JP2006130209A - Ultrasonic irradiation system and informed consent information presentation method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an ultrasonic irradiation system capable of explaining a patient about a treatment before the treatment and starting the treatment with consent thereto. <P>SOLUTION: A storage part 23 prestores informed consent information for explaining the patient about the treatment for obtaining the consent of the patient to have the treatment, a monitor means 4 or a printer 5 outputs the informed consent information stored in the storage part 23, an input showing the consent of the patient to the output informed consent information is inputted with an operation panel 3 or an input means 6, and a control part 21, when the operation of the system is started, is started in an inaction mode of non-permitting the execution of the treatment and, when there is the input showing the consent, switched into a treatment mode of permitting the execution of the treatment. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to an ultrasonic irradiation system for treating a tumor in a living body using ultrasonic waves, and an informed consent information presentation method in the ultrasonic irradiation system.

  Conventionally, surgical excision has been used extensively as a cancer treatment method, but it has sometimes imposed physical and mental burdens on patients. On the other hand, for cases in which surgical resection is not indicated, pharmacotherapy using anticancer drugs is used, but side effects may occur. Therefore, a treatment method called minimally invasive treatment (MIT), which has less physical and mental burden on the patient, is one keyword. For example, percutaneous ethanol injection therapy that injects ethanol from a puncture needle that has punctured into the cancer area and causes cancer tissue to become necrotic, or heat denaturation of a protein that is heated by irradiation with microwaves or radio waves from the puncture needle Puncture therapy has been developed to induce cancer and kill cancer cells. However, the above-mentioned percutaneous ethanol injection therapy and puncture therapy are also pointed out that they are invasive in the sense that a puncture needle is inserted into a cancer cell and there is a risk of seeding the cancer cell. .

  Therefore, hyperthermia therapy, which is minimally invasive, has been developed that irradiates electromagnetic waves or the like from outside the living body to a target region in the living body, heats cancer cells, induces apoptosis, and leads to necrosis. This is a treatment method in which cancer cells are selectively killed by heating and maintaining the affected area at 42.5 ° C. or higher by utilizing the difference in heat sensitivity between tumor tissue and normal tissue. In particular, for a tumor in the deep part of the living body, a method using ultrasonic energy having a high depth of penetration is considered (for example, see Patent Document 1). Further, a treatment method in which the above-described warming treatment method is further advanced and the ultrasonic wave generated by the concave-shaped piezo element is focused on the affected part and heated in a short time to be thermally denatured necrosis is also considered (for example, Patent Document 2). reference.). Further, in the above-mentioned treatment method, by focusing the energy of ultrasonic waves, it is possible to heat only a limited region having a width of about 1 to 3 mm to 60 ° C. or more and lead to heat degeneration necrosis within several seconds. Application of this technique to liver tumors, breast tumors, uterine fibroid tumors, brain tumors, and urological tumors is being studied.

  Furthermore, recent improvements in the performance of diagnostic equipment are striking, and the early cancer detection rate is improving year by year. In addition, it has become statistically clear that the earlier the start of treatment for cancer, the better the treatment results. Therefore, it is important to find out how early cancer can be detected and treated. For this reason, when there is a suspicion of a malignant tumor as a result of diagnosis, it has been proposed to perform a minimally invasive treatment that immediately irradiates the above-described ultrasonic waves.

  On the other hand, in recent years, the idea of informed consent that the patient should be given sufficient explanations regarding the medical condition and treatment method, etc., and the treatment should be obtained after obtaining the consent of the person concerned has been emphasized. . Therefore, as a means for supporting such informed consent, a computer system (for example, refer to Patent Document 3 or Patent Document 4) for presenting in an easy-to-understand manner using a drawing, or patient disease information is registered in advance. A medical support method (see, for example, Patent Document 5) is disclosed in which information such as the treatment policy and medical expenses of each medical institution based on the information is disclosed to the patient.

JP-A 61-13955 US Pat. No. 5,150,711 JP-A-10-97405 JP-A-10-94520 JP 2003-345905 A

  Therefore, even when it is desired to perform early detection as described above and treatment that immediately irradiates ultrasound, it is necessary to explain to the patient, and treatment without consent must be avoided.

