CN111013012A - A remote monitoring system for implantable devices - Google Patents
A remote monitoring system for implantable devices Download PDFInfo
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- CN111013012A CN111013012A CN201910234801.7A CN201910234801A CN111013012A CN 111013012 A CN111013012 A CN 111013012A CN 201910234801 A CN201910234801 A CN 201910234801A CN 111013012 A CN111013012 A CN 111013012A
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- 238000012544 monitoring process Methods 0.000 title claims abstract description 18
- 230000000638 stimulation Effects 0.000 claims abstract description 44
- 230000007613 environmental effect Effects 0.000 claims abstract description 26
- 210000005036 nerve Anatomy 0.000 claims abstract description 26
- 238000004891 communication Methods 0.000 claims abstract description 21
- 230000007383 nerve stimulation Effects 0.000 claims abstract description 4
- 238000012360 testing method Methods 0.000 claims description 42
- 238000000034 method Methods 0.000 claims description 12
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 7
- 239000008280 blood Substances 0.000 claims description 7
- 210000004369 blood Anatomy 0.000 claims description 7
- 229910052760 oxygen Inorganic materials 0.000 claims description 7
- 239000001301 oxygen Substances 0.000 claims description 7
- 230000001133 acceleration Effects 0.000 claims description 5
- 230000036772 blood pressure Effects 0.000 claims description 4
- 230000004936 stimulating effect Effects 0.000 claims description 3
- 230000008439 repair process Effects 0.000 abstract description 3
- 230000008929 regeneration Effects 0.000 abstract 1
- 238000011069 regeneration method Methods 0.000 abstract 1
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- 230000008569 process Effects 0.000 description 7
- 230000003750 conditioning effect Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
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- 230000002051 biphasic effect Effects 0.000 description 3
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- 208000028389 Nerve injury Diseases 0.000 description 1
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- 230000006378 damage Effects 0.000 description 1
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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
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
- A61N1/36139—Control systems using physiological parameters with automatic adjustment
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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
- A61N1/37211—Means for communicating with stimulators
- A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
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Abstract
The invention discloses a remote monitoring system of an implantable instrument, which consists of a wireless implantable nerve electrical stimulator, an intelligent physiological parameter acquisition unit, an intelligent environment parameter acquisition unit, a local central control unit, a local wireless communication module, a cloud storage system, a remote wireless communication module, a remote control center, a remote expert decision support system and a remote case database. The system of the invention utilizes the intelligent physiological parameter acquisition unit and the intelligent environmental parameter acquisition unit to acquire the feedback physiological parameter information of the tested object, completes the closed-loop electrical nerve stimulation of the tested object through the remote monitoring center, and utilizes the remote case database and the remote expert decision support system to apply the variable-parameter electrical stimulation waveform to the tested object, thereby realizing the repair or regeneration of the damaged nerve of the tested object.
Description
Technical Field
The invention relates to the technical field of biomedicine and information, in particular to a remote monitoring system for an implantable instrument.
Background
Parkinson's disease is a common degenerative disease of the nervous system in the middle-aged and elderly. The Parkinson's disease treatment method comprises a surgical damage operation method and a medicine method, and the medicine method has the defects that the medicine cannot prevent the development of the state of an illness, and needs to be taken for life, so that the treatment cost is high. A drawback of surgical lesioning is that the risk of surgery is high and there is an irreversible risk of brain tissue once it has been destroyed.
Rehabilitation therapy also has a certain effect on improving symptoms as an auxiliary treatment means for the Parkinson's disease, and can improve the life quality of patients. At present, the main rehabilitation treatment means is high, medium and low frequency electrical stimulation to treat pain of the Parkinson disease. At present, implantable nerve electrical stimulation and non-implantable nerve electrical stimulation are adopted as electrical stimulation, the non-implantable nerve electrical stimulation depends on external equipment, the equipment is generally placed in a rehabilitation hospital, and the treatment time cost is high. An implantable nerve stimulator is an electronic device for helping the functional recovery after nerve injury, and the function of the brain, muscle or nerve is recovered or adjusted by applying a certain degree of current pulse to stimulate target nerves, so that the biological function is recovered to be normal.
