CN102921105B - In-vitro test stimulator - Google Patents

In-vitro test stimulator Download PDF

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CN102921105B
CN102921105B CN201210249175.7A CN201210249175A CN102921105B CN 102921105 B CN102921105 B CN 102921105B CN 201210249175 A CN201210249175 A CN 201210249175A CN 102921105 B CN102921105 B CN 102921105B
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pulse
output
circuit
testing
testing stimulus
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CN102921105A (en
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马伯志
钱星
郝红伟
李路明
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Tsinghua University
Beijing Pins Medical Co Ltd
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Tsinghua University
Beijing Pins Medical Co Ltd
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Abstract

In-vitro test stimulator, belongs to implantation medical equipment technical field, is mainly used in the test of nerve electric stimulation therapy.The invention provides the in-vitro test stimulator that a kind of dual pathways pulse with user interface exports, the exportable electric stimulation pulse of Parameter adjustable accurately, for the treatment test of patient in embedded nerve stimulator operation process or the electrical stimulating therapy experience of short-term.It is characterized in that: testing stimulus device adopts integrated structure design, primarily of the part such as shell, toggle switch, film key and display screen, battery, printed circuit board composition, low-profile is simple; Can regulating impulse parameter, test electrode load impedance and electrode contacts polarity is set, operation intuitive and convenient by button and switch; Auto-lock function and fool proof design effectively can prevent the maloperation in patient's use procedure, safe and reliable.This testing stimulus device can be widely used in testing evaluation and the experience of the treatment of all kinds of nerve electric stimulation.

Description

In-vitro test stimulator
Technical field
The present invention is that doctor or patient test and assess the in-vitro test stimulator used in implantation type electric stimulation therapy operation process, belongs to implantation medical equipment technical field.
Background technology
At present, implantation type electric stimulation system has been widely used in the treatment of sacred disease, and such as, deep brain stimulation device (brain pacemaker) is often used to the dyskinetic disorders such as treatment parkinson disease, spinal stimulator effectively can improve chronic pain, etc.The composition of implantation type electric stimulation system generally comprises an implantable pulse generator, one or more electrode, and connects the extension lead of pulse generator and electrode.Wherein, pulse generator is the core of system, be used for producing the electric stimulation pulse of parameter (as amplitude, frequency, pulsewidth etc.) adjustable specific waveforms, electric pulse flows to electrode by subcutaneous extension lead, act on target stimulus target spot by electrode contacts, play the effect that regulation and control are neural.
Example is implanted as with brain pacemaker, the operation process that electric stimulation is implanted generally can be described as: before implantable pulse generator, first accurately located by the technology such as magnetic resonance imaging and stereotaxis, find after stimulating target coordinate accurately, electrode is implanted brain.The damage of this process is very little, and does not have the pain sensation, the thus imperceptible pain of patient due to brain.The implantation of pulse generator after this and the placement of extension lead then comprise several relatively invasive operative process, such as, use special equipment to beat tunnel etc. subcutaneous.Before implantable pulse generator, electrode is connected to testing stimulus device pulse output end mouth by test lead by doctor, carry out preliminary test, such as, patient is allowed to do some simple actions, as taken cup, stretching one's arm, drawing helix etc., according to impression and the symptom improvement degree of patient, the position of further adjustment electrode and stimulus parameter, to obtain best therapeutic effect.If patients symptomatic is controlled in test, doctor can implant whole brain pacemaker system further.Concrete operation is implantable pulse generator below the infraclavicular skin of chest, then pulse generator and Electrode connection is got up by extension lead subcutaneous.This process can be carried out at once, also can carry out by observed number in the future, such as patient may require experience electrical stimulating therapy being carried out to a period of time before the operation carried out implantable pulse generator and assemble subcutaneous extension lead, determine that this therapy can suppresses disease thus, and whether have side reaction, if any then accepting.This test is experienced the stage and can not continued several hours to 30 days not etc.
