JP2011045672A - Electric stimulus apparatus for ophthalmology - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an electric stimulus apparatus for ophthalmology which is capable of setting each stimulus parameter accurately and performing treatment appropriately. <P>SOLUTION: The electric stimulus apparatus for the ophthalmology includes an electrode to be applied to a patient eye and pulse-generation means to generate an electric stimulus pulse from the electrode. The apparatus also includes: a control unit having stimulus-condition setting means for setting the current value of the pulse generated by the pulse-generation means and each value of the stimulus condition including the stimulating time; mode-selection means to select a treatment mode for generating the pulse under the set stimulus condition, and a test mode for generating a test pulse; and control means which operates the pulse-generation means according to the condition set by the stimulus-condition setting means when the treatment mode is selected, and which operates the pulse-generation means for generating the pulse by the number of the predetermined pulses regardless of the set value with respect to the stimulating time according to the set stimulus condition when the test mode is selected. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to an ophthalmic electrical stimulation apparatus that applies electrical stimulation to an eyeball of a patient's eye.

  In order to treat retinal and optic nerve diseases such as glaucoma, an apparatus for applying an electrical stimulation pulse from an electrode in contact with an eyeball has been proposed (for example, see Patent Document 1). In such a device, a contact lens electrode provided with an electrode for outputting a current for stimulating the fundus is used, and electrical stimulation is output to the eyeball from the contact lens electrode attached to the eyeball. The stimulation parameters that are electrical stimulation conditions include the current value, pulse width, frequency, and stimulation time (treatment time) of the electrical stimulation pulse. Each value is suitable for treatment depending on the disease of the patient's eye and its degree. Is set. The stimulation time for achieving the therapeutic effect requires several tens of minutes to several hours.

JP 2003-210513 A

  When setting each stimulation parameter, it is necessary to pay particular attention to the setting of the current value so that the patient's eyes can feel light (phosphene, intraocular flash) and no discomfort such as pain sensation. If the patient's reaction is obtained and the set values are changed while starting to apply electrical stimulation, an extra burden is placed on the patient's eyes. If it takes time to set each stimulation parameter, an appropriate electrical stimulation cannot be given in the scheduled stimulation time. Also, if the contact lens attached to the patient's eye and the patient's cornea are misaligned, the electrodes may not contact the eyeball properly, and an accurate response from the patient can be obtained when setting each stimulation parameter. Thus, it becomes impossible to give an appropriate electrical stimulus without causing discomfort to the patient's eyes. Since the electrical stimulation is applied for a long time, if the treatment is not performed without noticing that the electrode has been detached halfway, it is not possible to provide the appropriate electrical stimulation according to the set time.

  This invention makes it a technical subject to provide the ophthalmic electrical stimulation apparatus which can set each irritation | stimulation parameter exactly and can perform a treatment appropriately in view of the said prior art.

In order to solve the above problems, the present invention is characterized by having the following configuration.
(1) An ophthalmic electrical stimulation apparatus comprising: an electrode provided on a main body to be mounted on a patient's ocular cornea; and an electrical stimulation pulse generating unit that generates an electrical stimulation pulse from the electrode. A control unit having stimulation condition setting means for setting each value of a stimulation condition including a current value and a stimulation time of the electric stimulation pulse to be generated; a treatment mode for generating an electric stimulation pulse of the set stimulation condition; and an electric stimulation pulse A mode selection means for selecting a test mode to be generated as a test, and when the treatment mode is selected, the electrical stimulation pulse generation means is operated in accordance with the stimulation condition set by the stimulation condition setting means, and the test mode is selected. Other than the stimulation time, it follows the stimulation conditions set by the stimulation condition setting means, Control means for operating the electrical stimulation pulse generating means so as to generate electrical stimulation pulses for a predetermined time or a predetermined number of pulses regardless of a set value;
An energization monitoring unit that monitors the energization state of the electrode and the control unit, and displays the energization state monitored by the energization monitoring unit in the test mode and the treatment mode as a waveform of a current value along a time axis. And a display means.
(2) The ophthalmic electrical stimulation device according to (1) is a timer unit that measures the stimulation time of the electrical stimulation pulse generated by the electrical stimulation pulse generation unit, and the energization of the electrode is cut off by the energization monitoring unit. Timer means for stopping the measurement of the stimulation time when it is detected and restarting the measurement of the stimulation time when it is detected that the energization of the electrode has been recovered, and the control means When the energization monitoring unit detects that the electrode is de-energized, the generation of the electrical stimulation pulse is stopped, and the total stimulation time measured by the timer unit is set by the stimulation condition setting unit. The electrical stimulation pulse generating means is operated so as to stop the generation of the electrical stimulation pulse when the time is reached.
(3) When the generation of the electrical stimulation pulse is started by selecting the treatment mode, the ophthalmic electrical stimulation device according to (1) fixes the setting of each stimulation condition to be unchangeable until the set stimulation time is completed. Condition setting fixing means is provided.

