CN103638599B - Implantable neural electrical stimulation control method, Apparatus and system - Google Patents
Implantable neural electrical stimulation control method, Apparatus and system Download PDFInfo
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- 230000001537 neural effect Effects 0.000 title claims abstract description 66
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- 238000012360 testing method Methods 0.000 claims abstract description 110
- 230000004936 stimulating effect Effects 0.000 claims abstract description 35
- 230000003321 amplification Effects 0.000 claims abstract description 25
- 238000003199 nucleic acid amplification method Methods 0.000 claims abstract description 25
- 230000000694 effects Effects 0.000 claims abstract description 24
- 230000008859 change Effects 0.000 claims abstract description 19
- 230000005611 electricity Effects 0.000 claims description 16
- 230000007794 irritation Effects 0.000 claims description 16
- 230000002452 interceptive effect Effects 0.000 claims description 3
- 210000005036 nerve Anatomy 0.000 abstract description 11
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Abstract
Present invention is disclosed a kind of implantable neural electrical stimulation control method, Apparatus and system, wherein, described method includes: receive test instruction；Often through a unit interval, according to preset algorithm, pulse amplitude is amplified once；Pulse amplitude after output amplification, to change the output pulse of internal stimulating electrode continuously.Compared to prior art, the invention has the beneficial effects as follows: Realtime program implantable nerve electric pulse generator patient can be carried out side effect test, simple to operate, and safety is high.
Description
Technical field
The present invention relates to a kind of Implanted medical system, especially relate to a kind of implantable neural electrical stimulation control method, Apparatus and system.
Background technology
Implanted medical system is increasingly widely applied in recent years on clinical medicine, generally includes implantable neural electrical stimulator, implantable cardiac electricity irritation system system, implanted drug infusion system etc..As a example by implantable neural electrical stimulator, mainly include implantable nerve electric pulse generator, extension wire, stimulating electrode and the external controller implanted.Wherein, implantable nerve electric pulse generator is connected with stimulating electrode by extension wire, thus electric stimulation pulse produced by implantable nerve electric pulse generator is transferred to stimulating electrode, the pulse signal that implantable nerve electric pulse generator produces is carried out electricity irritation, to treat the diseases such as such as Parkinson's disease so that function of human body returns to the state of normal operation by stimulating electrode transmission to specific neuronal target.
In current implantable nerve stimulating system, doctor needs to carry out patient side effect test, i.e. quick increase pulses amplitude under one group of given stimulation output parameter, to observe patient's side effect to electricity irritation.At existing doctor's program control instrument, it is impossible to the pulse amplitude of Realtime program implantable nerve electric pulse generator is to observe patient's side effect to electricity irritation.
Summary of the invention
It is an object of the invention to provide a kind of implantable neural electrical stimulation control method, Apparatus and system, described method, Apparatus and system program-controlled implantable nerve electric pulse generator carry out side effect test to patient.
Correspondingly, the implantable neural electrical stimulation control method of one embodiment of the present invention, including:
Receive test instruction；
Often through a unit interval, automatically according to preset algorithm, pulse amplitude is amplified once, and described pulse amplitude is in magnifying state all the time；
Pulse amplitude after output amplification, to change the output pulse of internal stimulating electrode continuously.
As a further improvement on the present invention, described " output amplify after pulse amplitude, to change the output pulse of internal stimulating electrode continuously " specifically include:
Pulse amplitude after amplifying sends to pulse generator；
The pulse amplitude after described amplification downloaded by described pulse generator, and changes the output pulse of described stimulating electrode according to the pulse amplitude after described amplification.
As a further improvement on the present invention, described " often through a unit interval, amplified once by pulse amplitude according to preset algorithm " step specifically includes:
Often through a unit interval, the pulse amplitude within a upper unit interval added default amplitude variations, as the pulse amplitude of output.
As a further improvement on the present invention, described preset algorithm is: testing time (S) the * amplitude variations (V) of the pulse amplitude (V) of pulse amplitude (V)=initial+accumulative.
As a further improvement on the present invention, described accumulative testing time (S)=unit interval (S) x n, n is positive integer.
As a further improvement on the present invention, described " often through a unit interval; amplified once by pulse amplitude according to preset algorithm ", step was particularly as follows: often through a unit interval, according to preset algorithm, pulse amplitude is amplified once, and along with the increase of the number of times through the unit interval, amplitude variations will be gradually reduced.
As a further improvement on the present invention, described preset algorithm is: according to the relation of accumulative testing time with the timing node preset, and selects the respective magnitudes variable preset, and adjusts pulse amplitude according to respective magnitudes variable and accumulative testing time.
As a further improvement on the present invention, described preset algorithm is: as accumulative testing time≤very first time node t1, testing time * first amplitude variations of pulse amplitude=accumulative, as the testing time≤the second timing node t2 of very first time node t1≤accumulative, pulse amplitude=very first time node t1* the first amplitude variations+(accumulative testing time-very first time node t1) * the second amplitude variations.
As a further improvement on the present invention, described method also includes:
Judge whether the pulse amplitude in next unit interval exceedes predetermined threshold value；
The most then stop output；If it is not, then export the pulse amplitude of next unit interval.