If the pulse generator implanted directly is used as test use, subject matter is high cost.Pulse generator is disposable aseptic medical equipment, once open its aseptic packaging, so needs of patients pays the buying expenses of tens0000 yuan, if be unsatisfied with curative effect, then forms huge waste.In addition, pulse generator parameters is set and by the remote control of vitro program controlled instrument, doctor and the operational inconvenience of patient need be caused, and cannot the duty of read pulse generator and pulse parameter intuitively.Then often volume ratio is comparatively large for the Medical pulse generator that can buy on the market, is not easy to patient and carries, and affect the freely movable of patient, and the impulse waveform of its output and parameter and precision also not necessarily meet Clinical practice demand.
For these problems, a kind of in-vitro test stimulator exported for the dual pathways pulse with user interface of testing evaluation of invention, can not only provide Parameter adjustable electric pulse accurately, and compact structure is attractive in appearance for test phase, simple to operation, be easy to carry.Electrode load testing impedance function auxiliary judgment can stimulate the accuracy of target spot location, judges whether electrode can normally work, and estimates service life of stimulator for implantation.Although the structural design of this testing stimulus device is not distinguished for doctor and patient, there is the design preventing maloperation.For example, being used for the combination of choice electrode contact polarity and the switch of stimulus modelity only allows doctor to operate, a leather sheath can be designed to shelter from these switch regions, to prevent the maloperation in patient's test process, leather sheath is then designed to transparent at display screen place, can not affect the reading of testing stimulus device current operating state.In addition, this testing stimulus appliance mains switch can shield parameter regulating key function from backset, this design also serve prevent button by by mistake by effect.
Summary of the invention
The object of the present invention is to provide the in-vitro test stimulator that a kind of dual pathways pulse with user interface exports, Parameter adjustable electric stimulation pulse accurately can be provided for patient in electrical stimulating therapy test and experience stage.This testing stimulus utensil has the control button of multiple difference in functionality and toggle switch and a LCDs, pulse can be exported to the dual pathways very intuitively and carry out Parameter Programming, and test electrode load impedance, enhance convenience and the intuitive of operation, its lock function and anti-misoperation design effectively prevent the maloperation of patient and doctor, enhance reliability and safety.
A kind of testing in vitro stimulator for nerve electric stimulation therapy testing evaluation, it is characterized in that, contain: pulse parameter setting device, output-controlling device, display device, microcontroller, impulse output circuit module, power supply, electric power management circuit and operator scheme switching part, wherein:
Pulse parameter setting device, for generation of one of following command signal: amplitude upwards regulates, amplitude regulates downwards, frequency upwards regulates, frequency regulates downwards, pulsewidth upwards regulates, pulsewidth regulates downwards, electrode impedance test;
Output-controlling device, for arranging switching-on and switching-off state and user operation mode, also for arranging the combinations of polarities of each electrode contacts under each passage, and for selecting stimulus modelity and arranging effective passage to parameter current;
Display device, for showing current PRF output parameter, electrode impedance test result, and the warning message when electric quantity of power supply is not enough;
Impulse output circuit module, comprising: voltage modulation circuit, pulse output control circuit, charge balancing circuit and electrode impedance test circuit;
Microcontroller, it can receive the command signal that described pulse parameter setting device exports, the signal that described output-controlling device exports can also be received, export the instruction and data for showing to described display device, and monitor the output of described impulse output circuit module;
Wherein,
Described testing stimulus utensil has the first operator scheme being suitable for doctor's operation and the second operator scheme being suitable for patient's operation, described operator scheme switching part is for switching the operator scheme of described testing stimulus device, in described first operator scheme, doctor can arrange described testing stimulus device running parameter, and in described second operator scheme, patient only can check display and the reading of described display device.
Preferably, described operator scheme switching part be on and off switch shelves from backset, and be arranged at the leather sheath of hull outside of described testing stimulus device.
Preferably, described testing stimulus device is suitable for using in vitro, and described pulse parameter setting device comprises control button, and described output-controlling device comprises toggle switch, and described power supply is battery.
Preferably, the displaying contents of described display device comprises: the amplitude of the output pulse of described testing stimulus device, frequency, pulsewidth and unit thereof, electrode impedance, power supply low-voltage warning information under electrode impedance test result and each passage.
Preferably, the polarity of described electrode contacts is selected from "+" "-" and " 0 ", and described stimulus modelity is constant current mode or constant voltage mode.