At present, an implanted nerve stimulator generally controls the generation of nerve stimulation signals through local equipment, directly applies standard electrical stimulation signals to a test object, and does not acquire physiological signals fed back by the test object to perform closed-loop stimulation on the test object, so that the electrical stimulation process is an open-loop mode, the control means is inflexible, the stimulation effect is not obvious, the application of the electrical stimulation signals depends heavily on personal experience knowledge of testers, and the implanted nerve stimulator has the defect of certain one-sidedness. On the other hand, when the processor program in the current implantable neural stimulator is upgraded, most situations need to perform secondary operation on the test object to upgrade the test object, so that the life quality of the test object is poor.
Disclosure of Invention
The invention aims to provide a remote monitoring system of an implantable instrument, which can remotely and dynamically adjust the electric stimulation waveform applied to a tested object by collecting the physiological parameter information and the environmental parameter information of the tested object, combining a remote expert decision support system and a remote case database and utilizing a wireless communication technology, thereby improving the electric stimulation effect.
A remote monitoring system of an implantable instrument comprises a testing device and a remote monitoring center;
the testing device consists of a wireless implanted nerve electrical stimulator, an intelligent physiological parameter acquisition unit, an intelligent environmental parameter acquisition unit, a local central control unit and a local wireless communication module which are arranged on a test object;
the remote monitoring center consists of a cloud storage system, a remote wireless communication module, a remote control center, a remote expert decision support system and a remote case database.
The wireless implantable nerve electrical stimulator is implanted in the body of the tested object, is used for electrically stimulating the tested object and is communicated with the local central control unit in a wireless mode.
The intelligent physiological parameter acquisition unit and the intelligent environmental parameter acquisition unit are arranged outside the tested object, belong to portable wearable equipment, are used for acquiring physiological parameter information and environmental parameter information of the tested object, and are communicated with the local central control unit in a wireless mode.
The physiological parameter information includes electrocardiogram, blood pressure, blood oxygen saturation and other medically describable parameter information.
The environmental parameter information comprises temperature, humidity and acceleration.
The wireless mode is Bluetooth, Zigbee and other modules capable of realizing wireless transmission.
The local central control unit sends the physiological parameter information and the environmental parameter information to a remote monitoring center in a wireless mode through a local wireless communication module.
The remote control center receives physiological parameter information and environment parameter information of a test object through a remote wireless communication module, searches a remote case database through the Internet and accesses a remote expert decision support system to generate an optimal electric stimulation scheme of the test object, stores the physiological parameter information, the environment parameter information and the corresponding electric stimulation scheme of the test object in a cloud storage system, sends the optimal electric stimulation scheme of the test object to a wireless implanted nerve electric stimulator in the test object through a remote wireless communication module, feeds the physiological parameter information and the environment parameter information back to the remote control center at certain intervals, and dynamically adjusts the electric stimulation scheme of the test object through the remote case database and the remote expert decision support system according to the fed-back information, thereby completing the closed loop electrical nerve stimulation of the subject.
The invention has the beneficial effects that: the invention realizes the remote dynamic adjustment of the electrical stimulation waveform applied to the test object by collecting the physiological parameter information (such as electrocardiogram, blood pressure and blood oxygen saturation) and the environment parameter information of the tested object, combining a remote expert decision support system and a remote case database and utilizing the wireless communication technology, thereby improving the effect of electrical stimulation and being widely applied to the biomedical frontier technical fields of nerve repair, spine repair, limb movement recovery, human brain control artificial limbs and the like. Meanwhile, the program of the wireless implantable nerve electrical stimulator is upgraded for the second time in a wireless mode by using the program online upgrading principle, so that the pain of secondary operation required by upgrading the program is avoided, and the flexibility of the equipment is improved.
Drawings
Fig. 1 is a general block diagram of a remote monitoring system for an implantable device according to the present invention.
Fig. 2 is a flow chart of a remote monitoring system for an implantable device of the present invention.
Fig. 3 is a structural block diagram of a wireless implanted nerve electrical stimulator.
Fig. 4 is a waveform diagram of electrical stimulation commonly used by a wireless implanted neural electrical stimulator.
Fig. 5 is a schematic structural diagram of an intelligent environmental parameter acquisition unit.
Fig. 6 is a schematic structural diagram of an intelligent physiological parameter acquisition unit.
