CN105079963B - A kind of electric pulse stimulation is tested device and uses the test system of this device - Google Patents
A kind of electric pulse stimulation is tested device and uses the test system of this device Download PDFInfo
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
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- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36125—Details of circuitry or electric components
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- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36146—Control systems specified by the stimulation parameters
- A61N1/36167—Timing, e.g. stimulation onset
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36146—Control systems specified by the stimulation parameters
- A61N1/36167—Timing, e.g. stimulation onset
- A61N1/36175—Pulse width or duty cycle
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
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Abstract
The present invention relates to a kind of electric pulse stimulation test device, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes a pulse generating module, wherein, described pulse generating module at least can produce frequency conversion stimulation pulse signal, this frequency conversion stimulation pulse signal includes that the electric stimulation pulse string of at least two different frequency alternately stimulates and forms multiple burst periods, and the electric stimulation pulse string of each frequency duration in each burst periods is 0.1 second ~ 60 minutes.Further, the invention still further relates to a kind of electric pulse stimulation test system using this electric pulse stimulation test device.The electric pulse stimulation test device of the present invention or test system, by introducing frequency conversion stimulation pulse signal, may be used for testing patient if appropriate for using frequency conversion stimulation pulse signal to treat.
Description
Technical field
The invention belongs to mini-medical instrument field, the implanted electric pulse stimulation system used particularly to a kind of medical treatment, a kind of electric pulse stimulation tests system and the method using this implanted electric pulse stimulation system to stimulate nervous tissue.
Background technology
Implantation medical equipment kind is a lot, such as cardiac pacemaker and defibrillator, embedded nerve stimulator, implanted muscle stimulator etc..Implantation medical equipment generally comprises et al. Ke device and outer control device, exchanges information by bidirectional wireless communication between the two.
In existing technology, implantation medical equipment typically utilizes battery to power, and sends the boost pulse of characteristic frequency, specific target spot carries out long-time stimulus, thus improves the symptom of patient.This stimulus modelity is referred to as constant frequency stimulus modelity.Under constant frequency stimulus modelity, the stimulation time of target spot is typically lasted for more than several days by single-frequency, some months, the most several years.But from the point of view of clinic, existing stimulating method is to the poor effect of some symptom and can produce certain adaptability.Such as, for the deep brain stimulation of parkinson symptom, under the stimulation of constant frequency, dysarthria, gait are freezed, the non-motor symptoms such as unusual fluctuation improves little.It addition, according to the nerve electric stimulation Couple herbs to anti-Parkinson and epileptic, patient, under the stimulation of constant frequency, easily produces adaptability to stimulating so that therapeutic effect is deteriorated, and is similarly to reusing the Drug resistance that medicine produces for a long time.
And, stimulating electrode (comprise or do not comprise extension lead), pulse generator are all implanted into the human body by the using method of implantation medical equipment typically by operation at present, treat a few time-of-week of postoperative recovery, then open pulse generator and stimulate, observe and assess effect of stimulation.But there is symptom and improve inconspicuous or without improvement situation in some patients, now needs to take out implant.In practice for observing and assessment effect of stimulation, it is chronically implanted the pulse generator of use and extension lead not necessarily, and patient is caused bigger physical impairment by the operation technique needed for implanting two assemblies.Therefore, for this some patients, current procedure pattern there are two drawbacks, and one is the waste of apparatus, and two is the excessive use of operation.
In order to avoid above-mentioned drawback, it is thus proposed that use electric pulse stimulation test system first patient observed and assess.Such as, first only at implantable stimulation electrode in the patient, then this stimulating electrode and an electric pulse stimulation are tested system electrical connection.Tested by this electric pulse stimulation test system, and observe and assess to determine that this patient is if appropriate for electrical stimulating therapy.But, existing electric pulse stimulation test system is only capable of testing the constant frequency stimulus modelity of single-frequency.
Summary of the invention
In view of this, necessary offer is a kind of can realize electric pulse stimulation test device and the test system that frequency conversion stimulates.
A kind of electric pulse stimulation test device, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes a pulse generating module, wherein, described pulse generating module at least can produce frequency conversion stimulation pulse signal, this frequency conversion stimulation pulse signal includes that the electric stimulation pulse string of at least two different frequency alternately stimulates and forms multiple burst periods, and the electric stimulation pulse string of each frequency duration in each burst periods is 0.1 second ~ 60 minutes.
The electric stimulation pulse string of each frequency duration in each burst periods is 0.1 second ~ 30 minutes.
The electric stimulation pulse string of each frequency duration in each burst periods is 3 seconds ~ 60 seconds.
The electric stimulation pulse string of each frequency duration in each burst periods is 5 seconds ~ 30 seconds.
The frequency of described electric stimulation pulse string is 10 hertz ~ 400 hertz.The frequency of described electric stimulation pulse string is 30 hertz ~ 250 hertz.
The frequency of described electric stimulation pulse string is 50 hertz ~ 150 hertz.
The number of the electric stimulation pulse string of described different frequency is N, and 2≤N < 10.
The number of the electric stimulation pulse string of described different frequency is 2 or 3, and the time ratio that the electric stimulation pulse string of described different frequency is in each burst periods is more than 5%.
Between the electricity irritation arteries and veins string of described different frequency, the time interval between separated in time, and the electric stimulation pulse string of adjacent two different frequencies is 0.01 second ~ 60 minutes.
Time interval between separated in time between the plurality of burst periods, and adjacent two burst periods is 0.01 second ~ 60 minutes.
Described pulse generating module has frequency sweep function；When setting this swept frequency range as F1min ~ F1max, frequency sweep precision is S1, sweep time is T1, described pulse generating module will be with F1min, F1min+S1, F1min+2S1, F1min+3S1 ... F1min+nS1 and F1max exports an electric stimulation pulse string respectively, and each electric stimulation pulse string persistent period is T1, wherein, n is natural number, and n≤(F1max-F1min)/S1.
Described pulse generating module has frequency sweep function；When setting this swept frequency range as F2min ~ F2max, frequency sweep precision is S2, sweep time is T2, described pulse generating module will be with F2min and F2max, F2min+S2 and F2max-S2, F2min+2S2 and F2max-2S2 ... and F2min+nS2 and F2max-nS2 alternately two electric stimulation pulse strings of output respectively, and the persistent period of each two electric stimulation pulse string alternately output is T2, wherein, n is natural number, and n < (F2max-
F2min)/2S2。
Described pulse generating module has frequency sweep function；nullWhen setting reference frequency as Fb1 and Fb2，Swept frequency range is F3，Frequency sweep precision is S3，And sweep time is T3，Described pulse generating module will be respectively with Fb1 and Fb2、Fb1+S3 and Fb2、Fb1+2S3 and Fb2 ... Fb1+nS3 and Fb2、Fb1-S3 and Fb2、Fb1-2S3 and Fb2 ... Fb1-nS3 and Fb2、Fb1 and Fb2+S3、Fb1 and Fb2+2S3 ... Fb1 and Fb2+nS3、Fb1 and Fb2-S3、Fb1 and Fb2-2S3 ... Fb1 and Fb2-nS3 alternately two electric stimulation pulse strings of output，And the persistent period of each two electric stimulation pulse string alternately output is T3，Wherein，N is natural number，And n=F3/S3.
