KR101639016B1 - Skin Temperature Alarm System in Focused Ultrasound Surgery - Google Patents

Skin Temperature Alarm System in Focused Ultrasound Surgery Download PDF

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KR101639016B1
KR101639016B1 KR1020150076027A KR20150076027A KR101639016B1 KR 101639016 B1 KR101639016 B1 KR 101639016B1 KR 1020150076027 A KR1020150076027 A KR 1020150076027A KR 20150076027 A KR20150076027 A KR 20150076027A KR 101639016 B1 KR101639016 B1 KR 101639016B1
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이영한
서진석
양재문
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연세대학교 산학협력단
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N7/02Localised ultrasound hyperthermia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating

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  • Otolaryngology (AREA)
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  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

The present invention relates to a novel focused ultrasound therapy system which is capable of easily detecting a temperature rise above the threshold near a target tissue. In order to perform focused ultrasound surgery which is non-invasive and promising, the system of the present invention prevents damage on peripheral tissues such as burn, by accurately detecting the temperature rise in real time without focusing on a monitor displaying much information at the same time during a complicated operational process. In addition, by adding a simple command to an existing program for magnetic-resonance-guided focused ultrasound surgery, the system can be easily produced and applied to procedures in the more safe and useful way.

Description

[0001] The present invention relates to a skin temperature alarm system,

The present invention relates to a skin temperature warning system in high temperature or hyperthermia therapy, including ultrasound integrated surgery (FUS) and radiofrequency therapy.

High intensity focused ultrasound (HIFU) is a mechanism by which high intensity ultrasound energy is absorbed into tissue and converted into heat energy, which melts the target tissue. Magnetic resonance imaging (MR) -guided focused ultrasound surgery (MRGFUS) is a combination of magnetic resonance imaging (MRI) as an imaging device for HIFU and soft tissue tumors (uterine cancer, breast cancer, etc.) , Brain cancer, etc.), and bone metastasis have been used to alleviate pain in cancer. In particular, pain from bone metastases, which account for the largest portion of cancer pain, strongly influence the quality of life (QoL) of tumor patients, It is often difficult to obtain satisfactory results with treatment (analgesics, chemotherapy, hormone therapy and bisphosphonates) or topical treatment [radiotherapy, surgery, laser ablation or RFA (radiofrequency percutaneous ablation)]. Recently, musculoskeletal magnetic resonance guided ultrasound (MRgFUS) is growing in popularity.

In MRgFUS, magnetic resonance imaging (MRI) is used to determine the location of lesions before treatment, and the response after treatment is assessed. (1) The target temperature is monitored by measuring the tissue temperature using the PRF (proton resonance frequency) , (2) temperature rise can be predicted by looking at signal intensity changes through T2 weighted images. At this time, it is important to proceed with the procedure considering the damage to the surrounding tissues, especially the skin (burns) caused by the temperature rise of the target tissue. However, if the operator does not pay attention to the monitor during the complicated procedure, the skin temperature may be missed and the patient can not respond to pain because the patient is also in general anesthesia. In addition, the PRF technique may not clearly recognize the actual temperature rise due to noise. When the temperature change is monitored through the signal intensity of the T2 weighted image, the signal intensity of the T2 weighted image captured in real time It is difficult for practitioners to concentrate on the procedure. Accordingly, when the temperature of the localized part of the procedure is raised above a predetermined reference level, the operator can be effectively recognized and the accurate and real-time information on the patient's condition being performed can be provided, thereby performing safe and efficient ultrasound Development is required.

Numerous papers and patent documents are referenced and cited throughout this specification. The disclosures of the cited papers and patent documents are incorporated herein by reference in their entirety to better understand the state of the art to which the present invention pertains and the content of the present invention.

The inventors of the present invention have found that when a high-temperature or hyperthermia treatment including a typical non-invasive treatment such as ultrasound integrated surgery (FUS) and radiofrequency therapy is performed, We have tried to develop a system that can recognize the temperature rise of the surrounding tissues efficiently so that the surrounding tissues are not damaged. As a result, by adopting the image processing unit for generating the warning message on the display unit screen that provides the diagnostic image when the raised body surface temperature exceeds the specific temperature, a large attention is paid to a monitor in which a lot of information is simultaneously displayed in a complicated procedure It is possible to clearly recognize the real-time temperature rise without tilting the temperature sensor.

It is therefore an object of the present invention to provide a novel ultrasound therapy system capable of easily recognizing a temperature rise above a threshold value in the vicinity of a target tissue.

Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, claims and drawings.

