Self-applied supracutaneous acupressure for overactive bladder

Abstract

A device having a body defining at least one curved solid surface configured for manual supracutaneous stimulative pressure to a bodily acupoint resulting in a physiological response to a nerve leading to the spinal cord entry level and the brainstem to block or lessen overactive nerve impulses associated with overactive bladder (OAB), including nocturia, that result in a frequent urge to urinate. The body is shaped to interact and conform with the musculature and dermal folds that make up the soft contours of the human body to remain in place and to further promote stimulation of relevant acupoints.

Description

SELF-APPLIED SUPRACUTANEOUS ACUPRESSURE FOR OVERACTIVE BLADDERRELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 621,231, filed on January 16, 2024, the disclosure of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure relates to devices, systems, and methods for relief of urges to urinate associated with overactive bladder (OAB) and nocturia to promote healthy sleep outcomes.BACKGROUND

[0003] Known also as overactive bladder syndrome, OAB is a condition in which a frequent feeling of an urge or a need to urinate exists to such a degree that it results in situations that negatively affect a person’s life. A related condition, nocturia, as defined by the International Continence Society (ICS), is where an individual has to wake at night one or more times for voiding (i.e. to urinate). The effect of OAB, nocturia, or both may result in a chronic inability to attain regular and extended sleep throughout the night, thus, causing exhaustion, inability to function while awake, depression, a lack of sociability, a lessening of cognitive and bodily functions, a decrease in work performance, and a decrease in quality of life, all of which result in additional medical, bodily, mental, and psychological ailments and dysfunction. Often OAB and nocturia are age related, but can also be related to other physiological diseases and anomalies.

[0004] With respect to numbers, an analysis of forty -three (43) separate studies in 2010 showed that, even among the young age range of 20-40 years of age, already between approximately 2-17% of men and 4-18% of women live with an overactive bladder that requires more than two or more (2+) trips to the bathroom each night (Bosch JL, Weiss JP. The prevalence and causes of nocturia. J Urol. 2010 Aug; 184(2): 440-6. doi: 10.1016 / j.juro.2010.04.011. Epub 2010 Jun 17. PMID: 20620395). As humans age, the condition generally worsens. As to the age group of those over seventy (70) years of age and older, for men the number is between 29-59% for men and 28-62% among women. (Bosch, supra). In the European Union (EU), specifically, the numbers have been shown to be quite similar. Among the broader age range of 40-99 years of age, those numbers have beenestimated to be on average 12.9% for women and 15% for men (van Kerrebroeck P, Holm- Larsen T. The cost of nocturia in Europe. Int. Urogynecol. J. 201 l;22(Suppl 2):S355-S356). All in all, this condition affects hundreds of millions of people all across the world.

[0005] In the United States, in 2008 wages, the economic value of productivity lost in relation to nocturia requiring 2+ trips to the bathroom each night was estimated to be $61 billion per year, with estimated medical costs of injuries due to falls alone being an additional $1.5 billon (Holm-Larsen T, Weiss J, Langkilde L, Economic burden of nocturia in the U.S. adult population 2. J Urol. 2010 Apr; 183(4):el-el. doi: 10.1016 / j.juro.2010.02.045). Within the European Union alone, the economic costs of nocturia in just the E-15, that is, fifteen (15) of the EU’s twenty-seven (27) member nations, was once estimated, at 2007 wages, in cases of 3+ trips to the bathroom each night, to be approximately €29 billion each year and with nocturia related hip fractures alone adding an additional estimated €1 billion per year, (van Kerrebroeck, supra). Thus, the economic costs of OAB worldwide can certainly be said to be both momentous and extensive.

[0006] The condition is characterized by four main symptoms: urgency (e.g., a sudden, compelling desire to pass urine that is difficult to defer); urinary frequency (e.g., feeling the need to urinate more than eight times a day); nocturia (e.g., interrupted sleep caused by an urge to urinate); and urge incontinence (e.g., urinary incontinence characterized by the involuntary loss of urine occurring for no apparent reason while urinary urgency is experienced).

[0007] Generally, the urge to urinate manifests itself as a physical bodily pressure perceived through the senses of the body’s central nervous system, daytime or nighttime, at times in one (1) but often in both of two (2) key specific body portions, these being, firstly, in the lower pelvic region running from between the anus and upward to the urethra (the “lower pelvic region”), resulting in a “lower pelvic urge,” and, secondly, in the upper frontal pelvic region, that is, in the bladder, located directly below the navel and centered on and extending slightly upward from behind the pubic symphysis cartilage (the “bladder region”), resulting in an “upper frontal urge.” While both urges most often present simultaneously, these are each separate urges and are capable of being controlled, at least temporarily, by distinct means.

[0008] The causes of an overactive bladder can vary. Risk factors include age, obesity, constipation (or an otherwise full bowel) as well as caffeine, sodium, sugar, and alcohol consumption. Poorly controlled diabetes, poor functional mobility, and chronic pelvic painmay also result in the symptoms of OAB becoming worse. Other factors can include, among other things, nocturnal polyuria, benign prostatic obstruction, detrusor overactivity, reduced bladder capacity, uncompensated heart disease, kidney disease or deficiencies, cancer, infections, untreated diabetes mellitus or insipidus, estrogen deficiency, primary polydipsia, and psychological sleep problems.

[0009] To the detriment of those suffering from these conditions, it often remains difficult to successfully treat an overactive bladder. Behavioral treatment methods, such as bladder training, pelvic floor exercises, and life-style changes are often difficult for sufferers to maintain, and, thus, are often unsuccessful in treating an overactive bladder. Medications too are also problematic since they are often associated with negative bio-chemical and physiological side effects, and, thus, may be no more effective than behavioral methods.

