CN1817382A - Closed-loop blood-pressure adjusting method with chip inplanted and system thereof - Google Patents
Closed-loop blood-pressure adjusting method with chip inplanted and system thereof Download PDFInfo
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Abstract
A chip implanted closed-loop blood pressure control method and system features that after a microprocessor chip is implanted in human body, its blood pressure sensor can acquire the arterial blood pressure signal and the electric stimulation with the intensity relative to said arterial blood pressure signal is output via electrode to act on the lead-in nerve channel. Said stimulation intensity is dynamically regulated by the chip to form a closed-loop negative feedback regulation, so controlling the blood pressure in a predefined range.
Description
Technical field
The present invention relates to the method that electricity irritation acts on the afferent pathway of baroreceptor reflex, especially closed-loop blood-pressure adjusting method with chip inplanted and system.
Background technology
Built-in type device and implanted chip system: implanted method and device (Implanted MedicalDevice) are for medical diagnosis or therapeutic purposes and device or device in " for a long time " implant into body, its volume is less, good with the biological tissue compatibility, special function is arranged.All the time, the research of relevant implantable medical device all is the research focus of biomedical engineering field.Implanted chip system (Implanted ChipSystem) belongs to a kind of of implantable medical device.The core of implanted chip system is little process chip, it is except that the characteristics that possess the implantable medical device, still has automatic control function, can participate in body physiological regulation, can and the host between carry out information exchange, finish the information storage function and can with external upper machine communication, carry out uploading and down operation of information.Generally be the afferent pathway that acts on susceptibility by electricity irritation, the achievement in research of a lot of implanted chips has fundamentally been upgraded the basic conception of clinical treatment.
The chip implant system that is used for the comparative maturity of clinical treatment at present has NCP (the Neural Cybernetic Prosthesis System) system of the insulin pump of treatment diabetes, treatment epilepsy, the cochlear implant of treatment nerve deafness etc., these implanted chip systems have all been obtained satisfied curative effect in process of clinical application, fundamentally changed the understanding of the past people to the disease treatment pattern.In addition, also developed a kind of identification and therapeutic medical implanted chip Verichip of being used for recently abroad, formally be used for clinical experiment by drugs approved by FDA.Yet, still do not develop the implanted chip system that is used for finally reaching blood pressure regulating so far.The core of implanted chip system is little process chip, it is except that the characteristics that possess other implantable medical devices, still has automatic control function, can participate in body physiological regulation, can and the host between carry out information exchange, finish the information storage function and can with external upper machine communication, carry out uploading and down operation of information.
Insulin pump is the microelectromechanicdevices devices of a kind of normal person's of simulation B cell according to friction speed lasting uelralante in body, and its core is the numerical controlled machinery pump of little process chip control.Adopting insulin pump treatment diabetes mainly is insulin expense every day that diet, motion, blood glucose fluctuation level according to the patient are judged, evenly import as basal dose with 40%～50% of total amount, the insulin of remainder is in before the meal by the interim infusion of keying.By the accurate quantification administration of insulin pump, the glycemic control that can avoid conventional subcutaneous intramuscular injection insulin to cause is not steady, the adverse effect that property hyperglycemia or hypoglycemia etc. may cause life danger is crossed in appearance one.
The NCP system is a kind of implanted chip system that is used for nerve stimulation.The application that NCP is the most successful is to treat epilepsy by vagus nerve stimulation.Electrophysiologic study shows that epilepsy is because cerebral cortex neuron pool paroxysmal over-discharge causes, this discharge is a kind of unusual synchronization discharge.Vagus nerve stimulation can make cortex electrical activity desynchronization, so vagus nerve stimulation can produce antiepileptic effect.The NCP system by being loaded with stimulation programs in subcutaneous implantation chip one pulse generator and at cervical region implantable stimulation electrode, by the effect of vagus nerve stimulation performance treatment epilepsy.
