A transcutaneous electrical nerve stimulator 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 relates generally to devices and methods for improving cognitive function in dementia patients, and in particular to an ultra-low constant current head-mounted transcutaneous electrical nerve stimulation (TENS) device with thermal modality adapted to stimulate acupuncture points in dementia patients to improve cognitive function. [Background technology]

[0002] Neurodegenerative diseases, sometimes referred to as Alzheimer's and Parkinson's, are a collective term for a variety of disorders that affect the nerve cells of the human brain or the peripheral nervous system. It is generally an age-dependent disease and is becoming increasingly prevalent with the growing elderly population in the community. Patients with neurodegenerative diseases suffer from a progressive deterioration of brain function, which leads to dementia with symptoms related to mobility, coordination, strength, speech, cognition, swallowing ability, etc. There are no effective therapies to treat neurodegenerative diseases, and treatments may only serve to alleviate some of the associated physical or mental symptoms.

[0003] Another group of patients suffers from dementia known as vascular dementia. It is primarily due to problems with poor blood circulation to the brain. Pre-existing medical problems including high blood pressure, smoking, diabetes, high cholesterol, a history of minor warning strokes, evidence of disease in other arteries, and heart rhythm abnormalities can contribute to vascular dementia. Pure vascular dementia is relatively rare, statistically contributing to only about 10% of cases. The majority of patients suffer from a mix of dementia resulting from various types of neurodegenerative disease in combination with vascular dementia.

[0004] Both pharmacological and non-pharmacological treatments exist to relieve patients' symptoms. Non-pharmacological interventions aim to slow the deterioration of mental abilities, allow patients to remain more independent in their daily lives, and improve the patient's wellbeing and quality of life.

[0005] Evidence suggests that a glucose or energy deficiency in the brain may be the first step to Alzheimer's disease. Improving blood circulation in patients with vascular dementia provides neurons with nutrients and energy to support their metabolic and regenerative needs. For this reason, it has been suggested that TENS may be useful. TENS is a therapeutic procedure that uses electrical currents to stimulate peripheral nerves under the skin. It is believed that TENS, which is non-invasive and has relatively few side effects, could be a treatment option for dementia patients by improving blood flow to the brain. Evidence from recent animal and human studies supports the effectiveness of using TENS to improve cognitive function.

[0006] The hippocampus and cholinergic basal forebrain (CBF) system play important roles in memory processes [1], [2]. Neurophysiological studies in animals have shown that TENS can stimulate the CBF system through different pathways to improve memory and cognitive function. Animal studies in rats have shown that TENS can directly stimulate the hippocampus through the spinoseptal pathway [3], [4] and indirectly stimulate the CBF system through 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 the major sources of noradrenergic and serotonergic neurotransmitters, respectively [8], [9]. Both the LC and DRN provide anatomical substrates to relay TENS signals and stimulate the CBF system through rostral projections of noradrenergic and serotonergic neurotransmitters [5], [6], [7]. A recent review also concluded that TENS can induce reactivation of metabolically impaired neurons

[10] , which may explain the improvement in cognitive function following repetitive 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

[11] ,

[12] ,

[13] in patients with different stages of Alzheimer's disease, repetitive TENS (5 days per week for 6 weeks) was able to induce significantly greater improvements in non-verbal 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 produced greater beneficial effects on short-term and long-term memory in patients with early stages of Alzheimer's disease compared to patients with the middle stages of Alzheimer's disease. In contrast, a recent study showed that TENS did not show any positive effects on various aspects of memory in patients with 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 function in patients with Alzheimer's disease and non-dementia concluded that TENS may improve memory, emotional behavior, and rest-activity rhythm 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 special and specified therapeutic effects. Acupuncture involves inserting thin needles into the skin very precisely at acupuncture points and must be performed by a professional acupuncturist. Although the benefits and therapeutic effects of acupuncture for patients suffering from vascular dementia are constantly being discussed and acknowledged, such alternative medicine is not very widespread and generally not very accessible to the elderly community.