According to one aspect of the invention, the present invention provides a hyperthermia therapy system comprising:

(a) a heat irradiating unit for applying a therapeutic high temperature or heat to a lesion site of a subject;

(b) a real-time image acquiring unit for acquiring a real-time image of a lesion site of a subject;

(c) an image processor for processing the real-time image obtained in (b); And

(d) a display unit for displaying the image processed in (c)

The image processing performed in (c) includes: (i) measuring and displaying a body surface temperature rise of the object using the information obtained in (b); And (ii) generating a warning message if the measured and displayed body surface temperature rise exceeds a predetermined temperature.

The inventors of the present invention have recognized that the temperature increase of the surrounding tissues is efficiently recognized in order to prevent the surrounding tissues with increased temperature from being damaged due to the addition of the therapeutic heat or heat to the lesion site in performing the typical noninvasive treatment, We have tried to develop a system that can do this. As a result, by adopting the image processing unit for generating the warning message on the display screen providing the diagnostic image when the raised body surface temperature exceeds the specific temperature, It was noted that real-time temperature rise can be clearly recognized without paying attention.

The term " hyperthermia treatment " in the present invention means treatment for removing unnecessary tissue or lesion tissue by applying heat at a high temperature, and " hyperthermia treatment " means that the body tissue is maintained at a temperature It means treatment to remove lesion tissue / cell by exposing to high temperature. Generally, in the treatment of hyperthermia, heat is applied at about 60 ° C to remove tissue, while in the case of hyperthermia, heat is applied at about 45 ° C to specifically kill cancer cells sensitive to heat change. In the treatment of hyperthermia or hyperthermia, local heat is applied to the lesion according to the heat transfer means, or the target tissue is operated in a state sensitive to the temperature rise compared to the surrounding normal tissue, The lesion tissue can be specifically removed by applying heat thereto.

As used herein, the term "heat transfer means" means means for dissipating heat to the outside by itself or by external stimulation. Thus, " in vivo heat transfer means " means means for increasing in vivo temperature by releasing heat in vivo. The heat transfer means of the present invention includes all means for artificially raising the natural temperature in vivo for therapeutic purposes and includes, for example, ultrasound, fulguration, infrared, microwave, Any means of delivering heat in vivo for therapeutic purposes, including, but not limited to, nanoparticle-magnetic field therapy, infusion of warmed liquid, may be applied. The heat transfer means of the present invention can be used for the purpose of inducing the death of target cells, and in this case, the composition of the present invention may be defined as " means for inducing apoptosis. &Quot;

As used herein, the term " heat irradiating unit " is made up of the above-mentioned heat transfer means, and it is intended to include not only a device for directly emitting a heat source such as an ultrasonic wave or a high frequency wave but also a device Device (e.g., a magnetic field generator that induces heat generation of nanoparticles injected into a lesion site). Therefore, the heat irradiating portion may be expressed as a heat transfer portion or a heat generating portion.

According to a specific embodiment of the present invention, the heat-irradiating unit for adding heat or heat to the treatment of the present invention is an ultrasound irradiating unit for irradiating ultrasonic waves for treatment.

In the present invention, the term " ultrasound-integrated therapy " refers to a method of concentrating high intensity focused ultrasound (HIFU), which is stronger than diagnostic ultrasound intensity, on a target lesion site and transmitting the ultrasound energy to heat energy It means treatment. The high-intensity ultrasound can use a short-period signal or a long-period signal depending on the treatment environment, and generally has a strength about 100,000 times higher than the intensity of the diagnostic ultrasound.

According to the present invention, the present invention provides a real-time image acquisition unit for acquiring a real-time image, thereby providing an ultrasound image and / or a magnetic resonance diagnostic image of a region where the operation is performed and a peripheral portion thereof. Therefore, the present invention can be applied to magnetic resonance (MR) -guided focused ultrasound surgery (MRgFUS) that combines MRI technology that provides information on the location, state, etc. of the lesion in the above- And can provide real-time image diagnosis by ultrasound imaging, magnetic resonance imaging, and combinations thereof. Thus, the configurations (a) and (b) of the present invention can include the same configurations as those employed in the conventional MRgFUS, and these configurations are well known in the art. In addition, the present invention can obtain dual imaging through ultrasound imaging as well as magnetic resonance imaging, thereby providing more reliable information about a body part undergoing high-temperature or hyperthermia treatment.

The real-time image acquisition unit of the present invention is configured to acquire ultrasound and / or magnetic resonance signals in real time from within a target zone. Typically, the magnetic resonance imaging acquiring unit includes magnets, gradient coils, and antennas or coils to transmit and receive radio frequency signals to obtain magnetic resonance signals from a portion of the body. The target compartment is an area of magnetic field sufficient to obtain magnetic resonance signals that can be reconstructed into a magnetic resonance image.

