CN112604157A - Nasal cavity nerve stimulation system - Google Patents

Nasal cavity nerve stimulation system Download PDF

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Publication number
CN112604157A
CN112604157A CN202011438558.XA CN202011438558A CN112604157A CN 112604157 A CN112604157 A CN 112604157A CN 202011438558 A CN202011438558 A CN 202011438558A CN 112604157 A CN112604157 A CN 112604157A
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China
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stimulation
module
voltage
unit
wireless communication
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CN202011438558.XA
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Chinese (zh)
Inventor
周雪华
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Hangzhou Jingcheng Medical Technology Co ltd
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Hangzhou Jingcheng Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0546Nasal electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • A61N1/36034Control systems specified by the stimulation parameters

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Otolaryngology (AREA)
  • Cardiology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

The invention discloses a nasal cavity nerve stimulation system.A logic control module is respectively connected with a power supply management module, a wireless communication module, a data storage module, a user interface module and a stimulation module, analyzes and processes signals received from the wireless communication module or the user interface module, and outputs control signals to the stimulation module; the stimulating electrode unit comprises a stimulating electrode and a stimulating contact, wherein the stimulating contact is provided with 2 contacts and is a good biocompatible conductor; and the stimulation module sets the stimulation parameters after receiving the control signal from the logic control module, generates stimulation pulses and outputs the stimulation pulses to the stimulation contacts through the stimulation electrodes. The invention generates controllable electric pulse stimulation signals through the nerve stimulator unit, transmits the signals to the target stimulation parts such as the nasal cavity and the like through the stimulation electrode unit, electrically stimulates the lacrimal gland nerves through the nasal cavity, and can be used for the electric stimulation treatment in the related fields such as xerophthalmia and the like.

