CN106139399A - 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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- CN106139399A CN106139399A CN201610628487.7A CN201610628487A CN106139399A CN 106139399 A CN106139399 A CN 106139399A CN 201610628487 A CN201610628487 A CN 201610628487A CN 106139399 A CN106139399 A CN 106139399A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36053—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36125—Details of circuitry or electric components
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—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
- A61N1/36171—Frequency
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/3605—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/37—Monitoring; Protecting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3925—Monitoring; Protecting
Abstract
The present invention relates to a kind of electric pulse stimulation test device, it is practically applicable to use constant frequency to stimulate one period and the patient of subsidiary ill symptoms, comprising: a pulse generating module, 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 stimulus frequency of this frequency conversion stimulation pulse signal is determined by following steps: record primary frequency A that this patient uses constant frequency to stimulate;Make this patient of impulse stimulation of pulse generator output constant frequency, and record subsidiary improved pulse frequency B of symptom of this patient;And according to formula C=A2/ B is calculated corresponding frequency C used, and described B and C is the stimulus frequency of this frequency conversion stimulation pulse signal.
Description
This case is Application No. 201510211704.8 filed in 29 days April in 2015, entitled " a kind of electric pulse stimulation
Test device and use the test system of this device " the division of Chinese invention patent application.In December, 2014 is advocated in this case
Application No. 201410849257.4 filed in 31 days, entitled " a kind of electric pulse stimulation is tested device and uses this device
Test system " the domestic priority of Chinese invention patent application.
Technical field
The invention belongs to mini-medical instrument field, the implanted electric pulse stimulation system used particularly to a kind of medical treatment
System, 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 flesh
Meat stimulator etc..Implantation medical equipment generally comprises et al. Ke device and outer control device, between the two by two-way
Wireless telecommunications exchange information.
In existing technology, implantation medical equipment typically utilizes battery to power, and sends the boost pulse of characteristic frequency,
Specific target spot is carried out long-time stimulus, thus improves the symptom of patient.This stimulus modelity is referred to as constant frequency stimulus modelity.In constant frequency
Under 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 it is clinical
From the point of view of, existing stimulating method is to the poor effect of some symptom and can produce certain adaptability.Such as, for parkinson symptom
Deep brain stimulation, under the stimulation of constant frequency, dysarthria, gait are freezed, the non-motor symptoms such as unusual fluctuation improves little.Separately
Outward, according to the nerve electric stimulation Couple herbs to anti-Parkinson and epileptic, patient is under the stimulation of constant frequency, the most right
Stimulate and produce adaptability so that therapeutic effect is deteriorated, be similarly to reusing the Drug resistance that medicine produces for a long time.
And, stimulating electrode (is comprised or does not wraps typically by operation by the using method of current implantation medical equipment
Containing extension lead), pulse generator all implant into the human body, treat a few time-of-week of postoperative recovery, then open pulse generator and enter
Assassinate and swash, observe and assess effect of stimulation.But there is symptom and improve inconspicuous or without improvement situation in some patients, now needs
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
It is necessary, and patient is caused bigger physical impairment by the operation technique needed for implanting two assemblies.Therefore, for this portion
For dividing patient, 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 comment
Estimate.Such as, first only at implantable stimulation electrode in the patient, then this stimulating electrode and an electric pulse stimulation are tested system and be electrically connected
Connect.Tested by this electric pulse stimulation test system, and observe and assess to determine that this patient treats if appropriate for electricity irritation
Method.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
System.
A kind of electric pulse stimulation test device, it is practically applicable to use constant frequency stimulate one period and attach bad
The patient of symptom, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes a pulse
Module occurs, and described pulse generating module at least can produce frequency conversion stimulation pulse signal, and this frequency conversion stimulation pulse signal includes
The electric stimulation pulse string of at least two different frequency alternately stimulates and forms multiple burst periods, and the electricity irritation arteries and veins of each frequency
Punching string duration in each burst periods is 0.1 second ~ 60 minutes;Wherein, the stimulation of this frequency conversion stimulation pulse signal
Frequency is determined by following steps:
Record primary frequency A that this patient uses constant frequency to stimulate;
Make this patient of impulse stimulation of pulse generator output constant frequency, and record the subsidiary improved arteries and veins of symptom of this patient
Rush frequency B;And
According to formula C=A2/ B is calculated corresponding frequency C used, and described frequency B and frequency C are this frequency conversion stimulates arteries and veins
Rush the stimulus frequency of signal.
As above-mentioned electric pulse stimulation tests device, further, the electric stimulation pulse string of each frequency is in each train of pulse week
Interim duration is 0.1 second ~ 30 minutes;Preferably, the electric stimulation pulse string of each frequency is in each burst periods
Duration is 3 seconds ~ 60 seconds;It is highly preferred that the electric stimulation pulse string of each frequency is lasting in each burst periods
Time is 5 seconds ~ 30 seconds.