Detailed Description
Specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings, but it should be understood that the scope of the present invention is not limited to the specific embodiments.
Fig. 1 is a general block diagram of a remote monitoring system of an implantable device, which includes a wireless implantable neural electrical stimulator, an intelligent physiological parameter acquisition unit, an intelligent environmental parameter acquisition unit, a local central control unit, a local wireless communication module, a cloud storage system, a remote wireless communication module, a remote control center, a remote expert decision support system and a remote case database, all of which are installed on a test subject. The wireless implantable nerve electrical stimulator is implanted in the body of the tested object and is used for electrically stimulating the tested object; the intelligent physiological parameter acquisition unit and the intelligent environmental parameter acquisition unit are installed outside a tested object and belong to portable wearable equipment. The communication mode among the wireless implanted nerve electrical stimulator, the intelligent physiological parameter acquisition unit, the intelligent environmental parameter acquisition unit and the local central control unit is Zigbee or Bluetooth. The wireless communication mode of the test object and the remote monitoring center is 4G mobile communication.
Fig. 2 is a flow chart of a remote monitoring system of an implanted device, and the working flow of the device is as follows:
(1) after the wireless implantable nerve electrical stimulator is powered on, firstly, whether the equipment is under-voltage or not is detected, when the equipment is under-voltage, the equipment enters a wireless charging process, and when the equipment is charged, the equipment enters a normal process;
(2) in a normal working process, when a local parameter command of a local central control unit is not received, the intelligent physiological parameter acquisition unit, the intelligent environment parameter acquisition unit and the wireless implanted nerve electrical stimulator on the test object are in a low power consumption mode; when a local parameter command of a local central control unit is received, an intelligent physiological parameter acquisition unit on a test object enters a physiological parameter acquisition process to acquire physiological parameter information (such as an electrocardiogram, blood pressure and blood oxygen saturation) of the test object, meanwhile, an intelligent environmental parameter acquisition unit enters an environmental parameter acquisition process to acquire environmental information (such as temperature, humidity and acceleration information) of the test object, after the information acquisition is completed, the local central control unit starts a local physiological parameter and environmental parameter wireless transmission process by controlling a local wireless communication module, the acquired physiological parameter and environmental parameter are sent to a remote monitoring center by 4G mobile communication, the remote monitoring center stores the physiological parameter and environmental parameter information in a cloud storage system after receiving the physiological parameter and environmental parameter information, and then searches a remote case database by a special local area network and accesses a decision support system to search for an optimal electrical stimulation scheme, if the physiological parameters of the tested object are abnormal, the remote control center sends the optimal electrical stimulation scheme to the local central control unit on the tested object through the encrypted wireless communication system.
(3) The local central control unit on the test object sends the electrical stimulation scheme to the wireless implantable neural electrical stimulator to complete the electrical stimulation of the test object, meanwhile, the intelligent physiological parameter acquisition unit continuously acquires the physiological parameter information of the test object and sends the physiological parameter information to the remote monitoring center in a wireless mode, and the remote monitoring center dynamically adjusts the electrical stimulation scheme according to the physiological parameter information fed back by the test object.
Fig. 3 is a structural block diagram of a wireless implanted nerve electrical stimulator, which consists of a wireless communication unit, a program online upgrading unit, a power supply unit, a microcontroller, a boosting unit, a DAC module, a constant current source unit and a stimulation current output unit. The microcontroller can be realized by using a single chip microcomputer, a DSP or an FPGA, in order to realize the dynamically changeable electrical stimulation waveform, the characteristic of the FPGA dynamically programmable changing circuit structure is combined, the realization of controlling the DAC module and the analog circuit by using the FPGA is preferentially recommended, the waveform information to be generated is written into an internal memory of the FPGA, and then the DAC module and the analog circuit are driven to realize the stimulation waveform with changeable parameters. The power supply unit has wireless chargeable capability, and the program online upgrading unit can upgrade the program of the microprocessor in a wireless mode, so that the pain that the wireless implanted nerve electrical stimulator structure needs secondary operation for charging and upgrading the program is avoided, and the flexibility of the device is improved. The constant current source unit can ensure that the output current keeps unchanged when the resistance of the stimulation part changes.