  According to the present invention, each stimulation parameter can be set accurately and appropriately treated.

  Embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a schematic external view of an ophthalmic electrical stimulation apparatus according to the present invention. FIG. 2 is a diagram for explaining a screen display of the electrical stimulation device. FIG. 3 is a control block diagram of the electrical stimulation apparatus. The electrical stimulation apparatus according to the present embodiment applies an electrode to an eyeball of a patient's eye and excites (fires) cells constituting the retina by flowing a weak current from the electrode, thereby suppressing cell death. .

  In FIG. 1, the electrical stimulation device 100 includes an electrode unit 10 and a main body unit 20. The electrode unit 10 includes a base 13 that is a main body mounted on the cornea and a pair of electrodes 11 and 12. The base 13 has a contact lens as its shape, and its inner wall surface is formed in a shape that substantially follows the surface of the eyeball E. The base 13 is made of an insulating material. In the present embodiment, the electrode 11 is arranged in an annular shape around the lower end of the base 13. The electrode 12 is arranged in an annular shape around the inner wall surface between the electrode 11 and the top (the side in contact with the corneal surface), and is separated from the electrode 11. As materials for these electrodes 11 and 12, generally used conductors such as platinum, gold and silver are used. Conductive wires 15a and 15b are connected to the electrodes 11 and 12, and the conductive wires 15a and 15b are connected to terminals 21a and 21b of the main body portion 20 through a connection cable 15 which is an insulating tube.

  In addition, as the electrode part 10, it is good also as a structure which makes one electrode put on a cornea and positions the other electrode used as a pair in another site | parts, such as a head. The electrode unit 10 may be a sheet-type electrode shape or a cylindrical stick-type electrode shape.

  The main body 20 is an electric stimulation pulse generating means for generating an electric stimulation pulse, sets a stimulation parameter which is a condition of the electric stimulation pulse, controls a start / stop of the electric stimulation, and the like, A display 40 is provided for displaying parameter setting information and a stimulus state. Various conditions of electrical stimulation (current value of electrical stimulation pulse, frequency, pulse width of electrical stimulation pulse (current duration), stimulation time) can be set by the control unit 30. The pulse waveform of the electrical stimulation pulse is set according to the current value of the electrical stimulation pulse.

  The control unit 30 includes a power switch 31, a setting dial 32, a test switch 33, a start / stop (start / stop) switch 34, an energization indicator lamp 35 that displays the energization state of the electrode unit 10, and an emergency stop switch 36. The power switch 31 is a switch for starting / ending the apparatus 100 by turning on / off. The setting dial 32, which is a stimulus parameter input means, inputs a signal for increasing or decreasing the value of the selected stimulus parameter by rotating the dial left and right, and a signal for selecting a setting item of the display 40 by pressing the dial. And a function to perform. The test switch 33 is a means for inputting a test mode selection signal to be described later, and sends a trigger signal for starting a test to the control unit 70 when pressed. The start / stop switch 34 is a means for inputting a treatment mode selection signal, which will be described later, and sends a treatment start / stop trigger signal to the control unit 70 when pressed. The energization indicator lamp 35 is formed of a light emitting element such as an LED, and has a role of notifying a therapist (operator) of the energization state of the electrode unit 10 by turning on or blinking the LED. The emergency stop switch 36 is a switch that forcibly shuts down (stops) the stimulation power supply 82 and is an input means for forcibly terminating the output of the electrical stimulation pulse from the stimulation circuit 81.