  The present invention has been made in view of the above circumstances, and the purpose of the present invention is to explain the treatment to the patient before the treatment and to start treatment after obtaining consent for the treatment. It is to provide a simple ultrasonic irradiation system and to provide an informed consent information presentation method in the ultrasonic irradiation system.

  In order to solve the above-mentioned problems, an invention according to claim 1 is an ultrasonic irradiation system that includes an irradiation unit that irradiates ultrasonic waves and performs treatment by irradiating ultrasonic waves, and consent of the patient receiving the treatment is obtained. Informed consent information storage means for preliminarily storing informed consent information for explaining the treatment for the patient, and the informed consent information stored in the informed consent information storage means can be visually recognized It is characterized by comprising an output means for outputting to.

  In an ultrasonic irradiation system for performing treatment by irradiating ultrasonic waves, an information system for explaining the treatment to the patient in order to obtain consent of the patient receiving the treatment. An informed consent information presentation method for presenting consent information, comprising: storing the informed consent information in advance; and outputting the stored informed consent information in a visually recognizable manner. .

  According to the ultrasonic irradiation system of the first aspect, by outputting the informed consent information, the treatment can be explained to the patient in order to obtain the consent of the patient receiving the treatment. In addition, since the contents stored in advance are output, it is possible to prevent the occurrence of explanation leakage.

  According to the informed consent information presentation method according to claim 11, by outputting informed consent information, the treatment can be explained to the patient in order to obtain the consent of the patient receiving the treatment. . In addition, since the contents stored in advance are output, it is possible to prevent the occurrence of explanation leakage.

[First Embodiment]
Hereinafter, a first embodiment of the present invention will be described with reference to the drawings. As an embodiment, an ultrasonic irradiation system for performing ultrasonic diagnosis and treatment of irradiating focused ultrasonic waves will be described as an example.

(Constitution)
FIG. 1 is a block diagram showing an electrical configuration of an ultrasonic irradiation system as a first embodiment according to the present invention.

  The ultrasonic irradiation system shown in FIG. 1 is an apparatus main body 2, an ultrasonic applicator 1 for performing treatment connected to the apparatus main body 2, and a diagnosis connected to and driven by the apparatus main body 2. A diagnostic ultrasonic probe (hereinafter sometimes simply referred to as a “probe”) 16b, an operation panel 3, a monitor means 4 as a display means, a printer 5, and an input means 6 are provided.

  The operation panel 3 is connected to the apparatus main body 2 and is used to input various information such as instruction information from an operator and a password. Although not shown, various keys (such as alphabet keys and numeric keys), a mouse, a trackball, etc. Is connected or installed. In addition, the ultrasonic irradiation system of the present embodiment is a non-operating mode in the present embodiment. In this embodiment, the diagnosis mode in which the treatment cannot be performed and the diagnosis can be performed, and the treatment mode in which the therapy can be performed. Thus, diagnosis or treatment can be performed based on the instruction information from the operation panel 3. However, although details will be described later, an input indicating the consent of the patient is required for switching to the treatment mode. The operation panel 3 is one of the input means of the present invention, but is separated from the input means 6 in the present embodiment for explanation.

  The monitor means 4 (display means) is connected to the apparatus main body 2 and is based on image data transmitted from the apparatus main body 2, for example, an ultrasonic tomogram, the focus of focused ultrasound, and informed consent information (explained later). ) (Consent), and displays an image input from the input means 6.

  The printer 5 is an image output apparatus according to the present invention. The printer 5 is connected to the apparatus main body 2 and forms and outputs an image on an image recording medium (for example, recording paper) based on image data transmitted from the apparatus main body 2. . In particular, in the present embodiment, informed consent information (explanation) (consent) is output. The output means in the present invention is the monitor means 4 or the printer 5.

  The input unit 6 is an image input unit, a voice information input unit, or a biological information reader. The image input means includes a scanner, a digital camera, a CCD camera, an input pad, a light pen, and the like. The voice information input means includes a microphone, and inputs voices of an operator who is a doctor and a patient. The biometric information reading device reads fingerprint information and iris information, for example.

  The probe 16b is detachably connected to the apparatus main body 2 by a connector 32. Although not shown in the drawings, the apparatus includes a plurality of ultrasonic transducers that are driven by the apparatus main body 2 and generate diagnostic ultrasonic waves, receive reflected ultrasonic waves on a living body such as a patient and receive reflected waves as echo signals, The received echo signal is transmitted to the apparatus main body 2.