As a further improvement on the present invention, described " often through a unit interval, amplified once by pulse amplitude according to preset algorithm " step specifically includes:
Inquiry pulse amplitude array, determines initial pulse amplitude position in pulse amplitude array；
Often through a unit interval, using the default amplitude corresponding to the next position of current location in described pulse amplitude array as the pulse amplitude exported.
As a further improvement on the present invention, described pulse amplitude array is a non-arithmetic progression being made up of multiple pulse amplitudes amplified successively.
Correspondingly, the implantable neural electrical stimulation of one embodiment of the present invention controls device, including:
Input module, is used for receiving test instruction；
Central processing module, for often through a unit interval, amplifying pulse amplitude once automatically according to preset algorithm, and described pulse amplitude be in magnifying state all the time；
Output module, the pulse amplitude after exporting amplification, to change the output pulse of internal stimulating electrode continuously.
As a further improvement on the present invention, described input module be provided with receive starts, suspend, continue, stop, making zero or gesture operation change pulse amplitude interactive interface.
As a further improvement on the present invention, described output module specifically for:
Pulse amplitude after amplifying sends to pulse generator；
Described pulse generator is used for: downloads the pulse amplitude after described amplification, and changes the output pulse of described stimulating electrode according to the pulse amplitude after described amplification.
As a further improvement on the present invention, described device also includes a data memory module, and described data memory module is used for storing default amplitude variations,
Described central processing module specifically for: often through a unit interval, the pulse amplitude within a upper unit interval added default amplitude variations, as output pulse amplitude.
As a further improvement on the present invention, described preset algorithm is: testing time (S) the * amplitude variations (V) of the pulse amplitude (V) of pulse amplitude (V)=initial+accumulative.
As a further improvement on the present invention, described accumulative testing time (S)=unit interval (S) x n, n is positive integer.
As a further improvement on the present invention, described central processing module specifically for: often through a unit interval, being amplified once by pulse amplitude according to preset algorithm, and along with the increase of the number of times through the unit interval, amplitude variations will be gradually reduced.
As a further improvement on the present invention, described device also includes a data memory module, and described data memory module is for storing default multiple amplitude variations and multiple timing node；
Described central processing module specifically for: according to accumulative testing time and the relation of timing node preset, select the respective magnitudes variable preset, and adjust pulse amplitude according to respective magnitudes variable and accumulative testing time.
As a further improvement on the present invention, described preset algorithm is: as accumulative testing time≤very first time node t1, testing time * first amplitude variations of pulse amplitude=accumulative, as the testing time≤the second timing node t2 of very first time node t1≤accumulative, pulse amplitude=very first time node t1* the first amplitude variations+(accumulative testing time-very first time node t1) * the second amplitude variations.
As a further improvement on the present invention, described device also includes that a data memory module, described data memory module are used for storing predetermined threshold value,
Described central processing module is additionally operable to: judge whether the pulse amplitude in next unit interval exceedes predetermined threshold value；
The most then stop output；If it is not, then export the pulse amplitude of next unit interval.
As a further improvement on the present invention, described device also includes a data memory module, and described data memory module has default pulse amplitude array for storage,
Described central processing module is additionally operable to:
Inquiry pulse amplitude array, determines initial pulse amplitude position in pulse amplitude array；
Often through a unit interval, using the default amplitude corresponding to the next position of current location in described pulse amplitude array as the pulse amplitude exported.
As a further improvement on the present invention, described pulse amplitude array is a non-arithmetic progression being made up of multiple pulse amplitudes amplified successively.
As a further improvement on the present invention, described device also includes that one reports amplitude device automatically, and described automatic report amplitude device is for the sound for controlling described device, and/or light, and/or the output of image, automatically to report amplitude size.
As a further improvement on the present invention, described implantable neural electrical stimulation controls device and also includes a bluetooth module, described bluetooth module can connect outside bluetooth equipment, and receives the outside bluetooth equipment wireless control signal to described implantable neural electrical stimulation control device.
Correspondingly, the implantable neural electrical stimulation control system of one embodiment of the present invention, including:
Stimulating electrode；And
Implantable neural electrical stimulation controls device, and described implantable neural electrical stimulation controls device and is electrically connected with described stimulating electrode.
Correspondingly, the implantable neural electrical stimulation control system of one embodiment of the present invention, including:
Pulse generator, the stimulating electrode being electrically connected with pulse generator, and
Implantable neural electrical stimulation controls device, and described implantable neural electrical stimulation controls device and communicates to connect with pulse generator.
As a further improvement on the present invention, described implantable neural electrical stimulation control system also includes the sensor being arranged on patient, and described sensor is for transmitting the feedback signal that patient's electricity irritation has side effects；Described implantable neural electrical stimulation controls device and is used for when receiving described feedback signal, is automatically stopped the output of pulse amplitude or reduces the pulse amplitude of output.
Compared to prior art, the invention has the beneficial effects as follows: Realtime program implantable nerve electric pulse generator patient can be carried out side effect test, simple to operate, and safety is high.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of implantable neural electrical stimulator in an embodiment of the present invention.
Fig. 2 is the flow chart of implantable neural electrical stimulation control method in an embodiment of the present invention.
Fig. 3 is the module map that in an embodiment of the present invention, implantable neural electrical stimulation controls device.
Fig. 4 is the functional arrangement of first embodiment of the invention.