Preferably, the stimulus modelity that described pulse output control circuit is arranged according to described output-controlling device, correspondingly be operated in constant voltage mode or constant current mode, in described constant voltage mode, the voltage amplitude that described impulse output circuit module exports is 0 ~ 10V, in described constant current mode, the current intensity that described impulse output circuit module exports is 0 ~ 25mA.
Preferably, after each pulse electrical signal that described impulse output circuit module exports, described charge balancing circuit produces a reverse equalizing pulse signal of telecommunication;
Described electrode impedance test circuit can measure the load impedance of the electrode that described testing stimulus device connects;
Described electric power management circuit contains:
Mu balanced circuit, is stabilized in setting value described cell output voltage, for described microcontroller and display screen are powered;
Latching circuit, for locking testing stimulus device duty, cuts out keypress function;
Supply voltage sample circuit, for often detecting supply voltage at regular intervals, if magnitude of voltage is lower than set threshold value, microcontroller then sends low-voltage alarm by described display device.
Compared with prior art, the present invention has following beneficial effect:
(1) integrated structure design, low-profile is attractive in appearance, convenient and reliable operation, has the design preventing maloperation function;
(2) pulse of dual pathways programmable parameter exports, for electrical stimulating therapy test phase provides high-precision electric impulse signal;
(3) can accurately test electrode load impedance, thus auxiliary judgment can stimulate the accuracy of target spot location, judge whether electrode normally works, and estimate the service life of stimulator for implantation;
(4) use general dry battery to power, add the convenience of use;
(5) of many uses, can be used for the test in all kinds of implantable neural electrical stimulation device operation process, the present invention has high economic benefit and social benefit.
Accompanying drawing explanation
Below in conjunction with the drawings and specific embodiments, the present invention is further detailed explanation.
Fig. 1 is the schematic diagram of testing stimulus device using method.
Electric pulse schematic diagram when Fig. 2 is testing stimulus device dual pathways pulse output.
Fig. 3 is a kind of concrete structure and the composition proposal schematic diagram of testing stimulus device.
Fig. 4 is a kind of concrete information display scheme of testing stimulus device display screen.
Fig. 5 is the schematic block circuit diagram of testing stimulus device.
Fig. 6 is the block diagram of testing stimulus device electrode impedance test.
Detailed description of the invention
Described testing stimulus device, is made up of parts such as shell, toggle switch, film key, display screen, battery, printed circuit boards.Wherein:
Shell is made up of housing and cap, and cap can be opened, and changes battery.
Switch, button and display screen provide man-machine interaction passage, and testing stimulus device has 11 toggle switches, wherein: an on and off switch is SP3T switch, for the break-make of testing stimulus device power supply and the locking of testing stimulus device duty;
Two single-pole double-throw switch (SPDT)s are respectively used to the selection of stimulus modelity and parameter current are arranged to the selection of effective passage; The polarity also having eight SP3T switches to be respectively used to two passages totally eight electrode contacts is in addition selected, and can be set to positive pole, negative pole and sky respectively.Seven film keys are used for electrical pulse amplitudes, frequency, upwards, downwards the regulating of pulsewidth, and electrode impedance test.Testing stimulus device also has display screen, for showing basic parameter, the electrode impedance test result of testing stimulus device output electric pulse, shows warning information when cell voltage is not enough simultaneously.
Supplying cell is two joint general dry batteries, can change easily.
Printed circuit board realizes the various functions such as the pulse output of testing stimulus device, and printed circuit board take microcontroller as core, comprises electric power management circuit, key-press input and part such as instruction control circuit, impulse output circuit etc.The function of microcontroller implementation comprises: key-press input response, control display screen, control impuls output circuit etc.Electric power management circuit comprises mu balanced circuit and lock circuit, and battery output buck is for the control circuits such as microcontroller are powered after 3.3V by mu balanced circuit, lock circuit locking testing stimulus device current operating state, shielding parameter regulating key function.Impulse output circuit is for generation of the electric stimulation pulse consistent with institute setting parameter.
