Cochlear implant simulation rapid integration test system and method

Abstract

The application discloses a cochlear implant simulation fast integration test method and system, wherein the system comprises an upper computer installed with a fast integration test system software, an integration tester, a salinity tester, a debugging box, a synchronization signal line, a speech processor, an implant, an electrode line and a serial port line. The upper computer configures the integration tester to collect parameters, generate stimulation and send, receive collected data, calculate the salinity impedance, the implant electrode impedance, the amplitude symmetry ratio and the charge symmetry ratio of the electrode stimulation signal; the integration tester receives the synchronization signal, transmits, collects and amplifies the data; the salinity tester tests the salinity concentration of the implant; the debugging box converts the instruction sent by the upper computer into a signal acceptable by the speech processor, and simultaneously transmits the synchronization signal to the integration tester through the synchronization signal line. The application reduces the risk of cochlear implant electrode stimulation anomaly, can realize pre-implantation troubleshooting, and is convenient for post-implantation clinical research.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to a system and method for simulating quick integration test of a cochlear implant. BACKGROUND

[0002] A cochlear implant is a hearing rehabilitation device that converts acoustic signals into electrical signals, stimulates the stimulating electrodes in the body through radio frequency, and stimulates the auditory nerve of a patient in an electrical stimulation manner to enable the patient to regain hearing. Cochlear implantation enables most patients with severe or extremely severe hearing loss to regain hearing, and most cochlear implant recipients can exhibit nearly normal language understanding ability in a quiet language environment. However, in the use process of the patient, due to factors such as impact on the implant site of the patient or some diseases of the cochlea, the patient's hearing effect is reduced or abnormal stimulation is generated due to abnormal stimulation of the electrode, in which case, the stimulation signal of each electrode of the implanted body needs to be collected and amplified to determine whether the electrode stimulation signal is symmetrical, whether the charge is balanced, and the subsequent adjustment machine can focus on the electrode with the stimulation signal not meeting the requirements, and even some abnormal stimulation electrodes are closed, thereby providing a strict judgment and detection method for whether to remove and re-implant.

[0003] The quick integration test is generally performed when hearing statement is obviously reduced or abnormal sound exists in the rehabilitation process after implantation, and if electrode stimulation problems that cannot be solved by the debugging software method are found, unnecessary harm to the human body is caused, and a set of expensive cochlear implant is also wasted. SUMMARY

[0004] Therefore, the present application aims to provide a system and method for simulating quick integration test of a cochlear implant, which can effectively detect the stimulation signal of the electrode of the implanted body before implantation, effectively evaluate the working state of the implanted body, provide effective data for subsequent adjustment, and improve uncomfortable nerve stimulation.

[0005] To achieve the above-mentioned purpose, the present application provides a system for simulating quick integration test of a cochlear implant, which comprises a host computer, an integration tester, a debugging box, a synchronization signal line, a speech processor, an implanted body, an electrode line, an electrode end, and a salinity tester, the host computer is connected with the debugging box and the integration tester respectively, the debugging box is further connected with the speech processor, the integration tester is connected with the electrode end through the electrode line, and wherein,

[0006] The host computer is configured to collect parameters, generate and send stimulation, receive collected data, calculate test data, and give a test result.

[0007] The integration tester receives a synchronization signal, collects, transmits, and amplifies data.

[0008] The salinity tester tests the concentration of the saline water in which the implant is placed;

[0009] The debugging box converts the instruction from the host computer into a signal acceptable by the speech processor, and transmits the synchronization signal to the integrated tester through the synchronization signal line;

[0010] The synchronization signal line transmits the synchronization acquisition signal to the integrated tester;

[0011] The speech processor receives the signal from the debugging box and sends a stimulation signal to the implant;

[0012] The implant receives the stimulation signal and outputs electrical stimulation through the implant electrode;

[0013] The electrode end includes a positive electrode end, a negative electrode end, and a ground end.

[0014] Preferably, the integrated tester includes an electrode end signal collector, an ADC sampling module, a gain control module, an analog signal processing module, an analog-digital conversion module, a digital signal processing module, and a signal output end connected in sequence, wherein,

[0015] The electrode end signal collector collects and inputs the stimulation raw voltage signal of the electrode end;

[0016] The ADC sampling module receives the sampling rate configuration and sampling opening instruction from the host computer, and when the ADC sampling module is opened, the integrated tester starts collecting data;

[0017] The gain control module receives the gain configuration instruction from the host computer, amplifies the collected voltage signal, and the gain includes three levels, which are 1.5 times, 7.5 times, and 30 times, respectively;

[0018] The analog signal processing module processes the amplified analog signal;

[0019] The analog-digital conversion module converts the analog signal into a digital signal;

[0020] The digital signal processing module processes the converted digital signal;

[0021] The signal output end transmits the processed digital signal to the host computer through the serial port line.