[0010] Among the most ancient forms of providing relief from pain and overactive nerve impulses is by means of the stimulation of myofascial trigger points using dry needling acupuncture, acupressure, intense cold, intense heat, or by chemical irritation, as in medicinal plasters. Each of these, of course, for various but rather obvious reasons, have not generally been acceptable interventions in treating maladies relating to the genitals and the groin area. Whereas acupuncture is an invasive treatment that punctures the surface of the skin using extremely thin needles that are strategically placed upon specific acupoints over certain parts of the body to apply pressure, in acupressure, manual or physical pressure, usually using the fingertips or a mechanical device, is applied to the body’s acupoints.

[0011] Relief of overactive nerve impulses or pain by distant trigger points has been described as the “gate control theory.” It was first in 1972 that Pang L. Man and Calvin H. Chen devised the theory, the two-gate control theory, known in common parlance as the gate control theory, to explain the effectiveness of acupuncture. (Man PL, Chen CH. Mechanism of acupunctural anesthesia. The two-gate control theory. Dis Nerv Syst. 1972Nov;33(l l):730-5. PMID: 4347637). According to the gate control theory, an acupuncture or acupressure mechanism can lead to stimulation of the large transmitter fibers of the nervous impulses to the spinal cord, thus, resulting in the closure of the nerve impulse or pain transmission gates and, thereby, achieving a dissipation of the overactive nerve impulse, meaning a reduction of pain. (Stux G, Pomeranz B. Basics of acupuncture. 5th ed. Berlin: Springer; 2003. 367 p., 8-11, 23-40, 189-234 pp.; Akbarzadeh M, Moradi Z, Zare N, Fard MJH, Jowkar A. If different acupressure points have the same effect on the pain severity of active phase of delivery among primiparous women referred to the selected hospitals ofShiraz University of Medical Sciences. Asian J. Inf. Manag. 2015 Jan;9(l): l-8. doi: 10.3923 / ajim.2015.1.8). Brainstem areas are known to exhibit a powerful inhibiting control over transmission within the pain or nerve impulse signaling system. These neurological areas may be seen as a central biasing system receiving inputs from remote parts of the body and projecting them inward towards remote parts of both the spinal cord and the brain. The stimulation of particular nerves or tissues, characterized by certain acupoints, has been known to bring about an increased input to the central biasing mechanism, which, in turn, is capable of closing the gate to inputs from selected body areas.

[0012] More specifically, the body contains receptors for receiving the body’s signals of stress or pain that are known as nociceptors. These consist of nerve cell endings that respond to signals of bodily stress of some kind, where it concerns signals relating to the body’s most basic and fundamental physical needs, or that respond to signals of tissue damage, where it concerns signals relating to a bodily injury of some kind.

[0013] In the case of acupuncture and acupressure points, three-hundred and sixty-one (361) recognized pressure or reflective points all-in-all, these are located at very special areas under the skin that also contain neural vascular bundles, meaning that underneath the skin in these places there are free nerve endings, an artery and vein, a lymphatic vessel, and mast cells. Mast cells are special types of cells within the body that release a bio-chemical known as a histamine. The release of histamine serves as an important step in triggering the immune system to respond during stress or inflammation.

[0014] It is these receptors, the nociceptors, which initiate the stress or pain signal to be dispatched to the brain. The information in this signal is relayed to the spinal cord via two (2) sorts of nerve pathways. The “A-Delta fiber,” which is the smaller nerve fiber that possesses a protective covering called myelin, which greatly increases the speed of the information transmitted, and the “C fiber,” which does not possess the myelin covering and, thus, transmits the information making up the stress or pain signal on the way to the brain far more slowly.

[0015] Upon reaching the spinal cord, the signal transits across various areas within the spinal cord via a pathway known as the “Tract of Lissauer.” The signal then traverses the spinal cord from one side to the other and then continues upward toward the brain. Most of a stress or pain sensation signal is processed in the brainstem, that is, within the lower portion of the brain. A portion of the signal arrives at the thalamus, hypothalamus, pituitary, and themid-brain area. While still a lesser amount of the signal will arrive at the higher center located in the area of the cerebral cortex.

[0016] To avoid experiencing the body’s signal of stress or pain, there are three (3) basic options for avoiding it: 1) prevent the signal from getting to the spinal cord; 2) prevent the signal from reaching the brain; or 3) prevent the signal from being processed within the brain’s various reception centers. This is, in effect, what both acupuncture and acupressure accomplish. Each prevents, in fact, blocks, the stress or pain signal sent from a bodily area from reaching the place where the body intends it to arrive.

[0017] When an acupuncture or acupressure point is stimulated, the local nerve fibers are activated by that external sensory input such as that of the non-painful insertion of an acupuncture needle, by the application of non-painful pressure or touch using acupressure, or by the application of non-painful physical or electrical vibration or current to the body. Both painful and non-painful external mechanical and thermal inputs travel through precisely the same pathways, the A-Delta fibers and C fibers. The bio-chemical inputs of bodily stress or pain, however, that result in the sending of these signals are only allowed to travel via the slower C fibers. All of these types of signals eventually arrive at the spinal cord, brainstem, or the mid-brain area, those traveling along the A-Delta fibers, however, are capable of arriving more quickly.

[0018] In reaction to the external thermal or mechanical sensory inputs applied by acupuncture or acupressure, these centers in the brain then send out neurotransmitters to block the stress or pain signals. In practical terms, neurotransmitters can be seen as minidefenders, launched by external inputs via acupuncture or acupressure, that are then sent out to block feelings of stress or pain by blocking the stress or pain signal’s access to the different areas of the brain so that the stress or pain signal is rendered unable to enter and register.

[0019] Stated from the perspective of the gate control theory, the region in the spinal cord responsible for relaying messages of bodily stress or pain to the brain is known as the substantial gelatinous. The external mechanical sensory input from acupuncture needles, for example, or a mechanical acupressure device exerting force on an acupoint, travels faster via the myelinated nerve fibers, that is, the A-Delta fibers, and, thus, this information arrives at the substantial gelatinous more quickly than do the bio-chemical inputs signaling stress or pain impulses produced by the body that can only travel along the slower acting nerve fibers,the non-myelinated C fibers. As a result, the impulse initiated by acupuncture or acupressure is able to arrive first and close a gateway that would otherwise allow more stress or pain signals to get through to the brain.