Shown in Fig. 1 is for deep brain stimulation, the use operation signal of testing stimulus device 1.During use, testing stimulus device 1 is placed in external, and the electric impulse signal of generation flows to the stimulating electrode 3 in patients with implantation brain deep successively by test lead interface 4 and test lead 2.
Testing stimulus device can produce the electric impulse signal of a road or two-way by button operation, Figure 2 shows that the pulse signal produced when two-way pulse exports, the amplitude of passage 1 and passage 2 pulse and pulsewidth all can pass through face on-board switching and button independent regulation, the frequency of two passages is identical, and in sequential separately, after each stimulation electric pulse 59 output of each passage, a reverse low amplitude pulse 60 can be produced after short time time delay (200 μ about s), realizing the charge balance to stimulating target spot, avoiding producing damage to the tissue of target spot.The effect of short time time delay is that boost pulse is fully acted on target spot, and avoiding causing stimulates weakening of physiological effect.The pulsewidth of back discharge pulse does not need identical with boost pulse with amplitude, and phase reaction is little of as far as possible to avoid by patient's consciousness and the therapeutic effect affecting boost pulse.Here, the amplitude of back discharge pulse and pulsewidth are variable.Such as, when boost pulse frequency is lower, discharge pulse pulsewidth slightly increases (correspondingly, discharge pulse amplitude slightly reduces).And when boost pulse frequency increases, discharge pulse pulsewidth slightly reduces (correspondingly, discharge pulse amplitude slightly increases).
The optimum configurations that testing stimulus device exports boost pulse comprises: amplitude, pulsewidth, frequency and electrode contacts and polarity are selected, thus provide diversified stimulation to combine.Stimulate electrical pulse amplitudes range of accommodation to be 0 ~ 10V under constant voltage stimulus modelity, be 0 ~ 25mA under constant current stimulus modelity; Frequency-tuning range is 2 ~ 250Hz; Pulse-width regulated scope is 30 ~ 450us, has 266600 kinds of stimulus parameter combinations, have 666500 kinds under constant current mode under constant voltage mode.Clinician can select the combination of suitable stimulus parameter according to patient's practical situation, in addition, also needs to finely tune stimulus parameter according to the test effect of patient and reaction, to select optimum stimulus parameter combination, reaches best therapeutic effect.
Fig. 3 gives a kind of concrete structure and the composition of testing stimulus device.Wherein (a) is the front schematic view of testing stimulus device, and (b) is the testing stimulus device back side and internal structure schematic diagram, and (c) is testing stimulus device end face schematic diagram.Testing stimulus device comprises shell 5, film on surface 6, and testing stimulus device man-machine interaction part comprises power supply and locking switch 33, ten toggle switches (8,9,10,11,12,13,14,15,16,17), seven film keys (18,19,20,21,22,23,24), display screen 7.Power supply and locking switch 33 are SP3T switch, corresponding power pass (zero) are distinguished in three positions of switch, power supply opens (I) and lock-out state ( ), under lock-out state, testing stimulus device exports locked, button 19,20, and 21,22,23,24 function conductively-closeds are inoperative.Electrode contacts polar selecting switch (10,11,12,13,14,15,16,17) be SP3T switch, three positions corresponding "-" " 0 " "+" respectively of switch, pushes corresponding position and then represents that the electrode contacts polarity of being answered by this Switch Controller is set to negative polarity, sky and positive polarity respectively.Channel selector switch 8 is single-pole double-throw switch (SPDT), can be pushed " 1 " or " 2 ", represents that parameter current adjustment operation is effective to current set passage (1 or 2).Stimulus modelity selector switch 9 is single-pole double-throw switch (SPDT), can be pushed " V " or " I ", represents that current output pulse is constant voltage mode or constant current mode.Testing impedance button 18 is for the electrode load impedance of TCH test channel 1 and passage 2.Button 19,20,21,22,23,24 for regulation output electric pulse parameter, and button 19 function is that pulse amplitude increases, and button 20 function is that pulse amplitude reduces, button 21 function is that pulse frequency increases, button 22 function is that pulse frequency reduces, and button 23 function is that pulse width increases, and button 24 function is that pulse width reduces.Display screen 7 for showing testing stimulus device current operating state, i.e. the amplitude of current output electric pulse, frequency and pwm value, electrode impedance test result, and battery low-voltage warning information.Dotted portion under battery cabin cap 30 is battery placement location, and testing stimulus device is powered by two joints No. five general dry batteries.The circuit board 25 that enclosure is placed is fixed on enclosure with four screws.Shell is provided with four screw positions 26,27,28,29 for assembling.Testing stimulus device cover top portion has film on surface 32, and pulse output interface 34,35, and interface adopts the earphone interface of band buckle slot 36.
