WO2018124460A1 - Tête de traitement hifu et dispositif hifu le comprenant - Google Patents

Tête de traitement hifu et dispositif hifu le comprenant Download PDF

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Publication number
WO2018124460A1
WO2018124460A1 PCT/KR2017/012696 KR2017012696W WO2018124460A1 WO 2018124460 A1 WO2018124460 A1 WO 2018124460A1 KR 2017012696 W KR2017012696 W KR 2017012696W WO 2018124460 A1 WO2018124460 A1 WO 2018124460A1
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Prior art keywords
transducer
treatment head
unit
wobbling
treatment
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PCT/KR2017/012696
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English (en)
Korean (ko)
Inventor
김대승
김명덕
최걸
손건호
Original Assignee
알피니언메디칼시스템 주식회사
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Publication of WO2018124460A1 publication Critical patent/WO2018124460A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5207—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of raw data to produce diagnostic data, e.g. for generating an image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A61N7/022—Localised ultrasound hyperthermia intracavitary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0052—Ultrasound therapy using the same transducer for therapy and imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0082—Scanning transducers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0086—Beam steering
    • A61N2007/0091—Beam steering with moving parts, e.g. transducers, lenses, reflectors
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/10—Image acquisition modality
    • G06T2207/10132—Ultrasound image
    • G06T2207/10136—3D ultrasound image

Definitions

  • the present invention relates to a diagnosis and treatment technique using ultrasound, and more particularly, to an image scanning and treatment technique using a high-intensity focused ultrasound (HIFU) device for treatment. It's about.
  • HIFU high-intensity focused ultrasound
  • the present invention was supported by the national research and development project, task unique number: 2015M3D5A1065935, Department: Ministry of Science, ICT and Future Planning, Research and Management Agency: Korea Research Foundation, Project name: New market creation next generation medical device development project, research title: Non-invasive Development of precision proximity ultrasound fusion therapy device, contribution rate: 1/1, Host organization: Alpinion Medical System Co., Ltd., Research period: 2016.08.01 ⁇ 2017.07.31.
  • Hypo signals may be used to treat biological tissues such as cancer, tumors, lesions, and the like.
  • the treatment method using the hi-fu is a method in which the tissue of the subject is necrotic through heat generated by transmitting a hi-fu signal to the target of the target.
  • Haifu treatment can lessen the trauma of the patient and realize non-invasive treatment.
  • Applications include Liver cancer, Bone sarcoma, Breast cancer, Pancreas cancer, Kidney cancer, Soft tissue tumors and Pelvic tumors ) And so on.
  • an ultrasound image is obtained by irradiating a hifu signal to a subject to be treated and receiving a backscattering signal returned from the subject.
  • cavitation may occur at the focal region of the subject.
  • the cavitation phenomenon means that small bubbles are formed by the action of sound pressure and positive pressure caused by the pressure change in the object as the ultrasonic waves touch the object, and the cells in the object are destroyed as the bubble expands and bursts to the maximum. .
  • Cavitation promotes an increase in the temperature of the subject's focal point, thereby damaging the lesion corresponding to the focal point and thereby treating the disease.
  • a hi-fu treatment head capable of three-dimensional image scanning and focusing by automatically aligning a hi-fu head in a treatment area on a three-dimensional target with a hi-fu head that can be inserted into a body and a hi-fu apparatus including the same Suggest.
  • the hi-fu treatment head has a rod-shaped outer body, which is inserted into the body and translates and rotates, and is provided at the front end of the body and wobbling and rotated by the movement of the body, thereby three-dimensionally treating the object. And a transducer for transmitting an ultrasonic signal for image scanning and three-dimensional focusing.
  • the body includes a wobbling drive unit for generating a rotational force, a shaft translating by the rotation of the wobbling drive unit, and a connecting unit for wobbling the transducer unit within a set angle range about the wobbling axis by the translational movement of the shaft. It may include a first body and a second body including a rotation drive for generating a rotational force to rotate the transducer body to rotate the entire first body.
  • the shaft is disposed in a direction perpendicular to the wobbling axis of the transducer part and rotated by a rotational force of the wobble drive, a movable member linearly reciprocating in the longitudinal direction of the screw by rotation of the screw, and a movable member. It may include a linear moving member that moves linearly reciprocating together.
  • the connection part includes a connection hole which is formed in the ultrasonic transducer part so as to wobble the ultrasonic transducer part within a set angle range about the wobbling axis according to the linear reciprocating movement of the linear moving member, and fits one end of the linear moving member.
  • the adjustable angle range of the ultrasonic transducer can be adjusted according to the length of the connection hole.