[0020] In short, sensory information sent out via the body’s A-Delta nerve pathways by means of acupuncture and acupressure, that is, non-painful thermal or mechanical impulses, are capable of traveling faster than the body’s own bio-chemically derived stress or pain impulses that are restricted to travel via the body’s slower C fibers. Thus, the non-painful impulses sent by means of, for example, manual pressure placed upon an acupressure device arrive to the processing center in the spinal cord more quickly, thus closing the gate, and thus, at least temporarily, blocking all subsequent bodily stress or pain signals.

[0021] By temporarily blocking an overactive bodily stress signal that is overactively - and sometimes falsely - indicating a need or an urge to urinate, which thus causes the sufferer to repeatedly wake up, void urine (often in a quantity well less than the bladder is capable of holding), and then to attempt to fall back to sleep again - only to have this experience repeat again multiple times throughout the same night, each and every night, it is in this way that a sufferer of an overactive bladder can easily, without medication, and with little expense, time, or trouble, perhaps ultimately attain a full eight (8) hours of solid sleep per night. Or, in the worst case, at least hopefully extend the periods of their sleep cycle so that, at minimum, they can add to the number of hours of continuous sleep that they actually do attain each night.

[0022] In the world of Chinese acupuncture, there are one-hundred and twelve (112) pressure points located along the surface of the human body. Among these, there are three-hundred and sixty-one (361) named pressure or reflective points that are categorized into twelve (12) primary meridians and two (2) major extraordinary vessels, as follows: Heart Meridian (HT1- 9), Pericardium Meridian (PC 1-9), Lung Meridian (LUI-11), Spleen Meridian (SP1-21), Liver Meridian (LR1-14), Kidney Meridian (KI1-27), Small Intestine Meridian (SI1-19), Triple Energizer Meridian (TE1-23), Large Intestine Meridian (LI1-20), Stomach Meridian (STI-45), Gallbladder Meridian (GB1-44), Urinary Bladder Meridian (BL1-67), Conception Vessel (CV1-24), and Governing Vessel (GV1-28).

[0023] According to Chinese medical philosophy, these three-hundred and sixty-one (361) pressure or reflective points act as “sensors” spread across the human body. A maleffected organ registers its distress or discomfort upon certain of these, which can often be both intuitively and physiologically distant from the actual organ effected. When touched, thosepressure points “registering” the distress or discomfort signal are often felt by the sufferer to present sensations in the form of reflective numbness, pain, or soreness or, physically, as a node, cramp, or lump. The acupuncture needle may be used as a direct and effective means to apply stimulation to these acupoints. The human fingers or hand, or a device in their grasp, employing the principles of acupressure, have also shown good effect.

[0024] Acupuncture and acupressure have gradually gained acceptance with respect to their medical benefits, particularly in the relief and management of undesirable nerve impulses and pain. As a consequence of and in recognition of this acceptance, a uniform, standardized nomenclature for acupuncture and these acupoints was published in 1993. (World Health Organization (WHO), Standard acupuncture nomenclature: a brief explanation of 361 classical acupuncture point names and their multilingual comparative list. 2nd ed. Manila: WHO; 1993. 266 p.).

[0025] With the above well in mind, the great need for developing and making available to the afflicted devices and methods that are capable of managing and lessening the suffering from an overactive bladder, especially in those cases, such as nocturia, in which healthy sleep patterns are also interfered with, has become very readily apparent.

[0026] Over the years, various methods of treating and suppressing OAB and nocturia have become known, including, among these, the development of a variety of pharmaceutical preparations, therapeutic agonist compounds used to chemically stimulate therapeutic points within the body, supracutaneous electro-acupressure devices, and implantable electroacupuncture devices. These latter systems generally consist of a physical device, whether external to the human body or implantable, that stimulates the central nervous system via its various acupoints.

[0027] U.S. Patent Application No. 2021 / 0379382, filed by Michael Sasha John, et al., published December 9, 2021, and entitled, “Methods for Treating the Symptoms of Nocturia,” provides for methods for treating nocturia. It includes methods for assessing and identifying a person suffering from nocturia. Generally, a neurostimulator having a processor is connected to an electrical generator. The processor receives data from the person obtained during a sleep stimulation protocol. A determination is then made as to whether the data in conjunction with the sleep stimulation protocol indicates a nocturia condition. If so, a therapy regimen provides electrical or magnetic stimulation to the leg of the person between the ankle and knee per the sleep stimulation protocol.

[0028] U.S. Patent Application No. 2021 / 0101007, filed by Samuel Richard Hamner, et al., published April 8, 2021, and entitled, “Systems, Methods and Devices for Peripheral Neuromodulation for Treating Diseases Related to Overactive Bladder,” describes systems and methods that include a wearable device with an electrically conductive skin interface that stimulates the underlying nerves by means of a transcutaneous surface stimulator. The stimulation can include burst stimulation and involve receiving input relating to autonomic nervous system activity of the patient and, when fitting, modifying at least one brain or spinal cord autonomic feedback loop relating to bladder function based on input suggesting a need to balance parasympathetic and sympathetic nervous system activity of the patient. The device can be sized for a range of user sizes with stimulation electrodes positioned to target the appropriate acupoints, for example, the saphenous nerves, tibial nerves, or combinations thereof.

