Wearable minimally invasive tibial nerve stimulation apparatus

Abstract

The present invention relates to the technical field of nerve stimulation, and in particular, to a wearable minimally invasive tibial nerve stimulation apparatus, which comprises a nerve stimulation unit, a nerve conduction monitoring unit, a surface-mounted minimally invasive needle electrode unit, a return electrode unit, an auxiliary positioning and binding unit, a button unit, a display unit, a power management unit, and a wireless signal transmission unit. According to the present invention, electrical stimulation signals are effectively transmitted to subcutaneous tissues by means of the wearable microneedle puncture technology, achieving effective stimulation of tibial nerves deep in the tissues; adaptive adjustment of output signals of the nerve stimulation unit is achieved based on nerve conduction monitoring and plantar motion decoding technologies, achieving individual adaptive stimulation, thereby reducing the discomfort of transcutaneous stimulation, and improving the therapeutic effect.

Description

A wearable minimally invasive tibial nerve stimulation device Technical Field

[0001] This invention relates to the field of nerve stimulation technology, specifically a wearable minimally invasive tibial nerve stimulation device. Background Technology

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

[0003] It is estimated that approximately 50 to 100 million people worldwide suffer from overactive bladder (OAB). A survey in the United States showed that among people over the age of 18, 16.9% of women and 16.0% of men had OAB symptoms, and the incidence rate increased with age.

[0004] OAB can occur without a clear precipitating factor (also known as idiopathic OAB). OAB can also appear as a symptom of 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.

[0005] Currently, conservative treatments for overactive bladder (OAB) mainly include behavioral therapy and anticholinergic drug therapy. Anticholinergic drugs work by antagonizing M receptors to inhibit detrusor muscle contractions during the storage phase. Commonly used drugs include tolterodine and oxybutynin. Common adverse reactions include dry mouth, constipation, headache, abdominal pain, blurred vision, nausea, indigestion, dry eye, sinusitis, and difficulty urinating. Neurostimulation therapy, also known as "electronic medication," is characterized by low risk, high safety, and significant efficacy, but most are still invasive treatments, such as sacral nerve stimulation. The posterior tibial nerve is a mixed nerve containing L4-S3, originating from the S2-S4 nerve roots, similar to the bladder parasympathetic nerve. Surface percutaneous tibial nerve stimulation can inhibit S2-S3 afferent signals by stimulating the tibial nerve, thereby inhibiting detrusor muscle overactivity and treating OAB. In 2021, the FDA approved the wearable Zida device for OAB treatment, and in 2023, the FDA approved the vivoly device for OAB treatment.

[0006] The evidence-based medicine level of tibial nerve modulation therapy for the treatment of overactive bladder has been academically recommended and recognized by experts. However, it is unavoidable that percutaneous non-invasive electrical stimulation therapy has problems such as low energy penetration efficiency, unstable treatment effect, and skin tingling caused by increased stimulation intensity. These problems urgently need to be solved.

[0007] In summary, to help more patients resolve the problem of overactive bladder, this invention proposes a wearable minimally invasive tibial nerve stimulation technique. Summary of the Invention

[0008] The purpose of this invention is to provide a wearable minimally invasive tibial nerve stimulation device to solve the problems mentioned in the background art.

[0009] To achieve the above objectives, the present invention provides the following technical solution: a wearable minimally invasive tibial nerve stimulation device, comprising a nerve stimulation unit, a nerve conduction listening 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.

[0010] The nerve stimulation unit is configured with voltage-controlled voltage and current source circuits, which adaptively adjust the power supply rail according to the human body load characteristics to generate pulse electrical signals with different frequencies, pulse widths, and amplitudes.

[0011] The neural conduction listening unit is used to sense and listen to the active neural conduction potentials on the tibial nerve plexus and the characteristics of foot movement behavior. It also establishes a correlation mapping between the characteristics of neural conduction potentials and the output signal of the neural stimulation unit, detects the plantar flexion and dorsiflexion responses of the foot after the stimulation device is activated, and generates a closed-loop control strategy.