[0008] The idea of ​​combining TENS with acupuncture has also been proposed. This is considered to be superior to pure acupuncture because it does not require puncturing the skin and does not require very precise identification of acupuncture points. TENS differs from transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), both of which do not require the use of acupuncture points. Electroacupuncture has also been used to improve the 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 to deliver focused microcurrents for pain management, muscle stimulation, stroke rehabilitation, and cardiovascular disease treatment

[18] ,

[19] . Since it was first patented in 1991 under U.S. Patent No. US4989605A, many companies have also developed various devices for pain treatment. Devices have been designed with a controller having four to eight pads to provide various massage modes for home use. The user may place the device in the desired position for pain relief and comfort. The frequency of the current from such devices is usually about 10 Hz to 50 Hz, and the current administered is in the mA (milliamp) range. One of the most recognized dangers has been the strength of the current delivered and used. As mentioned above, commercially available TENS devices deliver TENS currents in the mA range, which is unbearably strong for most people, not to mention the possibility of causing burns or feeling sharp pain. In addition, 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] Thus, there is a need in the art for a head-mounted device that can be easily used by unskilled caregivers to stimulate selected acupuncture points to improve cognitive function and memory in dementia patients. Furthermore, other desirable features and characteristics will become apparent from the following detailed description and the appended claims, taken in conjunction with the accompanying drawings and background of the disclosure. [Prior art documents] [Non-patent literature]

[0011] Below is a list of documents cited from time to time throughout this specification, the disclosures of each of which are incorporated herein by reference in their entirety. [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] Provided herein is an ultra-low constant current head-mounted TENS device with thermal modality adapted to stimulate acupuncture points.The objective of the present disclosure is to improve cognitive function in dementia patients by providing stimulation to selected acupuncture points 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, there is provided a head-mounted 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. 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 at least one of the acupuncture points.

[0014] In one embodiment, the plurality of contacts includes a first group of contacts configured to contact the patient's Baihui (GV-20) acupoint and Sishenso (EX-HN1) acupoint, 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) acupuncture point and four adjacent contact pads positioned around the first contact pad to contact the Si Shensou (EX-HN1) acupuncture point.

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

[0017] In one embodiment, the individual contact comprises a spring and a contact pad, the spring being 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 the pulse stimulation signal or a low reference voltage. Alternatively, 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 a PWM generator for coupling the pulse stimulation signal, and the second zone is electrically connected to a low reference voltage.

[0018] In another embodiment, the individual contacts include a spring and a contact pad having a plurality of pin electrodes, the spring being arranged to press the plurality of pin electrodes against the head at the acupuncture points through the patient's hair. Optionally, at least one pin electrode of the plurality of pin electrodes is electrically connected to a PWM generator for coupling the pulse stimulation signal, and at least one other pin electrode 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, preferably, the ultra-low current is between 1 μA and 8 μA. Optionally, the pulsed stimulation signal is a square wave having a pulse frequency of 50 Hz to 200 Hz, preferably, the pulse frequency is between 96 Hz to 100 Hz.

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

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

[0022] In one embodiment, the 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 and lower frames are adjustably connected with a connecting means, optionally comprising a strap or belt 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 fastening means for applying tension to the upper and lower frames toward the acupuncture points. Optionally, the fastening means comprises a chin strap fastened around the patient's chin and two side straps extending from the upper frame to the lower frame, the chin strap and each of the side straps being connected to form a Y-shaped configuration around the ear region to secure the head-mounted TENS device in position on the head.

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

[0026] In a second aspect of the present invention, there is provided a TENS device adapted to transcutaneously stimulate acupuncture points of a patient for the treatment or prevention of dementia, the TENS device comprising a head article, a plurality of contacts concealed within the head article for contacting acupuncture points of the head, a PWM generator configured to generate a pulsed stimulation signal to stimulate the acupuncture points and couple the pulsed stimulation signal to the plurality of contacts, and one or more thermal pads concealed within the head article for applying a thermal treatment to the acupuncture points.

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

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

[0029] In a third aspect of the present invention, there is provided a method for treating or preventing dementia in a patient, the method comprising the steps of positioning a TENS device on the patient's head, the TENS device comprising a plurality of contacts and one or more thermal pads disposed on an inner surface for contacting acupuncture points on the head; generating a pulsed stimulation signal by a PWM generator; coupling the pulsed stimulation signal to the plurality of contacts for transcutaneously stimulating the acupuncture points; and enabling the one or more thermal pads to apply thermal treatment to the acupuncture points.