  The display screen of the display 40 is divided into a stimulation parameter setting display screen 41 on the left side and a state display screen 45 displaying the waveform of the electrical stimulation pulse state on the right side. As the display 40, display means such as an LCD is used. On the setting display screen 41, four stimulation parameters including a current value (Current), a stimulation frequency (Frequency), a pulse width (Duration), and a stimulation time (Time), and a stimulation time (treatment time) measured in the treatment mode are displayed. A display column for the remaining stimulus time (Time Left) for displaying the remaining time is arranged in a column. A blinking cursor 41a is displayed in the stimulation parameter column in which the numerical value can be changed. The cursor 41a is moved to the next stimulation parameter item every time the push signal of the setting dial 32 is input, and the setting value of the parameter item where the cursor 41a is positioned can be changed by the rotation signal of the setting dial 32.

  On the status display screen 45, the horizontal axis indicates the time and the vertical axis indicates the current value coordinates, and is displayed as a waveform 46 along the time axis of the electrical stimulation pulse energized by the electrodes 11 and 12 of the electrode unit 10. . The waveform 46 is displayed based on the energization state of the electrodes 11 and 12 monitored by the detection circuit 85 described later. The state display screen 45 shows an example of the electrical stimulation pulse. The electrical stimulation pulse is a bipolar (bipolar, biphasic) pulse paired with a positive and negative single-phase pulse, and the positive and negative single-phase pulses are combined so that the positive and negative charges are approximately the same. It has been. As shown in the figure, the width D of the single-phase pulse is the pulse width of the electrical stimulation pulse. The amplitude of the single phase pulse is defined as a current value A. The interval (period) T from the positive single phase pulse to the next positive single phase pulse is the reciprocal of the frequency F. In other words, the frequency F is the reciprocal of the interval T. In this embodiment, the current value A can be set in steps of 50 μA between 0 μA and 3 mA, the frequency can be set in steps of 5 Hz between 1 and 50 Hz, and the pulse width can be set in 5, 10 and 20 ms. It is said that. The stimulation time can be set in 5 minute steps between 5 and 60 minutes.

  Next, the control system of the apparatus 100 will be described. Connected to the control unit 70 are a memory 71, a buzzer 22 as a notification means, a setting dial 32, a test switch 33, a start / stop switch 34, a power indicator 35, a display 40, a stimulation circuit 81, and a detection circuit 85. . The power switch 31 is not shown. The control unit 70 has a timer function 70 a that measures the stimulation time of the electrical stimulation pulse output from the electrodes 11 and 12. The memory 71 stores a program for controlling the apparatus and setting values of stimulation parameters. A stimulation power supply 82 is connected to the stimulation circuit 81, and an emergency stop switch 36 is connected to the stimulation power supply 82. The stimulation power supply 82 is a power source for generating electrical stimulation pulses and has a function of supplying a constant current to the stimulation circuit 81. The stimulation circuit 81 receives power from the stimulation power supply 82, generates an electrical stimulation pulse corresponding to the stimulation parameter set based on the command signal from the control unit 70, and outputs the electrical stimulation pulse from the electrodes 11 and 12.

  The detection circuit 85 has a role of monitoring the energization state of a current (electric stimulation pulse) flowing between the electrode 11 and the electrode 12. Specifically, a resistor R is disposed between the electrode 11 and the stimulation circuit 81, and the voltage of the resistor R is monitored by the detection circuit 85. If the detection circuit 85 detects the voltage change of the resistor R, it means that the presence or absence of energization is detected. Further, by detecting (monitoring) a change in the voltage of the resistor R along the time axis, the waveform of the electrical stimulation pulse that is energized by the electrodes 11 and 12 can be detected.