  The ultrasonic applicator 1 is detachably connected to the apparatus main body 2 with a connector 32. It includes an ultrasonic wave generation element (piezo element) group 11 composed of a plurality of vibrators, and is responsible for the irradiation of focused ultrasonic waves on a living body. FIG. 2 shows an example of the ultrasonic applicator 1. The ultrasonic applicator 1 is a group of ultrasonic generating elements (piezo elements) in which a plurality of vibrators divided in the circumferential direction are two-dimensionally arranged in an annular shape. 11, a coupling material 13 for guiding ultrasonic waves from the ultrasonic wave generation element group 11 to the living body S, a film 14 that holds the coupling material 13 and serves as a direct contact medium with the living body S, and an ultrasonic wave generation element group 11 is composed of a probe 16a inserted and arranged in the central hole 11 and cables 12 for electrical connection with the apparatus main body.

  Here, as the coupling material 13, a medium is selected that efficiently propagates the ultrasonic wave generated from the ultrasonic wave generation element group 11 to the living body S, and here, to the focal point F. In addition, the coupling material 13 also has a heat insulating effect for blocking heat generated in the ultrasonic wave generation element group 11 and not transmitting it to the living body S. Therefore, a cooling means 15 for releasing heat generated in the ultrasonic wave generation element group 11 is added to the opposite side of the ultrasonic wave generation surface of the ultrasonic wave generation element group 11, that is, the opposite side to the ultrasonic coupling material 13. It is.

  The apparatus main body 2 includes a therapeutic ultrasonic wave drive unit 22, a storage unit 23, an image reconstruction unit 27, a connection unit 30, and a control unit (operation control unit) 21.

  It comprises a connection unit 30, an interface 33, and connectors 31 and 32. The connectors 31 and 32 are for mechanically and electrically connecting the probe 16b and the ultrasonic applicator 1 described above. In addition, the interface 33 is a signal for driving the ultrasonic transducer of the probe 16, an echo signal, and the ultrasonic wave generation element group 11 between the connectors 31 and 32, the therapeutic ultrasonic wave drive unit 22 and the image reconstruction unit 27. Relay the signal that drives Further, the number of connectors is not limited to two in the present embodiment, and may be one or three or more.

  The image reconstruction unit 27 includes a diagnostic ultrasonic transmission / reception unit 28 and an echo signal processing unit 29, and reconstructs an ultrasonic tomographic image.

  Although not shown, the diagnostic ultrasonic transmission / reception unit 28 includes a transmission circuit such as a delay circuit and a pulsar circuit, and a reception circuit such as an A / D converter and an adder, and is controlled by the control unit 21 to transmit pulsed ultrasonic waves. It is generated and sent to the ultrasonic transducer of the probe 16 via the connection unit 30, and the echo signal received by the probe 16 is received via the connection unit 30 as an inspection result.

  The echo signal processing unit 29 is connected to the diagnostic ultrasonic transmission / reception unit 28. The echo signal processing unit 29 performs echo signal logarithmic amplification, envelope detection processing, and the like on the echo signal received by the diagnostic ultrasonic transmission / reception unit 28, thereby increasing the signal intensity. Image data of an ultrasonic tomographic image expressed by luminance data indicating the height is generated.

  The therapeutic ultrasonic wave drive unit 22 is for driving the ultrasonic wave generation element group 11 of the ultrasonic applicator 1, and includes an impedance matching circuit group 24, a drive unit group 25, and a phase control unit group 26. These are divided into channels of the number of ultrasonic transducers, and each ultrasonic wave generating element is operated for each channel. The control unit 21 irradiates focused ultrasonic waves based on the irradiation plan. Be controlled. A so-called known phased array technique is used to control the focal position by adjusting the phase of the ultrasonic wave generated by each ultrasonic wave generating element. The ultrasound generating element group 11 and the therapeutic ultrasound driving unit 22 constitute an irradiation unit.