[0030] In one embodiment, the method includes recording the current flowing through the patient and temperature values ​​of an area proximate one or more thermal pads, storing the current and temperature values ​​locally in a memory of the TENS device, and uploading the current and temperature values ​​to a cloud system for access by a medical professional or therapist.

[0031] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features 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 present invention are disclosed as illustrated in the following embodiments. [Brief description of the drawings]

[0032] The accompanying drawings include figures for further explaining and clarifying the above and other aspects, advantages, and features of the present disclosure. It will be understood that these drawings depict only certain embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. It will also be understood that these drawings are illustrated for simplicity and clarity and are not necessarily drawn to scale. The present disclosure will be described with more specificity and detail with reference to the accompanying drawings.

[0033] [Figure 1A] FIG. 1 illustrates the location of the Baihui (GV-20), Sishensou (EX-HN1), Fengchi (GB-20), and Shenting (GV-24) acupoints, which when properly stimulated, can have beneficial effects on dementia patients. [Figure 1B] FIG. 1 illustrates the location of the Baihui (GV-20), Sishensou (EX-HN1), Fengchi (GB-20), and Shenting (GV-24) acupoints, which when properly stimulated, can have beneficial effects on dementia patients. [Figure 1C] FIG. 1 illustrates the location of the Baihui (GV-20), Sishensou (EX-HN1), Fengchi (GB-20), and Shenting (GV-24) acupoints, which when properly stimulated, can have beneficial effects on dementia patients. [Diagram 2] FIG. 1 illustrates a patient wearing an exemplary head-mounted TENS device in accordance with certain embodiments of the present disclosure. [Diagram 3] FIG. 3 is a side view of FIG. 2. [Figure 4] FIG. 4 is an enlarged view of FIG. 3 showing that an exemplary head-mounted TENS device has a shape that conforms to a normal adult skull. [Diagram 5] FIG. 2 illustrates an inner surface of an exemplary head-mounted TENS device according to certain embodiments of the present disclosure. [Figure 6] 1A-1C illustrate three possible embodiments of contact pads and heating pads according to certain embodiments of the present disclosure. [Figure 7]FIG. 1 is a system block diagram of a TENS device adapted to stimulate acupoints of a patient for the treatment or prevention of dementia, in accordance with certain embodiments of the present disclosure. [Figure 8] 1 is a flow chart illustrating a method of stimulating acupoints on a patient for the treatment or prevention of dementia, according to certain embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] The present disclosure relates generally to devices and methods for improving cognitive function in dementia patients. More specifically, but without limitation, the present disclosure provides an ultra-low constant current head-mounted Transcutaneous Electrical Nerve Stimulation (TENS) device with thermal modality. The objective of the present disclosure is to improve cognitive function in dementia patients by providing stimulation to selected acupuncture points on the patient's head for the treatment or prevention of dementia.

[0035] The present disclosure provides a safe and reliable means to treat and improve the condition known as dementia. As discussed in the previous section, dementia is caused by neurodegenerative diseases such as Alzheimer's and Parkinson's. The use of TENS is a proven therapy to provide beneficial effects to patients and can provide both long-term and short-term improvements to cognitive behavior. The device of the present disclosure is designed for the convenience of the caregiver and patient. Most importantly, the device is non-invasive and essentially painless to use. The caregiver can simply place the device on the patient's head and the device will remain in place while the patient performs other tasks or simple exercises. The device allows transcutaneous electrical stimulation of various selected acupuncture points with mild warm therapy to promote blood flow. Additionally, the collected data can be streamed via wireless communication to the caregiver, medical professional, or therapist to keep track of the patient's treatment.

[0036] Benefits, advantages, solutions to problems, and elements that may cause or make a benefit, advantage, or solution more noticeable should not be construed as critical, essential, or essential elements of any or all claims. The invention is defined solely by the appended claims, including any amendments made during the pendency of this application, and all equivalents of those claims as issued.

[0037] In the following claims and in the specification of the invention preceding the claims, unless the context requires otherwise by express language or necessary implication, the words "comprises," "has," "comprises," "has," or variations thereof, are used in an inclusive sense, i.e., to specify the presence of the described features, but do not exclude the presence or addition of further features in various embodiments of the invention. As used herein, the term "proximate," when used in reference to a location, refers to an area within ±1 centimeter of that location, and preferably refers to an area within ±0.5 centimeters of that location.

