WO2012017731A1 - 凍結治療素子及び凍結治療装置 - Google Patents
凍結治療素子及び凍結治療装置 Download PDFInfo
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- WO2012017731A1 WO2012017731A1 PCT/JP2011/062660 JP2011062660W WO2012017731A1 WO 2012017731 A1 WO2012017731 A1 WO 2012017731A1 JP 2011062660 W JP2011062660 W JP 2011062660W WO 2012017731 A1 WO2012017731 A1 WO 2012017731A1
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- freezing
- size
- ultrasonic
- frozen
- cryotherapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00106—Sensing or detecting at the treatment site ultrasonic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00041—Heating, e.g. defrosting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0293—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument interstitially inserted into the body, e.g. needle
Definitions
- the present invention relates to a cryotherapy element and a cryotherapy device for treating an affected area by repeating freezing and thawing of the affected area.
- the cryotherapy element uses the Joule-Thompson effect or the like to repeatedly freeze and thaw the affected area several times, thereby necrotizing the affected area. This treatment is called cryotherapy.
- the affected part freezes with a predetermined extent by freezing and melts by thawing. By repeating this freezing and thawing once (one cycle) or more, for example, twice or three times, reliable necrosis is caused.
- the frozen affected area is frozen. Freezing size is determined by organ type (tissue) and freezing temperature. When repeating two or more cycles, the icing volume at the second cycle tends to be larger than the first cycle.
- a treatment plan such as the size of the treatment element and the time sequence of freezing and thawing is made according to the tissue and lesion state of the affected area. Treatment is performed under this treatment plan. It is preferable to know the frozen state at the time of freezing during treatment, that is, the frozen size in the frozen state, but the frozen size is not visually observable because the affected part is in the body such as the lung. Therefore, it is conceivable to perform imaging using an MRI apparatus or CT apparatus in parallel with the treatment and determine the ice size from the image.
- MRI and CT measurements are performed online while performing cryotherapy.
- the apparatus itself is large, and must be combined with an image processing apparatus, and the system must be large.
- the ice size can be measured easily and online without using an MRI apparatus or CT apparatus.
- An object of the present invention is to provide a cryotherapy element and a cryotherapy device that can meet such demands.
- a further object of the present invention is to provide a cryotherapy element and a cryotherapy device that can easily detect the freezing size using ultrasonic waves.
- the present invention discloses a cryotherapy apparatus comprising a freezing terminal for freezing and thawing, and a size detecting means for measuring a frozen part of an affected area and obtaining a freezing size.
- the present invention provides a cryotherapy element that has a metal outer cylinder and a freezing terminal for freezing and thawing inserted into the outer cylinder, and enables treatment of freezing and thawing of the affected area.
- An ultrasonic transducer that is attached to the outer cylinder, sends an ultrasonic wave to the frozen part of the affected part, and receives an ultrasonic reflected wave from the frozen part of the affected part for detecting the size of the frozen part of the affected part;
- a cryotherapy element comprising: is disclosed.
- the present invention discloses a cryotherapy element in which the ultrasonic transducer is detachable from a cylindrical outer peripheral portion of the outer cylinder.
- the present invention discloses a cryotherapy element in which a material having an ultrasonic conduction characteristic worse than that of the metal is provided inside the distal end side of the outer cylinder.
- the present invention has a metal outer cylinder and a freezing and thawing freezing terminal inserted into the outer cylinder to enable the treatment of the affected area freezing and thawing.
- a cryotherapy element having an ultrasonic transducer to be mounted; An ultrasonic transducer attached to the outer cylinder; Transmitting means for exciting the ultrasonic transducer and transmitting ultrasonic waves to the affected part freezing part; Receiving means for receiving a reflected signal from the vibrator that has received an ultrasonic reflected wave from a frozen part of the affected area; A size detecting means for obtaining the size of the affected part frozen region based on the reflected signal;
- a cryotherapy apparatus characterized by comprising:
- the ultrasonic device includes an ultrasonic transducer, Transmitting means for exciting the ultrasonic transducer and transmitting ultrasonic waves to the affected site frozen site; Receiving means for receiving a reflected signal from the vibrator that has received an ultrasonic reflected wave from a frozen part of the affected area; A size detecting means for obtaining the size of the affected part frozen region based on the reflected signal;
- a cryotherapy apparatus characterized by comprising:
- the present invention discloses a cryotherapy apparatus in which the size detection means obtains the icing size based on the amplitude of the reflected signal and the area of the envelope of time change.
- the present invention discloses a cryotherapy apparatus in which the size detection means obtains the icing size based on the peak value of the amplitude of the reflected signal.
- the size detection means performs size detection based on a reflection signal received after the reflection signal, except for a reflection signal corresponding to a distance from the ultrasonic transducer installation position to the outer cylinder part.
- a cryotherapy device is disclosed.
- the present invention has a metal outer cylinder provided with a material material having an ultrasonic conduction characteristic worse than that of the metal inside the tip side, and a freezing terminal for freezing and thawing inserted into the outer cylinder.
