JP2001161707A - Ultrasonic therapeutic apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To change setting for of the therapy and to record images before and after the setting by grasping the change of images immediately during the therapy. SOLUTION: The apparatus comprises an image region setting part 14 for setting an image collection region bear the focal point ultrasonic waves for the treatment irradiated from an applicator 1, an image data processing part 17 for processing image data within the setting region and generating signals when a characteristic change is detected, a therapeutic setting control part 12 for changing the therapeutic setting by the signals, and an image data saving device 18 for recording image data for a prescribed period of time from the time going back by a prescribed period of time from the detection of the signals. Therefore, a characteristic change of a part to be treated can be recognized and the setting of therapy can be changed at the same time, so that excessive energy will not be applied to the part to be treated. In addition, images during a prescribed period of time around the time when the characteristic change, significant as a record, appears can be securely saved.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an ultrasonic treatment apparatus for performing treatment by focusing and irradiating a powerful ultrasonic wave to a treatment site in a subject.

[0002]

2. Description of the Related Art In recent years, in the field of medicine, the concept of minimally invasive treatment that exerts a sufficient therapeutic effect while minimizing the burden on a patient has been emphasized, and an ultrasonic treatment device plays a part in that. Attention has been paid. This ultrasonic therapy device focuses and irradiates the ultrasound on the calculi in the body such as urinary tract stones and gallstones, thereby crushing the calculus and irradiating the focused portion of the ultrasound on the affected part such as cancer. And a thermal treatment device for heating and heating the affected part to necrosis cancer cells and the like. Such lithotripsy, which performs treatment by irradiating a powerful ultrasonic pulse to the calculus from outside the body, has become the first choice for calculus treatment in the urological field. In addition, therapeutic techniques for focusing heat-induced ultrasound on tumor cells and causing thermal degeneration and necrosis have been spotlighted.
Compared with surgical operation, it is expected as a treatment method that requires less invasiveness to patients.

[0003] Therefore, regarding a conventional ultrasonic therapy apparatus,
A schematic configuration is shown in a block diagram in FIG. 5, and will be described first. That is, the ultrasonic treatment apparatus generates an intense ultrasonic wave for treatment and irradiates the treatment site of the subject with an applicator 1, a driving unit 2 for driving the applicator 1, and an inside of the applicator 1. Unit 3 that manages water for properly coupling with a subject (living body) by filling the device, an ultrasound diagnostic device 4 for obtaining an ultrasound image for observing a treatment site of the subject, ultrasound An ultrasonic probe 5 provided in the applicator 1 in which transmission and reception of ultrasonic waves are controlled by the diagnostic device 4, a monitor 6 for displaying an image obtained by the ultrasonic diagnostic device 4, and a control unit for controlling each of these constituent units as a whole 7 is comprised.
In the ultrasonic therapy apparatus configured as described above, a method using a piezoelectric element is widely used as a source provided in the applicator 1 to generate strong ultrasonic waves. This method has a small focus, no consumables,
Easy control of ultrasonic intensity, phase control of drive voltage applied to multiple piezoelectric elements (ie, delay control)
By doing so, it has excellent characteristics such that the focal position can be easily changed.

What is important in the ultrasonic therapy apparatus is to align the focal point of high-intensity ultrasonic waves applied to the affected part during treatment and to observe the treatment area in real time. Therefore, a plurality of piezoelectric elements that emit strong ultrasonic waves for treatment are arranged in a spherical shape in the applicator 1, and
The ultrasonic probe 5 is set on the axis so as to focus on the treatment site, and an imaging ultrasonic probe 5 for capturing an image of the treatment region is provided at the center of the plurality of piezoelectric elements. Therefore, a tomographic image on the focal axis is obtained from the ultrasonic probe 5, the position of the affected part is determined from the ultrasonic tomographic image (B-mode image), and the position of the treatment applicator 1 is adjusted. The progress of the treatment was confirmed by monitoring the image inside, and it was determined whether the treatment should be continued or terminated based on the change in the image of the treatment site.