  In other words, the driving means group 25 supplies the electric energy from the driving means group 25 via the impedance matching circuit group 24 so that the ultrasonic wave generation element group 11 emits focused ultrasonic waves based on the irradiation plan. It has a role of amplifying the signal waveform, but the initial phase of the signal waveform input to the driving means group 25 is adjusted for each channel so that the focus F is formed at a position based on the irradiation plan. It has become. This initial phase adjustment is performed by the phase control means group 26 under the control of the control unit 21. In FIG. 1, the output of the phase control means group 26 is the same as the number of drive means groups 25, that is, the ultrasonic wave generation element groups 11. On the other hand, the input of the phase control means group 26 is one system. The drive signal waveform generated by the control unit 21 is input to this input. Also in the phase control means group 26, the output frequency and waveform are controlled by the control unit 21.

  The storage unit 23 includes a flash memory, a hard disk, and the like, and stores the entire control program and application program. In addition, patient information, which will be described later, or informed consent information (explanation) (consent) is stored, and voice input from a microphone or the like is stored as voice information. In addition, the patient's private key and a public key corresponding to the private key are stored in association with the patient.

  The patient information is patient ID, diagnostic data, basic data, or the like, which is one piece of information indicating a patient, and is stored in the storage unit 23 in association with the patient ID of the patient. The basic data includes patient specifying information for specifying a patient in the present invention in addition to information indicating the patient such as name and gender, for example, authentication information such as a password and a patient fingerprint, It is a seal (image information) or a signature (image information).

  Informed consent information (explanation) is information about the treatment in this ultrasonic irradiation system that is explained to the patient in order to obtain consent for treatment. For example, the treatment content, the expected effect, risk, side effects, etc. Information. The informed consent information in the present invention corresponds to informed consent information (explanation). The informed consent information (consent) is consent information in the present invention indicating that the patient has consented, and is composed of the contents of the informed consent information (explanation) and the contents indicating that the patient has consented. Informed consent information (agreement) is stored in association with the patient ID. In addition, patient specifying information is added and stored as will be described later.

  Therefore, the memory | storage part 23 has a function as an audio | voice information storage means of this invention, a patient specific information storage means, an informed consent information storage means, and a consent information storage means.

  The control unit 21 receives inputs from the operation panel 3 and the input unit 6 and performs drive control of each unit of the ultrasonic irradiation system based on a control program. In the diagnostic mode, the image reconstruction unit 27 is operable, and the therapeutic ultrasonic drive unit 22 is not operated. In the therapeutic mode, both the therapeutic ultrasonic drive unit 22 and the image reconstruction unit 27 are used. These modes can be switched so as to be operable. Although details will be described later, it has a function as mode control means for controlling switching between the diagnosis mode and the treatment mode. In addition, it has a function as consent information creating means for receiving informed consent information and creating informed consent information (consent) as consent information.

  The control unit 21 stores a CPU (not shown), various programs, and various data necessary for executing the programs, and executes the various programs in order to realize the above-described functions. And a system memory (not shown) that constitutes the work area.

(procedure)
Next, diagnosis and treatment procedures performed in the ultrasonic irradiation system of the present embodiment will be described. In the process of explaining the procedure of diagnosis and treatment, output of informed consent information (description) (display on the monitor means 4 and image output on the printer 5), switching between the diagnosis mode and treatment mode in the ultrasonic irradiation system To clarify. Further, in the following procedure, there are operations / input operations performed by the operator. For example, it can be easily performed if a wizard function is provided and performed according to the instructions.

  For example, in the case of a first visit to a patient who feels an abnormality in his / her body or an abnormality is found in a regular medical examination, first, the probe 16b of the ultrasonic irradiation system as described above placed in the examination room is used. Using, an ultrasonic diagnosis is performed as follows.

  FIG. 3 is a flowchart showing procedures of diagnosis and treatment. As shown in FIG. 3, when the operator turns on the power or starts the system operation such as logon (step S100 in FIG. 3, Y. Hereinafter, “step S100 in FIG. 3” is simply abbreviated as “S100”). Thereafter, the other steps are also abbreviated in the same manner.), The control unit 21 starts up the ultrasonic irradiation system in the diagnosis mode (S101). First, the patient is diagnosed (S102).

  The operator inputs the patient ID. Here, by inputting a patient ID, diagnostic data and informed consent information (consent) obtained by a diagnosis to be performed can be stored in association with the patient ID, and stored patient information can be read. Then, the operator operates the operation panel 3 to apply the probe 16b to the patient and display an ultrasonic tomographic image on the monitor unit 4 to make a diagnosis.