[0022] Preferably, the speech processor is wirelessly connected with the implant through the speech processor transmitting coil and the implant receiving coil through magnetic positioning, sends stimulation to the implant receiving coil through wireless induction, and reversely receives data from the implant; the speech processor is connected with the debugging box through I2C to realize communication with the debugging box;

[0023] Preferably, the saline water is mixed with 0.9% physiological saline and pure water.

[0024] Preferably, the concentration of the salt water is 1.5-1.6‰;

[0025] Based on the above purpose, the application further provides a method for simulating rapid integration test of cochlear implant, comprising the following steps:

[0026] S10, taking a cuboid container with a length of 80-100mm, a width of 80-100mm, a height of 150-200mm and a wall thickness of 2-3mm, attaching the implant receiving coil to the side wall of the container, placing the stimulating electrodes of the implant along the container wall, and placing the speech processor outside the container wall, and absorbing the implant receiving coil through the 4-6mm thick partition plate and the implant receiving coil of the speech processor;

[0027] S20, attaching the positive and negative electrode ends of the electrode wire to the other two side walls of the container respectively, and attaching the ground end to the bottom of the container wall, connecting the other end of the electrode wire to the input end of the integration tester, and connecting the integration tester to the upper computer through the serial port line;

[0028] S30, filling the container with 0.9% physiological saline and pure water to form salt water with a salt concentration of 1.5‰-1.6‰, and the salt water depth is at least completely submerged in the electrode end of the implant and the electrode wire;

[0029] S40, setting the sampling rate of the integration tester to 500000Hz, setting the gain to 7.5 times, and testing the salt water impedance;

[0030] S50, connecting the speech processor to the upper computer through the debugging box, connecting the debugging box to the synchronization interface of the integration tester through the synchronization signal line, and attaching the speech processor transmitting coil to the implant receiving coil;

[0031] S60, measuring the impedance of each stimulating electrode of the implant, and confirming the electrode number of short circuit and open circuit;

[0032] S70, scanning stimulation under different current sources, different stimulation modes and different stimulation amplitudes for all electrodes with impedance within the preset range, collecting and amplifying the actual stimulation signal, calculating the positive and negative charge symmetry ratio and the positive and negative amplitude symmetry ratio of the electrode stimulation signal, and obtaining the stimulating normal electrode, the stimulating potential risk electrode, the stimulating greater risk electrode and the stimulating abnormal electrode according to the results of the charge symmetry ratio and the amplitude symmetry ratio.

[0033] Preferably, the salt water impedance value of the positive electrode end and the negative electrode end tested in S40 is not greater than 5kΩ;

[0034] Preferably, the electrode impedance measurement in S60 simultaneously uses two extracochlear electrodes MP1 and MP2 as loop electrodes for impedance test, and uses P_N current source as the current source;

[0035] Preferably, the stimulation signal in S70 is a negative phase pulse followed by a positive phase pulse, and there is an interval between the negative and positive pulses.

[0036] Preferably, the symmetry ratio of positive and negative charges and the amplitude of the stimulation signal for stimulating the normal electrode in S70 is between 0.90 and 1.10; the symmetry ratio of positive and negative charges and the amplitude of the stimulation signal for stimulating the electrode with potential risk is between 0.75 and 0.90 or 1.10 and 1.25; the symmetry ratio of positive and negative charges and the amplitude of the stimulation signal for stimulating the electrode with greater risk is between 0.50 and 0.75 or 1.25 and 1.50; and the symmetry ratio of positive and negative charges and the amplitude of the stimulation signal for stimulating the abnormal electrode is less than 0.50 or greater than 1.50.