Described pulse generating module has frequency sweep function；nullWhen setting reference frequency as Fb1 and Fb2，Swept frequency range is F3，Frequency sweep precision is S3，And sweep time is T3，Described pulse generating module will be respectively with Fb1 and Fb2、Fb1+S3 and Fb2+S3、Fb1+2S3 and Fb2+2S3 ... Fb1+nS3 and Fb2+nS3、Fb1-S3 and Fb2-S3、Fb1-2S3 and Fb2-2S3 ... Fb1-nS3 and Fb2-nS3、Fb1+S3 and Fb2-S3、Fb1+2S3 and Fb2-2S3 ... Fb1+nS3 and Fb2-nS3、Fb1-S3 and Fb2+S3、Fb1-2S3 and Fb2+2S3 ... Fb1-nS3 and Fb2+nS3 alternately two electric stimulation pulse strings of output，And the persistent period of each two electric stimulation pulse string alternately output is T3，Wherein，N is natural number，And n=F3/S3.
Described swept frequency range F3 is 1 hertz ~ 20 hertz, and described frequency sweep precision S3 is 1 hertz ~ 10 hertz, the time T3 of described scanning be 5 seconds ~ 60 minutes adjustable.
Described swept frequency range F3 is 5 hertz ~ 10 hertz, and described frequency sweep precision S3 is 2 hertz ~ 5 hertz, the time T3 of described scanning be 30 seconds ~ 10 minutes adjustable.
A kind of electric pulse stimulation test device, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes a pulse generating module, and wherein, described pulse generating module at least can produce frequency conversion stimulation pulse signal.
A kind of electric pulse stimulation test device, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes a pulse generating module, wherein, described pulse generating module at least can produce frequency conversion stimulation pulse signal, and this frequency conversion stimulation pulse signal only includes that the electric stimulation pulse string of two or three different frequency alternately stimulates and forms multiple burst periods.
A kind of electric pulse stimulation test system using above-mentioned electric pulse stimulation test device.
Compared with prior art, the electric pulse stimulation test device of the present invention or test system, by introducing frequency conversion stimulation pulse signal, may be used for testing patient if appropriate for using frequency conversion stimulation pulse signal to treat.
Accompanying drawing explanation
The structural representation of the implanted electric pulse stimulation system that Fig. 1 provides for the embodiment of the present invention.
Fig. 2 is the module diagram of the pulse generator of the implanted electric pulse stimulation system of Fig. 1.
The frequency conversion stimulation pulse signal of the implanted electric pulse stimulation system that Fig. 3 provides for the embodiment of the present invention and the comparison diagram of the constant frequency stimulation pulse signal of prior art.
The first frequency conversion stimulation pulse signal schematic diagram that the implanted electric pulse stimulation system that Fig. 4 provides for the embodiment of the present invention produces.
The second frequency conversion stimulation pulse signal schematic diagram that the implanted electric pulse stimulation system that Fig. 5 provides for the embodiment of the present invention produces.
The third frequency conversion stimulation pulse signal schematic diagram that the implanted electric pulse stimulation system that Fig. 6 provides for the embodiment of the present invention produces.
The 4th kind of frequency conversion stimulation pulse signal schematic diagram that the implanted electric pulse stimulation system that Fig. 7 provides for the embodiment of the present invention produces.
The 5th kind of frequency conversion stimulation pulse signal schematic diagram that the implanted electric pulse stimulation system that Fig. 8 provides for the embodiment of the present invention produces.
The frequency-time graph of a relation of the electric stimulation pulse signal of the first frequency sweep mode of the pulse generator of the implanted electric pulse stimulation system that Fig. 9 provides for the embodiment of the present invention.
The frequency-time graph of a relation of the electric stimulation pulse signal of the second frequency sweep mode of the pulse generator of the implanted electric pulse stimulation system that Figure 10 provides for the embodiment of the present invention.
The frequency-time graph of a relation of the electric stimulation pulse signal of the third frequency sweep mode of the pulse generator of the implanted electric pulse stimulation system that Figure 11 provides for the embodiment of the present invention.
The frequency-time graph of a relation of the electric stimulation pulse signal of the 4th kind of frequency sweep mode of the pulse generator of the implanted electric pulse stimulation system that Figure 12 provides for the embodiment of the present invention.
The structural representation of the electric pulse stimulation test system that Figure 13 provides for the embodiment of the present invention.
Figure 14 is the module diagram of the pulse generating module of the electric pulse stimulation test system of Figure 13.
Main element symbol description
| Implanted lesions located in deep brain device | 10 |
| Pulse generator | 11 |
| Microprocessor module | 111, 211 |
| Power module | 112, 212 |
| Wireless communication module | 114 |
| Stimulating electrode | 12 |
| Extension lead | 13 |
| Vitro program controlled instrument | 14 |
| Electric stimulation pulse signal | 15 |
| Frequency conversion stimulation pulse signal | 150 |
| Burst periods | 151 |
| Electric stimulation pulse string | 152 |
| Time interval | 154 |
| Electric pulse stimulation test system | 20 |
| Testing in vitro stimulator | 21 |
| Pulse generating module | 210 |
| Control module | 213 |
| Test cable | 22 |
| Test lead | 23 |
Following detailed description of the invention will further illustrate the present invention in conjunction with above-mentioned accompanying drawing.
Detailed description of the invention
Below in conjunction with the accompanying drawings and the specific embodiments, to the present invention provide implanted electric pulse stimulation system, electric pulse stimulation test system, and use this implanted electric pulse stimulation system stimulate nervous tissue method.
It is appreciated that the implanted electric pulse stimulation system that the present invention provides can be cardiac pacemaker, defibrillator, lesions located in deep brain device, spinal stimulator, vagus nerve stimulator, the intestines and stomach stimulator, muscle stimulator, peripheral nerve stimulation device or other similar stimulators.The embodiment of the present invention only illustrates as a example by implanted lesions located in deep brain device.
Refer to Fig. 1-2, the embodiment of the present invention provides an implanted lesions located in deep brain device 10, comprising: one implants subcutaneous pulse generator 11, one stimulating electrode 12 implanting deep brain position, one connects this stimulating electrode 12 and the extension lead 13 of pulse generator 11, and one for the vitro program controlled instrument 14 of this pulse generator 11 program control.
Described pulse generator 11 produces specific electric stimulation pulse signal 15, and is conducted to stimulation location by described extension lead 13 and stimulating electrode 12 and carries out stimulating regulation and control.Described vitro program controlled instrument 14 with the wireless connections of described pulse generator 11, and can change its electric pulse stimulation parameter.
Described stimulating electrode 12 tip has multiple contact, and after stimulating electrode 12 is implanted target position, at least a contact contact closely with stimulating target spot, with by suitable electricity irritation conduction to target spot, treat the disease of nerve class.It is appreciated that described stimulating electrode 12 can be one or more according to stimulating needs, corresponding position is stimulated, to ensure effect of stimulation.It is appreciated that the number of described stimulating electrode 12 is not limited to one, can select as required.
