Transcutaneous electroneurostimulator with thermal modality for stimulating acupoints in dementia patients

Abstract

A head-mounted transcutaneous electrical nerve stimulation (TENS) device adapted to be worn on a patient's head to transcutaneously stimulate acupuncture points of the patient for the treatment or prevention of dementia is disclosed. The TENS device includes one or more frames, a plurality of contacts, a pulse width modulation (PWM) generator, and one or more thermal pads. The one or more frames are arranged to have a contour that matches the anatomical shape of the head. The plurality of contacts are arranged on an inner surface of the one or more frames for contacting acupuncture points of the head. The PWM generator is configured to generate a pulsed stimulation signal to stimulate the acupuncture points and couple the pulsed stimulation signal to the plurality of contacts. The one or more thermal pads are arranged on an inner surface of the one or more frames for applying a thermal treatment to the acupuncture points.

Description

Technical Field

[0001] The present disclosure generally relates to devices and methods for improving the cognitive function of dementia patients. In particular, the present disclosure relates to a low-constant current head-mounted transcutaneous electrical nerve stimulation (TENS) device having a thermal modality adapted to stimulate the acupoints of dementia patients in order to improve cognitive function.

Background Art

[0002] Neurodegenerative diseases, which may also be referred to as Alzheimer's disease and Parkinson's disease, are a general term for various diseases that affect the nerve cells of the human brain or the peripheral nervous system. This is generally an age-dependent disease, and it is spreading more and more with the increase in the elderly population in the community. Patients with neurodegenerative diseases suffer from a progressive deterioration of brain function, which causes dementia with symptoms related to mobility, coordination, strength, speech, cognition, swallowing ability, etc. There is no effective treatment for neurodegenerative diseases, and the treatment may only help to relieve some of the related physical or mental symptoms.

[0003] Another group of patients suffers from dementia known as vascular dementia. It is mainly due to problems associated with poor blood circulation to the brain. Past medical problems including high blood pressure, smoking, diabetes, high cholesterol, a history of mild warning strokes, evidence of diseases in other arteries, and cardiac arrhythmias can contribute to vascular dementia. Pure vascular dementia is relatively rare and statistically contributes to only about 10% of cases. The majority of patients suffer from a mixture of dementia caused by a combination of dementia due to various types of neurodegenerative diseases and vascular dementia.

[0004] Both pharmacological and non-pharmacological treatments exist to alleviate patients' symptoms. Non-pharmacological interventions aim to slow the decline of mental capacity, help patients maintain greater independence in daily life, and improve their well-being and quality of life.

[0005] There is evidence suggesting that glucose or energy deficiency in the brain may be the first step toward Alzheimer's disease. Improving blood circulation in patients with vascular dementia provides neurons with the nutrients and energy they need to support their metabolic and regenerative needs. For this reason, TENS is suggested to be useful. TENS is a treatment procedure that uses electric current to stimulate peripheral nerves beneath the skin. Non-invasive and with relatively few side effects, TENS is thought to be a potential treatment option for dementia patients by improving blood flow to the brain. Evidence from recent studies in animals and humans supports the effectiveness of using TENS to improve cognitive function.

[0006] The hippocampus and cholinergic basal forebrain (CBF) system play a vital role in memory processes [1][2]. Neurophysiological studies in animals have shown that TENS can stimulate the CBF system via different pathways to improve memory and cognitive function. Animal studies in rats have shown that TENS can directly stimulate the hippocampus via the spinoseptal pathway [3][4] and indirectly stimulate the CBF system via the brain nuclei [5][6][7]. Neuroanatomical studies in rats have identified two brain nuclei, the locus coeruleus (LC) and the dorsal raphe nucleus (DRN), as major sources of noradrenergic and serotonergic neurotransmission, respectively [8][9]. Both the LC and DRN provide anatomical substrates that relay TENS signals and stimulate the CBF system via rostral projections of noradrenergic and serotonergic neurotransmission [5][6][7]. Furthermore, a recent review concluded that TENS may induce the reactivation of metabolically damaged neurons

[10] , which may explain the improvement in cognitive function following repeated TENS. In human studies, TENS has been found to improve memory and cognitive function in individuals with cognitive impairment (e.g., Alzheimer's disease) and in non-demented older adults. In a series of studies involving patients with different stages of Alzheimer's disease

[11] ,

[12] ,

[13] , repeated TENS (5 days a week for 6 weeks) was able to induce significantly greater improvements in nonverbal short-term and long-term memory, verbal long-term memory, and verbal fluency compared to patients receiving placebo stimulation. In another clinical trial

[14] , TENS had a greater beneficial effect on short-term and long-term memory in patients with early-stage Alzheimer's disease compared to patients with mid-stage Alzheimer's disease. In contrast, recent studies have shown that TENS has no positive effect on any aspect of memory in patients in the preclinical stages of dementia (i.e., older adults with mild cognitive impairment)

[15] .A review of eight studies on the effects of TENS on non-pain-related cognitive and behavioral functions in patients with Alzheimer's disease and non-dementia patients concluded that TENS may improve memory, affective behavior, and rest-activity rhythms in patients with Alzheimer's disease.

[16]

[0007] In traditional Chinese medicine, the practice of acupuncture has a long history of being used to achieve specific and designated therapeutic effects. Acupuncture involves inserting very fine needles into the skin at acupoints and must be performed by a professional acupuncturist. While the benefits and therapeutic effects of acupuncture for patients suffering from vascular dementia are constantly discussed and acknowledged, such alternative medicine is not very widespread and is generally not very accessible to the elderly community.