[0012] The surface-mounted minimally invasive needle electrode unit includes a needle electrode post, which is used to effectively transmit the electrical pulses output by the nerve stimulation device to the subcutaneous tissue.

[0013] The loop electrode unit includes loop electrodes for forming an electrical circuit for electrical stimulation and for use as reference electrodes during nerve conduction potential detection.

[0014] The auxiliary positioning and binding unit is used to help users conveniently, quickly and accurately position the stimulator wearing site, effectively fix the wearable stimulation device, reduce the contact resistance between the circuit electrodes and the body surface, and prevent it from falling off.

[0015] The button unit is located on the front of the nerve stimulation device and has the functions of parameter increase, parameter decrease and confirmation button.

[0016] The display unit is used to display the control parameters, treatment status, stimulation output waveform, and foot movement behavior status of the nerve stimulation unit.

[0017] The power management unit is used to manage the charging and discharging of the rechargeable battery in the neurostimulation device, prevent the battery from being overcharged or over-discharged, and simultaneously perform high-voltage and low-voltage potential switching to achieve adaptive power supply for the neurostimulation system.

[0018] The wireless signal transmission unit uses a radio frequency transmission antenna designed based on the communication requirements of the human body area to establish a wireless transmission circuit with an external programmable software.

[0019] Compared with existing technologies, the beneficial effects of this invention are: the soft microneedles inserted subcutaneously cause much less trauma than traditional acupuncture needles, effectively transmitting the electrical pulses output by the nerve stimulation device to the subcutaneous tissue; after puncturing the skin, they can be left in place subcutaneously for a short period of time; they are waterproof; and their use is similar to pressing with a "thumbtack"; the application of auxiliary positioning and binding devices allows users to easily, quickly, and accurately locate the stimulator wearing site, improving the effect and increasing treatment efficiency. Attached Figure Description

[0020] Figure 1 is a structural block diagram of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention;

[0021] Figure 2 is a top view of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention.

[0022] Figure 3 is a side view of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention.

[0023] Figure 4 is a schematic diagram of a wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention.

[0024] Figure 5 is a diagram of wearing the wearable minimally invasive tibial nerve stimulation device according to a specific embodiment of the present invention.

[0025] Figure 6 is a diagram of the needle electrode snapping point and alignment line in a specific embodiment of the present invention;

[0026] Figure 7 is a schematic diagram of foot dorsiflexion and plantarflexion motion capture according to a specific embodiment of the present invention.

[0027] The unit includes: a nerve stimulation unit 10, a nerve conduction listening 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 Implementation

[0028] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0029] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0030] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0031] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0032] Please refer to Figures 1-7. A wearable minimally invasive tibial nerve stimulation device includes a nerve stimulation unit 10, a nerve conduction listening unit 20, a surface-mount 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.

[0033] The nerve stimulation unit 10 is configured as a voltage source and current source circuit controlled by voltage. It adaptively adjusts the power supply rail according to the human body load characteristics to generate pulse electrical signals with different frequencies, pulse widths and amplitudes.

[0034] The neural conduction listening unit 20 is used to sense and listen to the active neural conduction potentials on the tibial nerve plexus and the characteristics of foot movement behavior, and to establish a correlation mapping between the characteristics of neural conduction potentials and the output signal of the neural stimulation unit 10, detect the plantar flexion and dorsiflexion responses of the foot after the stimulation device is working, and generate a closed-loop control strategy.

[0035] The surface-mounted minimally invasive needle electrode unit 30 includes a needle electrode post, which is used to effectively transmit the electrical pulses output by the nerve stimulation device to the subcutaneous tissue.

[0036] The loop electrode unit 40 includes a loop electrode for forming an electrical circuit for electrical stimulation and also for use as a reference electrode for listening to nerve conduction potentials.

[0037] The auxiliary positioning and binding unit 50 is used to assist the user in conveniently, quickly and accurately positioning the stimulator wearing site;

[0038] The button unit 60 is located on the front of the nerve stimulation device and has the functions of parameter increase, parameter decrease and confirmation button.

