Ultrasound probe and apparatus for skin treatment based on high intensity focused ultrasound

Abstract

A high intensity focused ultrasound probe according to an embodiment of the present application includes a transducer module including a plurality of transducer elements that generate ultrasound by receiving an electric signal, and a circuit that provides a driving signal to the plurality of transducer elements based on a control signal input from a control system, wherein the plurality of transducer elements having a concave shape in a first axial direction that is a focusing direction of ultrasound are arranged in an array in a second axial direction perpendicular to the first axis, and a cut is interposed between the plurality of transducer elements, and 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 driving signal.

Description

Technical Field

[0001] This invention relates to a high intensity focused ultrasound (HIFU) probe and an ultrasound device for skin treatment using the probe, and more specifically, to a high intensity focused ultrasound probe and ultrasound device that can focus high intensity ultrasound for skin treatment at multiple points and multiple depths based on the geometry and arrangement of an array of transducer elements without causing mechanical movement of the transducer elements. Background Technology

[0002] In recent years, the application of high-intensity focused ultrasound (HIFU) in skin treatments such as skin lifting and tightening has attracted much attention.

[0003] High-intensity focused ultrasound (HIFU) is a technique that treats lesions by focusing high-intensity sound energy onto a localized area of ​​the body to raise the temperature at the focal point and induce thermal changes. When HIFU is applied to the skin, it works by creating a wound through thermal changes at the focused area, thereby promoting the regeneration of degenerated tissue, removing wrinkles, and restoring skin elasticity.

[0004] Traditional high-intensity focused ultrasound (HIFU) devices are transducers that generate ultrasound and use a method that utilizes a circular single-element ultrasound transducer to transmit strong ultrasound energy to the treatment site. Because multiple focal points should be formed to transmit ultrasound energy for skin treatment to a wide range of areas, traditional single-element ultrasound transducers employ a method of mechanically moving a single-element ultrasound transducer to focus ultrasound on individual body parts.

[0005] Therefore, traditional high-intensity focused ultrasound (HIFU) uses a circular, single-element ultrasonic transducer. This presents a problem when applying treatment depths (focal points), as the geometry of the cylinder and transducer, designed to have different ultrasonic frequencies, must be changed each time. To address this, existing technologies use levers, motors, or scanners mounted on the tip of a handheld device to allow users to manually, semi-automatically, or fully automatically select and adjust the depth of the target area, thus enabling focused ultrasound. However, the problem with these existing technologies is that mechanical movement is still required, as the transducer still needs to be moved using a motor. This results in prolonged treatment time, and the need to mechanically change the position of the ultrasonic transducer within the handheld device to alter the treatment depth limits the improvement in treatment effectiveness.

[0006] On the other hand, in the case of diagnostic ultrasound equipment that produces low ultrasound energy, such as Figure 19As shown, an ultrasonic transducer in the form of an array element is used. That is, by electrically controlling the transmission time of multiple ultrasonic transducers in the lateral direction (x-direction), ultrasound is focused at the desired location, and the reflected ultrasound is received and imaged. In this case, to improve diagnostic resolution, focusing techniques can be used in the elevation direction (y-direction) to transmit high-energy ultrasound to the focal point. As a method, there are... Figure 19 The method of using natural focusing shown in (a) and as... Figure 19 (b) shows the method of focusing using an acoustic lens.

[0007] Even in the case of conventional diagnostic ultrasound equipment, geometric focusing may not be used in array element ultrasound transducers due to difficulties in the manufacturing process. As mentioned above, high-intensity focused ultrasound equipment used as therapeutic ultrasound equipment uses a single ultrasound transducer element.

[0008] Despite these issues, it is difficult to achieve high-intensity focused ultrasound (HIFU) devices using array-type ultrasound transducer elements. Natural focusing is unsuitable due to energy dispersion; therefore, acoustic lenticular focusing or geometric focusing is suitable for increasing the temperature of lesions. However, in the case of acoustic lenticular focusing, it is difficult to deliver high-intensity energy to the treatment site due to ultrasound attenuation caused by the material used as the lens. Furthermore, there is a problem with geometric focusing, which presents difficulties in forming the geometry of array-type ultrasound transducers (at least several dozen ultrasound transducers with at least one focusable geometry should be configured to control the electrical propagation time of the array-type ultrasound transducer). Summary of the Invention

[0009] [Technical Issues]

[0010] The present invention seeks to provide a high-intensity focused ultrasound probe and ultrasound device, wherein multiple transducers capable of geometric focusing are configured in an array based on a geometric structure.

[0011] The present invention seeks to provide a high-intensity focused ultrasound probe and ultrasound device, wherein multiple transducers can be easily manufactured at low cost, geometrically focused, and configured in an array.

[0012] The present invention seeks to provide a high-intensity focused ultrasound probe and ultrasound device, wherein multiple transducers capable of delivering high energy to the treatment site while reducing grating lobes are arranged in an array.

[0013] The present invention seeks to provide a high-intensity focused ultrasound probe and ultrasound device, wherein multiple transducers arranged in an array can shorten treatment time without mechanical movement by electrically controlling the ultrasound transmission time of each ultrasound transducer element.

[0014] The present invention seeks to provide an ultrasound device in which therapeutic ultrasound is focused at multiple points or multiple depths based on multiple transducers configured in an array.

[0015] The present invention seeks to provide an ultrasound device that prevents lacerations in patients caused by ultrasound generated from multiple transducers arranged in an array.

[0016] [Technical Solution]

[0017] One embodiment of the present invention provides a high-intensity focused ultrasound probe and an ultrasound device.

[0018] According to one embodiment of the present invention, a high-intensity focused ultrasound (HIFU) probe includes: a transducer module comprising a plurality of transducer elements that generate ultrasound by receiving electrical signals; and a circuit that provides a drive signal to the plurality of transducer elements based on a control signal received from a control system, wherein the plurality of transducer elements, having concave shapes in a first axial direction which is the ultrasound focusing direction, are arranged in an array in a second axial direction perpendicular to the first axis, and a cut is located between the plurality of transducer elements, and 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.