As above-mentioned electric pulse stimulation tests device, further, the frequency of described electric stimulation pulse string is 10 hertz ~ 400 hertz
Hereby;Preferably, the frequency of described electric stimulation pulse string is 30 hertz ~ 250 hertz;It is highly preferred that described electric stimulation pulse string
Frequency is 50 hertz ~ 150 hertz.
As above-mentioned electric pulse stimulation tests device, further, the number of the electric stimulation pulse string of described different frequency is N,
And 2≤N < 10, and the time ratio that the electric stimulation pulse string of described different frequency is in each burst periods is more than 5%.
As above-mentioned electric pulse stimulation tests device, further, between the electricity irritation arteries and veins string of described different frequency, interval is certain
Time interval between time, and the electric stimulation pulse string of adjacent two different frequencies is 0.01 second ~ 60 minutes;Or it is the plurality of
Time interval between separated in time between burst periods, and adjacent two burst periods is 0.01 second ~ 60 minutes.
As above-mentioned electric pulse stimulation tests device, further, the appearance order of each cycle moderate stimulation train of pulse is for by frequency
Rate reaches from little, or occurs from big to small or at random.
As above-mentioned electric pulse stimulation tests device, further, described pulse generating module also has single-frequency frequency sweep merit
Energy;This single-frequency frequency sweep function is: when setting this swept frequency range as F1min ~ F1max, frequency sweep precision is S1, and 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, and wherein, n is natural number, and n
≤(F1max-F1min)/S1。
As above-mentioned electric pulse stimulation tests device, further, frequency and the amplitude of described electric stimulation pulse string are the most adjustable;
Or the frequency of described electric stimulation pulse string and pulse width the most adjustable.
A kind of electric pulse stimulation test device, it is practically applicable to use constant frequency stimulate one period and attach bad
The patient of symptom, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes a pulse
Module occurs, and described pulse generating module at least can produce frequency conversion stimulation pulse signal;Wherein, this frequency conversion stimulation pulse signal
Stimulus frequency determined by following steps:
Record primary frequency A that this patient uses constant frequency to stimulate;
Make this patient of impulse stimulation of pulse generator output constant frequency, and record the subsidiary improved arteries and veins of symptom of this patient
Rush frequency B;And
According to formula C=A2/ B is calculated corresponding frequency C used, and described frequency B and frequency C are this frequency conversion stimulates arteries and veins
Rush the stimulus frequency of signal.
A kind of electric pulse stimulation test device, it is practically applicable to use constant frequency stimulate one period and attach bad
The patient of symptom, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes a pulse
Module occurs, and described pulse generating module at least can produce frequency conversion stimulation pulse signal, and this frequency conversion stimulation pulse signal only wraps
The electric stimulation pulse string including three kinds of different frequencies alternately stimulates the multiple burst periods of formation;Wherein, this frequency conversion boost pulse letter
Number stimulus frequency determined by following steps:
Record primary frequency A that this patient uses constant frequency to stimulate;
Make this patient of impulse stimulation of pulse generator output constant frequency, and the subsidiary symptom recording this patient two kinds different obtains
To pulse frequency B improved1And B2;And
According to formula C=A2/B1It is calculated corresponding frequency C used, according to formula D=A2/B2It is calculated another correspondence to make
Frequency D, described frequency B, C, D are the stimulus frequency of the frequency conversion stimulation pulse signal of these three kinds of different frequencies.
A kind of electric pulse stimulation test system, comprising: electric pulse stimulation test device and a stimulating electrode, its
In, described electric pulse stimulation test device is that above-mentioned electric pulse stimulation such as tests any one in device.
Compared with prior art, electric pulse stimulation test device or the test system of the present invention stimulates by introducing frequency conversion
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 existing skill
The comparison diagram of the constant frequency stimulation pulse signal of art.
The first frequency conversion boost pulse letter that the implanted electric pulse stimulation system that Fig. 4 provides for the embodiment of the present invention produces
Number schematic diagram.
The second frequency conversion boost pulse letter that the implanted electric pulse stimulation system that Fig. 5 provides for the embodiment of the present invention produces
Number schematic diagram.
The third frequency conversion boost pulse letter that the implanted electric pulse stimulation system that Fig. 6 provides for the embodiment of the present invention produces
Number schematic diagram.
The 4th kind of frequency conversion boost pulse letter that the implanted electric pulse stimulation system that Fig. 7 provides for the embodiment of the present invention produces
Number schematic diagram.
The 5th kind of frequency conversion boost pulse letter that the implanted electric pulse stimulation system that Fig. 8 provides for the embodiment of the present invention produces
Number schematic diagram.