  When the operator determines that treatment is unnecessary from the diagnosis result based on the ultrasonic tomogram displayed on the monitor unit 4, the operator operates the operation panel 3 to end the operation of the ultrasonic irradiation system (S103, end). ), The system operation is terminated (S111).

  On the other hand, when, for example, a small polyp is displayed on the ultrasonic tomogram displayed on the monitor means 4, it is often not immediately known whether the polyp is benign or malignant. In such a case, examinations or polyps by other modalities are usually extracted, and a benign / malignant definitive diagnosis is performed at a conference that will be performed at a later date, and the result is treated if necessary. However, it takes a considerable time (for example, several weeks) until the result of a definitive diagnosis is obtained, and if it is malignant, the possibility of being too late due to the progress of the lesion during that time cannot be denied. Therefore, if it is a polyp that does not affect health even if it is removed regardless of benign / malignant, it should be removed as soon as possible, and if possible, it should be removed at the time it is found. Therefore, treatment by ultrasonic irradiation using the ultrasonic applicator 1 of the ultrasonic irradiation system as described above is performed. However, since the patient's consent is required in the case of a therapeutic action, for example, even if the operator tries to treat the patient by operating the operation panel 3, at this stage, the control unit 21 receives the accepted input. Is controlled so that the therapeutic ultrasonic wave drive unit 22 is not operated. In addition, when starting the diagnosis and treatment, an operation soft key is displayed on the monitor means 4 and when the mouse is operated and the soft key is pressed, the diagnosis key is displayed and the treatment key is displayed. Can be controlled not to display. Therefore, first, when the operator operates the operation panel 3 so as to display informed consent information (explanation) (S103, display), the control unit 21 performs informed consent information (stored in the storage unit 23). (Description) is read out and displayed (output) on the monitor means 4 is controlled (S104).

  For example, FIG. 4 shows an example of the informed consent information (explanation) to be displayed. Information such as the treatment content, the expected effect, risk, and side effects of the treatment is displayed. The operator explains information about the treatment to the patient using the displayed contents. In addition, information about treatment in the ultrasonic irradiation system, which is informed consent information (explanation), may be controlled to be output from the printer 5, and in this case, information about treatment using the output product. To the patient.

  In this way, by displaying and outputting informed consent information (explanation), it is possible to explain the treatment to the patient, and information to be explained to the patient stored in advance is displayed or displayed. Since it is output, it is possible to prevent the explanation from being lost. Moreover, it is possible to display and output on the spot, and it is not necessary to check informed consent information (explanation) about the treatment system or to procure from a storage place.

  Further, the ultrasonic applicator is provided with storage means (informed consent information storage means), and informed consent information (explanation) relating to the ultrasonic applicator is stored, so that a plurality of types of ultrasonic applicators can be stored. May be displayed or output informed consent information (explanation) about the treatment by the connected ultrasonic applicator.

  Next, when the patient does not agree to perform the treatment, the operator operates the operation panel 3 to end the operation of the ultrasonic irradiation system (S105, do not agree), and ends the operation of the system. (S111). If the patient agrees to perform treatment, an input indicating consent is made (S105, agree).

  Since it is necessary to indicate that the consent is an action of the patient, it is preferable that the input including the patient specifying information for specifying the patient is included. For example, the operation panel 3 is operated so that patient specifying information can be input, and then the patient specifying information is input. When inputting authentication information such as patient password and biometric information such as a fingerprint, for example, the operation panel 3 is used for input of the password so that the patient specifying information is not altered by a third party. The biometric information is input by the biometric information reader. Further, image information such as a seal or a signature may be used. For example, informed consent information (explanation) is output to a recording sheet by the printer 5, and the patient stamps or hand signs on the recording sheet, and the input means 6 is a scanner, a CCD camera, a digital camera, etc. You may read by. Alternatively, the patient may directly input a signature so that the input means 6 is displayed on informed consent information (explanation) displayed using an input pad or a light pen. In addition, when using image information as described above, when making the image information ready for input, for example, the user is requested to input authentication information such as a patient password or biometric information, and the authentication information is input. After that, it may be possible to input image information. In this way, if it is possible to input a seal or signature as image information for specifying a patient on the condition that authentication information is input, the seal or signature is not input by a third party.