[0039] Display unit 70 is used to display the control parameters, treatment status, stimulation output waveform, and foot movement behavior status of nerve stimulation unit 10;

[0040] The power management unit 80 is used to manage the charging and discharging of the rechargeable battery in the neurostimulation device, prevent the battery from being overcharged or over-discharged, and simultaneously perform high-voltage and low-voltage potential switching to achieve adaptive power supply for the neurostimulation system.

[0041] The wireless signal transmission unit 90 has a radio frequency transmission antenna designed based on the human body area communication requirements to establish a wireless transmission circuit with the external programmable software.

[0042] In one embodiment of the present invention, the pulse electrical signal is divided into active balanced and passive balanced, the pulse amplitude supports amplitude modulation, and the pulse frequency supports frequency modulation.

[0043] Specifically, the regulatory strategies are summarized as follows:

[0044] Stim px =δ T (t)+K p ×[(Stim Tn -Stim T0 )+K d × ]+N cap ×δ delay ×M t

[0045] Among them, Stim px As a closed-loop control paradigm, δ T (t) is the threshold compensation value, K p Stim is the difference proportionality coefficient. Tn Let Stim be the stimulus output value at time n. T0 K is the threshold at the start time. d To supplement the difference, d t To stimulate the output time series, N cap Characteristic of nerve conduction potential, δ delayM is used for delaying the neural conduction potential group. t The plantar flexion response coefficient.

[0046] In a preferred embodiment of the present invention, the needle electrode post is made of a soft conductive material, the root of the needle electrode has a certain rigidity, and is a detachable and replaceable component, which is connected to the nerve stimulator device by a spiral buckle.

[0047] The outer layer of the needle electrode post is made of insulating material, and there are snap-on contacts and alignment lines at the base to ensure effective assembly of the electrode. The needle tip is a good conductor, the needle electrode post is sterile, and a small amount of local anesthetic is applied to the surface of the needle electrode. After puncturing the skin, it can be left in place under the skin for a short period of time and has waterproof properties.

[0048] In a preferred embodiment of the present invention, the loop electrode is made of a flexible anti-sensitivity 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-sensitivity gel material can be removed and replaced separately.

[0049] Meanwhile, the circuit electrode has a large adhesion area to human skin, which can form an effective adhesion effect, prevent the nerve stimulation device from falling off, and is waterproof and infection-resistant.

[0050] As a preferred embodiment of the present invention, the auxiliary positioning and binding unit 90 is positioned with the ankle joint as the reference point, two finger-widths above the medial ankle joint and one finger-width behind it as the ideal placement position. At the same time, it can effectively fix the wearable stimulation device, reduce the contact resistance between the circuit electrode and the body surface, and effectively fix the nerve stimulation device to prevent it from falling off.

[0051] In a preferred embodiment of the present invention, the confirmation key can be used for rotation encoding in addition to pressing, for quick menu switching and parameter adjustment. When used for rotation encoding, the effect is equivalent to the combined use of parameter addition and subtraction. The display unit 70 can be turned on or off according to the key operation.

[0052] In a preferred embodiment of the present invention, the wireless signal transmission unit 90 is used to send the parameters of the programmable App to the nerve stimulation device, and at the same time, transmit the nerve potentials, plantar flexion and dorsiflexion movement characteristics collected by the nerve conduction listening unit 20 to the programmable App. The App can perform in-depth analysis of the nerve potentials and combine them with the user's daily physiological parameters to train the stimulation model. Finally, the mature 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.

[0053] The working principle of this invention is as follows: When using this device, after assembling the surface-mounted minimally invasive needle electrode 30 and the loop electrode unit 40, the device is positioned and effectively worn at the intended location with the help of the auxiliary positioning and binding unit 50. Parameters are set via the button unit 60 and human-computer interaction is performed via the display unit 70. The standard treatment parameters built into the stimulator drive the nerve stimulation unit 10 to output preset parameters and capture and analyze nerve conduction potentials and decode foot movement characteristics via the nerve conduction listening unit 20. At the same time, the nerve stimulation device is connected to an external programming App via 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 manage the charging and discharging of the built-in rechargeable battery and to generate and monitor the various potentials required for circuit operation.