Fig. 5 is the functional arrangement of second embodiment of the invention.
Fig. 6 is the functional arrangement of third embodiment of the invention.
Fig. 7 is the schematic diagram of the current location inquiring about in fifth embodiment of the invention to determine initial pulse amplitude in pulse amplitude array.
Detailed description of the invention
In order to make the technical characteristic of the present invention, goal of the invention and technique effect be more clearly understood from, the now detailed description of the invention of the comparison accompanying drawing explanation present invention, the most identical label represents the part that step is identical.In this article, " schematically " expression " serves as example, example or explanation ", not should by being described herein as any diagram of " schematically ", embodiment is construed to a kind of preferred or more advantage technical scheme.
As it is shown in figure 1, implantable neural electrical stimulator includes doctor's program control instrument 10, pulse generator 20, and it is placed in stimulating electrode (not shown) in the patient.Described stimulating electrode implantable patient brain target tissue, sacral nerves target tissue, spinal nerves target tissue etc..
It is external that this pulse generator 20 is placed in patient, it is possible to is placed in the patient.Usually, before being placed in the patient, can patient is external now carries out electricity irritation test, to be tested complete and after preserving stimulus parameter, this pulse generator 20 can be placed in the patient.
Described doctor's program control instrument 10 can communicate to connect with described pulse generator 20.Described pulse generator 20 is electrically connected with described stimulating electrode.
In an embodiment of the present invention, described doctor's program control instrument 10 can control and adjust the pulse amplitude of electricity irritation, and sends the pulse amplitude of this electricity irritation to described pulse generator 20.Described pulse generator 20 can download the pulse amplitude of described electricity irritation, and the output pulse of the pulse amplitude described stimulating electrode of change according to described electricity irritation, to observe patient's side effect to electricity irritation.
Certainly, in other embodiments of the present invention, it is possible to directly controlled by described pulse generator 20 and adjust the pulse amplitude of electricity irritation, to change the output pulse of described stimulating electrode, patient's side effect to electricity irritation is observed.
This implantable neural electrical stimulator also includes the sensor being arranged on patient, sensor can the perception side reaction such as cause the unexpected unusual fluctuation of patient, mouth eye crooked when pulse amplitude increases suddenly, described sensor is for transmitting the feedback signal that electricity irritation is had side effects by patient, when doctor's program control instrument 10 or described pulse generator 20 receive feedback signal, the output of pulse amplitude can be automatically stopped or reduce the pulse amplitude of output.Realize the most automatically testing side effect, it is not necessary to by the experience of doctor, make test conclusion more accurate.
As in figure 2 it is shown, in an embodiment of the present invention, described implantable neural electrical stimulation control method includes:
Receive test instruction；In an embodiment of the present invention, described doctor's program control instrument 10 or described pulse generator 20 receive test instruction by the input module arranged on it.Described input module includes that operable hardware, described operable hardware can be provided in the roller on doctor's program control instrument 10 or described pulse generator 20, plus-minus button, switch, handle controller, knob, potentiometer, touch induction device etc. one of them or the combination of wherein part/whole.It can receive the operation of doctor, and instruction is tested in input accordingly.Such as, doctor's program control instrument 10 can be panel computer, the app about electricity irritation can be run on this panel computer, multiple functional keys can be set in this app, such as receive startup, suspend, continue, stop, making zero or gesture operation change pulse amplitude interactive interface.Preferably, described input module also includes the coded treatment device being electrically connected with described operable hardware, described coded treatment device for by operable hardware acceptance to signal carry out real-time coding process, by the hardware instruction of described operable hardware, be converted to the discernible instruction of software.
Often through a unit interval, according to preset algorithm, pulse amplitude is amplified once；
Pulse amplitude after output amplification, to change the output pulse of internal stimulating electrode continuously.The numerical value of the pulse amplitude of output can preserve to Local or Remote data base every time, inquires about when facilitating program control.
Multiple embodiment is provided below, to illustrate:
First embodiment:
It is preset with amplitude variations in described doctor's program control instrument 10 or described pulse generator 20.When described doctor's program control instrument 10 or described pulse generator 20 by it on after the input module that arranges receives described test instruction, often through a unit interval, i.e. added amplitude variations on the pulse amplitude within a upper unit interval, as the pulse amplitude of output.Such as, initial pulse amplitude is 0V, and the default unit interval is 1 second, and the amplitude variations preset is 0.1V, then, after receiving test instruction, through 1 second, pulse amplitude is changed into 0V+0.1V=0.1V；Again after 1 second, system can add amplitude variations 0.1V automatically on the basis of 0.1V, and pulse amplitude now is 0.1V+0.1V=0.2V ..., the rest may be inferred.Certainly, it is possible to after receiving test instruction, at once pulse amplitude being changed into 0.1V, after 1 second, add amplitude variations 0.1V on the basis of 0.1V, pulse amplitude now is 0.1V+0.1V=0.2V ..., the rest may be inferred.Preferably, in the present embodiment, for ensureing the safety of patient, described method also includes: judge whether the pulse amplitude in next unit interval exceedes predetermined threshold value；The most then stop output；If it is not, then export the pulse amplitude of next unit interval.Pulse amplitude and the unit interval of process in this embodiment are a linear relationship.