  Upon receiving an input indicating consent, the control unit 21 creates informed consent information (consent) indicating that the patient has consented (S106). For example, when a patient's signature is input as patient-specific information, as shown in FIG. 5, at the end of the informed consent information (explanation) previously displayed or output, a sentence indicating consent, for example, “I am , ... I agree, "the patient's signature will be created. In the case where authentication information is input, text data of a patient name corresponding to the input authentication information may be used instead of the patient's signature. In addition, if the patient stamps or signs the output informed consent information (explanation) and is read by a scanner, CCD camera, digital camera, etc., the read image data is informed consent information (consent). And it is sufficient.

  Next, informed consent information (consent) is stored in the storage unit 23 in association with the patient ID (S107). When authentication information is input, the input authentication information is added and stored. Thus, by storing informed consent information (consent), it can be confirmed later, or can be used as evidence indicating that the patient has consented. Further, if the image data stored as informed consent information (consent) is in a format that cannot be tampered with, for example, a PDF format, it can be safely stored without being tampered with by a third party. The date and time may be added and stored, and if the date and time are added, the date and time of consent can be confirmed later.

  Furthermore, the control unit 21 switches the ultrasonic irradiation system to the treatment mode (S108). Therefore, if the operator performs an operation for treatment using the operation panel 3, the control unit 21 can receive the input and operate the treatment ultrasonic driving unit 22. In the case where the operation soft key is displayed and the operation is performed using the soft key, the diagnosis key may be controlled to be displayed and the treatment key may be displayed. According to this, if the informed consent information (consent) as the consent information is stored, switching to the treatment mode is performed, that is, if the consent information is not stored, the treatment cannot be performed.

  Further, the ultrasound irradiation system may be switched to the treatment mode on condition that an input indicating consent in S104 is made.

  Further, as a condition for switching to the treatment mode, identity verification is performed on the patient identification information that is input or stored, and if it is confirmed that the entered patient identification information is that of the person, the ultrasound irradiation system is switched to the treatment mode. You may control as follows. For example, when the patient specifying information is authentication information, the authentication information stored in the storage unit 23 is searched, and the authentication information input or stored matches the patient authentication information stored in advance. Switch to mode. When the patient specifying information is image information, a search is made for a seal or signature stored in advance in the storage means 23, and the input or stored seal or signature matches the prestored seal or signature. Switch to treatment mode. According to this, if it is confirmed that the patient specifying information belongs to the person, the mode is switched to the treatment mode, that is, treatment cannot be performed unless the person confirmation is made. At this time, if it cannot be confirmed with the person, the consent information is input again or the operation of the ultrasonic irradiation system is terminated.

  When the treatment is performed, the patient is treated (S110) by inputting an operation for performing the treatment using the operation panel 3 (S109, Y). The treatment uses the ultrasonic applicator 1, refers to the ultrasonic tomogram by the probe 16a displayed on the monitor means 4, and uses the mouse or the like to treat the focal point F of the displayed focused ultrasonic wave to be treated. When the irradiation command is input from the operation panel 3 in accordance with the above, the control unit 21 receives the irradiation command from the operation panel 3 and calculates the focal position so that the focused ultrasonic wave is irradiated to the input focal point F position. Then, irradiation is performed according to the focal position. Then, when the operator inputs an operation for ending the operation of the system using the operation panel 3 (S111, Y), the control unit 21 ends the operation of the system (S112).

  Also, the voice of interaction between the doctor who is the operator and the patient between the time when at least informed consent information (explanation) is displayed or output and the time when input indicating consent is at least input from the microphone as the input means If the voice information is stored together with the informed consent information (consent), it can be confirmed later on informed consent or support that the patient has agreed.

  By performing diagnosis and treatment according to such a procedure, the treatment can be explained to the patient before the treatment, and the treatment can be started after obtaining consent regarding the treatment method.

[Second Embodiment]
Next, a second embodiment of the present invention will be described with reference to the drawings. In the following, detailed description of configurations substantially similar to those of the first embodiment will be omitted, and different points will be mainly described.