The first frequency sweep mould 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 formula.
The second frequency sweep 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 pattern.
The third frequency sweep 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 pattern.
4th kind of frequency sweep of the pulse generator of the implanted electric pulse stimulation system that Figure 12 provides for the embodiment of the present invention
The frequency-time graph of a relation of the electric stimulation pulse signal of pattern.
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, the implanted electric pulse stimulation system that the present invention is provided, electric pulse
Stimulate 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 that cardiac pacemaker, defibrillator, brain are deep
Portion's electrostimulator, 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.
Referring to Fig. 1-2, the embodiment of the present invention provides an implanted lesions located in deep brain device 10, comprising: one implants skin
Under pulse generator 11, one implants the stimulating electrode 12 of deep brain position, and one connects this stimulating electrode 12 and pulse generator 11
Extension lead 13, 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 by described extension lead 13 and stimulation
Electrode 12 is conducted to stimulation location to carry out stimulating regulation and control.Described vitro program controlled instrument 14 can be with the described wireless company of pulse generator 11
Connect, and change its electric pulse stimulation parameter.
Described stimulating electrode 12 tip has multiple contact, and after stimulating electrode 12 is implanted target position, and at least one
Individual contact contacts closely with stimulating target spot, with by suitable electricity irritation conduction to target spot, the disease for the treatment of nerve class.Can manage
Solving, described stimulating electrode 12 can be one or more according to stimulating needs, stimulates corresponding position, to ensure thorn
Swash effect.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 to this arteries and veins
Rush on generator 11.Only when the distance after described stimulating electrode 12 implants with this pulse generator 11 is bigger, just need
Extension lead 13 to be passed through connects.
Described pulse generator 11 is internal to be included: microprocessor module 111, power module 112 and wireless telecommunications
Module 113.It is electrically connected with between described microprocessor module 111, power module 112 and wireless communication module 113.Described micro-place
Reason device module 111 has the program editted, it is possible to produce different frequency, different pulse width, the electric stimulation pulse of different amplitude
Signal 15.The stimulus waveform of this electric stimulation pulse signal 15 is including but not limited to square wave, sine wave, exponential wave, triangular wave.Separately
Outward, described wireless communication module 113 and the wireless connections of described vitro program controlled instrument 14, thus permissible by described vitro program controlled instrument 14
Select the program of described microprocessor module 111, regulate program parameter, thus change the electric stimulation pulse signal 15 of output.Institute
State microprocessor module 111 and can include that one stimulates control module and a use for producing the constant frequency of constant frequency stimulation pulse signal
Control module is stimulated in the frequency conversion producing frequency conversion stimulation pulse signal.But, described microprocessor module 111 at least includes frequency conversion
Stimulate control module.Described constant frequency stimulates control module and frequency conversion to stimulate control module to be the integrated electricity storing certain procedures
Road, its structure does not limits, and those skilled in the art can design as required.Be appreciated that described constant frequency stimulate control module and
Frequency conversion stimulates 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.
Referring to Fig. 4-6, described frequency conversion stimulation pulse signal 150 includes the electric stimulation pulse string of at least two different frequency
152 alternately stimulate the multiple burst periods 151 of formation, and the electric stimulation pulse string 152 of each frequency is in each burst periods
In 151, duration is 0.1 second ~ 60 minutes.Be appreciated that if the electric stimulation pulse string 152 of each frequency lasting time
Between 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, different frequency
Pulse is closely coupled, and effect has the biggest uncontrollability.And if electric stimulation pulse string 152 duration of each frequency
Oversize, such as, more than 60 minutes, single-frequency can be produced and adapt to by patient, and long-time stimulation easily makes patient produce stimulating
Adaptability, 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
It it 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
It it is 5 seconds ~ 30 seconds.Within this time period, both can guarantee that comprised frequency can produce sufficient effect to target cell, again
Can prevent 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, institute
The frequency stating 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, at more low frequency
Its motor symptoms is even made to deteriorate during rate.Constant frequency stimulus frequency used by clinic is good at 100 hertz effectiveness comparison, thus excellent
Select the field stimulation of 50 hertz ~ 150 hertz, ensureing to chief complaint effect or on the premise of improving cardinal symptom, simultaneously
Subsidiary symptom is improved.
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
Hereby ~ 120 hertz.