[0037] As can be seen from the above, the system and method for simulating the rapid integration test of the artificial cochlea provided by the application detect the stimulation performance of the electrode of the artificial cochlea implant by cooperating the stimulation of the upper computer software with the collection of the stimulation signal by the integration tester, thereby providing a basis for the disposal of the electrode in the subsequent machine adjustment, avoiding the problems of abnormal stimulation of the auditory nerve and unbalanced stimulation charge of the artificial cochlea after implantation, improving the safety and reliability, and reducing the cost. BRIEF DESCRIPTION OF DRAWINGS

[0038] In order to make the purpose, technical scheme and advantages of the application more clear, the application is described below with reference to the following drawings:

[0039] Figure 1 FIG. 1 is a structural block diagram of the artificial cochlea simulation rapid integration test system according to an embodiment of the application;

[0040] Figure 2 FIG. 2 is a structural schematic diagram of the artificial cochlea simulation rapid integration test system according to an embodiment of the application;

[0041] Figure 3 FIG. 3 is a structural block diagram of the integration tester of the artificial cochlea simulation rapid integration test system according to an embodiment of the application;

[0042] Figure 4 FIG. 4 is a flowchart of the artificial cochlea simulation rapid integration test method according to an embodiment of the application. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical scheme and advantages of the application more clear, the application is described below with reference to the following drawings:

[0044] Reference is made to Figure 1 and Figure 2This is a structural diagram of the rapid integration testing system for cochlear implants according to an embodiment of the present invention. It includes a host computer 10, an integration testing instrument 50, a debugging box 20, a synchronization signal line, a speech processor 30, an implant 40, electrode wires 61, and electrode terminals. The host computer 10 is connected to the debugging box 20 and the integration testing instrument 50, respectively. The debugging box 20 is also connected to the speech processor 30. The integration testing instrument 50 is connected to the electrode terminals via the electrode wires 61.

[0045] The host computer 10 configures the acquisition parameters, generates and sends stimuli, receives the acquired data, calculates the test data, and provides the test results; the integrated testing instrument 50 receives the synchronization signal, acquires, transmits, and amplifies the data; the salinity meter 90 tests the concentration of the saline solution in which the implant 40 is placed; the debugging box 20 converts the instructions issued by the host computer 10 into signals acceptable to the speech processor 30, and simultaneously transmits the synchronization signal to the integrated testing instrument 50 through the synchronization signal line; the synchronization signal line transmits the synchronization acquisition signal to the integrated testing instrument 50, with both ends being 3.5mm audio interfaces, one end connected to the EP port of the debugging box 20, and the other end connected to the trigger signal port of the integrated testing instrument 50, the synchronization signal issued by the debugging box 20 being transmitted to the integrated testing instrument 50 via the synchronization signal line; the speech processor 30 receives the signal from the debugging box 20 and sends a stimulation signal to the implant 40; the implant 40 receives the stimulation signal and, through the electrodes of the implant 40 ( Figure 2 The implant 40 refers specifically to the implant electrode, which outputs electrical stimulation; the electrode terminals include the positive electrode 60, the negative electrode 70, and the ground terminal 80.

[0046] See Figure 3 The integrated tester 50 includes, in sequence, an electrode signal acquisition unit 51, an ADC sampling module 52, a gain control module 53, an analog signal processing module 54, an analog-to-digital conversion module 55, a digital signal processing module 56, and a signal output terminal 57.

[0047] The electrode signal acquisition unit 51 acquires the original voltage signal from the stimulation of the electrode; the ADC sampling module 52 receives the sampling rate configuration and sampling start command from the host computer 10. When the ADC sampling module 52 is turned on, the integrated tester 50 starts acquiring data; the gain control module 53 receives the gain configuration command from the host computer 10 and amplifies the acquired voltage signal; the analog signal processing module 54 processes the amplified analog signal; the analog-to-digital conversion module 55 converts the analog signal into a digital signal; the digital signal processing module 56 processes the converted digital signal; and the signal output terminal 57 transmits the processed digital signal to the host computer 10 via a serial port.

[0048] The speech processor 30 is connected with the implanted body receiving coil 41 through the speech processor transmitting coil 31 by magnetic positioning and wireless connection, and sends stimulation to the implanted body receiving coil 41 through wireless induction and reversely receives data of the implanted body 40; the speech processor 30 is connected with the debugging box 20 through I2C to realize communication with the debugging box 20.

[0049] The saline is prepared by mixing 0.9% physiological saline with pure water; the concentration of the saline is 1.5-1.6 ‰.

[0050] Referring to Figure 4 The method is a method for simulating rapid integration test of an artificial cochlea, and a flow chart of steps of the method comprises the following steps.