  The feature of this embodiment is that an electronic signature is added to the consent information, and the identity is confirmed using the electronic signature. The control unit 21 has a function as an encryption unit that encrypts data using a secret key, and a function as a decryption unit that decrypts data encrypted using a secret key using a public key. Further, the control unit 21 has a function as a processing unit that compresses the data so that the data cannot be restored to a message digest, encrypts the message digest using a secret key, and creates an electronic signature. The function as the mode control means includes a function for confirming the identity of the input indicating consent and confirming that the data has not been tampered with using an electronic signature or the like.

  Hereinafter, diagnosis and treatment procedures in the case of using an electronic signature will be described. FIG. 6 is a flowchart showing procedures of diagnosis and treatment. As shown in FIG. 6, first, as in the first embodiment, the system starts operating (S200), the controller 21 starts up in the diagnosis mode (S201), and the patient is diagnosed (S202).

  Next, when the operator determines from the diagnosis result that treatment is unnecessary, the operation panel 3 is operated to end the operation of the ultrasonic irradiation system (S203, end), and the operation of the system is ended (S215). . When performing treatment, first, the operation panel 3 is operated so as to display informed consent information (explanation) (S203, display).

  The control unit 21 reads out information about treatment in the ultrasonic irradiation system, which is informed consent information (explanation) stored in the storage unit 23, and controls the information to be displayed on the monitor unit 4 or a printer. Control is performed so as to output from 5 (S204). The operator explains information about the treatment to the patient using the displayed or output contents.

  Next, when the patient does not agree to perform the treatment, the operator operates the operation panel 3 to end the operation of the ultrasonic irradiation system (S205, do not agree), and ends the operation of the system. (S215). When the patient agrees to perform the treatment, as in the first embodiment, an input indicating consent is performed (S205, agree). Upon receiving the input indicating consent, the control unit 21 receives the first input. Similar to the embodiment, informed consent information (consent) indicating that the patient has consented is created (S206).

  Next, informed consent (consent) is compressed by a hash function to create a message digest (S207). The creation of this message digest is one-way (it cannot be changed back to informed consent information (consent) based on the message digest).

  Further, the created message digest is encrypted with a private key for encryption given as data of a predetermined bit length with a random number associated with the patient ID, for example (S208). The ciphertext of this message digest becomes an electronic signature.

  Next, the ciphertext of the message digest, which is an electronic signature, is added to the informed consent information (agreement) and encrypted with the secret key (S209).

  Then, the informed consent information (agreement) to which the encrypted message digest ciphertext is added is stored in the storage unit 23 (S210). And the control part 21 switches an ultrasonic irradiation system to treatment mode (S211).

  In addition, if identity verification is performed, the encrypted text of the message digest encrypted with the private key is added and the informed consent information (consent) is decrypted with the public key corresponding to the private key used for patient compression. Turn into. Then, the informed consent information (consent) obtained by decryption is compressed by a hash function, and compared with the added message digest. If they match, the informed consent information (consent) is not altered. Since the patient's public key can be used for decryption, identity verification can be performed. In addition, when the stored informed consent information (consent) is confirmed at a later date, the authentication can be performed at the same time as the identity verification. Thereafter, as in the first embodiment, input for treatment is performed (S212), the patient is treated (S213), and when the treatment is completed, the operation of the system is terminated using the operation panel 3. The operation of the system is terminated (S215) by inputting an operation for performing the operation (S214, Y).

1 is a block diagram showing an electrical configuration of an ultrasonic irradiation system according to an embodiment of the present invention. It is a schematic sectional drawing which shows the structure of the ultrasonic applicator used for the ultrasonic irradiation system shown in FIG. It is a flowchart which shows the procedure of the diagnosis and treatment performed with the ultrasonic irradiation system of 1st Embodiment. It is a figure which shows an example of the content of an informed consent (explanation). It is a figure which shows an example of the content of an informed consent (explanation). It is a flowchart which shows the procedure of the diagnosis and treatment performed with the ultrasonic irradiation system of 2nd Embodiment.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Ultrasonic applicator 11 Ultrasonic wave generation element group 12 Cables 13 Coupling material 14 Film | membrane 15 Cooling means 16a Diagnosis ultrasonic probe 2 Apparatus main body 21 Control part 22 Treatment ultrasonic drive part 23 Memory | storage part 24 Impedance matching circuit group Reference Signs List 25 drive means group 26 phase control means group 27 image reconstruction unit 28 diagnostic ultrasound transmission / reception part 29 echo signal processing part 30 connection part 31 connector 32 connector 33 interface 3 operation panel 4 monitor means 5 printer 6 input means 16b diagnostic ultrasound Acoustic probe F Focus S Living body