From the point of view of clinical data, the high frequency stimulation between 90 hertz ~ 400 hertz is conducive to disturbances in patients with Parkinson disease cardinal symptom
Improving, the stimulation of 10 ~ 90 hertz, beneficially dysarthria and gait freeze to wait the improvement of incidentally 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
Mesh makes regulation process more complicated in implementation process, can be by first using the impulse stimulation of a small amount of different frequency to patient
Regulate and control, determine whether this stimulation mode is adapted to by patient, and determine whether to improve towards more excellent direction.Further according to trouble
The reaction of person, suitably increases the quantity of different frequency, optimizes 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
Ground, the electric stimulation pulse string 152 of described different frequency time ratio in each burst periods 151 is more than 10%.More preferably
Ground, the electric stimulation pulse string 152 of described different frequency time ratio in each burst periods 151 is more than 30%.Because it is different
The pulse characteristics of 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, it is preferable that the electric stimulation pulse of described different frequency
152 times in each burst periods 151 of string, ratio was for 1/N, and wherein, N is the electric stimulation pulse string 152 of described different frequency
Number.Such as, when the number of the electric stimulation pulse string 152 of described different frequency is 2, the electricity irritation arteries and veins of described different frequency
The punching string 152 time ratios in each burst periods 151 are 50%.
The electric stimulation pulse string 152 of described different frequency in each burst periods 151 appearance order can be from
Low frequency is to high frequency, from high frequency to low frequency, it is also possible to occur with certain random manner, as long as guaranteeing in same burst periods
In 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.Described electric stimulation pulse
Frequency and the amplitude of string 152 are the most adjustable.According to current-mode, current amplitude size be 0 milliampere ~ 30 milliamperes adjustable, regulation
Precision 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.Enter
One step, 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 can
Adjust.
Specifically, referring to Fig. 3, the first frequency conversion stimulation pulse signal 150 that the present invention provides includes two kinds of different frequencies
The electric stimulation pulse string 152 of rate alternately stimulates and forms multiple burst periods 151, and the electric stimulation pulse string 152 of every kind of frequency
Time accounting is identical.Referring to Fig. 4, the second frequency conversion stimulation pulse signal 150 that the present invention provides includes two kinds of different frequencies
Electric stimulation pulse string 152 alternately stimulate and form multiple burst periods 151, and during the electric stimulation pulse string 152 of every kind of frequency
Between accounting different.Referring to Fig. 5, the first frequency conversion stimulation pulse signal 150 that the present invention provides includes three kinds of different frequencies
Electric stimulation pulse string 152 alternately stimulates and forms multiple burst periods 151, and electric stimulation pulse string 152 time of every kind of frequency
Accounting 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
Occur.That is, can be with separated in time between the electric stimulation pulse string 152 of adjacent two different frequencies.The plurality of train of pulse
Cycle 151 can occur continuously, it is also possible to is interrupted and occurs.That is, can also be spaced between adjacent two burst periods 151 certain
Time.Time interval 154 between the electric stimulation pulse string 152 of described adjacent two different frequencies and adjacent two trains of pulse
Time interval 154 between cycle 151 can be 0.01 second ~ 60 minutes.Preferably, the electricity thorn of described adjacent two different frequencies
The time interval 154 swashed between time interval 154 and adjacent two burst periods 151 between train of pulse 152 can be
0.01 second ~ 60 seconds.In one embodiment, this interval time is T/N, wherein, when T is the circulation of a burst periods 151
Between, N is the number of the electric stimulation pulse string 152 of different frequency.So technical ability ensures the effectiveness of interval time, between can guarantee that again
Interval is unlikely to too big, prevent excessive time interval cause stimulating invalid.
Further, the electric stimulation pulse string 152 of multiple experience stimulus frequency can also be stored in described pulse generator 11
Combination, it is adaptable to regular situation.This experience stimulus frequency electric stimulation pulse string 152 combination can be 50 hertz with 150 hertz,
60 hertz and 140 hertz, 70 hertz and 130 hertz, 80 hertz and 120 hertz, 90 hertz and 110 hertz, and every kind of frequency
The time accounting of electric stimulation pulse string 152 is 50%.The different frequencies of electric stimulation pulse string 152 combination of this experience stimulus frequency
The meansigma methods of rate is identical.The stimulating current value of multiple experience, example can also be stored in being appreciated that described pulse generator 11
As: 0.5 milliampere, 1 milliampere, 1.5 milliamperes, 2 milliamperes, 2.5 milliamperes.This stimulating current value can be 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, exist
Under normal operating conditions, 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%, stimulating current size is 1.5 milliamperes.
Further, described pulse generator 11 has frequency sweep function.This pulse generator is set by vitro program controlled instrument 14
After the sweep parameters of 11, this pulse generator 11 can carry out frequency sweep according to this parameter.Described pulse generator 11 introduced below
Different frequency sweep mode.
