A wearable minimally invasive tibial nerve stimulation device

Abstract

The present invention relates to the field of nerve stimulation technology, specifically a wearable minimally invasive tibial nerve stimulation device, including a nerve stimulation unit, a nerve conduction monitoring unit, a surface-mounted minimally invasive needle electrode unit, a loop electrode unit, an auxiliary positioning and binding unit, a button unit, a display unit, a power management unit, and a wireless signal transmission unit. The present invention effectively transmits electrical stimulation signals to subcutaneous tissue through wearable microneedle puncture technology to achieve effective stimulation of the tibial nerve deep in the tissue, combines nerve conduction monitoring and plantar motion decoding technology to achieve adaptive adjustment of the output signal of the nerve stimulation unit, achieve individual adaptive stimulation, reduce the discomfort of percutaneous stimulation, and improve the treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of nerve stimulation, and in particular to a wearable minimally invasive tibial nerve stimulation device. Background Art

[0002] Overactive bladder (OAB) is defined by the International Continence Society (ICS) as a syndrome characterized by urinary urgency, often accompanied by symptoms of urinary frequency and nocturia, with or without urge incontinence, in the absence of urinary tract infection or other clear pathological changes.

[0003] OAB may not have a clear inducing factor (also called idiopathic OAB), and OAB may also appear in the symptoms caused by some diseases, especially some neurological diseases that often produce OAB symptoms: spinal cord injury, spinal cord dysplasia, cerebrovascular disease, Parkinson's syndrome, multiple sclerosis, Alzheimer's disease, basal ganglia lesions, frontal lobe brain tumors, iatrogenic factors, etc.

[0004] Currently, conservative treatment for overactive bladder mainly includes behavioral therapy and anticholinergic drug therapy. Anticholinergic drugs achieve therapeutic effects by antagonizing M receptors to inhibit detrusor contraction during storage. Commonly used drugs include tolterodine, oxybutynin, etc. Common adverse reactions of drugs include: dry mouth, constipation, headache, abdominal pain, blurred vision, nausea, indigestion, dry eyes, sinusitis, dysuria, etc. Neurostimulation therapy is also called "electronic medicine". Neurostimulation has the characteristics of low risk, high safety, and significant efficacy, but most of them are still invasive treatments, such as sacral nerve stimulation. The posterior tibial nerve is a mixed nerve containing L4-S3. It originates from the S2-S4 nerve roots like the parasympathetic nerve of the bladder. Superficial percutaneous tibial nerve stimulation can inhibit S2-S3 afferents by stimulating the tibial nerve, thereby inhibiting detrusor overactivity and treating overactive bladder. In 2021, the FDA approved the wearable ZIDA device for the treatment of OAB, and in 2023, the FDA approved the Viva Lly device for the treatment of OAB.

[0005] The evidence-based medicine level of tibial nerve regulation therapy for the treatment of overactive bladder has been academically recommended and recognized by experts, but it is inevitable that there are problems such as low energy penetration efficiency, unstable treatment effect, and increased stimulation intensity causing skin tingling in the wearing area during transcutaneous non-invasive electrical stimulation treatment. The above problems need to be solved urgently.

[0006] In summary, in order to help more patients solve the problem of overactive bladder, the present invention proposes a wearable minimally invasive tibial nerve stimulation technology. Summary of the invention

[0007] The purpose of the present invention is to provide a wearable minimally invasive tibial nerve stimulation device to solve the problems raised in the above-mentioned background technology.

[0008] To achieve the above-mentioned object, the present invention provides the following technical solutions: a wearable minimally invasive tibial nerve stimulation device, comprising a nerve stimulation unit, a nerve conduction monitoring unit, a surface-mounted minimally invasive needle electrode unit, a loop electrode unit, an auxiliary positioning and binding unit, a button unit, a display unit, a power management unit, and a wireless signal transmission unit;

[0009] The neural stimulation unit is configured as a voltage-controlled voltage source and current source circuit, which adaptively adjusts the power supply rail according to the load characteristics of the human body to generate pulse electrical signals of different frequencies, pulse widths, and amplitudes;

[0010] The nerve conduction monitoring unit is used to sense and monitor the active nerve conduction potentials and foot movement behavior characteristics on the tibial nerve plexus, and establish a correlation mapping between the nerve conduction potential characteristics and the output signal of the nerve stimulation unit, detect the plantar flexion and dorsiflexion reactions of the foot after the stimulation device works, and generate a closed-loop control strategy;