Figure 4 shows that a kind of concrete information displaying situation of display screen, after turning on the power switch, display screen is as shown in Fig. 4 (a), and display information comprises the parameter of passage 1, the current output electric pulse of passage 2, comprise pulse amplitude, frequency and pulse width, and Parameter units, when stimulus modelity is set in constant voltage mode, pulse amplitude unit is shown as " V ", as Fig. 4 (a), when being set in constant current mode, pulse amplitude unit is shown as " mA ", as Fig. 4 (b).In Fig. 4 (a)-(b), display icon implication is: ---pulse amplitude; ---pulse frequency; ---pulse width.After pressing testing impedance button, display screen display " in test, please wait a moment ... " printed words, as Fig. 4 (c), after recording result then show electrode impedance information as shown in Fig. 4 (d)." cell voltage is low in display screen display when cell voltage being detected lower than set threshold value! " printed words make alarm, get back to main display frame after last for several seconds, the display screen upper right corner occurs symbol continues alarm, as shown in Fig. 4 (f).
The circuit composition of testing stimulus device as shown in Figure 5, mainly comprises microcontroller 37, power management and latching circuit 38, battery voltage sampling circuit 50, impulse output circuit module 40, display screen 49, button inputting circuits 47, on-off circuit 44 and 48 etc.Wherein:
Microcontroller 37 is control cores of testing stimulus device circuit, mainly realizes two aspect functions: one is control man-machine interaction, and response button, switch input, arrange display screen and export; Two is that control impuls output module 40 produces electric pulse output.
Testing stimulus device is powered by two joints No. five common batteries 39, and cell voltage voltage stabilizing is 3.3V by power management and latching circuit 38 is that microcontroller 37 is powered, and provides auto-lock function, and namely lock pulse exports constant, and microcontroller 37 is response parameter regulating key not.Battery voltage sampling circuit obtains the partial pressure value of cell voltage by the voltage of AD sampling resistor, by calculating battery voltage value, each hour measures once, if lower than set low voltage threshold, microcontroller 37 sends low-voltage warning information by display screen 49.
Pulse parameter adjustment and electrode impedance test command are inputed to microcontroller 37 and process by button inputting circuits 47, and current selection mode is supplied to microcontroller 37 by model selection and channel selecting two switches 48.
Pulse output module 40 for generation of the electric impulse signal of constant voltage or constant current two kinds of patterns, primarily of DC-DC circuit 41, constant voltage/constant current impulse output circuit 42, charge balance and the composition such as electrode impedance test circuit 43, electrode contacts polarity selecting circuit 44.Wherein DC-DC circuit 41 not only can have been boosted but also can blood pressure lowering, output voltage range 0 ~ 10V, pulse current fan-out capability is not less than 20mA under 500 ohm load: channel selection circuit 51 exports with DC-DC circuit 41 and is connected, select one or two electric energy storage capacitor to carry out charging and pulse output by microcontroller 37, and set the output polarity combination of each passage by electrode contacts polarity selecting circuit 44; The pulse that constant voltage/constant current impulse output circuit 42 can produce constant current or constant voltage two kinds of patterns exports; Charge balancing circuit in charge balance and electrode impedance measuring circuit 43, for generation of the pulse signal reverse with boost pulse, realizes the forward and reverse charge balance to stimulating target spot, avoids damaging target tissue.
Fig. 6 is the block diagram of electrode impedance test.Testing stimulus device 56 provides electric stimulation pulse to electrode 53, when there being electrode impedance test command, the current information that the voltage acquisition pulse that electrode impedance test circuit 54 gathers sampling resistor by AD exports, gives 57 and carries out software processes, return test result 58 to testing stimulus device 56.Test result can with data in advance as compared with early stage electrode impedance measured value or the value pre-estimated, thus judge whether electrode can normally work, whether accurate positioning, and whether effectively can transmit stimulus signal, and roughly can estimate the working life of implantable pulse generator according to test result.