Being appreciated that described extension lead 13 is an optional element, described stimulating electrode 12 can be directly connected on this pulse generator 11.Only when the distance after described stimulating electrode 12 implants with this pulse generator 11 is bigger, just need to be connected by extension lead 13.
Described pulse generator 11 is internal to be included: microprocessor module 111, power module 112 and a wireless communication module 113.It is electrically connected with between described microprocessor module 111, power module 112 and wireless communication module 113.Described microprocessor module 111 has the program editted, it is possible to produce different frequency, different pulse width, the electric stimulation pulse signal 15 of different amplitude.The stimulus waveform of this electric stimulation pulse signal 15 is including but not limited to square wave, sine wave, exponential wave, triangular wave.It addition, described wireless communication module 113 and the wireless connections of described vitro program controlled instrument 14, thus the program of described microprocessor module 111 can be selected by described vitro program controlled instrument 14, regulate program parameter, thus change the electric stimulation pulse signal 15 of output.Described microprocessor module 111 can include that one stimulates control module and to stimulate control module for producing the frequency conversion of frequency conversion stimulation pulse signal for producing the constant frequency of constant frequency stimulation pulse signal.But, described microprocessor module 111 at least includes that frequency conversion stimulates control module.Described constant frequency stimulates control module and frequency conversion to stimulate control module to be the integrated circuit storing certain procedures, and its structure does not limits, and those skilled in the art can design as required.It is appreciated that described constant frequency stimulates control module and frequency conversion to stimulate control module can be integrated into same module.
Referring to Fig. 3, the stimulus waveform of the electric stimulation pulse signal 15 that described pulse generator 11 produces can be common constant frequency stimulation pulse signal, it is also possible to for frequency conversion stimulation pulse signal.But, described pulse generator 11 at least can produce frequency conversion stimulation pulse signal.
Refer to Fig. 4-6, described frequency conversion stimulation pulse signal 150 includes that the electric stimulation pulse string 152 of at least two different frequency alternately stimulates and forms multiple burst periods 151, and the electric stimulation pulse string 152 of each frequency duration in each burst periods 151 is 0.1 second ~ 60 minutes.Be appreciated that if electric stimulation pulse string 152 duration of each frequency is the shortest, such as, less than 0.1 second, then the pulsewidth size of stimulation time and individual pulse exists together an order of magnitude, and the pulse of different frequency is closely coupled, and effect has the biggest uncontrollability.And if electric stimulation pulse string 152 duration of each frequency is oversize, such as, more than 60 minutes, single-frequency can be produced and adapt to by patient, long-time stimulation easily makes patient produce adaptability to stimulating, and the similar Drug resistance producing medicine, effect is similar to constant frequency to stimulate.
Preferably, the electric stimulation pulse string 152 of each frequency duration in each burst periods 151 can be 0.1 second ~ 30 minutes.Preferably, the electric stimulation pulse string 152 of each frequency duration in each burst periods 151 is 3 seconds ~ 60 seconds.It is highly preferred that the electric stimulation pulse string 152 of each frequency duration in each burst periods 151 is 5 seconds ~ 30 seconds.Within this time period, both can guarantee that comprised frequency can produce sufficient effect to target cell, and can prevent again patient from the stimulation of certain frequency is produced adaptability.
The frequency of described electric stimulation pulse string 152 is less than or equal to 400 hertz, such as 10 hertz ~ 400 hertz.Preferably, the frequency of described electric stimulation pulse string 152 is 30 hertz ~ 250 hertz.It is highly preferred that the frequency of described electric stimulation pulse string 152 is 50 hertz ~ 150 hertz.When stimulus frequency is less than 30 hertz, the motor symptoms of patient is improved in confused situation aobvious, even makes when lower frequency its motor symptoms deteriorate.Constant frequency stimulus frequency used by clinic is good at 100 hertz effectiveness comparison, it is advantageous to the field stimulation of 50 hertz ~ 150 hertz, is ensureing to chief complaint effect or on the premise of improving cardinal symptom, is improving subsidiary symptom simultaneously.
The meansigma methods of the electric stimulation pulse string 152 of described different frequency is 60 hertz ~ 180 hertz, is preferably, 80 hertz ~ 120 hertz.The geometrical mean of the electric stimulation pulse string 152 of described different frequency is 60 hertz ~ 180 hertz, is preferably, 80 hertz ~ 120 hertz.
From the point of view of clinical data, the high frequency stimulation between 90 hertz ~ 400 hertz is conducive to the improvement of disturbances in patients with Parkinson disease cardinal symptom, and the stimulation of 10 ~ 90 hertz, beneficially dysarthria and gait such as freeze at the improvement of subsidiary symptom.
The number of the electric stimulation pulse string 152 of described different frequency is N, and N >=2.Generally, 2≤N < 10.Preferably, 2≤N≤5.It is highly preferred that the number of the electric stimulation pulse string 152 of described different frequency is 2 or 3.It is appreciated that, too much frequency number makes regulation process more complicated in implementation process, can determine whether this stimulation mode is adapted to by patient by first using the impulse stimulation of a small amount of different frequency that patient is regulated and controled, and determine whether to improve towards more excellent direction.Further according to reaction, suitably increase the quantity of different frequency, optimize effect of stimulation.
The electric stimulation pulse string 152 of described different frequency time ratio in each burst periods 151 is more than 5%.Preferably, the electric stimulation pulse string 152 of described different frequency time ratio in each burst periods 151 is more than 10%.It is highly preferred that the time ratio that the electric stimulation pulse string 152 of described different frequency is in each burst periods 151 is more than 30%.Because the pulse characteristics of different frequency may corresponding different symptom, control its accounting more than 5%, to guarantee the regulating effect to this symptom.When the number of the electric stimulation pulse string 152 of described different frequency is 2 or 3, preferably, the electric stimulation pulse string 152 of the described different frequency time in each burst periods 151, wherein, N was the number of the electric stimulation pulse string 152 of described different frequency than for 1/N.Such as, when the number of the electric stimulation pulse string 152 of described different frequency is 2, the electric stimulation pulse string 152 of described different frequency time ratio in each burst periods 151 is 50%.
The electric stimulation pulse string 152 of described different frequency appearance order in each burst periods 151 can be from low to high, from high frequency to low frequency, can also occur with certain random manner, as long as guaranteeing that, in same burst periods 151, the time scale shared by each electric stimulation pulse string 152 is necessarily.
The electric stimulation pulse string 152 of described different frequency can be current-mode or voltage mode.Frequency and the amplitude of described electric stimulation pulse string 152 are the most adjustable.According to current-mode, current amplitude size be 0 milliampere ~ 30 milliamperes adjustable, degree of regulation is 0.1 milliampere.According to voltage mode, voltage magnitude size is 0 volt ~ 15 volts scalable, and degree of regulation is 0.1 volt.Further, frequency and the pulse width of described electric stimulation pulse string 152 are the most adjustable, and pulse width is that 0 microsecond ~ 1000 microsecond is adjustable.