[0008] The idea of ​​combining TENS with acupuncture has also been proposed. This is considered superior to pure acupuncture because it does not involve puncturing the skin and does not require the precise identification of acupoints. TENS differs from transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), both of which do not require the use of acupoints. Electroacupuncture has also been used to improve symptoms of vascular dementia

[17] and has effectively improved cognitive function in patients with mild cognitive impairment.

[0009] Commercially, portable TENS devices have been developed and commercialized for delivering concentrated microcurrents for pain management, muscle stimulation, stroke rehabilitation, and the treatment of cardiovascular disease.

[18]

[19] Since the initial patent was granted in 1991 under U.S. Patent No. US4989605A, many companies have also developed a variety of devices for pain treatment. Devices have been designed with controllers that have 4 to 8 pads to provide a variety of home massage modes. Users may position the device in the desired location for pain relief and comfort. The frequency of the current from such devices is typically around 10 Hz to 50 Hz, and the current delivered is in the range of mA (milliamperes). One of the most recognized dangers was the strength of the current delivered and used. As mentioned above, commercially available TENS devices deliver TENS currents in the mA range, which is undeniably strong enough to be unbearable for most people and can cause burns or sharp pain. Furthermore, it is difficult for inexperienced caregivers to use TENS devices to stimulate specific acupoints to improve cognitive function and memory in patients with vascular dementia.

[0010] Therefore, prior art requires a head-mounted device that can be easily used by an inexperienced caregiver to stimulate selected acupoints to improve cognitive function and memory in dementia patients. Furthermore, other desirable features and characteristics will become apparent when the following detailed description and the attached claims are combined with the attached drawings and the background of this disclosure. [Prior art documents] [Non-patent literature]

[0011] The following is a list of references cited from time to time in this specification. All disclosures in these documents are incorporated herein by reference. [1]Salzmann E. et al., Importance of the hippocampus and parahippocampus with reference to normal and disordered memory function, Fortschr Neurol Psychiatr 1992; 60:163-76. [2]Swaab DF, et al., Brain aging and Alzheimer’s disease; use it or lose it, Prog Brain Res 2002; 138:343-73. [3]Burstein R, et al., Retrograde labeling of neurons in spinal cord that project directly to nucleus accumbens or the septal nuclei in the rat, Brain Res 1989; 497:149-54. [4]Giesler Jr GJ, et al., Direct spinal pathways to the limbic system for nociceptive information, Trends Neurosci 1994; 17:244-50. [5]Cape EG, et al., Differential modulation of high-frequency gamma-electroencephalogram activity and sleep-wake state by noradrenaline and serotonin microinjections into the region of cholinergic basalis neurons, J Neurosci 1998; 18:2653-66. [6]Fort P, et al., Noradrenergic modulation of cholinergic nucleus basalis neurons demonstrated by in vitro pharmacological and immunohistochemical evidence in the guinea-pig brain, Eur J Neurosci 1995; 7:1502. [7]Kalen P, et al., Projections from the medial septum and diagonal band of Broca to the dorsal and central superior raphe nuclei: a non-cholinergic pathway, Exp Brain Res 1989; 75:401-16. [8]Kayama Y, et al., Brainstem Neural Mechanisms of Sleep and Wakefulness, Eur Urol. 1998; 33 Suppl 3:12-5. [9]Waterhouse BD, et al., The distribution of neocortical projection neurons in the locus coeruleus, J Comp Neurol. 1983; 217:418-431.

[10] Swaab DF, et al., Therapeutic strategies for Alzheimer disease: focus on neuronal reactivation of metabolically impaired neurons, Alzheimer Dis Assoc Disord 2003; 17(Suppl 4): S114-22.

[11] Scherder EJA, et al., Influence of transcutaneous electrical nerve stimulation on memory in patients with dementia of the Alzheimer type, J Clin Exp Neuropsychol 1992; 14:951-960.

[12] Scherder EJA, et al., Effects of short-term transcutaneous electrical nerve stimulation on memory and affective behavior in patients with probable Alzheimer’s disease, Behav Brain Res 1995; 67:211-219.

[13] Scherder EJA, et al., Effects of a follow-up treatment of short-term transcutaneous electrical nerve stimulation on memory and affective behavior in a patient with probable Alzheimer’s disease, Behav Neurol 1996; 9:33-35.

[14] Scherder EJ, et al., Effects of transcutaneous electrical nerve stimulation on memory and behavior in Alzheimer’s disease may be stage-dependent, Biol Psychiatry 1999; 45: 743-9.

[15] Luijpen MW, et al., Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on memory in elderly with mild cognitive impairment, Behavorial Brain Research 2005; 158: 349-357.

[16] Van Dijk KRA, et al., Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on non-pain related cognitive and behavorial functioning, Reviews in the Neurosciences 2002; 13: 257-270.

[17] Zhang H, et al., Clinical observation on effect of scalp electroacupuncture for mild cognitive impairment, Tradit Chin Med 2013, 33(1):46-50.

[18] Dowswell T, et al., Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour, Cochrane Database Syst Rev. 2009, 2: CD007214.