Above-described embodiment, the just one of the present invention's more preferably detailed description of the invention, the change that those skilled in the art carries out within the scope of technical solution of the present invention and replacing all should be included in protection scope of the present invention.

Claims (7)

1. the testing in vitro stimulator for nerve electric stimulation therapy testing evaluation, described testing stimulus utensil has user interface, before implantable pulse generator, electrode is connected to testing stimulus device pulse output end mouth by test lead by doctor, carry out preliminary test, it is characterized in that, contain: pulse parameter setting device, output-controlling device, display device, microcontroller, impulse output circuit module, power supply, electric power management circuit and operator scheme switching part, wherein:
Pulse parameter setting device, for once producing one of following command signal: amplitude upwards regulates, amplitude regulates downwards, frequency upwards regulates, frequency regulates downwards, pulsewidth upwards regulates, pulsewidth regulates downwards, electrode impedance test;
Output-controlling device, for arranging switching-on and switching-off state and user operation mode, also for arranging the combinations of polarities of each electrode contacts under each passage, and for selecting stimulus modelity and arranging effective passage to parameter current;
Display device, for showing current PRF output parameter, electrode impedance test result, and the warning message when electric quantity of power supply is not enough;
Impulse output circuit module, comprising: voltage modulation circuit, pulse output control circuit, charge balancing circuit and electrode impedance test circuit;
Microcontroller, it can receive the command signal that described pulse parameter setting device exports, the signal that described output-controlling device exports can also be received, export the instruction and data for showing to described display device, and monitor the output of described impulse output circuit module;
Wherein,
Described testing stimulus utensil has the first operator scheme being suitable for doctor's operation and the second operator scheme being suitable for patient's operation, described operator scheme switching part is for switching the operator scheme of described testing stimulus device, in described first operator scheme, doctor can arrange described testing stimulus device running parameter, and in described second operator scheme, patient only can check display and the reading of described display device.
2. testing stimulus device according to claim 1, is characterized in that, described operator scheme switching part be on and off switch shelves from backset, and design the leather sheath of the hull outside in described testing stimulus device.
3. testing stimulus device according to claim 2, is characterized in that, described testing stimulus device is suitable for using in vitro, and described pulse parameter setting device comprises control button, and described output-controlling device comprises toggle switch, and described power supply is battery.
4. testing stimulus device according to claim 1, it is characterized in that, the displaying contents of described display device comprises: the unit of the amplitude of the amplitude of the output pulse of described testing stimulus device, frequency, pulsewidth and pulse, frequency, pulsewidth, electrode impedance, power supply low-voltage warning information under electrode impedance test result and each passage.
5. testing stimulus device according to claim 1, is characterized in that, the polarity of described electrode contacts is selected from "+" "-" and " 0 ", and described stimulus modelity is constant current mode or constant voltage mode.
6. testing stimulus device according to claim 1, it is characterized in that, the stimulus modelity that described pulse output control circuit is arranged according to described output-controlling device, correspondingly be operated in constant voltage mode or constant current mode, in described constant voltage mode, the voltage amplitude that described impulse output circuit module exports is 0 ~ 10V, and in described constant current mode, the current intensity that described impulse output circuit module exports is 0 ~ 25mA.
7. testing stimulus device according to claim 1, is characterized in that, after each pulse electrical signal that described impulse output circuit module exports, described charge balancing circuit produces a reverse equalizing pulse signal of telecommunication;
Described electrode impedance test circuit can measure the impedance of the electrode that described testing stimulus device connects;
Described electric power management circuit contains:
Mu balanced circuit, is stabilized in setting value described electric power output voltage, for described microcontroller and display screen are powered;
Latching circuit, for locking testing stimulus device duty, cuts out keypress function;
Supply voltage sample circuit, for often detecting supply voltage at regular intervals, if magnitude of voltage is lower than set threshold value, microcontroller then sends low-voltage alarm by described display device.
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