm to 600 μm at intervals of 50 μm, in contrast to FIG.

[0094] This set the range of element widths in which the relative magnitude of the grating lobes was less than about -15 dB. Figure 11(a) shows the beam profile when the element width was 450 μm, and Figure 11(b) shows the beam profile when the element width was 600 μm. Figure 11(c) shows a linear plot when the element widths were 450 μm and 600 μm. Figure 11(d) shows a graph of the relative magnitude of the grating lobes as a function of the element width. It was confirmed that when the element width was 500 μm, the relative magnitude of the grating lobes was about -16.26 dB, and when the element width was 550 μm, it was -14.35 dB, which is larger than -15 dB. It can be seen that under these conditions, the element width can be increased to about 500 to 550 μm.

[0095] The simulations shown in Figures 10 and 11 are the results of a simulation performed at a single frequency (4 MHz) with the element width and kerf width fixed, and the set ranges may be different depending on various changes in conditions. The simulations shown in Figures 10 and 11 show that the size of the grating lobe increases and the total energy decreases as the element and kerf width increases, so the element width, kerf width, and element spacing can be determined to maximize the total energy.

[0096] Another embodiment of an array-type high intensity focused ultrasound probe according to an embodiment of the present disclosure will be described with reference to FIG.

[0097] Detailed explanations of parts that overlap with those previously explained will be omitted, and the explanation will focus on the transducer module.

[0098] The high intensity focused ultrasound probe 100 can include a transducer module, and the transducer module has transducer elements 311, which are portions that generate ultrasound waves, formed at multiple locations on curved transducer portions 310, 320 by kerfs 313.

[0099] The transducer module may include curved transducer units 310, 320, and bent units 315a, 315b that are bent in a direction opposite to the ultrasonic focusing direction to form a plane at least one of both ends in the third axis direction of the transducer units 310, 320. The curved transducer units 310, 320 may have a concave shape in the opposite direction to the first axis direction, which is the ultrasonic focusing direction.

[0100] In one embodiment, ultrasonic waves can be generated by applying an electrical signal to the transducer elements 311 formed in a plurality of locations by separating a portion of the curved transducer portions 310, 320 by the kerf 313. A signal line for applying the electrical signal can be connected to the transducer elements 311 by soldering 117 at the rear surface 310 opposite to the ultrasonic focusing direction. In one embodiment, a separating member as shown in FIG. 4 is disposed in the kerf 313.

[0101] In one embodiment, the ground electrode is formed on at least a part of the front surface 320 of the curved transducer portion in the ultrasonic focusing direction, and may be formed by a sputtering method to reduce ultrasonic attenuation. The ground electrode is formed on at least a part of the front surface 320 of the transducer elements 311 in the ultrasonic focusing direction.

[0102] The multi-part transducer element 311, in which a portion of the transducer section 310, 320 is separated and formed into multiple parts, means a part separated by a kerf 313 formed by extending its length along the third axis direction, and therefore at least one of the two ends of the transducer element 311 in the third axis direction may be connected to each other.

[0103] A method for manufacturing an array-type high-intensity focused ultrasonic probe according to an embodiment of the present disclosure will be described with reference to FIGS.

[0104] First, a method for manufacturing an array type transducer of a high intensity focused ultrasonic probe by a lamination method will be described with reference to Figs.

[0105] When an electrical signal is applied, a plurality of transducer elements 911 are provided, each having a predetermined thickness in a first axis direction in which ultrasonic waves are generated and focused, a predetermined curvature concave in the opposite direction to the first axis direction, and a shape extending in a third axis direction perpendicular to the first axis (S810).

[0106] A plurality of plate-shaped separating members having a second predetermined thickness are provided (S820). The plate-shaped separating members are made of a material having a thermal stability of 300° C. or more, and may be, for example, polyimide.

[0107] A transducer module is manufactured by alternately stacking a plurality of curvature type transducer elements and a plurality of plate-shaped separation members in the first axis direction and in the second axis direction perpendicular to the third axis (S830) so that the plate-shaped separation members are disposed in the kerf 913, and then, signal lines are connected to the rear surfaces (surfaces opposite to the ultrasonic focusing direction) of the plurality of curvature type transducer elements by soldering 117, and a ground electrode can be formed on the front surface. The stacking method has the advantage of being easy to manufacture.

[0108] A method for manufacturing an array type transducer of a high intensity focused ultrasonic probe by a polishing or grinding method will be described with reference to FIGS.