[0051] S10, a cuboid container with a length of 80-100 mm, a width of 80-100 mm, a height of 150-200 mm and a wall thickness of 2-3 mm is taken, the implanted body receiving coil is attached to the side wall of the container, the stimulation electrodes of the implanted body are placed along the wall of the container, the speech processor is on the outer wall of the container, and the speech processor transmitting coil is adsorbed to the implanted body receiving coil through a 4-6 mm thick partition;

[0052] S20, the positive and negative electrode ends of the electrode wire are respectively attached to the other two side walls of the container, the grounding end is attached to the bottom of the container wall, the other end of the electrode wire is connected to the input end of the integration tester, and the integration tester is connected to the upper computer through a serial port line;

[0053] S30, 0.9% physiological saline is mixed with pure water to prepare saline with a salt concentration of 1.5 ‰-1.6 ‰ in the container, and the depth of the saline is at least completely submerged in the electrode ends of the implanted body and the electrode wire;

[0054] S40, the sampling rate of the integration tester is set to 500000 Hz, the gain is set to 7.5 times, and the electrode impedance in the saline is tested;

[0055] S50, the speech processor is connected to the upper computer through the debugging box, the debugging box is connected to the synchronization interface of the integration tester through a synchronization signal line, and the speech processor transmitting coil is attached to the implanted body receiving coil;

[0056] S60, impedance measurement is performed on each stimulation electrode of the implanted body, and the electrode numbers of short circuit and open circuit are confirmed;

[0057] S70, scanning stimulation is performed on all electrodes with impedance within a preset range under different current sources, different stimulation modes and different stimulation amplitudes, actual stimulation signals are collected and amplified, positive and negative charge symmetry ratios and positive and negative amplitude symmetry ratios of the electrode stimulation signals are calculated, and stimulation normal electrodes, stimulation potential risk electrodes, stimulation greater risk electrodes and stimulation abnormal electrodes are obtained according to the results of the charge symmetry ratios and the amplitude symmetry ratios.

[0058] The saline impedance value of the positive electrode end and the negative electrode end tested in S40 is not greater than 5kΩ, otherwise the integrated tester needs to be recalibrated.

[0059] In S60, the electrode impedance measurement simultaneously uses two outer cochlea electrodes MP1 and MP2 as loop electrodes for impedance testing, and the current source uses P_N current source, the pulse width is 50us, and the pulse interval is 10us.

[0060] In S70, the stimulation signal is a negative phase pulse followed by a positive phase pulse, and there is an interval between the negative and positive pulses, the current source uses N mode No.1 current source, N mode No.2 current source, P_N mode No.1 current source and P_N mode No.2 current source respectively, the amplitude is set to 66 current units and 132 current units, the stimulation mode uses MP1+2, the pulse width is 50us, and the pulse interval is 10us.

[0061] In S70, the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the normal electrode are between 0.90 and 1.10; the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the electrode with potential risk are between 0.75 and 0.90 or 1.10 and 1.25; the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the electrode with greater risk are between 0.50 and 0.75 or 1.25 and 1.50; the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the abnormal electrode are less than 0.50 or greater than 1.50.

[0062] After calculating the stimulation signal parameters, stop collecting, and draw the curve of the symmetry ratio of all electrodes as a background record.

[0063] Finally, it should be pointed out that the above only describes specific embodiments of the present application, although the above preferred embodiments have been described in detail, those skilled in the art should understand that various changes can be made in form and details without departing from the scope defined by the claims of the present application.

Claims

1. An artificial cochlea simulation fast integration test system, characterized in that, The application relates to a speech processing system, which comprises a host computer, an integrated tester, a debugging box, a synchronous signal line, a speech processor, an implant, an electrode line, an electrode end and a salinity tester, the host computer is connected with the debugging box and the integrated tester respectively, the debugging box is connected with the speech processor, the integrated tester is connected with the electrode end through the electrode line, wherein, The host computer is configured to collect parameters, generate and send stimulation, receive collected data, calculate test data and give a test result; The integrated tester receives a synchronous signal, collects, transmits and amplifies data; The salinity tester tests the concentration of the saline water in which the implant is placed; The debugging box converts the instruction sent by the host computer into a signal acceptable by the speech processor, and simultaneously transmits the synchronous signal to the integrated tester through the synchronous signal line; The synchronous signal line transmits a synchronous collection signal to the integrated tester; The speech processor receives the signal of the debugging box and sends a stimulation signal to the implant; The implant receives the stimulation signal and outputs electric stimulation through the implant electrode; The electrode end comprises a positive electrode end, a negative electrode end and a grounding end.