[0038] In this specification and claims, "coupled" or "connected" means directly or indirectly electrically coupled or connected through one or more electrical means, unless otherwise specified. The recitation of numerical ranges in this specification does not limit the individual numerical values, but represents each and every value within the range individually, unless otherwise specified.

[0039] The present 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, an "acupoint" (sometimes called an acupuncture point) is a selected location on the human body. Generally, an acupuncture point is identified by a name followed by a reference formed by a combination of letters and numbers. From this reference, the location of the body organ or tissue associated with or affected by that acupuncture point can be identified.

[0040] In this specification and claims, "transcutaneous electrical nerve stimulation" or "TENS" may refer to a treatment procedure that uses electrical current to stimulate peripheral nerves beneath the skin. When the location of stimulation is selected according to traditional acupuncture, the treatment may be referred to as electroacupuncture. Traditional acupuncture requires the insertion of thin needles to penetrate the skin very precisely at acupuncture points. The TENS device of the present disclosure does not use such thin needles, but rather uses several electrodes or contact pads arranged to rest on the skin for stimulation.

[0041] 1A-1C, the locations of selected acupoints according to the present disclosure are shown: Baihui (GV-20) 11, Sishensou (EX-HN1) 14, Fengchi (GB-20) 13, and Shenting (GV-24) 12. In the literature, the therapeutic effects of simulating different acupoints have been widely studied using various cognitive tests. Most previous studies have concluded that TENS treatment for vascular dementia patients is effective, but sometimes the effects are temporary.

[0042] This disclosure provides a selection of potential acupoints that may be used to treat vascular dementia. Based on the study of modern literature, Baihui (GV-20) 11, Sishensou (EX-HN1) 14, Fengchi (GB-20) 13, Shuigou (GV-26) 15, and Shenting (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, acupuncture points, when properly stimulated, can have beneficial effects on patients. The use of TENS on selected acupuncture points can achieve even better specified therapeutic effects. Since there is no skin puncture, it does not require a professional acupuncturist and can be performed by a caregiver. However, the accuracy of contacting and stimulating the acupuncture points must not be sacrificed. Among the above relevant acupuncture points, Baihui (GV-20) 11, Sishensang (EX-HN1) 14, Fengchi (GB-20) 13, and Shenting (GV-24) 12 on the head 20 are selected for stimulation using the TENS device of the present disclosure. These acupuncture points are selected in consideration of the ease of developing a device that can accurately fit the TENS electrodes and thermal pads. As shown in Figures 1A-1C, all these selected acupuncture points are located on the head 20. In particular, Baihui (GV-20) 11 and Sishensang (EX-HN1) 14 are located in the parietal region 22. The Four Gods' Souls (EX-HN1) 14 is located 1 sun around the Baihui (GV-20) 11. The Shenbai (GV-24) 12 is located in the frontal region 21, 0.5 sun 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 top of the neck.

[0044] 2-4 show various views of a non-limiting exemplary head-mounted TENS device 100. The head-mounted TENS device 100 is adapted to be worn on a patient's head 20 to transcutaneously stimulate the patient's acupuncture points for the treatment or prevention of dementia. By properly positioning the TENS device 100 on the head 20, the TENS electrodes are precisely positioned over the selected acupuncture points without professional assistance. Thus, it is possible for a regular caregiver to use the TENS device 100 to stimulate the acupuncture points to improve the cognitive function of the dementia patient. In one preferred treatment, the dementia patient wears the TENS device 100 for at least one hour per day while being able to perform other tasks, and the collected data is kept in a log for the caregiver, medical professional, or therapist to evaluate the treatment condition.

