JP2002102361A - Correction system for buried medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a correction system for buried medical instrument, with which a buried medical instrument can be easily corrected even when a plurality of kinetic load tests are executed. SOLUTION: This system has a buried medical instrument 21, with which a treatment control index is calculated by a signal reflected with the kinetic strength of a patient and a treatment control index calculation parameter, and external correctors 11-1 and 31-1 for receiving information related to medical treatment containing the signal reflected with the kinetic strength of the patient at least from the buried medical instrument, setting the treatment control index calculation parameter on the basis of the received information and transmitting the set treatment control index calculation parameter to the buried medical instrument and each of external correctors is composed of a hand-held setter 11-1 for outputting the information from the buried medical instrument and a programmer 31-1 for transmitting the treatment control index calculation parameter to the buried medical instrument on the basis of the information of the setter.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to calibration of an implantable medical device such as a cardiac pacemaker for controlling the frequency of cardiac stimulation and an artificial medical device such as an artificial heart for controlling the blood output. It is about the system.

[0002] Examples of the implantable medical device to which the present invention can be applied and which have an adjustable therapeutic effect include an artificial heart having a blood volume control mechanism and a cardiac pacemaker having a stimulation frequency control mechanism. Although known, a cardiac pacemaker provided with a stimulation frequency control mechanism will be described herein as a typical example. In this specification, the blood ejection volume and the stimulation frequency are collectively referred to as a treatment control index.

[0003]

2. Description of the Related Art A cardiac pacemaker is used for patients having cardiac dysfunction or impaired stimulus conduction system, and provides electrical stimulation to the myocardium when no cardiac activity occurs for a certain period of time.
It supplements heart activity by artificially contracting the heart. In past cardiac pacemakers, the frequency of electrical stimulation was constant irrespective of the patient's metabolic demand, so it was not possible to secure a circulating blood volume commensurate with the metabolism, which could limit patient exercise. there were. However, in recent years, a cardiac pacemaker equipped with a stimulus frequency control mechanism that detects the metabolic demand of the patient and automatically adjusts the stimulus frequency, a so-called rate response pacemaker, has been developed to increase the patient's exercise endurance and improve the quality of life. Has contributed to.

[0004] The rate response pacemaker monitors the activity state of the patient by using an equipped sensor, and performs a hard and / or soft process on the sensor output to extract a target metabolic demand index. For the cardiac stimulation frequency, a cardiac stimulation frequency function using the metabolic demand index as a variable is set in advance, and the stimulation frequency is set based on the extracted metabolic demand index level. The sensors to be equipped include a vibration sensor, a respiration sensor, a body temperature sensor, etc., the body movement is extracted from the vibration sensor, the respiratory rate and ventilation volume is extracted from the respiration sensor, and the central venous blood temperature is extracted from the body temperature sensor as a metabolic demand index. .

[0005] In a rate response pacemaker equipped with a vibration sensor, a vibration sensor is installed inside the pacemaker, the physical vibration in the front-rear direction or the vertical direction of the patient is captured, and the output of the filtered vibration sensor is integrated over a certain period of time. In general, a body movement is detected. In a rate response pacemaker equipped with a respiratory sensor, a weak current flows between the electrode placed in the heart and the pacemaker case, and the respiratory rate and ventilation volume are detected from the frequency and amount of change in the thoracic impedance due to respiratory movements Things are common. In a rate response pacemaker equipped with a body temperature sensor, a thermistor is installed on the electrode lead connected to the pacemaker, and the thermistor is placed in the central vein where the peripheral venous blood that transfers heat generated in muscles and organs joins In general, a device that detects a central venous blood temperature is used.

[0006] The relationship between the metabolic demand index and the frequency of cardiac stimulation is
Usually, it varies from patient to patient. It is considered that this difference reflects not only general physical characteristics such as age, gender, weight, and physique, but also the patient's lifestyle and previous exercise history. Therefore, in order to realize the cardiac stimulation frequency control optimized for each patient, the doctor performs an exercise load test or the like on the patient and adjusts the control parameters related to the cardiac stimulation frequency control based on the exercise load test results. It has become common to do.

The control parameters related to the cardiac stimulus frequency control include a sensor gain and a threshold in extracting a metabolic demand index, and a stimulus frequency setting includes a maximum stimulus frequency, a slope, a stimulus frequency increasing speed and a stimulating frequency decreasing speed. Have been.

[0008] The sensor gain controls the amplification of the signal from the sensor. When the sensor gain is set to a large value, the detected metabolic demand index level increases, and therefore the frequency of cardiac stimulation increases. The threshold is used as a detection level when measuring the frequency of the sensor signal, or by reflecting only the signal exceeding the threshold in the detection of the metabolic demand index, for example, when the vibration sensor is not derived from the patient's metabolism when getting on the means of transportation. Prevents response to extraneous vibration.

The maximum stimulus frequency is the maximum stimulus frequency that can be controlled, and is generally set with reference to age, basic disease, physical strength, and past exercise history. The maximum stimulation frequency is set high for a young and physically strong patient. The slope is
A parameter that determines how much the stimulus frequency is increased according to the detected change in the metabolic demand index level. If the slope is set to be large, the stimulus frequency change value increases for the same change in the metabolic demand index level. The stimulus frequency increase rate is the maximum stimulus frequency increase rate and represents the maximum stimulus frequency that can be increased in one second. The stimulus frequency descending speed is the maximum stimulus frequency descending speed and represents the maximum stimulus frequency that can be reduced in one second.

The present inventors have proposed a form of exercise of walking on a flat ground, climbing a stair, and descending a stair based on the ratio of the acceleration strength in the front-rear direction of the patient parallel to the horizontal plane and the acceleration strength in the vertical direction of the patient parallel to the vertical plane. (Japanese Patent Application No. 9-100306). In this patent, the ratio between the acceleration intensity in the front-rear direction and the acceleration intensity in the vertical direction is measured, and the measured value is compared with a preset threshold value. And stairs descending, and using this exercise form as one of the metabolic demand indices in cardiac stimulation frequency control is proposed. Therefore, the threshold value of the ratio between the acceleration intensity in the front-rear direction and the acceleration intensity in the up-down direction is a control parameter for extracting the metabolic demand index using the exercise form as the metabolic demand index.

As a method for calibrating the control parameters related to the control of the frequency of cardiac stimulation by an exercise load test, there are the following methods. The physician walks or runs the patient on the treadmill, applying a communication probe connected to an external setting device called a programmer to the patient's heart pacemaker implantation site. Between the cardiac pacemaker and the programmer, it is possible to exchange information by electromagnetic wave signals via communication coils mounted inside the cardiac pacemaker and the communication probe of the programmer, respectively.
Using this communication mechanism, the behavior of the patient's metabolic demand index during the exercise stress test period and the behavior of the cardiac stimulation frequency determined by the cardiac pacemaker based on the metabolic demand index and the control parameters set in the cardiac pacemaker at that time Is sent from the cardiac pacemaker to the programmer. The physician operates the programmer to judge whether the received metabolic demand index and cardiac stimulation frequency behavior match the response considering the patient's age, physical fitness, lifestyle, underlying disease, etc. If this is the case, a new appropriate control parameter is determined, and the new control parameter is reset to the cardiac pacemaker via the programmer.

Another method for calibrating control parameters related to the frequency control of cardiac stimulation is as follows. The behavior of the metabolic demand index during the exercise load test is recorded as time-series data in a recording device in the cardiac pacemaker, and after the exercise load test, the data is read out from the recording device and sent to the programmer. The physician operates the programmer to judge whether the received metabolic demand index and cardiac stimulation frequency behavior match the response considering the patient's age, physical fitness, lifestyle, underlying disease, etc. If this is the case, a new appropriate control parameter is determined, and the new control parameter is reset to the cardiac pacemaker via the programmer.

[0013]

However, a method in which a communication probe of a programmer is applied to a site where a cardiac pacemaker is implanted in a patient and a metabolic demand index and a behavior of a cardiac stimulation frequency of the patient during an exercise stress test are transmitted from the cardiac pacemaker to the programmer. Now, either place the programmer near the patient and perform the exercise test while staying within the communication probe cable length, or if the attendant of the exercise test has the programmer after the patient during the exercise test. Must follow. In particular, in the calibration of the rate response pacemaker using the metabolic demand index as the exercise form discrimination such as ascending and descending stairs, it is necessary to perform an out-of-hospital test such as ascending and descending stairs as an exercise load test. Either several steps of the stair climbing test must be performed while staying within the length of the communication probe cable, or an attendant of the exercise stress test must follow the patient performing the stair climbing test with the programmer. Generally, a programmer is not suitable for carrying because of its large size and heavy weight and the fact that it has to be powered by a power cable.

As described above, when the programmer is installed, the execution of the exercise load test is limited to the range of the cable length of the communication probe. In addition, since the follow-up of the patient by carrying the programmer is too heavy for the attendant of the exercise load test, the exercise load test and the calibration of the pacemaker based on the above method are very difficult in practice.

Further, the behavior of the metabolic demand index and cardiac stimulation frequency of the patient during the exercise load test is recorded as time-series data in a recording device in the cardiac pacemaker, and after the exercise load test, the data is read out from the recording device. Also in the method of sending to the programmer, at the start and end of the exercise stress test and at the time of receiving data, the programmer must be placed near the patient or moved to the side of the programmer. In particular, when performing an exercise load test in the form of exercise such as stair climbing or stair descending, it is necessary to transport the programmer to the stairs or to reciprocate the patient between the stairs and the hospital room where the programmer is located.