Description

Nasal cavity nerve stimulation system
Technical Field
The invention belongs to the field of nerve stimulation, and relates to a nasal cavity nerve stimulation system.
Background
Dry eye, also known as keratoconjunctival xerosis, refers to a general term for a variety of diseases characterized by abnormal quality or quantity of tear fluid or abnormal kinetics, resulting in decreased tear film stability (tear film breakdown and formation of dry spots on the cornea) and associated ocular discomfort and/or ocular surface tissue pathology, caused by any cause, including aging, wearing contact lenses, certain medications, eye disease, other diseases or environmental factors, etc.
Due to the aging population and the change of eye habits caused by the popularization of electronic products, the prevalence rate of xerophthalmia is increased year by year, and about 7500 million of people suffering from xerophthalmia in China are the most common eye surface diseases at present. Although there are several drugs available clinically for the treatment of dry eye, most drugs are not satisfactorily effective. With the advance of technology, the treatment of dry eye is not limited to external eye drop treatment, and a large number of new drugs and devices are introduced in foreign markets, and the main treatment method is the use of artificial tears.
Disclosure of Invention
In order to achieve the purpose, the technical scheme of the invention is as follows: a nasal cavity nerve stimulation system comprises a nerve stimulator unit and a stimulation electrode unit which are connected with each other, wherein the nerve stimulator unit comprises a logic control module, a power supply management module, a wireless communication module, a data storage module, a user interface module and a stimulation module,
the logic control module is respectively connected with the power management module, the wireless communication module, the data storage module, the user interface module and the stimulation module, analyzes and processes signals received from the wireless communication module or the user interface module, and outputs control signals to the stimulation module;
the stimulation electrode unit comprises a stimulation electrode and a stimulation contact, wherein the stimulation contact is provided with 2 contacts and is a good biocompatible conductor;
the stimulation module sets stimulation parameters after receiving the control signal from the logic control module, generates stimulation pulses and outputs the stimulation pulses to the stimulation contacts through the stimulation electrodes;
the power management module comprises a low-voltage power supply, a battery and a stimulation high-voltage power supply, wherein the low-voltage power supply is used for generating voltage used by the digital circuit, and the stimulation high-voltage power supply supplies power to the stimulation module;
the data storage module stores stimulation related data;
the wireless communication module comprises a wireless communication circuit and an antenna and transmits stimulation data with external equipment.
Preferably, the logic control module comprises an MCU or an MPU or a DSP or an FPGA or an ASIC.
Preferably, the stimulation module comprises a voltage stimulation generation unit, a current stimulation generation unit and an output channel control unit, the voltage stimulation generation unit and the current stimulation generation unit are both connected with the output channel control unit, and the output of the output channel control unit is connected with the stimulation electrode.
Preferably, the user interface module comprises an indicator light, a key unit and a buzzer, and supports the user to adjust the stimulation intensity and feed back the state information to the user.
Preferably, the stimulation high-voltage power supply generates controllable voltage larger than 13V and supplies power to the voltage stimulation generation unit, the current stimulation generation unit and the output channel control unit.
Preferably, the amplitude range of the stimulation pulse of the voltage stimulation generation unit is 0V-13V, the stimulation voltage step size is greater than or equal to 50mV, and the stimulation parameters can be configured.
Preferably, the stimulation parameters comprise a stimulation pulse width of 50-500us, a stimulation pulse width step size of 10us or more, a stimulation frequency of 1-200Hz, a stimulation frequency step size of 1Hz or more, a biphasic positive and negative wave or monophasic wave and a stimulation duration of 1-5 min.
Preferably, the current stimulation range of the stimulation pulse generated by the current stimulation generating unit is 0-20mA, the stimulation current step size is 100uA, and the stimulation parameters can be configured.
Preferably, the stimulation parameters are configurable and comprise a stimulation pulse width of 50-500us, a stimulation pulse width step size of 10us or more, a stimulation frequency of 1-200Hz, a stimulation frequency step size of 1Hz or more, a biphasic positive and negative wave or monophasic wave and a stimulation duration of 1-5 min.
Preferably, the data storage module stores the stimulation parameters of the user and historical data, and the stimulation data is not lost when the power is cut off.
The invention relates to a hand-held nasal nerve stimulation device, which does not contain medicines or eye drops, can effectively promote the generation of tears, can restore the eye surface to a normal physiological state without eye drops or operation, and is suitable for most patients with insufficient tear secretion.