[0045] The TENS device 100 may comprise a head article having a plurality of contacts 300 and one or more thermal pads concealed therein for providing stimulation to the patient's head 20. It is understood that the head article may have a variety of shapes and configurations. For example, the head article may be a helmet, a hat, a headband, a crown, a headgear, a headwear, a hood, or any combination thereof. In an embodiment, the head article may further comprise a fastening means for providing tension to hold the TENS device firmly to the patient's head 20 so that acupuncture points can be stimulated. The illustrated embodiment is a non-limiting example of a TENS device 100, which may be referred to in the claims and specification as a "head-mounted TENS device." 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, the one or more frames 200 include an upper frame 220 and a lower frame 230 adjustably connected to each other using a connecting means 201. The upper frame 220 and the lower frame 230 may include insertion slots 145 (shown in FIG. 5) or other attachment holes for the connecting means 201 and fastening means 140 (described in detail below) to provide fixation. Preferably, the connecting means 201 may include an adjustable length strap or belt to provide flexibility to adjust the contour to match the anatomical shape of the head 20, so that the TENS device 100 can 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, the Shishensou (EX-HN1) 14, and the Shenting (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 Fengchi (GB-20) 13 of the head 20.

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

[0047] Although various fastening means 140 are possible, in the illustrated embodiment, the TENS device 100 is secured to the patient's head 20 by fastening means comprising a chin strap 141 and two lateral straps 142. The chin strap 141 is fastened around the patient's chin 24. The lateral straps 142 extend from the upper frame 220 to the lower frame 230. There is one lateral strap 142 on the left side of the upper frame 220 and another lateral strap 142 on the right side of the upper frame 220. It will be apparent that the two lateral straps 142 may be replaced by one long lateral strap disposed from one side of the upper frame 220 across the lower frame 230 to the second side of the upper frame 220. The chin strap 141 and each lateral 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 side 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 the one or more frames 200 is provided with a plurality of contacts 300 for contacting the acupuncture points of the head 20 and one or more thermal pads 340 (see FIG. 5) for applying heat treatment to the acupuncture points. 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 for contacting the patient's Baihui (GV-20) 11 acupuncture point and the Sishensou (EX-HN1) 14 acupuncture point. The second contact group 330 is configured for contacting the patient's Fengchi (GB-20) 13 acupuncture point. The third contact 320 is configured for contacting the patient's Shenting (GV-24) 12 acupuncture point. The inventors have found that the improvement of cognitive function in dementia patients is most significant 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 the present disclosure. Whether having one or two contacts, the TENS device 100 can achieve a reasonable improvement in cognitive function for the patient.

[0049] A control box 210 is attached to, and preferably disposed on, the upper frame 141. The control box 210 includes an electrical circuit board and associated accessories for controlling the 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 the battery 120 via the cable 130. In an alternative embodiment, the battery 120 may be located within the control box 210. The control box 210 further includes a communication module for transmitting and receiving signals from a portable or computing device using Bluetooth or other wireless communication protocols.

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

[0051] 5 shows an inner surface of a TENS device 100 according to the present disclosure. Three contact groups 310, 320, 330 are shown. The first contact group 310 includes a first contact pad 315 positioned to contact the Baihui (GV-20) 11 acupuncture point and four adjacent contact pads 311, 312, 313, 314 positioned around the first contact pad 315 to contact the Si Shenzong (EX-HN1) 14 acupuncture point. The second contact group 330 is provided on the lower frame 230, which adjustably positions the second and third contact pads 331, 332 on the occipital region 23 of the head 20. A caregiver can first identify the base of the skull and the top of the neck, and then adjust the connection means 201 to position the second and third contact pads 331, 332 around the Fengchi (GB-20) 13 acupuncture point. The third contact group 320 is provided on the front of the upper frame 220 and includes a fourth contact pad 321 positioned to contact the Shintai (GV-24) 12 acupuncture point.

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

[0053] In the first embodiment, each individual contact of the plurality of contacts 300 includes a spring 401 and a contact pad 410. The spring 401 is arranged to press the contact pad 410 against the head 20 at the acupuncture point. 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 is developed for patients with less hair, and preferably, in the first contact group 310, the first contact pad 315 is used as a negative terminal and the four adjacent contact pads 311, 312, 313, 314 are used as positive terminals. The circular plate-like contact pad 410 can be directly placed on the skull at the acupuncture point. Each contact pad 410 can be coupled to a signal, so that the contact pads 410 are electrically connected to a PWM generator 740 for coupling a pulse stimulation signal or electrically connected 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 a pulsed stimulation signal, and the second zone is electrically connected to a low reference voltage. The second embodiment is developed for use with the second contact group 330 and the third contact group 320, which are single contacts positioned to contact the GV-24 12 acupuncture point and the GB-20 13 acupuncture point.