[0019] According to another embodiment of the present invention, a high-intensity focused ultrasound (HIFU) device includes: a probe that emits high-intensity focused ultrasound (HIFU); and a control system that sends a control signal to the probe, wherein the probe includes a transducer module, the transducer module including a plurality of transducer elements for generating ultrasound based on the control signal, the plurality of transducer elements having a concave shape in a first axial direction which is the ultrasound focusing direction are arranged in an array in a second axial direction perpendicular to the first axis, and a cut is located between the plurality of transducer elements, and the control system controls at least two different elements among the plurality of transducer elements to generate the high-intensity focused ultrasound at different times.

[0020] [Beneficial Effects]

[0021] According to one embodiment of the present invention, a high-intensity focused ultrasound probe and ultrasound device can geometrically focus ultrasound generated based on the geometry of multiple high-intensity focused ultrasound transducer elements.

[0022] According to one embodiment of the present invention, a high-intensity focused ultrasound probe and ultrasound device, wherein multiple high-intensity focused ultrasound transducer elements electrically control the transmission time, thereby shortening the treatment time and improving the skin treatment effect in a cost-effective and easy manner.

[0023] According to one embodiment of the present invention, a high-intensity focused ultrasound probe and ultrasound device can prevent lacerations in patients by differentiating cooling based on the operating modes of a plurality of high-intensity focused ultrasound transducer elements. Attached Figure Description

[0024] Figure 1 This is a diagram illustrating the implementation environment of the array-type high-intensity focused ultrasound probe and ultrasound device according to an embodiment of the present invention.

[0025] Figure 2 This is a block diagram schematically illustrating the configuration of an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0026] Figure 3 These are perspective views and plan views illustrating the geometry of the transducer elements in an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0027] Figure 4 These are perspective and side views used to describe a portion of the transducer module in an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0028] Figure 5 This is a block diagram schematically illustrating the configuration of an array-type high-intensity focused ultrasound device according to an embodiment of the present invention.

[0029] Figure 6 This is a block diagram schematically illustrating the configuration of the transducer module of an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0030] Figure 7 This is a diagram describing the control signals sent to an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0031] Figure 8 and Figure 9 This is a diagram illustrating the operating mode of an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0032] Figure 10 These are experimental results regarding the incision spacing of an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0033] Figure 11 These are experimental results regarding the device width of the array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0034] Figure 12 This is a perspective view showing a portion of the transducer module in an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0035] Figure 13This is a flowchart describing a method for manufacturing an array-type transducer of an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0036] Figure 14 This is a diagram illustrating a method for manufacturing an array-type transducer for an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0037] Figure 15 This is a flowchart describing a method for manufacturing an array-type transducer of an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0038] Figure 16 This is a diagram illustrating a method for manufacturing an array-type transducer for an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0039] Figure 17 This is a flowchart describing a method for manufacturing an array-type transducer of an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0040] Figure 18 This is a diagram illustrating a method for manufacturing an array-type transducer for an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention.

[0041] Figure 19 This is a diagram illustrating the ultrasound focusing method of ultrasound probes used in conventional diagnostic ultrasound imaging equipment. Detailed Implementation

[0042] In the following description, embodiments of the invention will be described in detail with reference to the accompanying drawings. Regardless of the figure numbering, identical or similar components are given the same reference numerals and will not be described repeatedly. The component suffixes “module” and / or “unit” used in the following description are given or used interchangeably for ease of writing only, and therefore their meanings or functions are not inherently distinguishable. Furthermore, detailed descriptions will be omitted when it is determined that a detailed description of known technology related to the invention may obscure the essential points of the invention. Moreover, it should be understood that the accompanying drawings are provided merely to facilitate an understanding of exemplary embodiments of the invention, but the spirit of the invention is not limited to the drawings, but includes all modifications, equivalents, and substitutions contained within the spirit and scope of the invention.

[0043] Terms such as first, second, etc., can be used to describe various components, but components are not limited to these terms. These terms are only used to distinguish one component from another.

[0044] Furthermore, it should be understood in this specification that when a component is referred to as "connected to" or "attached to" another component, it can be directly connected to or attached to the other component, or connected to the other component with another component in between. On the other hand, it should be understood that when an element is referred to as "directly connected to" or "directly attached to" another element, it can be connected to or attached to the other element without any other element in between.

[0045] An ultrasound device according to an embodiment of the present invention includes an array-type high-intensity focused ultrasound probe 100 and a control system 200. (Refer to...) Figure 1 Describe the implementation environment of the array-type high-intensity focused ultrasound probe 100 and the control system 200.

[0046] refer to Figure 1 In the ultrasound device according to an embodiment of the present invention, the control system 200 controls the high-intensity focused ultrasound probe 100 to focus the ultrasound generated by the high-intensity focused ultrasound probe 100 onto a specific point inside the body, thereby transmitting acoustic energy to the patient's internal tissues (dermis, superficial musculoaponeurotic system (SMAS) layer, etc.). The control system 200 can change the focal point by electrically controlling the transmission time of multiple array-type transducer elements included in the transducer module of the high-intensity focused ultrasound probe 100. The high-intensity focused ultrasound probe 100 can transmit high-intensity focused ultrasound energy into the body for non-invasive facelift surgery, skin tightening surgery, non-invasive subcutaneous fat reduction or removal surgery, etc.

[0047] In one embodiment, the control system 200 controls a plurality of array transducer elements of the high-intensity focused ultrasound probe 100 to focus ultrasound energy at a plurality of locations at the same depth, or controls a plurality of array transducer elements in the high-intensity focused ultrasound probe 100 to focus ultrasound energy at different depths.