The hand-held nasal nerve stimulation device of the present invention can be provided with an intranasal stimulation electrode plug, and is inserted into the nasal cavity to stimulate the lacrimal gland to secrete natural tears by providing tiny pulse energy, so that the hand-held nasal nerve stimulation device is a novel method for patients with insufficient tear secretion. The mechanism is that nerve impulse is transmitted to lacrimal gland and meibomian gland by stimulating trigeminal nerve terminal in nasal cavity, and then the nerve impulse is stimulated to secrete water and grease, thereby achieving the stimulation effect. Several clinical studies conducted in a number of adult patients with aqueous deficient dry eye have shown that tear production can be temporarily increased safely and effectively.
Drawings
FIG. 1 is a block diagram of a nasal neurostimulation system according to an embodiment of the present invention;
FIG. 2 is a block diagram of a neurostimulator unit of the nasal neurostimulation system in accordance with an exemplary embodiment of the present invention;
FIG. 3 is a block diagram of a particular configuration of a neurostimulator unit of the nasal neurostimulation system in accordance with an embodiment of the present invention;
FIG. 4 is a block diagram of a stimulation generation portion of a stimulation module of the nasal neurostimulation system in accordance with an exemplary embodiment of the present invention;
FIG. 5 is a block diagram of a stimulation waveform generation portion of a stimulation module of the nasal neurostimulation system in accordance with an exemplary embodiment of the present invention;
FIG. 6 is a diagram of a positive and negative phase stimulation waveform for a nasal nerve stimulation system in accordance with an embodiment of the present invention;
fig. 7 is a monophasic stimulation waveform of a nasal neurostimulation system according to an embodiment of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
On the contrary, the invention is intended to cover alternatives, modifications, equivalents and alternatives which may be included within the spirit and scope of the invention as defined by the appended claims. Furthermore, in the following detailed description of the present invention, certain specific details are set forth in order to provide a better understanding of the present invention. It will be apparent to one skilled in the art that the present invention may be practiced without these specific details.
Referring to fig. 1-5, a structural block diagram of a nasal cavity neurostimulation system according to an embodiment of the present invention is shown, which includes a neurostimulator unit 10 and a stimulation electrode unit 20, which are connected to each other, wherein the neurostimulator unit 10 includes a logic control module 101, a power management module 102, a wireless communication module 103, a data storage module 104, a user interface module 105, and a stimulation module 106. Wherein,
the logic control module 101 includes but is not limited to an MCU, an MPU, a DSP, an FPGA, a CPLD, an ASIC, etc., and is respectively connected to the power management module 102, the wireless communication module 103, the data storage module 104, the user interface module 105, and the stimulation module 106, analyzes and processes a signal received from the wireless communication module 103 or from the user interface module 105, and outputs a control signal to the stimulation module 106; optionally, the logic control module 101 may be an MCU chip such as MSP430, PIC24, or the like.
The stimulation module 106 includes a voltage stimulation generation unit 116, a current stimulation generation unit 126, and an output channel control unit 136; the amplitude range of the stimulation pulse of the voltage stimulation generation unit 116 is 0V-13V, the step length of the stimulation voltage is more than or equal to 50mV, the stimulation parameters can be configured, and comprise a stimulation pulse width of 50-500us, a stimulation pulse width step length of more than or equal to 10us, a stimulation frequency of 1-200Hz, a stimulation frequency step length of more than or equal to 1Hz, a two-phase positive and negative wave/monophasic wave, a stimulation time of 1-5 minutes, a step length of 20s and the like; the current stimulation range of the stimulation pulse of the current stimulation generating unit 126 is 0-20mA., the stimulation current step length is 100uA, and the stimulation parameters can be configured, including the stimulation pulse width of 50-500us, the stimulation pulse width step length of more than or equal to 10us, the stimulation frequency of 1-200Hz, the stimulation frequency step length of more than or equal to 1Hz, the two-phase positive and negative wave/monophasic wave, the stimulation time length of 1-5 minutes, the step length of 20s and the like; after receiving the control signal from the logic control module 101, the stimulation module 106 sets the stimulation parameters to generate stimulation pulses, and outputs the stimulation pulses to the stimulation contact 202 through the stimulation electrode 201; the stimulation target is generally the upper part of the nasal cavity, the peripheral part of the lacrimal nerve. Alternatively, the stimulation target may be external to the nose, etc.
The data storage module 104 is used for storing the stimulation parameters and historical data of the user, and the stimulation data is not lost when the power is cut off. The data storage module 104 may be composed of digital circuits such as EEPROM, Flash, etc. Optionally, the data storage module 104 may also be integrated in the logic control module 101.