Although the implanted chip system has been used to the various clinical treatment of diseases, do not see relevant report so far both at home and abroad yet yet be used for the treatment of hypertensive implanted chip system.On the one hand, because the regulatory mechanism of blood pressure is very complicated, and the past is unclear fully yet to pathogenesis of hypertension, and the principle design difficulty of implanted chip system is very big; On the other hand, aforementionedly be used for clinical implantable chip system such as insulin pump, NCP etc. and be open cycle system, chip system can only carry out the function replacement treatment of traditional sense to body, in good time, the dynamic regulation of blood pressure under the similar body physiological state can't be finished, thereby controlling blood pressure can't be used for.Referring to Mussalo H, Vanninen E, Ikaheimo R, Laitinen T, Laakso M, Lansimies E.Baroreflex sensitivity in essential and secondary hypertension. (the baroreflex sensitivity of constitutional and secondary hypertension) Clin Auton Res 2002; 12:465-71; Borgonio A, Pummer S, Witte K.Reduced baroreflex sensitivity and blunted endogenous nitric oxide synthesisprecede the development of hypertension in TRG (mREN2) 27 rats. (TRG (mREN2) 27 rat baroreflex sensitivity reduce and nitric oxide is synthetic suppresses early than hypertensive formation); Yi Weijun, Zhu cloud of travelling, Luo Yunzhang, Lv Jianfeng, in towering, Jia Fengtao. the development of insulin pump and progress. health care equipment, 2004; 25 (7): 29-31.
CN86103049 is the implantable nerve stimulator of a kind of multichannel, comprise a conveyer, one implantable receptor and the method that above-mentioned conveyer is coupled to above-mentioned receptor, above-mentioned receptor comprises a plurality of output channels of receiving implantation person's nerve, above-mentioned receptor comprises with one pole or bipolar fashion, perhaps alternately looks for above-mentioned each passage simultaneously to stimulate above-mentioned nerve with analog form.
CN03810835.6 is to the method and system of nerve stimulation, this implant comprise preferred orientation near or away from the ramose sampling of carotid sinus nerve and the impulse stimulation electrode of the nervus glossopharyngeus of carotid sinus baroreceptor.Stimulator has an external control unit, and the mutual communication of this control unit and implant also is used for determining appropriate operational parameters, and be used for giving self registering information again for change from the data base of this device.Usually implant two internal devices at patient's cervical region, each one of every side.System is a kind of cardiovascular function system of carrying out nerve stimulation for the control live body, and it comprises: a pulse generator that is used to produce the pulse electrical signal of variable output frequency, and described pulse generator comprises: a Neural stimulation electrodes; One first is led, and is used for described pulse electrical signal is transferred to described Neural stimulation electrodes; One first communication interface is used to accept external control signal, and described output frequency responds to described control signal; Wherein said output frequency is in the field of activity of pressure receptor.
Essential hypertension at China's sickness rate up to 11.88%, yet its pathogenesis is still unclear so far.Drug therapy is the topmost means of present controlling blood pressure, but Drug therapy easily produces a lot of side effect, and drug resistance may occur.Therefore exploring hypertensive non-drug therapy remains one key subjects to be solved is arranged.The development and the exploitation of the medical chip of various implantables have become the research focus of current biomedical engineering field.The achievement in research of a lot of implanted chips has fundamentally been upgraded the basic conception of clinical treatment, enters the practical stage at present.Yet can use the close loop negative feedback technology treats hypertensive implanted chip and there is no report so far both at home and abroad.
Summary of the invention
The present invention seeks to: closed-loop blood-pressure adjusting method with chip inplanted and system provide a kind of more rational regulating blood pressure method of control mode of stimulus intensity.Make full use of chip and possessed certain autonomous regulatory function, the mode that adopts closed-loop adjustment to arteriotony carry out in good time, dynamic regulation accurately.The implanted chip of the present invention exploitation is also progressively to the intelligent direction development, and open loop stimulation or medicine that chip system no longer is confined to body is carried out traditional sense substitute, but the treatment of a kind of physiology.Adopt the external radio-frequency power supply to solve the persistent problem that chip is implanted, adopt closed-loop fashion to solve the postural hypotension problem, adopt the synchronous stimulation mode of heartbeat to solve adaptability problem and make this invention become a kind of brand-new non-drug therapy method.