[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 allows the contact pad 420 to penetrate the hair to contact the skin of the head 20. The third embodiment is developed for patients with a lot of hair, and preferably uses the first contact pad 315 as a negative terminal and the four adjacent contact pads 311, 312, 313, 314 as positive terminals in the first contact group 310. The spring 401 is arranged to press the plurality of pin electrodes 421 against the head 20 at the acupuncture points 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 one contact. As shown, at least one pin electrode 421A of the plurality of pin electrodes 421 is electrically connected to a PWM generator 740 for coupling a pulse stimulation signal, and at least one other pin electrode 421B of the plurality of pin electrodes 421 is electrically connected to a low reference voltage.

[0056] The contact pads 300 are required to be able to couple electrical signals to the patient, and therefore are made of a low resistance conductive material 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 modalities to acupuncture points. In the illustrated embodiment, the upper frame 220 is provided with one thermal pad near the first group of contacts 310. The lower frame 230 is provided with two thermal pads near the second group of contacts 330. It should be apparent that additional thermal pads (not shown) may be provided near the third group of contacts 320 without departing from the scope and spirit of the present disclosure.

[0058] The one or more thermal pads 340 are electrically generated heating pads configured to deliver heat to at least one acupuncture point of a patient and to an area proximate the at least one acupuncture point. As shown in FIG. 6, each of the one or more thermal pads 340 includes an electrical cable 342 and a winding 341 of a thermally conductive material for delivering a temperature 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 the at least one acupuncture point and to an area proximate the at least one acupuncture point at a temperature in the range of 36° C. to 40° C. The increase in temperature above normal body temperature can improve blood circulation in the head, which can improve the patient's cognitive function and memory. Each thermal pad 340 is sized and positioned to correspond to the location of the acupuncture point to be stimulated. In an embodiment, the thermal pads 340 are provided on a plurality of contacts 300.

[0059] 7, there is shown an exemplary system block diagram of the TENS device 100. 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, the one or more temperature sensors 760 obtain temperature values ​​of an area in the vicinity of the 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 a circuit through the patient by connecting to GND or a low reference voltage. The current sensor 720 is provided to detect a current flowing through the plurality of contacts 300 to the patient. The current sensor 720 is a high-precision current sensor capable of detecting ultra-low currents in the μA range. The processor 710 is configured to continuously monitor and adjust the one or more thermal pads 340 and the PWM generator 740 based on the temperature detected by the 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 to indicate the status of the TENS device 100 and can alert a caregiver in the event of 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] FIG. 8 is a flow chart showing a method of stimulating acupuncture points of a patient using the TENS device 100 of the present disclosure for treating or preventing dementia. First, the caregiver can properly place and position the TENS device 100 on the head 20 so that the multiple contacts 300 and one or more thermal pads 340 disposed on the inner surface of the TENS device 100 can properly contact the acupuncture points of the patient's head 20. Once this is completed, the TENS device 100 will be connected to an app 810 by wireless communication for control and data logging. Using the app, the caregiver selects the intensity and processing time 820. Processing is then started (830). As processing continues (850), current and temperature values ​​of an area adjacent to the thermal pad 340 are recorded (840). The processor 710 periodically determines (860) whether the operation processing should continue, and when processing is completed, the recorded current and temperature values ​​are stored locally in the memory 870 of the TENS device 100. The output of these data can be viewed by the app from the control device or computer system. In some embodiments, these data are presented as charts and graphs. At any time, the caregiver can upload the stored data (880) to a cloud system that is accessible to medical personnel or therapists.

[0062] In accordance with the present disclosure, an ultra-low constant current head-mounted TENS device with thermal modality is presented. It will be apparent that the above-disclosed and other features and functions of the modified or alternative embodiments can be combined into many other different configurations and systems. Therefore, the present embodiment should be considered in all respects as illustrative and not restrictive. The scope of the present disclosure is indicated by the appended claims, rather than the above specification, and therefore all changes that come within the meaning and range of equivalence of the claims are intended to be embraced therein.