[0029] U.S. Patent No. 9,174,045, issued November 3, 2015 to inventor Bruce J. Simon, et al. and entitled, “Non-Invasive Electrical and Magnetic Nerve Stimulators Used to Treat Overactive Bladder and Urinary Incontinence,” describes transcutaneous electrical and magnetic nerve stimulation devices and methods to generate energy that is delivered noninvasively to selected nerve fibers within the patient to treat lower urinary tract disorders. The disorders include overactive bladder, urge incontinence, stress, incontinence, urge frequency, non-obstructive urinary retention, and interstitial cystitis / painful bladder syndrome. In the preferred embodiment, a posterior tibial nerve of a patient is stimulated non-invasively to treat these bladder disorders.

[0030] U.S. Patent No. 11,305,113, issued on April 19, 2022, to inventor Hoo-Min D. Toong, et al. and entitled, “Nocturia Reduction System,” describes a nocturia reduction systems and methods using a patch configured to be coupled to an ankle of a user and contains a processor, electrodes, and a communication device. A bladder monitoring device determines the state of the bladder of the user. A sleep detection device determines the sleep state of the user. The patch, as necessary, applies electrical stimulation via the electrodes to a tibial nerve of the user in response to an activation signal.

[0031] U.S. Patent Application No. US 2017 / 0224584, filed by Jeffrey H. Greiner, et al., published August 10, 2017, entitled, “Methods and Systems for Treating Overactive Bladder Using an Implantable Electroacupuncture Device,” now abandoned, contemplated an implantable electroacupuncture device to be implanted beneath the skin of a patient at anacupoint corresponding to a tibial nerve. The method centered upon applying stimulation sessions to the tibial nerve by way of a central electrode and an annular electrode.

[0032] Though it appears that none have been used in a manner similar to that described by the present disclosure, a review of prior art includes the following with respect to the use of spherical or ball-shaped devices generally in the field of acupressure, a few of which have related to urinary ailments.

[0033] China Patent No. CN2706040Y was published on June 29, 2005, on behalf of inventor Zhu, ende and entitled, “Ball Ring Structure Having Massaging Function,” describes an acupoint massaging device including a ring sized to fit on a human finger and defining a plurality of holes in which balls are tightly fitted. Among its list of treatable maladies, under the “E Acupoint” on a ring-finger of a human, the patent describes use for the treatment of excessive urination. The device provides a ball ring structure that offers a massaging function and is composed of a ring. A number of helical penetrate holes are arranged on the circumferential surface of the ring, while a number of balls are inserted to fit tightly into the penetrate holes. The rolling of the balls can then be used to massage the acupoints of the human body to best meet health needs. Among the advantages named for the device are healthcare outcomes.

[0034] U.S. Patent Application No. 2016 / 0235625, published on August 18, 2016, on behalf of inventor Walton Lee, entitled “Back AcuBalls,” describes a device that includes two small rubber balls (tennis ball size) held closely together by a cord of seven inches in total length. The cord can be adjusted for length and spacing of the balls can be locked into place. Each ball is then placed on each side of the spine against the vertebrae in contact with the user's paired vertebral acupoints and then manipulated by the user using his or her own bodyweight.

[0035] Japan Patent No. JP2014097273 A, published May 29, 2014, on behalf of inventor Yoko Kawabata, et al., entitled “Acupuncture Point Placement Ball,” describes a device that consists of two soft rubber balls made of natural rubber that are placed within a microfiber material, and an elongated toweling is sewn into a rectangular shape. Both sides are then tied together and mechanically kept from moving apart. It appears that by using the elongated toweling as a handgrip, the balls are used as a massage device that “. . . can be applied to any point in the body.” It specifically notes use as to backaches, stiff shoulders, muscle ache, etc.

[0036] Japan Patent No. JP2013106730 A, published on August 6, 2013, on behalf of inventor Kuen Oyoung, entitled “Massage Ball,” describes a massage ball that includes a plurality ofmassage balls as a plurality of projections on the surface of a spherical body. The device includes a weight within the device. It is used to apply pressure via massage to an acupressure point on a corresponding muscle. The body of the device has a sphere-like shape formed with a hollow portion at its center while the plurality of projections are distributed outwardly upon the outer surface. The total number of the projections is 24-30, the interval between the top ends of optional two projections adjacent to each other is 15-20 mm, and the perpendicular distance from the top end of the projection to the outer surface is 5-15 mm. The interval between the top ends of the optional two projections adjacent to one another is 15-20 mm, which increases stimulation to a radial vein and the acupressure points of a body. The weight is contained within the hollow part of the center of the device, which adds to its total weight.

[0037] China Patent No. CN111135067A, published on May 12, 2020, by inventor Li, Bingqi, entitled “Convex Point-type Palm Centered Acupoint Massage Device and Manufacturing Method thereof,” describes a hand-focused palm acupoint massage device and a manufacturing method thereof. The device is made up of a spherical inner core coated with an elastic rubber layer on the surface, a silica gel layer covering the outer part of the elastic rubber layer, and a number of rigid massage assemblies that are uniformly arranged over the outer surface. The device is held in the hand and adjusted to a proper position so that targeted fixed-point massage can be carried out on the numerous acupressure points on the palm in ways a regular ball cannot.

[0038] U.S. Patent No. 6,102,875, issued on August 15, 2000, to Rick E. Jones, entitled “Apparatus for Combined Application of Massage, Acupressure, and Biomagnetic Therapy,” describes a device that is made up of peripherally spaced apertures on the bottom of a rotating head below a handle. Within the head there are metal balls. Generally, three apertures and three balls arranged in a triangular fashion so as to be capable of providing a kneading motion during rotation.

[0039] Japan Patent No. JP2020110219A, published on July 27, 2020, on behalf of inventor Masako Imaeda, entitled “Acupressure Point Massage Device for Limb,” describes a ball pierced by cable, which is attached at each respective end to an ankle / wrist brace. The ball is placed under the bottom of the foot or under the hand while the ankle / wrist brace is opened to fasten around the ankle or wrist. The device provides an acupressure point massage to the sole of the foot or the hand by pressing acupressure points on the bottom of the foot or the hand while rolling the ball over a hard surface.