[19] Schoenen J, et al., Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial, Neurology 2013, 80(8):697-704

Summary of the Invention

Problems to be Solved by the Invention

[0012] This specification provides an ultra-low constant current head-mounted TENS device having a thermal modality adapted to stimulate acupoints. The object of this disclosure is to improve the cognitive function of dementia patients by stimulating selected acupoints on the patient's head for the treatment or prevention of dementia. [Means for solving the problem]

[0013] In a first aspect of the present invention, a head-mounted TENS device is provided, adapted to be worn on a patient's head to percutaneously stimulate a patient's acupoints for the treatment or prevention of dementia. The TENS device includes one or more frames, a plurality of contacts, a pulse-width modulation (PWM) generator, and one or more thermal pads. The one or more frames are positioned to have a contour that matches the anatomical shape of the head. The plurality of contacts are positioned on the inner surface of one or more frames to contact acupoints on the head. The PWM generator is configured to generate pulsed stimulation signals to stimulate the acupoints and to couple the pulsed stimulation signals to the plurality of contacts. One or more thermal pads are positioned on the inner surface of one or more frames to apply heat treatment to at least one of the acupoints.

[0014] In one embodiment, the plurality of contacts includes a first group of contacts configured to contact the patient's Baihui (GV-20) and Sishencong (EX-HN1) acupoints, a second group of contacts configured to contact the patient's Fengchi (GB-20) acupoint, and a third group of contacts configured to contact the patient's Shenting (GV-24) acupoint.

[0015] In one embodiment, the first contact group includes a first contact pad positioned to contact the Baihui (GV-20) acupoint, and four adjacent contact pads positioned around the first contact pad to contact the Si Shen Cong (EX-HN1) acupoint.

[0016] In one embodiment, each individual contact of a plurality of contacts has an elastic structure made of a low-resistance conductive material.

[0017] In one embodiment, the individual contact includes a spring and a contact pad, and the spring is arranged to press the contact pad against the head at the acupuncture point. Optionally, the contact pad is a circular plate electrically connected to a PWM generator for coupling a pulsed stimulation signal or a low reference voltage. Alternatively, the contact pad includes a first zone and a second zone. The first zone and the second zone are separated by an insulating material, the first zone is electrically connected to a PWM generator for coupling a pulsed stimulation signal, and the second zone is electrically connected to a low reference voltage.

[0018] In other embodiments, the individual contact includes a spring and a contact pad having a plurality of pin electrodes, and the spring is arranged to press the plurality of pin electrodes against the head at the acupuncture point through the patient's hair. Optionally, at least one of the plurality of pin electrodes is electrically connected to a PWM generator for coupling a pulsed stimulation signal, and at least one other of the plurality of pin electrodes is electrically connected to a low reference voltage.

[0019] In one embodiment, the pulsed stimulation signal has an ultra-low current of 20 μA or less, and preferably, the ultra-low current is 1 μA to 8 μA. Optionally, the pulsed stimulation signal is a square wave having a pulse frequency of 50 Hz to 200 Hz, and preferably, the pulse frequency is 96 Hz to 100 Hz.

[0020] In one embodiment, one or more thermal pads are configured to deliver heat to at least one of the patient's acupuncture points and an area near at least one acupuncture point.

[0021] In one embodiment, each of the one or more thermal pads includes a winding of a heat-conducting material for delivering thermal energy to at least one acupuncture point and an area near at least one acupuncture point at a temperature in the range of 36°C to 40°C.

[0022] In one embodiment, one or more frames include an upper frame that at least partially covers the frontal and parietal regions of the head, and a lower frame that at least partially covers the occipital region of the head.

[0023] In one embodiment, the upper frame and the lower frame are adjustablely connected using connecting means. Optionally, the connecting means may include straps or belts to provide flexibility for adjusting the contour to match the anatomical shape of the head.

[0024] In one embodiment, the head-mounted TENS device includes a tightening means for applying tension to the upper and lower frames toward acupoints. Optionally, the tightening means comprises a chin strap that is tightened around the patient's chin and two transverse straps extending from the upper frame to the lower frame, with the chin strap and each of the transverse straps connected to form a Y-shape around the ear region to secure the head-mounted TENS device in a position on the head.

[0025] In one embodiment, a head-mounted TENS device includes one or more temperature sensors for obtaining temperature readings of areas near one or more thermal pads, a current sensor for detecting currents flowing to the patient through multiple contacts, and a processor configured to continuously monitor and adjust one or more thermal pads and a PWM generator based on the temperature detected by one or more temperature sensors and the current detected by the current sensors.

[0026] In a second aspect of the present invention, a TENS device is provided adapted to percutaneously stimulate a patient's acupoints for the treatment or prevention of dementia. The TENS device comprises a head article; a plurality of contacts concealed within the head article for contacting acupoints on the head; a PWM generator configured to generate pulsed stimulation signals to stimulate the acupoints and to couple the pulsed stimulation signals to the plurality of contacts; and one or more thermal pads concealed within the head article for applying heat treatment to the acupoints.

[0027] In one embodiment, the TENS device includes a tightening means for applying tension to securely hold the TENS device to the head.

[0028] In one embodiment, the head article is a helmet, hat, headband, crown, headgear, headwear, hood, or any combination thereof.

[0029] A third aspect of the present invention provides a method for treating or preventing dementia in a patient, comprising the steps of: positioning a TENS device on the patient's head, wherein the TENS device comprises a plurality of contacts and one or more thermal pads positioned on the inner surface for contact with acupoints on the head; generating pulsed stimulation signals with a PWM generator; coupling the pulsed stimulation signals to the plurality of contacts to transcutaneously stimulate the acupoints; and enabling one or more thermal pads to apply heat treatment to the acupoints.