Second embodiment:
Amplitude variations in described doctor's program control instrument 10 or described pulse generator 20.Unlike embodiment one, in the present embodiment, as shown in Figure 4, pulse amplitude (V) and accumulative testing time (S) are linear.Its relation is represented by by function algorithm: testing time (S) the * amplitude variations (V) of the pulse amplitude (V) of pulse amplitude (V)=initial+accumulative, usually, when original state, initial pulse amplitude is 0, then this function algorithm is represented by: testing time (S) the * amplitude variations (V) of pulse amplitude (V)=accumulative.Such as, initial pulse amplitude is 0, and the accumulative testing time is 0.1S, and amplitude variations is 1V, then the pulse amplitude exported is 0.1V；Continuing test, when the accumulative testing time is 0.2S, the pulse amplitude of output is 0.2V ..., the like.Wherein, this accumulative testing time (S)=unit interval (S) x n, n is positive integer.
3rd embodiment:
Unlike embodiment one, as it is shown in figure 5, the pulse amplitude in the present embodiment and the number of times through the unit interval are non-linear relation.Along with the increase of the number of times through the unit interval, its amplitude variations will be gradually reduced.Such as, for the first time after the unit interval, its amplitude variations added is 4V, and second time is after the unit interval, and its amplitude variations added is 3V, and third time is after the unit interval, and its amplitude variations added is 2.5V ..., the like.
Usually, patient has side effects the boost pulse reacted probably at 6 ~ 8V to stimulating electrode, so, according to the technical scheme of the present embodiment, can be when pulse amplitude be less, by the amplification bigger to pulse amplitude, quickly test, and when pulse amplitude is bigger, by the amplification less to pulse amplitude, test the most accurately.
4th embodiment:
As shown in Figure 6, the pulse amplitude in this embodiment and accumulative testing time are non-linear relation.It is with the difference of this first embodiment, multiple amplitude variations and multiple timing node it is preset with in described doctor's program control instrument 10 or described pulse generator 20, and according to the relation of accumulative testing time Yu timing node, select corresponding amplitude variations, and adjust pulse amplitude according to corresponding amplitude variations and accumulative testing time.The functional relationship of this embodiment is represented by: as accumulative testing time≤very first time node t1, testing time * first amplitude variations of pulse amplitude=accumulative, as the testing time≤the second timing node t2 of very first time node t1≤accumulative, pulse amplitude=very first time node t1* the first amplitude variations+(accumulative testing time-very first time node t1) * the second amplitude variations ..., the like.Wherein, the first amplitude variations is more than the second amplitude variations.
Usually, patient has side effects the boost pulse reacted probably at 6 ~ 8V to stimulating electrode, so, according to the technical scheme of the present embodiment, can be when pulse amplitude be less, by the amplification bigger to pulse amplitude, quickly test, and when pulse amplitude is bigger, by the amplification less to pulse amplitude, test the most accurately.
5th embodiment:
As it is shown in fig. 7, be preset with pulse amplitude array in doctor's program control instrument 10 or described pulse generator 20, described pulse amplitude array is a non-arithmetic progression being made up of multiple pulse amplitudes amplified successively.
When described doctor's program control instrument 10 or described pulse generator 20 by it on after the input module that arranges receives described test instruction, first, can be according to the size of initial pulse amplitude, described pulse amplitude array is inquired about, to determine initial pulse amplitude position in pulse amplitude array.Secondly, when often through a unit interval, in described pulse amplitude array, the pulse amplitude as output of the default amplitude corresponding to the next position of current location is i.e. taken；Usually, pulse amplitude corresponding to the next position is more than the pulse amplitude corresponding to current location, preferably, the difference of the pulse amplitude of adjacent position is gradually reduced along with the extension of ordered series of numbers, such as 2.3V, 2.8V, 3.2V, 3.5V, 3.7V, 3.9V ..., if initial pulse amplitude is 3.2V, then can be inquired about in described pulse amplitude array by initial pulse amplitude, to determine that initial pulse amplitude is positioned at the position of described pulse amplitude array, being i.e. the position at 3.2V, amplitude around is 2.8V and 3.5V respectively.Usually, described test instruction is the instruction increasing described pulse amplitude, then after receiving described test instruction, through first unit interval, the amplitude of the next position taking current location is the pulse amplitude of output, i.e. 3.5V ... the rest may be inferred.Certainly, it is possible to after receiving described test instruction, at once take the amplitude of the next position of current location as the pulse amplitude of output, i.e. 3.5V, after the first unit interval, then take the 3.7V pulse amplitude as output.Preferably, for ensureing patient safety, this pulse amplitude array is provided with higher limit, higher limit during i.e. this initial pulse amplitude at most can only increase to this pulse amplitude array.
Above-described embodiment, doctor has only to input an instruction, it is possible to continuously carry out the side effect test of each pulse amplitude, simple to operate.
It is worth mentioning that: in above-described embodiment so that it is can continuously export the condition of each pulse amplitude be the accumulative testing time through one or more unit interval, this unit interval can determine by presetting, and revocable unit interval.Certainly, in other embodiments of the present invention, it is also possible to substitute the unit interval by input module, be i.e. input module as trigger condition, input module often receives and once tests instruction, i.e. by one of them the change pulse amplitude in the respective embodiments described above.