[0048] The control system 200 may include a control unit that includes a therapeutic beamformer for calculating the ultrasound transmission time delay of each transducer element of the high-intensity focused ultrasound probe 100 to change the focal point.

[0049] In one embodiment, the control system 200 may include an input unit or an output unit for user input.

[0050] The input unit may include a user interface (UI) comprising a microphone and a touch interface for receiving information from the user. The UI may include mechanical and electronic interfaces implemented in the device, as well as a mouse and keyboard, and the method and form are not particularly limited, as long as user commands can be input. The electronic interface includes a display capable of touch input. The output unit is used to send information to the user by expressing the output of the control system 200 to an external source, and may include a display, LEDs, speakers, etc., for expressing visual, auditory, or tactile output. When the high-intensity focused ultrasound probe 100 includes an imaging transducer element module, the display can show ultrasound images of internal body tissues.

[0051] The control system 200 may include peripheral device interfaces for transmitting data to various types of connected external devices, and includes memory card ports, external device input / output (I / O) ports, etc.

[0052] The control system 200 can control the high-intensity focused ultrasound probe 100 by connecting it via cable or wirelessly.

[0053] In one embodiment, the high-intensity focused ultrasound probe 100 may include a handheld component (or rod) 100b and a cylindrical portion 100a. In this case, the ultrasound transducer module may be implemented in the cylindrical portion 100a. In another embodiment, the high-intensity focused ultrasound probe 100 may be implemented by integrating the handheld component 100b and the cylindrical portion 100a.

[0054] When the handheld part 100b and the cylindrical part 100a are implemented separately, electrical connection terminals and guide members for physical connection can be implemented in the handheld part 100b and the cylindrical part 100a, so that the cylindrical part 100a can be connected to the handheld part 100b. In one embodiment, the guide member can be implemented in the form of a protruding rod, a protrusion, etc., in the direction in which the cylindrical part 100a is connected to the front end portion of the handheld part 100b.

[0055] Reference Figure 2 The configuration of a high-intensity focused ultrasound probe 100 according to an embodiment of the present invention is described.

[0056] The high-intensity focused ultrasound probe 100 may include a transducer module 110 that generates ultrasound by receiving electrical signals and a circuit 120 that inputs electrical signals to the transducer module 110.

[0057] In one embodiment, when the high-intensity focused ultrasound probe 100 consists of an array of a small number of transducer elements of the transducer module 110, the high-intensity focused ultrasound probe 100 may include a stepper motor capable of moving the transducer module 110 one-dimensionally by moving the handpiece 100b in a front-back direction to focus ultrasound on a plurality of focal points (i.e., such that the ultrasound focal points are formed at regular intervals along the same straight line), the front-back direction being the axial direction of the handpiece 100b.

[0058] In one embodiment, the high-intensity focused ultrasound probe 100 may include a sensor 130 capable of determining the position of the transducer module 110. The sensor 130 may be an optical sensor, a ball sensor, or the like.

[0059] In another implementation, the encoder is connected to the motor used to move the transducer module 110, without using the sensor 130 to calculate the displacement and determine the current position of the transducer module 110.

[0060] In one embodiment, the sensor 130 may be used differently for various purposes to detect the movement of the transducer module 110 and the connection between the handpiece 100b and the cylinder 100a (in this case, it may be a pressure sensor or switch that detects the electrical connection), the angle of the handpiece 100a relative to the ground, and the user's grip on the handpiece 100b.

[0061] In one embodiment, sensor 130 may be a temperature sensor that measures at least one of the following: the temperature of the transducer element within transducer module 110, the temperature of the degassed water in loading space 112 within transducer module 110, and the temperature of the patient’s skin in contact with high-intensity focused ultrasound probe 100.

[0062] As another implementation, when an array with multiple transducer elements is configured, the control system 200 can control at least some or all of the multiple transducer units based on a delay signal determined by the treatment beamformer 210, such that ultrasound is simultaneously or sequentially focused at multiple ultrasound focusing positions. By changing the delay signal used to control the controlled transducer elements, the control system 200 can focus ultrasound at multiple focal points in the axial-forward direction of the handheld device 100b, or focus ultrasound at different skin depths of the patient. In this case, movement of the transducer module 110 is not required. Reference will be made below. Figures 7 to 9 It is described in detail.

[0063] As another implementation, when an array with multiple transducer elements is configured, multiple transducer elements (transducer modules) can be rotated at a predetermined angle around an axis in the longitudinal direction of the handheld device by using a motor. In this case, a wider area can be treated simultaneously.

[0064] As another example, in a one-dimensional arrangement of transducer elements, the axis in the direction of connection of the transducer elements can be orthogonal to the axis in the longitudinal direction of the handheld part 100b.

[0065] Therefore, in this configuration, the transducer module can be moved such that multiple array-type transducer elements move along an axis in the longitudinal direction of the handheld component 100b (i.e., along a reference axis). Figure 3 (Move in the third axial direction). In this case, treatment time can be shortened by simultaneously transmitting ultrasound energy to a wider area.

[0066] Reference Figure 3 The array-type transducer elements included in the transducer module 110 of the array-type high-intensity focused ultrasound probe 100 according to an embodiment of the present invention are described.

[0067] In this specification, the axis oriented from the point where ultrasound is generated and focused from multiple transducer elements is described as the first axis (height direction, also known as the axis in the axial direction), the direction in which the multiple transducer elements are arranged is described as the second axis (lateral direction, also known as the transverse axis), and the axis perpendicular to the first and second axes and being the longitudinal direction in which each transducer element extends is described as the third axis (elevation direction axis, also known as the elevation direction axis). The first, second, and third axes are orthogonal to each other. The expression "along an axis" includes proceeding in a direction similar to the axis while maintaining an angle parallel or non-parallel to the axis.