Technical solution of the present invention is: implanted chip blood pressure closed loop regulate and control method, the body interplantation is process chip sampling arterial blood pressure signal in a subtle way, chip will act on the afferent pathway (aortic nerve, hole nerve and carotid sinus) of baroreceptor reflex according to the electricity irritation (generally passing through electrode) that blood pressure signal is exported respective intensities, stimulate output with the close loop negative feedback mode adjusting.Chip will form close loop negative feedback and regulate according to the height dynamic adjustments resultant stimulus intensity of arteriotony.
The method of stimulus intensity of the present invention control can be: adopt the single boost pulse intensity of constant voltage pulsewidth restraining formula output control, i.e. and fixing output voltage, the pulsewidth by changing individual pulse is to regulate the energy intensity of individual pulse.
Chip will be provided with output pulse width according to the impedance of stimulating electrode, and the stimulation output intensity of individual pulse stimulates the intensity of output to be set in 2-3 threshold intensity doubly by the decision of pulsewidth degree size.
Chip obtains " difference " after the comparison after relatively with arterial pressure signal and inner artificial set point, again according to the comprehensive strength that should " difference " calculate out stimulation output.Artificial set point can dynamically arrange according to the needs of medical treatment, also can time dependent program control set point be set according to the biological cycle of blood pressure.
Chip is stored in the blood pressure signal of blood pressure trend curve and collection among the memorizer F1ash, can upload and download with outer machine at any time.
The set point algorithm of chip system is the sequence of boost pulse and the relation between the blood pressure, and resultant stimulus intensity is expressed by the sequence density of boost pulse.Relation between stimulating pulsatile series and the blood pressure is by the chip system inner setting.
The present invention can also adopt differential type to stimulate the mode of output, improves output voltage, reduces to stimulate pulsewidth, prevents instantaneous electrolytic lesion; The i.e. opposite pulse of output synchronously on two lead-out terminals of chip.
Implant part (handset) is charged pool not, and it is the implant part power supply that external part sees through skin by radio-frequency current, and inside and outside two parts can pass through the wireless mode communication, to upload the blood pressure signal that handset is gathered, download control information at any time.The peripheral circuit of implant part adopts the mode of moment power supply to work, and peripheral hardware is not powered at ordinary times, only moment power supply before each sampling, the determining that the pick off amplification system can be set up stable level when sampling and be as the criterion of power supply lead.The mastery routine of chip is after having finished initialization, and system enters resting state, and waiting timer wakes up.The work of all conventional operations is all finished in the intervalometer interruption routine, and the accounting for of work and sleep/empty is than 1: in the 100-2000 scope.
Stimulate the output set point: amplitude is 0.5-5.95V (interpolar), and ripple is wide to be 0.01～0.40mS.Between the instantaneous density of the sequence that stimulates and the heartbeat corresponding phase relation is arranged.
Implanted chip regulating blood pressure system is characterized in that comprising: the I implant part: a little process chip is used to gather blood pressure signal, generation pulsewidth, the pulse electrical signal that sequence is adjustable; Special-purpose stimulating electrode; Non-blood contact arteriotony sensing device; Radio-frequency (RF) energy receiving element and communication unit.The external part of II: radio frequency powered unit, communication unit and battery.
Adopt half embedding formula Neural stimulation electrodes, make olive-shaped support with insulant, vertically fluting makes in the neural embedded groove, forms 3/4 parcel.Lay platinum electrode in the groove, the electrode trend is vertical with nerve fiber.The groove inner surface is through polishing, and two ends are bell mouth shape.This design can prevent nerve injury, also avoids stimulating simultaneously other nerve that closes on.
The present invention finishes the acute experiment of implanted chip system regulation and control normal rabbits blood pressure:
The present invention at first is applied to normal rabbits with chip system, has carried out the regulating blood pressure of 15 minutes and 60 minutes respectively, with the controlling of blood pressure effect of this system of preliminary assessment.Experimental result shows that chip can stop to regulate and control the back blood pressure and recover rapidly with controlling of blood pressure in the artificial set point level of setting, and does not have obviously knock-on.In addition, the regulation and control of chip have also caused the decline of heart rate, also return to normal after regulation and control finish rapidly.
