Reaction type nerve electric stimulation system and feedback thereof
Technical field
The present invention relates to the implantable nerve electric stimulation, especially a kind of reaction type nerve electric stimulation system and the feedback thereof that can regulate output as required automatically.
Background technology
Nerve electric stimulation has important effect in maladjusted nervous system treatment and nerve injury rehabilitation.The implantable nerve electric stimulation through in human body such as nervus motorius, sensorineural specific neural place implant electrode, discharge high-frequency electrical stimulation, so that specific nerve is stimulated, thereby make function of human body return to the state of normal operation.
At present; The implantable nerve electric stimulation mainly comprises and is used to treat the implanted brain deep electricity irritation (DBS with typical motion obstruction type diseases such as parkinson disease; Be commonly called as brain pacemaker); The implanted cortex stimulates (CNS); Implanted spinal cord stimulation trial system (SCS); Implanted sacral nerves electric stimulation (SNS), implanted vagus nerve electric stimulation (VNS) or the like.
Known implantable nerve electric stimulation mainly comprises pulse generator, electrode, extension wire and control device usually.Wherein, pulse generator is connected with extension wire, extension wire and then be connected to electrode again, thereby with burst transmissions that pulse generator produced to electrode, so that nerve is carried out electricity irritation.
Nerve electric stimulation system does not in the market all have feedback control function automatically.With the brain pacemaker is example, and its impulse stimulation output relies on the predefined formula of doctor fully and carries out open loop control.Many cases clinical medicine data show that can alleviate or eliminate by symptom when sleeping soundly night for dyskinetic disease patient (especially parkinson patient), originally can stop fully stimulating to reduce the unnecessary power consumption of pacemaker.And existing system for want of detects and feedback automatically, stimulation can not be provided automatically as required, thereby waste the suitable energy content of battery, and the life-span of pacemaker is had a greatly reduced quality.
In order to address the above problem, to have occurred dependence patient itself in the prior art and reached " as required " and stimulate and then reach the method for purpose of saving through using Magnet or patient's controller that pacemaker is initiatively carried out on-off control.Yet these means obviously can only could effectively be used when patient is in waking state, can't operate when sleeping soundly.
In addition, another measure is to set set time in night section (as sleeping soundly the time period) by the doctor to shut down function automatically to reach purpose of saving.But this method supposition patient daily life is rule very, lacks motility, just in case patient gets up and go to toilet or wake up for some reason midnight, and pacemaker is in off-mode, then can bring beyond thought trouble to patient.
Chinese patent 200580031533.5 is employed in patient an acceleration movement pick off is installed on one's body in addition; System judges through this motion perceptron whether patient is in morbidity state and then regulates stimulating output to carry out switch, has increased extra awareness tool and is not that closed loop is controlled automatically.
Summary of the invention
To the deficiency that exists in the prior art, the technical problem that the present invention will solve provides a kind ofly utilizes existing electrode to detect automatically to judge user whether to be in the deep sleep and the reaction type nerve electric stimulation system of the output pulse signal of automatic regulating impulse generator as required.
According to technical scheme provided by the present invention, a kind of reaction type nerve electric stimulation system, comprise pulse generator, with the electrode that said pulse generator is connected, said pulse generator comprises:
Electrode is selected control unit, and said electrode selects the input of control unit to be connected with existing one or more pairs of electrode contacts of nerve electric stimulation system;
The A/D converting unit, the input of said A/D converting unit selects the outfan of control unit to be connected with said electrode;
Be used to extract, judge the signal processing unit of deep sleep's characteristic, the input of said signal processing unit is connected with the outfan of said A/D converting unit;
Output control unit, the input of said output control unit is connected with the outfan of said signal processing unit;
The outfan of said output control unit and said electrode are selected another input of control unit formation feedback circuit that is connected;
Said electrode is imported described electrode again through described electrode switch control unit, A/D converter, signal processing unit, output control unit successively as the electroneurographic signal of signal gathering unit collection and is selected control unit to form feedback circuit; Judge user when said signal processing unit and be in deep sleep following time that said output control unit weakens or the output pulse signal of stop pulse generator automatically.
Preferably; Said reaction type nerve electric stimulation system is implanted brain deep electric stimulation, implanted cortex stimulating system, implanted spinal cord stimulation trial system, implanted sacral nerves electric stimulation or implanted vagus nerve electric stimulation, through electrode implant into body different parts is treated different diseases.
Preferably, the deep sleep that extracts of said signal processing unit is characterized as the wave character that brain wave waveshape signal or this waveshape signal under numerous crowds or the given patient deep sleep are derived.