The first frequency sweep mode is single-frequency frequency sweep.In this single-frequency frequency sweep mode, when set swept frequency range as
F1min ~ F1max, frequency sweep precision is S1, and sweep time is T1, described pulse generator 11 will with F1min, F1min+S1,
F1min+2S1, F1min+3S1 ... F1min+nS1 and F1max exports an electric stimulation pulse string 152, and each electricity respectively
The persistent period of boost 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, preferably by 10 seconds ~
30 minutes adjustable.Such as, set swept frequency range as 50 hertz ~ 150 hertz, frequency sweep precision 10 hertz, single-frequency sweep time
10 seconds.Described pulse generator 11 will be respectively with 50 hertz, 60 hertz, 70 hertz, 80 hertz, 90 hertz, 100 hertz, 110 hertz
Hereby, 120 hertz, 130 hertz, 140 hertz and 150 hertz export an electric stimulation pulse string 152, and each electricity irritation arteries and veins respectively
Punching string 152 continues 10 seconds.Refer to Fig. 9, for the electricity of the first frequency sweep mode of the pulse generator that the embodiment of the present invention provides
The frequency-time graph of a relation of stimulation pulse signal, 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, works as setting
Swept frequency range is F2min ~ F2max, and frequency sweep precision is S2, and sweep time is T2, described pulse generator 11 will with F2min and
F2max, F2min+S2 and F2max-S2, F2min+2S2 and F2max-2S2 ... and F2min+nS2 and F2max-nS2 is respectively
The persistent period of alternately two electric stimulation pulse strings 152 of output, and each two electric stimulation pulse string 152 alternately output is T2, its
In, n is natural number, and n < (F2max-F2min)/2S2.It is appreciated that described sweep time, T2 should be each burst periods
The integral multiple of the persistent period of 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 was permissible
Be 5 seconds ~ 60 minutes adjustable, adjustable preferably by 30 seconds ~ 10 minutes.Such as, set 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 electricity irritation
Train of pulse 152 persistent period is 1 second.Described pulse generator 11 will with 50 hertz with 150 hertz, 60 hertz with 140 hertz, 70
Hertz and 130 hertz, 80 hertz and 120 hertz and 90 hertz alternately export two electric stimulation pulse strings respectively with 110 hertz
152 thus form 15 burst periods 151.Refer to Figure 10, for the second of the pulse generator that the embodiment of the present invention provides
Plant the frequency-time graph of a relation of the electric stimulation pulse signal of frequency sweep mode, wherein, n=2.
The third frequency sweep mode is multi-frequency alternate combinations frequency sweep.In this multi-frequency alternate combinations frequency sweep mode, work as setting
Reference frequency is Fb1 and Fb2, and swept frequency range is F3, and frequency sweep precision is S3, and sweep time is T3, and described pulse generator 11 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 and
Fb2-S3, Fb1 and Fb2-2S3 ... Fb1 and Fb2-nS3 alternately two electric stimulation pulse strings 152 of output, and each two electricity thorn
The persistent period swashing train of pulse 152 alternately output is T3, and wherein, n is natural number, and n=F3/S3.It is appreciated that described scanning
Time T3 should be the integral multiple of the persistent period of each burst periods 151, and swept frequency range be F3 be the whole of frequency sweep precision S3
Several times.Described reference frequency is that Fb1 and Fb2 can select according to actual needs, and usual described reference frequency is that Fb1 and Fb2 exists
Between 60 hertz ~ 120 hertz.Described swept frequency range F3 can select between 1 hertz ~ 20 hertz, preferably F3 5 hertz ~
Select between 10 hertz.Described frequency sweep precision S3 can be 1 hertz ~ 10 hertz adjustable, can preferably by 2 hertz ~ 5 hertz
Adjust.Described sweep time T3 can be 5 seconds ~ 60 minutes adjustable, adjustable preferably by 30 seconds ~ 10 minutes.Such as, benchmark is set
Frequency is 80 hertz and 100 hertz, swept frequency range is 10 hertz, frequency sweep precision 5 hertz, the scanning of every class frequency combined and alternatively time
Between 1 minute, the persistent period of each burst periods 151 is two electricity irritation arteries and veins in 3 seconds, and each burst periods 151
Punching 152 persistent period of string are respectively 1 second and 2 seconds.Described pulse generator 11 will be 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 alternately export two electric stimulation pulse strings 152 respectively thus are formed
20 burst periods 151.Refer to Figure 11, for the third frequency sweep mode of the pulse generator that the embodiment of the present invention provides
The frequency-time graph of a relation of electric stimulation pulse signal, wherein, F3=S3.