In the treatment with high-intensity ultrasonic waves, it is sufficient that a necessary and sufficient energy is given to a patient, and further irradiation may cause a safety-related problem.
Therefore, treatment is performed based on treatment conditions such as irradiation intensity and irradiation time set in advance, and irradiation is automatically stopped when the set irradiation time is reached. However, even within the set irradiation time, it may be possible to determine from the change in the ultrasonic image of the treatment site displayed on the monitor 6 that the treatment purpose has been achieved, and in such a case, the treatment is immediately stopped. It is important to stop the irradiation of the high-intensity ultrasonic wave in order to ensure patient safety.

[0000]

However, in the conventional ultrasonic therapy apparatus, while the operator monitors the ultrasonic image of the treatment site by the imaging ultrasonic probe 5, the operator recognizes a change in the image and recognizes the change in the image. There is a certain time delay before the irradiation of the sound wave is stopped, and excessive energy is given to the patient, which may cause a problem in safety. In addition, the state of the change in the image near the affected area during treatment brings useful information on treatment, such as grasping the treatment situation and reflecting it in the next treatment and reflecting on it, so we want to record the image However, there is a problem that recording is difficult and sufficient data cannot be obtained because the irradiation part changes instantaneously. Regarding the recording of the image, for example, even if the operator recognizes a change in the image and performs a recording operation on the image memory, there is a problem that a required image cannot be recorded due to a time delay of the operation. In addition, it is conceivable to continuously record video or the like during the treatment, but when observing the image after the treatment, there is a problem that it takes time to find a desired image, and the image quality deteriorates and a clear image is obtained. There was also a problem that it could not be obtained. The present invention has been made to solve such a problem.

[0007]

According to a first aspect of the present invention, there is provided a therapeutic ultrasonic wave generating means for irradiating a therapeutic ultrasonic wave to a treatment site of a subject, and the subject comprises: And an image data collecting means for collecting image data in the vicinity of the treatment site, wherein an image acquisition area is set near the focal position of the therapeutic ultrasonic wave radiated by the therapeutic ultrasonic wave generating means. Image area setting means;
Image data information processing means for processing image data collected by the image data collection means in the area set by the image area setting means and issuing a signal when a predetermined characteristic change is detected And a signal from the image data information processing means, wherein the image data storage means for recording image data near the treatment site of the subject for a predetermined time, with a time point which is a predetermined time retroactive from the signal detection time as a recording start time point. It is characterized by having. As a result, it is possible to recognize a characteristic change that appears instantaneously from the image data of the treatment site and, at the same time, reliably save an image of a certain time before and after the time when a significant characteristic change appears as a record.

According to a second aspect of the present invention, there is provided a therapeutic ultrasonic wave generating means for irradiating a therapeutic ultrasonic wave to a treatment site of a subject, and an image data for collecting image data near the treatment site of the subject. In the ultrasonic treatment apparatus provided with image data collecting means, a reflected wave from the vicinity of the treatment site based on the treatment ultrasonic waves emitted from the treatment ultrasonic wave generation means is collected by the treatment ultrasonic wave generation means. Processing the collected reflected wave data to generate a signal when a predetermined characteristic change is detected; and detecting a signal based on the signal from the reflected wave data information processing means. An image data storage means for recording image data in the vicinity of the treatment site of the subject over a predetermined period of time, with a point in time which is a predetermined period from the time set as a recording start point, is provided. By this, at the same time as recognizing characteristic changes that appear instantaneously from the reflected wave data from the vicinity of the treatment site based on the therapeutic ultrasound, images of a certain period of time before and after the time when significant characteristic changes appeared as records were recognized. Can be stored reliably.

[0009] The invention described in claim 3 is the first invention.
3. The ultrasonic therapy apparatus according to claim 2, wherein the therapy setting unit sets operating conditions of the therapeutic ultrasonic wave generating unit, and character data indicating the operating conditions set by the therapy setting unit. 4. And an image synthesizing unit for processing the image data to be displayed on the same screen as the image data collected by the image data collecting unit. Thus, the contents of the treatment setting can be displayed and recorded together with the image of the treatment site, and can be accumulated as effective data for grasping the treatment status and reflecting it in the next treatment.