Claims

1. 1. A head-mounted transcutaneous electrical nerve stimulation (TENS) device adapted to be worn on a user's head to transcutaneously stimulate acupuncture points of the user, comprising: one or more frames arranged to have a contour that matches the anatomical shape of the head; a plurality of contacts disposed on an inner surface of the one or more frames for contacting the acupuncture points of the head; a pulse width modulation (PWM) generator configured to generate a pulsed stimulation signal to stimulate the acupuncture point and to couple the pulsed stimulation signal to the plurality of contacts; one or more thermal pads disposed on the inner surface of the one or more frames for applying heat treatment to at least one of the acupuncture points; A head-mounted TENS device comprising:

2. the plurality of contacts comprises a first group of contacts configured to contact the Baihui (GV-20) acupuncture point and the Sishenso (EX-HN1) acupuncture point of the user; The head-mounted TENS device of claim 1 .

3. the plurality of contacts includes a second group of contacts configured to contact Fengchi (GB-20) acupuncture points of the user. The head-mounted TENS device of claim 1 .

4. the plurality of contacts includes a third contact configured to contact a GV-24 acupuncture point of the user; The head-mounted TENS device of claim 1 .

5. The plurality of contacts include a first set of contacts configured to contact the Baihui (GV-20) acupuncture point and the Sishenso (EX-HN1) acupuncture point of the user; a second set of contacts configured to contact the user's Fengchi (GB-20) acupuncture points; and a third contact configured to contact the user's Shinba (GV-24) acupuncture point. The head-mounted TENS device of claim 1 .

6. the first contact group comprises a first contact pad positioned to contact the Baihui (GV-20) acupuncture point, and four adjacent contact pads positioned around the first contact pad to contact the Sishenso (EX-HN1) acupuncture point; A head-mounted TENS device according to claim 2 or 5.

7. each individual contact of the plurality of contacts has a resilient 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 contacts include a spring and a contact pad, the spring being positioned to press the contact pad against the head at the acupuncture point. The head-mounted TENS device of 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 stimulation signal; The head-mounted TENS device of 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 stimulation signal, and the second zone is electrically connected to the low reference voltage; The head-mounted TENS device of claim 8.

11. The individual contacts include a spring and a contact pad having a plurality of pin electrodes, the spring being arranged to press the plurality of pin electrodes against the head at the acupuncture points via the user's hair. The head-mounted TENS device of claim 7.

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

13. The pulse stimulation signal has an ultra-low current of 20 μA or less, and preferably, the ultra-low current is 1 μA to 8 μA. A head-mounted TENS device according to any one of claims 1 to 5.

14. The pulse 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.

14. The head-mounted TENS device of claim 13.

15. the one or more thermal pads are configured to deliver heat to at least one acupuncture point and an area proximate to the at least one acupuncture point of the user; 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 thermally conductive material for delivering thermal energy to the at least one acupuncture point and the area proximate the at least one acupuncture point at a temperature in the range of 36° C. to 40° C.; 16. A head-mounted TENS device as described in claim 15.

17. The one or more frames include an upper frame at least partially covering a frontal region and a parietal region of the head, and a lower frame at least partially covering an occipital region of the head. A head-mounted TENS device according to any one of claims 1 to 5.

18. The upper frame and the lower frame are adjustably connected using a connecting means.

18. A head-mounted TENS device as described in claim 17.

19. the connecting means comprises a strap or belt to provide flexibility to adjust the contour to conform to the anatomical shape of the head; 20. The head-mounted TENS device of claim 18.

20. Further, a fastening means is provided for applying tension to the upper frame and the lower frame toward the acupuncture point.

18. A head-mounted TENS device as described in claim 17.

21. the fastening means comprises a chin strap which is fastened around the user's chin and two lateral straps which extend from the upper frame to the lower frame; the chin strap and the side straps are each connected to form a Y-shaped configuration around an ear region to secure the head-mounted TENS device in position on the head.