[0068] According to an embodiment of the present invention, the transducer element of the array-type high-intensity focused ultrasound transducer module 110 may be a plurality of transducer elements 111 arranged in a one-dimensional array in the second axial direction, wherein the cutout 113 is located between the plurality of transducer elements 111.

[0069] The notch refers to the spacing between transducer elements and is called the device spacing, which includes the notch and the width of transducer element 111 in the second axial direction. The size of the grating lobe and the amount of energy transmitted into the body can vary depending on the device spacing and the size of the notch. Therefore, in a high-intensity focused ultrasound transducer in the form of an array of elements, the optimal spacing of the ultrasound elements should be pre-selected to maximize the size of the main lobe and minimize the size of the side lobes.

[0070] Each transducer element 111 may have a concave geometry in a direction opposite to the first axial direction, and this geometry relates to setting the focal point of the ultrasound generated from the transducer element 111. That is, based on the plane formed by the second and third axial directions, the inner surface of each transducer element 111 may have a concave shape in a direction opposite to the first axial direction. The ultrasound generated by receiving electrical signals from each transducer element 111 can travel in the first axial direction and be focused at a specific depth point inside the body to transmit energy.

[0071] Each transducer element 111 can extend in the third axial direction. Therefore, the length of each transducer element 111 in the third axial direction can be longer than its width in the second axial direction.

[0072] The ultrasound generated by each transducer element 111 that receives the electrical signal travels in the first axial direction and is focused at a specific depth point inside the body. Therefore, the energy transmitted at the focal point (i.e., the ultrasound output energy of the transducer module) can be 0.5 J / cm². 2 Or even greater. Alternatively, the output energy per area of ​​transducer element 111 can be 500 W / cm². 2 Or even higher. Therefore, a thermal transformation can be generated at a focal point inside the body by transferring energy, so that the temperature of the focal point inside the body is equal to or higher than a specific temperature.

[0073] Reference Figure 4 The array-type transducer elements of the array-type high-intensity focused ultrasound transducer module 110 according to an embodiment of the present invention are described.

[0074] An array-type high-intensity focused ultrasound transducer module 110 according to an embodiment of the present invention may include a separation member 115 disposed in a cut 113 between high-intensity focused ultrasound transducer elements 111. The separation member 115 separates the plurality of transducer elements and prevents the plurality of transducer elements from contacting each other.

[0075] In one embodiment, the high-intensity focused ultrasound transducer elements 111 are not directly connected to each other and are arranged in an array, but can be assembled in a fixed form by means of separation members 115 while they are separated from each other.

[0076] In one embodiment, the separation member 115 may be made of a material with thermal stability of 300°C or higher, and may be made of, for example, polyimide (PI). Therefore, when the signal line 119 is connected to the transducer element 111 by means of soldering 117, in order to prevent thermal deformation of the separation member 115, the separation member 115 may be made of a material whose physical properties hardly change even when exposed to high temperatures for a long time.

[0077] In the array-type high-intensity focused ultrasound transducer module according to an embodiment of the present invention, signal lines for applying electrical signals to the rear surface in a direction opposite to each ultrasound focusing direction can be connected by soldering 117. Since the high-intensity focused ultrasound transducer elements apply signals with high energy sufficient to cause a thermal transition to the desired lesion, high heat can be generated instantaneously, and in order to connect the signal lines to the transducer elements 11 while preventing the signal lines from separating due to high heat, a soldering method with a melting point of about 300°C or higher can be used.

[0078] In one embodiment, the length of the separating 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, when the signal line is connected to the transducer element 111 by the welding method 117, the separating member 115 can act as a dam to prevent molten lead from connecting to other elements.

[0079] Reference Figure 5 The configuration of the control system 200 of the ultrasonic device according to an embodiment of the present invention is described.

[0080] The control system 200 may include a therapeutic beamformer 210 that generates a delayed signal, such that at least some of the plurality of array-type transducer elements of the ultrasound probe 100 receive electrical control signals at different times or generate ultrasound at different times.

[0081] In one embodiment, the delayed signals generated by the treatment beamformer 210 can be transmitted to the probe 100 via a treatment circuit 220 including a pulse generator, a digital-to-analog converter (DAC), and an amplifier. The treatment circuit 220 may include digital device units and analog device units. Multiple delayed signals can be sent to the pulse generator and converted into high-voltage signals (HV signals). The control system 200 can send drive signals (HV signals) generated based on the delayed signals to the probe 100, the delayed signal calculation signals being input to the timing of each transducer element to control the position and depth of the focused ultrasound for treatment.

[0082] In one embodiment, the processing circuit 220 may include a multiplexer and, through multiplexing, send drive signals to different transducer elements 111 of the probe 100 at different times according to the delay signal.

[0083] In one embodiment, the control system 200 can generate a mode B ultrasound image based on the received ultrasound, wherein the generated ultrasound (for treatment or separate ultrasound for imaging) is reflected from inside the body. In this case, the probe 100 may include analog front-end circuitry for processing the electrical signal (referred to as the received ultrasound signal) obtained by converting the ultrasound signal. The analog front-end circuitry may include a low-noise amplifier (LNA) for attenuation correction and a depth gain compensation (TGC). The ultrasound received by the transducer element 111 in the probe 100 is converted into an electrical signal and sent to the imaging circuit 250, which may include an analog-to-digital converter (ADC), a first input first output (FIFO) memory, etc. The digitally processed received ultrasound signal may be Rx-focused based on the delay signal of the treatment beamformer 2110 in the imaging beamformer 240, scanned and converted in the image processor 260, and displayed on the display 270.

[0084] In one embodiment, the control system 200 may include a controller 230 that controls whether to operate in an ultrasound imaging mode (mode B) for imaging received ultrasound signals or in a treatment mode for performing high-intensity focused ultrasound therapy on a subject.