When several types of exercise load tests are performed in one data measurement, one type of data includes several types of exercise load data. Is difficult to understand, and the analysis becomes complicated. In particular, stairs climb in one data measurement,
When the exercise load test is performed in a plurality of exercise modes such as stair descent, one data includes data of a plurality of exercise modes, and the analysis becomes extremely complicated. In addition, a large-capacity recording device is required to record time-series data such as body motion, respiration, and body temperature in a recording device in a cardiac pacemaker.

SUMMARY OF THE INVENTION In view of the above-mentioned conventional problems, the present invention uses a small, lightweight, portable handheld setting device to perform a plurality of exercises in a form of exercise that can only be performed outside a hospital room, such as stair climbing or stair descending. An object of the present invention is to provide a calibration system for an implantable medical device that can easily perform calibration of the implantable medical device even when a load test is performed.

The small, lightweight and portable hand-held type here is about the size of a palm, weighs 1 kg or less, and hopefully 500 g or less. No size and weight.

[0019]

In order to solve this problem, a hand-held setting device of the present invention is small, lightweight and portable, and an implantable medical device, a hand-held setting device and a programmer can treat each other. Related information and treatment control index calculation parameters can be transmitted and received. The patient performs an unrestrained exercise test, both inside and outside the room, and the handheld setter receives and stores information related to the treatment from the implantable medical device during that time. After the exercise test, the handheld setter sends the treatment-related information to the programmer. The programmer sets treatment control index calculation parameters from the information related to the treatment received from the handheld type setting device, transmits the parameters to the implantable medical device,
By setting the parameters, the implantable medical device is easily calibrated.

The hand-held setting device of the present invention is small, lightweight and portable, and the implantable medical device, the hand-held setting device and the programmer can transmit and receive information related to the treatment and parameters for calculating the treatment control index to each other. And The patient performs an unrestrained exercise load test inside or outside the hospital room, and the hand-held setting device receives information related to the treatment during that period from the implantable medical device and sets a treatment control index calculation parameter. After the exercise stress test, the hand-held setting device sends the treatment control index calculation parameters to the programmer. The programmer modifies the treatment control index calculation parameters received from the handheld setting device,
By transmitting to the implantable medical device and setting parameters, the implantable medical device is easily calibrated.

Further, the hand-held setting device of the present invention is small, lightweight and portable, and the implantable medical device, the hand-held setting device and the programmer can transmit and receive information related to the treatment and parameters for calculating the treatment control index to each other. And The patient performs an unrestrained exercise test in and out of the room, the handheld setting device receives and stores information related to the treatment from the implantable medical device during that time, and sets the treatment control index calculation parameters I do. After the exercise test, the hand-held setting device sends information related to the treatment and parameters for calculating the treatment control index to the programmer. The programmer sets the treatment control index calculation parameters from the information related to the treatment received from the handheld setting device, corrects the treatment control index calculation parameters received from the handheld setting device, compares the two, and selects one of the treatments. By selecting the control index calculation parameter, transmitting the parameter to the implantable medical device, and setting the parameter, the implantable medical device is easily calibrated.

Further, the handheld setting device of the present invention transmits the set treatment control index calculation parameters directly to the implantable medical device, and sets the parameters.
Easily calibrate implantable medical devices.

Further, the handheld setting device of the present invention instructs the patient on the type of exercise, exercise intensity, etc. by voice, tuned sound, vibration, light, etc., makes the patient perform an exercise load test, and exercises during that time. By storing information such as the type of exercise and the intensity of exercise, the implantable medical device can be easily calibrated.

Further, the hand-held setting device of the present invention instructs the patient to exercise in a free motion form, and the hand-held setting device and / or the programmer discriminates the motion type of the motion and performs the free motion of the patient. Calibrate implantable medical devices easily by substituting for exercise testing.

Further, according to the present invention, a treatment control index calculation parameter of an implantable medical device having a plurality of motion sensors and controlling a treatment with a plurality of metabolic demand indices is set by one hand-held setting device. Easily calibrate implantable medical devices.

[0026]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The features of the present invention will be described in detail with reference to the drawings showing a plurality of embodiments of a calibration system for an implantable medical device according to the present invention. Although the embodiment described below corresponds to a calibration system for cardiac stimulation frequency control of a cardiac pacemaker, the present invention is not limited to this embodiment. It can be applied as a calibration system to all implantable medical devices that perform adjustable therapeutic actions, such as calibration of output control.

<Example of System Configuration of First Embodiment> FIG. 1 shows a first embodiment of the rate response pacemaker of the present invention.

The cardiac pacemaker (21) comprises a stimulus frequency control section (1), a stimulus output control section (22), a stimulus output section (23), and a cardiac activity input section (24). Connected to the heart (41). The stimulus frequency control unit (1) determines a cardiac stimulus frequency suitable for the living body, and transmits the determined cardiac stimulus frequency to the stimulus output control unit (22). In the cardiac activity input unit (24), cardiac activity is detected based on cardiac information obtained via the electrode lead (25) connected to the heart (41),
The detected heart activity is transmitted to the stimulus output control unit (22). In the stimulus output control unit (22), if a heart activity having a frequency corresponding to the cardiac stimulus frequency determined by the stimulus frequency control unit (1) is not transmitted by the heart activity input unit (24), the stimulus output unit
A command is issued to (23), and the commanded stimulus output section (23) stimulates the heart (41) via the electrode lead (25). The stimulus frequency control unit (1) further includes a motion sensor (2), a stimulus frequency calculation unit (3),
It comprises a storage unit (4), a transmission unit (5), and a reception unit (6). Note that the storage of the stimulus frequency control-related information by the storage unit (4) is not essential, and the storage of the stimulus frequency control-related information by the storage unit (14) of the handheld type setting device (11) may be substituted.

In the motion sensor (2), a vibration sensor, a respiration sensor, a body temperature sensor, and the like are used, and sensor information is transmitted to the stimulus frequency calculation unit (3). Stimulus frequency calculator (3)
Then, the heart stimulation frequency suitable for the living body is calculated based on the sensor information transmitted from the motion sensor (2) and the stimulation frequency calculation parameter stored in the storage unit (4). The stimulus frequency calculation parameters include sensor gain, threshold, etc., which are control parameters for extracting metabolic demand indices, and maximum stimulus frequency, slope, stimulus frequency rise speed, stimulus frequency decrease speed, which are control parameters for stimulus frequency setting. Etc. are included. Further, a threshold value of the ratio between the acceleration intensity in the front-rear direction and the acceleration intensity in the vertical direction is included as a control parameter for extracting a metabolic request index using the exercise form as a metabolic request index.
The stimulation frequency calculation parameters stored in the storage unit (4) can be changed by an external device via the receiving unit (6). All or selected information of the stimulus frequency control related information, which is the information of the calculation process in the control index calculation unit (3), is read out immediately or by the external device via the transmission unit (5) from the storage unit (4). Is possible. The stimulus frequency control-related information includes sensor information, a calculated metabolic demand index, a stimulus frequency, a stimulus frequency calculation parameter, and the like.

The hand-held setting device (11-1) has a receiving unit (1-1).
2), a transmission unit (13), a storage unit (14), and an exercise instruction unit (15). The storage unit (14) receives and stores stimulus frequency control-related information from the transmission unit (5) of the cardiac pacemaker (21) via the reception unit (12). The stimulus frequency control related information stored in the storage unit (14) can be read by an external device via the transmission unit (13). The exercise instructing unit (15) gives instructions to the patient by outputting voice or tuning sound to load information such as the start and stop of exercise, exercise speed, etc. Maintain and continue street exercise. At this time, the load information is sent to the storage unit (14) and stored in the storage unit (14) together with the stimulus frequency control related information.

Some typical exercise load test protocols having different load times and exercise speeds are registered in advance in the exercise instructing section (15), and the physician, healthcare professional, or patient can use the handheld type setting. It is possible to select a specific exercise load test protocol registered in the exercise instruction unit (15) by operating an operation panel arranged on the vessel (11-1) and connected to the exercise instruction unit (15). it can. In addition, a protocol in which a load time, an exercise speed, and the like are freely combined can be registered in the exercise instruction unit (15) from an operation panel or an external device via the reception unit (12). Several event detection buttons are arranged on the operation panel, and when this button is pressed, the event information is sent to the storage unit (14) via the exercise instruction unit (15), and together with the stimulus frequency control related information. Stored in the storage unit (14). The event detection button
Without being bound by the exercise stress test protocol, in order to investigate the load of stairs, slopes, climbing, etc., and the effects of using transportation, etc. in free daily life, the load of stairs, slopes, climbing, etc. In addition, the patient can press the event detection button when using transportation or the like, and record the information together with the stimulus frequency control-related information.

The programmer (31-1) includes a receiving unit (32), a transmitting unit
(33), storage unit (34), stimulus frequency calculation parameter setting unit (3
5), comprising a stimulus frequency simulation unit (36). The storage unit (34) receives and stores the stimulus frequency control-related information of the storage unit (14) of the hand-held setting device (11-1) via the receiving unit (32). Note that the storage unit (34) may be replaced with the storage unit (14) of the handheld setting device (11-1). In the stimulation frequency calculation parameter setting unit (35), the sensor gain,
The stimulus frequency calculation parameters including the threshold, the maximum stimulus frequency, the slope, the stimulus frequency increase speed, the stimulus frequency decrease speed, etc. were set.In the stimulus frequency simulation unit (36), the stimulus frequency calculation parameter setting unit (35) was set. By applying the stimulus frequency calculation parameter to the stimulus frequency control related information stored in the storage unit (34), a simulation of the stimulus frequency calculation is performed, and an appropriate stimulus frequency calculation parameter is determined. The stimulus frequency calculation parameter set in the stimulus frequency calculation parameter setting unit (35) by the simulation is sent to the reception unit (6) of the cardiac pacemaker (21) via the transmission unit (33), and the storage unit (4) Is set to

<System Operation Example of First Embodiment> Next, a method of using the calibration system will be described.