Preferably, when the side effect test continuously carrying out each pulse amplitude, operable doctor's program control instrument 10 or described pulse generator 20 carry out pro-active intervention, stop output pulse amplitude, make side effect test interrupt.Such as, can actively stop doctor's program control instrument 10 or described pulse generator 20 and export pulse amplitude according to above-mentioned embodiment or embodiment continuous print, when stopping, initial pulse amplitude zero.
As it is shown on figure 3, in an embodiment of the present invention, it can be doctor's program control instrument 10 that described implantable neural electrical stimulation controls device, certainly, in another embodiment of the present invention, this implantable neural electrical stimulation controls device and is alternatively pulse generator 20, comprising:
Input module 100, is used for receiving test instruction；In an embodiment of the present invention, described doctor's program control instrument 10 or described pulse generator 20 receive test instruction by the input module arranged on it.Described input module includes that operable hardware, described operable hardware can be provided in the roller on doctor's program control instrument 10 or described pulse generator 20, plus-minus button, switch, handle controller, knob, potentiometer, touch induction device etc. one of them or the combination of wherein part/whole.It can receive the operation of doctor, and instruction is tested in input accordingly.Preferably, described input module also includes the coded treatment device being electrically connected with described operable hardware, described coded treatment device for by operable hardware acceptance to signal carry out real-time coding process, by the hardware instruction of described operable hardware, be converted to the discernible instruction of software.
Central processing module 200, for initial pulse amplitude and preset algorithm, often through a unit interval, amplifies pulse amplitude once.
Described implantable neural electrical stimulation controls device and also includes output module 300, and in an embodiment of the present invention, this output module 300 pulse amplitude after exporting amplification, to change the output pulse of internal stimulating electrode continuously.
Multiple embodiment is provided below, to illustrate:
First embodiment:
Data memory module 400 at described doctor's program control instrument 10 or described pulse generator 20 stores default amplitude variations.When described doctor's program control instrument 10 or described pulse generator 20 receive after described test instructs by its upper input module 100 arranged, can be processed by central processing module 200: often through a unit interval, i.e. added amplitude variations on the pulse amplitude within a upper unit interval, as current pulse amplitude.Such as, initial pulse amplitude is 0V, and the default unit interval is 1 second, and the amplitude variations preset is 0.1V, then, after receiving test instruction, through 1 second, pulse amplitude is changed into 0V+0.1V=0.1V；Again after 1 second, system can add amplitude variations 0.1V automatically on the basis of 0.1V, and pulse amplitude now is 0.1V+0.1V=0.2V ..., the rest may be inferred.Certainly, it is possible to after receiving test instruction, at once pulse amplitude being changed into 0.1V, after 1 second, add amplitude variations 0.1V on the basis of 0.1V, pulse amplitude now is 0.1V+0.1V=0.2V ..., the rest may be inferred.Preferably, in the present embodiment, for ensureing the safety of patient, described central processing module 200 is additionally operable to: judge whether the pulse amplitude in next unit interval exceedes predetermined threshold value；The most then stop output；If it is not, then continue " often changing the pulse amplitude size once exported through a unit interval, to change the output pulse of internal stimulating electrode continuously ".Pulse amplitude and the unit interval of process in this embodiment are a linear relationship.
In second embodiment of the invention:
Second embodiment:
Data memory module 400 internal memory at described doctor's program control instrument 10 or described pulse generator 20 contains amplitude variations.Unlike embodiment one, as shown in Figure 4, in the present embodiment, pulse amplitude (V) and accumulative testing time (S) are linear.Its relation is represented by by function algorithm: testing time (S) the * amplitude variations (V) of the pulse amplitude (V) of pulse amplitude (V)=initial+accumulative, usually, when original state, initial pulse amplitude is 0, then this function algorithm is represented by: testing time (S) the * amplitude variations (V) of pulse amplitude (V)=accumulative.Such as, initial pulse amplitude is 0, and the accumulative testing time is 0.1S, and amplitude variations is 1V, then the pulse amplitude exported is 0.1V；Continuing test, when the accumulative testing time is 0.2S, the pulse amplitude of output is 0.2V ..., the like.Wherein, this accumulative testing time (S)=unit interval (S) x n, n is positive integer.
3rd embodiment:
Unlike embodiment one, as it is shown in figure 5, the pulse amplitude in the present embodiment and the number of times through the unit interval are non-linear relation.When described doctor's program control instrument 10 or described pulse generator 20 receive after described test instructs by its upper input module 100 arranged, can be processed by central processing module 200: along with the increase of the number of times through the unit interval, its amplitude variations will be gradually reduced.Such as, for the first time after the unit interval, its amplitude variations added is 3V, and second time is after the unit interval, and its amplitude variations added is 4V, and third time is after the unit interval, and its amplitude variations added is 4.5V ..., the like.
Usually, patient has side effects the boost pulse reacted probably at 6 ~ 8V to stimulating electrode, so, according to the technical scheme of the present embodiment, can be when pulse amplitude be less, by the amplification bigger to pulse amplitude, quickly test, and when pulse amplitude is bigger, by the amplification less to pulse amplitude, test the most accurately.