[0085] In one embodiment, the control system 200 or a separate external device may include a motor for circulating degassed water to the loading space 112 within the transducer module 110, and a cooling device for cooling the degassed water discharged from the loading space 112. The controller 230 may control the circulation rate of the degassed water introduced into or discharged from the loading space 112 based at least on any one of the following: the temperature of the transducer elements inside the transducer module 110 as measured by the temperature sensor 130; the temperature of the degassed water in the loading 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. Therefore, patient lacerations due to high-intensity focused ultrasound treatment can be prevented.

[0086] Reference Figure 6 The conceptual configuration of the transducer module 110 of the array-type high-intensity focused ultrasound probe 100 according to an embodiment of the present invention is described. For ease of description, Figure 6 The state in which the transducer module 110 is implemented as a cylindrical section 100a is shown.

[0087] In one embodiment, the transducer module 110 can be implemented as a separate housing so that it can be detached from the handheld device 100b. In another embodiment, the transducer module 110 can be implemented in the same housing as the handheld device 100b. (See reference...) Figure 6The described implementation will be described as an implementation in which the transducer module 110 is implemented as a housing separate from the handheld component 100b.

[0088] The transducer module 110 includes an array of transducer elements 111, wherein a plurality of transducer elements 111 are arranged having cutouts therebetween. In one embodiment, a separation member 115 for preventing contact between the transducer elements 111 may be included in the cutouts between the transducer elements 111.

[0089] In one embodiment, in transducer module 110, the two axes, namely the longitudinal axis of handheld component 100b and the arrangement direction axis of the plurality of transducer elements, are parallel to each other, but in another embodiment they may intersect each other.

[0090] In one embodiment, the transducer module 110 may include a loading space 112, which contains degassed water or other materials with high acoustic transparency, and the loading space 112 may be filled with degassed water. In another embodiment, the loading space 112 may remain empty without being filled with separate material.

[0091] In one embodiment, the transducer module 110 may include a circulation channel 116 that allows degassed water to circulate within the loading space 112, and the circulation channel 116 may include an inlet 116a and an outlet 116b. Degassed water cooled from outside the transducer module 110 is introduced into the loading space 112 inside the transducer module 110 through the inlet 116a, and degassed water whose temperature has increased due to the heat generated by the transducer element 111 is discharged from the loading space 112 to the outside through the outlet 116b.

[0092] In one embodiment, when the transducer module 110 is implemented as a separate housing detachable from the handheld device 100b, the transducer module 110 may include an electrical interface 114 that can be electrically connected to the control system 200 via the handheld device 100b. The electrical interface 114 may include a PCB serving as an electro-mechanical connector.

[0093] In one embodiment, the housing of the transducer module 110 may have an open window on an axis in the direction in which the ultrasound generated from the transducer element 111 is radiated, through which the ultrasound can pass, and when the loading space 112 is filled with a material with high acoustic transparency (e.g., degassed water), a covering member 118 may be formed to prevent the material from escaping through the window.

[0094] Ultrasound generated from multiple transducer elements 111 with different delays is focused on a specific point 1010 in one axial direction.

[0095] Reference Figure 7 A control method based on a delay signal of a plurality of array-type ultrasonic transducer elements 111 is described according to another embodiment of the present invention. Figure 7 This description assumes that the delay element 211 is connected to each transducer element 111 individually. However, in another embodiment, the analog front-end section 210b may include a high-voltage multiplexer (HV multiplexer). In this case, the delay element 211 is not connected to each transducer element 111, and the high-voltage multiplexer can be used to select the element to be activated (to generate ultrasound) from among the multiple transducer elements 111. Furthermore, the analog front-end section 210b may be implemented within the control system 200 or within the handheld device 100b.

[0096] refer to Figure 7 The system can send a delayed signal to the analog front-end section 210b, and perform analog beamforming in the analog front-end section 210b to control at least two different elements of a plurality of transducer elements 111, thereby generating high-intensity focused ultrasound at different times based on the drive signal of the control system 200. In one embodiment, the analog front-end section 210b may include a signal generator 213, a delay element 211, a high-voltage amplifier, a filter (DAC filter, etc.), and an impedance matching transformer. RF pulses generated by the signal generator 213 are transmitted to the delay element 211, and the delay element 211 can supply drive signals to the plurality of transducer elements 111 according to a delay value referenced to a delay table stored in a separate memory.

[0097] Reference Figure 8 and Figure 9 The different modes of generating high-intensity focused ultrasound by the array-type transducer element 111 according to an embodiment of the present invention are described.

[0098] refer to Figure 8 Multiple transducer elements 111 can be exclusively divided and belong to multiple different subgroups 1021, 1022, 1023 and 1024. Exclusive division means that any transducer element belongs to only one subgroup.

[0099] In one embodiment, each subgroup 1021, 1022, 1023, and 1024 of the plurality of transducer elements 111 has focal points 1011, 1012, 1013, and 1014, which have the same depth but are located at different positions for each subgroup 1021, 1022, 1023, and 1024. Therefore, the delays transmitted to the subgroups 1021, 1022, 1023, and 1024 can be equal to each other.

[0100] In one embodiment, the control system 200 can control each subgroup 1021, 1022, 1023, and 1024 of the plurality of transducer elements 111 to simultaneously focus high-intensity focused ultrasound onto a plurality of focal points 1011, 1012, 1013, and 1014. Therefore, high-intensity focused ultrasound treatment can be performed simultaneously at multiple locations within the patient's tissue, thereby shortening the patient's treatment time.

[0101] refer to Figure 9 Multiple transducer elements 111 can be divided into each other and belong to multiple different subgroups 1041 and 1042. Mutual division means that any transducer element does not belong to any subgroup 1041, but belongs to another subgroup 1042.