According to the present invention, a system of the present invention includes an image processing unit for processing a real-time ultrasound image and / or a real-time magnetic resonance image acquired by a real-time image acquisition unit. The image processing unit of the present invention includes a series of computing devices that process the information obtained in the real-time image acquisition unit to process the information into readable information and then control the process of displaying the information on the screen. Specifically, the image processing unit of the present invention measures (i) the body surface temperature rise of the object through information obtained from the obtained real-time MRI image and displays it on the display unit, (ii) And generating a warning message when the set temperature is exceeded. The processing of (i) above can be performed through the same configuration as that employed in the conventional MRgFUS, and these configurations are well known in the art. Specifically, the measurement of the body surface temperature rise can be performed by using ultrasound temperature imaging, magnetic resonance temperature imaging, signal intensity of T2 image, or a combination thereof, do.

Magnetic resonance (MR) temperature imaging utilizes the phenomenon that hydrogen electrons decrease the resonant frequency of a proton by forming a shield from the magnetic field to the nucleus. Hydrogen bonds present between water molecules efficiently increase the resonance frequency by pushing electrons away from the proton, but as the temperature of the tissue rises, the hydrogen bonds in the tissue become strained, bent, and broken. As a result, electrons become stronger to protect the nucleus from the magnetic field, and the total magnetic field observed by the proton decreases. The temperature measurement using this principle is called proton resonance frequency (PRF) shift thermometry .

The display of the body surface temperature rise according to the present invention is performed by outputting a predetermined color corresponding to the body surface temperature in a pixel constituting a certain section inside the body surface of the object on the screen of the display unit displaying the processed image . That is, the skin line (body surface) is searched from the magnetic resonance image, and it is confirmed whether or not there is a temperature increase along the pixels of the skin inside the skin line, so that the pixel corresponding to the temperature rise portion is distinguished from the non- Color. Since the threshold for temperature display can be adjusted on the screen, a specific color can be displayed only at a desired temperature according to the setting of the user or the operator. The corresponding color can also be appropriately selected by the user or the operator. For example, when the temperature rises above a preset value, it can be displayed as a red spot.

The process (ii) by the image processing unit of the present invention is the most important feature of the present invention. It can recognize in real time the increase in the skin temperature, which can be overlooked by the practitioner in the course of complicated procedures, . The generation of the warning message can be performed in various ways by a simple computer program known in the art. Specifically, a pop-up window is created on the screen of the display unit displaying the processed image.

The monitoring temperature image in the currently commercialized MRgFUS system basically shows the skin line as a red curve (Fig. 2). At this time, when the temperature rises above the set reference temperature along the skin line, a red dot is displayed on the skin line. Due to the characteristic of the MR temperature image according to the PRF moving temperature measurement method, there is a lot of noise. The system of the present invention displays an alarm window on a test screen as a pop-up when the temperature increases in the MR temperature image and when there is a significant signal intensity change in the T2 weighted image, thereby inducing confirmation of the operator.

 According to a specific embodiment of the present invention, the warning message of the present invention is generated on condition that information reflecting the excessive increase of the body surface temperature of the lesion site of the patient during the procedure appears on the screen of (d) Specifically, when a pixel for outputting a color corresponding to a temperature exceeding a predetermined temperature exists on the screen of (d), it is automatically generated. In the MRgFUS system, raw data for the PRF shift was required to quantitatively grasp the actual temperature change of the target tissue through the MR information. However, the system of the present invention can display the raw data on the screen without accessing the raw data. By predicting the temperature only by the color of the pixel shown and generating a warning message based on the prediction result, the operator is prompted and prompted more promptly. This feature of the present invention not only dramatically improves safety by allowing the procedure to be interrupted quickly in an emergency, but also allows the program used in the existing MRgFUS system to be "modified" without a simple add-on of new instructions Give the advantage. In the present invention, the generation of the warning message according to the satisfaction of a certain condition can be performed by a macro program, for example. As used herein, the term " macro program " has the same meaning as a macro generating program. In the present specification, a macro program is a program in which a program in a series of related commands is regarded as one macro instruction, it means.

More specifically, the pop-up window displays on-screen coordinates of a pixel outputting a color corresponding to a temperature exceeding the predetermined temperature.

According to a specific embodiment of the present invention, the magnetic resonance image of the present invention is a T2 image.