4th embodiment:
As shown in Figure 6, the pulse amplitude in this embodiment and accumulative testing time are non-linear relation.It is with the difference of this first embodiment, data memory module 400 at described doctor's program control instrument 10 or described pulse generator 20 stores default multiple amplitude variations and multiple timing node, and according to the relation of accumulative testing time Yu timing node, select corresponding amplitude variations, and adjust pulse amplitude according to corresponding amplitude variations and accumulative testing time.The functional relationship of this embodiment is represented by: as accumulative testing time≤very first time node t1, testing time * first amplitude variations of pulse amplitude=accumulative, as the testing time≤the second timing node t2 of very first time node t1≤accumulative, pulse amplitude=very first time node t1* the first amplitude variations+(accumulative testing time-very first time node t1) * the second amplitude variations ..., the like.Wherein, the first amplitude variations is more than the second amplitude variations.
Usually, patient has side effects the boost pulse reacted probably at 6 ~ 8V to stimulating electrode, so, according to the technical scheme of the present embodiment, can be when pulse amplitude be less, by the amplification bigger to pulse amplitude, quickly test, and when pulse amplitude is bigger, by the amplification less to pulse amplitude, test the most accurately.
Fifth embodiment of the invention:
As it is shown in fig. 7, storage has default pulse amplitude array, described pulse amplitude array to include a non-arithmetic progression being made up of multiple pulse amplitudes amplified successively in the data memory module 400 of doctor's program control instrument 10 or described pulse generator 20.
When described doctor's program control instrument 10 or described pulse generator 20 receive after described test instructs by its upper input module 100 arranged, can be processed by central processing module 200: first, can be according to the size of initial pulse amplitude, described pulse amplitude array is inquired about, to determine initial pulse amplitude position in pulse amplitude array.Secondly, when often through a unit interval, in described pulse amplitude array, the pulse amplitude as output of the default amplitude corresponding to the next position of current location is i.e. taken；Usually, pulse amplitude corresponding to the next position is more than the pulse amplitude corresponding to current location, preferably, the difference of the pulse amplitude of adjacent position is gradually reduced along with the extension of ordered series of numbers, such as 2.3V, 2.8V, 3.2V, 3.5V, 3.7V, 3.9V ..., if initial pulse amplitude is 3.2V, then can be inquired about in described pulse amplitude array by initial pulse amplitude, to determine that initial pulse amplitude is positioned at the position of described pulse amplitude array, being i.e. the position at 3.2V, amplitude around is 2.8V and 3.5V respectively.Usually, described test instruction is the instruction increasing described pulse amplitude, then after receiving described test instruction, through first unit interval, the amplitude of the next position taking current location is the pulse amplitude of output, i.e. 3.5V ... the rest may be inferred.Certainly, it is possible to after receiving described test instruction, at once take the amplitude of the next position of current location as the pulse amplitude of output, i.e. 3.5V, after the first unit interval, then take the 3.7V pulse amplitude as output.Preferably, for ensureing patient safety, this pulse amplitude array is provided with higher limit, higher limit during i.e. this initial pulse amplitude at most can only increase to this pulse amplitude array.
Above-described embodiment, doctor has only to input an instruction, it is possible to continuously carry out the side effect test of each pulse amplitude, simple to operate.
Preferably, in above-described embodiment, described data memory module 400 is additionally operable to store the pulse amplitude of each time period and various stimulus parameter group, such as polarity, pulsewidth, frequency etc..
Described device may also include one and automatically reports amplitude device, automatically reports amplitude device and is used for controlling the sound of described device, and/or light, and/or the output of image, automatically to report amplitude size.Such as, when amplitude increases, described report amplitude device controls the audio frequency output element of described device and sends the most sharp-pointed sound, and/or the light-emitting component controlling described device sends the brightest light, and/or control the pattern of the display screen exporting change of described device, give doctor to remind, convenient use.
Preferably, this device can also include a bluetooth module, such as, device is panel computer, this bluetooth module can connect outside bluetooth equipment, and receives the outside bluetooth equipment wireless control signal to this panel computer, as, pulse amplitude after output amplification, to change the output pulse of internal stimulating electrode continuously.So, doctor can be without checking panel computer, while observing patient reaction, and the button that only need to control on outside bluetooth equipment can realize Realtime program, facilitates doctor to use.
It is worth mentioning that: in above-described embodiment so that it is can continuously export the condition of each pulse amplitude be the accumulative testing time through one or more unit interval, this unit interval can determine by presetting, and revocable unit interval.Certainly, in other embodiments of the present invention, it is also possible to substitute the unit interval by input module, be i.e. input module as trigger condition, input module often receives and once tests instruction, i.e. by one of them the change pulse amplitude in the respective embodiments described above.
Preferably, when the side effect test continuously carrying out each pulse amplitude, operable doctor's program control instrument 10 or described pulse generator 20 carry out pro-active intervention, stop output pulse amplitude, make side effect test interrupt.Such as, can actively stop doctor's program control instrument 10 or described pulse generator 20 and export pulse amplitude according to above-mentioned embodiment or embodiment continuous print, when stopping, initial pulse amplitude zero.
Compared with prior art, the implantable neural electrical stimulation control method of the present invention and device can carry out side effect test to patient by Realtime program implantable nerve electric pulse generator, simple to operate, and safety is high.