[0102] In one embodiment, each subgroup 1041 and 1042 of the plurality of transducer elements 111 may have focal points 1031 and 1032, which have the same depth but are located at different positions for each subgroup 1041 and 1042. Therefore, the form of the delay transmitted to each subgroup 1041 and 1042 may be equal to each other.

[0103] In one embodiment, the control system 200 can control each subgroup 1041 and 1042 of the plurality of transducer elements 111 to focus high-intensity focused ultrasound at a plurality of focal points 1031 and 1032 at different times. Therefore, high-intensity focused ultrasound therapy can be performed on multiple locations within the patient's tissue without mechanically moving the transducer elements, thereby shortening the patient's treatment time.

[0104] In one embodiment, the control system 200 can control a plurality of transducer elements 111 to operate by being divided into a first mode and a second mode. In the first mode, the plurality of transducer elements 111 are exclusively divided into a plurality of different subgroups and controlled. In the second mode, the plurality of transducer elements are mutually divided into a plurality of different subgroups and controlled. The control system 200 can control the plurality of transducer elements 111 in the corresponding mode according to the operator's selection.

[0105] In one embodiment, the control system 200 can control a plurality of transducer elements 111 such that the spacing between points of high-intensity focused ultrasound focused in a first mode is wider than the spacing between points of high-intensity focused ultrasound focused in a second mode.

[0106] Therefore, high-intensity focused ultrasound therapy can be performed in different ways depending on the patient's condition.

[0107] In one embodiment, the control system 200 can control a plurality of transducer elements 111 such that the energy transmitted to the focal point (i.e., the ultrasonic output energy of the transducer module) differs in a first mode and a second mode. For example, the plurality of transducer elements 111 can be controlled such that in the second mode, where the spacing between the points focused by high-intensity focused ultrasound is denser, the energy transmitted to the focal point is lower.

[0108] In one embodiment, the control system 200 can control the operating speed of the circulation motor that circulates the deaerated water, such that the circulation speed of the deaerated water in the loading space 112 inside the transducer module 110 is different in the first mode and the second mode, or the control system 200 can control the cooling rate used to cool the deaerated water differently.

[0109] Reference Figure 10 The cut width (size) and the width of the transducer element of the array-type high-intensity focused ultrasound transducer module according to an embodiment of the present invention are described.

[0110] Figure 10 Simulation results for sidelobe size based on slit width are shown. In the simulation, the transducer element width was fixed at approximately 460 μm, and simulations were performed at 20 μm intervals, with the slit width ranging from 20 μm to 160 μm. In this case, the sidelobe size was set within the range of the slit width and was approximately -15 dB less than the maximum energy.

[0111] Figure 10 (a) shows the beam profile when the slit width is 40 μm, while Figure 10 (b) shows the beam profile with a cut width of 160 μm. Figure 10 (c) shows line graphs when the cut width is 40 μm and 160 μm. Figure 10 Figure (d) shows the relative size of the side lobe as a function of the incision width. When the incision width is 100 μm, the relative size of the side lobe becomes approximately -15.34 dB; when the incision width is 120 μm, the relative size becomes approximately -14.74 dB, which is greater than -15 dB. Therefore, it can be seen that under the corresponding conditions, the incision width can be increased to approximately 100 μm.

[0112] and Figure 10 On the contrary, Figure 11 In the simulation, the kerf width was fixed at 40 μm, and the device width was changed from 400 μm to 600 μm at 50 μm intervals.

[0113] In this way, the range of device width is set so that the relative size of the side lobes is less than about -15dB. Figure 11(a) shows the beam profile when the device width is 450 μm. Figure 11 (b) shows the beam profile when the device width is 600 μm. Figure 11 (c) shows line graphs when the device width is 450 μm and 600 μm. Figure 11 (d) is a graph showing the relative size of the side lobes as the device width changes. When the device width is 500 μm, the relative size of the side lobes is approximately -16.26 dB. When the device width is 550 μm, the relative size of the side lobes is -14.35 dB, which is greater than -15 dB. Therefore, it can be seen that under the corresponding conditions, the device width can be increased to 500 μm to 550 μm.

[0114] Figure 10 and Figure 11 The simulations performed are based on simulations with fixed device width and notch width and a single frequency of 4MHz, and the settings can be varied according to various conditions. Figure 10 and Figure 11 In this approach, since the size of the side lobes increases with both the device width and the notch width, the total energy can be reduced. Therefore, the device width, notch width, and device spacing can be determined to maximize the total energy.

[0115] Reference Figure 12 Another embodiment of the array-type high-intensity focused ultrasound probe according to an embodiment of the present invention is described.

[0116] Detailed descriptions of components that overlap with the above components will be omitted, and the description will focus on the transducer module.

[0117] The high-intensity focused ultrasound probe 100 may include a transducer module. In the transducer module, the transducer element 311, which is a component that generates ultrasound, may be formed as multiple portions of the curved transducer units 310 and 320 due to the cut 313.

[0118] The transducer module may include curved transducer portions 310 and 320 and bent portions 315a and 315b, the bent portions 315a and 315b being bent in a third axial direction at at least one of the ends of the transducer portions 310 and 320 in a direction opposite to the ultrasonic focusing direction to form a flat surface. The curved transducer units 310 and 320 may have a concave shape in a direction opposite to the first axial direction which is the ultrasonic focusing direction.

[0119] In one embodiment, a portion of the bent transducer portions 310 and 320 can be separated by a cut 313 to apply an electrical signal to a plurality of transducer elements 311 formed in multiple portions to generate ultrasound, and the signal line for applying the electrical signal can be connected to the transducer elements 311 by a weld 117 at a rear surface 310 opposite to the direction of ultrasound focusing. In one embodiment, as Figure 4 The separation component shown can be arranged on the cutout 313.