(Exercise load test example) The patient holds the handheld setting device (11-1) in his / her hand and puts it on the heart pacemaker (21) implantation site, or uses an adhesive tape or the like to place the heart pacemaker (21) implantation site. Mount on the top, or only the receiving part (12) of the handheld setting device (11-1) with adhesive tape etc. on the heart pacemaker (21) implanted part, and the main body of the handheld setting device (11-1) (Receiver (12)
Can transmit and receive signals by wire or wirelessly) to be held in the patient's hand, fixed to the body with a belt, or inserted into a pocket of clothing.

When an exercise load test registered in advance in the handheld setting device (11-1) is performed, a doctor or a patient prepares for exercise by using buttons on the operation panel of the handheld setting device (11-1). The exercise instructing unit (15) is notified of the completion, and the exercise instructing unit (15) instructs the patient to perform an exercise load test by voice and rhythm sound according to a predetermined protocol. or,
When performing an exercise load test with an arbitrary exercise speed and exercise form, the doctor or patient can use the buttons on the operation panel or an external device to set the protocol such as the exercise speed and exercise form using the handheld setting device (11-1). When set in the exercise instructing section (15), the exercise instructing section (15) instructs the patient to perform an exercise load test by voice and rhythm sound according to the set protocol.

According to the instructions, the patient performs the exercise load test without restriction both inside and outside the hospital room. The stimulus frequency control related information during the exercise load test is transmitted to the outside via the transmission unit (5) of the cardiac pacemaker (21), and is received by the reception unit (12) of the handheld type setting device (11-1), It is stored in the storage section (14) of the hand-held setting device (11-1). At that time,
Information such as the exercise speed and the exercise form of the exercise exercise test is also stored in the storage unit (14) from the exercise instruction unit (15).

After the end of the exercise test, the patient removes the handheld setting device (11-1) from the body and hands it to the doctor. The physician communicates between the handheld setting device (11-1) and the programmer (31-1), and
The stimulus frequency control related information stored in the storage unit (14) of (11-1) is stored in the storage unit (34) of the programmer (31-1).

(Stimulation Frequency Simulation and Setting Example of Stimulation Frequency Calculation Parameter 1) Stimulation Frequency Simulation Unit
In (36), the stimulus frequency is simulated from the metabolic demand index stored in the storage unit (34) using the stimulus frequency setting parameter of the stimulus frequency calculation parameter setting unit (35). Incidentally, the storage unit (34) is a handheld type setting device (11-1)
When the storage unit (14) is substituted, the stimulus frequency calculation parameter setting unit (35) and the stimulus frequency simulation unit are directly sent from the storage unit (14) via the transmission unit (13) and the reception unit (32). (36)
Is transmitted to the stimulus frequency control.

For example, the metabolic demand index (body movement volume, ventilation volume, central venous blood temperature, exercise form information, etc.) of the stimulus frequency control-related information is selectively received and stored by the hand-held type setting device (11-1). When the stored metabolic demand index is read from the handheld setting device (11-1) to the programmer (31-1), the stimulus frequency simulation unit (36) calculates the maximum stimulus frequency, slope, stimulus from the metabolic demand index information. The stimulus frequency corresponding to the change of the frequency rise speed, the stimulus frequency fall speed, etc. is calculated by simulation. The physician checks the behavior of the stimulus frequency calculated by simulation on the display of the programmer (31-1), and selects the purpose from among the control parameters such as the maximum stimulus frequency, slope, stimulus frequency increase speed, stimulus frequency decrease speed. The maximum stimulus frequency, slope, stimulus frequency increase speed, stimulus frequency decrease speed, etc. are adjusted by changing the control parameter values to match the stimulus frequency response in consideration of the patient's age, physical strength, lifestyle, underlying disease, etc. Set the value of.

(Stimulation Frequency Simulation and Evaluation Example of Stimulation Frequency Calculation Parameter 1) Also, the maximum stimulation frequency, slope, and stimulus frequency increasing speed currently set in the cardiac pacemaker (21) together with the metabolic demand index as the stimulation frequency control-related information. When the values of the stimulus frequency descending speed and the like are read out to the programmer (31-1), the stimulus frequency simulation unit (36)
Simulation calculation of the stimulation frequency response actually controlled during the exercise load test from the metabolic demand index and values such as the maximum stimulation frequency, slope, stimulation frequency increasing speed, stimulation frequency decreasing speed currently set in the cardiac pacemaker (21) And the stimulus frequency when the values of the maximum stimulus frequency, slope, stimulus frequency increase speed, stimulus frequency decrease speed, etc. are changed, and the stimulus frequency response actually controlled on the display of the programmer (31-1) It is also possible to display the responses simultaneously and compare them.

(Stimulation frequency simulation and setting example of stimulation frequency calculation parameters 2) Sensor information (acceleration, thoracic impedance, temporal change in central venous blood temperature) which is a signal reflecting exercise intensity as stimulation frequency control related information
Is selectively received and stored by the hand-held setting device (11-1), and the sensor information which is a signal reflecting the stored exercise intensity is transmitted from the hand-held setting device (11-1) to the programmer (31-1).
, The stimulation frequency simulation unit (36) calculates the threshold, sensor gain, maximum stimulation frequency,
Based on the simulation calculation of the metabolic demand index corresponding to the change of the threshold and the sensor gain with respect to the change of the slope, the stimulation frequency rising rate, and the stimulation frequency falling rate, and subsequently, based on the simulation calculation result of the metabolic demand index,
The stimulus frequency corresponding to the change of the maximum stimulus frequency, the slope, the stimulus frequency increase speed, and the stimulus frequency decrease speed is calculated by simulation. The physician checks the behavior of the stimulus frequency calculated by simulation on the display of the programmer (31), and controls the control parameters such as the threshold, the sensor gain, the maximum stimulus frequency, the slope, the stimulus frequent rise rate, and the stimulus frequency fall rate. By changing the value of the target control parameter from the middle, the threshold, sensor gain, maximum stimulation frequency, slope, slope, so as to match the stimulation frequency response considering the patient's age, physical strength, lifestyle, underlying disease, etc.
Set the values of the stimulus frequency increase speed and the stimulus frequency decrease speed.

(Stimulation Frequency Simulation and Evaluation Example of Stimulation Frequency Calculation Parameter 2) Alternatively, the thresholds and sensors currently set in the cardiac pacemaker (21) together with sensor information which is a signal reflecting exercise intensity as stimulation frequency control-related information When values such as gain, maximum stimulus frequency, slope, stimulus frequency increase speed, and stimulus frequency decrease speed are read out to the programmer (31-1), the stimulus frequency simulation section (36) uses a sensor, which is a signal that reflects exercise intensity. From the information and the values currently set for the cardiac pacemaker (21) such as threshold, sensor gain, maximum stimulation frequency, slope, stimulation frequency rising speed, stimulation frequency falling speed, etc., the stimulation frequency actually controlled during the exercise stress test The response is reproduced by simulation calculation and the programmer (31-
1) Actually controlled stimulus frequency response on the display, threshold, sensor gain, maximum stimulus frequency,
It is also possible to simultaneously display the stimulus frequency responses when the values of the slope, the stimulus frequency increasing speed, the stimulus frequency decreasing speed, and the like are changed, and to compare the two.

(Stimulation Frequency Simulation and Setting Example of Stimulation Frequency Calculation Parameter 3) In addition, a rate response pacemaker (Japanese Patent Application No. 2002-214,197) using the exercise form previously applied by the present inventors as one of the metabolic demand indexes in the stimulation frequency control. In Japanese Patent Application Laid-Open No. 9-100306), a threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity is set as a metabolic requirement index parameter for extracting a movement form, which is a metabolic requirement index. The acceleration data is selectively received and stored by the hand-held setting device (11-1) as stimulus frequency control-related information, and the stored acceleration data is read out from the hand-held setting device to the programmer (31-1). The simulation unit (36) simulates the exercise form corresponding to the change in the threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity with respect to the change in the threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity. Based on the calculation and subsequently the simulation calculation result of this exercise form, the maximum stimulation frequency,
With respect to changes in the slope, the stimulus frequency increasing speed, and the stimulus frequency decreasing speed, the stimulus frequency corresponding to the maximum stimulus frequency, the slope, the stimulus frequency increasing speed, and the stimulus frequency decreasing speed is calculated by simulation. The physician uses the programmer (31-
While checking on the display of 1), match the exercise form of the exercise test actually performed with the exercise form calculated by simulation, or respond to the stimulation frequency response considering the patient's age, physical fitness, lifestyle, basic disease etc. To match, a threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity,
Set the values of the maximum stimulus frequency, slope, stimulus frequency increase speed, and stimulus frequency decrease speed.