Specifically, referring to Fig. 3, the first frequency conversion stimulation pulse signal 150 that the present invention provides includes that the electric stimulation pulse string 152 of two kinds of different frequencies alternately stimulates and forms multiple burst periods 151, and the electric stimulation pulse string 152 time accounting of every kind of frequency is identical.Referring to Fig. 4, the second frequency conversion stimulation pulse signal 150 that the present invention provides includes that the electric stimulation pulse string 152 of two kinds of different frequencies alternately stimulates and forms multiple burst periods 151, and the electric stimulation pulse string 152 time accounting of every kind of frequency is different.Referring to Fig. 5, the first frequency conversion stimulation pulse signal 150 that the present invention provides includes that the electric stimulation pulse string 152 of three kinds of different frequencies alternately stimulates and forms multiple burst periods 151, and the electric stimulation pulse string 152 time accounting of every kind of frequency is different.
Refer to Fig. 7-8, it will be understood that the electric stimulation pulse string 152 of different frequency can occur continuously, it is also possible to be interrupted and occur.That is, can be with separated in time between the electric stimulation pulse string 152 of adjacent two different frequencies.The plurality of burst periods 151 can occur continuously, it is also possible to is interrupted and occurs.That is, can also separated in time between adjacent two burst periods 151.The time interval 154 between time interval 154 and adjacent two burst periods 151 between the electric stimulation pulse string 152 of described adjacent two different frequencies can be 0.01 second ~ 60 minutes.Preferably, the time interval 154 between time interval 154 and adjacent two burst periods 151 between the electric stimulation pulse string 152 of described adjacent two different frequencies can be 0.01 second ~ 60 seconds.In one embodiment, this interval time is T/N, and wherein, T is the circulation time of a burst periods 151, and N is the number of the electric stimulation pulse string 152 of different frequency.So technical ability ensures the effectiveness of interval time, can guarantee that again and is unlikely to too big interval time, prevent excessive time interval cause stimulating invalid.
Further, the electric stimulation pulse string 152 that can also store multiple experience stimulus frequency in described pulse generator 11 combines, it is adaptable to regular situation.It can be 50 hertz and 150 hertz, 60 hertz and 140 hertz, 70 hertz and 130 hertz, 80 hertz and 120 hertz, 90 hertz and 110 hertz that the electric stimulation pulse string 152 of this experience stimulus frequency combines, and the time accounting of the electric stimulation pulse string 152 of every kind of frequency is 50%.The meansigma methods of the different frequency of electric stimulation pulse string 152 combination of this experience stimulus frequency is identical.The stimulating current value of multiple experience can also be stored, such as: 0.5 milliampere, 1 milliampere, 1.5 milliamperes, 2 milliamperes, 2.5 milliamperes in being appreciated that described pulse generator 11.This stimulating current value can with above-mentioned electric stimulation pulse string 152 combine with the use of.
During use, different electric stimulation pulse string 152 combinations and stimulating current value can be selected as required.Such as, in normal operation, using the alternately stimulation of 80 hertz and 120 hertz, every kind of time accounting is 50%, and stimulating current size is 2 milliamperes.Or, for the patient that the state of an illness is lighter, using the alternately stimulation of 80 hertz and 120 hertz, every kind of time accounting is 50%, and stimulating current size is 1.5 milliamperes.
Further, described pulse generator 11 has frequency sweep function.Set the sweep parameters of this pulse generator 11 by vitro program controlled instrument 14 after, this pulse generator 11 can carry out frequency sweep according to this parameter.The different frequency sweep mode of described pulse generator 11 introduced below.
The first frequency sweep mode is single-frequency frequency sweep.In this single-frequency frequency sweep mode, when setting swept frequency range as F1min ~ F1max, frequency sweep precision is S1, and sweep time is T1, and described pulse generator 11 will be with F1min, F1min+S1, F1min+2S1, F1min+3S1 ...
F1min+nS1 and F1max exports an electric stimulation pulse string 152 respectively, and the persistent period of each electric stimulation pulse string 152 is T1, and wherein, n is natural number, and n≤(F1max-F1min)/S1.Described swept frequency range F1min ~ F1max can select between 0 hertz ~ 380 hertz.Described frequency sweep precision S1 can be 1 hertz ~ 10 hertz adjustable, adjustable preferably by 2 hertz ~ 5 hertz.Described sweep time T1 can be 5 seconds ~ 60 minutes adjustable, adjustable preferably by 10 seconds ~ 30 minutes.Such as, set swept frequency range as 50 hertz ~ 150 hertz, frequency sweep precision 10 hertz, 10 seconds sweep times of single-frequency.Described pulse generator 11 will export an electric stimulation pulse string 152 with 50 hertz, 60 hertz, 70 hertz, 80 hertz, 90 hertz, 100 hertz, 110 hertz, 120 hertz, 130 hertz, 140 hertz and 150 hertz respectively respectively, and each electric stimulation pulse string 152 continues 10 seconds.Refer to Fig. 9, the frequency-time graph of a relation of electric stimulation pulse signal of the first frequency sweep mode of the pulse generator provided for the embodiment of the present invention, wherein, n=4.
The second frequency sweep mode is that multi-frequency alternately goes forward one by one frequency sweep.This multi-frequency alternately goes forward one by one in frequency sweep mode, when setting swept frequency range as F2min ~ F2max, frequency sweep precision is S2, sweep time is T2, described pulse generator 11 will be with F2min and F2max, F2min+S2 and F2max-S2, F2min+2S2 and F2max-2S2 ... and F2min+nS2 and F2max-nS2 alternately two electric stimulation pulse strings 152 of output respectively, and the persistent period of each two electric stimulation pulse string 152 alternately output is T2, wherein, n is natural number, and n < (F2max-F2min)/2S2.It is appreciated that described sweep time, T2 should be the integral multiple of the persistent period of each burst periods 151.Described swept frequency range F2min ~ F2max can select between 0 hertz ~ 380 hertz.Described frequency sweep precision S2 can be 1 hertz ~ 10 hertz adjustable, adjustable preferably by 2 hertz ~ 5 hertz.Described sweep time T2 can be 5 seconds ~ 60 minutes adjustable, adjustable preferably by 30 seconds ~ 10 minutes.Such as, setting swept frequency range as 50 hertz ~ 150 hertz, frequency sweep precision 10 hertz, sweep time, T2 was 30 seconds, and the persistent period of described burst periods 151 is 2 seconds, and each electric stimulation pulse string 152 persistent period is 1 second.Described pulse generator 11 will with 50 hertz with 150 hertz, 60 hertz with 140 hertz, 70 hertz with 130 hertz, 80 hertz with 120 hertz and 90 hertz with 110 hertz respectively alternately two electric stimulation pulse strings 152 of output thus form 15 burst periods 151.Refer to Figure 10, the frequency-time graph of a relation of electric stimulation pulse signal of the second frequency sweep mode of the pulse generator provided for the embodiment of the present invention, wherein, n=2.