[0040] U.S. Patent No. 8,182,503, issued on May 22, 2012, to Jiro Takashima, entitled “Prostate Massage Apparatus,” describes a device configured to stimulate the prostate as well as the GV1 and CV1 acupoints. The device includes a body having a substantially ellipsoid shape and sized to pass through the anus and fit into the rectum through the sphincter. The body of the device possesses a head portion and a neck portion, wherein the head portion indirectly contacts the prostate through the rectum wall when inserted into the rectum. The neck portion has a tapered section with gradually reducing diameters distal to the head portion; and a retainer bar joined the body at one end of the neck portion to form a substantially T-shaped structure. At each end of the T-shaped structure is a ball-shaped “contact point,” each of which are employed to make contact with, respectively, acupoints GV1 and CV1.

[0041] U.S. Patent Application No. US 2016 / 0128933 Al, published on May 12, 2016, by Tiangang Shang, et al., entitled “Therapeutic Methods and Compositions,” describes a method to stimulate therapeutic points of a mammal subject using chemical compounds, as opposed to acupuncture or acupressure, in order to generate action potentials that are then transmitted to the central nervous system and may produce therapeutic action. The method includes applying to a set of therapeutic points or one or more therapeutic points of a mammal subject a therapeutically effective amount of an agonist (activated by various compounds, including, among others, allicin, eugenol, gingerol, linalool, camphor, 1.8- cineole, etc.) to act on a receptor at defined therapeutic point channel sites. Included among the therapeutic points named in the disclosure include the GV1, though not, however, the CV1 acupoint. Moreover, as to GV1, the disclosure names no specific maladies for which GV1 might be useful as a treatment point.

[0042] U.S. Patent No. US 9,254,382 B2, issued February 9, 2016, to Neurowave Medical Technologies, LLC on behalf of inventors Aftab Ahmad, Matthew J. Geary, and Farhan Hussain, entitled, “Apparatus for Transcutaneous Electrical Stimulation of the Tibial Nerve,” now abandoned, claims an electro- acupuncture device for controlling overactive bladder. The device consists of a housing, circuitry situated within a housing for generating electroacupuncture stimulus, and at least one strap for securing the housing to the ankle. A pair of electrodes are contained within the bottom outer surface of the housing, which is flexible, has a low profile, and is shaped so that it conforms to a person's ankle. The device, when strapped to a person’s ankle, causes the electrodes to come into contact with the ankle andprovide electric stimulation of the tibial nerve, thus allowing for control of an overactive bladder.SUMMARY

[0043] The present disclosure has been developed to solve the problems of the prior art as described above, and it is an object of the present disclosure to provide relief from an overactive bladder, including nocturia, via acupressure that is not only directly and selfapplied but that is also highly effective, minimally invasive, and not disruptive to the user’s daily life or sleep patterns.

[0044] More specifically, the present disclosure is an acupressure option that, in many cases, should further make possible the avoidance of any need for pharmacological compounds, which otherwise might leave a sufferer to be potentially burdened with undesirable neurological and bodily side-effects and, perhaps, additional complications to medicinal regimens potentially already in place. It is, moreover, an acupressure option that dispenses with the need for potentially dangerous and time-consuming surgeries and time for healing or, just as much, onerously complicated devices that require a sufferer to connect distant parts of the human anatomy to cumbersome or complex massage or electro-acupressure devices, all resulting in the impossibility of quickly and easily defeating an urge to urinate or ever increasing any likelihood of swiftly returning to sleep.

[0045] With the device described herein, it becomes possible to achieve rapid relief from urges to urinate by making it possible for a user to self-apply, while still in a half-sleepful state, acupressure via the device to acupoints GV1, CV1, and, for males, the prostate as well, pursuant to the proposed method, and, thereby, to greatly minimize both neural and bodily disturbance to the user’s sleepful state, and, in this way, thus vastly improving the degree of comfort and the amount of potential sleep a user may be capable of attaining.

[0046] Though all manner of compositions characterized by, or that largely consist of, all or in substantial part, convex side edges are described herein and work both highly effectively and comfortably for a user, the choice of a spherical or ball-shaped embodiment as the preferred embodiment here has been favored as it provides a number of conscious benefits both in terms of efficacy and comfort.

[0047] By utilizing a sphere or ball-shaped structure, when manual pressure is placed upon the device, the force is directed equally outward in all directions in accordance with the vector of force being applied, thus making it usefully capable of stimulating the acupointsand areas so desired. Moreover, on the other hand, when force is not being applied and the device is resting among the dermal folds and musculature of the lower pelvic region, the sphere or ball-shaped structure floats seemingly weightlessly and with little to no perceptible contact to the surrounding skin and musculature, which lends to a feeling of there being no device in place at all. Thus, the preferred embodiment achieves well its purpose for being highly effective when in use and nearly imperceptible when not in use.

[0048] This embodiment and use of the disclosure is based in peripheral findings evidencing a wholly unexpected effect on repeated occasions, which showed that by stimulating these two acupressure points in question here, GV1 and CV1, followed immediately by lifting upward and inward the uppermost pairs of rectus abdominis muscles as well as the diaphragm muscles and holding this position, not only is pressure on the bladder below also relieved and the body’s attention refocused away from the muscles involved in the urge to urinate, but also, in this way, any remaining upper frontal urge was also dispensed with and alleviated. This proved so effective so as to be able to accommodate, for hours, as much as twenty-five percent (25%) more urine beyond a full bladder (defined for men as being 3 cups and for women being 2 cups), while, with some discomfort in the area of the bladder, still fully efficaciously suppressing any urge to urinate.