[0054] The preferred embodiments of this patent have been described in detail above. However, this patent is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of this patent.

Claims

1. A wearable minimally invasive tibial nerve stimulation device, characterized in that, It includes a nerve stimulation unit (10), a nerve conduction listening unit (20), a surface-mount 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 source and current source circuit controlled by voltage, which adaptively adjusts the power supply rail according to the human body load characteristics to generate pulse electrical signals; The neural conduction listening unit (20) is used to sense and listen to the active neural conduction potentials on the tibial nerve plexus and the characteristics of foot movement behavior, and to establish a correlation mapping between the characteristics of neural conduction potentials and the output signal of the neural stimulation unit (10), detect the plantar flexion and dorsiflexion responses of the foot after the stimulation device is working, and generate a closed-loop control strategy. The regulatory strategy is summarized as follows: Stim px =δ T (t)+K p ×[(Stim Tn -Stim T0 )+K d × ]+N cap ×δ delay ×M t ; Among them, Stim px As a closed-loop control paradigm, δ T (t) is the threshold compensation value, K p Stim is the difference proportionality coefficient. Tn Let Stim be the stimulus output value at time n. T0 K is the threshold at the start time. d To supplement the difference, d t To stimulate the output time series, N cap Characteristic of nerve conduction potential, δ delay M is used for delaying the neural conduction potential group. t The plantar flexion response coefficient; The surface-mount minimally invasive needle electrode unit (30) includes a needle electrode post, which is used to effectively transmit the electrical pulses output by the nerve stimulation device to the subcutaneous tissue; the circuit electrode unit (40) includes a circuit electrode, which is used to form an electrical circuit for electrical stimulation and also serves as a reference electrode for nerve conduction potential detection; the auxiliary positioning and binding unit (50) is used to assist the user in conveniently, quickly and accurately positioning the stimulator wearing site. The button unit (60) is located 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 foot 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) establishes a wireless transmission circuit with the radio frequency transmission antenna designed based on the human body area communication requirements and the external programmable App.

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

3. The wearable minimally invasive tibial nerve stimulation device according to claim 1, characterized in that, The needle electrode post 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 by a spiral buckle.

4. The wearable minimally invasive tibial nerve stimulation device according to claim 4, characterized in that, The outer layer of the needle electrode post is made of insulating material, with snap-fit ​​contacts and alignment lines at the base. The needle tip is a good conductor, the needle electrode post is sterile, and a small amount of local anesthetic is applied to the surface of the needle electrode. After puncturing the skin, it is left in place subcutaneously for a short period of time.

5. A wearable minimally invasive tibial nerve stimulation device according to claim 1, characterized in that, The circuit electrode is made of flexible anti-allergy 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-allergy gel material can be removed and replaced separately.

6. A wearable minimally invasive tibial nerve stimulation device according to claim 6, characterized in that, The circuit electrode has an adhesion area with human skin, forming an effective adhesion effect.

7. The wearable minimally invasive tibial nerve stimulation device according to claim 1, characterized in that, The auxiliary positioning and binding unit is based on the ankle joint as a reference point, located two finger-widths above and one finger-width behind the medial ankle joint, and is used to fix the wearable stimulation device, reduce the contact resistance between the circuit electrode and the body surface, and prevent it from falling off.

8. The 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 parameters of the programmable App to the nerve stimulation device and send the nerve potential, plantar flexion and dorsiflexion movement characteristics collected by the nerve conduction listening unit (20) to the programmable App. The App can perform in-depth analysis of the nerve potential and combine it with the user's daily physiological parameters to train the stimulation model. The mature model is used to optimize and update the initial algorithm model built into the nerve stimulation unit (10).

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