- a cryotherapy element that enables treatment of the affected area freezing and thawing;
- An ultrasonic transducer attached to the outer cylinder;
- a sending means for exciting the vibrator to send an ultrasonic wave to the frozen part of the affected part and sending the ultrasonic wave to the frozen part of the affected part;
- Sending means for sending an excitation signal to the affected part frozen part;
- Receiving means for receiving a reflected signal from the vibrator that has received an ultrasonic reflected wave from a frozen part of the affected area;
- a size detecting means for obtaining the size of the affected part frozen region based on the reflected signal;
- the size detection means distinguishes the reflected wave through the material material and the reflected wave through the material material by using a time difference, based on the area or peak
- cryotherapy element and the cryotherapy apparatus of the present invention it is possible to detect the freezing size from the reflected signal from the affected area.
- the ice size can be accurately detected from the amplitude envelope area of the reflected signal.
- the ultrasonic transducer according to the present invention can be detachably mounted on the circumference of a metal outer cylinder, so that it can be mounted when necessary to measure the freezing size.
- FIG. 1 shows an exploded view of a cryotherapy element of the present invention. It is an Example figure of the ultrasonic vibration apparatus which can be detachably attached to a cryotherapy element. It is a schematic diagram of the freezing treatment to an affected part. It is a figure which shows the icing state by freezing. It is an equivalent circuit diagram for ultrasonic propagation reflection when the ultrasonic transducer of the cryotherapy element of the present invention is attached. It is explanatory drawing of propagation of the ultrasonic wave of this invention, and its reflection. It is a reflected wave measurement example figure. The transition diagram of the frozen state from the start of freezing to thawing is shown. The time chart of the reflection in the icing state of FIG. 8 is shown.
- FIG. 11 shows a time chart of a reflected signal from the cylinder 1 shown in FIG. It is a figure which shows the signal identification with respect to the time chart of FIG. It is an Example figure of a size detection apparatus. It is a specific structural example figure of the transmission / reception part 5 of this invention. It is an example circuit diagram for ultrasonic excitation of the present invention. It is another Example figure of a size detection apparatus. 1 is a basic configuration diagram of the present invention. It is a data table example figure of this invention.
- FIG. 17 is an overall configuration diagram of the cryotherapy apparatus of the present invention.
- the cryotherapy apparatus includes a cryotherapy element 100 and an ice size detection apparatus 200.
- cryotherapy elements 100 There are two types of cryotherapy elements 100. The first is an example in which a freezing element (frozen probe, hereinafter the same) is placed in a metal or plastic cylinder as an outer cylinder and integrated with the cylinder. The second is an example of only a freezing element without using an outer cylinder.
- the freezing element has a function of causing the necrosis of the affected part by freezing and thawing the affected part of the subject in contact with the outer cylinder or the freezing element by alternately entering the freezing gas and the thawing gas.
- the first type is often used for puncturing the subject from outside the body
- the second type is used to puncture the affected part by operating the affected part of the subject to be partially or completely opened.
- the first type is an example of use in an invisible case
- the second type is an example of use in a state where the puncture state is visible to some extent.
- the first type is an example in which a freezing element is inserted into the outer cylinder, so that it is safer for the subject against damage during use of the freezing element and external leakage of freezing gas and thawing gas. Element. Therefore, even if it is used in a state where the puncture state is visible to some extent, it may be used.
- the icing size detection apparatus 200 is an apparatus that detects the icing size of the frozen part of the affected part of the subject.
- the freezing size detection apparatus 200 is an example of an image diagnostic apparatus such as an X-ray CT apparatus, an MRI apparatus, or an ultrasonic diagnostic apparatus.
- An ultrasonic vibrator is attached to a cryotherapy element 100 described later, and the freezing size detection apparatus is attached to the vibrator.
- the frozen size includes a frozen diameter, a frozen area, and a frozen volume.
- the freezing size is detected in real time as the freezing progresses.
- fluoroscopic or tomographic imaging of an affected part is performed while irradiating X-rays during freezing (including during thawing).
- the freezing size is obtained from the fluoroscopic data or tomographic image data obtained by this imaging.
- MRI imaging is performed during freezing to obtain tomographic image data, and the freezing size is obtained therefrom.
- ultrasonic diagnostic apparatus an ultrasonic trading company is performed during freezing to obtain fluoroscopic data or tomographic image data.
- the ice size is obtained from this fluoroscopic data or tomographic image data.
- Another method is to ask automatically. For example, only the icing site is automatically detected, and the icing size is detected from the detected icing site.
- the size of the pixel data differs between the icing site and the non-icing site.
- the pixel data of the frozen part has a pixel value larger than the pixel data of the non-iced part. Therefore, a threshold value for distinguishing both is set, and pixel data belonging to the frozen site is selected.
- This pixel data group indicates an icing site.
- the freezing size can be determined from this freezing site.
- the ice size detection method has been described with reference to fluoroscopic data and tomographic image data. However, when ultrasonic waves are used, there is a method of detecting from the envelope of the reflected wave signal. In the detection method using this envelope, only the reflected signal from the frozen part is identified, and the frozen size is obtained from the envelope of the identified reflected signal.