  • the transducer unit includes an image transducer for transmitting and receiving an ultrasound image signal for scanning a 3D image of a medium and a treatment area of an object, and a treatment for focusing a hi-fu signal on a treatment area on a 3D image to form a thermal lesion. It may include a transducer for.
  • the transducer unit further includes a water inlet disposed at the front of the transducer to supply water for cooling the therapeutic transducer, a water outlet for recovering water, and a temperature sensor disposed at the front of the transducer to measure the temperature of the water. It may include.
  • a hi-pu device has a rod-shaped outer body which is inserted into the body and translates and rotates, and a three-dimensional image of an object while wobbling and rotating by the movement of the body. It includes a treatment head including a transducer for transmitting an ultrasonic signal for scanning and three-dimensional focusing, and a control unit for controlling the movement of the treatment head.
  • the control unit applies a control signal to the treatment head to translate and rotate the body to move the transducer around the treatment area in the body, and to move the treatment head around the treatment area through the first mechanical adjustment part.
  • the second mechanical adjustment unit for applying a control signal to the treatment head in the state, wobbling and rotating the transducer unit toward the target of the object, and then aligning the three-dimensional image of the object or focusing the hi-fu signal on the treatment area. It may include.
  • the second mechanical adjuster calculates a target position in the treatment area, calculates a rotation matrix for aligning the transducer part with the calculated target position, and applies a control signal to the treatment head using the calculated rotation matrix to wobble the transducer part. And rotate to align toward the target of the object.
  • the control unit may further include an electronic adjustment unit that adjusts the position of the transducer electronically according to the calculated distance by calculating the distance between the transducer unit and the target.
  • the hi-pu device may further comprise a mechanical arm that supports and moves the treatment head and is operable by the user.
  • an image can be scanned in three dimensions and volume treatment may be performed by using an insertable hi-fu head.
  • the mechanical adjustment including the wobbling and rotation of the transducer of the hi-fu head automatically increases the resolution of the image for the treatment site and can accurately treat the treatment site.
  • the hi-fu head can be automatically aligned to the target, eliminating the need to change the cartridge with the transducer appropriate for each treatment environment and various body conditions.
  • FIG. 1 is an external view of a hi-fu device according to an embodiment of the present invention
  • FIG. 2 is a reference view showing a wobbling operation of a transducer unit according to an embodiment of the present invention
  • 3 is a reference view showing the wobbling and rotation operation of the transducer unit according to an embodiment of the present invention
  • FIG. 4 is a reference diagram showing an operation by electronic adjustment of a transducer unit according to an embodiment of the present invention
  • FIG. 5 is a detailed configuration diagram of a control unit according to an embodiment of the present invention.
  • FIG. 6 is an external view of a hi-fu apparatus for explaining the operation of the treatment head through mechanical adjustment according to an embodiment of the present invention
  • FIG. 7 and 8 are internal structural views of the treatment head for explaining the wobbling and rotation mechanism of the transducer unit according to an embodiment of the present invention
  • 9 to 11 is a plan view showing a detailed configuration of the treatment head and its working example according to an embodiment of the present invention.
  • FIG. 13 is an external view of a hi-fu device showing an example of operation for mechanical operation and an example of mechanical adjustment through the operation according to an embodiment of the present invention
  • FIG. 14 is an external view of a hi-fu device showing an example of operation for the electronic operation and an example of electronic adjustment through the operation according to an embodiment of the present invention
  • 15 is a reference diagram sequentially illustrating an example of forming a thermal lesion by focusing on three dimensions through a wobbling operation of a transducer according to an embodiment of the present invention
  • FIG. 16 is a reference diagram sequentially illustrating an example of forming a thermal lesion by focusing on three dimensions by wobbling and rotating operations of another transducer according to an embodiment of the present disclosure.
  • FIG. 1 is an external view of a hi-fu device according to an embodiment of the present invention.
  • the hi-pu device comprises a treatment head 1, a mechanical arm 2 and a support 3.
  • the treatment head 1 includes a body 10 and a transducer portion 12.
  • the hi-fu device has a treatment head (also called a 'diagnosis head') 1 inserted into the body for a procedure using a hi-fu.
  • the treatment head 1 may be in the form of a rod as shown in FIG. 1.
  • the treatment head 1 can be inserted into a woman's uterus or large intestine. In particular, it can be inserted into the vagina and used to treat gynecological diseases.
  • Gynecological diseases can be broadly classified into tumors, neoplastic diseases, inflammatory diseases, menstrual disorders, sexually transmitted diseases, and sexual dysfunction. Representative tumors include cervical cancer and ovarian cancer, and tumor diseases include uterine myoma.