Claims (11)

An ultrasonic irradiation system that includes an irradiation means for irradiating ultrasonic waves and performs treatment by irradiating ultrasonic waves,
Informed consent information storage means for preliminarily storing informed consent information for explaining the treatment to the patient in order to obtain consent of the patient receiving the treatment;
An ultrasonic irradiation system comprising output means for outputting the informed consent information stored in the informed consent information storage means so as to be visible. An operation control unit capable of switching between a treatment mode capable of performing treatment performed by irradiating ultrasonic waves with the irradiation means and a non-operation mode incapable of performing the treatment;
An input means for performing an input indicating the consent of the patient including at least patient specifying information for specifying the patient with respect to the informed consent information output so as to be visible;
The operation control unit is controlled to be in the non-operation mode at the start of system operation, and when there is an input indicating the consent from the input means, the non-operation mode is switched to the treatment mode. The ultrasonic irradiation system according to claim 1, further comprising mode control means for controlling. An operation control unit capable of switching between a treatment mode capable of performing treatment performed by irradiating ultrasonic waves with the irradiation means and a non-operation mode incapable of performing the treatment;
An input means for performing an input indicating the consent of the patient including at least patient specifying information for specifying the patient with respect to the informed consent information output so as to be visible;
Consent information creating means for receiving the input and creating consent information indicating that the patient has consented;
Consent information storage means for storing the created consent information;
The operation control unit is controlled to enter the non-operation mode at the start of system operation, and when the consent information is stored in the consent information storage means, the operation mode is switched from the non-operation mode to the treatment mode. The ultrasonic irradiation system according to claim 1, further comprising mode control means for controlling. Further comprising patient specifying information storage means for previously storing information indicating the patient and the patient specifying information in association with each other;
The mode control means receives the patient identification information of the patient stored in the patient identification information storage means when the inputted patient identification information is stored together with the consent information in the consent information storage means. The ultrasonic irradiation system according to claim 3, wherein control is performed to switch to the treatment mode when the two pieces of patient identification information coincide with each other.   The ultrasonic irradiation system according to claim 2, wherein the patient specifying information is authentication information or image information for specifying a patient. The consent information is compressed using a predetermined function to obtain a message digest, and the message digest is encrypted using a private key for encryption corresponding to the patient to create an electronic signature, and the electronic signature is It further comprises consent information processing means for encrypting using the secret key in addition to the created consent information,
The said mode control means performs control which switches to the said treatment mode, when the said created consent information with which the said electronic signature encrypted was added to the said consent information storage means was memorize | stored. Ultrasonic irradiation system.   The mode control means, when the storage is made, further opens the stored consent information to which the encrypted electronic signature added is decrypted corresponding to the patient. A message digest obtained by decrypting the consent information obtained by the decryption using the key, and a digital signature obtained by the decryption, further decrypted by using the public key. The ultrasonic irradiation system according to claim 6, wherein a message digest obtained by converting to a therapeutic mode is compared, and control is performed to switch to the treatment mode when two message digests match. Voice information input means for inputting voices of the doctor performing the treatment and the patient;
A voice that stores voices of the doctor and the patient inputted from the voice input means as voice information after at least the output means outputs the informed consent information and before an input indicating the consent is made. The ultrasonic irradiation system according to claim 2, further comprising an information storage unit.   9. The output unit according to claim 1, wherein the output unit is a display unit that displays the informed consent information in a visible manner, or an image output apparatus that outputs the informed consent information to an image recording medium in a visible manner. The ultrasonic irradiation system according to Crab.   The ultrasonic irradiation system according to claim 1, wherein the informed consent information is information including a treatment content, an expected effect, a risk, and a side effect. In an ultrasonic irradiation system for performing treatment by irradiating ultrasonic waves, informed consent information presentation for presenting informed consent information for explaining the treatment to the patient in order to obtain consent of the patient receiving the treatment A method,
Pre-store the informed consent information;
And outputting the stored informed consent information in a visually recognizable manner.

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