- the freezing size can be determined by the ratio between the energy of the ultrasonic wave to be transmitted and the energy of the ultrasonic wave reflected and received from the freezing site.
- the ultrasonic energy is determined by the product of the waveform and its time width.
- the ultrasonic wave is a trigonometric function such as a burst wave, a pulse wave, or a sine wave, and its time width and waveform can be known in advance.
- the ultrasonic reflected wave from the icing site is determined by the tissue, disease state (morbidity), and icing size of the target treatment site, which is obtained by measurement.
- the freezing size S to be obtained is that the energy of the ultrasonic wave is E 1 and the energy of the ultrasonic wave is E 2 .
- E 1 and E 2 are V 1 (t) for the transmitted wave, t i to t j for the time width, V 2 (t) for the received wave, and t m to t n for the time width.
- the above E 1 and E 2 are mathematically envelope functions of a transmission wave and a reception wave.
- the freezing size varies depending on the freezing cycle, the thawing cycle, the progress of freezing in each cycle, and the progress of thawing. Measurements for detecting ice size are performed at various timings. (1) When it is desired to obtain only the freezing size at the final point of each freezing cycle, the reflected wave signal is measured immediately after the freezing cycle and the freezing size is detected. (2) When it is desired to monitor the progress of icing size due to the progress of freezing in each freezing cycle, the reflected wave signal is measured at a plurality of timings in each freezing cycle to detect the freezing size. For example, for each cycle, the first ultrasonic radiation is performed and the reflected wave is received to determine the first freezing size.
- the second ultrasonic radiation is performed at the timing when the first reflected wave disappears completely, and the reflected wave is received to obtain the second frozen size.
- the same measurement is performed at the same timing to detect the ice size.
- the relationship between the calculated value S 0 and the freezing size D is obtained in advance using an object model or the like using the organ type, tumor type, etc. as parameters, and stored in the data table 300 as reference data. Keep it. And for calculating values S 0 obtained from the actual object, reads the freezing size D corresponding from the data table.
- the actual freezing size D has three parameters: organ type a (lesion site such as lung, kidney, liver), disease state b such as tumor type, and calculated value S 0 (this is called parameter c).
- organ type a lesion site such as lung, kidney, liver
- disease state b such as tumor type
- calculated value S 0 this is called parameter c.
- the calculated value S 0 becomes parameter c, since it is the actual calculated value S 0 which is obtained based on that measurement in accordance with the progress of the freezing and the actual freezing size at that time does not necessarily coincide This means that it is a parameter.
- the parameter c is not necessary for the case where both coincide.
- the data table 300 calculates value data S 0 and 3 based on the parameter data D (a, b, c) allowed to store in correspondence a. For example, suppose that it is a freezing treatment example for a certain organ a 1 and a certain tumor b 1 . Assume that the actual calculated value S 0 at a certain timing is S 01 (this corresponds to the parameter c 1 ). Therefore, the data table 300 is referred to.
- the ice size data D 1 corresponding to the calculated value data S 01 from the data column that is, the data D (a 1 , b 1 , C 1 ).
- This data D (a 1 , b 1 , c 1 ) is specified as the actual ice size at that timing, and is output for the control device or the display screen.
- the corresponding freezing size data D 2 that is, data D (a 1 , b 1 , c 2 ) is read out in the same manner.
- the ice size at that timing is identified and output for the control device and display screen.
- an ultrasonic apparatus using the above-described detection method using an envelope there are an example using the above-described ultrasonic diagnostic apparatus and an example in which an ultrasonic transducer is attached to the cryotherapy element 100 for measurement and detection.
- the former ultrasonic diagnostic apparatus is separate from the cryotherapy element 100, has a group of electronically controllable multi-channel ultrasonic transducers, and enables ultrasonic radiation in various directions by channel switching. .
- the reflected ultrasonic wave from each direction is measured for each direction, and all the significant directions are measured by the envelope.
- the ice size is detected from the measurement results of envelopes in all possible directions.
- multi-channel there is an example of only one channel.
- an ultrasonic detector is connected to the ultrasonic vibrator.
- the reflected wave from the ultrasonic transducer attached by the ultrasonic detector is detected to detect the ice size.
- the ultrasonic transducer and the ultrasonic detection device are the frozen size detection device of FIG.
- a one-channel type is fundamental. Of course, there are examples of multiple channels such as two channels. All channels are provided with directivity characteristics for each channel that can cover all icing sites, and ultrasonic emission and reception are performed for each channel, and data for the entire icing portion is acquired to obtain the icing size S.
- This detection method using envelopes is not obtained from fault plane data, but uses time-series reflected wave signals from icing sites, so the amount of data to be processed is less than that of fault plane data usage examples. And there is an advantage that the data capacity is much smaller.
- FIGS. 1 and 2 are exploded views showing a cryotherapy element equipped with the ultrasonic transducer of the present invention.
- This element includes a metal cylinder 1 serving as an outer cylinder shown in FIG. 1, a guide needle 2, a freezing element (freezing probe) 3, and an ultrasonic transducer 4.