[0030] In one embodiment, the method includes the steps of: recording the current flowing through the patient and the temperature values ​​of areas near one or more thermal pads; locally storing the current and temperature values ​​in the memory of the TENS device; and uploading the current and temperature values ​​to a cloud system for access by healthcare professionals or therapists.

[0031] This abstract is provided to introduce, in a simplified form, a selection of concepts that will be further described in the detailed description below. This abstract is not intended to identify any important or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. Other aspects and advantages of the invention are disclosed as shown in the embodiments below. [Brief explanation of the drawing]

[0032] The accompanying drawings include diagrams intended to further illustrate and clarify the above and other aspects, advantages, and features of the Disclosure. It should be understood that these drawings illustrate only specific embodiments of the Disclosure and are not intended to limit the scope of the Disclosure. It should also be understood that these drawings are provided for simplification and clarity and are not necessarily drawn to scale. The Disclosure will be described more specifically and in detail with reference to the accompanying drawings.

[0033] [Figure 1A] This diagram shows the locations of the Baihui (GV-20), Si Shen Cong (EX-HN1), Feng Chi (GB-20), and Shen Ting (GV-24) acupoints, which, when properly stimulated, can have beneficial effects on dementia patients. [Figure 1B] This diagram shows the locations of the Baihui (GV-20), Si Shen Cong (EX-HN1), Feng Chi (GB-20), and Shen Ting (GV-24) acupoints, which, when properly stimulated, can have beneficial effects on dementia patients. [Figure 1C] This diagram shows the locations of the Baihui (GV-20), Si Shen Cong (EX-HN1), Feng Chi (GB-20), and Shen Ting (GV-24) acupoints, which, when properly stimulated, can have beneficial effects on dementia patients. [Figure 2] This figure shows a patient wearing an exemplary head-mounted TENS device according to a particular embodiment of the present disclosure. [Figure 3] This is a side view of Figure 2. [Figure 4] This is an enlarged view of Figure 3, showing that an exemplary head-mounted TENS device has a shape that fits a normal adult skull. [Figure 5] This figure shows the inner surface of an exemplary head-mounted TENS device according to a particular embodiment of the present disclosure. [Figure 6] This figure shows three possible embodiments of a contact pad and a heating pad according to a specific embodiment of the present disclosure. [Figure 7]This is a system block diagram of a TENS device adapted to stimulate a patient's acupoints for the treatment or prevention of dementia, according to a specific embodiment of the present disclosure. [Figure 8] This flowchart shows a method for stimulating a patient's acupoints for the treatment or prevention of dementia, according to a specific embodiment of the present disclosure. [Modes for carrying out the invention]

[0034] This disclosure relates in general to devices and methods for improving cognitive function in patients with dementia. More specifically, but not limited to, this disclosure provides an ultra-low constant current head-mounted transcutaneous electrical nerve stimulation (TENS) device with thermal modality. The object of this disclosure is to improve cognitive function in patients with dementia by stimulating selected acupoints on the patient's head for the treatment or prevention of dementia.

[0035] This disclosure provides a safe and reliable means for treating and improving a condition known as dementia. As described in the previous section, dementia is caused by neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. The use of TENS is a proven therapy that can produce beneficial effects on patients and can result in both long-term and short-term improvements in cognitive behavior. The device of this disclosure is designed with the convenience of caregivers and patients in mind. Most importantly, the device is non-invasive and its use is essentially painless. Caregivers can easily attach the device to the patient's head, and the device remains in place so that the patient can perform other tasks or light exercises. The device can deliver transcutaneous electrical stimulation with a low-temperature treatment to promote blood flow to various selected acupoints. The collected data can also be streamed wirelessly to caregivers, healthcare professionals, or therapists to understand the patient's treatment status.

[0036] Benefits, advantages, solutions to problems, and elements that may produce or make more prominent such benefits, advantages, or solutions should not be construed as material, essential, or indispensable elements in any claim or in all claims. The present invention is defined solely by the appended claims, including any amendments made during the pendency of this application, and all equivalents of these claims issued.

[0037] In the claims and the specification preceding the claims set forth herein, unless explicitly stated or necessary to indicate a different context, the words “include,” “equip,” “have,” or variations thereof are used in an inclusive sense, that is, to identify the presence of the described features, but not to preclude the presence or addition of further features in the various embodiments of the present invention. As used herein, the term “neighborhood,” when used in relation to a location, refers to an area within ±1 centimeter of that location, preferably within ±0.5 centimeters of that location.

[0038] In this specification and in the claims, “joining” or “connecting” means being electrically coupled or connected, directly or indirectly, via one or more electrical means, unless otherwise specified. Unless otherwise specified, numerical ranges described herein are not limiting to individual numbers, but rather indicate all values ​​within the range individually.

[0039] This disclosure is based on the principles of acupuncture, an alternative medicine that treats patients by inserting and manipulating needles into the body at selected locations. As used herein and in the claims, “acupoint” (sometimes called an acupuncture point) refers to a selected location in the human body. Generally, an acupoint is identified by a name that follows a reference formed by a combination of letters and numbers. From this reference, the location of an organ or tissue in the body associated with or affected by that acupoint can be identified.

[0040] In this specification and in the claims, “transcutaneous electrical nerve stimulation” or “TENS” may refer to a therapeutic procedure that uses an electric current to stimulate peripheral nerves beneath the skin. When the stimulation sites are selected in accordance with traditional acupuncture, the treatment may be called electroacupuncture. Traditional acupuncture requires the insertion of a very fine needle to penetrate the skin very precisely at an acupoint. The TENS devices of this disclosure do not use such fine needles and instead use several electrodes or contact pads positioned to be placed on the skin for stimulation.