Fig. 4 is a diagram of an electrical stimulation waveform commonly used by a wireless implanted neural electrical stimulator, which mainly comprises a monophasic pulse type electrical stimulation waveform, a monophasic triangle wave type electrical stimulation waveform and a biphasic trapezoidal waveform stimulation waveform. The main parameters of the monophasic pulse type electrical stimulation waveform pulse are t1, t2 and t3, which respectively represent the high-level pulse width, the pulse period and the pulse application interval time of the pulse. The main parameters of the monophasic triangular wave type electrical stimulation waveform are Ta, Tb, Tc and Td, which respectively represent the rising process duration of the triangular wave, the total duration of the triangular wave, the period of the triangular wave and the application interval time of the triangular wave. The main parameters of the biphasic trapezoidal wave electrical stimulation waveform are a, b, c, d, e, f, g and h, and mainly represent the rising edge time, the maximum value time, the falling edge time, the rising edge time, the minimum value time, the rising edge time and the interval time of the biphasic trapezoidal wave application. The main parameter information of the three electrical stimulation oscillograms is encrypted and sent to the wireless implanted nerve electrical stimulator by the remote monitoring center in a 4G mobile communication mode. It should be noted that the electrical stimulation waveform diagrams of the present invention are not limited to the three waveforms.
Fig. 5 is a schematic structural diagram of an intelligent environmental parameter acquisition unit. The intelligent environment parameter acquisition unit can analyze the influence of the external environment on the electrical stimulation effect and adjust the electrical stimulation by acquiring the environment information of the test object. The intelligent environment parameter acquisition unit consists of a temperature sensor, a humidity sensor, an acceleration sensor, an analog multi-way switch, a signal conditioning unit, a digital potentiometer, a low-power consumption hybrid single chip microcomputer and a Bluetooth module. The analog multi-way switch sequentially collects temperature, humidity and acceleration information under the control of the low-power consumption hybrid single chip microcomputer and then transmits the information to the signal conditioning unit, the signal conditioning unit completes filtering, amplification and range conversion of a sensor signal and then sends the information to an internal AD (analog-to-digital) unit of the low-power consumption hybrid single chip microcomputer, and then the signal after AD conversion is sent to a local central control unit on a test object through the Bluetooth module. The low-power consumption hybrid single chip microcomputer controls the digital potentiometer to dynamically adjust parameters of the signal conditioning unit (such as cut-off frequency, amplification factor, bandwidth and the like of a filter in the signal conditioning unit).
Fig. 6 is a schematic structural diagram of an intelligent physiological parameter acquisition unit. The intelligent physiological parameter acquisition unit belongs to intelligent wearable equipment, the circuit structure of the intelligent physiological parameter acquisition unit is similar to that of the intelligent environment parameter acquisition unit, and the circuit structure of the intelligent physiological parameter acquisition unit is illustrated in fig. 6 by taking the acquisition of the blood oxygen saturation as an example, and the difference is only that the parameters acquired by the sensors are different. The blood oxygen saturation can reflect the physiological state of the respiratory system and the circulatory system of the human body, and has important clinical significance. The oxyhemoglobin saturation acquisition intelligent acquisition unit consists of a constant current source driving circuit, an adjustable light source, an optical signal receiver, a low-power consumption single chip microcomputer and a Bluetooth module. The low-power-consumption single chip microcomputer drives the adjustable light source to generate two alternate light waves to irradiate the skin of the body surface of the test object through the internal DAC, signals reflected by the blood vessels are converted through the photoelectric receiver and then are input to the low-power-consumption single chip microcomputer, the low-power-consumption single chip microcomputer obtains light intensity signals attenuated by the tissue of the test object according to the digital pulse signals, therefore, the blood oxygen saturation information is resolved, and then the light intensity signals are sent to a local central control unit on the test object through the Bluetooth module.
It will be appreciated by those of ordinary skill in the art that the examples described herein are intended to assist the reader in understanding the manner in which the invention is practiced, and it is to be understood that the scope of the invention is not limited to such specifically recited statements and examples. Those skilled in the art can make various other specific changes and combinations based on the teachings of the present invention without departing from the spirit of the invention, and these changes and combinations are within the scope of the invention.
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