It is to be understood that, although this specification is been described by according to embodiment, but the most each embodiment only comprises an independent technical scheme, this narrating mode of description is only for clarity sake, those skilled in the art should be using description as an entirety, technical scheme in each embodiment can also form, through appropriately combined, other embodiments that it will be appreciated by those skilled in the art that.
The a series of detailed description of those listed above is only for illustrating of the feasibility embodiment of the present invention; they also are not used to limit the scope of the invention, and all equivalent implementations or changes made without departing from skill of the present invention spirit should be included within the scope of the present invention.
Claims (28)
1. an implantable neural electrical stimulation control method, it is characterised in that described method includes:
Receive test instruction；
Often through a unit interval, automatically according to preset algorithm, pulse amplitude is amplified once, and described pulse amplitude is in magnifying state all the time；
Pulse amplitude after output amplification, to change the output pulse of internal stimulating electrode continuously.
Implantable neural electrical stimulation control method the most according to claim 1, it is characterised in that described " pulse amplitude after output amplification, to change the output pulse of internal stimulating electrode continuously " specifically includes:
Pulse amplitude after amplifying sends to pulse generator；
The pulse amplitude after described amplification downloaded by described pulse generator, and changes the output pulse of described stimulating electrode according to the pulse amplitude after described amplification.
Implantable neural electrical stimulation control method the most according to claim 1, it is characterised in that described " often through a unit interval, amplified once by pulse amplitude according to preset algorithm " step specifically includes:
Often through a unit interval, the pulse amplitude within a upper unit interval added default amplitude variations, as the pulse amplitude of output.
Implantable neural electrical stimulation control method the most according to claim 1, it is characterised in that described preset algorithm is: testing time (S) the * amplitude variations (V) of the pulse amplitude (V) of pulse amplitude (V)=initial+accumulative.
Implantable neural electrical stimulation control method the most according to claim 4, it is characterised in that described accumulative testing time (S)=unit interval (S) x n, n is positive integer.
Implantable neural electrical stimulation control method the most according to claim 1, it is characterized in that, described " often through a unit interval; amplified once by pulse amplitude according to preset algorithm ", step was particularly as follows: often through a unit interval, according to preset algorithm, pulse amplitude is amplified once, and along with the increase of the number of times through the unit interval, amplitude variations will be gradually reduced.
Implantable neural electrical stimulation control method the most according to claim 1, it is characterized in that, described preset algorithm is: according to the relation of accumulative testing time with the timing node preset, select the respective magnitudes variable preset, and adjust pulse amplitude according to respective magnitudes variable and accumulative testing time.
Implantable neural electrical stimulation control method the most according to claim 1, it is characterized in that, described preset algorithm is: as accumulative testing time≤very first time node t1, testing time * first amplitude variations of pulse amplitude=accumulative, as the testing time≤the second timing node t2 of very first time node t1≤accumulative, pulse amplitude=very first time node t1* the first amplitude variations+(accumulative testing time-very first time node t1) * the second amplitude variations.
9. according to the implantable neural electrical stimulation control method described in any one in claim 3 to 8, it is characterised in that described method also includes:
Judge whether the pulse amplitude in next unit interval exceedes predetermined threshold value；
The most then stop output；If it is not, then export the pulse amplitude of next unit interval.
Implantable neural electrical stimulation control method the most according to claim 1, it is characterised in that described " often through a unit interval, amplified once by pulse amplitude according to preset algorithm " step specifically includes:
Inquiry pulse amplitude array, determines initial pulse amplitude position in pulse amplitude array；
Often through a unit interval, using the default amplitude corresponding to the next position of current location in described pulse amplitude array as the pulse amplitude exported.
11. implantable neural electrical stimulation control methods according to claim 10, it is characterised in that described pulse amplitude array is a non-arithmetic progression being made up of multiple pulse amplitudes amplified successively.
12. 1 kinds of implantable neural electrical stimulations control device, it is characterised in that described device includes:
Input module, is used for receiving test instruction；
Central processing module, for often through a unit interval, amplifying pulse amplitude once automatically according to preset algorithm, and described pulse amplitude be in magnifying state all the time；
Output module, the pulse amplitude after exporting amplification, to change the output pulse of internal stimulating electrode continuously.
13. implantable neural electrical stimulations according to claim 12 control device, it is characterised in that described input module is provided with reception and starts, suspends, continues, stops, making zero or the interactive interface of gesture operation change pulse amplitude.
14. implantable neural electrical stimulations according to claim 12 control devices, it is characterised in that described output module specifically for: will amplify after pulse amplitude send to pulse generator；
Described pulse generator is used for: downloads the pulse amplitude after described amplification, and changes the output pulse of described stimulating electrode according to the pulse amplitude after described amplification.
15. implantable neural electrical stimulations according to claim 12 control device, it is characterised in that
Described device also includes a data memory module, and described data memory module is used for storing default amplitude variations,
Described central processing module specifically for: often through a unit interval, the pulse amplitude within a upper unit interval added default amplitude variations, as output pulse amplitude.
16. implantable neural electrical stimulations according to claim 12 control devices, it is characterised in that described preset algorithm is: testing time (S) the * amplitude variations (V) of the pulse amplitude (V) of pulse amplitude (V)=initial+accumulative.
17. implantable neural electrical stimulations according to claim 16 control device, it is characterised in that described accumulative testing time (S)=unit interval (S) x n, n is positive integer.