The term " T2 image " refers to a magnetic resonance image obtained by a T2 contrast agent, and the term " T2 contrast agent " magnetizes when a magnetic field is externally applied to generate an induced magnetic field, - refers to a contrasting material that exhibits a dark or negative contrast effect compared to water by amplifying a magnetic resonance imaging signal by affecting the spin relaxation process. T2-weighted images have a lower tissue resolution than T1-weighted images, but most lesions have a higher signal intensity than normal tissues on T2-weighted images. In addition, the T2 image can measure the temperature rise of the target site by the change of the relaxation time according to the temperature of the surrounding tissues.

The features and advantages of the present invention are summarized as follows:

(a) The present invention provides a new ultrasonic wave accumulation treatment system capable of easily recognizing a temperature rise above a threshold value in the vicinity of a target tissue.

(b) The present invention clearly demonstrates that real-time temperature elevation can be clearly demonstrated in a high-temperature or hyperthermia treatment, or more specifically in ultrasound intensive surgery, which is a promising non-invasive treatment, It is possible to prevent damage to the surrounding tissues such as burns.

(c) The present invention can be easily manufactured by adding a simple command to a program for conventional magnetic resonance guided ultrasound integration surgery or the like, and can be usefully used for safer procedures.

1 is a schematic diagram showing an algorithm of the MRgFUS skin temperature alarm system. This alarm system is activated during magnetic resonance guided ultrasound intensive surgery (MRgFUS) and searches the skin line and checks whether there is a temperature rise along the pixels of the skin inside the skin line. An alarm is sent when there is a pixel that exceeds the temperature set by the operator (for example, 50 ° C).
FIG. 2 is a view showing an actual monitoring screen of a conventional MRgFUS. The skin line (red line) is displayed on the procedure screen. The actual body surface is the curve (yellow triangle), and the operator should visually confirm the temperature change on the body surface (yellow star: the bottom right graph shows the temperature of the target tissue)
3 is another diagram showing a real monitoring screen of a conventional MRgFUS. As the temperature of the target tissue rises, a red spot (yellow arrow) starts to appear on the screen when the surface temperature rises. However, it is difficult to draw attention to the noise around the tissue and the characteristics of the clinical field at the time of the procedure.
FIG. 4 is a view showing an MRgFUS monitoring screen accompanied by a skin temperature alarm according to the present invention. If the body surface temperature exceeds the temperature specified by the operator and a red dot (yellow arrow) occurs, the alarm screen is displayed in a pop-up window asking the operator to confirm.

Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are only for describing the present invention in more detail and that the scope of the present invention is not limited by these embodiments in accordance with the gist of the present invention .

Example

Experimental Method

Alarm system

In the present invention, a flowchart of a " skin temperature alarm " system for preventing skin burns that may occur in the MRgFUS procedure was configured (Fig. 1). The MRgFUS monitoring temperature image basically shows the skin line, and the actual skin appears as a red curve (FIG. 2). At this time, when the temperature rises above the set reference temperature along the skin line, a red dot is displayed on the skin line. Because of the nature of the MR temperature image (PRF technique), it is easy to miss without paying special attention because it has a lot of noise. The system of the present invention displays an alarm window pop-up on the inspection screen to induce confirmation of the operator when the temperature increases in the temperature image and when there is a significant signal intensity change in the T2 weighted image (FIG. 4). The alarm system was run every time the patient's MRgFUS cauterization.

The development tool is available from the official website, AutoHotkey (Free Software Foundation, Cambridge, MA), which is an open source macro program and can be downloaded from the official web page at http://www.autohotkey.com .

MRgFUS simulator

Using a magnetic resonance guided ultrasound integrated surgery (MRgFUS) simulator, the previously developed skin temperature alarm system was operated and its operation was confirmed. The skin line displayed during the intensive surgery plan is indicated by a red line on the MRgFUS monitoring screen throughout the procedure (FIG. 2). At the time of sonication, the skin temperature image is displayed at the bottom left of the simulator. Since this position is fixed, the alarm system can use the corresponding screen. A T2-weighted image is displayed on the screen on the screen. A pixel can be obtained from the T2W-weighted image corresponding to the pixel position of the temperature image, and the signal intensity change can be predicted.

Usability evaluation

We assumed the actual MRgFUS procedure through the simulator and operated this alarm system. We have applied the alarm system to images that have no temperature change along the skin line and images that are suspected of temperature change along the skin line.