4th kind of frequency sweep mode is also multi-frequency alternate combinations frequency sweep.In this multi-frequency alternate combinations frequency sweep mode, when setting
Determining reference frequency is Fb1 and Fb2, and swept frequency range is F3, and frequency sweep precision is S3, and 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
With 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
The persistent period of alternately two electric stimulation pulse strings 152 of output, and each two electric stimulation pulse string 152 alternately output is T3, its
In, n is natural number, and n=F3/S3.It is appreciated that described 4th kind of frequency sweep mode and the above-mentioned basic phase of the third frequency sweep mode
With, it is distinguished as: in the third frequency sweep mode, and when in Fb1 and Fb2 changes, another holding is constant;And the 4th kind
In frequency sweep mode, when in Fb1 and Fb2 changes, another can also change.Such as, reference frequency is set as 80 hertz
Hereby with 105 hertz, swept frequency range be 10 hertz, frequency sweep precision 5 hertz, every class frequency combined and alternatively scanning 1 minute time, often
The persistent period of individual burst periods 151 is that two the electric stimulation pulse strings 152 in 3 seconds, and each burst periods 151 continue
Time is respectively 2 seconds and 1 second.Described pulse generator 11 will with 80 hertz and 105 hertz, 85 hertz and 110 hertz, 90 hertz
With 115 hertz, 75 hertz and 100 hertz, 70 hertz and 95 hertz, 85 hertz and 100 hertz, 90 hertz and 95 hertz, 75 hertz
Hereby with 110 hertz, 70 hertz and 115 hertz alternately export two electric stimulation pulse strings 152 respectively thus form 20 trains of pulse
Cycle 151.Refer to Figure 12, for the electric stimulation pulse of the 4th kind of frequency sweep mode of the pulse generator that the embodiment of the present invention provides
The frequency-time graph of a relation of signal, 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: one
Testing in vitro stimulator 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 test device for electric pulse stimulation.
During use, stimulating electrode 12 is implanted, by one end of described test lead 23 by this test cable 22 with
Described testing in vitro stimulator 21 electrically connects, and 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 by described test cable 22, test lead 23 and stimulation electricity
Pole 12 is conducted to stimulation location and carries out stimulating regulation and control.If patient is suitable for electronic stimulation, then this stimulating electrode implanted
12 without taking out.
Being appreciated that described test cable 22 is an optional element, described test lead 23 can also be directly connected to this
On 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 real with described test cable 22 or stimulating electrode 12
Now electrically connect.During owing to using, described test lead 23 can be in partial insertion organism, therefore, described test lead 23 at least with
The part that stimulating electrode 12 connects uses biocompatible materials to prepare.Preferably, described test lead 23 all uses biology
Prepared by compatibility material.
Described testing in vitro stimulator 21 includes an external pulse generating module 210.Described pulse generating module 210 is with upper
State above-mentioned pulse generator 11 structure identical.Specifically, described pulse generating module 210 includes a microprocessor module 211,
Power module 212 and a control module 213.Described microprocessor module 211, power module 212 and control module 213 it
Between be electrically connected with.Described microprocessor module 211 has the program editted, it is possible to produce different frequency, distinct pulse widths, different width
The electric stimulation pulse signal 15 of value.Described control module 213 includes display, input keyboard etc..By described control module 213
The program of described microprocessor module 211 can be selected, regulate program parameter, thus change the electric stimulation pulse signal of output
15.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 change that above-mentioned pulse generator 11 produces
Frequently stimulation pulse signal.Further, referring to Fig. 9-12, described pulse generating module 210 also has above-mentioned pulse generator 11
Frequency sweep function.The electric pulse stimulation test system 10 of the present invention, by introducing frequency conversion stimulation pulse signal, may be used for test
Patient treats if appropriate for employing frequency conversion stimulation pulse signal.
The present invention further provides a kind of method using above-mentioned frequency conversion stimulation pulse signal that target nerve is stimulated,
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 remember
Record primary frequency A that this patient uses constant frequency to stimulate.Generally, different patients use what constant frequency stimulated normally to make
By frequency for determining value.Then, utilize vitro program controlled instrument 14 that the pulse generator 11 of patient is controlled, be allowed to export constant
The pulse of frequency, observes 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 obtains with subsidiary symptom
Improve frequency B geometrical mean be primary frequency A.Described frequency B and frequency C are this frequency conversion boost pulse letter
Number stimulus frequency.
It is appreciated that if patient attaches two or more subsidiary symptom, can be respectively according to said method and public affairs
Formula obtains frequency C of corresponding use, D etc..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 a pair
Frequency C that should use.That is, frequency C that this correspondence uses and subsidiary improved frequency B of symptom arithmetic mean of instantaneous value be just
Often use frequency A.
Method three, the patient treated for using electric pulse stimulation to carry out first.Utilize vitro program controlled instrument 14 to patient's
Pulse generator 11 is controlled, and makes this pulse generator 11 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.Use constant frequency stimulation to carry out stimulation and find patient
The improved pulse frequency of symptom requires a very short time, and 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 patient's different symptoms obtain
Pulse frequency B of improvement, C, D ....Described frequency B, C, D etc. are the stimulus frequency of this frequency conversion stimulation pulse signal.