[0011] A surface-mounted minimally invasive needle electrode unit, comprising a needle electrode column, for effectively transmitting the electrical pulses output by the nerve stimulation device to the subcutaneous tissue;

[0012] A loop electrode unit, including a loop electrode, used to form an electrical circuit for electrical stimulation and also used as a reference electrode for monitoring nerve conduction potentials;

[0013] Auxiliary positioning and binding unit, used to assist users to conveniently, quickly and accurately locate the wearing part of the stimulator, effectively fix the wearable stimulation device, reduce the contact impedance between the loop electrode and the body surface, and prevent it from falling off;

[0014] The button unit is located on the front of the nerve stimulation device and has the functions of parameter addition, parameter subtraction and confirmation key;

[0015] A display unit, used to display the control parameters, treatment status, stimulation output waveform, and plantar movement behavior status of the nerve stimulation unit;

[0016] The power management unit is used to manage the charging and discharging of the rechargeable battery in the neurostimulation device to prevent overcharging and overdischarging of the battery, and to convert high-voltage and low-voltage potentials to achieve adaptive power supply of the neurostimulation system;

[0017] The wireless signal transmission unit, a radio frequency transmission antenna designed based on the communication requirements of the human body area, and an in vitro programmable control software establish a wireless transmission circuit.

[0018] Compared with the prior art, the beneficial effects of the present invention are: soft microneedles are inserted into the subcutaneous tissue, which causes much less trauma than traditional acupuncture needles. The microneedles are used to effectively transmit the electrical pulses output by the nerve stimulation device to the subcutaneous tissue. After puncturing the skin, the microneedles can be retained in the subcutaneous tissue for a short period of time. The microneedles are waterproof and are used in a manner similar to pressing with a thumbtack. The auxiliary positioning and binding device can facilitate users to simply, quickly and accurately locate the wearing part of the stimulator, thereby improving the use effect and the treatment efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a structural block diagram of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention;

[0020] Figure 2 A top view of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention;

[0021] Figure 3 A side view of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention;

[0022] Figure 4 A schematic diagram of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention;

[0023] Figure 5 This is a diagram of wearing a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention;

[0024] Figure 6 It is a diagram of the needle electrode buckling points and alignment lines of a specific embodiment of the present invention;

[0025] Figure 7 The figure is a schematic diagram of capturing the dorsiflexion and plantar flexion movements of the foot according to a specific embodiment of the present invention.

[0026] Among them: a nerve stimulation unit 10, a nerve conduction monitoring unit 20, a surface-mounted minimally invasive needle electrode unit 30, a loop electrode unit 40, an auxiliary positioning and binding unit 50, a button unit 60, a display unit 70, a power management unit 80, and a wireless signal transmission unit 90. DETAILED DESCRIPTION

[0027] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0028] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and the like are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", and the like may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0029] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0030] The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

[0031] See also Figure 1-Figure 7 , a wearable minimally invasive tibial nerve stimulation device, comprising a nerve stimulation unit 10, a nerve conduction monitoring unit 20, a surface-mounted minimally invasive needle electrode unit 30, a loop electrode unit 40, an auxiliary positioning and binding unit 50, a button unit 60, a display unit 70, a power management unit 80, and a wireless signal transmission unit 90;

[0032] The neural stimulation unit 10 is configured as a voltage-controlled voltage source and current source circuit, which adaptively adjusts the power supply rail according to the load characteristics of the human body to generate pulse electrical signals of different frequencies, pulse widths, and amplitudes;

[0033] The nerve conduction monitoring unit 20 is used to sense and monitor the active nerve conduction potentials and foot movement behavior characteristics on the tibial nerve plexus, and establish a correlation mapping between the nerve conduction potential characteristics and the output signal of the nerve stimulation unit 10, detect the plantar flexion and dorsiflexion reactions of the foot after the stimulation device works, and generate a closed-loop control strategy;

[0034] The surface-mounted minimally invasive needle electrode unit 30 includes a needle electrode column, which is used to effectively transmit the electrical pulses output by the nerve stimulation device to the subcutaneous tissue;

[0035] The loop electrode unit 40 includes a loop electrode, which is used to form an electrical circuit for electrical stimulation and is also used as a reference electrode for monitoring nerve conduction potentials;

[0036] The auxiliary positioning and binding unit 50 is used to assist the user to conveniently, quickly and accurately locate the wearing part of the stimulator;

[0037] The button unit 60 is distributed on the front of the nerve stimulation device and has the functions of parameter addition, parameter subtraction and confirmation keys;

[0038] The display unit 70 is used to display the control parameters, treatment status, stimulation output waveform, and plantar movement behavior status of the nerve stimulation unit 10;

[0039] The power management unit 80 is used to manage the charging and discharging of the rechargeable battery in the nerve stimulation device to prevent overcharging and overdischarging of the battery, and to convert high voltage and low voltage potentials to achieve adaptive power supply of the nerve stimulation system;

[0040] The wireless signal transmission unit 90, a radio frequency transmission antenna designed based on the communication requirements of the human body area, establishes a wireless transmission circuit with the external program control App.