(Transportation Riding Test Example 1) A rate response pacemaker using body movement as a metabolic demand index has a function of reflecting only a body movement signal exceeding a threshold to the calculation of the body movement amount. It is mainly used to minimize the effects of extraneous vibrations when riding in transportation. To set this threshold,
It is desirable to conduct a transportation ride test instead of an exercise load test. The patient stores the body motion signal at the time of getting on the means of transportation in the storage unit (14) of the hand-held setting device (11-1), and performs the hand-held setting device (11-1) at the time of periodic diagnosis of the pacemaker.
Bring to hospital. The doctor receives the hand-held setting device (11-1) from the patient, and outputs the body motion signal at the time of getting on the transportation means stored in the storage unit (14) of the hand-held setting device (11-1).
It is stored in the storage section (34) of the programmer (31-1). The doctor displays the body motion signal data on the display of the programmer (31-1) as a graph, and the stimulation frequency simulation unit (36) simulates the amount of body motion and the stimulation frequency when the threshold is changed from the body motion signal data by simulation. And set the threshold.

Similarly, information on stimulus frequency control when the patient feels a physical disorder is transmitted to the handheld setting device (11-
It is also possible to store the data in the storage unit (14) of (1) and bring the handheld setting device (11-1) to the hospital at the time of periodic diagnosis of the pacemaker, consult a doctor, and search for the cause of the malfunction.

(Storing Example of Stimulus Frequency Calculation Parameter 1) The doctor sets the set stimulation frequency calculation parameter to a programmer (31-
Confirm on the screen of 1), and programmer with built-in transmitter (33)
(31-1) Communication probe for patient cardiac pacemaker (21)
The stimulus frequency calculation parameter is transmitted from the transmission unit (33) of the programmer (31-1) by hitting the embedment site. The transmitted stimulus frequency calculation parameter is the receiving unit of the cardiac pacemaker (21).
It is received in (6) and stored in the storage unit (4).

<Example of Block Configuration of Each Element Constituting System of First Embodiment> FIGS. 4 to 9 show an example of a hardware block configuration of each element composing the system of the first embodiment. The flowchart of the operation example is shown.
It is to be noted that a configuration example and an operation example of the systems of the second and third embodiments can be inferred from the disclosure of the system of the first embodiment, and thus details are not described.

(Example of Hardware Configuration of Cardiac Pacemaker) FIG. 4 shows an example of the hardware configuration of a cardiac pacemaker 21 constituting the system of the first embodiment.

Reference numeral 41 denotes a CPU for calculation and control for controlling the entire cardiac pacemaker 21. Reference numeral 42 denotes a ROM for storing a program executed by the CPU 41, fixed parameters, and the like. Frequency calculation program 42a for calculating a stimulus frequency and outputting a stimulus signal corresponding to the stimulus frequency, a metabolic demand index extraction program 42b for extracting a metabolic demand index from detection information from a sensor or the like, and a handheld type setting from the cardiac pacemaker 21 A transmission / reception program 42c for controlling data transmission to the device 11 and reception of data from the programmer 31 or the handheld setting device 11 to the cardiac pacemaker 21.

Reference numeral 43 denotes a rewritable RAM of a storage unit, which stores a stimulus frequency calculation parameter 43a and, if necessary, stimulus frequency control related information 43b.
Is also used as a temporary storage unit used when executing a program. It is preferable that the stimulus frequency control-related information be transmitted from the cardiac pacemaker 21 to the hand-held setting device 11 and stored in the hand-held setting device 11 in order to make the cardiac pacemaker 21 more compact. 44
Is a transmission unit that transmits data, for example, a stimulus frequency calculation parameter and stimulus frequency control-related information to the hand-held setting device 11, and 45 receives data, for example, a stimulus frequency calculation parameter from the programmer 31 or the hand-held setting device 11. It is a receiving unit. In this example, the program is fixed in the ROM 42, but a part of the program may be stored in the RAM and rewritten through the receiving unit 45.

An input interface 47 receives a detection signal from the motion sensor 2 or the like and inputs it as data that can be processed by the CPU 41. The stimulus signal data output from the CPU 41 is input to the stimulus output control unit 22, and the heart stimulus signal is output via the stimulus output unit 23 with reference to the heart activity data from the heart via the heart activity input unit 24. Output.

(Example of Operation Flowchart of Cardiac Pacemaker) FIG. 5 is a flowchart of an operation example of the cardiac pacemaker 21 constituting the system of the first embodiment.

In step S50, the heart pacemaker 21 is initialized. This initialization is performed before implanting in the body. After the initialization is once performed, the stimulus frequency calculation parameters and the like are set and embedded in the body, step S51 and the subsequent steps are executed. In steps S51 and S52, it is determined whether to transmit data or to receive data.

In the case of data transmission, the process proceeds from step S51 to S52, in which stimulus frequency control related information and the like are directly transmitted.
Alternatively, if it is stored in the RAM 43, it is transmitted from the RAM 43 to the hand-held setting device 11 via the transmission unit 44. If the data is received, steps S53 to S5
Proceeding to 4, the stimulus frequency calculation parameter is set to the programmer 31.
(Hand-held setting device 11), and step S
At 55, the received stimulus frequency calculation parameter 43a is
It is stored and stored in M43 and is used for calculating the stimulus frequency thereafter. The above processing is repeated until data transmission and data reception are completed.

In the middle of data transmission / data reception, or when data transmission / data reception is not performed, step S56
If there is an input from the sensor in steps S56 to S5
Proceeding to 7, the metabolic demand index is extracted with reference to the detection data from the sensor, and stored in the RAM 43 if necessary. Next, in step S58, the stimulus frequency is calculated based on the stimulus frequency calculation parameter 43a using the metabolic demand index and sent to the stimulus output control unit 22.
It is stored in M43.

(Example of Hardware Configuration of Handheld Type Setting Device) FIG. 6 shows an example of a hardware configuration of the handheld type setting device 11 constituting the system of the first embodiment.

Reference numeral 61 denotes a CPU for calculation and control for controlling the entire hand-held type setting device 11, and 62 denotes an RO for storing programs executed by the CPU 61 and fixed parameters.
M, an exercise instruction program 62 for displaying an exercise instruction on the display unit 68a in response to an instruction from the exercise instruction unit 15.
a. The stimulus frequency control-related information received from the cardiac pacemaker 21 is stored and held, and the cardiac pacemaker 2 is stored.
Receiving data from 1 to the handheld setting device 11,
It has a data storage / transmission / reception program 62b for controlling the transmission of data from the handheld setting device 11 to the programmer 31 or the cardiac pacemaker 21.

Reference numeral 63 denotes a RAM of a rewritable storage unit, which stores stimulus frequency control related information 63a,
The PU 61 is also used as a temporary storage unit used when executing a program. Reference numeral 64 denotes data to the programmer 31 or the cardiac pacemaker 21, for example, the cardiac pacemaker 2.
Reference numeral 1 denotes a transmission unit for transmitting stimulus frequency calculation parameters, and a programmer 31 transmits stimulus frequency control-related information and the like. Reference numeral 65 denotes a reception unit that receives data from the cardiac pacemaker 21, for example, stimulus frequency control-related information. In this example, the program is fixed in the ROM 62, but a part of the program is in the RAM 62.
And may be configured to be rewritten via the receiving unit 45. 66 is a portable external storage device such as a floppy disk, CD, memory card, etc.
It is used to assist or replace M63 and to transfer data between the handheld setting device 11 and the programmer 31 instead of communication.

Reference numeral 67 denotes an input interface, which receives a detection signal from the exercise instruction section 15 and the like and inputs the data as data that can be processed by the CPU 41. Reference numeral 68 denotes an output interface. Exercise instruction data output by the CPU 61 is displayed on the display unit via the output interface 68. still,
It is natural that the display unit 68a displays not only the exercise instruction but also other instruction information and error information.

(Example of Operation Flowchart of Handheld Setting Device) FIG. 7 shows a flowchart of an operation example of the handheld setting device 11 constituting the system of the first embodiment.

In step S70, the handheld setting device 1
Initialize 1. In steps S71, S75, S77,
It is determined whether it is an exercise instruction, data transmission, or data reception.

If the input is a motion instruction, step S71
The process proceeds from S72 to S72, in which load information relating to the load applied to the exercise is stored, and in Step S73, the subject is instructed to exercise by sound or display. This exercise instruction is repeated until the end is detected in step S74.

If the data is to be transmitted, the process proceeds from step S75 to S76, where the stimulus frequency control related information and the like are stored in the RAM 6.
3 to the programmer 31 via the transmission unit 64. In this case, when data is transferred by a portable storage medium, the data to be transferred is stored in an external storage medium.

If the data is to be received, the process proceeds from step S77 to S78 to receive stimulus frequency control-related information and the like from the cardiac pacemaker 21. The stimulus frequency control-related information received in step S79 is stored and held in the RAM 63. It is used for calculating the stimulus frequency calculation parameters thereafter.

(Example of Hardware Configuration of Programmer) FIG.
2 shows an example of a hardware configuration of a programmer configuring the system according to the first embodiment.

Reference numeral 81 denotes a CPU for calculation and control for controlling the entire programmer 31; 82, a ROM for storing programs executed by the CPU 81, fixed parameters, and the like;
The stimulus frequency is simulated by the stimulus frequency calculation parameter, and the stimulus frequency calculation parameter is set based on the stimulus frequency control-related information received from the hand-held setting device 11. The stimulus frequency calculation parameter setting program 82b includes a data storage / transmission / reception program 82c that controls reception of data from the handheld setting device 11 to the programmer 31 and transmission of data from the programmer 31 to the cardiac pacemaker 21.