[0041] Referring to Figures 1A to 1C, the locations of the selected acupoints in accordance with this disclosure are shown: Baihui (GV-20)11, Si Shen Cong (EX-HN1)14, Feng Chi (GB-20)13, and Shen Ting (GV-24)12. The therapeutic effects of simulating different acupoints have been widely studied in the literature using various cognitive tests. Most previous studies have concluded that TENS treatment is effective for patients with vascular dementia, although the effects are sometimes temporary.

[0042] This disclosure provides a selection of acupoints that may be used in the treatment of vascular dementia. Based on recent studies of modern literature, Baihui (GV-20)11, Si Shen Cong (EX-HN1)14, Feng Chi (GB-20)13, Shuigou (GV-26)15, and Shen Ting (GV-24)12 appear to be the most relevant acupoints that may be stimulated in dementia patients as a treatment for vascular dementia.

[0043] In the practice of Traditional Chinese Medicine, acupoints, when properly stimulated, can produce beneficial effects on patients. The use of TENS on selected acupoints can achieve even better specified therapeutic effects. Because there is no skin puncture, it does not require a professional acupuncturist and can be performed by a caregiver. However, the precision of contact with and stimulation of the acupoints should not be sacrificed. Of the relevant acupoints mentioned above, Baihui (GV-20) 11, Si Shen Cong (EX-HN1) 14, Feng Chi (GB-20) 13, and Shen Ting (GV-24) 12 are selected for stimulation using the TENS device of this disclosure. These acupoints were selected considering that a device that can accurately fit TENS electrodes and thermal pads is easy to develop. As shown in Figures 1A-1C, all of these selected acupoints are located on the head 20. In particular, Baihui (GV-20) 11 and Si Shen Cong (EX-HN1) 14 are located in the vertebral region 22. The Four Gods Cong (EX-HN1) 14 is located 1 cun away from the Baihui (GV-20) 11. The Shenting (GV-24) 12 is located in the frontal region 21, 0.5 cun above the midpoint of the anterior hairline. The Fengchi (GB-20) 13 is located in the occipital region 23, where the base of the skull meets the upper part of the neck.

[0044] Figures 2-4 show various diagrams of a non-limiting, exemplary head-mounted TENS device 100. The head-mounted TENS device 100 is adapted to be worn on the patient's head 20 to transcutaneously stimulate the patient's acupoints for the treatment or prevention of dementia. By properly positioning the TENS device 100 on the head 20, the TENS electrodes can be precisely positioned over selected acupoints without the need for professional assistance. Thus, a typical caregiver can use the TENS device 100 to stimulate acupoints to improve the cognitive function of a dementia patient. In one preferred treatment, the dementia patient wears the TENS device 100 for at least one hour a day while still able to perform other tasks, and the collected data is logged for the caregiver, healthcare professional, or therapist to evaluate the treatment conditions.

[0045] The TENS device 100 may comprise a head article having a plurality of contacts 300 and one or more thermal pads concealed inside to stimulate the patient's head 20. The head article is understood to have a variety of shapes and configurations. For example, the head article may be a helmet, cap, headband, crown, headgear, headwear, hood, or any combination thereof. In one embodiment, the head article may further include tightening means for applying tension to securely hold the TENS device on the patient's head 20 so that acupoints can be stimulated. The illustrated embodiment is a non-limiting example of the TENS device 100, which may be referred to as a “head-mounted TENS device” in the claims and specification. The TENS device 100 is formed by one or more frames 200 arranged to have a contour that matches the anatomical shape of the head 20. Preferably, and optionally, one or more frames 200 include an upper frame 220 and a lower frame 230 that are adjustably connected to each other using connecting means 201. The upper frame 220 and lower frame 230 may include insertion slots 145 (shown in Figure 5) or other mounting holes for connecting means 201 and fastening means 140 (described in detail below) to provide fixation. Preferably, the connecting means 201 may include a length-adjustable strap or belt to provide flexibility for adjusting the contour to match the anatomical shape of the head 20, thereby allowing the TENS device 100 to fit patients with different head sizes. The upper frame 220 at least partially covers the frontal region 21 and parietal region 22 of the head 20 to stimulate the Baihui (GV-20) 11, Si Shen Cong (EX-HN1) 14, and Shen Ting (GV-24) 12 of the head 20. The lower frame 230 at least partially covers the occipital region 23 of the head 20 to stimulate the Feng Chi (GB-20) 13 of the head 20.

[0046] The TENS device 100 further comprises a tightening means 140 for applying tension toward acupuncture points to the upper frame 220 and the lower frame 230. The function of the tightening means 140 is to ensure that the TENS device 100 can be attached to the patient's head 20 and does not fall off even when the patient is performing other tasks or exercising.

[0047] While various fastening means 140 are conceivable, in the illustrated embodiment, the TENS device 100 is secured to the patient's head 20 by a fastening means comprising a chin strap 141 and two transverse straps 142. The chin strap 141 is fastened around the patient's chin 24. The transverse straps 142 extend from the upper frame 220 to the lower frame 230. One transverse strap 142 is located on the left side of the upper frame 220, and another transverse strap 142 is located on the right side of the upper frame 220. It is evident that the two transverse straps 142 may be replaced by one long transverse strap that runs from one side of the upper frame 220 across the lower frame 230 to a second side of the upper frame 220. The chin strap 141 and each transverse strap 142 are connected to form a Y-shaped configuration around the ear region 25 of the head 20 to secure the TENS device 100 in position on the head. In one embodiment, the chin strap 141 and the two transverse straps 142 may further include Velcro® tape, buttons, or other fasteners to improve the fit of the TENS device 100 to different patients having different head shapes.