  The detection result of the detection circuit 85 is sent to the control unit 70. The control unit 70 displays the waveform of the electrical stimulation pulse on the display 40 based on the detection result of the detection circuit 85. Moreover, if the electrodes 11 and 12 are in an energized state (a state in which energization is maintained), the energization indicator lamp 35 is continuously lit. When the electrodes 11 and 12 are not energized (disconnected), the control unit 70 causes the energization indicator lamp 35 to blink. Further, the control unit 70 monitors the energization state of the electrodes 11 and 12, and when the energization state becomes a certain threshold value or less during the stimulation time or when it is disconnected, the electrical stimulation pulse of the stimulation circuit 81 is While stopping the output, the timer function 70a temporarily stops the measurement of the stimulation time.

  Next, the treatment operation by the apparatus 100 will be described. The therapist lays the patient on his back and performs treatment by attaching the electrode unit 10 to the patient's eye. During treatment, the therapist sets each stimulation parameter by operating the setting dial 32 of the control unit 30 according to the disease of the patient's eye. Each stimulation parameter is set to a value that achieves a therapeutic effect according to the disease content and its degree, but especially regarding the setting of the current value, the patient should not feel discomfort such as pain (not to worry about it) ) It is necessary to consider. Therefore, this apparatus is provided with a treatment mode in which electrical stimulation is applied according to the set stimulation parameter, and a test mode in which electrical stimulation is applied on a test basis in order to set an appropriate stimulation parameter. The test mode is started by the switch 33, and the treatment mode is started by the switch 34.

  The test mode will be described. When the test switch 33 is pressed, the control unit 70 outputs the electrical stimulation pulse with the values set on the screen 41 for the current value, stimulation frequency, and pulse width of the stimulation parameters, and sets the stimulation time to the set value. Regardless, the electrical stimulation pulse is output for a certain time (or a certain number of pulses) determined to be suitable for the test. The fixed time during which the electrical stimulation pulse is output in the test mode is set to such an extent that the patient has little burden and the patient can recognize the electrical stimulation pulse, for example, about 1 to 5 seconds. When it is output as the number of pulses, it is about 5 to 50 pulses. In this device, 20 pulses are set.

  With the test output of electrical stimulation pulses at a certain time (or a certain number of pulses) in the test mode, the therapist gets the patient's response whether the patient does not feel pain or other discomfort or the patient feels light sense Check. When the current value is large, the patient can feel light sense but also feel pain. The therapist changes the current value setting so that the patient feels light and does not feel pain. Even if the current value is too high and the patient feels pain, in the test mode, the electrical stimulation pulse is output and stopped only for a short period of time, so there is little discomfort to the patient. Even if the patient's response cannot be obtained immediately, the discomfort given to the patient is completed only in a short time. On the other hand, if an electrical stimulation pulse is suddenly output in the treatment mode and an attempt is made to confirm its accuracy, the electrical stimulation pulse is obtained until the patient's response is obtained or until the therapist inputs a stop signal by the switch 34. Can continue to give patients pain for a long time. In setting the value of the electrical stimulation parameter suitable for the patient, the setting value may be changed many times while obtaining the response of the patient, but if this test mode is used, the burden on the patient can be reduced, The therapist can also save time and effort of pressing the switch for stopping the electrical stimulation pulse, and can perform an efficient treatment.

  After the set values of the respective stimulation parameters are set to be suitable for the patient by the test mode, the treatment mode is started by pressing the switch 34. The control unit 70 outputs an electrical stimulation pulse from the electrode unit 10 for the set stimulation time, and measures the elapsed time when the electrical stimulation pulse is output by the timer function 70a. The remaining stimulation time is displayed in the “Time Left” display field of the screen 41. When the switch 34 is pressed during the treatment mode, the control unit 70 stops the output of the electrical stimulation pulse and temporarily stops the elapsed time measurement. If the switch 34 is pressed again, the elapsed time measurement is resumed. Thereby, the treatment of the set stimulation time is appropriately performed.