[0109] A plurality of plate-shaped transducer elements 1111 having a predetermined thickness in the second axis direction are provided (S1010), and a plurality of plate-shaped separating members 1113 having different predetermined thicknesses are provided (S1020). Then, a composite is formed by alternately stacking the plurality of transducer elements 1111 and the plurality of separating members 1113 in the second axis direction (S1030), and one or both surfaces perpendicular to the first axis of the composite are ground by a grinder 1123 (S1040). At this time, the curvature of the grinding blade of the grinder 1123 is set so as to have a geometric structure taking into consideration the ultrasonic focusing point. One surface is ground to have a predetermined thickness in the first axis direction, which is the direction in which ultrasonic waves are generated and focused, and to have a predetermined curvature that is concave in the first axis direction, and the other surface in the opposite direction, which is the rear surface (the surface opposite to the ultrasonic focusing direction), can be ground to have a predetermined curvature that is convex in the first axis direction. The grinding method has the advantage of being easy to manufacture and having low sensitivity.

[0110] A method for manufacturing an array type transducer of a high intensity focused ultrasonic probe by a cutting method will be described with reference to Figs.

[0111] A transducer module 1311 is provided (S1210), which includes curved transducer portions 1331, 1333 having at least a portion concave in a first axis direction which is the ultrasonic focusing direction, and bent portions 1310a, 1310b formed by bending both ends of the transducer portions 1331, 1333 in a third axis direction perpendicular to the first axis in the opposite direction to the ultrasonic focusing direction.

[0112] A plurality of kerfs 1313 are formed in the curved transducer portions 1331, 1333 by cutting at least a portion of the curved transducer portions 1331, 1333 with a cutting machine 1340, the kerfs 1313 being extended in a third axis direction and extending in a second axis direction perpendicular to the first axis and the third axis (S1220).

[0113] The curved transducer portions 1331, 1333 are partially separated by the kerf 1313, so that ultrasonic waves can be generated by applying an electrical signal to the transducer elements 1311 formed at multiple locations. A signal line for applying the electrical signal can be connected by soldering 117 to the transducer elements 1311 at the rear surface 1333 opposite to the ultrasonic focusing direction. In one embodiment, a separation member as shown in FIG. 4 is disposed in the kerf 1313. In one embodiment, a ground electrode is formed on the front surface 1331 of the curved transducer portions 1331, 1333 by a sputtering method.

[0114] In the specification of this disclosure (particularly in the claims), the use of the term "said" and similar indicators may refer to both the singular and the plural. Also, when a range is described in this disclosure, it includes the invention to which each individual value within the range is applied (unless otherwise stated), as if each individual value constituting the range was described in the detailed description of the invention.

[0115] The steps making up the methods of the present disclosure are clearly sequenced and, unless otherwise stated, the steps may be performed in any suitable order.

[0116] The order of the steps described above is not necessarily intended to limit the present disclosure. The use of all examples or exemplary terms (such as, for example, etc.) in this disclosure is merely for the purpose of describing the present disclosure in detail, and the scope of the present disclosure is not limited by the examples or exemplary terms, as long as the scope of the claims is not limited. In addition, it is understood that a person skilled in the art can make various modifications, combinations, and changes within the scope of the claims or their equivalents, depending on design conditions and factors.

[0117] Therefore, the idea of ​​the present disclosure should not be limited to the above-described embodiments, and not only the scope of the claims described below, but also all scopes equivalent to or equivalently modified from the scope of the claims belong to the scope of the idea of ​​the present disclosure.

Claims

1. a transducer module including a plurality of transducer elements that receive electrical signals and generate ultrasonic waves; and a circuit for providing drive signals to the plurality of transducer elements based on control signals input from a control system; The plurality of transducer elements having a concave shape in a direction opposite to a first axis direction, which is a focusing direction of ultrasonic waves, are arranged in an array in a second axis direction perpendicular to the first axis across a kerf, At least two different elements of the plurality of transducer elements are configured to emit high intensity focused ultrasound at different times based on the drive signal; a length of the isolation member disposed in the kerf in the first axial direction is greater than a length of the transducer element in the first axial direction; In the first axial direction, a height of a top surface of the transducer element relative to a bottom surface of the transducer element is lower than a height of a top surface of the separating member. High Intensity Focused Ultrasound (HIFU) probe.

2. Each of the plurality of transducer elements is formed with a geometric structure that receives an electrical signal and generates an ultrasonic wave and focuses the ultrasonic wave at a predetermined point in the first axis direction, and each of the plurality of transducer elements has a shape in which a length in a third axis direction perpendicular to the first axis direction and the second axis direction is longer than a length in the second axis direction. The high intensity focused ultrasound (HIFU) probe of claim 1 .