[0048] The inner surface of one or more frames 200 is provided with a plurality of contacts 300 for contacting acupoints of the head 20, and one or more thermal pads 340 (see Figure 5) for heat treatment of the acupoints. The plurality of contacts 300 are arranged in groups. In a preferred embodiment, the plurality of contacts 300 comprises three contact groups. The first contact group 310 is configured to contact the patient's Baihui (GV-20) acupoint 11 and Sishencong (EX-HN1) acupoint 14. The second contact group 330 is configured to contact the patient's Fengchi (GB-20) acupoint 13. The third contact group 320 is configured to contact the patient's Shenting (GV-24) acupoint 12. The inventors have found that improvement in cognitive function in dementia patients is most pronounced when all three contact groups are utilized to stimulate the patient. However, it is clear that stimulation may be performed on any one or two contact groups, without departing from the scope and spirit of this disclosure. Even with only one or two contact groups, the TENS device 100 can achieve a reasonable improvement in cognitive function for the patient.

[0049] The control box 210 is mounted on the upper frame 141 and preferably positioned on top of the upper frame 141. The control box 210 includes an electrical circuit board and associated accessories for controlling a plurality of contacts 300 and one or more thermal pads 340. Electrical wiring is provided to connect the control box 210 to the upper frame 220 and the lower frame 230. In one embodiment, the control box 210 is connectable to a battery 120 via a cable 130. In an alternative embodiment, the battery 120 may be located inside the control box 210. The control box 210 further includes a communication module for sending and receiving signals from a portable device or computer device using Bluetooth or other wireless communication protocols.

[0050] The TENS device 100 further comprises a pulse-width modulation (PWM) generator 740 (shown in Figure 7) configured to generate pulsed stimulation signals to stimulate acupoints and to couple these pulsed stimulation signals to a plurality of contacts 300. In one embodiment, the PWM generator 740 is located within a control box 210. In previous studies, TENS currents of 0.7 mA or higher and constant voltages have typically been used. These TENS devices, while currently commercially available, are unbearably strong for most people. In some cases, continuous use of a TENS device can cause burns or sharp pain to the patient. This is caused by TENS currents in the mA range that typically produce strong pulses that result in a sense of stress and pain in the patient. In this disclosure, the TENS device 100 minimizes pain to the patient by using an ultra-low constant current for extended periods of 60 minutes or more. In particular, the pulsed stimulation signal has an ultra-low current of 20 μA or less, preferably an ultra-low current of 1 μA to 8 μA. In one embodiment, the pulsed stimulation signal is a square wave having a pulse frequency of 50 Hz to 200 Hz, more preferably 96 Hz to 100 Hz. The current is constant, and the pulse width is less than 120 ms. The ultra-low current is delivered for stimulation to each acupoint by coupling the pulsed stimulation signal with a low reference voltage to the patient. The low reference voltage preferably has a ground (GND) potential.

[0051] Figure 5 shows the inner surface of the TENS device 100 according to this disclosure. Three contact groups 310, 320, and 330 are shown. The first contact group 310 comprises a first contact pad 315 positioned to contact the Baihui (GV-20) acupoint 11, and four adjacent contact pads 311, 312, 313, and 314 positioned around the first contact pad 315 to contact the Si Shen Cong (EX-HN1) acupoint 14. The second contact group 330 is provided on the lower frame 230, thereby allowing the second and third contact pads 331 and 332 to be adjusted to the occipital region 23 of the head 20. The caregiver can first identify the base of the skull and the upper part of the neck, and then adjust the connecting means 201 to position the second and third contact pads 331 and 332 around the Fengchi (GB-20) acupoint 13. The third contact group 320 is located at the front of the upper frame 220 and includes a fourth contact pad 321 positioned to contact the Shenting (GV-24) 12 acupoint.

[0052] Since the shape of the head 20 varies from patient to patient, it is essential that the multiple contact pads 300 have an elastic structure. Figure 6 shows three possible embodiments of contact pads that offer different advantages.

[0053] In the first embodiment, each individual contact of the plurality of contacts 300 comprises a spring 401 and a contact pad 410. The spring 401 is positioned to press the contact pad 410 against the head 20 at the acupoint. Preferably, the contact pad 410 is a circular plate. Alternatively, the spring 401 and the contact pad 410 may be replaced with an elastic member or a piston, without departing from the scope and spirit of the present disclosure. The first embodiment was developed for patients with sparse hair, and preferably, in the first group of contacts 310, the first contact pad 315 is used as the negative terminal, and the four adjacent contact pads 311, 312, 313, and 314 are used as the positive terminals. The circular plate-shaped contact pads 410 can rest directly on the skull at the acupoint. Since each contact pad 410 can be coupled to one signal, the contact pads 410 are electrically connected to a PWM generator 740 for coupling pulsed stimulation signals or to a low reference voltage.