[0049] One aspect of the disclosure relates then to an apparatus for temporarily blocking or relieving sensatory feelings of the need or urge to urinate by the placement of a device, one embodiment of which possesses a substantially spherical shape and is sized to fit over the anus, which minimally also covers the supracutaneous distal area of the internal and external sphincter muscles, wherein said device comprises a portion configured to activate the first acupressure point (GV1) and the second acupressure point (CV1), directly or indirectly, depending upon the amount of force upon and the trajectory of that force upon the device when pressed inward toward the human body. For example, because of the location of the GV1 and CV1 acupoints, depending on if one presses forward, backward, or inward, or a combination of these, the device may directly interact with GV1 or both GV1 and CV1 acupoints. Because GV1 is located within the periphery of the anus itself, like the anus, it is nearly always going to be directly contacted by the device. CV1 lies slightly outside the periphery of the anus, and hence may be contacted through the peripheral tissue adjacent the anus. If one pushes inward and deeply, however, the device may directly contact both GV1 and CV1 acupoints. With respect to stimulated selected tissues, as described herein, such stimulation may include direct or indirect stimulation unless explicitly stated.

[0050] An additional aspect of the disclosure relates to an apparatus that consists of a complete and singular solitary unit in its form, firmness, and composition that is characterized by, or largely consists of, all or in substantial part, convex side edges.

[0051] An additional aspect of the disclosure relates to an apparatus consisting of, or largely consisting of, all or in substantial part, convex side edges, wherein the preferred embodiment provides for the device to be separated into a smaller inner support body that consists of a firmer grade material that is, itself, all or substantially enveloped within a perfectly-fitting larger outer cover body made of a softer grade material, the cover body thereby providing, while being maintained by the harder inner support body, a softening or dampening effect when the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0052] An additional aspect of the disclosure relates to an apparatus consisting of, or largely consisting of, all or in substantial part, convex side edges, wherein the portion of the device interacting directly with the anus itself consists of a main body that is made up of a softer grade material, to which a preferably round convex, concave, or flat cap or button, or a cap or button that is made up of a combination of convex, concave, or flat surfaces, that consists of a harder grade material is affixed upon the opposite side, whether by using an anchoring mechanism, mechanical affixment, glue or cement, chemical bonding, molecular bonding, or any combination of the foregoing, said harder cap or button, thus, providing for an increased focus of all force manually applied to the device, while the larger and softer portion below provides a softening or dampening effect when the entirety of the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0053] An additional aspect of the disclosure relates to an apparatus containing micro-sensor technology capable of collecting the device user’s physiological and health data specifically relating to the need or urge to urinate by building into said device minute micro-sensors that are capable of recording and storing the details of the user’s bodily sleep cycle, circadian cycle, bladder status, urinary habits, regional muscular tensions, muscular movements, bodily movements, skin and body temperature, time details, cardio and respiratory performance, and other relevant health-related data and patterns.

[0054] An additional aspect of the disclosure relates to an apparatus for massaging and stimulating acupoints GV1 and CV1 and the anus, sphincter muscles, perineum, and prostateby the placement of a device on or adjacent to acupoints GV1 and CV1, the embodiments of which require applying a peripheral supracutaneous device characterized by a body consisting of, or largely consisting of, all or in substantial part, convex side edges and conformed and sized to fit over the anus, which minimally also covers the supracutaneous distal area of the internal and external sphincter muscles, wherein said device comprises a portion configured to activate the first acupressure point (GV1) and the second acupressure point (CV1), directly or indirectly, both when placed upon or pressed inward toward the anus and sphincter, creating pressure upon acupoints GV1 and CV1, the anus, sphincter muscles, perineum, and, in men, the prostate, causing these to react to the device, thus creating a massage action, causing, for example, the sphincter’s contraction and relaxation to cause the prostate itself, in men, or, in women, the vaginal muscles to begin, in alternating motions, to contract and relax, thus, producing acupressure therapeutic effects that stimulate and strengthen the musculature in these areas, including the prostate, for therapeutic purposes.

[0055] An additional aspect of the disclosure relates to an apparatus containing micro vibrating technology capable of stimulating acupoints GV1 and CV1 and the anus, sphincter muscles, perineum, and prostate by means of building into said device of a minute directly or remotely controlled vibrating technology that can be included into the device to increase therapeutic stimulation as well as to increase prostate, genital, and pelvic floor muscle strength.

[0056] Another aspect of the disclosure relates to methods for temporarily blocking or relieving sensatory feelings of a need or urge to urinate, more specifically the physical stress experienced as a lower pelvic urge. A method in accordance with any one embodiment of the disclosure includes: providing a device configured to contact the first acupressure point (GV1) and the second acupressure point (CV1), directly or indirectly; inserting the device into place between the gluteus maximus muscles directly over the anus and sphincter, wherein the device when posited over the anus and sphincter has a rounded surface area coming into contact with and capable of transferring manually exerted pressure upon the first acupressure point (GV1) and the second acupressure point (CV1), whether directly or indirectly, depending upon the amount of force upon and the trajectory of that force upon the device when manually pressed inward towards the body; compressing the device, when the user feels an urge to urinate, to exert force upon the first acupressure point (GV1) and the second acupressure point (CV1) causing the brain to then send out neurotransmitters to block the overactive stress or pain signals so that, as to the subject disclosure, the slower-movingbio-chemical signal carrying the overactive stress or pain signal of the urge to urinate arrives to the brain subsequent to the faster-moving mechanical blocking neurotransmitter signal sent by the activation of the acupressure device, thus rendering the bio-chemical signal unable to enter and register and, thereby, temporarily dispensing with the urinary urge experienced and allowing the user to return to sleep; and, further, repeating this method with each further such urge until the user determines that the bladder is truly full of urine and must be voided.