Experiment result

The developed alarm system works well on Windows based PC. The 'skin temperature alarm' was able to detect the skin line in the simulator screen without major errors, and it was able to detect the temperature change of the pixel corresponding to the skin line and the skin adjacent to it. In the MRGFUS simulator, when there was no temperature change of the pixels adjacent to the skin line, the image was terminated without a separate message. When the temperature of the adjacent pixel in the temperature image increased, the alarm was normally activated and displayed as a pop-up window ).

conclusion

An alarm system for skin anomalies during magnetic resonance guided ultrasound integrated surgery (MRgFUS) may be helpful in the safe operation of unconscious patients. If the system is used for actual patient treatment in the future, it is expected that the MRgFUS procedure will protect both the patient and the practitioner from the complication of the procedure.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the same is by way of illustration and example only and is not to be construed as limiting the scope of the present invention. Accordingly, the actual scope of the present invention will be defined by the appended claims and their equivalents.

Claims (10)

Hyperthermia therapy system including:
(a) an ultrasound irradiating unit for irradiating a therapeutic ultrasound wave to a heat-irradiating unit for applying a therapeutic high temperature or heat to a lesion site of a subject;
(b) a real-time image acquisition unit for acquiring a combination of real-time ultrasound imaging and real-time magnetic resonance imaging as a real-time image of a lesion of a subject, the magnetic resonance image being obtained by T2 Image;
(c) an image processor for processing the real-time image obtained in (b); And
(d) a display unit displaying an image processed in (c); And
The magnetic resonance temperature image of the above (b) is obtained through proton resonance frequency shift thermometry,
The image processing performed in (c) includes: (i) measuring and displaying a body surface temperature rise of the object using the information obtained in (b); And (ii) generating a warning message if the measured and indicated body surface temperature rise exceeds a predetermined temperature,
The body surface temperature rise of the subject in (i) above may be measured by a combination of the ultrasound temperature imaging, magnetic resonance temperature imaging and signal intensity of the T2 image obtained in (b) And,
The display of the body surface temperature rise of (i) above is performed by outputting a predetermined color corresponding to the body surface temperature in a pixel constituting a certain section inside the body surface of the object in the screen of (d)
The warning message (ii) is generated when a pixel for outputting a color corresponding to a temperature exceeding a predetermined temperature exists on the screen of (d)
The generation of the warning message in (ii) is performed by creating a pop-up window on the screen of (d)
The pop-up window displays on-screen coordinates of a pixel outputting a color corresponding to a temperature exceeding the predetermined temperature.
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111175382A (en) * 2020-01-20 2020-05-19 邯郸钢铁集团有限责任公司 Method for eliminating steel rail ultrasonic flaw detection thermal printing alarm
KR102389164B1 (en) * 2021-06-25 2022-04-25 주식회사 엘트라글로벌 Skin treatment laser output apparatus capable of measuring real-time skin temperature
WO2022250304A1 (en) * 2021-05-25 2022-12-01 주식회사 유니온메디칼 Handpiece capable of treatment site observation and temperature control

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KR20120046521A (en) * 2010-11-02 2012-05-10 삼성메디슨 주식회사 Ultrasonic diagnostic device
KR20140092717A (en) * 2013-01-16 2014-07-24 삼성메디슨 주식회사 Ultrasound apparatus and method for providing information using the ultrasound apparatus
KR20140094955A (en) * 2013-01-23 2014-07-31 삼성전자주식회사 Method and apparatus for generating a temperature image, and ultrasound system
JP2015512284A (en) * 2012-03-22 2015-04-27 コーニンクレッカ フィリップス エヌ ヴェ Estimation of interpolated 3D thermal energy using magnetic resonance imaging

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Publication number Priority date Publication date Assignee Title
KR20120046521A (en) * 2010-11-02 2012-05-10 삼성메디슨 주식회사 Ultrasonic diagnostic device
JP2015512284A (en) * 2012-03-22 2015-04-27 コーニンクレッカ フィリップス エヌ ヴェ Estimation of interpolated 3D thermal energy using magnetic resonance imaging
KR20140092717A (en) * 2013-01-16 2014-07-24 삼성메디슨 주식회사 Ultrasound apparatus and method for providing information using the ultrasound apparatus
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Cited By (4)

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Publication number Priority date Publication date Assignee Title
CN111175382A (en) * 2020-01-20 2020-05-19 邯郸钢铁集团有限责任公司 Method for eliminating steel rail ultrasonic flaw detection thermal printing alarm
CN111175382B (en) * 2020-01-20 2021-09-14 邯郸钢铁集团有限责任公司 Method for eliminating steel rail ultrasonic flaw detection thermal printing alarm
WO2022250304A1 (en) * 2021-05-25 2022-12-01 주식회사 유니온메디칼 Handpiece capable of treatment site observation and temperature control
KR102389164B1 (en) * 2021-06-25 2022-04-25 주식회사 엘트라글로벌 Skin treatment laser output apparatus capable of measuring real-time skin temperature

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