[0054] In the second embodiment, each individual contact of the plurality of contacts 300 comprises a spring 401 and a contact pad 410, the contact pad 410 comprising a first zone 431 and a second zone 432. The first zone 431 and the second zone 432 are separated by an insulating material 433. The first zone 431 is electrically connected to a PWM generator 740 for coupling pulsed stimulation signals, and the second zone is electrically connected to a low reference voltage. The second embodiment has been developed for use in a second group of contacts 330 and a third group of contacts 320, which are single contacts positioned to contact the Shenting (GV-24) 12 acupoints and the Fengchi (GB-20) 13 acupoints.

[0055] In the third embodiment, each individual contact of the plurality of contacts 300 comprises a spring 401 and a contact pad 420 having a plurality of pin electrodes 421. The plurality of pin electrodes 421 allow the contact pad 420 to penetrate the hair to contact the skin of the head 20. The third embodiment was developed for patients with abundant hair and preferably, in the first group of contacts 310, the first contact pad 315 is used as the negative terminal and the four adjacent contact pads 311, 312, 313, and 314 are used as the positive terminals. The spring 401 is positioned to press the plurality of pin electrodes 421 against the head 20 at the acupoint through the patient's hair. Thus, the pin electrodes 421 can ensure better contact with the skin under the hair canopy. Another advantage provided by the third embodiment is the possibility of coupling multiple signals to a single contact. As shown in the figure, at least one pin electrode 421A of the plurality of pin electrodes 421 is electrically connected to a PWM generator 740 for coupling pulsed stimulus signals, and at least one other pin electrode 421B of the plurality of pin electrodes 421 is electrically connected to a low reference voltage.

[0056] Multiple contact pads 300 must be able to couple electrical signals to the patient. Therefore, multiple contact pads 300 are made of low-resistance conductive materials such as copper, aluminum, gold, nickel, other metallic materials, or any combination thereof.

[0057] Another aspect of the present disclosure provides one or more thermal pads 340 for applying thermal modality to acupoints. In the illustrated embodiment, the upper frame 220 is provided with one thermal pad near the first contact group 310. The lower frame 230 is provided with two thermal pads near the second contact group 330. It is obvious that, without departing from the scope and spirit of the present disclosure, further thermal pads (not shown) may be provided near the third contact group 320.

[0058] One or more thermal pads 340 are electrically generated heating pads configured to deliver heat to at least one acupoint and the area surrounding at least one acupoint in a patient. As shown in Figure 6, each of the one or more thermal pads 340 comprises an electrical cable 342 and a winding 341 of a heat-conducting material for delivering temperatures in the range of 36°C to 40°C. The winding 341 may have a symmetrical wiring pattern, a spiral wiring pattern, or other patterns. The purpose of the one or more thermal pads 340 is to deliver thermal energy to at least one acupoint and the area surrounding at least one acupoint at temperatures in the range of 36°C to 40°C. A temperature rise above normal body temperature can improve blood circulation in the head, thereby improving the patient's cognitive function and memory. Each thermal pad 340 is sized and positioned to match the location of the acupoint to be stimulated. In one embodiment, the thermal pads 340 are provided on a plurality of contacts 300.

[0059] Referring to Figure 7, an exemplary system block diagram of the TENS device 100 is shown. The TENS device 100 further comprises a processor 710, a PWM generator 740, a boost regulator 750, one or more temperature sensors 771, a current sensor 720, and one or more light-emitting diode (LED) indicators 760.

[0060] In particular, one or more temperature sensors 760 acquire temperature values ​​in the vicinity of one or more thermal pads 340 to ensure that the temperature is between 36°C and 40°C. The PWM generator 740 is configured to generate a pulsed stimulation signal at the positive terminal 731, and the negative terminal 732 completes the circuit through the patient by connecting to GND or a low reference voltage. A current sensor 720 is provided to detect the current flowing to the patient through multiple contacts 300. The current sensor 720 is a high-precision current sensor capable of detecting ultra-low currents in the range of μA. The processor 710 is configured to continuously monitor and adjust one or more thermal pads 340 and the PWM generator 740 based on the temperature detected by one or more temperature sensors 771 and the current detected by the current sensor 720. The processor 710 is preferably a microcontroller embedded in the control box 210. In other alternative embodiments, the processor 710 may be a discrete control device, a computing system implemented by a portable device, a personal computer, a cloud-based server, or other electronic device capable of performing calculations. The control box 210 is also provided with one or more LED indicators 760 that show the status of the TENS device 100, and can warn the caregiver if there is any abnormal operation. The boost regulator 750 is configured to generate a reference voltage for the PWM generator 740 and other electronic components. In one embodiment, the boost regulator 750 generates a voltage range from 5V to 120V.

[0061] Figure 8 is a flowchart illustrating a method for stimulating a patient's acupoints using the TENS device 100 of this disclosure for the treatment or prevention of dementia. First, the caregiver can properly position and place the TENS device 100 on the patient's head 20 so that the multiple contacts 300 and one or more thermal pads 340 arranged on the inner surface of the TENS device 100 can properly contact the acupoints on the patient's head 20. Once this is complete, the TENS device 100 will be connected to an app 810 by wireless communication for control and data logging. The caregiver uses the app to select the intensity and processing time 820. Then, the processing begins (830). While the processing continues (850), current and temperature values ​​in the vicinity of the thermal pads 340 are recorded (840). The processor 710 periodically determines whether to continue the operation (860), and once the processing is complete, it locally saves the recorded current and temperature values ​​to the memory 870 of the TENS device 100. The output of this data can be viewed in the app from a control device or computer system. In one embodiment, this data is presented as figures and graphs. Caregivers can upload the stored data at any time to a cloud system accessible to healthcare professionals or therapists (880).