- the tip 1A of the cylinder 1 is open. This tip 1A is a part that contacts the affected part.
- the tip 1A has, for example, a sharp blade shape, and can puncture the affected area.
- the tip side of the cylinder 1 is needle-shaped.
- the inner diameter of the cylinder 1 is such that the guide needle 2 and the freezing probe 3 can be inserted independently.
- the guide needle 2 is a needle with a pointed tip and serves as a guide for progression to the affected area.
- the freezing probe 3 is an element that freezes and thaws the affected area using the Joule-Thompson effect.
- a freezing gas such as argon and a thawing gas are alternately fed into the probe and discharged.
- a feed / discharge mechanism (not shown) is connected to the probe 3.
- the ultrasonic transducer 4 has a bowl-shaped support portion 4A and two ultrasonic vibration portions 4B and 4C attached to the tip thereof.
- the support portion 4A having the spring 4D is a grasping means such as an operator.
- the ultrasonic vibration parts 4 ⁇ / b> B and 4 ⁇ / b> C have cylindrical pieces 40 and 41 that can be sandwiched between outer cylindrical surfaces of the cylinder 1 and fixed to the cylinder 1.
- the vibration element bodies 42 and 43 are attached to the inner surfaces of the cylindrical pieces 40 and 41 by bonding.
- an operator or the like grasps the support portion 4 ⁇ / b> A and bends it inside, and then the cylindrical pieces 40 and 41 are brought into contact with the outer periphery of the cylinder 1, and then the support portion 4 ⁇ / b> A. Is removed from the hand and attached to the cylinder 1 by the action of the spring 4D. As a result, the vibrator main bodies 42 and 43 are brought into close contact with the outer periphery of the cylinder 1.
- the spring 4D there are examples other than the spring, and there are also examples in which it is fixedly installed on the outer periphery of the cylinder 1.
- the ultrasonic transmitter / receiver 5 is connected to the vibrator main bodies 42 and 43 of the ultrasonic vibrator 4.
- the ultrasonic transmission / reception unit 5 transmits a signal for oscillation for ultrasonic excitation to the ultrasonic transducer bodies 42 and 43, and reflects the reflected waves from the ultrasonic transducer bodies 42 and 43 that have received the reflected waves.
- Wave signal receiving means The vibration pieces 42 and 43 and the ultrasonic transmission / reception unit 5 are connected by a lead wire 44 provided along the hook-shaped member of the support portion 4A.
- the ultrasonic vibrator In the case of the ultrasonic vibrator with the second type freezing element, the ultrasonic vibrator is directly attached to the freezing element 3 as shown in FIG. In the following, the case of the first type freezing element will be described, but the same applies to the second type freezing element.
- the guide needle 2 is inserted into the cylinder 1, and an operator or the like applies the cylinder 1 into which the guide needle 2 is inserted to a living tissue such as skin and / or pushes the cylinder to puncture the guide needle 2 and perform a puncturing operation. Then push it to the affected area. When reaching the affected area, the guide needle 2 is extracted from the cylinder 1. Next, instead of the guide needle 2, the freezing probe 3 is inserted into the cylinder 1. Since there is a slight gap between the cylinder 1 and the freezing probe 3, physiological saline is poured into the gap.
- the frozen gas is sent to the freezing probe 3 to freeze (freeze) the affected part including the part in contact with the cylinder 1 and the surrounding part of the freezing probe 3, and then the thawed gas is sent to thaw the frozen part of the affected part. I do.
- This freezing and thawing is repeated for at least one cycle, preferably about 2 to 4 cycles.
- the ultrasonic transducer 4 is used for measurement of ice size (including volume or diameter size). It may be performed every time of freezing or may be measured only during freezing in the first cycle. This is convenient when the ice size after the second cycle can be predicted.
- FIG. 3 shows a state in which the frozen probe 3 is punctured from the skin 6 and penetrates the affected area 7.
- the ultrasonic transducer 4 is already attached to the cylinder 1.
- the affected part 7 is frozen. This treatment is performed by injecting frozen (freezing) gas (for example, argon) from the outside into the frozen probe 3 through the pipe 8.
- frozen gas injection control by the pipe 8 is performed by a gas inflow / exhaust mechanism (not shown) provided outside.
- the affected part 7 around the probe 3 and the cylinder 1 is frozen by freezing treatment.
- a thawing procedure is performed immediately after the freezing procedure.
- This thawing treatment is performed by flowing a thawing gas into the freezing probe 3 through the pipe 8, and this thawing gas is performed by a gas inflow / discharge mechanism (not shown). Note that both the frozen gas and the thawed gas are appropriately sent to the probe 3 from a gas inflow / discharge mechanism (not shown).
- ultrasonic waves are emitted from the vibrating pieces 42 and 43 of the vibrator 4 at an appropriate timing by the action of the ultrasonic transmission / reception unit 5. Timing can be either continuous or intermittent.
- the ultrasonic waves from the vibration pieces 42 and 43 propagate through the cylinder 1 and are emitted to the outside. There is a living tissue including the affected part 7 outside, and the reflected waves of the living tissue including the affected part 7 are received by the vibration pieces 42 and 43.