The invention described in claim 4 is the same as the claim 1.
4. The ultrasonic therapy apparatus according to claim 3, wherein the image data collecting unit is an ultrasonic diagnostic apparatus. 5. This makes it possible to provide a more convenient ultrasonic therapy apparatus.

The invention described in claim 5 is the first invention.
5. The ultrasonic treatment apparatus according to claim 4, wherein the operating condition of said therapeutic ultrasonic wave generating means set in said treatment setting means is changed to said image data information processing means or said reflection. The present invention is characterized by including a treatment setting control means for changing by a signal from the wave data information processing means. And the invention according to claim 6 is:
6. The ultrasonic treatment apparatus according to claim 5, wherein the operating condition of the therapeutic ultrasonic wave generating means, which is changed by the treatment setting control means, stops at least irradiation of therapeutic ultrasonic waves or weakens the irradiation intensity. It is characterized by being. As a result, it is possible to recognize the characteristic change of the treatment site from the image data and the reflected wave data of the treatment ultrasonic wave and to change the treatment setting at the same time, so that there is no time lag until the change and unnecessary unnecessary energy is removed from the treatment region. And the safety for the subject can be extremely improved.

Further, according to a seventh aspect of the present invention, in the ultrasonic therapy apparatus according to the third aspect, the ultrasonic treatment apparatus receives the signal from the image data information processing means or the reflected wave data information processing means. The apparatus further comprises a treatment setting recording means for recording the operating condition of the treatment ultrasonic wave generating means set in the treatment setting means at the time of signal detection. According to an eighth aspect of the present invention, in the ultrasonic treatment apparatus according to the seventh aspect, the operating condition of the therapeutic ultrasonic wave generating means recorded in the treatment setting recording means is at least the therapeutic ultrasonic wave. And the elapsed time from the start of irradiation.
These make it extremely easy to confirm the course of treatment.

[0013]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of an ultrasonic therapy apparatus according to the present invention will be described below in detail with reference to FIGS. In these figures, the same parts as those in FIG. 5 are denoted by the same reference numerals.

FIG. 1 is a block diagram showing the configuration of a first embodiment of an ultrasonic therapy apparatus according to the present invention. In addition, the following units are provided.
That is, for the drive unit 2 that drives the applicator 1 that generates intense ultrasonic waves for treatment, operating conditions,
Irradiation intensity of strong ultrasonic wave, irradiation time, number of repeated irradiation,
A treatment setting unit 11 for setting treatment parameters such as a sound field setting, an irradiation frequency, and the like by phase difference driving; a treatment setting control unit 12 for performing treatment setting in the treatment setting unit 11 or changing the set contents; A treatment setting recording unit 13 that records treatment parameters set or changed in the treatment setting unit 11 by the treatment setting control unit 12 is provided. In addition, in the vicinity of the focal position of the therapeutic ultrasonic wave emitted from the applicator 1, that is, in the therapeutic region, a range in which an ultrasonic image is collected by the ultrasonic probe for imaging 5 is set, and a marker is attached to the range. Of the image region setting unit 14, processing to superimpose character data representing the treatment parameters set in the treatment setting unit 11 on the ultrasonic image including the region set by the image region setting unit 14, and to display them on the same screen. Image synthesizing unit 15 and image synthesizing unit 1
A readable image temporary recording unit 16 is provided which continuously records the image data synthesized in step 5 in time series while sequentially updating the oldest data to the latest data for a predetermined time determined by the memory capacity. I have.