[0120] In one embodiment, a ground electrode may be formed in at least a portion of the front surface 320 in the ultrasonic focusing direction within a curved transducer unit, and may be formed by a sputtering method to reduce ultrasonic attenuation. The ground electrode may be formed in at least a portion of the front surface 320 of a plurality of transducer elements 311 in the ultrasonic focusing direction.

[0121] The transducer element 311 in the plurality of portions formed by separating a portion of transducer portions 310 and 320 refers to the portion separated by a cut 313 formed by extending along the third axial direction, so that at least one end of the transducer element 311 at both ends in the third axial direction can be connected to each other.

[0122] Reference Figures 13 to 18 A method for manufacturing an array-type high-intensity focused ultrasound probe according to an embodiment of the present invention is described.

[0123] First, refer to Figure 13 and Figure 14 This paper describes a method for fabricating an array-type transducer for high-intensity focused ultrasound probes using a stacking method.

[0124] When an electrical signal is applied, a plurality of transducer elements 911 are provided having a predetermined thickness in a first axial direction and a predetermined concave curvature in a direction opposite to the first axial direction (which is the direction of ultrasonic generation and focusing), and the plurality of transducer elements 911 have a shape extending in a third axial direction perpendicular to the first axis (S810).

[0125] A plurality of plate-shaped separation members (S820) having a predetermined second thickness are provided, and the plate-shaped separation members may be made of a material having thermal stability of 300°C or higher, and may be, for example, polyimide.

[0126] The transducer module is manufactured such that multiple curved transducer elements and multiple plate-shaped separation components are alternately stacked in a second axial direction orthogonal to the first and third axial directions (S830) to arrange the plate-shaped separation components on the cutout 913. Signal lines can then be connected to the rear surfaces (surfaces opposite to the ultrasonic focusing direction) of the multiple curved transducer elements using welding 117, and a ground electrode can be formed on the front surface. This stacking method offers the excellent advantage of ease of manufacture.

[0127] Reference Figure 15 and Figure 16 This paper describes a method for manufacturing an array-type transducer for a high-strength focused ultrasound probe by polishing or grinding.

[0128] A plurality of plate-shaped transducer elements 1111 having a predetermined thickness in the second axial direction are provided (S1010), and a plurality of plate-shaped separation members 1113 having different predetermined thicknesses are provided (S1020). The plurality of transducer elements 1111 and separation members 1113 are then alternately stacked in the second axial direction to form a composite (S1030), and one or both sides of the composite perpendicular to the first axis are ground (S1040) by a grinding machine 1123 (1121). In this case, the curvature of the grinding blade of the grinding machine 1123 is set to have a geometry that takes into account the ultrasonic focusing point. One surface is ground to have a predetermined thickness that is concave in the first axial direction while also having a predetermined thickness in the first axial direction, which is the direction of ultrasonic generation and focusing, and the rear surface (the surface on the opposite side of the ultrasonic focusing direction) can be ground to have a predetermined convex curvature in the first axial direction. This grinding method has excellent ease of manufacture and low sensitivity.

[0129] Reference Figure 17 and Figure 18 This paper describes a method for fabricating an array-type transducer for a high-intensity focused ultrasound probe using a cutting method.

[0130] A transducer module 1300 is provided, which includes curved transducer units 1331 and 1333 having a partially concave shape in a first axial direction that is the ultrasonic focusing direction, and curved portions 1310a and 1310b formed by bending at both ends in a direction opposite to the ultrasonic focusing direction in a third axial direction perpendicular to the first axis of the transducer units 1331 and 1333.

[0131] At least a portion of the bent transducer units 1331 and 1333 are cut by the cutting machine 1340 in a second axial direction perpendicular to the first axis and the third axis, forming a plurality of cuts 1313 (S1220) extending from the bent transducer units 1331 and 1333 in the third axial direction and in the second axial direction perpendicular to the first axis and the third axis.

[0132] A portion of the curved transducer portions 1331 and 1333 can be separated by a cut 1313 to apply an electrical signal to a plurality of transducer elements 1311 formed in the plurality of portions to generate ultrasound, and the signal line for applying the electrical signal can be connected to the transducer elements 1311 by a weld 117 at the rear surface 1333 opposite to the direction of ultrasound focusing. In one embodiment, as Figure 4 The separation components shown can be arranged on the cutout 1313. In one embodiment, the ground electrode can be formed on the front surface 1331 of the curved transducer units 1331 and 1333 by sputtering.

[0133] In the description of this invention (particularly in the claims), the use of the term "above" and similar descriptive terms may correspond to both the singular and the plural. Furthermore, when a scope is described in this invention, it includes the invention taking into account various values ​​belonging to that scope (unless otherwise stated), and the various values ​​constituting that scope are described in the detailed description of the invention.

[0134] Unless the order of the steps constituting the method according to the invention is explicitly stated or otherwise stated, these steps may be performed in any suitable order.

[0135] This invention is not necessarily limited to the order in which the steps are described. All examples or exemplary terms used in this invention (e.g., etc.) are merely for the purpose of explaining the invention in detail, and the scope of the invention is limited by these examples or exemplary terms unless limited by the claims. Furthermore, those skilled in the art will understand that various modifications, combinations, and changes can be made according to design conditions and factors within the scope of the appended claims or their equivalents.

[0136] Therefore, the spirit of the present invention should not be limited to these exemplary embodiments, but rather the claims and all modifications identical or equivalent to the claims are intended to fall within the scope and spirit of the present invention.

Claims

1. A high-intensity focused ultrasound (HIFU) probe, comprising: A transducer module comprising multiple transducer elements that generate ultrasound by receiving electrical signals; as well as The circuit provides drive signals to the plurality of transducer elements based on control signals received from the control system. In this configuration, the plurality of transducer elements, which have concave shapes in a direction opposite to the first axial direction serving as the ultrasound focusing direction, are arranged in an array in a second axial direction perpendicular to the first axis, and a cutout is located between the plurality of transducer elements. 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, and The separating component is arranged in the cut. The length of the separating member in the first axial direction is greater than the length of each of the plurality of transducer elements in the first axial direction, and In the first axial direction, the height of the top surface of each of the plurality of transducer elements, measured from the bottom surface of the transducer element, is lower than the height of the top surface of the separating member.