The third frequency sweep mode is multi-frequency alternate combinations frequency sweep.nullIn this multi-frequency alternate combinations frequency sweep mode，When setting reference frequency as Fb1 and Fb2，Swept frequency range is F3，Frequency sweep precision is S3，Sweep time is T3，Described pulse generator 11 will be respectively with Fb1 and Fb2、Fb1+S3 and Fb2、Fb1+2S3 and Fb2 ... Fb1+nS3 and Fb2、Fb1-S3 and Fb2、Fb1-2S3 and Fb2 ... Fb1-nS3 and Fb2、Fb1 and Fb2+S3、Fb1 and Fb2+2S3 ... Fb1 and Fb2+nS3、Fb1 and Fb2-S3、Fb1 and Fb2-2S3 ... Fb1 and Fb2-nS3 alternately two electric stimulation pulse strings 152 of output，And the persistent period of each two electric stimulation pulse string 152 alternately output is T3，Wherein，N is natural number，And n=F3/S3.Be appreciated that T3 described sweep time should be the integral multiple of the persistent period of each burst periods 151, and swept frequency range be F3 be the integral multiple of frequency sweep precision S3.Described reference frequency is that Fb1 and Fb2 can select according to actual needs, and usual described reference frequency is that Fb1 and Fb2 is between 60 hertz ~ 120 hertz.Described swept frequency range F3 can select between 1 hertz ~ 20 hertz, and preferably F3 selects between 5 hertz ~ 10 hertz.Described frequency sweep precision S3 can be 1 hertz ~ 10 hertz adjustable, adjustable preferably by 2 hertz ~ 5 hertz.Described sweep time T3 can be 5 seconds ~ 60 minutes adjustable, adjustable preferably by 30 seconds ~ 10 minutes.Such as, set reference frequency as 80 hertz and 100 hertz, swept frequency range is as 10 hertz, frequency sweep precision 5 hertz, the 1 minute time of every class frequency combined and alternatively scanning, the persistent period of each burst periods 151 is two electric stimulation pulse string 152 persistent period in 3 seconds, and each burst periods 151 to be respectively 1 second and 2 seconds.Described pulse generator 11 alternately will export two electric stimulation pulse strings 152 respectively with 80 hertz and 100 hertz, 85 hertz and 100 hertz, 90 hertz and 100 hertz, 75 hertz and 100 hertz, 70 hertz and 100 hertz, 80 hertz and 105 hertz, 80 hertz and 110 hertz, 80 hertz and 95 hertz, 80 hertz and 90 hertz thus form 20 burst periods 151.Refer to Figure 11, the frequency-time graph of a relation of electric stimulation pulse signal of the third frequency sweep mode of the pulse generator provided for the embodiment of the present invention, wherein, F3=S3.
4th kind of frequency sweep mode is also multi-frequency alternate combinations frequency sweep.nullIn this multi-frequency alternate combinations frequency sweep mode，When setting reference frequency as Fb1 and Fb2，Swept frequency range is F3，Frequency sweep precision is S3，Sweep time is T3，Described pulse generator 11 will be respectively with Fb1 and Fb2、Fb1+S3 and Fb2+S3、Fb1+2S3 and Fb2+2S3 ... Fb1+nS3 and Fb2+nS3、Fb1-S3 and Fb2-S3、Fb1-2S3 and Fb2-2S3 ... Fb1-nS3 and Fb2-nS3、Fb1+S3 and Fb2-S3、Fb1+2S3 and Fb2-2S3 ... Fb1+nS3 and Fb2-nS3、Fb1-S3 and Fb2+S3、Fb1-2S3 and Fb2+2S3 ... Fb1-nS3 and Fb2+nS3 alternately two electric stimulation pulse strings 152 of output，And the persistent period of each two electric stimulation pulse string 152 alternately output is T3，Wherein，N is natural number，And n=F3/S3.Being appreciated that described 4th kind of frequency sweep mode is essentially identical with the third frequency sweep mode above-mentioned, it is distinguished as: in the third frequency sweep mode, and when in Fb1 and Fb2 changes, another holding is constant；And in the 4th kind of frequency sweep mode, when in Fb1 and Fb2 changes, another can also change.Such as, set reference frequency as 80 hertz and 105 hertz, swept frequency range is as 10 hertz, frequency sweep precision 5 hertz, the 1 minute time of every class frequency combined and alternatively scanning, the persistent period of each burst periods 151 is two electric stimulation pulse string 152 persistent period in 3 seconds, and each burst periods 151 to be respectively 2 seconds and 1 second.Described pulse generator 11 alternately will export two electric stimulation pulse strings 152 respectively with 80 hertz and 105 hertz, 85 hertz and 110 hertz, 90 hertz and 115 hertz, 75 hertz and 100 hertz, 70 hertz and 95 hertz, 85 hertz and 100 hertz, 90 hertz and 95 hertz, 75 hertz and 110 hertz, 70 hertz and 115 hertz thus form 20 burst periods 151.Refer to Figure 12, the frequency-time graph of a relation of electric stimulation pulse signal of the 4th kind of frequency sweep mode of the pulse generator provided for the embodiment of the present invention, wherein, F3=S3.
Referring to Figure 13-14, the embodiment of the present invention further provides for an electric pulse stimulation test system 20, comprising: an external testing stimulus device 21, a test cable 22, test lead 23 and a stimulating electrode 12.Wherein, the present invention defines this testing in vitro stimulator 21, test cable 22 and test lead 23 and tests device for electric pulse stimulation.
During use, being implanted by stimulating electrode 12, electrically connected with described testing in vitro stimulator 21 by this test cable 22 one end of described test lead 23, the stimulating electrode 12 that the other end and implants electrically connects.Described testing in vitro stimulator 21 produces specific electric stimulation pulse signal 15, and is conducted to stimulation location by described test cable 22, test lead 23 and stimulating electrode 12 and carries out stimulating regulation and control.If patient is suitable for electronic stimulation, then the stimulating electrode 12 that this implants is without taking out.
Being appreciated that described test cable 22 is an optional element, described test lead 23 can also be directly connected on this testing in vitro stimulator 21.Described test cable 22 is without using biocompatible materials to prepare.
Described test lead 23 be respectively arranged at two ends with adapter, in order to realize electrically connecting with described test cable 22 or stimulating electrode 12.During owing to using in described test lead 23 meeting partial insertion organism, therefore, the part that described test lead 23 is at least connected with stimulating electrode 12 uses biocompatible materials to prepare.Preferably, described test lead 23 all uses biocompatible materials to prepare.
Described testing in vitro stimulator 21 includes an external pulse generating module 210.Described pulse generating module 210 is identical with above-mentioned pulse generator 11 structure.Specifically, described pulse generating module 210 includes microprocessor module 211, power module 212 and a control module 213.It is electrically connected with between described microprocessor module 211, power module 212 and control module 213.Described microprocessor module 211 has the program editted, it is possible to produce different frequency, distinct pulse widths, the electric stimulation pulse signal 15 of different amplitude.Described control module 213 includes display, input keyboard etc..The program of described microprocessor module 211 can be selected by described control module 213, regulate program parameter, thus change the electric stimulation pulse signal 15 of output.Owing to this external pulse generating module 210 is without implanting, it is prepared without using biocompatible materials.
Referring to Fig. 3-8, described pulse generating module 210 the most at least can produce the frequency conversion stimulation pulse signal that above-mentioned pulse generator 11 produces.Further, referring to Fig. 9-12, described pulse generating module 210 also has the frequency sweep function of above-mentioned pulse generator 11.The electric pulse stimulation test system 10 of the present invention, by introducing frequency conversion stimulation pulse signal, may be used for testing patient if appropriate for using frequency conversion stimulation pulse signal to treat.