Further, with respect to the latest image data recorded in the image temporary recording section 16, the image data in the image collection area surrounded by the marker set by the image area setting section 14 is converted into RGB (pixel) for each pixel. By extracting luminance data of a red, green, blue) signal or a B / W (black, white) signal and performing a calculation process, an image data information processing unit 17 which emits a detection signal when a characteristic change is detected, When a detection signal is issued from the image data information processing section 17, the detection signal is received, and the image recorded in the image temporary recording section 16 for a predetermined time before and after the time when the detection signal is issued is set as a reference. An image data storage device 18 for reading and storing data is provided. These components, including the components included in the conventional device, are all controlled by the control unit 7. Also, as shown in FIG.
2 is displayed before the intense ultrasonic wave for treatment is irradiated from the applicator 1 to the affected part.
FIG. 2A shows an image as shown in FIG. 2. After a lapse of time after the start of the irradiation of the therapeutic ultrasonic wave, a high echo image near the focal point as shown in FIG. Here, 6a in FIG. 2 is the irradiation range of the therapeutic ultrasonic wave irradiated toward the focal point F, 6b
Denotes a marker indicating an area for acquiring an ultrasonic image set by the image area setting unit 14, and 6 c denotes a display position of character data of the treatment parameter set in the treatment setting unit 11.

Next, the operation of the first embodiment of the ultrasonic therapy apparatus according to the present invention configured as described above will be described. The treatment condition is set in advance in the treatment setting unit 11 via the treatment setting control unit 12 in accordance with the treatment plan.
The treatment parameters set here include the irradiation intensity of the treatment ultrasonic wave irradiated from the applicator 1, the irradiation time, the number of repeated irradiations within the irradiation time (that is, including the irradiation stop cycle and the stop interval), the position, and the like. The sound field setting and the irradiation frequency by the phase difference drive are used. The irradiation of the therapeutic ultrasonic wave is set so that, for example, a stop interval of 0.05 second is provided for one second, and this is repeated, and the irradiation is repeated for 10 seconds and 30 seconds.
The treatment is given for seconds, 60 seconds, etc. The irradiation time of this therapeutic ultrasonic wave can be lengthened if the treatment site is not affected by respiration or the like and is difficult to move with time. Conversely, when treating organs that move due to breathing, etc., set a short irradiation time and take a pause, repeat the irradiation while checking the focal point position during the pause, and remove the therapeutic ultrasound from the treatment site. Is not irradiated. The cycle of irradiation and rest can be fixed, or the treatment setting can be changed during treatment.
Regarding the content of the change, what is changed at what time and how is set in advance. These set contents and changed contents are recorded in the treatment setting recording unit 13 as characters as irradiation data so that the progress of the treatment can be understood.

The applicator 1 irradiates ultrasonic waves for treatment under the conditions set in the treatment setting section 11, and image data of the treatment site is collected by the ultrasonic diagnostic apparatus 4 via the ultrasonic probe 5. At this time, the image synthesizing unit 15 adds the marker data 6b set by the image area setting unit 14 and the character data representing the treatment parameters set in the treatment setting unit 11 to the ultrasonic image collected by the ultrasonic diagnostic apparatus 4. On the same screen. Therefore, an operator such as a doctor can check the progress of treatment, setting conditions, and the like while viewing the screen of the monitor 6. Then, by driving the applicator 1 and the ultrasonic probe 5 in parallel, the state of the treatment site being treated is monitored 6.
And can be observed in real time. However, when the therapeutic ultrasonic wave is received by the ultrasonic probe 5,
This may make it difficult to see the ultrasonic image as noise. Therefore, by acquiring ultrasonic images during a short period of time during which the irradiation of therapeutic ultrasonic waves is stopped, when irradiation of therapeutic ultrasonic waves starts, a noise-free image immediately before that is recorded in memory. Then, by repeatedly displaying the image, the state of the treatment site during irradiation of the treatment ultrasonic wave may be observed. An ultrasonic therapy apparatus that performs such control is described in detail in Japanese Patent Application No. 11-17600.