[0057] Another aspect of the disclosure relates to methods for temporarily blocking or relieving sensatory feelings of a need or urge to urinate, more specifically the physical stress experiences as an upper frontal urge. A method in accordance with any one embodiment of the disclosure includes: providing a device configured to contact the first acupressure point (GV1) and the second acupressure point (CV1), directly or indirectly; inserting the device into place between the gluteus maximus muscles directly over the anus and sphincter, wherein the device when posited over the anus and sphincter has a rounded surface area coming into contact with and capable of transferring manually exerted pressure upon the first acupressure point (GV1) and the second acupressure point (CV1), whether directly or indirectly, depending upon the amount of force upon and trajectory of that force upon the device when manually pressed inward towards the body; compressing the device, when the user feels an urge to urinate, to exert force upon the first acupressure point (GV1) and the second acupressure point (CV1) causing the brain to then send out neurotransmitters to block the overactive stress or pain signals so that, as to the subject disclosure, the slower-moving bio-chemical signal carrying the overactive stress or pain signal of the urge to urinate arrives to the brain subsequent to the faster-moving mechanical blocking neurotransmitter signal sent by the activation of the acupressure device, thus rendering the bio-chemical signal unable to enter and register and, thereby, temporarily dispensing with the urinary urge experienced; a lifting upward and inward of the uppermost pairs of rectus abdominis muscles as well as the diaphragm muscles and holding this position, thus, relieving pressure on the bladder below, refocusing the body’s attention away from the muscles involved in the urge to urinate, and, in this way, dispensing with and suppressing any remaining urge, thereby, allowing the user to return to sleep; and, further, repeating this method with each further such urge until the user determines that the bladder is truly full of urine and must be voided.

[0058] Another aspect of the disclosure relates to methods for reminding the user that he or she is wearing the device upon arrival at the toilet for the purpose of voiding urine, more specifically a device to remind the user to remove the device prior to sitting down on thetoilet and, thus, losing the device in the toilet water or sewage system. A method in accordance with any one embodiment of the disclosure includes: providing a token reminder piece in any shape or form and of any material configured to be placed within sight of the device user, for example and without limitation, that can be hung, balanced, placed, or set in or upon any place and in any manner or location that confronts the device user, in the preferred embodiment, to be placed upon the surface of the closed toilet seat cover prior to going to bed or again subsequent to any visit to the toilet to void the bladder; being a token reminder piece that reminds the user both to remove the device prior to sitting down on the toilet and to replace the device over the anus upon returning to bed.

[0059] Other aspects and advantages of the disclosure will be apparent from the following description and the appended claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0060] FIGS. 1 A and IB are conceptual diagrams illustrating respectively a portion of the pelvic anatomy in an example male and an example female with a peripheral modulation device received in the intergluteal cleft and positioned adjacent the anal sphincter and between acupoints GV1 and CV1.

[0061] FIGS. 2A and 2B top view and side view of a peripheral modulation device.

[0062] FIGS. 3A and 3B top view and side view of a peripheral modulation device including an off-center core and a shell.

[0063] FIGS. 4 A and 4B top view and side view of a peripheral modulation device including a core and a shell.

[0064] FIGS. 5 A and 5B top view and side view of a peripheral modulation device including a button.

[0065] FIGS. 6 A and 6B top view and side view of a peripheral modulation device including an anchored button.

[0066] FIG. 7 is a conceptual diagram illustrating a peripheral modulation device having processing circuitry that is operable coupled to a remote device and an external power source.

[0067] FIG. 8 is a conceptual diagram illustrating a processing circuitry of the peripheral modulation device illustrated in FIG. 7.

[0068] FIG. 9 is a flow diagram illustrating an example technique of reducing an urge to urinate using a peripheral modulation device.

[0069] FIG. 10 is an example kit including a peripheral modulation device, reminder token, and instruction manual.

[0070] FIGS. 11 A and 1 IB are conceptual diagrams illustrating peripheral modulation device having an orienting tail coupled to a body of the device.

[0071] FIGS. 12A through 12C are conceptual diagrams illustrating peripheral modulation device having a concave button flanked by orienting fins extending from a body of the device.

[0072] FIGS. 13A through 13C are conceptual diagrams illustrating peripheral modulation device having a concave button surrounded by a raised crown structure extending from a body of the device.

[0073] FIGS. 14A through 14C are conceptual diagrams illustrating example arrangements of components, such as the components illustrated in FIGS. 7 and 8, within a device.DETAILED DESCRPTION

[0074] The device herein described can take the form of a peripheral supracutaneous device characterized by a body consisting of, or largely consisting of, all or in substantial part, convex side edges, any and all of which may be molded with edges and curvatures in such a manner so as to best fit and grip, and to best be fitted and gripped within, the dermal and muscular contours of the human body; here, in the lower pelvic region between the gluteus maximus muscles within the region of the anus and perineum, and, preferably, centered upon the anus within the external sphincter muscles, themselves nested among the transverse perineal and levator ani muscles.

[0075] For the purpose of illustrating the disclosure, there is shown in the drawings a spherical form which is presently preferred; it being understood, however, that this disclosure is not limited to the precise arrangements and instrumentalities shown.

[0076] FIGS. 1 A and IB are conceptual diagrams illustrating respectively a portion of the pelvic anatomy in an example male 100 A and an example female 100B with a peripheral modulation device 102 received in the intergluteal cleft and positioned adjacent the anal sphincter and between acupoints GV1 and CV1. The two relevant acupoints are both located within the region of the anus and perineum in the lower pelvis.

[0077] The first relevant acupoint is the GV1 acupoint (hereinafter, first acupoint 104), also referred to as GV1, Chang Qiang (Chinese name), Chokyo (Japanese name), or Chang Chiang (Wade-Gilles name). First acupoint 104 is located on the lower outer periphery of the anus, about midway between the center of the anus and the tip of coccyx (the tailbone), in both males and females, as respectively illustrated in FIGS. 1 A and IB. First acupoint 104 is the first acupoint along the Governor Vessel Meridian. In acupuncture, first acupoint 104 is for the treatment of hemorrhoids, rectal prolapse, anal fissure, and various genitourinary ailments, including urinary tract disorder, urine retention, sexual exhaustion, impotence, and seminal emission. Thus, applying acupressure over or near first acupoint 104 may provide therapeutic benefits with respect to these and other maladies.