The wireless communication module 103 includes a wireless communication circuit 113 and an antenna 123 for transmitting stimulation information including, but not limited to, stimulation amplitude, stimulation frequency, stimulation pulse width, stimulation time length, etc. with other wireless devices such as mobile phones, computers, etc. Optionally, radio frequency communication modes such as bluetooth communication and WIFI may be adopted, and the wireless communication circuit 113 may be a bluetooth chip of companies such as TI and CSR.
The power management module 102 comprises a low voltage power supply 112, a battery 122 and a stimulation high voltage power supply 132, wherein the low voltage power supply 112 is used for generating voltages for digital circuits, and comprises a wireless communication circuit 113, a logic control module 101 and a buzzer 135, and the stimulation high voltage power supply 132 can generate controllable voltage larger than 13V to supply power to the voltage stimulation generation unit 116, the current stimulation generation unit 126 and the output channel control unit 136; the power management module 102 is composed of a DC-DC and LDO, and the typical voltage output by the low voltage power supply 112 is 3V.
The user interface module 105 includes an indicator 115, a key unit 125 and a buzzer 135, which are respectively connected to the logic control module 101, wherein the indicator 115 is used to indicate different stimulation intensities, states, etc., the key unit 125 is used to receive key information operated by a user, and the buzzer 135 is used to remind the user under certain conditions, such as key operation, stimulation start, stimulation completion, etc.
Fig. 4 illustrates a stimulation generation circuit of the nasal neurostimulation system in accordance with an embodiment of the present invention. The DAC 1161 with controllable output is controlled by the logic control module 101 to generate analog voltage with a certain magnitude, and the typical value is 0-2V. The analog voltage is amplified by the voltage amplifying circuit 1162 to generate a stimulus voltage of a given magnitude, typically 0-13V. The output controllable DAC 1161 is controlled by the logic control module 101 to generate an analog voltage of a certain magnitude, typically 0-2V, and a voltage-to-current unit 1262 is activated to convert the voltage generated by 1261 to a given current magnitude, typically 0-20mA. The output-controllable DAC 1161 may be a conventional DAC chip. Optionally, the output-controllable DAC 1161 may be integrated in the logic control module 101. The voltage amplifying circuit 1162 is a common operational amplifier forward circuit, and can be built by common operational amplifiers and resistors. The voltage-to-current unit 1262 may be a conventional voltage-to-current circuit or a current feedback circuit composed of an operational amplifier and a transistor.
Fig. 5 illustrates a stimulation waveform generation circuit of the nasal neurostimulation system according to an embodiment of the invention. Specifically, the voltage stimulus generation unit 116 and the current stimulus generation unit 126 are respectively connected to the forward channel 1361. The forward and reverse channels 1361 and 1362 connect to the stimulation target 1, while the other set of forward and reverse channels 1361 and 1362 connect to the stimulation target 2. The forward channel 1361 generates a stimulus voltage or stimulus current and the reverse stimulus channel is grounded to discharge the stimulus. A certain blocking capacitance can be arranged between the stimulation channel and the target point. By switching control of the forward and reverse channels 1361-1362, a desired stimulation waveform can be generated between stimulation target 1 and stimulation target 2.
Fig. 6 is a waveform diagram of positive and negative phase stimulation pulses of a nasal neurostimulation system according to an embodiment of the invention, and fig. 7 is a waveform diagram of monophasic stimulation pulses of a nasal neurostimulation system according to an embodiment of the invention. In the stimulation waveform generation circuit of fig. 4, if the forward path 1361 is opened during the positive half cycle of stimulation and the backward path 1362 is opened during the discharge, a monophasic stimulation pulse can be generated at the stimulation target 1. Similarly, monophasic stimulation pulses can be generated at the stimulation target 2 by controlling the other set of forward channels 1361 and backward channels 1362 if the forward channel 1361 is opened for a certain time and then the other forward channel 1361 is opened for a certain time, then a positive and negative phase stimulation pulse is generated between the stimulation targets 1, 2.
The parameters of the stimulation waveforms of the present invention are controllable, and the stimulation parameters include, but are not limited to, stimulation amplitude, stimulation frequency, stimulation pulse width, stimulation interval, and stimulation length.
Furthermore, the amplitude range of the stimulation pulse is 0V-13V, and the stimulation voltage step size is more than or equal to 50 mV. The current range of the stimulation pulse is 0mA-20mA, and the step length of the stimulation current is more than or equal to 0.1 mA.
Furthermore, the frequency range of the stimulation pulse is l-200Hz, and the step length of the stimulation frequency is more than or equal to 1 Hz.
Further, the pulse width of the stimulation pulse ranges from 50 us to 500us, and the step size of the stimulation pulse width is greater than or equal to 30 us.
Further, the time length of the stimulation is controllable, the range is 1-5 minutes, and the step length is 20 s.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.