The image synthesized by the image synthesizing unit 15 is, for example, a FIFO (first-in-firsts).
t-out) Temporary image recording unit 1 composed of a memory or the like
6 is stored in time series over a certain period of time. That is, when new image data is input to the image synthesized by the image synthesis unit 15 beyond the memory capacity of the image temporary recording unit 16, the oldest image data is discarded and new image data is stored. I do. Then, of the sequentially recorded image data, the image data of the area designated by the marker 6b is cut out and sent to the image data information processing unit 17,
Here, RGB or B / W luminance data is extracted for each pixel and subjected to calculation processing. This calculation process
1) a luminance adding process of simply adding the luminance of each pixel,
2) luminance difference detection processing for detecting the difference between the maximum and minimum luminance values, 3) luminance variance value processing for detecting luminance variance, 4)
A color component luminance addition process for adding the luminance of the color component (R or B) of the color Doppler image of the blood flow; 5) an image which obtains a difference from the luminance of the image data before treatment and obtains a total value or an average value of the differences. For example, data difference detection processing. When these tissues are irradiated with ultrasonic waves, when the temperature of the irradiated area, that is, the treatment area, rises and thermal denaturation progresses, they become high echoes on the ultrasonic image, and the brightness increases. By using the fact that the blood flow becomes uniform or the blood flow stops, it is intended to detect a characteristic change in the image. In addition, when a solid object is irradiated with ultrasonic waves like a calculus, the calculus is broken, and conversely, a uniform image becomes non-uniform.

Therefore, as a result of performing various processes in the image data information processing section 17 as described above, when it is detected that a characteristic change has appeared in the image data, a detection signal is output from the image data information processing section 17. Emits. The characteristic change is when the luminance of each pixel is simply added in the above-mentioned 1) luminance addition processing, and it is detected that the total luminance exceeds or falls below a set threshold value. Yes, 2) In the luminance difference detection processing, it is detected that the difference between the maximum value and the minimum value of the luminance of the image data exceeds or falls below a set threshold value. 3)
In the luminance variance processing, it is detected that the variance of the luminance in the region exceeds or falls below a set threshold. 4) In the color component luminance addition processing, the color Doppler image of the blood flow is detected. This is when it is detected that the added luminance of the color components (R or B) exceeds or falls below a set threshold value. 5) In the image data difference detection processing, the image data during the treatment and the image data before the treatment are detected. This is when it is detected that the total value or the average value of the luminance differences from the image data exceeds or falls below a set threshold value. The determination as to whether or not a characteristic change has appeared in the image data is made by simply weighting each of the detected binary values. In detail, however, the data such as the actual luminance added value is used. On the other hand, determination is made by performing similar weighting. Then, if the determination result is “yes”, a detection signal is sent to the control unit 7.

Upon receiving the detection signal, the control unit 7 determines whether the image data already recorded in the image temporary recording unit 16 and the image data to be recorded from now on are determined before and after the time when the detection signal is received. The image data is stored in the image data storage device 18 for the time. The image to be stored may be a still image or a moving image. Further, upon receiving the detection signal from the image data information processing unit 17, the control unit 7 receives the contents of the change of the treatment condition via the treatment setting control unit 12, and controls the driving unit 2 to control the irradiation intensity of the therapeutic ultrasonic wave. Change the treatment pattern such as irradiation time. For this change, for example, the irradiation is immediately stopped according to the setting, or the irradiation time is reduced without changing the irradiation intensity, or the irradiation intensity is reduced without changing the irradiation time. These changes can be set arbitrarily in advance, in addition to the irradiation intensity and irradiation time, the number of repeated irradiations,
Image data information processing unit 17 such as sound field setting and irradiation frequency
Various patterns can be selected according to the contents of the processing in.

As described above, according to the present invention, it is possible to recognize a characteristic change of an image and simultaneously change a treatment setting without causing a time lag from the time when the image is changed to the time when the operator changes the treatment setting. As a result, unnecessary excess energy is not applied to the treatment site, and safety for the subject can be greatly improved. In addition, since images can be stored for a certain period of time before and after the time when the characteristic change of the image is recognized, only images that are meaningful as a record can be obtained, so that the treatment status can be grasped and the next time. It is effective as a material to reflect on the treatment of the disease.