Preferably, the deep sleep of said signal processing unit extraction is characterized as the brain wave spectrum signature signal under numerous crowds or the given patient deep sleep.
Preferably, said electrode selects to be provided with between control unit and the A/D converting unit that the signal of telecommunication that is used for said electrode collection amplifies, the signal condition unit of filtering.
Preferably; Described pulse generator has " the sleep self feed back starts " and " the sleep self feed back is closed " at least two mode of operations; When described pulse generator was in " the sleep self feed back starts " mode of operation, said electrode selection control unit selection electrode contacts was as signal input part self-timing sampling electroneurographic signal and form feedback circuit; When described pulse generator was in " the sleep self feed back is closed " mode of operation, said electrode selected control unit to select electrode contacts only as signal output part target spot to be carried out electric-impulse stimulation.User can select whether to open sleep self feed back function through " sleep self feed back " parameter setting of program controller.
Preferably; The brain wave waveshape signal under preset numerous crowds of described signal processing unit or the given patient deep sleep or the wave character of being derived by this waveshape signal be as basic waveform or foundation characteristic, and the brain wave waveshape signal that collects when said electrode contacts and the matching degree of said basic waveform or foundation characteristic judge that then user is in deep sleep during greater than preset value.
Preferably, the preset brain wave spectrum signature scope of described signal processing unit is 1~15HZ, judges that then user is in deep sleep when the brain wave spectrum signature that collects when said electrode contacts is between 1~15HZ.
Preferably, judge user when said signal processing unit and be not in deep sleep following time that the conventional output pulse signal of pulse generator is kept or recovered automatically to said output control unit.
Another technical problem that the present invention will solve provides a kind of feedback that can regulate the reaction type nerve electric stimulation system that stimulates output as required automatically, comprises the steps:
A: existing one or more pairs of electrode contacts are as signal gathering unit self-timing sampling electroneurographic signal in the use nerve electric stimulation system;
B: through signal processing unit one or more groups sampling electroneurographic signal of above-mentioned acquisition is handled extraction deep sleep characteristic, judge whether user is in deep sleep;
C: the outfan of said signal processing unit is connected with the input of pulse signal output control unit;
D: with the outfan of the said pulse signal output control unit formation feedback control loop that is connected with said one or more pairs of electrode contacts; When said signal processing unit judged that user is in deep sleep, said pulse signal output control unit weakened or stops output pulse signal automatically; When judging that user is not in deep sleep following time, the conventional output pulse signal of pulse generator is kept or recovered automatically to said pulse signal output control unit.
Preferably, also comprise in the said steps A to one or more pairs of electrode contacts select to control, to the step of sampled signal amplification, filtering, A/D conversion.
Preferably; In said nerve electric stimulation system, be preset with at least two mode of operations of " the sleep self feed back starts " and " the sleep self feed back is closed ", the step of " the sleep self feed back startup " mode of operation of judging in addition whether this nerve electric stimulation system is in before the said steps A.
Preferably, the electroneurographic signal of said one or more pairs of electrode contacts collections is an eeg signal.
Preferably, the deep sleep that extracts of the said signal processing unit wave character that is characterized as the brain wave waveshape signal under numerous crowds or the given patient deep sleep or derives by this waveshape signal.
Preferably, the deep sleep of said signal processing unit extraction is characterized as the brain wave spectrum signature signal under numerous crowds or the given patient deep sleep.
Preferably; The brain wave waveshape signal under preset numerous crowds of described signal processing unit or the given patient deep sleep or the wave character of being derived by this waveshape signal be as basic waveform or foundation characteristic, and the brain wave waveshape signal that collects when said electrode contacts and the matching degree of said basic waveform or foundation characteristic judge that then user is in deep sleep during greater than preset value.
Preferably, the preset brain wave spectrum signature scope of described signal processing unit is 1~15HZ, judges that then user is in deep sleep when the brain wave spectrum signature that collects when said electrode contacts is between 1~15HZ.
Advantage compared with prior art of the present invention is: because the present invention has utilized one or more pairs of electrode contacts of having implanted to gather electroneurographic signal as signal gathering unit; And the output pulse signal of the automatic clamp-pulse generator of formation closed loop; Need not increase extra awareness tool, not need manual intervention can reach the purpose of carrying out nerve electric stimulation automatically as required; Reduced patients such as dyskinetic disease when sleeping soundly night because of remission or eliminate and originally can stop to stimulate the power consumption of waste fully, thereby prolonged the service life of nerve electric stimulation system greatly.