The present invention further provides a kind of method using above-mentioned frequency conversion stimulation pulse signal to stimulate target nerve, the method includes:
Step S10, determines the stimulus frequency of this frequency conversion stimulation pulse signal；And
Step S20, acts on target nerve by this frequency conversion stimulation pulse signal.
In described step S10, the present invention provides the method for two kinds of stimulus frequency determining this frequency conversion stimulation pulse signal.
Method one, for having used constant frequency to stimulate one period, and the patient of more subsidiary ill symptomses.First record primary frequency A that this patient uses constant frequency to stimulate.Generally, the primary frequency that different patients use constant frequency to stimulate is for determining value.Then, utilize vitro program controlled instrument 14 that the pulse generator 11 of patient is controlled, be allowed to export the pulse of constant frequency, observe the reflection of patient.If patient's subsidiary symptom under a certain frequency is improved, record this pulse frequency B.According to formula: C=A2/ B is calculated corresponding frequency C used.That is, frequency C that this correspondence uses and subsidiary improved frequency B of symptom geometrical mean be primary frequency A.Described frequency B and frequency C are the stimulus frequency of this frequency conversion stimulation pulse signal.
It is appreciated that if patient's two or more subsidiary symptom subsidiary, frequency C of corresponding use, D etc. can be obtained according to said method and formula respectively.Described frequency B, C, D etc. are the stimulus frequency of this frequency conversion stimulation pulse signal.
Method two, the method two is essentially identical with method one, and it is distinguished as, according to formula: C=2A-B is calculated corresponding frequency C used.That is, frequency C that this correspondence uses and subsidiary improved frequency B of symptom arithmetic mean of instantaneous value be primary frequency A.
Method three, the patient treated for using electric pulse stimulation to carry out first.Utilize vitro program controlled instrument 14 that the pulse generator 11 of patient is controlled, this pulse generator 11 is made to carry out frequency sweep according to the first single-frequency frequency sweep mode above-mentioned, export the pulse signal of different constant frequencies, and record makes improved pulse frequency B of patient's different symptoms and C respectively.Described frequency B and frequency C are the stimulus frequency of this frequency conversion stimulation pulse signal.Using constant frequency to stimulate to carry out stimulation and find the improved pulse frequency of patients symptomatic to require a very short time, usually tens seconds to a few minutes.
Be appreciated that if patient suffer from three kinds or three kinds with different symptoms, the most respectively record improved pulse frequency B of patient's different symptoms, C, D ....Described frequency B, C, D etc. are the stimulus frequency of this frequency conversion stimulation pulse signal.
Further, stimulus frequency B and C replacing stimulation pulse signal using said method to obtain is not optimum to the stimulation of patient.The present invention can on the basis of B and C frequency, carry out frequency sweep by the pattern of the third multi-frequency alternate combinations frequency sweep above-mentioned, with obtain optimum stimulus frequency B and C.
In described step S20, can first set the time of electric stimulation pulse of different frequency than for 1/N, wherein, N is the number of the electric stimulation pulse of described different frequency.It is appreciated that and can according to actual needs the parameter of this frequency conversion stimulation pulse signal be mediated.Such as, if certain symptom is improved inconspicuous, then the corresponding time accounting increasing the stimulus frequency corresponding with this symptom, reduces the time accounting of stimulus frequency corresponding to other symptoms, until making the symptom of patient improve reach equilibrium.
In existing stimulus modelity, stimulus waveform is that the constant frequency of upper frequency stimulates, and this constant frequency has improvement to the symptom of patient, but inevitably attaches some ill symptomses, and patient easily stimulates generation adaptability to this constant frequency.The present invention is by introducing frequency conversion stimulation pulse signal, under ensureing the effect of stimulation premise to patient, it is possible to improves or eliminates subsidiary symptom.
Such as, in clinic, disturbances in patients with Parkinson disease implants brain pacemaker to stimulate its subthalamic nuclei, it is possible to significantly improve its tremble, the symptom such as health is stiff.But, in prior art, subthalamic nuclei is stimulated the stimulation to constant frequency.After stimulating for a long time, some patients can produce gait freeze, dysarthria, the subsidiary symptom such as unusual fluctuation.It addition, the stimulation of long-time single-frequency, such as 100 hertz, making patient easily this stimulation be produced adaptability, be similar to patient's adaptability to medicine, effect of stimulation is deteriorated.
In some clinical cases, frequency conversion stimulus modelity is used for treating disturbances in patients with Parkinson disease.Clinical research shows that variable-frequency electric stimulates can improve the motor symptoms of parkinson, as trembled or/and health is stiff, while improve the non-motor symptoms of parkinson, as gait is freezed, dysarthria, mobile etc., and it can be avoided that the adaptability that causes of constant frequency.It addition, research shows, this frequency conversion stimulating system for relevant Other diseases such as the myodystonia of motion, and to relevant nervous system disease such as depression, addiction etc. cognitive, psychological, have good curative effect.
The present invention has been used to improve subsidiary symptom and the adaptability that disturbances in patients with Parkinson disease causes due to long term constant frequency stimulation.Below for the real case of the application present invention.
Case 1
Disturbances in patients with Parkinson disease X, after long 130 hertz of constant frequencies stimulate, produces dysarthric symptom.Primary frequency A of this patient X is 130 hertz.
Utilize vitro program controlled instrument 14 that the pulse generator 11 of patient X is controlled, be allowed to export the pulse of constant frequency, observe the reflection of patient X.Patient X under the stimulation of 60Hz, dysarthric state be improved significantly.The frequency conversion stimulation pulse signal using 60 hertz and 130 hertz carries out stimulation therapy to patient X.The time accounting setting two kinds of frequencies is 50%, and the electric stimulation pulse string of each frequency duration in each burst periods is 10 seconds.Through stimulation after a while, observing the improvement degree of the symptom of patient X, dysarthric situation is significantly improved.Stimulated by the frequency conversion of the present invention, on the premise of ensureing therapeutic effect, minute symptom of patient is improved.The following is patient and stimulate the sounding effect contrast obtained with frequency conversion stimulation by common constant frequency.
Table 1 constant frequency stimulates the phonation efficiency contrast stimulated with frequency conversion
| Phonation efficiency index | Normal range | 100Hz constant frequency stimulates | 60&130Hz frequency conversion stimulates |
| Air pressure peak value (cmH2O) | 6.65±1.96 | 36.23 | 3.9 |
| Average peak air pressure (cmH2O) | 5.57±1.72 | 22.42 | 3.79 |
| Expiratory airflow peak value (Lit/Sec) | 0.19±0.10 | 3.41 | 0.78 |
| Target airflow (Lit/Sec) | 0.11±0.05 | 1.25 | 0.16 |
| Expiration capacity (Liters) | 0.17±0.12 | 1.72 | 0.13 |
| Sounding average air flow (Lit/Sec) | 0.11±0.05 | 1.27 | 0.12 |
| Aerodynamic power (watts) | 0.060±0.040 | 2.743 | 0.060 |
| Aerodynamic resistance cmH2O/(l/s) | 55.18±30.64 | 17.62 | 23.03 |
Case 2
Disturbances in patients with Parkinson disease Y suffers from body rigidity symptom and gait freezes symptom, and uses electric pulse stimulation to treat first.