[0041] In one embodiment of the present invention, the pulse electrical signal is divided into active balance and passive balance, the pulse amplitude supports amplitude modulation, and the pulse frequency supports frequency modulation;

[0042] Specifically, the regulatory strategies are outlined as follows:

[0043]

[0044] Among them, Stim px For the closed-loop control paradigm, δ T (t) is the threshold compensation value, K p is the difference proportional coefficient, Stim Tn is the stimulus output value at time n, Stim T0 is the threshold at the start time, K d is the difference supplement coefficient, d t is the stimulus output time series, N cap is the characteristic of nerve conduction potential, δ delay M is the group delay of nerve conduction potential, t is the plantar flexion reaction coefficient.

[0045] As a preferred embodiment of the present invention, the needle electrode column is made of a soft conductive material, the root of the needle electrode has a certain rigidity, is a detachable and replaceable component, and is connected to the neurostimulator device through a screw buckle;

[0046] The outer layer of the needle electrode cylinder is made of insulating material, and there are snap contacts and alignment lines at the root to ensure the effective assembly of the electrode. The needle tip is a good conductor, the needle electrode cylinder is sterile, and the surface of the needle electrode is coated with a trace amount of local anesthetic. After puncturing the skin, it can be retained subcutaneously for a short period of time and has waterproof properties.

[0047] As a preferred embodiment of the present invention, the loop electrode is made of a flexible anti-allergic gel material, and is attached to the back cover of the nerve stimulation device. After attachment, it will be integrated with the back cover, and the anti-allergic gel material can be removed and replaced separately;

[0048] At the same time, the loop electrode has a large adhesion area with the human skin, which can form an effective adhesion effect, prevent the nerve stimulation device from falling off, and is waterproof and anti-infection.

[0049] As a preferred embodiment of the present invention, the auxiliary positioning and binding unit 90 is based on the ankle joint as a reference point, and is ideally placed two fingers above and one finger behind the medial ankle joint. It can also effectively fix the wearable stimulation device, reduce the contact impedance between the loop electrode and the body surface, and effectively fix the nerve stimulation device to prevent it from falling off.

[0050] As a preferred embodiment of the present invention, the confirmation key can perform rotation encoding in addition to the pressing operation, which is used for fast menu switching and parameter adjustment. When used for rotation encoding, the effect is equivalent to the combination of parameter addition and parameter subtraction. The display unit 70 can be turned on or off according to the button operation.

[0051] As a preferred embodiment of the present invention, the wireless signal transmission unit 90 is used to send the program-controlled App parameters to the nerve stimulation device, and at the same time send the nerve potentials, plantar flexion, and dorsiflexion movement characteristics collected by the nerve conduction monitoring unit 20 to the program-controlled App. The App side can perform in-depth analysis of the nerve potentials and train the stimulation model in combination with the user's daily physiological parameters. Finally, the maturely trained model can optimize and update the initial algorithm model built into the nerve stimulation unit 10, making the wearable minimally invasive tibial nerve stimulation device work more intelligently.

[0052] The working principle of the present invention is: when the device is in use, after assembling the surface-mounted minimally invasive needle electrode 30 and the loop electrode unit 40, the auxiliary positioning and binding unit 50 is used to find the expected wearing position and effectively wear it, and the parameters are set through the button unit 60 and the human-computer interaction is performed through the display unit 70. The standard treatment parameters built into the stimulator are used to drive the nerve stimulation unit 10 to output the preset parameters and the nerve conduction potential is captured and analyzed and the plantar movement characteristics are decoded through the nerve conduction listening unit 20. At the same time, the nerve stimulation device is connected to the external programmable App through the wireless signal transmission unit 90, and the App performs operations such as parameter setting, stimulation on or off, and nerve conduction potential depth analysis; the power management unit 80 is used to charge and discharge the built-in rechargeable battery and generate and monitor and protect various potentials required for circuit operation.