Reference numeral 83 denotes a RAM of a rewritable storage unit that stores a stimulus frequency calculation parameter 83a, and stores stimulus frequency control related information 63a if necessary.
The PU 81 is also used as a temporary storage unit used when executing a program. Reference numeral 84 denotes a transmission unit that transmits a stimulus frequency calculation parameter or the like to the cardiac pacemaker 21, and reference numeral 85 denotes a reception unit that receives data from the handheld type setting device 11, for example, stimulus frequency control-related information. In this example,
The program is fixed in the ROM 62, but a part is
It may be configured to be stored in the AM and rewritten via the receiving unit 45. 86 is a floppy disk, C
D, a portable external storage device such as a memory card, which is used to supplement or substitute for the RAM 83 and to perform data transfer between the hand-held setting device 11 and the programmer 31 instead of communication.

Reference numeral 87 denotes an input interface, and the CPU 81 executes processing in response to input instructions such as setting of a stimulus frequency calculation parameter and stimulus frequency simulation from the keyboard 87a and the mouse 87b. Reference numeral 88 denotes an output interface, and data such as a stimulus frequency calculation parameter output by the CPU 81 is displayed on the display unit 88 a via the output interface 88. It is natural that the display unit 88a displays other instruction information, error information, and the like.
A printer 8 for outputting a hard copy as required.
8b is also connected.

(Example of Operation Flowchart of Programmer) FIG. 9 is a flowchart of an example of the operation of the programmer constituting the system of the first embodiment.

In step S90, the programmer 31 is initialized. In steps S91, S94, S96, and S98, it is determined whether simulation, parameter setting, data transmission, or data reception.

If the input is a simulation instruction, the flow advances from step S91 to S92 to simulate the stimulus frequency using the stimulus frequency calculation parameter. In step S93, the parameter is changed based on the simulation result. Steps S92 to S93 are repeated until a desired simulation result is obtained, and the process ends when the desired result is obtained.

For setting the stimulus frequency calculation parameter,
Proceeding from step S94 to S95, the stimulus frequency calculation parameters are set and stored.

In the case of data transmission, the process proceeds from step S96 to S97, where the stimulus frequency calculation parameters and the like are stored in the RAM.
From 83, the data is transmitted to the cardiac pacemaker 21 via the transmission unit 84.

If the data is received, the flow advances from step S98 to S99 to receive the stimulus frequency control-related information and the like from the hand-held setting device 11, and if necessary, the stimulus frequency control-related information received in step S100 to the RAM 83.
And is used to calculate the stimulus frequency calculation parameters thereafter.

According to the present embodiment, since the hand-held setting device (11-1) can be freely carried anywhere, the patient conducts an exercise load test at home or at work, and the hand-held setting device (11-1) is used. The stimulation frequency control related information is stored in the storage unit (14) of (11-1), the handheld type setting device (11-1) is brought to the hospital at the time of periodic diagnosis of the pacemaker, and the doctor sets the stimulation frequency calculation parameter to the cardiac pacemaker ( It is also possible to set to 21).

<System Modification of First Embodiment>
Note that the transmitting unit (13) of the hand-held setting device (11-1) and the receiving unit (32) of the programmer (31-1) have communication means by infrared communication such as IrDA, so that the hand-held setting device (11-1) can be used. Only communication between 11-1) and the programmer (31-1) can be performed by infrared communication.

The hand-held setting device (11-1) is stored in a PC card, and the transmitting section (13) of the hand-held setting device (11-1) is used.
Has a PCMCIA-compliant communication function, the programmer (31-1) has a PC card slot or a PC card reader, and the receiving section (32) of the programmer (31) has a PCMCIA-compliant communication function. Of the hand-held setting device (11-1) into the PC card slot or PC card reader provided in the programmer (31-1), and communication between the hand-held setting device (11-1) and the programmer (31-1) Only P
It is also possible to use a communication protocol conforming to CMCIA.

The transmitting section (13) (and the storage section (14)) in the hand-held setting device (11-1) is provided with a program storage in a data storage section for storing in a removable and small storage medium such as a smart media. The receiving unit (32) (and the storage unit (34)) in (31-1) mounts a small storage medium such as a smart media detached from the handheld setting device (11-1) and reproduces data. It is also possible to replace the data reproducing unit with a data reproducing unit.

The cardiac pacemaker (21) has a storage unit.
Equipped with (4), it is also possible to temporarily store the stimulus frequency control related information during the exercise load test in the storage unit (4) and then transmit it from the transmission unit (5) to the handheld type setting device (11-1) It is.

Even when the cardiac pacemaker (21) has various types of motion sensors (2), the hand-held setting device (11-1) receives various types of stimulus frequency control related information, and (31-1) is the stimulus frequency calculation parameter setting unit
By setting many kinds of stimulation frequency calculation parameters in (35), it is possible to set many kinds of stimulation frequency calculation parameters with one handheld setting device.

If the stimulus frequency calculation parameter setting section (35) of the programmer (31-1) further has a motion form discriminating section, the motion form is discriminated from the received stimulus frequency control related information, and the discrimination is made. A stimulus frequency calculation parameter is set from the exercise form and the stimulus frequency control related information in the same manner as described above. Therefore, the patient can carry out the exercise load test in a free form of exercise.

<System Configuration Example of Second Embodiment> FIG. 2 shows a system configuration example of the second embodiment of the present invention. The configuration of the cardiac pacemaker (21) is the same as that of the first embodiment (FIG. 1).

The hand-held setting device (11-2) has a receiving unit (1-2).
2), a storage unit (14) for storing stimulus frequency control-related information, a stimulus frequency calculation parameter setting unit (16) for setting a stimulus frequency calculation parameter from the stored stimulus frequency control-related information, and a stimulus frequency simulation unit (17). , Transmission unit (13), exercise instruction unit
It consists of (15).

The programmer (31-2) includes a receiving unit (32), a transmitting unit
(33), a storage unit (37) that stores the stimulation frequency calculation parameters set by the handheld type setting device (11-2), and a stimulation frequency calculation parameter correction unit (38) that corrects the stored stimulation frequency calculation parameters. Be composed. Note that, similarly to the first embodiment, the storage of the stimulus frequency control related information by the storage unit (4) is not essential, and the stimulus frequency by the storage unit (14) of the hand-held setting device (11-2) is not required. The storage of the control-related information may be substituted. Also, the stimulus frequency control related information is not stored in the storage unit (14), and the stimulus frequency calculation parameter setting unit (1
By storing the stimulus frequency calculation parameter set in 6) in the storage unit (14), the stimulus frequency calculation parameter is stored in the storage unit (34).
May be substituted.

<Example of System Operation of Second Embodiment> Procedures until a patient performs an exercise load test are the same as those of the first embodiment (FIG. 1).

The stimulus frequency calculation parameter setting section (16) of the hand-held type setting device (11-2) automatically sets stimulus frequency calculation parameters from the stimulus frequency control related information stored in the storage section (14).

(Stimulation Frequency Simulation and Setting Example of Stimulation Frequency Calculation Parameter 4) For example, the metabolic demand index (body movement, ventilation, central venous blood temperature, exercise form information, etc.) of the stimulation frequency control-related information is selectively selected. Handheld setting device
When received and stored in (11-2), the stimulus frequency simulation unit (17) calculates, from the metabolic demand index, the stimulus frequency corresponding to the change in the maximum stimulus frequency, slope, stimulus frequency increase speed, stimulus frequency decrease speed, and the like. Simulations are calculated, and values such as the maximum stimulation frequency, slope, stimulation frequency rising speed, and stimulation frequency falling speed are automatically set to match the stimulation frequency response considering the patient's age, physical strength, lifestyle, underlying disease, etc. Is done.

(Stimulation Frequency Simulation and Stimulation Frequency Calculation Parameter Setting Example 5) Sensor information (acceleration, thoracic impedance, central venous blood temperature change over time) which is a signal reflecting exercise intensity as stimulation frequency control-related information
Is selectively received and stored by the hand-held setting device (11-2), the stimulus frequency simulation section (17) provides a threshold, a sensor gain, a maximum stimulus frequency, a slope,
For changes in the stimulus frequency increase speed and stimulus frequency decrease speed,
Based on the simulation calculation of the metabolic demand index corresponding to the change of the threshold and the sensor gain, and based on the simulation calculation result of this metabolic demand index, it corresponds to the change of the maximum stimulus frequency, slope, stimulus frequency rise rate, stimulus frequency fall rate The stimulus frequency is calculated by simulation,
Threshold, sensor gain, maximum stimulus frequency, slope, stimulus increase rate, and stimulus decrease rate are automatically set to match the stimulus frequency response in consideration of the patient's age, physical strength, lifestyle, underlying disease, etc. Is done.

(Stimulation Frequency Simulation and Setting Example of Stimulation Frequency Calculation Parameter 6) In addition, a rate response pacemaker (Japanese Patent Application No. 2002-214,197) using the exercise form previously filed by the present inventors as one of the metabolic demand indexes in the stimulation frequency control. In JP-A-9-100306), a threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity is set as a control parameter for extracting the exercise form, which is a metabolic demand index. After selectively receiving and storing the acceleration data as the stimulus frequency control related information with the handheld type setting device (11-2),
In the stimulus frequency simulation unit (17), the exercise form corresponding to the change in the threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity is compared with the change in the threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity. Based on the simulation calculation of the exercise form and the simulation calculation result of this exercise form, the maximum stimulation frequency, slope, stimulation frequency increase rate, The stimulus frequency corresponding to the stimulus frequency descending speed is calculated by simulation, and the exercise form of the exercise test that was actually performed is matched with the exercise form calculated by simulation, or the patient's age, physical strength, lifestyle, basic disease, etc. are considered. To match the stimulus frequency response, a threshold value of the ratio between the longitudinal acceleration intensity and the vertical acceleration intensity,
The values of the maximum stimulus frequency, slope, stimulus frequency increase speed, and stimulus frequency decrease speed are automatically set.