3. The ultrasonic output energy of the transducer module is 0.5 J / cm2 or more at the focal point; The high intensity focused ultrasound (HIFU) probe of claim 1 .

4. The ultrasonic transducer further includes a signal line connected by soldering to a rear surface of each of the transducer elements in a direction opposite to the ultrasonic focusing direction, and configured to apply an electrical signal. The high intensity focused ultrasound (HIFU) probe of claim 1 .

5. The separation member is made of a material having a thermal stability of 300°C or more. The high intensity focused ultrasound (HIFU) probe of claim 1 .

6. The separation member is made of polyimide. The high intensity focused ultrasound (HIFU) probe of claim 5.

7. Each of the plurality of transducer elements is not directly coupled in the second axial direction. The high intensity focused ultrasound (HIFU) probe of claim 1 .

8. The transducer module includes a loading space capable of loading degassed water, A first housing in which the transducer module and the load space are arranged is detachably connected to a second housing in which the circuit is arranged, and the load space is connected to an inlet tube or an outlet tube through which degassed water can be circulated. The high intensity focused ultrasound (HIFU) probe of claim 1 .

9. A probe that emits high intensity focused ultrasound (HIFU); a control system for transmitting control signals to the probe; the probe includes a transducer module including a plurality of transducer elements that generate ultrasonic waves based on the control signal; The plurality of transducer elements having a concave shape in a first axis direction, which is a focusing direction of ultrasonic waves, are arrayed in a second axis direction perpendicular to the first axis across a kerf, The control system controls at least two different elements of the plurality of transducer elements to generate high intensity focused ultrasound at different times; a length of the isolation member disposed in the kerf in the first axial direction is greater than a length of the transducer element in the first axial direction; In the first axial direction, a height of a top surface of the transducer element relative to a bottom surface of the transducer element is lower than a height of a top surface of the separating member. High intensity focused ultrasound (HIFU) device.

10. Each of the plurality of transducer elements is formed with a geometric structure that focuses an ultrasonic wave generated based on the control signal at a predetermined point in the first axis direction, and each of the plurality of transducer elements has a shape in which a length in a third axis direction perpendicular to the first axis direction and the second axis direction is longer than a length in the second axis direction.

10. The high intensity focused ultrasound (HIFU) device of claim 9.

11. The probe further includes a loading space capable of loading degassed water therein, the probe further includes a temperature sensor for measuring a temperature of at least one of the transducer element, the degassed water in the load space, and an object in contact with the probe; The control system controls an operating speed of a circulation motor connected to the loading space for circulating the degassed water or a cooling speed for cooling the degassed water based on the temperature measured by the temperature sensor.

10. The high intensity focused ultrasound (HIFU) device of claim 9.

12. The plurality of transducer elements are exclusively classified and belong to a plurality of different subgroups, the control system transmits the control signals to the probe such that the high intensity focused ultrasound waves emitted by the transducer elements of the subgroups are simultaneously focused at different points.

10. The high intensity focused ultrasound (HIFU) device of claim 9.

13. The plurality of transducer elements are at least partially mutually divided and belong to a plurality of different subgroups; the control system transmits the control signals to the probe such that the high intensity focused ultrasound waves emitted by the transducer elements of the subgroups are focused at different points at different times.

10. The high intensity focused ultrasound (HIFU) device of claim 9.

14. The control system includes: A first mode in which the plurality of transducer elements are exclusively divided into a plurality of different subgroups and controlled; A second mode in which the plurality of transducer elements are mutually divided into a plurality of different subgroups and controlled; the control system transmits the control signals to the probe in the first mode and the second mode such that a distance between points at which the high intensity focused ultrasound is focused in the first mode is greater than a distance between points at which the high intensity focused ultrasound is focused in the second mode.

10. The high intensity focused ultrasound (HIFU) device of claim 9.

15. The probe further includes a degassed water storage space therein, The control system includes: A first mode in which the plurality of transducer elements are exclusively divided into a plurality of different subgroups and controlled; A second mode in which the plurality of transducer elements are mutually divided into a plurality of different subgroups and controlled; The control system controls an operating speed of a circulation motor connected to the loading space for circulating the degassed water or a cooling speed for cooling the degassed water to be different from each other in the first mode and the second mode.

10. The high intensity focused ultrasound (HIFU) device of claim 9.

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