[0053] The above describes in detail the preferred implementation of this patent, but this patent is not limited to the above implementation. Various changes can be made within the knowledge scope of ordinary technicians in this field without departing from the purpose of this patent.

Claims

1. A wearable minimally invasive tibial nerve stimulation device, characterized in that: It comprises a nerve stimulation unit (10), a nerve conduction monitoring unit (20), a surface-mounted minimally invasive needle electrode unit (30), a loop electrode unit (40), an auxiliary positioning and binding unit (50), a button unit (60), a display unit (70), a power management unit (80), and a wireless signal transmission unit (90); The nerve stimulation unit (10) is configured as a voltage-controlled voltage source and current source circuit, adaptively adjusting the power supply rail according to the load characteristics of the human body to generate a pulse electrical signal; The nerve conduction monitoring unit (20) is used to sense and monitor the active nerve conduction potentials and foot movement behavior characteristics on the tibial nerve plexus, and to establish a correlation mapping between the nerve conduction potential characteristics and the output signal of the nerve stimulation unit (10), to detect the plantar flexion and dorsiflexion reactions of the foot after the stimulation device is working, and to generate a closed-loop control strategy; The regulatory strategy is outlined as follows: Among them, Stim px For the closed-loop control paradigm, δ T (t) is the threshold compensation value, K p is the difference proportional coefficient, Stim Tn Stim is the stimulus output value at time n. T0 is the threshold at the start time, K d is the difference supplement coefficient, d t is the stimulus output time series, N cap is the characteristic of nerve conduction potential, δ delay is the nerve conduction potential group delay, M t is the plantar flexion reaction coefficient; The surface-mounted minimally invasive needle electrode unit (30) comprises a needle electrode column, which is used to effectively transmit the electrical pulse output by the nerve stimulation device to the subcutaneous tissue; the loop electrode unit (40) comprises a loop electrode, which is used to form an electrical circuit for electrical stimulation and is also used as a reference electrode for monitoring nerve conduction potential; the auxiliary positioning and binding unit (50) is used to assist the user in conveniently, quickly and accurately locating the wearing part of the stimulator; The needle electrode column is made of a soft conductive material, and the root of the needle electrode has a certain rigidity. It is a detachable and replaceable component and is connected to the neurostimulator device through a screw buckle; The outer layer of the needle electrode column is made of insulating material, the root has a snap contact and an alignment line, the needle tip is a good conductor, the needle electrode column is sterile, the surface of the needle electrode is coated with a trace amount of local anesthetic, and after puncturing the skin, it is indwelled under the skin for a short period of time; The loop electrode is made of a flexible anti-allergic gel material and is attached to the back cover of the nerve stimulation device. After attachment, it will be integrated with the back cover. The anti-allergic gel material can be removed and replaced separately. The button unit (60) is distributed on the front of the nerve stimulation device; the display unit (70) is used to display the control parameters, treatment status, stimulation output waveform, and plantar movement behavior status of the nerve stimulation unit (10); the power management unit (80) is used to manage the charging and discharging of the rechargeable battery in the nerve stimulation device; the wireless signal transmission unit (90) is a radio frequency transmission antenna designed based on the requirements of human body regional communication to establish a wireless transmission circuit with an external programmable control App.

2. A wearable minimally invasive tibial nerve stimulation device according to claim 1, characterized in that: The pulse electrical signal is divided into active balance and passive balance, the pulse amplitude supports amplitude modulation, and the pulse frequency supports frequency modulation.

3. A wearable minimally invasive tibial nerve stimulation device according to claim 1, characterized in that: The loop electrode has an adhesion area with human skin, forming an effective adhesion effect.

4. A wearable minimally invasive tibial nerve stimulation device according to claim 1, characterized in that: The auxiliary positioning and binding unit uses the ankle joint as a reference point, is located two fingers above the inner ankle joint and one finger behind, and is used to fix the wearable stimulation device, reduce the contact impedance between the loop electrode and the body surface, and prevent it from falling off.

5. A wearable minimally invasive tibial nerve stimulation device according to claim 1, characterized in that: The wireless signal transmission unit (90) is used to send the program-controlled App parameters to the nerve stimulation device, and to send the nerve potential, plantar flexion and dorsiflexion movement characteristics collected by the nerve conduction monitoring unit (20) to the program-controlled App. The App end can perform in-depth analysis of the nerve potential and train the stimulation model in combination with the user's daily physiological parameters. The trained mature model optimizes and updates the initial algorithm model built into the nerve stimulation unit (10).

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