2. The high-intensity focused ultrasound (HIFU) probe according to claim 1, wherein: Each of the plurality of transducer elements is formed with a geometry such that ultrasound generated by receiving an electrical signal is focused at a predetermined point in the first axial direction, and the shape of each of the plurality of transducer elements is such that its length in a third axial direction perpendicular to the first and second axial directions is greater than its length in the second axial direction.

3. The high-intensity focused ultrasound (HIFU) probe according to claim 1, wherein: The ultrasonic output energy at the focal point of the transducer module is 0.5 J / cm. 2 Or larger.

4. The high-intensity focused ultrasound (HIFU) probe according to claim 1 further comprises: The signal line is connected to the rear surface of each of the plurality of transducer elements by welding in a direction opposite to the ultrasonic focusing direction to apply an electrical signal.

5. The high-intensity focused ultrasound (HIFU) probe according to claim 1, wherein: The separation component is made of a material with thermal stability of 300°C or higher.

6. The high-intensity focused ultrasound (HIFU) probe according to claim 5, wherein: The separation component is made of polyimide.

7. The high-intensity focused ultrasound (HIFU) probe according to claim 1, wherein: Each of the plurality of transducer elements is not directly connected in the second axial direction.

8. The high-intensity focused ultrasound (HIFU) probe according to claim 2, wherein: At least one end of each of the plurality of transducer elements is connected to each other in the third axial direction.

9. The high-intensity focused ultrasound (HIFU) probe according to claim 8, wherein: In the ultrasonic focusing direction, a ground electrode is formed in at least a portion of the front surface of each of the plurality of transducer elements.

10. The high-intensity focused ultrasound (HIFU) probe according to claim 9, wherein: At least one end of each of the plurality of transducer elements has an extension in the third axial direction including a folded portion that is folded in the direction opposite to the ultrasonic focusing direction.

11. The high-intensity focused ultrasound (HIFU) probe according to claim 1, wherein: The transducer module includes a loading space, in which degassed water is loaded, and The transducer module and the first housing with the loading space are detachably connected to the second housing with the circuitry, and the loading space is connected to an inlet or outlet pipe that allows the degassed water to circulate.

12. A high-intensity focused ultrasound (HIFU) device, comprising: A probe that emits high-intensity focused ultrasound (HIFU). and a control system, which sends control signals to the probe. The probe includes a transducer module, which comprises multiple transducer elements for generating ultrasound based on the control signal. The plurality of transducer elements, having concave shapes in a direction opposite to the first axial direction which is the ultrasonic focusing direction, are arranged in an array in a second axial direction perpendicular to the first axis, and a cutout is located between the plurality of transducer elements. The control system controls at least two different elements among the plurality of transducer elements to generate the high-intensity focused ultrasound at different times, and The separating component is arranged in the cut. The length of the separating member in the first axial direction is greater than the length of each of the plurality of transducer elements in the first axial direction, and In the first axial direction, the height of the top surface of each of the plurality of transducer elements, measured from the bottom surface of the transducer element, is lower than the height of the top surface of the separating member.

13. The high-intensity focused ultrasound (HIFU) device according to claim 12, wherein: Each of the plurality of transducer elements is formed with a geometry such that the ultrasound generated based on the control signal is focused at a predetermined point in the first axial direction, and the shape of each of the plurality of transducer elements is such that its length in a third axial direction perpendicular to the first axial direction and the second axial direction is longer than its length in the second axial direction.

14. The high-intensity focused ultrasound (HIFU) device according to claim 12, wherein: The probe also includes a loading space, in which degassed water is loaded. The probe further includes a temperature sensor for measuring the temperature of at least one of the transducer element, the degassed water in the loading space, and the object in contact with the probe. The control system controls the operating speed of the circulation motor connected to the loading space to circulate the deaerated water, or controls the cooling rate of the deaerated water, based on the temperature measured by the temperature sensor.

15. The high-intensity focused ultrasound (HIFU) device according to claim 12, wherein: The plurality of transducer elements are exclusively divided and belong to several different subgroups, and The control system sends the control signal to the probe, causing the high-intensity focused ultrasound emitted by the transducer elements of the subgroup to be simultaneously focused at different points.

16. The high-intensity focused ultrasound (HIFU) device according to claim 12, wherein: At least some of the plurality of transducer elements are divided into multiple subgroups and belong to multiple different subgroups. The control system sends the control signal to the probe, causing the high-intensity focused ultrasound emitted by the transducer elements of the subgroup to focus at different points at different times.

17. The high-intensity focused ultrasound (HIFU) device according to claim 12, wherein: The control system: In a first mode of operation, the plurality of transducer elements are exclusively divided into several distinct subgroups and controlled, and In a second mode of operation, the plurality of transducer elements are divided into and controlled into the plurality of different subgroups. The control system sends the control signal to the probe in the first mode and the second mode, such that the spacing between the points focused by the high-intensity focused ultrasound in the first mode is wider than the spacing between the points focused by the high-intensity focused ultrasound in the second mode.

18. The high-intensity focused ultrasound (HIFU) device according to claim 12, wherein: The probe also includes a loading space, in which degassed water is loaded, and The control system: In a first mode of operation, the plurality of transducer elements are exclusively divided into several distinct subgroups and controlled, and In a second mode of operation, the plurality of transducer elements are divided into and controlled into the plurality of different subgroups. The control system controls the operating speed of the circulation motor connected to the loading space in the first mode and the second mode to circulate the deaerated water, or controls the cooling rate for cooling the deaerated water differently.

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