  • the present invention proposes a technique for diagnosing the location of different tissues and treatment sites in tissues in three dimensions and treating a treatment area on three dimensions.
  • the treatment head 1 is inserted into the body and applies an ultrasound signal to the subject tissue.
  • the treatment head 1 includes a body 10 and a transducer part 12 connected to one end of the body 10.
  • the body 10 may include a shaft and a connection part connecting the transducer part 12 and the shaft.
  • a cooling fluid such as water may circulate to cool the heat of the transducer part 12.
  • the transducer unit 12 includes an imaging transducer and a therapeutic transducer.
  • the imaging transducer transmits an imaging ultrasound signal to the subject and receives an ultrasound signal reflected from the subject, thereby scanning the image of the subject, and the therapeutic transducer causes the Haifu signal to converge at a single focal point in the treatment area. Focus to form thermal lesions.
  • image scanning and focusing is possible on three-dimensional images of the object tissue.
  • mechanical steering of the treatment head 1 is possible, which may include wobbling and rotation.
  • it may include electrical steering of the treatment head 1.
  • the external design of the treatment head 1 is preferably ergonomic, since the user may hold it in one hand while moving the treatment head 1. Since the treatment head 1 will be supported by mechanical means, the ergonomic design should be adapted to holding and guiding, not supporting weight.
  • the treatment head 1 may be provided in a hand-held form to be separated from the apparatus body and to improve the convenience of user operation.
  • the handle may be provided. At this time, it may include a connection cable for electrically and physically connecting the equipment main body.
  • the hi-pu device comprises means for suspending the treatment head 1 in space, such as a mechanical arm 2.
  • Suspending means support most of the weight of the treatment head 1 and allow the user to manually adjust the position of the treatment head 1 in space or to automatically move the treatment head 1 via a robot controller.
  • the support 3 comprises a control unit 32, either as an independent device or as part of a large computer 30.
  • the control unit 32 controls the operation of the mechanical arm 2 and the treatment head 1 to support the weight of the treatment head 1.
  • the control unit 32 may be part of the computer 30, which is a separate information device, and may be used as a robot controller to automate the procedure.
  • the control unit 32 monitors the position and energy transfer of the treatment head 1 while providing the user with guidance as to where to move the treatment head 1 in the patient's body.
  • FIG. 2 is a reference diagram illustrating a wobbling operation of a transducer unit according to an exemplary embodiment of the present invention.
  • the transducer unit 12 of the treatment head may be wobbling about a wobbling axis to scan the treatment region of the object in three dimensions and focus the hi-fu signal on the treatment region in three dimensions to form a thermal lesion.
  • the transducer unit 12 may transmit a high-fu signal to the targets 200a, 200b, 200c, and 200d in the treatment area of the object along a movement trajectory (clockwise or counterclockwise). Focus to form a thermal lesion.
  • FIG. 3 is a reference diagram illustrating a wobbling and rotating operation of a transducer unit according to an exemplary embodiment of the present invention.
  • the transducer part 12 of the treatment head is rotatable about the wobbling axis while being rotatable at the same time.
  • FIG. 4 is a reference diagram illustrating an operation by electronic adjustment of a transducer unit according to an exemplary embodiment.
  • the treatment head may electronically adjust the transducer portion 12. For example, the distance between the transducer unit 12 and the targets 400a, 400b, and 400c is calculated to electronically adjust the position of the transducer unit 12 to focus the hi-fu signal on the target of the calculated distance.
  • FIG. 5 is a detailed configuration diagram of a control unit according to an embodiment of the present invention.
  • the controller 32 may include a first mechanical adjuster 320 and a second mechanical adjuster 322, and may further include an electronic adjuster 324.
  • Control of the treatment head 1 can be made automatically by the control unit 32.
  • the second mechanical adjustment unit 322 precisely and mechanically adjusts the transducer part 12 of the treatment head 1. (Wobble and rotate) to perform treatment through 3D image scanning and focusing on the treatment area.
  • the first mechanical adjuster 320 applies a control signal to the treatment head 1 to translate and rotate the body 10 of the treatment head 1 so that the transducer part 12 moves around the treatment area in the body. Move).
  • the second mechanical adjuster 322 applies a control signal to the treatment head 1 to wobble and rotate the transducer part 12 toward the target of the object to align with the target, and then the 3D image of the object. Scanning the 3D or focusing the hi-fu signal on the treatment area.
  • electronic adjust through the electronic adjuster 324 is possible.