Finish the acute experiment of implanted chip system regulation and control Wistar rat blood pressure, and carried out the SHR regulating blood pressure experiment of small sample.
(1) chip system is applied to normal arterial pressure rats such as Wistar, SD, obtains and the similar experimental result of rabbit experiment, the prompting chip system can effectively be regulated and control the blood pressure of multiple animal.In the acute regulation and control test of the blood pressure of rat, this research is also studied the mechanism of chip blood pressure lowering.With the atropine pretreatment or cut off the heart rate that bilateral vagal nerve interruption chip regulation and control cause and reduce, chip still can maintain blood pressure the set point level of setting, and prompting chip regulation and control blood pressure does not mainly depend on the reduction heart rate.
(2) chip system is applied to SHR (spontaneous hypertensive rat) and carries out regulating blood pressure, completed experimental result display chip can effectively reduce the SHR blood pressure, and its concrete blood pressure lowering amplitude can realize by setting different artificial set points.
Characteristics of the present invention are: the set point theory binding isotherm achievement with forefathers is a foundation, has designed the closed loop implanted chip system that can correct set point skew, automatic controlling blood pressure; Carried out the zoopery of chip regulation and control blood pressures at last, preliminary assessment the antihypertensive effect of this chip system.Result of study shows, chip system can obtain stable, lasting antihypertensive effect, compare with Drug therapy, characteristics such as chip implanted treatment hypertension has immediately, dynamic regulation, and the antihypertensive effect of chip is that the blood pressure regulating function by body self realizes, therefore the side effect that Drug therapy causes can not occur.Because hypertensive sickness rate is very high, so the development of this chip system has huge potential using value for clinical treatment hypertension.And utilize updating of chip performance, by with self inner setting artificial set point compare, if actual blood pressure is higher than the setting value of chip, chip will be exported in the afferent pathway that electricity irritation acts on the excited baroreceptor reflex of aortic nerve, be used to bring high blood pressure down.Chip regulation and control back pressure value returns chip once more as input signal, forms negative feedback and regulates, and has successfully designed the closed loop implanted chip system of controlling blood pressure automatically, and relevant soft, the hardware testing of the system that finished.
The present invention has designed first first by research and practicably has been used for the closed loop implanted chip system of dynamic regulation blood pressure.The Biological Principles of chip design mainly according to forefathers' set point theory and in conjunction with the inventor to hypertension incidence Study on Mechanism achievement; Chip by the afferent pathway of activation pressure susceptibility reflection realizes mainly that to the regulation and control of blood pressure regulating blood pressure intensity realizes by the stimulus sequence density of adjusting chip output.This method is similar to normal human's regulating blood pressure mode, does not have drug-induced side effect.
Description of drawings
The biological method sketch map of Fig. 1 implanted chip system regulation and control of the present invention blood pressure.
The hardware configuration schematic diagram of Fig. 2 chip of the present invention.
The software workflow figure of Fig. 3 chip of the present invention.
The set point algorithm of Fig. 4 chip system of the present invention and stimulus intensity schematic diagram and testing in vitro result.
The specific embodiment
Fig. 1 medium-sized artery blood pressure signal is behind pressure transducer input chip system, chip compares the artificial set point of blood pressure signal and self inside, if actual blood pressure is higher than the setting value of chip, chip will be exported electricity irritation and act on the excited baroreceptor reflex of aortic nerve, bring high blood pressure down.Chip regulation and control back pressure value returns chip once more as input signal, forms negative feedback and regulates, finally can make chip finish to blood pressure in good time, dynamic regulation.
Shown in Figure 2: the core of chip system mainly is a msp430 super low-power consumption microprocessor, integrated modules such as amplifier, A/D converter, flash flash memory, stimulator on the chip, the peripheral hardware of chip system mainly contains power supply, miniature pressure transducer, stimulating electrode etc.