- the vibrating pieces 42 and 43 may be provided, the provision of the two facing each other has an advantage that the ultrasonic waves can propagate evenly through the cylinder 1.
- the living tissue including the affected part has an icing site and a non-icing site, and the icing site is less attenuated in the ultrasonic wave like water, and the non-icing site is a biological tissue, and the attenuation is increased. Since the medium changes at the boundary between the icing site and the non-icing site, the emitted ultrasonic wave has a unique reflection at this boundary.
- the reflected waves are received by the vibration pieces 42 and 43 to be reflected signals, and the ultrasonic oscillation / reception unit 5 distinguishes them from other reflected wave signals.
- the signal of the reflected wave from the identified boundary reflects the ice size (area or diameter), and the ice size (area or diameter) is obtained by a predetermined conversion.
- FIG. 4 shows a schematic relationship among the frozen portion 10, the freezing probe 3, and the cylinder 1.
- the point P 1 is the installation position of the ultrasonic transducer (handled as a point for simplicity), and the point P 2 is the position of the tip of the cylinder in the affected area 7.
- the frozen part and the affected part may or may not match, it is an object of the present invention to measure the size of the frozen part 10.
- FIG. 5 shows an equivalent circuit of ultrasonic propagation, and equivalently shows the ultrasonic propagation as a transmission line network.
- P 1 is the transducer installation position shown in FIG. 4, and P 2 is the tip position of the cylinder 1 or the freezing probe 3.
- P 3 is the tip position of the probe that the protruding.
- P 3 often corresponds to the position of the maximum ice diameter.
- r 1, r 2, ... resistance component such as is not, depending on the freezing progresses, freezing size is increased, the resistance component one after another from the front side (P 2 from P 2 P 1 side) and P 2 ⁇ P 3 can be expressed.
- FIG. 6 is a diagram for explaining the emission of ultrasonic waves and the reflection thereof.
- P 1 is an installation position of the ultrasonic pieces 42 and 43
- 10 is an icing portion
- Q 1 is a reflected wave.
- the ultrasonic wave emitted from the position P 1 propagates through the cylinder 1.
- the cylinder 1 is made of metal, so that the reflected wave from the cylinder returns most quickly. And the amount of attenuation is small. This is the first reflected wave.
- the ultrasonic wave propagates from the outer periphery of the cylinder 1 to the inside of the icing portion 10 with more attenuation than the cylinder. And is reflected at the boundary between the entire 15 becomes a reflected wave Q 2 occurs.
- the reflected wave Q 3 are small.
- the reflected wave Q 1 includes the reflected waves Q 2 and Q 3 and the cylindrical reflected wave.
- the direct reflected wave from the cylinder itself has a large amplitude, but because of the reflected wave that returns immediately after being emitted, the physical condition such as the distance between the cylinder and P 1 is taken into account to consider the electrical conditions from the received wave. Can be removed. Since the reflection Q 3 is a reflected wave that returns later after the reflected wave of the icing portion 10, it is also identifiable on the time axis, or the appearance of an attenuation wave having a small amplitude is monitored and this is reflected. Remove it from the target by removing it.
- a section t 1 is a reflected wave signal from the cylinder itself, and this section t 1 is obtained in advance from the distance between the points P 1 and P 3 . Therefore, all the reflected signals existing in the section t 1 are excluded, and envelopes accompanying changes in amplitude and time are obtained for the reflected signals after time t 1, and the area V of the envelope is obtained.
- the area V is a value reflecting the freezing size, and the freezing size is calculated by a predetermined conversion.
- Time T 1 after the reflected signal is the interval t 2 until zero increases larger icing size smaller smaller.
- the series of processing, from ultrasonic transmission to freezing size calculation, is performed by the freezing size detection unit. Details thereof will be described later.
- FIG. 8 shows an example of measuring the ice size in a plurality of time phases over one cycle including freezing and thawing.
- FIG. 8 (a) is before the start of freezing
- FIGS. 8 (b) to 8 (d) are during freezing
- FIGS. 8 (e) and (f) are during thawing.
- FIGS. 9A to 9D are time charts of ultrasonic reflected signals corresponding to FIGS. 8B to 8E, and are reflected signals according to the ice size in each time phase. From there, the ice size at each phase can be determined.
- Detecting the ice size in multiple time phases in FIGS. 8 and 9 has an advantage that the state of ice growth during the freezing process can be understood.
- a reference value determined according to the freezing size and diameter is obtained in advance and stored in the memory.
- a reference value that matches or is close to an actually measured value or a calculated value is found, and a corresponding ice size or diameter is obtained therefrom.
- FIG. 10A shows an example in which a material piece 20 having an ultrasonic wave propagation characteristic worse (slower) than the metal material of the cylinder is attached toward the tip inside the cylinder 1.
- the inside of the cylinder is cut into a cylindrical shape, and a cylindrical material piece, for example, a plastic material 20 is attached to the cutting portion.
- FIG. 10B shows an example in which the plastic material 20 is attached to the inside without cutting.