(Transportation Riding Test Example 2) A rate response pacemaker using body movement as a metabolic demand index has a function of reflecting only a body movement signal exceeding a threshold to the calculation of the body movement amount. It is mainly used to minimize the effects of extraneous vibrations when riding in transportation. To set this threshold,
It is desirable to conduct a transportation ride test instead of an exercise load test. The patient stores the body motion signal at the time of getting on the means of transportation in the storage unit (14) of the handheld setting device (11-2), and changes the threshold from the body motion signal data in the heart stimulation frequency simulation unit (17). In this case, the amount of body motion and the frequency of heart stimulation are obtained by simulation, and the stimulus frequency calculation parameter setting unit (16) automatically sets a threshold so as to suppress the increase in the amount of body motion and frequency of heart stimulation.

(Storage Example 2 of Stimulation Frequency Calculation Parameters) After the end of the exercise load test, the patient sets the handheld type setting device (1
Hand 1-2) to your doctor. Doctors use a handheld setting device (1
If it is determined that the stimulation frequency calculation parameters set in 1-2) are valid, the received handheld setting device
(11-2) is directly applied to the heart pacemaker (21) implantation site of the patient, and the stimulus frequency calculation parameter is transmitted from the transmission unit (13) of the handheld type setting device (11-2). The transmitted stimulation frequency calculation parameter is received by the receiving unit (6) of the cardiac pacemaker (21) and stored in the storage unit (4). In this case, the exercise instructing unit (15) displays the contents of the stimulus frequency calculation parameter setting unit (16) and the stimulus frequency simulation unit (17) so that the doctor can easily determine the effectiveness. Is preferred.

When the doctor wants to modify the stimulus frequency calculation parameter, the doctor communicates between the received hand-held setting device (11-2) and the programmer (31-2) to change the set stimulus frequency calculation parameter. , Stored in the stimulus frequency calculation parameter storage unit (34) of the programmer (31-2). Doctor is a programmer
The stimulus frequency calculation parameter is confirmed on the display of (31-2), and is corrected by the stimulus frequency calculation parameter correction unit (38). After the correction, the physician sent a programmer (31-2) with a built-in transmitter (33)
Of the stimulus frequency calculation parameter to the programmer (3)
The data is transmitted from the transmission unit (33) in 1-2). The transmitted stimulation frequency calculation parameter is received by the receiving unit (6) of the cardiac pacemaker (21) and stored in the storage unit (4).

According to the present embodiment, since the hand-held setting device (11-2) can be freely carried anywhere, the patient performs the exercise load test at home or at work, and the hand-held setting device The stimulus frequency control related information is stored in the storage unit (14) of (11-2), and the stimulus frequency calculation parameter is set in the stimulus frequency calculation parameter setting unit (16) from the stored stimulus frequency control related information. It is also possible to bring the handheld setting device (11-2) to the hospital at the time of diagnosis and set a stimulus frequency calculation parameter in the cardiac pacemaker (21) by the doctor.

<System Modification of Second Embodiment>
The transmitting unit (13) of the hand-held setting device (11-2) and the receiving unit (32) of the programmer (31-2) have communication means by infrared communication such as IrDA, so that the hand-held setting device (11-2) can be used. Only the communication between 11-2) and the programmer (31-2) can be performed by infrared communication.

The hand-held setting device (11-2) is stored in a PC card, and the transmitting section (13) of the hand-held setting device (11-2) is inserted.
Has a PCMCIA-compliant communication function, the programmer (31) has a PC card slot or a PC card reader, and the receiving section (32) of the programmer (31-2) has a PCMCIA-compliant communication function. Of the hand-held setting device (11-2) to the PC card slot or PC card reader provided in the programmer (31-2), and communication between the hand-held setting device (11-2) and the programmer (31-2) Only P
It is also possible to use a communication protocol conforming to CMCIA.

The transmitting section (13) in the hand-held setting device (11-2) is provided in a data storage section for storing in a removable and small storage medium such as a smart media, and a programmer.
The receiving unit (32) in (31-2) is a handheld setting device (1
It is also possible to mount a small storage medium such as smart media removed from 1-2) and replace it with a data playback unit that plays back data.

Further, the cardiac pacemaker (21) temporarily stores the stimulus frequency control-related information during the exercise load test in the storage section (4), and then sends the information from the transmission section (5) to the handheld type setting device (11-2).
It is also possible to send to.

Further, even when the cardiac pacemaker (21) has various types of motion sensors (2), the handheld type setting device (11-2) receives the various types of stimulus frequency control related information, The stimulus frequency calculation parameter setting unit (16) sets various types of stimulus frequency calculation parameters, and the programmer (31-2) modifies the various types of stimulus frequency calculation parameters with the stimulus frequency calculation parameter correction unit (38). It is possible to set various kinds of stimulation frequency calculation parameters with one handheld type setting device.

If the stimulus frequency calculation parameter setting section (16) of the hand-held type setting device (11-2) further includes an exercise mode determination section, the exercise mode is identified from the received stimulus frequency control related information. In the same manner as in the first embodiment, a stimulus frequency calculation parameter is set from the determined exercise mode and stimulus frequency control-related information. Therefore, the patient can carry out the exercise load test in a free form of exercise.

<Example of System Configuration of Third Embodiment> FIG. 3 shows an example of a system configuration of the third embodiment in which the first embodiment and the second embodiment of the present invention are simultaneously implemented. .

The structure of the cardiac pacemaker (21) is the same as that of the first embodiment (FIG. 1). The configuration of the hand-held type setting device (11-3) is basically the same as that of the second embodiment (FIG. 2) except that the transmission unit (13) is set by the stimulus frequency calculation parameter setting unit (16). The configuration is such that the stimulus frequency calculation parameter and the stimulus frequency control related information stored in the storage unit (14) can be transmitted.

The programmer (31-3) includes a receiving unit (32), a transmitting unit
(33), a storage unit (34) for storing stimulus frequency control related information, a stimulus frequency calculation parameter setting unit (35) for setting a stimulus frequency calculation parameter from the stored information, and a handheld type setting device (11-3). A storage unit (34) for storing the set stimulus frequency calculation parameters, a stimulus frequency calculation parameter correcting unit (38) for correcting the stored stimulus frequency calculation parameters, and a stimulus set by the handheld setting device (11-3). The stimulus frequency calculation parameter selector (39) selects one of the frequency calculation parameter and the stimulus frequency calculation parameter set by the programmer (31-3).

Incidentally, similarly to the first and second embodiments,
The storage of the stimulus frequency control-related information by the storage unit (4) may be substituted by the storage of the stimulus frequency control-related information by the storage unit (14) of the handheld setting device (11-3). Alternatively, the stimulus frequency calculation parameter set by the stimulus frequency calculation parameter setting unit (16) may be stored in the storage unit (14), and the stimulus frequency calculation parameter may be stored in the storage unit (34) instead.

<Example of System Operation of Third Embodiment> An exercise load test is performed, and the stimulus frequency control-related information is stored in the storage section (14) of the hand-held type setting device (11-3), and the stimulus frequency is calculated. In the parameter setting section (16), a stimulus frequency calculation parameter is set from the stimulus frequency control related information stored in the storage section (14), as in the second embodiment (FIG. 2).

After completing the exercise test, the patient hands the handheld setting device (11-3) to the doctor. If the physician determines that the stimulation frequency calculation parameter set by the handheld setting device (11-3) is valid, the received handheld setting device (11-3) is used as it is by the patient's cardiac pacemaker.
(21) The stimulation frequency calculation parameter is transmitted from the transmission unit (13) of the hand-held setting device (11-3) by placing the parameter on the implanted part. The transmitted stimulation frequency calculation parameter is received by the receiving unit (6) of the cardiac pacemaker (21) and stored in the storage unit (4).

When the physician wants to modify and set the stimulus frequency calculation parameter by himself, he receives the received handheld setting device.
(11-3) and the programmer (31-3), and communicates the stimulus frequency control related information stored in the storage unit (14) of the handheld setting device (11-3) with the programmer (31-3). ) Is stored in the storage unit (34), and the stimulus frequency calculation parameters set by the handheld setting device (11-3) are stored in the storage unit (34) of the programmer (31-3).

The physician can correct the stimulus frequency calculation parameters stored in the storage section (34) by the stimulus frequency calculation parameter correction section (38). The physician also calculates a stimulus frequency calculation parameter from the stimulus frequency control-related information stored in the storage unit (34) in the stimulus frequency calculation parameter setting unit (35) while simulating the stimulus frequency calculation parameter in the same manner as in the first embodiment. Can also be set.

The doctor receives the corrected stimulus frequency calculation parameter received from the handheld setting device (11-3),
The stimulus frequency calculation parameter selection unit (39) selects one of the stimulus frequency calculation parameters set by the stimulus frequency calculation parameter setting unit (35) of (31-3) while looking at the display of the programmer (31). ) To select.