[0062] A very low constant current head-mounted TENS device with thermal modality is shown in accordance with this disclosure. It will be apparent that variations or alternatives of the above disclosure and other features and functions may be combined with many other different configurations and systems. Accordingly, this embodiment should be considered in all respects to be illustrative and not limiting. The scope of this disclosure is indicated by the appended claims rather than the above specification, and therefore all modifications that fall within the meaning and scope of equivalents of the claims are also intended to be encompassed by the claims.

Claims

1. A head-mounted transcutaneous electroneurostimulation (TENS) device adapted to be worn on the user's head to transcutaneously stimulate the user's acupoints, One or more frames arranged to have a contour that matches the anatomical shape of the head, A plurality of contacts arranged on the inner surface of one or more frames to contact the acupoints of the head, A pulse-width modulation (PWM) generator configured to generate pulse stimulation signals to stimulate the acupoints and to couple the pulse stimulation signals to the plurality of contacts, One or more thermal pads are placed on the inner surface of one or more frames in order to apply heat treatment to at least one of the acupuncture points, Equipped with, The one or more frames comprises an upper frame that at least partially covers the frontal and parietal regions of the head, and a lower frame that at least partially covers the occipital region of the head. The upper frame and the lower frame are connected in an adjustable manner using connecting means. The pulse stimulation signal is a head-mounted TENS device having an ultra-low current of 1 μA to 8 μA.

2. The plurality of contacts comprises a first group of contacts configured to contact the user's Baihui (GV-20) acupoint and Si Shen Cong (EX-HN1) acupoint. The head-mounted TENS device according to claim 1.

3. The plurality of contacts comprises a second group of contacts configured to contact the user's Fengchi (GB-20) acupoint. The head-mounted TENS device according to claim 1.

4. The plurality of contacts include a third contact configured to contact the user's Shenting (GV-24) acupoint. The head-mounted TENS device according to claim 1.

5. The aforementioned multiple contacts A first group of contacts configured to make contact with the user's Baihui (GV-20) acupoint and Si Shen Cong (EX-HN1) acupoint, A second group of contacts configured to make contact with the user's Fengchi (GB-20) acupoint, The system comprises a third contact configured to make contact with the user's Shen Ting (GV-24) acupoint, The head-mounted TENS device according to claim 1.

6. The first contact group comprises a first contact pad positioned to contact the Baihui (GV-20) acupoint, and four adjacent contact pads positioned around the first contact pad to contact the Si Shen Cong (EX-HN1) acupoint. The head-mounted TENS device according to claim 2 or 5.

7. Each individual contact of the plurality of contacts has an elastic structure made of a low-resistance conductive material. A head-mounted TENS device according to any one of claims 1 to 5.

8. The individual contact comprises a spring and a contact pad, and the spring is positioned to press the contact pad against the head at the acupoint. The head-mounted TENS device according to claim 7.

9. The contact pad is a circular plate electrically connected to the PWM generator or a low reference voltage for coupling the pulsed stimulus signal. The head-mounted TENS device according to claim 8.

10. The contact pad comprises a first zone and a second zone, The first zone and the second zone are separated by an insulating material. The first zone is electrically connected to the PWM generator for coupling the pulsed stimulus signal, and the second zone is electrically connected to a low reference voltage. The head-mounted TENS device according to claim 8.

11. The individual contact comprises a spring and a contact pad having a plurality of pin electrodes, the spring being positioned to press the plurality of pin electrodes against the head at the acupoint via the user's hair. The head-mounted TENS device according to claim 7.

12. At least one of the plurality of pin electrodes is electrically connected to the PWM generator for coupling the pulsed stimulus signal, and at least one of the other pin electrodes is electrically connected to a low reference voltage. The head-mounted TENS device according to claim 11.

13. The pulsed stimulation signal is a square wave having a pulse frequency of 50 Hz to 200 Hz. The head-mounted TENS device according to claim 1.

14. The pulse frequency is 96 Hz to 100 Hz. The head-mounted TENS device according to claim 13.

15. The one or more thermal pads are configured to deliver heat to at least one acupoint of the user and an area near at least one acupoint. A head-mounted TENS device according to any one of claims 1 to 5.

16. Each of the one or more thermal pads comprises a winding of a thermal conductive material for delivering thermal energy to the at least one acupoint and the region near the at least one acupoint at a temperature in the range of 36°C to 40°C. The head-mounted TENS device according to claim 15.

17. The connecting means includes a strap or belt for providing flexibility to adjust the contour to match the anatomical shape of the head. The head-mounted TENS device according to claim 1.

18. The upper frame and the lower frame are further provided with tightening means for applying tension toward the acupuncture points. The head-mounted TENS device according to claim 1.

19. The fastening means comprises a chin strap that is fastened around the user's chin and two transverse straps that extend from the upper frame to the lower frame. Each of the chin strap and the lateral strap is connected to form a Y-shape around the ear area to secure the head-mounted TENS device in the position on the head. The head-mounted TENS device according to claim 18.

20. One or more temperature sensors for acquiring the temperature value of a region near one or more of the thermal pads, A current sensor that detects the current flowing to the user through the plurality of contacts, A processor configured to continuously monitor and adjust one or more thermal pads and PWM generators based on the temperature detected by one or more temperature sensors and the current detected by the current sensors, A head-mounted TENS device according to any one of claims 1 to 5, further comprising:

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