Description of drawings
Accompanying drawing 1 is module principle figure of the present invention;
Accompanying drawing 2 is the module principle figure of pulse generator of the present invention;
Accompanying drawing 3 is a feedback control program flow diagram of the present invention;
Wherein:
1, pulse generator; 2, power supply; 3, electrode; 4, electrode is selected control unit; 5, signal condition unit; 6, A/D converting unit; 7, signal processing unit; 8, control output unit.
The specific embodiment
Below in conjunction with accompanying drawing the present invention is done further detailed explanation:
With reference to Fig. 1, reaction type implantable neural electric stimulation of the present invention mainly comprises pulse generator 1, the electrode 3 that implants, and is positioned at external control device.Pulse generator 1 is electrically connected with electrode 3, thereby the burst transmissions that pulse generator 1 is produced is arrived electrode 3, so that neuronal target is carried out electricity irritation, reaches the effect of treatment.Electrode 3 has many to the contact, for example 4 pairs, can select control unit 4 to select one or more pairs of electrode contacts as input or output through electrode.
With reference to Fig. 2; A kind of reaction type nerve electric stimulation system; For example can be implanted brain deep electric stimulation, implanted cortex stimulating system, implanted spinal cord stimulation trial system, implanted sacral nerves electric stimulation or implanted vagus nerve electric stimulation; Comprise the pulse generator 1 of implant into body, the electrode 3 that is electrically connected with pulse generator 1; Pulse generator 1 comprises the power supply 2 that electrode is selected control unit 4, signal condition unit 5, A/D converting unit 6, signal processing unit 7, output control unit 8 and supplied power for the said units module, wherein:
Electrode selects the input of control unit 4 to be connected with existing one or more pairs of electrode contacts of nerve electric stimulation system, and the multi channel selecting switching controls is carried out in the one or more pairs of contacts that are used on the counter electrode 3.
The input of signal condition unit 5 and electrode select the outfan of control unit 4 to be connected, be used for to the electroneurographic signal that said electrode 3 is gathered amplify, filtering.
The input of A/D converting unit 6 is connected with the outfan of signal condition unit 5, is used for the neuroelectricity analog signal conversion that electrode 3 is gathered is become digital signal.
The input of signal processing unit 7 is connected with the outfan of said A/D converting unit 6, is used for extracting, judging deep sleep's characteristic.
For implanted brain deep electric stimulation and implanted cortex stimulating system; Because electrode inserts brain deep or cortex; The human nerve signal of telecommunication of one or more pairs of electrode contacts collections is an eeg signal; Deep sleep's characteristic that signal processing unit 7 extracts can be brain wave waveshape signal or brain wave spectrum signature signal under numerous crowds or the given patient deep sleep, can extract above-mentioned deep sleep's characteristic through a series of signal Processing Algorithm such as FFT computing, wavelet transformation etc. by signal processing unit.
The input of output control unit 8 is connected with the outfan of said signal processing unit 7, is used for regulating automatically according to the output of signal processing unit 7 amplitude, pulsewidth, the frequency of output pulse;
The outfan of output control unit 8 and said electrode are selected another input of control unit 4 formation feedback circuit that is connected, thereby realize regulating automatically according to the needs of user the size of output pulse.
The present invention adopts the electrode of having implanted as signal gathering unit, the neuroelectricity input signal of gathering is imported described electrode through electrode switch control unit 4, signal condition unit 5, A/D converter 6, signal processing unit 7, output control unit 8 successively again select control unit 4 to form feedback circuit.Judge user when said signal processing unit 7 and be in deep sleep following time that said output control unit 8 weakens or the output pulse signal of stop pulse generator automatically.Judge user when said signal processing unit 7 and be not in deep sleep following time, the conventional output pulse signal of pulse generator 1 is kept or recovered automatically to said output control unit 8.
Pulse generator 1 has at least two mode of operations of " sleep self feed back start " and " the sleep self feed back is closed ", can realize above-mentioned pattern switching through being positioned at the parameter setting that external program controller paired pulses generator 1 sleeps self feed back.When this parameter is made as " opening "; Be that described pulse generator 1 is when being in " sleep self feed back start " mode of operation; Said electrode selection control unit 4 selection electrode contacts are as signal input part self-timing sampling electroneurographic signal and form feedback circuit, thereby start above-mentioned automatic feedback output regulatory function.At this moment, it can be identical with the output electrode contact that electrode is selected control unit 4 selected input electrode contacts or part is identical, also can be different electrode contacts.When this parameter is made as " pass "; Be that described pulse generator 1 is when being in " sleep self feed back cut out " mode of operation; Said electrode selects control unit 4 to select electrode contacts only as signal output part target spot to be carried out electric-impulse stimulation; Then close above-mentioned automatic feedback output regulatory function, to adapt to different patients' demand.