A doctor is a programmer with a built-in transmission unit (33).
(31-3) Communication probe for patient cardiac pacemaker (21)
The selected stimulus frequency calculation parameter is transmitted from the transmission unit (33) of the programmer (31-3) to the implanted part. The transmitted stimulation frequency calculation parameter is a cardiac pacemaker (2
It is received by the receiving unit (6) of 1) and stored in the stimulus frequency calculation parameter storage unit (4).

According to the present embodiment, since the hand-held setting device (11-3) can be freely carried anywhere, the patient performs the exercise load test at home or at work, and the hand-held setting device (11-3) is used. The stimulus frequency control-related information is stored in the storage unit (14) of (11-3), and the stimulus frequency calculation parameter is set in the stimulus frequency calculation parameter setting unit (16) from the stored stimulus frequency control-related information. It is also possible to bring the handheld setting device (11-3) to the hospital at the time of diagnosis and set the stimulus frequency calculation parameter in the cardiac pacemaker (21) by the doctor.

<System Modification of Third Embodiment>
The transmitting unit (13) of the hand-held setting device (11-3) and the receiving unit (32) of the programmer (31-3) have communication means by infrared communication such as IrDA. Only the communication between 11-3) and the programmer (31-3) can be performed by infrared communication.

The hand-held setting device (11-3) is stored in a PC card, and the transmission section (13) of the hand-held setting device (11-3) is used.
Has a PCMCIA-compliant communication function, the programmer (31-3) has a PC card slot or a PC card reader, and the receiver (32) of the programmer (31-3) has a PCMCIA.
PC equipped with a programmer (31-3) and a PC card type handheld setting device (11-3)
It is also possible to mount it in a card slot or a PC card reader and perform communication between the handheld setting device (11-3) and the programmer (31-3) using a communication protocol conforming to PCMCIA.

The transmitting section (13) of the hand-held setting device (11-3) is provided with a programmer (3) in a data storage section for storing in a removable and small storage medium such as a smart media.
The receiving unit (32) in 1-3) is a handheld setting device (11-
It is also possible to mount a small storage medium such as smart media removed from 3) and replace it with a data playback unit that plays back data.

The cardiac pacemaker (21) includes a storage unit (4) for storing information related to stimulus frequency control, and stores information related to the output of the exercise sensor (2) during the exercise load test. ), The data can be transmitted from the transmission unit (5) to the handheld setting device (11-3).

Further, even when the cardiac pacemaker (21) has various types of motion sensors (2), the hand-held setting device (11-3) receives various types of stimulus frequency control related information, and By setting many types of stimulus frequency calculation parameters in the frequency calculation parameter setting unit (16), the programmer (31-3) also sets many types of stimulus frequency calculation parameters in the stimulus frequency calculation parameter setting unit (35), It is possible to set various types of stimulus frequency calculation parameters with one handheld setting device.

If the stimulus frequency calculation parameter setting section (16) of the hand-held type setting device (11-3) further includes an exercise form discriminating section, the exercise form is discriminated from the received stimulus frequency control related information. In the same manner as in the second embodiment, a stimulus frequency calculation parameter is set from the determined exercise mode and stimulus frequency control-related information. In addition, if the stimulus frequency calculation parameter setting unit (35) of the programmer (31-3) further includes an exercise mode determination unit, the exercise mode is determined from the received stimulus frequency control related information, and the determined exercise mode is determined. A stimulus frequency calculation parameter is set from the stimulus frequency control-related information in the same manner as in the first embodiment. Therefore, the patient can carry out the exercise load test in a free form of exercise.

In the third embodiment, the transmitting section (13) stores the stimulus frequency calculation parameters set by the stimulus frequency calculation parameter setting section (16) and the stimulus frequency control related information stored in the storage section (14). Handheld setting device (1
Although an example in which 1-3) is connected has been described, the system provided by the cardiac pacemaker (21) and the programmer (31-3) of the third embodiment is different from the hand-held setting of the first embodiment. The device (11-1) and the handheld setting device (11-2) of the second embodiment may be considered to be connectable together.

[0118]

According to the present invention, when a small, lightweight, portable hand-held setting device is used to perform a plurality of exercise load tests in an exercise form that can only be performed outside a hospital room, such as stair climbing or stair descending. However, it is possible to provide an implantable medical device calibration system that facilitates the calibration of the implantable medical device.

That is, the hand-held setting device of the present invention is small, lightweight, and portable, and the implantable medical device, the hand-held setting device, and the programmer can transmit and receive information related to the treatment and parameters for calculating the treatment control index to each other. And The patient performs an unrestrained exercise test, both inside and outside the room, and the handheld setter receives and stores information related to the treatment from the implantable medical device during that time. After the exercise test, the handheld setter sends the treatment-related information to the programmer. The programmer can easily perform calibration of the implantable medical device by setting the treatment control index calculation parameters from the information related to the treatment received from the handheld type setting device, transmitting the parameters to the implantable medical device, and setting the parameters. Is possible.

Further, the hand-held setting device of the present invention is small, lightweight and portable, and the implantable medical device, the hand-held setting device and the programmer can transmit and receive information relating to the treatment and parameters for calculating the treatment control index to each other. And The patient performs an unrestrained exercise load test inside or outside the hospital room, and the hand-held setting device receives information related to the treatment during that period from the implantable medical device and sets a treatment control index calculation parameter. After the exercise stress test, the hand-held setting device sends the treatment control index calculation parameters to the programmer. The programmer modifies the treatment control index calculation parameters received from the handheld setting device,
By transmitting to the implantable medical device and setting the parameters, the calibration of the implantable medical device can be easily performed.

The hand-held setting device of the present invention is small, lightweight and portable, and the implantable medical device, the hand-held setting device and the programmer can transmit and receive information related to the treatment and parameters for calculating the treatment control index to each other. And The patient performs an unrestrained exercise test in and out of the room, the handheld setting device receives and stores information related to the treatment from the implantable medical device during that time, and sets the treatment control index calculation parameters I do. After the exercise test, the hand-held setting device sends information related to the treatment and parameters for calculating the treatment control index to the programmer. The programmer sets the treatment control index calculation parameter from the information related to the treatment received from the handheld type setting device, corrects the treatment control index calculation parameter received from the handheld type setting device, compares the two, and compares either one. By selecting the treatment control index calculation parameter, transmitting the parameter to the implantable medical device, and setting the parameter, the calibration of the implantable medical device can be easily performed.

The hand-held setting device of the present invention transmits the set treatment control index calculation parameters directly to the implantable medical device and sets the parameters.
Calibration of the implantable medical device can be easily performed.

Further, the hand-held setting device of the present invention instructs the patient on the type of exercise, exercise intensity, etc. by voice, tuning sound, vibration, light, etc., makes the patient carry out an exercise load test, and exercises during that time. By storing information such as the type of exercise and the intensity of exercise, calibration of the implantable medical device can be easily performed.

The hand-held setting device of the present invention instructs the patient to exercise in a free motion mode, and the hand-held setting device and / or the programmer discriminates the motion mode of the motion and performs the free motion of the patient. By replacing the exercise stress test, the calibration of the implantable medical device can be easily performed.

Further, according to the present invention, a treatment control index calculation parameter of an implantable medical device having a plurality of movement sensors and controlling treatment with a plurality of metabolic demand indices is set by one hand-held setting device. Calibration of the implantable medical device can be easily performed.

[Brief description of the drawings]

FIG. 1 is a diagram showing an example of a system configuration including a cardiac pacemaker, a handheld setting device, and a programmer according to a first embodiment of the present invention.

FIG. 2 is a diagram showing an example of a system configuration including a cardiac pacemaker, a handheld setting device, and a programmer according to a second embodiment of the present invention.

FIG. 3 is a diagram illustrating an example of a system configuration including a cardiac pacemaker, a handheld setting device, and a programmer according to a third embodiment of the present invention.

FIG. 4 shows an example of a hardware configuration of a cardiac pacemaker constituting the system of the first embodiment.

FIG. 5 shows a flowchart of an operation example of a cardiac pacemaker constituting the system of the first embodiment.

FIG. 6 illustrates an example of a hardware configuration of a hand-held setting device that configures the system according to the first embodiment.

FIG. 7 shows a flowchart of an operation example of the hand-held type setting device constituting the system of the first embodiment.

FIG. 8 illustrates a hardware configuration example of a programmer configuring the system according to the first embodiment.