Symptom according to patient Y selects different constant frequency stimulus frequency, finds that the body rigidity symptom of patient Y is significantly improved under the constant frequency of 130 hertz stimulates, and the gait of patient Y is freezed symptom and is improved under the constant frequency of 80 hertz stimulates.
The frequency conversion stimulation pulse signal using 130 hertz and 80 hertz carries out stimulation therapy to patient Y.The time accounting setting two kinds of frequencies is 50%, and the electric stimulation pulse string of each frequency duration in each burst periods is 20 seconds.Observe the improvement situation of patients symptomatic, find that gait is freezed to be significantly improved, but body rigidity improves undesirable.Further, regulating 130 hertz frequency accountings is 60%, and 80 hertz frequency accountings are 40%, then observes the improvement situation of patient, finds that gait is freezed all to be significantly improved with body rigidity.
Case 3
Disturbances in patients with Parkinson disease Z cardinal symptom body rigidity, has serious gait to freeze symptom simultaneously.
To frequency 130Hz, amplitude 2.7V, pulse width 60 μ s on the left of patient Z applying；Right side frequency 130Hz, amplitude 1.7V, the permanent frequency stimulation of pulse width 60 μ s, its stiff symptom be improved significantly, gait freezes exacerbation of symptoms.The stimulus frequency of patient is reduced to 60Hz, i.e. left side frequency 60Hz, amplitude 2.7V, pulse width 60 μ s；Right side frequency 60Hz, amplitude 1.7V, the constant frequency of pulse width 60 μ s stimulates, and this patient's gait is freezed symptom and improved substantially, but stiff severity of symptoms.The Frequency being adjusted to 60&130Hz stimulates, i.e. left side frequency 60&130Hz, amplitude 2.7V, pulse width 60 μ s；Right side frequency 60&130Hz, amplitude 2.7V, pulse width 60 μ s, one of them cycle 50s, the 60Hz comprising 20s stimulates and the 130Hz of 30s stimulates.The spasticity of patient be improved significantly, and gait freeze symptom be improved significantly.The following is gait evaluation table before and after patient's frequency conversion stimulates.
Before and after table 2 frequency conversion stimulates, gait evaluation contrasts
| Constant frequency stimulates 130Hz | Frequency conversion stimulates 60Hz&130Hz | |
| Start-up time (s) | 20 | 3 |
| Turning time (s) | 14 | 3 |
| Speed (m/s) | 0.75 | 0.83 |
| Step-length (m) | 0.40 | 0.42 |
| FOG-Q score | 20 | 8 |
| UPDRS III gait score (the 30th) (item 30) | 2 | 0 |
From upper table it will be seen that frequency conversion stimulate compare constant frequency stimulate, patient's start-up time, turn the dead time significantly reduce, gait freeze be improved significantly.
It addition, those skilled in the art can also do other changes in spirit of the present invention, these changes done according to present invention spirit, all should be included in scope of the present invention.
Claims (23)
1. an electric pulse stimulation test device, comprising: external testing stimulus device and a test lead,
And this testing in vitro stimulator includes that a pulse generating module, described pulse generating module at least can produce
Change frequency stimulation pulse signal, and this frequency conversion stimulation pulse signal includes the electricity thorn of at least two different frequency
Swash train of pulse and alternately stimulate the multiple burst periods of formation, and the electric stimulation pulse string of each frequency is often
In individual burst periods, duration is 0.1 second～60 minutes；It is characterized in that, this frequency conversion stimulates
The stimulus frequency of pulse signal is determined by following steps:
This pulse generating module carries out frequency sweep according to single-frequency frequency sweep mode, exports different constant frequencies
The pulse signal of rate, and record makes patient's different symptoms improved at least two pulse frequency respectively
Rate, and export frequency conversion stimulation pulse signal with this at least two pulse frequency；And
This pulse generating module first sets time of the electric stimulation pulse of different frequency than for 1/N, wherein,
N is the number of the electric stimulation pulse frequency of described different frequency；Further according to be actually needed corresponding increase with
Improve the time accounting of stimulus frequency corresponding to unconspicuous symptom, reduce the stimulation that other symptoms are corresponding
The time accounting of frequency, until making the symptom of patient improve reach equilibrium.
2. electric pulse stimulation test device as claimed in claim 1, it is characterised in that the electricity thorn of each frequency
Swashing train of pulse duration in each burst periods is 0.1 second～30 minutes.
3. electric pulse stimulation test device as claimed in claim 2, it is characterised in that the electricity thorn of each frequency
Swashing train of pulse duration in each burst periods is 3 seconds～60 seconds.
4. electric pulse stimulation test device as claimed in claim 3, it is characterised in that the electricity thorn of each frequency
Swashing train of pulse duration in each burst periods is 5 seconds～30 seconds.
5. electric pulse stimulation test device as claimed in claim 1, it is characterised in that described electric stimulation pulse
The frequency of string is 10 hertz～400 hertz.
6. electric pulse stimulation test device as claimed in claim 5, it is characterised in that described electric stimulation pulse
The frequency of string is 30 hertz～250 hertz.
7. electric pulse stimulation test device as claimed in claim 6, it is characterised in that described electric stimulation pulse
The frequency of string is 50 hertz～150 hertz.
8. electric pulse stimulation test device as claimed in claim 1, it is characterised in that described different frequency
The number of electric stimulation pulse string is N, and 2≤N < 10.
9. electric pulse stimulation test device as claimed in claim 8, it is characterised in that described different frequency
The number of electric stimulation pulse string is 2 or 3, and the electric stimulation pulse string of described different frequency is at each arteries and veins
Rush the time ratio in the string cycle more than 5%.
10. electric pulse stimulation test device as claimed in claim 1, it is characterised in that described different frequency
Electricity irritation arteries and veins string between separated in time, and the electric stimulation pulse string of adjacent two different frequencies it
Between time interval be 0.01 second～60 minutes.
11. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that the plurality of pulse
Time interval between separated in time between the string cycle, and adjacent two burst periods is 0.01
Second～60 minutes.
12. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that sting in each cycle
The appearance order of sharp train of pulse is for be reached from little by frequency, or occurs from big to small or at random.
13. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that described single-frequency
Frequency sweep mode is: when setting this swept frequency range as F1min～F1max, frequency sweep precision is S1, scanning
Time is T1, described pulse generating module will with F1min, F1min+S1, F1min+2S1,
F1min+3S1 ... F1min+nS1 and F1max exports an electric stimulation pulse string respectively, and each
The electric stimulation pulse string persistent period is T1, and wherein, n is natural number, and n≤(F1max-F1min)/S1.
14. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that described pulse generation
Module also has multi-frequency and alternately goes forward one by one frequency sweep function；This multi-frequency frequency sweep function of alternately going forward one by one is: when
Setting this swept frequency range as F2min～F2max, frequency sweep precision is S2, and sweep time is T2, described
Pulse generating module will be with F2min and F2max, F2min+S2 and F2max-S2, F2min+2S2
And F2max-2S2 ... and F2min+nS2 and F2max-nS2 alternately two electricity irritation of output respectively
Train of pulse, and the persistent period of each two electric stimulation pulse string alternately output be T2, wherein, n be oneself
So number, and n < (F2max-F2min)/2S2.
15. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that described pulse generation
Module also has multi-frequency alternate combinations frequency sweep function；This multi-frequency alternate combinations frequency sweep function is: when
Setting reference frequency as Fb1 and Fb2, swept frequency range is F3, and frequency sweep precision is S3, and scanning
Time is T3, described pulse generating module will respectively with Fb1 and Fb2, Fb1+S3 and Fb2,
Fb1+2S3 and Fb2 ... Fb1+nS3 and Fb2, Fb1-S3 and Fb2, Fb1-2S3 and Fb2 ...
Fb1-nS3 and Fb2, Fb1 and Fb2+S3, Fb1 and Fb2+2S3 ... Fb1 and Fb2+nS3, Fb1
With Fb2-S3, Fb1 and Fb2-2S3 ... Fb1 and Fb2-nS3 alternately two electric stimulation pulses of output
Going here and there, and the persistent period of each two electric stimulation pulse string alternately output is T3, wherein, n is natural number,
And n=F3/S3.
16. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that described pulse generation
Module also has multi-frequency alternate combinations frequency sweep function；This multi-frequency alternate combinations frequency sweep function is: when
Setting reference frequency as Fb1 and Fb2, swept frequency range is F3, and frequency sweep precision is S3, and scanning
Time is T3, described pulse generating module will respectively with Fb1 and Fb2, Fb1+S3 and Fb2+S3,
Fb1+2S3 and Fb2+2S3 ... Fb1+nS3 and Fb2+nS3, Fb1-S3 and Fb2-S3, Fb1-2S3
And Fb2-2S3 ... Fb1-nS3 and Fb2-nS3, Fb1+S3 and Fb2-S3, Fb1+2S3 and
Fb2-2S3 ... Fb1+nS3 and Fb2-nS3, Fb1-S3 and Fb2+S3, Fb1-2S3 and Fb2+2S3 ...
Fb1-nS3 and Fb2+nS3 alternately two electric stimulation pulse strings of output, and each two electric stimulation pulse string
Alternately the persistent period of output is T3, and wherein, n is natural number, and n=F3/S3.
17. as described in claim 15 or 16 electric pulse stimulations test devices, it is characterised in that described in sweep
Frequently scope F3 is 1 hertz～20 hertz, and described frequency sweep precision S3 is 1 hertz～10 hertz, described
Scanning time T3 be 5 seconds～60 minutes adjustable.
18. electric pulse stimulation as claimed in claim 17 test devices, it is characterised in that described swept frequency range
F3 is 5 hertz～10 hertz, and described frequency sweep precision S3 is 2 hertz～5 hertz, described scanning time
Between T3 be 30 seconds～10 minutes adjustable.
19. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that described electricity irritation arteries and veins
Frequency and the amplitude of punching string are the most adjustable.
20. electric pulse stimulation as claimed in claim 1 test devices, it is characterised in that described electricity irritation arteries and veins
Frequency and the pulse width of punching string are the most adjustable.
21. 1 kinds of electric pulse stimulation test devices, comprising: external testing stimulus device and a test lead,
And this testing in vitro stimulator includes that a pulse generating module, described pulse generating module at least can produce
Change frequency stimulation pulse signal；It is characterized in that, the stimulus frequency of this frequency conversion stimulation pulse signal passes through
Following steps determine:
This pulse generating module carries out frequency sweep according to single-frequency frequency sweep mode, exports different constant frequencies
The pulse signal of rate, and record makes patient's different symptoms improved at least two pulse frequency respectively
Rate, and export frequency conversion stimulation pulse signal with this at least two pulse frequency；And
This pulse generating module first sets time of the electric stimulation pulse of different frequency than for 1/N, wherein,
N is the number of the electric stimulation pulse frequency of described different frequency；Further according to be actually needed corresponding increase with
Improve the time accounting of stimulus frequency corresponding to unconspicuous symptom, reduce the stimulation that other symptoms are corresponding
The time accounting of frequency, until making the symptom of patient improve reach equilibrium.
22. 1 kinds of electric pulse stimulation test devices, comprising: external testing stimulus device and a test lead,
And this testing in vitro stimulator includes that a pulse generating module, described pulse generating module at least can produce
Change frequency stimulation pulse signal, and this frequency conversion stimulation pulse signal only includes two or three different frequency
Electric stimulation pulse string alternately stimulates and forms multiple burst periods；It is characterized in that, this frequency conversion stimulates arteries and veins
The stimulus frequency rushing signal is determined by following steps:
This pulse generating module carries out frequency sweep according to single-frequency frequency sweep mode, exports different constant frequencies
The pulse signal of rate, and record makes improved two or three pulse frequency of patient's different symptoms respectively
Rate, and export frequency conversion stimulation pulse signal with this two or three pulse frequency；And
This pulse generating module first sets time of the electric stimulation pulse of different frequency than for 1/N, wherein,
N is the number of the electric stimulation pulse frequency of described different frequency；Further according to be actually needed corresponding increase with
Improve the time accounting of stimulus frequency corresponding to unconspicuous symptom, reduce the stimulation that other symptoms are corresponding
The time accounting of frequency, until making the symptom of patient improve reach equilibrium.
23. 1 kinds of electric pulse stimulation test systems, comprising: an electric pulse stimulation test device and stimulates
Electrode, it is characterised in that described electric pulse stimulation test device is such as the claims 1 to 22
Described electric pulse stimulation tests any one in device.
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| CN201610628487.7A CN106139399B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation test device and the test system using the device |
| CN201610632499.7A CN106039555B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation test device and the test macro using the device |
| CN201610628233.5A CN106267561B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation test device and the test system using the device |
| CN201510211704.8A CN105079963B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation is tested device and uses the test system of this device |
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| CN2014108492574 | 2014-12-31 | ||
| CN201510211704.8A CN105079963B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation is tested device and uses the test system of this device |
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| CN201610632499.7A Division CN106039555B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation test device and the test macro using the device |
| CN201610628487.7A Division CN106139399B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation test device and the test system using the device |
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| CN201510211704.8A Active CN105079963B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation is tested device and uses the test system of this device |
| CN201610632499.7A Active CN106039555B (en) | 2014-12-31 | 2015-04-29 | A kind of electric pulse stimulation test device and the test macro using the device |
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| 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 |
| CN109011152B (en) * | 2018-08-22 | 2022-03-18 | 创领心律管理医疗器械（上海）有限公司 | Fixing device, testing device and testing method for pacemaker in-vitro test |
| CN109064712A (en) * | 2018-09-07 | 2018-12-21 | 重庆医科大学 | A kind of monitoring warning device and method for early warning for the monitoring of the elderly's sleep heart rate |
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| CN106267561A (en) | 2017-01-04 |
| CN106139399A (en) | 2016-11-23 |
| CN106039555B (en) | 2019-01-11 |
| CN106139399B (en) | 2018-10-02 |
| CN105079963A (en) | 2015-11-25 |
| CN104548349A (en) | 2015-04-29 |
| CN106267561B (en) | 2018-10-23 |
| CN106039555A (en) | 2016-10-26 |
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