  • a target position calculation and mechanical and electronic adjustment algorithms are needed to align the transducer part 12 towards the target position.
  • the second mechanical adjuster 322 calculates a target position, calculates a rotation matrix of the body 10 for the transducer unit 12 to three-dimensional focus on the calculated target position, and uses the calculated rotation matrix.
  • the electronic adjustment unit 324 electronically adjusts the position of the transducer unit 12 by calculating the distance between the transducer unit 12 and the target. A calculation method for the electronic adjustment will be described later with reference to FIG. 14.
  • FIG 6 is an external view of the hi-fu apparatus for explaining the operation of the treatment head through the mechanical adjustment according to an embodiment of the present invention.
  • 3D image scanning and 3D focusing of the treatment area may be performed by wobbling of the transducer unit 12.
  • the body 10 may be rotated about the z-axis and translated in the z-axis direction to treat the hi-fu signal by three-dimensional focusing on the focal point.
  • the translational movement in the Y-axis direction and the rotational movement around the X-axis can increase the operational convenience of the treatment head 1.
  • FIG 7 and 8 are internal structural diagrams of the treatment head for explaining the wobbling and rotation mechanism of the transducer unit according to an embodiment of the present invention.
  • the treatment head includes a first body 16, a second body 18, and a transducer portion 12.
  • the first body 16 may include a wobbling drive unit 160 generating a rotational force for wobbling of the transducer unit 12, a shaft 190 that is translated by the rotation of the wobbler drive unit 160, and a shaft.
  • 190 includes a connecting portion 192 for wobbling the transducer unit 12 within a set angle range around the wobbling axis.
  • the second body 18 includes a rotation drive unit 180 that rotates the entire first body 16 to rotate the shaft 190 and thereby generates a rotational force for the transducer unit 12 to rotate. As shown in FIG.
  • the shaft 190 translates in accordance with the driving of the wobbler 160, and the transducer part 12 connected thereto moves up and down.
  • the rotation driving unit 180 when the rotation driving unit 180 is driven, the entire first body 16 rotates so that the transducer unit 12 rotates.
  • the wobbling and rotational movement of the transducer unit 12 may be performed simultaneously or separately.
  • 9 to 11 are plan views of the treatment head showing a detailed configuration of the treatment head and its operation example according to an embodiment of the present invention.
  • the screw 150, the movable member 140, and the linear moving member 130 may be included in the shaft 190 of FIGS. 7 and 8.
  • the connection hole 122 may be included in the connection unit 192 of FIGS. 7 and 8.
  • the screw 150 is disposed long in a direction perpendicular to the wobbling axis of the transducer unit 12 and rotates by the rotational force of the wobbler driving unit 160.
  • the movable member 140 linearly reciprocates in the longitudinal direction of the screw 150 by the rotation of the screw 150.
  • the linear moving member 130 moves linearly with the movable member 140.
  • the connection hole 122 is formed in the ultrasonic transducer unit 12 to cause the ultrasonic transducer unit 12 to wobble in a set angle range about the wobbling axis according to the linear reciprocating movement of the linear moving member 130. It is a form to fit one end of the linear moving member 130.
  • the setting angle range of the ultrasonic transducer part 12 may be adjusted according to the length of the connection hole 122.
  • the movable member 140 is rotated by the screw 150 by the wobbling drive unit 160. Move linearly to approach 12). Then, the linear moving member 130 moves linearly with the movable member 140 in the same direction. At this time, the connecting holes 122 connected to the transducer part 12 are half the transducer part 12 as the translational movement and rotation from the position where the connecting shaft 131 of the linear moving member 130 is seated on the left edge. Wobble in a clockwise direction.
  • the connecting holes 122 are translated and rotated until the connecting shaft 131 is seated at the right edge, as illustrated in FIG. 10, the transducer part 12 may be wobbling to an intermediate angle. .
  • connection holes 122 move the transducer part 12 as the translational movement and rotation from the position where the connecting shaft 131 is seated on the right edge. Wobble in the same direction.
  • the connecting holes 122 are translated and rotated until the connecting shaft 131 is seated on the left edge, as illustrated in FIG. 11, the transducer part 12 may be positioned at a limit angle in the right direction. have.
  • the transducer unit 12 may be repeatedly wobbled in the set angle range.
  • the wobbling angle range of the transducer unit 12 may be controlled by adjusting the reciprocating movement distance of the linear moving member 130 by the wobble driver 160. Therefore, it is also possible to control the transducer unit 12 to wobble in an angle range smaller than the set angle range, if necessary.