Shown in Figure 3, miniature pressure transducer is experienced arterial blood pressure signal, input chip after amplifier amplifies, chip with arterial pressure signal and inner artificial set point relatively after, the electricity irritation of output corresponding frequencies, act on body through stimulating electrode, reduce arteriotony, proofread and correct the deviation between blood pressure and the set point.The reduction degree of blood pressure is returned chip again and is formed feedback, forms closed-loop adjustment.In addition, chip is stored in the blood pressure signal of gathering among the Flash, can upload and download with outer machine at any time.
Fig. 4 A: stimulate the experimental algorithm (for testing goal algorithm cut-off line) between output and input blood pressure.The stimulus frequency that is used to regulate and control rat of chip system inner setting and the relation between the blood pressure.When MAP was equal to or less than 70mmHg, chip did not give any stimulation; As MAP during at 70～100mmHg, input MAP is linear with the frequency that output stimulates, and promptly MAP is high more, and the output stimulus frequency is big more, and the chip underpressure is big more.After MAP reached more than the 100mmHg, chip output stimulus frequency no longer increased.The final effect of this program setting makes rat MAP reduce to the level of a little higher than 70mmHg.
Fig. 4 B, outer actual stimulus frequency that records of chip body and the relation between the input pressure (n=7, r=0.9999, P＜0.001).Stimulate the actual measurement relation between output and input blood pressure can reach designing requirement fully.
The design and fabrication of implanted chip regulating blood pressure system:
Along with the continuous progress of microchip manufacturing technology, to implant and develop towards microminiaturized, programme-controlled, individuation direction gradually with chip, the external radio-frequency power supply has more solved the persistent problem that chip is implanted.Updating of chip performance also driven the associated biomolecule research that the implanted chip system is used.The field of implanted chip system clinical practice also enlarges day by day, develop the multiple classes such as the interior chip implantation of Detection ﹠ Controling, maincenter, sensory organ reparation, identification and artificial limb control that physical signs, we can say that the technology of implanted chip system treatment clinical disease is ripe relatively.In addition, the implanted chip of a new generation's exploitation also progressively develops to intelligent direction, chip system no longer is confined to body is carried out the function replacement treatment of traditional sense, the more important thing is that chip has possessed certain autonomous regulatory function, can carry out in good time body, dynamic regulation accurately.
Implanted chip controlling of blood pressure system:
Belong to closed loop chip system of new generation on the implanted chip controlling of blood pressure systemic-function of the present invention, different being with open loop type chip system maximum previously, it can finish the automatic control of blood pressure according to the program of artificial setting, and the body blood pressure is carried out in time, regulates and control dynamically.Blood pressure regulating pattern under this control methods and the body normal condition is very similar, therefore more near the physiological regulating control of human body, the complication that Drug therapy causes can not occur.Below will specifically introduce the design of chip system, the feasibility checking of chip regulation and control arteriotony is for hypertensive non-drug therapy provides new method.
The design of chip system
1, Biological Principles
Body self has the mechanism of the complete maintenance blood pressure stabilization of a cover, and wherein baroreceptor reflex is a most important mechanism of keeping blood pressure stabilization fast.Its pressure receptor can be experienced the information of blood pressure, passes to maincenter by nervus centripetalis; These represent the information of actual blood pressure to maincenter by analysis, compare with set point again, send the activity of control information regulation and control heart and blood vessel, proofread and correct departing from of blood pressure, thereby guarantee the needs of stablizing and meet body of blood pressure.The whole control system is with degenerative pattern work, and when promptly actual blood pressure was higher, by regulating the effect that produces blood pressure lowering, and blood pressure was when on the low side, and maincenter gos up blood pressure.This negative feedback regulatory mechanism of hyperpietic is suppressed, and shows as gain and descends, and set point raises.This implanted chip system promptly utilizes the original blood pressure regulating path of body to participate in the regulation and control of blood pressure.During native system work, the signal that to take from arteriotony is after amplifying, change into stimulus information according to certain algorithm again and be injected in the afferent pathway (ADN) of baroreceptor reflex, correct the set point that hypertension raises by the mode of setting up artificial set point, it on the effect set point downward modulation that makes baroreceptor reflex, gain improves, and controlling of blood pressure is in the scope (Fig. 1) of setting the most at last.