Next, a second embodiment of the present invention will be described. FIG. 3 is a second view of the ultrasonic therapy apparatus according to the present invention.
FIG. 2 is a block diagram showing an embodiment of the present invention, in which a reflected wave data information processing unit 21 is provided instead of the image data information processing unit 17 of the ultrasonic therapy apparatus according to the first embodiment shown in FIG. It is. In the second embodiment, since the image area setting unit 14 is not particularly required, it is deleted.
Other parts that are the same as those in FIG.
The description of that part is omitted. By the way, in this embodiment, the reflected wave from the treatment site due to the irradiated strong ultrasonic wave is received by the piezoelectric element constituting the applicator 1 for generating the strong ultrasonic wave for treatment, and the reflected signal is processed. Then, a characteristic change of the treatment site is detected. That is, when the piezoelectric element provided in the applicator 1 is driven to irradiate a strong ultrasonic wave to the treatment site, reflection occurs on the tissue of the subject, and the reflected wave is received by the piezoelectric element. Therefore, the received reflected signal is guided to the reflected wave data information processing unit 21 via the driving unit 2. The reflected wave data information processing unit 21 calculates and processes the amplitude, frequency, phase difference, and the like of the reflected signal, and compares the data with each data at the start of irradiation. Judging that there was a characteristic change,
Generates a detection signal. Then, the reflected wave data information processing unit 2
When the control unit 7 receives the detection signal from the control unit 1, the control unit 7 determines whether the image data already recorded in the image temporary recording unit 16 and the image data to be recorded from now on for a predetermined time before and after the time when the detection signal is received. The image data is stored in the image data storage device 18, the contents of the change in the treatment condition are received via the treatment setting control unit 12, and the driving unit 2 is controlled to change the irradiation intensity and irradiation time of the treatment ultrasonic wave. The subsequent operation is the same as in the first embodiment, and a description thereof will be omitted.

In such an embodiment, the same effects as in the first embodiment can be obtained. Also,
FIG. 1 is a block diagram of the first embodiment, and FIG. 3 is a block diagram of the second embodiment. These are combined into one device as shown in FIG. The treatment setting may be changed or the image may be recorded by appropriately selecting the characteristic change of which is easy to recognize from the change in the image or the change in the reflected wave. In FIG. 4, the same parts as those in FIGS. 1 and 3 are denoted by the same reference numerals, and the description of those parts will be omitted. Furthermore, in each embodiment of the present invention, the description has been made assuming that the ultrasonic probe 5 is provided in the applicator 1 and the image data of the diagnostic site is obtained by the ultrasonic diagnostic apparatus 4, but it is not necessarily limited to the ultrasonic diagnostic apparatus. It goes without saying that an X-ray television fluoroscope, an X-ray CT apparatus, an MRI apparatus, or the like can be used as long as treatment can be performed while obtaining an image of a diagnosis site. In this case, if the acquired image data is analog data, it is converted into digital data and used as data for each pixel. In addition, X-ray television fluoroscopy, X-ray CT, MRI, etc.
When obtaining an image of a diagnostic site, there is no possibility that noise due to the therapeutic ultrasonic waves will be mixed in the image even if the driving of the applicator 1 and the collection of the image are performed in parallel.

[0024]

As described above in detail, according to the present invention, there is no time lag between the time when the image is changed and the time when the operator changes the treatment setting. Since the treatment setting can be changed at the same time as the characteristic change is recognized from the reflected wave data, unnecessary excess energy is not applied to the treatment site, and the safety for the subject can be greatly improved. In addition, images can be saved for a certain period of time before and after the time when a characteristic change is recognized from image data or reflected wave data of therapeutic ultrasound, so that only treatments at significant points in time can be stored. An ultrasonic therapy apparatus is provided which can obtain an image of a part and is effective as a material for grasping the treatment status and reflecting it in the next treatment.