Claims (10)

1. A nasal cavity nerve stimulation system is characterized by comprising a nerve stimulator unit and a stimulation electrode unit which are connected with each other, wherein the nerve stimulator unit comprises a logic control module, a power supply management module, a wireless communication module, a data storage module, a user interface module and a stimulation module,
the logic control module is respectively connected with the power management module, the wireless communication module, the data storage module, the user interface module and the stimulation module, analyzes and processes signals received from the wireless communication module or the user interface module, and outputs control signals to the stimulation module;
the stimulation electrode unit comprises a stimulation electrode and a stimulation contact, wherein the stimulation contact is provided with 2 contacts and is a good biocompatible conductor;
the stimulation module sets stimulation parameters after receiving the control signal from the logic control module, generates stimulation pulses and outputs the stimulation pulses to the stimulation contacts through the stimulation electrodes;
the power management module comprises a low-voltage power supply, a battery and a stimulation high-voltage power supply, wherein the low-voltage power supply is used for generating voltage used by the digital circuit, and the stimulation high-voltage power supply supplies power to the stimulation module;
the data storage module stores stimulation related data;
the wireless communication module comprises a wireless communication circuit and an antenna and transmits stimulation data with external equipment.
2. The system of claim 1, wherein the logic control module comprises an MCU or MPU or DSP or FPGA or ASIC.
3. The system according to claim 1, wherein the stimulation module comprises a voltage stimulation generation unit, a current stimulation generation unit and an output channel control unit, the voltage stimulation generation unit and the current stimulation generation unit are both connected with the output channel control unit, and the output of the output channel control unit is connected with the stimulation electrode.
4. The system of claim 1, wherein the user interface module comprises an indicator light, a key unit and a buzzer, and supports the user to adjust the stimulation intensity and feed back status information to the user.
5. The system of claim 3, wherein the stimulation high voltage power supply generates a controllable voltage greater than 13V to power the voltage stimulation generation unit, the current stimulation generation unit, and the output channel control unit.
6. The system of claim 3, wherein the voltage stimulation generation unit has a stimulation pulse amplitude ranging from 0V to 13V, a stimulation voltage step size greater than or equal to 50mV, and configurable stimulation parameters.
7. The system of claim 6, wherein the stimulation parameters include stimulation pulse width 50-500us, stimulation pulse width step size of 10us or more, stimulation frequency 1-200Hz, stimulation frequency step size of 1Hz or more, biphasic positive and negative waves or monophasic waves, and stimulation duration 1-5 min.
8. The system according to claim 3, wherein the current stimulation range of the stimulation pulse generated by the current stimulation generating unit is 0-20mA, the stimulation current step size is 100uA, and the stimulation parameters are configurable.
9. The system of claim 8, wherein the stimulation parameters are configurable, including stimulation pulse width 50-500us, stimulation pulse width step size 10us or more, stimulation frequency 1-200Hz, stimulation frequency step size 1Hz or more, biphasic positive and negative waves or monophasic waves, and stimulation duration 1-5 min.
10. The system of claim 1, wherein the data storage module stores user stimulation parameters and historical data, and stimulation data is not lost when power is removed.
CN202011438558.XA 2020-12-10 2020-12-10 Nasal cavity nerve stimulation system Pending CN112604157A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116943032A (en) * 2023-09-20 2023-10-27 江西省精一医疗科技有限公司 Electrical stimulation generating device, method, electronic device, and storage medium

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140316485A1 (en) * 2013-04-19 2014-10-23 Oculeve, Inc. Nasal stimulation devices and methods

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140316485A1 (en) * 2013-04-19 2014-10-23 Oculeve, Inc. Nasal stimulation devices and methods

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116943032A (en) * 2023-09-20 2023-10-27 江西省精一医疗科技有限公司 Electrical stimulation generating device, method, electronic device, and storage medium
CN116943032B (en) * 2023-09-20 2024-01-09 江西省精一医疗科技有限公司 Electrical stimulation generating device, method, electronic device, and storage medium

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