Resultant stimulus intensity is expressed by the sequence density of boost pulse; Chip system adopts the set point algorithm to obtain the pulse train of stimulus signal, and the height of the density of this sequence and arteriotony and set point is related.Stimulus intensity strong between daytime and night a little less than.Stimulate the output set point: amplitude is 0.5-5.95V (interpolar), and ripple is wide to be 0.01～0.40mS; Chip is stored in on-chip memory with the blood pressure signal and the compression of blood pressure trendgram of gathering, and can be by wireless mode and external host communication.
Between the instantaneous density of the sequence that stimulates and the heartbeat corresponding phase relation is arranged.It is higher to be typically when penetrating blood stimulating pulsatile series density.
2, electronics design, chip system are that the core structure forms with msp430 super low-power consumption microprocessor mainly, mainly finish work such as blood pressure collection, data analysis, stimulation output, data storage and external communication; On energy-saving design, adopt modes such as moment work, the preceding moment power supply of sampling, reduce system's power consumption; Improve differential amplifier circuit in addition, designed special anticoagulant blood pressure recording conduit.Chip soft, hardware testing is good.The hardware of chip system constitutes
Native system (model machine) is that example (but being not limited thereto model) super low-power consumption microprocessor is that the core structure forms with msp430, peripheral hardware mainly comprises micro pressure transducer, power supply, miniature implantable stimulating electrode etc., mainly finish the blood pressure collection, work such as data analysis, stimulation output, data storage and external communication.The hardware designs principle is seen Fig. 2.Implant not charged pool of chip part (handset), it is the implant part power supply that external part sees through skin by radio-frequency current, inside and outside two parts are by the wireless mode communication, (adopt carrier frequency serial communication mode) is to upload blood pressure signal that handset gathered at any time or to handset download control information (adopting 32 password codes checkings during data download).
The I implant part: a little process chip is used to gather blood pressure signal, generation amplitude, pulsewidth, the pulse electrical signal that sequence is adjustable; Special-purpose stimulating electrode; Non-blood contact arteriotony sensing device HU-3 type; Radio-frequency (RF) energy receiving element and radio communication unit; The external part of II: radio frequency powered unit, radio communication unit and power supply.The radio-frequency (RF) energy receiving element is made up of coupling element and radio frequency chip, and can adopt (1) French INSIDE company product is the scheme of 32KBit radio frequency chip or TIX's radio frequency chip.
3, the software design of chip system
Software design electricity core content comprises contents such as set point algorithm, stimulus intensity control and power save scheme, and software flow pattern is seen Fig. 3.Concrete set point algorithm, the stimulus intensity of chip mainly finished (Fig. 4 A) by the relation of setting input arteriotony and output stimulus frequency.During practical application, the relationship of the two is complicated, therefore claims the relation of the sequence density that arteriotony and output stimulate.This relation can be done the adjustment of individuation because of the dissimilar and state of an illness of disease.
4, save power source design
Prolong battery service life for saving power supply, implant part is saved the working method of power consumption.The peripheral circuit of implant part adopts the mode of moment power supply to work, and peripheral hardware is not powered at ordinary times, only moment power supply before each sampling, the determining that the pick off amplification system can be set up stable level when sampling and be as the criterion of power supply lead.The mastery routine of chip is after having finished initialization, and system enters resting state, and waiting timer wakes up; The work of all conventional operations is all finished in the intervalometer interruption routine, and the accounting for of work and sleep/empty is than 1: in the 100-2000 scope.
This program adopts the mode of moment work to move.Mastery routine is after having finished initialization, and system enters resting state (power consumption is about 6 μ A), and waiting timer wakes up.The work of all conventional operations is all finished in the intervalometer interruption routine, the accounting for of work and sleep/empty than minimum, and therefore average power consumption is minimum.Used diffuse si pick off needs externally fed to work, if continued power, then electric current is near 50mA, and power requirement is higher.Native system adopts the mode of the preceding moment power supply of sampling, and power consumption is reduced greatly.The power supply lead determine with when sampling the pick off amplification system can set up stable level and be as the criterion.Native system adopts built-in standard voltage source (secondary power supply) to be the pick off power supply, can guarantee that supply voltage is stable, and this is very important in portable or implanting device.