[Brief description of the drawings]

FIG. 1 is a block diagram showing a configuration of a first embodiment of an ultrasonic therapy apparatus according to the present invention.

FIG. 2 is an explanatory diagram of a monitor screen shown for explaining an operation of the present invention.

FIG. 3 is a block diagram showing a configuration of a second embodiment of the ultrasonic therapy apparatus according to the present invention.

FIG. 4 is a block diagram showing a configuration of another embodiment of the ultrasonic therapy apparatus according to the present invention.

FIG. 5 is a block diagram of a conventional ultrasonic therapy apparatus.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Applicator 2 Drive part 3 Water unit 4 Ultrasonic diagnostic apparatus 5 Ultrasonic probe 6 Monitor 7 Control part 11 Treatment setting part 12 Treatment setting control part 13 Treatment setting recording part 14 Image area setting part 15 Image synthesis part 16 Image temporary recording Unit 17 Image data information processing unit 18 Image data storage device

Claims (8)

[Claims] 1. An ultrasonic treatment comprising: a therapeutic ultrasonic wave generating means for irradiating a therapeutic ultrasonic wave to a treatment part of a subject; and an image data collecting means for collecting image data near the treatment part of the subject. In the apparatus, an image area setting means for setting an image acquisition area near a focal position of the therapeutic ultrasonic wave irradiated by the therapeutic ultrasonic wave generating means, and the image in an area set by the image area setting means Image data information processing means for processing image data collected by the data collection means and generating a signal when a predetermined characteristic change is detected; and signal detection based on a signal from the image data information processing means. Image data storage means for recording image data in the vicinity of the treatment site of the subject over a predetermined period of time, with a point in time that is a predetermined time from the time set as a recording start point. Ultrasonic treatment apparatus according to symptoms. 2. An ultra-sound system comprising: a therapeutic ultrasonic wave generating means for irradiating a therapeutic ultrasonic wave to a treatment part of a subject; and an image data collecting means for collecting image data near the treatment part of the subject. In the ultrasonic treatment apparatus, a reflected wave from the vicinity of the treatment site based on the treatment ultrasonic wave emitted from the treatment ultrasonic wave generation means is collected by the treatment ultrasonic wave generation means, and the collected reflected wave data is processed. Then, a reflected wave data information processing means for emitting a signal when a predetermined characteristic change is detected, and a time point a predetermined time before the signal detection is recorded by a signal from the reflected wave data information processing means. An ultrasonic treatment apparatus comprising: image data storage means for recording image data near the treatment site of the subject over a predetermined time as a start time. 3. A treatment setting means for setting an operating condition of the treatment ultrasonic wave generating means, and character data indicating the operating condition set by the treatment setting means, the image data collected by the image data collecting means. 3. The ultrasonic treatment apparatus according to claim 1, further comprising: an image synthesizing unit configured to perform processing to display the same on the same screen. 4. The ultrasonic therapy apparatus according to claim 1, wherein said image data collecting means is an ultrasonic diagnostic apparatus. 5. An operating condition of said therapeutic ultrasonic wave generating means set in said treatment setting means is changed by a signal from said image data information processing means or said reflected wave data information processing means. The ultrasonic treatment apparatus according to any one of claims 1 to 4, further comprising a treatment setting control unit. 6. The operation condition of the therapeutic ultrasonic wave generating means, which is changed by the treatment setting control means, is at least to stop irradiation of the therapeutic ultrasonic wave or weaken the irradiation intensity. An ultrasonic therapy apparatus according to claim 5. 7. A signal from the image data information processing means or the reflected wave data information processing means, the signal of the treatment ultrasonic wave generation means being set in the treatment setting means at the time of detection of the signal. The ultrasonic treatment apparatus according to claim 3, further comprising a treatment setting recording unit that records an operation condition. 8. The operation condition of the therapeutic ultrasonic wave generating means recorded in the treatment setting recording means includes at least irradiation intensity of the therapeutic ultrasonic wave and elapsed time from the start of irradiation. Item 8. An ultrasonic treatment apparatus according to item 7.