  • FIG. 12 is a detailed configuration diagram of the transducer unit according to an embodiment of the present invention.
  • the transducer unit 12 includes a treatment transducer 1200 and an image transducer 1210, a water inlet 1230, The apparatus may further include a water outlet (not shown) and a temperature sensor 1240.
  • the imaging transducer 1210 transmits and receives an ultrasound image signal for scanning a 3D image of the medium and the treatment area of the object.
  • the therapeutic transducer 1200 focuses the hi-fu signal to focus on a focal point in the treatment area on the 3D to form a thermal lesion.
  • cavitation may occur at the focal region of the subject.
  • the cavitation phenomenon means that small bubbles are formed by the action of sound pressure and positive pressure caused by the pressure change in the object as the ultrasonic waves touch the object, and the cells in the object are destroyed as the bubble expands and bursts to the maximum. . Cavitation promotes an increase in the temperature of the subject's focal point, thereby damaging the lesion corresponding to the focal point and thereby treating the disease.
  • the water inlet 1230 supplies water to cool the therapeutic transducer unit 12, and the water outlet recovers water.
  • the temperature sensor 1240 measures the temperature of the water.
  • the water inlet 1230 may be disposed in front of the transducer unit 12 to facilitate bubble removal.
  • the temperature sensor 1240 may be disposed on the front surface of the transducer unit 12 to enable real-time water temperature monitoring to prevent burns.
  • FIG. 13 is an external view of a hi-fu device showing an example of operation for mechanical operation and an example of mechanical adjustment through the operation according to an embodiment of the present invention.
  • control unit 32 performs a target position calculation and an operation for aligning the transducer unit 12 with the calculated target. do.
  • the second mechanical adjuster 322 calculates a target position, calculates a rotation matrix for aligning the transducer unit 12 with the calculated target position, and uses the calculated rotation matrix to treat the treatment head 1.
  • Apply a control signal to the Accordingly, the transducer unit 12 may be aligned by wobbling and rotating the object toward the target of the object. After the alignment, the transducer unit 12 may scan the 3D image of the object or 3D focus the hi-fu signal on the treatment area.
  • Rotation matrices R (x) and R (z) for rotating the body 10 about the x-axis and about the z-axis are shown in Equations 1 and 2, respectively.
  • the unit vector of the target is ( , , )
  • the equation for obtaining ⁇ x , ⁇ z is shown in Equation 3 below.
  • FIG. 14 is an external view of a hi-fu device showing an example of operation for an electronic operation and an example of electronic adjustment through the operation according to an embodiment of the present invention.
  • the electronic adjustment unit 324 electronically adjusts the position of the transducer unit 12 by calculating the distance between the transducer unit 12 and the target. At this time, the distance Z between the global coordinates (0,0,0) and the target coordinates is obtained, and the distance Za between the transducer part 12 and the global coordinates is subtracted from Z to calculate the distance between the transducer part 12 and the target. If the coordinates of the transducer unit 12 are (X H , Y H , Z H ) and the coordinates of the target are (X T , Y T , Z T ), then the distance between the transducer unit 12 and the target is Equation 4
  • C 0 is the sound velocity of the transmission medium.
  • 15 is a reference diagram sequentially illustrating an example of forming a thermal lesion by focusing on three dimensions through a wobbling operation of a transducer according to an embodiment of the present invention.
  • three-dimensional focusing may be performed by wobbling the transducer up and down.
  • FIG. 16 is a reference diagram sequentially illustrating an example of forming a thermal lesion by focusing on three dimensions by wobbling and rotating operations of another transducer according to an embodiment of the present disclosure.
  • the transducer may be rotated together with up and down wobbling to three-dimensional focusing.

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Abstract

L'invention concerne une tête de traitement HIFU et un dispositif HIFU le comprenant. La tête de traitement HIFU selon un mode de réalisation comprend : un corps dont la forme extérieure a une forme de tige, qui est insérée dans un corps, et qui effectue un mouvement de translation et de rotation; et une unité de transducteur qui est disposée à l'extrémité avant du corps, oscille et tourne selon le mouvement du corps, et transmet un signal ultrasonore pour un balayage d'image en trois dimensions et une mise au point en trois dimensions par rapport à un objet.
PCT/KR2017/012696 2016-12-30 2017-11-09 Tête de traitement hifu et dispositif hifu le comprenant WO2018124460A1 (fr)

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KR10-2016-0184279 2016-12-30
KR1020160184279A KR101772200B1 (ko) 2016-12-30 2016-12-30 Hifu 치료 헤드 및 이를 포함하는 hifu 장치

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