5, special differential amplifier circuit
Be to simplify circuit, guarantee that simultaneously symmetric first order input, higher common mode rejection ratio and less direct current are unbalance, native system has been done transformation to three amplifier schemes of classics.Adopt the double operational circuit, be aided with the difference amplification that few peripheral cell is finished sensor signal, calibration and zeroing realize with software.
6, pulsewidth restraining formula stimulates output
General stimulator adopts constant voltage or constant current mode output, and output intensity realizes in the mode of restraining output voltage or electric current.This restraining is actually stimulating the resistive composition of serial connection on the output loop, has consumed the part energy.Native system adopts pulsewidth restraining formula to stimulate output, makes output signal be operated on off state, and no resistive element on the output loop improves the power utilization rate.In this output mode, the stimulation output intensity of individual pulse is by the decision of pulsewidth degree size.According to the conclusion of electrophysiological research, stimulate the intensity of exporting should be set in 2 times threshold intensity (threshold intensity refers to cause the minimum stimulation intensity of tissue excitement), effective stimulation can be formed and waste of energy or nerve injury can be avoided again.And the influence of concrete threshold intensity irriate electrode and excited nerve position relation and body fluid environment also can change sometimes to a certain extent.
Native system adopts the mode of self-adapting type pulsewidth restraining to guarantee that stimulus intensity is in reasonable range.The information that modes such as stimulating loop external impedance and analysis effect of stimulation obtains electrode and neural mutual relation is measured in system's utilization.Be the electrolytic lesion that prevents to organize, the serial connection capacitor cuts off flip-flop in output circuit.Simultaneously, system has also adopted voltage-multiplying type to stimulate the mode of output, improves output voltage, reduces to stimulate pulsewidth, prevents instantaneous electrolytic lesion.The principle of multiplication of voltage output is the opposite pulse of output synchronously on two lead-out terminals of chip, and like this, when running voltage was 3V, making two interelectrode change in voltage was 6V.
7, biological Interface design
7..1 anti-blood coagulation design
Adopt non-blood contact blood pressure detection mode, under the sensor sensing spare implantable intravascular inner membrance, and the surface prevents blood coagulation coated with special material (anticoagulant 3# macromolecular material).
7.2 half embedding formula Neural stimulation electrodes
Make olive-shaped support with insulant, vertically fluting makes in the neural embedded groove, forms 3/4 parcel.Simultaneously, lay platinum electrode in the groove, the electrode trend is vertical with nerve fiber.The groove inner surface is through polishing, and two ends are bell mouth shape.This design can prevent nerve injury, also avoids stimulating simultaneously other nerve that closes on.
8, test and application
The complete machine power consumption average out to 12.23 μ A of system (the handset system voltage is 3V) stimulate output amplitude to be 5.95V (interpolar) to the maximum, and ripple is wide to be 0.01～0.40mS when the wide 0.08mS of ripple (can form effective stimulus usually).Chip can write down 24 hours blood pressure informations, and can be by wireless serial mode and outer machine communication, the output record data.
External software program test result to chip regulation and control blood pressure shows (Fig. 4 B), and chip system concerns work according to input blood pressure of setting and output stimulus frequency fully.Native system is applied to normal arterial pressure rabbit, normal arterial pressure rat and spontaneous hypertension rat all can effectively control arteriotony.
Claims (10)
1, closed-loop blood-pressure adjusting method with chip inplanted: it is characterized in that in body interplantation process chip in a subtle way, gather arterial blood pressure signal by pressure transducer, according to the electricity irritation of the blood pressure signal output respective intensities that is obtained, act on the afferent pathway of baroreceptor reflex by stimulating electrode; Chip will form close loop negative feedback and regulate according to the height dynamic adjustments resultant stimulus intensity of arteriotony, with the scope of controlling blood pressure in setting.