18. implantable neural electrical stimulations according to claim 12 control device, it is characterized in that, described central processing module specifically for: often through a unit interval, according to preset algorithm, pulse amplitude is amplified once, and along with the increase of the number of times through the unit interval, amplitude variations will be gradually reduced.
19. implantable neural electrical stimulations according to claim 12 control device, it is characterised in that
Described device also includes a data memory module, and described data memory module is for storing default multiple amplitude variations and multiple timing node；
Described central processing module specifically for: according to accumulative testing time and the relation of timing node preset, select the respective magnitudes variable preset, and adjust pulse amplitude according to respective magnitudes variable and accumulative testing time.
20. implantable neural electrical stimulations according to claim 12 control device, it is characterized in that, described preset algorithm is: as accumulative testing time≤very first time node t1, testing time * first amplitude variations of pulse amplitude=accumulative, as the testing time≤the second timing node t2 of very first time node t1≤accumulative, pulse amplitude=very first time node t1* the first amplitude variations+(accumulative testing time-very first time node t1) * the second amplitude variations.
21. control device according to the implantable neural electrical stimulation described in any one in claim 12 to 20, it is characterised in that
Described device also includes that a data memory module, described data memory module are used for storing predetermined threshold value,
Described central processing module is additionally operable to: judge whether the pulse amplitude in next unit interval exceedes predetermined threshold value；
The most then stop output；If it is not, then export the pulse amplitude of next unit interval.
22. implantable neural electrical stimulations according to claim 12 control device, it is characterised in that
Described device also includes a data memory module, and described data memory module has default pulse amplitude array for storage,
Described central processing module is additionally operable to:
Inquiry pulse amplitude array, determines initial pulse amplitude position in pulse amplitude array；
Often through a unit interval, using the default amplitude corresponding to the next position of current location in described pulse amplitude array as the pulse amplitude exported.
23. implantable neural electrical stimulations according to claim 22 control device, it is characterised in that described pulse amplitude array is a non-arithmetic progression being made up of multiple pulse amplitudes amplified successively.
24. implantable neural electrical stimulations according to claim 12 control device, it is characterized in that, described device also includes that one reports amplitude device automatically, described automatic report amplitude device is for the sound for controlling described device, and/or light, and/or the output of image, automatically to report amplitude size.
25. implantable neural electrical stimulations according to claim 12 control device, it is characterized in that, described implantable neural electrical stimulation controls device and also includes a bluetooth module, described bluetooth module can connect outside bluetooth equipment, and receives the outside bluetooth equipment wireless control signal to described implantable neural electrical stimulation control device.
26. 1 kinds of implantable neural electrical stimulation control systems, it is characterised in that described system includes:
Stimulating electrode；And
Implantable neural electrical stimulation as described in any one in claim 12 to 25 controls device, and described implantable neural electrical stimulation controls device and is electrically connected with described stimulating electrode.
27. 1 kinds of implantable neural electrical stimulation control systems, it is characterised in that described system includes:
Pulse generator, the stimulating electrode being electrically connected with pulse generator, and
Implantable neural electrical stimulation as described in any one in claim 12 to 25 controls device, and described implantable neural electrical stimulation controls device and communicates to connect with pulse generator.
28. according to a kind of implantable neural electrical stimulation control system described in claim 26 or 27, it is characterized in that, described implantable neural electrical stimulation control system also includes the sensor being arranged on patient, and described sensor is for transmitting the feedback signal that patient's electricity irritation has side effects；Described implantable neural electrical stimulation controls device and is used for when receiving described feedback signal, is automatically stopped the output of pulse amplitude or reduces the pulse amplitude of output.
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| CN107148294B (en) * | 2014-08-15 | 2021-08-24 | 艾克索尼克斯股份有限公司 | External pulse generator apparatus and associated method for experimental nerve stimulation |
| AU2016215425B2 (en) * | 2015-02-04 | 2018-03-29 | Boston Scientific Neuromodulation Corporation | Method and apparatus for programming charge recovery in neurostimulation waveform |
| DE102015109988B4 (en) * | 2015-06-22 | 2017-04-27 | Forschungszentrum Jülich GmbH | Device for effective invasive two-stage neurostimulation |
| CN106039564B (en) * | 2016-05-24 | 2019-06-18 | 苏州景昱医疗器械有限公司 | Implantable neural electrical stimulation control device, system and method |
| CN107970524A (en) * | 2017-12-01 | 2018-05-01 | 北京品驰医疗设备有限公司 | A kind of testing stimulus device |
| CN110346755B (en) * | 2019-07-10 | 2023-06-27 | 四川中电昆辰科技有限公司 | Signal amplitude detection device and method and arrival time correction method thereof |
| CN114404800B (en) * | 2021-12-22 | 2022-09-27 | 应脉医疗科技(上海)有限公司 | Neurostimulation device, neurostimulation system, electronic device and storage medium |
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| CN2058102U (en) * | 1988-12-30 | 1990-06-13 | 中山医科大学附属第一医院 | Phrenic muscle pacing and respiration apparatus |
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| CN2058102U (en) * | 1988-12-30 | 1990-06-13 | 中山医科大学附属第一医院 | Phrenic muscle pacing and respiration apparatus |
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