2. The cochlear implant analog fast-framing test system of claim 1, wherein, The integrated tester comprises an electrode end signal collector, an ADC sampling module, a gain control module, an analog signal processing module, an analog-digital conversion module, a digital signal processing module and a signal output end which are connected in sequence, wherein, The electrode end signal collector collects and inputs the stimulation original voltage signal of the electrode end; The ADC sampling module receives the sampling rate configuration and the sampling opening instruction of the host computer, and when the ADC sampling module is opened, the integrated tester starts to collect data; The gain control module receives the gain configuration instruction of the host computer, amplifies the collected voltage signal, and the gain comprises three grades, i.e. 1.5 times, 7.5 times and 30 times; The analog signal processing module processes the amplified analog signal; The analog-digital conversion module converts the analog signal into a digital signal; The digital signal processing module processes the converted digital signal; The signal output end transmits the processed digital signal to the host computer through a serial line.

3. The cochlear implant analog fast-framing test system of claim 1, wherein, The speech processor is wirelessly connected with the implant through the speech processor transmitting coil and the implant receiving coil through the magnet positioning, sends stimulation to the implant receiving coil through the wireless induction mode, reversely receives the data of the implant, is connected with the debugging box through I2C and realizes communication with the debugging box.

4. The cochlear implant analog fast-framing test system of claim 1, wherein, The saline water is prepared by mixing 0.9% physiological saline with pure water.

5. The cochlear implant analog fast-framing test system of claim 4, wherein, The concentration of the saline water is 1.5-1.6 ‰.

6. A method of simulating a fast integration test for a cochlear implant, the method comprising: The method comprises the following steps: S10, a cuboid container with a length of 80-100 mm, a width of 80-100 mm, a height of 150-200 mm and a wall thickness of 2-3 mm is taken, the implant receiving coil is attached to the side wall of the container, the stimulation electrode of the implant is placed along the container wall, the speech processor is arranged on the outer wall of the container, and the speech processor transmitting coil is adsorbed to the implant receiving coil through a 4-6 mm thick partition plate; S20, the positive and negative electrode ends of the electrode line are respectively attached to the other two side walls of the container, the grounding end is attached to the bottom of the container wall, the other end of the electrode line is connected with the input end of the integrated tester, and the integrated tester is connected with the host computer through a serial line. S30, in the container with 0.9% saline water and pure water into the salt concentration of 1.5‰-1.6‰ saline, the depth of the saline is at least completely submerged implant and electrode end of the electrode line; S40, the sampling rate of the integrated tester is set to 500000Hz, the gain is set to 7.5 times, and the saline impedance is tested; S50, the speech processor is connected with the upper computer through the debugging box, the debugging box is connected with the synchronization interface of the integrated tester through the synchronization signal line, and the speech processor transmitting coil is attached to the implant receiving coil; S60, impedance measurement is performed on each stimulating electrode of the implant, and the electrode numbers of short circuit and open circuit are confirmed; S70, scanning stimulation is performed on all electrodes with impedance in the preset range under different current sources, different stimulation modes and different stimulation amplitudes, actual stimulation signals are collected and amplified, positive and negative charge symmetry ratio and positive and negative amplitude symmetry ratio of the electrode stimulation signals are calculated, and stimulation normal electrode, stimulation potential risk electrode, stimulation greater risk electrode and stimulation abnormal electrode are obtained according to the results of charge symmetry ratio and amplitude symmetry ratio.

7. The method of claim 6, wherein the cochlear implant simulates a test of fast temporal integration, and The saline impedance values of the positive electrode end and the negative electrode end tested in the S40 are not greater than 5kΩ.

8. The method of claim 6, wherein the cochlear implant simulation fast- temporal integration test is characterized by, In the S60, two extracochlear electrodes MP1 and MP2 are used as loop electrodes for impedance measurement, and the current source uses P_N current source.

9. The method of claim 6, wherein the cochlear implant simulates a test of fast temporal integration. In the S70, the stimulation signal is negative phase pulse first, and positive phase pulse second, and there is an interval between the negative and positive pulses.

10. The method of claim 6, wherein the cochlear implant simulation fast- temporal integration test is characterized by, In the S70, the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the stimulation normal electrode are between 0.90 and 1.10; the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the stimulation potential risk electrode are between 0.75 and 0.90 or 1.10 and 1.25; the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the stimulation greater risk electrode are between 0.50 and 0.75 or 1.25 and 1.50; and the positive and negative charge symmetry ratio and the amplitude symmetry ratio of the stimulation signal of the stimulation abnormal electrode are less than 0.50 or greater than 1.50.

Images