2, by the described closed-loop blood-pressure adjusting method with chip inplanted of claim 1, it is characterized in that special stimulus intensity control method: adopt the single boost pulse intensity of constant voltage pulsewidth restraining formula output control, i.e. fixing output voltage, the pulsewidth by changing individual pulse is to regulate the energy intensity of individual pulse; Chip is provided with output pulse width according to the impedance of stimulating electrode, and the stimulation output intensity of individual pulse stimulates the intensity of output to be set in 2-3 threshold intensity doubly by the decision of pulsewidth degree size.
3,, it is characterized in that adopting differential type to stimulate the mode of output, i.e. the opposite pulse of output synchronously on two lead-out terminals of chip by claim 1 or 2 described closed-loop blood-pressure adjusting method with chip inplanted; Improve effective stimulus voltage, reduce to stimulate pulsewidth can prevent the electrode reaction that produces electrolysis again.
4, by claim 1 or 2 described closed-loop blood-pressure adjusting method with chip inplanted, it is characterized in that chip obtains " difference " after the comparison after relatively with arterial pressure signal and inner artificial set point, again according to the comprehensive strength that should " difference " calculate out stimulation output; Artificial set point dynamically arranges as required, or according to the biological cycle of blood pressure, time dependent program control set point is set; Stimulus intensity strong between daytime and night a little less than.
5,, it is characterized in that of the sequence density expression of resultant stimulus intensity by boost pulse by claim 1 or 2 described closed-loop blood-pressure adjusting method with chip inplanted; Chip system adopts the set point algorithm to obtain the pulse train of stimulus signal, and the height of the density of this sequence and arteriotony and set point is related; Stimulate the output set point: amplitude is interpolar 0.5-5.95V, and ripple is wide to be 0.01～0.40mS; Between the instantaneous density of the sequence that stimulates and the heartbeat corresponding phase relation is arranged.
6, by claim 1 or 2 described closed-loop blood-pressure adjusting method with chip inplanted, it is characterized in that chip is stored in on-chip memory with the blood pressure signal and the compression of blood pressure trendgram of gathering, and can be by wireless mode and external host communication.
7, by the described closed-loop blood-pressure adjusting method with chip inplanted of claim 1, it is characterized in that implanting not charged pool of chip part, it is the implant part power supply that external part sees through skin by radio-frequency current, inside and outside two parts are by the wireless mode communication, to upload blood pressure signal that handset gathered at any time or to the handset download control information.
8, by the described closed-loop blood-pressure adjusting method with chip inplanted of claim 1, the working method that it is characterized in that implant part saving power consumption is: the peripheral circuit of implant part adopts the mode of moment power supply to work, peripheral hardware is not powered at ordinary times, only moment power supply before each sampling, the determining that the pick off amplification system can be set up stable level when sampling and be as the criterion of power supply lead; The mastery routine of chip is after having finished initialization, and system enters resting state, and waiting timer wakes up; The work of all conventional operations is all finished in the intervalometer interruption routine, and the accounting for of work and sleep/empty is than 1: in the 100-2000 scope.
9, implanted chip regulating blood pressure system is characterized in that comprising:
(1) implant part: a little process chip is used to gather blood pressure signal, generation pulsewidth, the pulse electrical signal that sequence is adjustable; Stimulating electrode; Non-blood contact arteriotony sensing device HU-3 type; Radio-frequency (RF) energy receiving element and radio communication unit; (2) external part: radio frequency powered unit, radio communication unit and power supply.
10, by the described implanted chip of claim 9 regulating blood pressure system, it is characterized in that stimulating electrode adopts half embedding formula Neural stimulation electrodes, make olive-shaped support with insulant, vertically fluting makes neural the embedding in the groove, forms 3/4 parcel; Lay platinum electrode in the groove, the electrode trend is vertical with nerve fiber; The groove inner surface is through polishing, and two ends are bell mouth shape.
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| CN101918076A (en) * | 2007-10-15 | 2010-12-15 | 国立大学法人九州大学 | Blood pressure stabilization system using transdermal stimulation |
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