Particularly; For implanted brain deep electric stimulation and implanted cortex stimulating system; Signal processing unit 7 is when judging whether user is in deep sleep; Can be through the brain wave waveshape signal under preset numerous crowds or the given patient deep sleep as basic waveform, the brain wave waveshape signal that collects when said electrode contacts and the matching degree of said basic waveform judge that then user is in deep sleep during greater than preset value (for example 80%).Perhaps, through at the preset brain wave spectral ranges of signal processing unit 7,1~15HZ for example judges that then user is in deep sleep when the brain wave spectrum signature that collects when said electrode contacts is between 1~15HZ.
A kind of feedback that can be applicable to reaction type nerve electric stimulation systems such as implanted brain deep electric stimulation, implanted cortex stimulating system, implanted spinal cord stimulation trial system, implanted sacral nerves electric stimulation or implanted vagus nerve electric stimulation comprises the steps:
A: use in the nerve electric stimulation system existing one or more pairs of electrode contacts as signal gathering unit self-timing sampling electroneurographic signal, and to one or more pairs of electrode contacts select control, to sampled signal amplification, filtering, A/D conversion;
B: through signal processing unit one or more groups sampling electroneurographic signal of above-mentioned acquisition is handled extraction deep sleep characteristic, and judge whether user is in deep sleep;
C: the outfan of said signal processing unit is connected with the input of pulse signal output control unit;
D: with the outfan of the said pulse signal output control formation feedback control loop that is connected with said electrode selection control unit; When said signal processing unit judged that user is in deep sleep, said pulse signal output control unit weakened or the output pulse signal of stop pulse generator automatically; When judging that user is not in deep sleep following time, the conventional output pulse signal of pulse generator is kept or recovered automatically to said pulse signal output control unit.
In the nerve electric stimulation system, be preset with at least two mode of operations of " sleep self feed back start " and " the sleep self feed back is closed ", the step of " the sleep self feed back startup " mode of operation of before said steps A, judging in addition whether this nerve electric stimulation system is in.
For implanted brain deep electric stimulation and implanted cortex stimulating system; The human nerve signal of telecommunication of one or more pairs of electrode contacts collections is an eeg signal, and deep sleep's characteristic that the signal processing unit of this feedback extracts can be the brain wave waveshape signal under numerous crowds or the given patient deep sleep, the wave character or the brain wave spectrum signature signal of being derived by this waveshape signal.
Signal processing unit in step B is judged when whether user is in deep sleep; The wave character that can derive through the brain wave waveshape signal under preset numerous crowds or the given patient deep sleep or by this waveshape signal is as basic waveform or foundation characteristic, and the brain wave waveshape signal that collects when said electrode contacts and the matching degree of said basic waveform or foundation characteristic judge that then user is in deep sleep during greater than preset value (for example 80%).Perhaps, through at the preset brain wave spectral range of signal processing unit, 1~15HZ for example judges that then user is in deep sleep when the brain wave spectrum signature that collects when said electrode contacts is between 1~15HZ.
Fig. 3 is a feedback control program flow diagram of the present invention, is carried out by the programme-control in the signal generator.First, the program automatically determines the "sleep self-feedback" mode is started, it is not activated to maintain or restore the normal pulse stimulation pattern, as has been started by the signal selection control unit 4 selects a pair of electrodes or as a brain wave signal contacts input feedback loop, and then set the appropriate gain of the amplifier in a signal generator and a signal processing unit to extract the filter characteristic features of deep sleep, the program control of one or more of the electrode contact to the sampling clock signal nerve, followed by an signal processing unit determines whether the sampling nerve signals deep sleep signal characteristics, such as judgment, then weaken or stop pulse stimulation output; such judgments not, to maintain or restore the normal pulse stimulation modes.
Compared with prior art; The present invention has utilized one or more pairs of electrode contacts of having implanted to gather electroneurographic signal as signal gathering unit; And the formation closed loop control can be carried out nerve electric stimulation according to the output pulse signal of the automatic regulating impulse generator of the actual needs of user; Need not increase extra awareness tool and not need manual intervention; Significantly reduced patients such as dyskinetic disease when sleeping soundly night because of remission or eliminate and originally can stop to stimulate the power consumption of waste fully, thereby prolonged the service life of nerve electric stimulation system greatly.
Above specific embodiments of the invention is described.Be illustrative for description of the invention among this paper, thereby scope of the present invention should not be limited to the above-mentioned specific embodiment.It will be apparent to one skilled in the art that and under the situation that does not break away from purport of the present invention or substitutive characteristics, the above-mentioned specific embodiment is carried out other distortion or change, also should be considered as protection scope of the present invention.