- FIG. 11 shows a time chart of the ultrasonic reflection signal in the embodiment of FIG.
- FIG. 12 shows an example of detection. Since the reflected signal n from the plastic material 20 has a smaller amplitude than the reflected signal m from the portion where the plastic material 20 is not attached, the two can be distinguished. As a practical benefit, the peak amplitude value in the reflected signal m corresponds to the minor axis of the frozen part, and the boundary time between the reflected signal m and n corresponds to the major axis of the frozen part, so those times are detected. By doing this, the minor axis and the major axis of the frozen part can be obtained.
- Ice parts take various forms. Examples are close to a sphere, examples of shapes like rugby balls, and examples of shapes like vegetables. These are affected by the shape of the lesion site.
- the lesion site is affected by the surrounding organs. For example, if it occurs adjacent to a blood vessel, the shape is affected by the presence of the blood vessel. For example, even if the original shape is a sphere, the portion in contact with the blood vessel is different from the sphere.
- the center of the lesion and the center of the frozen probe coincide, but there are cases where they do not coincide.
- the long and short distances to the boundary of the lesion are Shoji, and the frozen part is also reflected in the shape.
- FIGS. 8 and 9 are effective techniques for detecting such minor axis and major axis.
- FIG. 13 is an embodiment diagram of the processing side of the freezing size detection unit.
- This embodiment includes an ultrasonic transmission / reception unit 5, a memory 22, a processing unit 23, and a display unit 24.
- the ultrasonic transmission / reception unit 5 transmits an ultrasonic excitation signal to the ultrasonic transducer 4 and receives a reflection signal detected by the transducer 4.
- the ultrasonic excitation signal is transmitted when measuring the ice size. This measurement is determined in advance, for example, for each time phase (a) to (f) shown in FIG.
- the memory 22 stores the received reflected signal amplitude and time as a pair.
- the memory 22 stores a conversion formula and a reference value for determining ice size and diameter.
- the processing unit 23 obtains an envelope area of the peak amplitude value from a plurality of significant amplitude values stored in the memory 22 for each time phase, and uses a conversion formula from this area, or The ice size is obtained by comparison with the reference value.
- the display unit 24 displays this result. In the case of peak detection, the processing unit 23 obtains the maximum amplitude value and uses this as a peak value to calculate the ice diameter.
- FIG. 14 shows a circuit example diagram for exciting the ultrasonic vibrating pieces 42 and 43.
- This circuit is a specific example of the ultrasonic transmission / reception unit 5 and includes a transmission unit 51, a reception unit 50, and a directional circuit 52, and the directional circuit unit 52 switches between the transmission unit 51 and the reception unit 50.
- the cylinder 1 was electrically grounded (E). This grounding (E) is for exciting the vibrating bars 40 and 41 in a balanced manner.
- FIG. 15 is a schematic diagram for exciting the vibration pieces 42 and 43.
- the transformer 53 couples the excitation source 54 and the vibration pieces 42 and 43.
- the vibration pieces 42 and 43 are connected to both sides of the secondary side coil of the transformer 53, and the midpoint of the secondary side coil is connected to the cylindrical surface and grounded (E).
- FIG. 16 is an embodiment diagram in which the detected ice size is actively used for freezing gas control.
- the freeze / thaw sequence control unit 25 is a device for setting a freeze time sequence, and the sequence is determined in advance, but this is corrected by the detected value of the frozen size. That is, it is checked whether or not the freezing size determined by the processing unit 23 is the target freezing size planned in advance, and if it is smaller, if it reaches the target freezing size, the freezing is stopped at that point. Control to shift to thawing treatment. Therefore, the sequence control unit 25 is controlled by the detection value of the processing unit 23, and actual gas control is performed by the gas control unit 26.