  In the treatment mode of this apparatus, once the treatment mode is started, the control unit 70 locks the setting of the stimulation parameter and disables the change of the value of each stimulation parameter until the set stimulation time ends. To do. Even when the stop signal by the switch 34 is input and the output of the electrical stimulation pulse is temporarily stopped, the setting of the stimulation parameter is continued to be locked. This is to prevent the set stimulation parameter from being changed accidentally during the treatment, and to perform a treatment that provides an electrical stimulation pulse under consistent conditions.

  In the configuration in which the setting values of the respective stimulation parameters are locked in such a treatment mode, the stimulation parameters can be set efficiently particularly by providing the test mode as described above. That is, once the treatment is started, if the set value is changed, the set value cannot be changed even if the output of the electrical stimulation pulse is stopped by pressing the switch 34. It is necessary to carry out by the operation of, is in front. When it is necessary to change the setting values of each stimulation parameter many times, the complexity further increases. On the other hand, when the test mode for a fixed time set short is completed, the setting values of the respective stimulation parameters can be changed, so that the work for determining the setting values can be made more efficient.

  In both the test mode and the treatment mode, the energization state of the electrodes 11 and 12 of the electrode unit 10 is monitored by the detection circuit 85. When the electrode 11 and the electrode 12 are appropriately in contact with the eyeball, a current flows between the electrode 11 and the electrode 12, and thus the waveform 46 of the electrical stimulation pulse whose energization is monitored by the detection circuit 85 is the control unit 70. Are displayed on the screen 45 by display control. The waveform 46 is sequentially updated and displayed along the time axis. Here, when at least one of the electrodes 11 and 12 is not in contact with the eyeball of the patient's eye, the waveform 46 of the electrical stimulation pulse is not displayed on the screen 45. In addition, when the contact of the electrodes 11 and 12 with the eyeball is unstable, the display of the waveform 46 is disturbed and is not stable. By displaying the waveform 46 on the screen 45, it is easy for the therapist to visually grasp the suitability of the energized state of the electrodes 11 and 12, and to easily notice the deterioration of the energized state.

  Even in the test mode, the energization state of the electrodes 11 and 12 is monitored by the detection circuit 85 and the waveform 46 is displayed on the screen 45, so that the therapist can appropriately set the current value and the like. That is, the treatment mode is performed while the current value is set high without realizing that the base 13 of the electrode unit 10 and the shape of the eyeball do not match and the electrodes 11 and 12 are not energized, and the energization of the electrodes 11 and 12 is restored. When this is done, a high value of current is output to the patient's eye. In response to such a problem, the waveform 46 of the energized state of the electrodes 11 and 12 is displayed even in the test mode, so that appropriate measures such as replacement with the electrode unit 10 that matches the shape of the eyeball at the time of the test mode can be appropriately performed. Can take.

  In addition, since the electrical stimulation treatment in the treatment mode is performed for a long time, the electrode unit 10 may come off during the movement of the patient's eyes. In this case, if it is detected from the monitoring result of the energization state of the detection circuit 85 that the electrodes 11 and 12 are de-energized (the fact that the energization current value has greatly changed with respect to the set current value is detected. In addition, the control unit 70 stops the output of the potential stimulation pulse, sounds the buzzer 22, and blinks the energization indicator lamp 35 to notify the therapist of the deterioration of the energized state. At the same time, the measurement of the treatment time by the timer function 70a is stopped. When the electrodes 11 and 12 are de-energized, the electrical stimulation pulse waveform 46 is not displayed on the screen 45. By such notification, the therapist can notice the deterioration of the energized state and can easily take measures to recover it. When the signal of the switch 34 is input, the control unit 70 starts outputting the electrical stimulation pulse again and restarts the measurement of the treatment time by the timer function 70a. And the control part 70 stops the output of an electrical stimulation pulse, when the total time measured by the timer function 70a reaches the set stimulation time. Thereby, the elapsed time during which the energization is stopped is removed, and the electrical stimulation pulse can be output to the patient's eye according to the set stimulation time, and appropriate treatment can be performed.