Further, use stimulus frequency B and C of the alternately stimulation pulse signal that said method obtains to the stimulation of patient also
Non-is optimum.The present invention can on the basis of B and C frequency, by the pattern of the third multi-frequency alternate combinations frequency sweep above-mentioned
Carry out frequency sweep, to obtain stimulus frequency B and C of optimum.
In described step S20, can first set the time of electric stimulation pulse of different frequency than for 1/N, wherein, N is institute
State the number of the electric stimulation pulse of different frequency.Being appreciated that can be according to actual needs to this frequency conversion stimulation pulse signal
Parameter is mediated.Such as, if certain symptom is improved inconspicuous, then corresponding increase the stimulus frequency corresponding with this symptom time
Between accounting, reduce the time accounting of stimulus frequency corresponding to other symptoms, until make patient symptom improve reach equilibrium.
In existing stimulus modelity, stimulus waveform is that the constant frequency of upper frequency stimulates, and this constant frequency is to patient
Symptom have an improvement, but inevitably attach some ill symptomses, and patient easily this constant frequency is stimulated produce suitable
Ying Xing.The present invention is by introducing frequency conversion stimulation pulse signal, under ensureing effect of stimulation premise to patient, it is possible to improve or
Eliminate 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 it
The symptom such as tremble, health is stiff.But, in prior art, subthalamic nuclei is stimulated the stimulation to constant frequency.For a long time
Stimulation after, some patients can produce gait freeze, dysarthria, the subsidiary symptom such as unusual fluctuation.It addition, long-time single-frequency
Stimulate, such as 100 hertz, make patient easily this stimulation be produced adaptability, be similar to patient's adaptability to medicine, stimulate effect
Fruit is deteriorated.
In some clinical cases, frequency conversion stimulus modelity is used for treating disturbances in patients with Parkinson disease.Clinical research shows variable-frequency electric
Stimulation can improve the motor symptoms of parkinson, as trembled or/and health is stiff, while improve the non-athletic disease of parkinson
Shape, 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 change
Frequently stimulating system for relevant Other diseases such as the myodystonia of motion, and to cognition, psychological relevant nervous system disease
Such as depression, addiction etc., there is good curative effect.
The present invention has been used to improve subsidiary symptom and the adaptation that disturbances in patients with Parkinson disease causes due to long term constant frequency stimulation
Property.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.This patient X's is normal
Using frequency A 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.Use 60 hertz and
The frequency conversion stimulation pulse signal of 130 hertz carries out stimulation therapy to patient X.The time accounting setting two kinds of frequencies is 50%, often
The electric stimulation pulse string of individual frequency duration in each burst periods is 10 seconds.Through stimulation after a while, see
Examining 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 to stimulate and frequency conversion by common constant frequency
Stimulate the sounding effect contrast obtained.
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 patient Y under the constant frequency of 130 hertz stimulates
Body rigidity symptom be significantly improved, and the gait of patient Y is freezed symptom and is obtained one under the constant frequency of 80 hertz stimulates
Fixed improvement.
The frequency conversion stimulation pulse signal using 130 hertz and 80 hertz carries out stimulation therapy to patient Y.Set two kinds of frequencies
Time accounting be 50%, the electric stimulation pulse string of each frequency duration in each burst periods is 20 seconds.See
Examine 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 frozen
Knot and body rigidity are all significantly improved.
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.By patient
Stimulus frequency be reduced to 60Hz, i.e. left side frequency 60Hz, amplitude 2.7V, pulse width 60 μ s;Right side frequency 60Hz, amplitude
The constant frequency of 1.7V, pulse width 60 μ s stimulates, and this patient's gait is freezed symptom and improved substantially, but stiff severity of symptoms.It is adjusted to
The Frequency of 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 thorn of 30s
Swash.The spasticity of patient be improved significantly, and gait freeze symptom be improved significantly.Before the following is patient's frequency conversion stimulation
Rear gait evaluation table.
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 stimulates compares constant frequency stimulation, patient's start-up time, the dead time of turning significantly reduces, step
State freeze be improved significantly.
It addition, those skilled in the art can also do other changes in spirit of the present invention, these are according to present invention spirit
The change done, all should be included in scope of the present invention.
Claims (10)
1. an electric pulse stimulation test device, it is practically applicable to use constant frequency to stimulate one period and subsidiary bad disease
The patient of shape, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes that a pulse is sent out
Raw module, described pulse generating module at least can produce frequency conversion stimulation pulse signal, this frequency conversion stimulation pulse signal include to
The electric stimulation pulse string of few two kinds of different frequencies alternately stimulates and forms multiple burst periods, and the electric stimulation pulse of each frequency
String duration in each burst periods is 0.1 second ~ 60 minutes;It is characterized in that, this frequency conversion stimulation pulse signal
Stimulus frequency is determined by following steps:
Record primary frequency A that this patient uses constant frequency to stimulate;
Make this patient of impulse stimulation of pulse generator output constant frequency, and record the subsidiary improved arteries and veins of symptom of this patient
Rush frequency B;And
According to formula C=A2/ B is calculated corresponding frequency C used, and described frequency B and frequency C are this frequency conversion boost pulse
The stimulus frequency of signal.