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Abstract
Description
凍結した患部は、その部位が氷結状態である。氷結サイズは、臓器の種類(組織)、凍結温度によって定まる。2サイクル以上のサイクルを繰返す場合、第1サイクルよりも第2サイクル時点での氷結体積が大きくなる傾向がある。
上記外筒に装着され、患部凍結部位に超音波を送出し、患部凍結部位のサイズ検出用の患部凍結部位からの超音波反射波を受信する超音波振動子と、
を備えたことを特徴とする凍結治療素子を開示する。
上記外筒に装着された超音波振動子と、
上記超音波振動子を励起して超音波を患部凍結部に送出する送信手段と、
患部凍結部位からの超音波反射波を受信した上記振動子からの反射信号を受信する受信手段と、
この反射信号に基づき患部凍結部位のサイズを求めるサイズ検出手段と、
を備えたことを特徴とする凍結治療装置を開示する。
上記超音波振動子を励起して超音波を患部凍結部位に送出する送信手段と、
患部凍結部位からの超音波反射波を受信した上記振動子からの反射信号を受信する受信手段と、
この反射信号に基づき患部凍結部位のサイズを求めるサイズ検出手段と、
を備えたことを特徴とする凍結治療装置を開示する。
上記外筒に装着された超音波振動子と、
患部凍結部位に超音波放出を行わせるべく上記振動子を励起して超音波を患部凍結部位に送出する送出手段と、
患部凍結部に励起信号を送出する送出手段と、
患部凍結部位からの超音波反射波を受信した上記振動子からの反射信号を受信する受信手段と、
この反射信号に基づき患部凍結部位のサイズを求めるサイズ検出手段と、
を備えると共に、サイズ検出手段は、上記材質材を介しての反射波と介さない反射波とを時間差を用いて区別し、介さない反射波の包絡線の面積又はピーク値に基づいて氷結サイズ又は径を求めるものとしたことを特徴とする凍結治療装置を開示する。
第1タイプは、目視できない事例での使用例、第2タイプは穿刺状態がある程度目視可能な状態での使用例である。
氷結サイズは、超音波送出波のエネルギーと氷結部位からの超音波反射受信波のエネルギーとの比率で定めることができる。
(1)各凍結サイクルの最終時点での氷結サイズのみを得たい場合には、各凍結サイクル終了直後に反射波信号を測定し氷結サイズを検出する。
(2)各凍結サイクルの凍結進行による氷結サイズの進行の様子を監視したいときには、各凍結サイクルの中の複数のタイミングで反射波信号を計測し氷結サイズの検出を行う。例えば、各サイクル毎に第1回目の超音波放射を行いその反射波受信を行って第1回氷結サイズを求める。第1回反射波が完全になくなったタイミングで第2回目の超音波放射を行い、その反射波受信を行って第2回氷結サイズを求める。以下、3回目が必要ならば、同様なタイミングのもとで同様な測定を行い氷結サイズを検出する。
(3)解凍サイクルでの解凍の様子を氷結サイズで監視したい時には、各解凍サイクルの中の複数のタイミングで氷結サイズの検出を行う。
上記検出法は、直接に氷結サイズSを求めるとしたが、算出値S0と氷結サイズとが一致しない例や数1の係数kが種々の値をとることへの対応のための別検出法を図18を用いて説明する。事前に、臓器の種別、腫瘍の種類などをパラメータとして、算出値S0と氷結サイズDとの関係を被検体モデル等を利用して求めておき、これをデータテーブル300に基準データとして記憶させておく。そして実際の被検体から得られた算出値S0に対して、そのデータテーブルから対応する氷結サイズDを読み出す。
データテーブル300には、算出値データS0と3つのパラメータに基づくデータD(a、b、c)を対応させて記憶させておく。例えばある臓器a1、ある腫瘍b1に対する凍結処置事例とする。あるタイミングでの実際の算出値S0がS01であったとする(これがパラメータc1に対応する)。そこで、データテーブル300を参照する。そして先ず臓器a1と腫瘍b1との両者に該当するデータ欄を参照し、次にそのデータ欄から算出値データS01に対応する氷結サイズデータD1、即ちデータD(a1、b1、c1)を読み出す。このデータD(a1、b1、c1)をそのタイミングでの実際の氷結サイズと特定し、制御装置や表示画面用に出力する。
スプリング4Dの働きによって着脱自在としたが、スプリング以外の例もあれば、また円筒1の外周に固定して設置しておく例もある。
以下では、第1タイプの凍結素子の事例で説明するが、第2タイプの凍結素子でも同様である。
超音波振動子4は、氷結サイズ(体積又は直径サイズを含む)の測定に使う。凍結毎に行ってもよく第1サイクルの凍結時のみの測定でもよい。これは第2サイクル以降の氷結サイズを予測できるときに便利である。
尚、凍結ガス、解凍ガス共に、ガス流入・排出機構(図示せず)からプローブ3へ適宜送られる。
図4は、氷結部位10と凍結プローブ3と円筒1との模式的な関係を示す。P1点が超音波振動子の設置位置(簡単のため点として扱う)、P2点が患部7の中の円筒先端位置である。氷結部と患部とは一致することもあれば一致しないこともあるが、氷結部10のサイズを測定するのが本発明の目的となる。
図6は、超音波の放出とその反射とを説明するための図である。P1は超音波片42、43の設置位置、10は氷結部、Q1は反射波、である。位置P1から放出された超音波は、円筒1を伝播する。伝播する超音波は、円筒1が金属であることから、この円筒からの反射波が最も早く戻ってくる。且つその減衰量は少ない。これが最初の反射波となる。
図7で区間t1は円筒自体からの反射波信号であり、この区間t1は、点P1とP3との距離から事前に求まる。そこで、区間t1に存在する反射信号は全て除外し、その後の時刻t1以降の反射信号について振幅及び時間変化に伴う包絡線を求め、この包絡線の面積Vを求める。面積Vは、氷結サイズを反映した値であり、所定の換算によって氷結サイズを算出する。
時刻T1以降の反射信号が零となるまでの区間t2は氷結サイズが大きければ大きくなり、小さければ小さくなる。