  In the above embodiment, the electrical stimulation device 100 is used alone to suppress the death of retinal ganglion cells, but it can be expected to obtain a synergistic effect by using it together with other therapeutic means, for example. Other therapeutic means include glaucoma therapeutic drugs such as parasympathomimetic drugs and sympathomimetic drugs, but by administering the therapeutic drug while using the ophthalmic electrical stimulation device of the present invention, Increases effectiveness. In this way, the combined effect of the device and the therapeutic agent can be expected.

  Further, in this embodiment, it is assumed that the death of retinal ganglion cells can be suppressed, but it can also be expected to suppress the death of cells constituting the retina such as photoreceptor cells (for example, photoreceptor cells). .

  In the embodiment described above, the switches 33 and 34 are used as the mode selection means (input means for the start signal of each mode) for the test mode and the treatment mode. However, the mode can be selected on the display 40. Alternatively, mode selection may be enabled with one switch.

1 is a schematic external view of an ophthalmic electrical stimulation device according to the present invention. It is a figure explaining the screen display of an electrical stimulator. It is a control block diagram of an electric stimulator.

DESCRIPTION OF SYMBOLS 10 Electrode part 30 Control part 33 Test switch 34 Start / stop switch 35 Energization indicator light 40 Display 81 Stimulation circuit 82 Power supply for stimulation 85 Detection circuit 100 Electrical stimulation apparatus for ophthalmology

Claims (3)

In an ophthalmic electrical stimulation apparatus comprising: an electrode provided on a body mounted on a patient's ocular cornea; and an electrical stimulation pulse generating means for generating an electrical stimulation pulse from the electrode,
A control unit having stimulation condition setting means for setting each value of stimulation conditions including the current value and stimulation time of the electrical stimulation pulse generated by the electrical stimulation pulse generating means;
Mode selection means for selecting a treatment mode for generating an electrical stimulation pulse of a set stimulation condition and a test mode for generating an electrical stimulation pulse on a test basis;
When the treatment mode is selected, the electrical stimulation pulse generating means is operated according to the stimulation condition set by the stimulation condition setting means, and when the test mode is selected, the stimulation set by the stimulation condition setting means except for the stimulation time Control means for operating the electrical stimulation pulse generating means so as to generate electrical stimulation pulses for a predetermined time or a predetermined number of pulses regardless of a set value for the stimulation time according to conditions,
Energization monitoring means for monitoring the energization state of the electrodes;
Display means arranged in the control unit and displaying the energization state monitored by the energization monitoring means during the test mode and the treatment mode as a waveform of the current value along the time axis;
An ophthalmic electrical stimulation device comprising: The ophthalmic electrical stimulation device according to claim 1 comprises:
Timer means for measuring the stimulation time of the electrical stimulation pulse generated by the electrical stimulation pulse generation means, wherein the stimulation time is measured when the energization monitoring means detects that the electrode is de-energized. Timer means for stopping and restarting the measurement of the stimulation time when it is detected that the energization of the electrode has been recovered,
The control means stops the generation of the electrical stimulation pulse when the energization monitoring means detects that the energization of the electrode is cut off, and the total stimulation time measured by the timer means is set to the stimulation condition An electrical stimulation apparatus for ophthalmology, wherein the electrical stimulation pulse generating means is operated so as to stop the generation of electrical stimulation pulses when the stimulation time set by the means is reached. The ophthalmic electrical stimulation device according to claim 1, wherein when the generation of the electrical stimulation pulse is started by the selection of the treatment mode, the setting of each stimulation condition is fixed to be unchangeable until the set stimulation time ends. An ophthalmic electrical stimulation device comprising: means.

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