2. electric pulse stimulation test device as claimed in claim 1, it is characterised in that the electric stimulation pulse string of each frequency exists
In each burst periods, duration is 0.1 second ~ 30 minutes;Preferably, the electric stimulation pulse string of each frequency is each
In burst periods, duration is 3 seconds ~ 60 seconds;It is highly preferred that the electric stimulation pulse string of each frequency is at each train of pulse
In cycle, duration is 5 seconds ~ 30 seconds.
3. electric pulse stimulation test device as claimed in claim 1, it is characterised in that the frequency of described electric stimulation pulse string is
10 hertz ~ 400 hertz;Preferably, the frequency of described electric stimulation pulse string is 30 hertz ~ 250 hertz;It is highly preferred that described electricity
The frequency of boost pulse string is 50 hertz ~ 150 hertz.
4. electric pulse stimulation test device as claimed in claim 1, it is characterised in that the electric stimulation pulse of described different frequency
The number of string is N, and 2≤N < 10, and the time ratio that the electric stimulation pulse string of described different frequency is in each burst periods
More than 5%.
5. electric pulse stimulation test device as claimed in claim 1, it is characterised in that the electricity irritation arteries and veins string of described different frequency
Between time interval between separated in time, and the electric stimulation pulse string of adjacent two different frequencies be 0.01 second ~ 60 points
Clock;Or time interval between separated in time, and adjacent two burst periods is between the plurality of burst periods
0.01 second ~ 60 minutes.
6. electric pulse stimulation test device as claimed in claim 1, it is characterised in that going out of each cycle moderate stimulation train of pulse
Now order is for be reached from little by frequency, or occurs from big to small or at random.
7. electric pulse stimulation test device as claimed in claim 1, it is characterised in that the frequency of described electric stimulation pulse string and
Amplitude is the most adjustable;Or the frequency of described electric stimulation pulse string and pulse width the most adjustable.
8. an electric pulse stimulation test device, it is practically applicable to use constant frequency to stimulate one period and subsidiary bad disease
The patient of shape, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes that a pulse is sent out
Raw module, described pulse generating module at least can produce frequency conversion stimulation pulse signal;It is characterized in that, this frequency conversion boost pulse
The stimulus frequency of signal is determined by following steps:
Record primary frequency A that this patient uses constant frequency to stimulate;
Make this patient of impulse stimulation of pulse generator output constant frequency, and record the subsidiary improved arteries and veins of symptom of this patient
Rush frequency B;And
According to formula C=A2/ B is calculated corresponding frequency C used, and described frequency B and frequency C are this frequency conversion boost pulse
The stimulus frequency of signal.
9. an electric pulse stimulation test device, it is practically applicable to use constant frequency to stimulate one period and subsidiary bad disease
The patient of shape, comprising: external testing stimulus device and a test lead, and this testing in vitro stimulator includes that a pulse is sent out
Raw module, described pulse generating module at least can produce frequency conversion stimulation pulse signal, and this frequency conversion stimulation pulse signal only includes
The electric stimulation pulse string of three kinds of different frequencies 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:
Record primary frequency A that this patient uses constant frequency to stimulate;
Make this patient of impulse stimulation of pulse generator output constant frequency, and the subsidiary symptom recording this patient two kinds different obtains
To pulse frequency B improved1And B2;And
According to formula C=A2/B1It is calculated corresponding frequency C used, according to formula D=A2/B2It is calculated another correspondence to make
Frequency D, described frequency B, C, D are the stimulus frequency of the frequency conversion stimulation pulse signal of these three kinds of different frequencies.
10. an electric pulse stimulation test system, comprising: electric pulse stimulation test device and a stimulating electrode, it is special
Levying and be, described electric pulse stimulation test device is in the electric pulse stimulation test device as described in the claims 1 to 9
Any one.
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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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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 |
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US5836994A (en) * | 1997-04-30 | 1998-11-17 | Medtronic, Inc. | Method and apparatus for electrical stimulation of the gastrointestinal tract |
US7024247B2 (en) * | 2001-10-15 | 2006-04-04 | Northstar Neuroscience, Inc. | Systems and methods for reducing the likelihood of inducing collateral neural activity during neural stimulation threshold test procedures |
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US8825164B2 (en) * | 2010-06-11 | 2014-09-02 | Enteromedics Inc. | Neural modulation devices and methods |
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