2 ガイドニードル
3 凍結端子
4 超音波振動子
5 超音波送受信部
100 凍結治療素子
200 氷結サイズ検出装置
Claims (13)
- 凍結及び解凍用の凍結端子と、患部凍結部位を測定し氷結サイズを求めるサイズ検出手段と、
を備えたことを特徴とする凍結治療装置。 - 金属製の外筒とこの外筒に挿入される被検体患部の凍結及び解凍用の凍結端子とを具えて患部の凍結と解体との処置を可能にする凍結治療素子と、
患部凍結部位に超音波を送出し、患部凍結部位からの超音波反射波を受信し氷結サイズを検出する超音波装置と、
を備えたことを特徴とする凍結治療装置。 - 上記超音波装置は、超音波振動子と、
上記超音波振動子を励起して超音波を患部凍結部位に送出する送信手段と、
患部凍結部位からの超音波反射波を受信した上記振動子からの反射信号を受信する受信手段と、
この反射信号に基づき患部凍結部位のサイズを求めるサイズ検出手段と、
を備えたことを特徴とする請求項2記載の凍結治療装置。 - 上記サイズ検出手段は、反射信号の振幅及び時間変化の包絡線の面積に基づいて氷結サイズを求めるものとした請求項3記載の凍結治療装置。
- 上記サイズ検出手段は、反射信号の振幅のピーク値に基づいて氷結サイズを求めるものとした請求項3記載の凍結治療装置。
- 金属製の外筒と、この外筒に挿入される凍結及び解凍用の凍結端子とを有して、患部の凍結と解凍との処置を可能にする凍結治療素子において、
上記外筒に装着され、患部凍結部位に超音波を送出し、患部凍結部位のサイズ検出用の患部凍結部位からの超音波反射波を受信する超音波振動子と、
を備えたことを特徴とする凍結治療素子。 - 上記超音波振動子は、上記外筒の円筒外周部に着脱自在とした請求項6記載の凍結治療素子。
- 上記外筒の先端側内部に当該金属よりも超音波伝導特性の悪い材質を設けた請求項6又は7記載の凍結治療素子。
- 金属製の外筒と、この外筒に挿入される凍結及び解凍用の凍結端子とを有して、患部の凍結と解凍との処置を可能にすると共に、上記外筒に装着される超音波振動子とを有する凍結治療素子と、
上記外筒に装着された超音波振動子と、
上記超音波振動子を励起して超音波を患部凍結部に送出する送信手段と、
患部凍結部位からの超音波反射波を受信した上記振動子からの反射信号を受信する受信手段と、
この反射信号に基づき患部凍結部位のサイズを求めるサイズ検出手段と、
を備えたことを特徴とする凍結治療装置。 - 上記サイズ検出手段は、反射信号の振幅及び時間変化の包絡線の面積に基づいて氷結サイズを求めるものとした請求項9記載の凍結治療装置。
- 上記サイズ検出手段は、反射信号の振幅のピーク値に基づいて氷結径を求めるものとした請求項9記載の凍結治療装置。
- 上記サイズ検出手段は、超音波振動子設置位置から外筒部位までの距離相当の反射信号を除き、この反射信号以降に受信する反射信号に基づいてサイズ検出を行うものとした請求項10又は11記載の凍結治療装置。
- 先端側内部に当該金属よりも超音波伝導特性の悪い材質材を設けた金属製の外筒と、この外筒に挿入される凍結及び解凍用の凍結端子とを有して、患部の凍結と解凍との処置を可能にする凍結治療素子と、
上記外筒に装着された超音波振動子と、
患部凍結部位に超音波放出を行わせるべく上記振動子を励起して超音波を患部凍結部位に送出する送出手段と、
患部凍結部に励起信号を送出する送出手段と、
患部凍結部位からの超音波反射波を受信した上記振動子からの反射信号を受信する受信手段と、
この反射信号に基づき患部凍結部位のサイズを求めるサイズ検出手段と、
を備えると共に、サイズ検出手段は、上記材質材を介しての反射波と介さない反射波とを時間差を用いて区別し、介さない反射波の包絡線の面積又はピーク値に基づいて氷結サイズ又は径を求めるものとしたことを特徴とする凍結治療装置。
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CN114271923A (zh) * | 2020-09-28 | 2022-04-05 | 上海微创惟美医疗科技(集团)有限公司 | 状态检测、控制方法、装置及介质 |
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US10037161B2 (en) | 2015-10-21 | 2018-07-31 | Kabushiki Kaisha Toshiba | Tiered storage system, storage controller, and method for deduplication and storage tiering |
EP3620801A1 (de) * | 2018-09-07 | 2020-03-11 | Erbe Elektromedizin GmbH | Gerät zur speisung eines medizinischen instruments und verfahren zur instrumentenüberwachung |
CN110882052A (zh) * | 2018-09-07 | 2020-03-17 | 厄比电子医学有限责任公司 | 用于供应医疗器械的装置以及用于监测器械的方法 |
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CN110882052B (zh) * | 2018-09-07 | 2023-06-30 | 厄比电子医学有限责任公司 | 用于供应医疗器械的装置以及用于监测器械的方法 |
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CN114271923A (zh) * | 2020-09-28 | 2022-04-05 | 上海微创惟美医疗科技(集团)有限公司 | 状态检测、控制方法、装置及介质 |
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