FIG. 9 is a flowchart illustrating an operation example of a programmer included in the system according to the first embodiment;

[Explanation of symbols]

 1 Stimulation frequency control unit 2 Exercise sensor 3 Stimulation frequency calculation unit 4 Storage unit 5 Transmission unit 6 Reception unit 11 Handheld setting unit 12 Reception unit 13 Transmission unit 14 Storage unit 15 Exercise instruction unit 16 Stimulation frequency calculation parameter setting unit 17 Heart stimulation Frequency simulation unit 21 Heart pacemaker 22 Stimulation output control unit 23 Stimulation output unit 24 Heart activity input unit 25 Electrode lead 31 Programmer 32 Receiving unit 33 Transmitting unit 34 Storage unit 35 Stimulation frequency calculation parameter setting unit 36 Heart stimulation frequency simulation unit 38 Stimulation frequency Calculation parameter correction unit 39 Stimulus frequency calculation parameter selection unit

 ────────────────────────────────────────────────── ─── Continuing on the front page (72) Inventor Yoshizo Ishizuka 1500 Inoguchi, Nakai-cho, Ashigara-gun, Kanagawa Prefecture Terumo Corporation F-term (reference) 4C038 VA04 VB01 VC20 4C053 JJ18 JJ40

Claims (23)

[Claims] 1. A calibration system for adapting an implantable medical device to a living body, the implantable medical device being communicable with an external calibration device outside the body and performing an adjustable therapeutic action. An implantable medical device, wherein an adjustable treatment effect is adjusted based on a treatment control index, and wherein the treatment control index is calculated by a signal reflecting a patient's exercise intensity and a treatment control index calculation parameter; And the external calibration device for setting treatment control index calculation parameters based on the received information, and transmitting the set treatment control index calculation parameters to the implantable medical device. A portable handheld setting device, wherein the external calibration device receives information from the implantable medical device and outputs predetermined information. And a programmer for transmitting a treatment control index calculation parameter to the implantable medical device based on the predetermined information input from the handheld type setting device. 2. The hand-held setting device receives and stores information related to the treatment from the implantable medical device, and outputs the stored information. 2. The implantable medical device according to claim 1, wherein the stored information is input, the treatment control index calculation parameter is set from the input information, and the parameter is transmitted to the implantable medical device. Calibration system. 3. The implantable medical device includes: a motion sensor that outputs a signal reflecting the intensity of exercise of a human body; a first receiving unit that receives the treatment control index calculation parameter from outside the body; First storage means for storing the treatment control index calculation parameter received by the means; treatment control index calculation means for calculating a treatment control index from the signal reflecting the treatment control index calculation parameter and the exercise intensity; A first transmitting unit for transmitting information related to the treatment to the outside of the body, wherein the handheld setting device receives the information related to the treatment transmitted by the first transmitting unit. Means, second storage means for storing the information received by the second reception means, and second transmission means for transmitting the stored information to the outside. And a third receiving unit that receives the treatment-related information transmitted from the second transmitting unit of the handheld setting device; and a treatment control index calculation parameter based on the received information. 3. A treatment control index calculation parameter setting unit that sets the treatment control index calculation parameter, and a third transmission unit that transmits the treatment control index calculation parameter to the implantable medical device. Equipment calibration system. 4. The apparatus according to claim 3, wherein said programmer further comprises third storage means for storing said information received by said third reception means and / or a set treatment control index calculation parameter. 3. The calibration system for an implantable medical device according to claim 1. 5. The calibration system for an implantable medical device according to claim 1, wherein the hand-held setting device further sets a treatment control index calculation parameter based on the received information. 6. The calibration system for an implantable medical device according to claim 5, wherein the programmer further corrects the set treatment control index calculation parameter. 7. The implantable medical device, a motion sensor that outputs a signal reflecting the exercise intensity of a human body, a first receiving unit that receives a treatment control index calculation parameter from outside the body, and the first receiving unit. A first storage unit for storing the treatment control index calculation parameter received by the first control unit; a treatment control index calculation unit for calculating a treatment control index from the signal reflecting the treatment control index calculation parameter and the exercise intensity; First transmitting means for transmitting information related to the treatment outside the body, wherein the handheld setting device receives the information related to the treatment transmitted by the first transmitting means. A treatment control index calculation parameter setting means for setting the treatment control index calculation parameter based on the received information; and the treatment control index calculation Second to send outgoing parameters to outside
Transmitting means for receiving the treatment control index calculation parameter transmitted from the first transmitting means of the hand-held setting device; and the received treatment. 7. The treatment control index calculation parameter correcting means for correcting a control index calculation parameter, and a third transmission means for transmitting the treatment control index calculation parameter to the implantable medical device. Calibration system for implantable medical devices. 8. The hand-held setting device according to claim 2, wherein
And / or further comprising second storage means for storing the information received by the receiving means and / or the set treatment control index calculation parameter, and / or wherein the programmer receives the information received by the third receiving means. The calibration system for an implantable medical device according to claim 7, further comprising a third storage unit that stores a treatment control index calculation parameter. 9. The hand-held setting device receives and outputs information related to the treatment from the implantable medical device, and sets and outputs a second treatment control index calculation parameter based on the information. The programmer inputs information related to the treatment output from the hand-held setting device, sets a first treatment control index calculation parameter, and sets the second treatment control parameter set by the hand-held setting device. The treatment control index calculation parameter is input and corrected, and one of the first treatment control index calculation parameter and the second treatment control index calculation parameter is transmitted to the implantable medical device. 2. The calibration system for an implantable medical device according to claim 1. 10. The implantable medical device, comprising: a motion sensor that outputs a signal reflecting the exercise intensity of the human body; a first receiving unit that receives a first treatment control index calculation parameter from outside the body; A first storage unit that stores the first treatment control index calculation parameter received by the receiving unit, and calculates a treatment control index from the signal that reflects the first treatment control index calculation parameter and the exercise intensity. A treatment control index calculation unit; and a first transmission unit for transmitting information related to treatment including a signal reflecting the exercise intensity of the human body to the outside of the body, wherein the handheld setting device includes the first transmission Second receiving means for receiving the information related to the treatment transmitted by the means, and a second treatment control index calculation parameter based on the received information related to the treatment. A first treatment control index calculation parameter setting unit that sets a meter; and a second transmission unit that transmits information related to the treatment and the set second treatment control index calculation parameter to the outside, A programmer, a third receiving unit that receives the information related to the treatment and the second treatment control index calculation parameter transmitted from the second transmitting unit of the handheld type setting device; A treatment control index calculation parameter correcting unit that corrects the second treatment control index calculation parameter; and a second treatment control index calculation parameter that is set based on the information related to the treatment received by the third receiving unit. Treatment control index calculation parameter setting means, and a treatment control index calculation parameter for instructing selection of the second and third treatment control index calculation parameters 10. The implantable medical device according to claim 9, further comprising: a selector, and a third transmitter that transmits the selected first treatment control index calculation parameter to the implantable medical device. 11. Calibration system. 11. The hand-held setting device further includes first storage means for storing the information received by the first receiving means and / or a set treatment control index calculation parameter, and / or Or, the programmer stores the treatment control index calculation parameter received by the second reception unit and / or the first treatment control index calculation parameter corrected by the treatment control index calculation parameter correction unit. The calibration system for an implantable medical device according to claim 10, further comprising a storage unit. 12. A calibration system for adapting an implantable medical device to a living body, the implantable medical device being communicable with a handheld setter outside the body and providing an adjustable therapeutic action. An implantable medical device, wherein the adjustable treatment effect is adjusted based on a treatment control index, and wherein the treatment control index is calculated by a signal reflecting the exercise intensity of the patient and a treatment control index calculation parameter; The hand-held setting device for receiving treatment-related information from the device, setting a treatment control index calculation parameter based on the received information, and transmitting the treatment control index calculation parameter to the implantable medical device. A calibration system for an implantable medical device, characterized in that: 13. The device of claim 1, wherein the handheld setting device includes means for indicating the intensity and type of exercise to a patient implanted with the implantable medical device. 13. The calibration system for an implantable medical device according to any one of claims 12 to 12. 14. The implantable medical device according to claim 13, wherein the handheld setting device stores information on the intensity of the exercise and the type of the exercise together with information related to the treatment. Calibration system. 15. The hand-held setting device has means for inputting patient information that is information on the age and / or physique and / or lifestyle and / or underlying disease of the patient, and the patient information 15. The calibration system for an implantable medical device according to claim 14, wherein a treatment control index calculation parameter is automatically set from information on the treatment and information on the intensity of the exercise and the type of the exercise. 16. The implant according to any one of claims 1, 2, 5, 9 and 12, wherein the implantable medical device further comprises means for storing information related to the treatment. Calibration system for portable medical devices. 17. The implantable medical device has various types of means for detecting the intensity of exercise of the human body, and the handheld type setting device and / or the programmer sets various types of the treatment control index calculation parameters. The calibration system for an implantable medical device according to claim 1, wherein the calibration is performed. 18. Transfer of information or parameters from the hand-held setting device to the programmer is performed using communication means of both the hand-held setting device and the programmer using electromagnetic waves or infrared rays, or a communication terminal of the programmer. 13. The method according to claim 1, wherein the communication is performed by using an electric signal by electrically connecting the communication terminal of the hand-held setting device to the hand-held setting device, or by using a removable storage medium. A calibration system for an implantable medical device according to one of the preceding claims. 19. The calibration system for an implantable medical device according to claim 18, wherein the storage means of the hand-held setting device and / or the programmer is a removable storage medium. 20. The information related to the treatment includes a signal reflecting the exercise intensity, a metabolic demand index of the human body calculated from the signal reflecting the exercise intensity, the treatment control index, and the treatment control index. 20. The calibration system for an implantable medical device according to claim 1, wherein the calibration parameter is at least one of the calculated parameters. 21. The treatment control index calculation parameter setting means sets an exercise form discrimination parameter as the treatment control index calculation parameter.
21. The calibration system for an implantable medical device according to any one of claims 20 to 20. 22. The treatment control index calculation parameter setting means, comprising: means for judging an exercise form based on the signal reflecting the exercise intensity; and information relating to the exercise form discrimination result and the signal reflecting the exercise intensity. 22. The calibration system for an implantable medical device according to claim 21, further comprising: means for setting the treatment control index calculation parameter based on the following. 23. The implantable medical device according to claim 1, wherein the implantable cardiac device includes an implantable cardiac pacemaker capable of controlling the frequency of cardiac stimulation or an implantable artificial heart capable of controlling the amount of blood output. 23. The calibration system for an implantable medical device according to any one of claims 22.