21. The head-mounted TENS device of claim 20.

22. one or more temperature sensors for obtaining temperature values ​​of areas proximate the one or more thermal pads; a current sensor for detecting a current flowing to the user through the plurality of contacts; a processor configured to continuously monitor and adjust the one or more thermal pads and the PWM generator based on the temperature detected by the one or more temperature sensors and the current detected by the current sensor; The head-mounted TENS device according to any one of claims 1 to 5, further comprising:

23. 1. A transcutaneous electrical nerve stimulation (TENS) device adapted to transcutaneously stimulate an acupuncture point of a user, comprising: A head article; a plurality of contacts concealed within the head article for contacting the acupuncture points on the head; a pulse width modulation (PWM) generator configured to generate a pulse stimulation signal to stimulate the acupuncture point and to couple the pulse stimulation signal to the plurality of contacts; one or more thermal pads concealed within the head article for applying heat to at least one of the acupuncture points; A TENS device comprising:

24. The plurality of contacts include a first set of contacts configured to contact the Baihui (GV-20) acupuncture point and the Sishenso (EX-HN1) acupuncture point of the user; a second set of contacts configured to contact the user's Fengchi (GB-20) acupuncture points; and a third contact configured to contact the user's Shinba (GV-24) acupuncture point.

24. The TENS device of claim 23.

25. the first contact group comprises a first contact pad positioned to contact the Baihui (GV-20) acupuncture point, and four adjacent contact pads positioned around the first contact pad to contact the Sishenso (EX-HN1) acupuncture point; 25. The TENS device of claim 24.

26. each individual contact of the plurality of contacts has a resilient structure made of a low resistance conductive material; 25. A TENS device as claimed in claim 23 or 24.

27. The individual contacts include a spring and a contact pad, the spring being positioned to press the contact pad against the head at the acupuncture point.

27. The TENS device of claim 26.

28. the contact pad is a circular plate electrically connected to the PWM generator or a low reference voltage for coupling the pulsed stimulation signal; 28. The TENS device of claim 27.

29. 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 stimulation signal, and the second zone is electrically connected to a low reference voltage; 28. The TENS device of claim 27.

30. The individual contacts include a spring and a contact pad having a plurality of pin electrodes, the spring being arranged to press the plurality of pin electrodes against the head at the acupuncture points via the user's hair.

27. The TENS device of claim 26.

31. At least one pin electrode of the plurality of pin electrodes is electrically connected to the PWM generator for coupling the pulsed stimulation signal, and at least one other pin electrode of the plurality of pin electrodes is electrically connected to a low reference voltage.

31. The TENS device of claim 30.

32. the one or more thermal pads are configured to deliver heat to at least one of the acupuncture points and to an area of ​​the user proximate to the at least one acupuncture point; 25. A TENS device as claimed in claim 23 or 24.

33. and a fastening means for applying tension to hold the TENS device firmly against the head.

25. A TENS device as claimed in claim 23 or 24.

34. The head article is a helmet, a hat, a headband, a crown, a headgear, a headwear, a hood, or any combination thereof; 25. A TENS device as claimed in claim 23 or 24.

35. 1. A method of stimulating a selected acupuncture point of a user, comprising: positioning a transcutaneous electrical nerve stimulation (TENS) device on the user's head, the TENS device comprising a plurality of contacts and one or more thermal pads disposed on an inner surface thereof for contacting acupuncture points on the head; generating a pulsed stimulus signal by a pulse width modulation (PWM) generator; coupling the pulse stimulation signal to the plurality of contacts to transcutaneously stimulate the acupuncture points; enabling the one or more thermal pads to apply heat treatment to the acupuncture points; A method comprising:

36. The plurality of contacts include: a first set of contacts configured to contact the Baihui (GV-20) acupuncture point and the Sishenso (EX-HN1) acupuncture point of the user; a second set of contacts configured to contact the user's Fengchi (GB-20) acupuncture points; and a third contact configured to contact the user's Shinba (GV-24) acupuncture point.

36. The method of claim 35.

37. the first contact group comprises a first contact pad positioned to contact the Baihui (GV-20) acupuncture point, and four adjacent contact pads positioned around the first contact pad to contact the Sishenso (EX-HN1) acupuncture point; 37. The method of claim 36.

38. recording a current flowing through the user and a temperature value in an area adjacent the one or more thermal pads; storing said current and said temperature values ​​locally in a memory of said TENS device; uploading the current and temperature values ​​to a cloud system for access by a medical professional or therapist; 36. The method of claim 35, further comprising:

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