[0078] The second relevant acupoint is the CV1 acupoint (hereinafter, second acupoint 106), also referred to as Huiyin (Chinese name), Ein (Japanese name), Hui Yin (Wade-Gilles name). It is located, in males as illustrated in FIG. 1 A, between the anus and the scrotum, or, as to females as illustrated in FIG. IB, between the anus and the posterior labial commissure. Second acupoint 106 is the first acupoint along the Conception Vessel Meridian. In the field of acupuncture, second acupoint 106 is most often accessed for the treatment of various genitourinary disorders, such as constipation and dysuria, incontinence of feces and urine, spermatorrhea, impotence, pruritus vulva, and to treat hemorrhoid conditions and rectal prolapse. Applying acupressure to the perineum region over or near second acupoint 106 may provide therapeutic benefits with respect to these and other maladies.

[0079] Because of the very personal and sensitive location of these highly important and highly sensitive acupressure points in the anal region, for a person suffering from health issues in this area of the body, including for a sufferer of an overactive bladder, the desire for both the use of needles in this area as well as the desire to have another person touch or view these sensitive body areas remains extremely limited. Thus, it follows, up to this point in time, this has limited not only every sufferer’s desire to seek relief, but his or her available options just as well.

[0080] Unlike acupressure balls chosen because they are capable of rolling over the skin of the human body and concentrating minimally focused force upon certain acupoints, peripheral modulation device 102 is characterized by a body consisting of, or largely consisting of, all or in substantial part, convex side edges, which has a quite opposite purpose. In particular a sphere or spheroid stays well in place in the intergluteal cleft. It does so, particularly because of its shape characterized by convex edges, most particularly, thesymmetrically radiating convex edges of a sphere. This allows the device, while consistently remaining secure in its position, to project uniform and considerably more focused force effectively in the directions in which it is pressed and, simultaneously, to be better and more comfortably held in place in the intergluteal cleft. Convex edges, in particular a spherically shaped body, not only provide maximum surface area for the device to be held in place among the dermal folds and musculature of the lower pelvic region, at the same time, also due to those convex edges, it remains nearly imperceptible for the user to feel. This imperceptibility is extremely important to a person who wishes to fall asleep and stay asleep, and who, after awakening to apply acupressure to dispense with an urge to urinate, also quickly wishes to return to sleep once again.

[0081] FIGS. 2 A and 2B are top and side views of a peripheral modulation device 200 (hereinafter, device 200). Device 200 may be made of any flexible or inflexible material and shaped to conform to the stated body portion of the user within which the lower urge to urinate registers, namely, the body portion containing acupoints GV1 and CV1. Device 200 includes a complete and singular solitary unit in its form, firmness, and composition that is characterized by, or largely consists of, all or in substantial part, convex side edges.

[0082] Device 200 may include any material suitable for both contact with the human body and application of acupressure to a portion of the human body. Example materials may include, but are not limited to, silicone, polystyrene, polypropylene, polyvinyl chloride, polychloroprene, polyethylene, polyurethane, polycarbonate, polyethylene terephthalate, polyetheretherketone, stainless steel, titanium or alloys thereof, cobalt-based alloys, magnesium-based alloys, tantalum, nitinol, platinum-based alloys, gold-based alloys, natural materials such as plant fiber and plant fiber-based materials, paper and paper-based materials, wood and wood-based materials, animal leather and animal leather-based materials, cloth and cloth-based materials (whether of natural or synthetic fibers), natural or synthetic sponge material, other forms of bio-materials and biocompatible materials, biodegradable plastics, and other biocompatible materials configured for external contact with the human body. In some examples, one or more materials of device 200 may be selected to provide a selected hardness, such as a Shore A hardness within a range from about 5 A to about 90A, and Shore OO hardnesses within a range from about 5 OO to about 100 OO.

[0083] Although described as including a single material for uniform firmness and composition, in other examples, device 200 may include two or more materials to provide selected firmness at predetermined portions of device 200, to facilitate application andhandling of device 200, to control a weight or center of mass of device 200, or the like. Additionally, or alternatively, device 200 may include material defining hollow or partially hollow three-dimensional shapes, layers of two or more materials, or both to reduce weight of device 200, provide a selected firmness of device 200, facilitate manufacture of device 200, or for compatibility with adjacent material or components of device 200.

[0084] Device 200 defines at least one curved solid surface 202. The at least one curved solid surface 202 is sized and shaped to be received in the intergluteal cleft of the human body and at least partially surrounded by a musculature and a skin of the human body to remain in place without any external support to secure it against the portion of the human body. In some examples, curved solid surface 202 defines a continuous convex surface. For example, device 200 may define a sphere, a spheroid, an oblate spheroid, or a prolate spheroid. As illustrated by the top view in FIG. 2A and the side view in FIG. 2B, device 200 is substantially congruent, i.e., a sphere.

[0085] Device 200 may include any suitable size configured to both contact the CV1 and GV1 acupoints, whether directly or indirectly, while positioned over the anus and to fit within the intergluteal cleft of a human body. As illustrated in FIG. 2A, device 200 has an outer diameter D. Diameter D maybe within a range from about 0.5 inches (1.27 centimeters (cm)) to about 3 inches (7.62 cm), such as within a range from about 0.75 inch (1.91 cm) to about 1.5 inches (3.81 cm), or about 1.125 inch (2.86 cm).

[0086] Although illustrated as a sphere including a single diameter, in other examples, dimensions of device 200 may be selected to conform with an anatomy of a human body. For example, a prolate spheroid may include a major diameter corresponding to an average distance between CV1 and GV1 acupoint (such as within a range from about 2 inches (5.08 cm) to about 5 inches (12.7) or within range from about 2.5 inches (6.35 cm) to about 4.5 inches (11.43 cm)) and a minor diameter corresponding to an average conformability of the intergluteal cleft (such as within a range from about 0.5 inches (1.27 cm) to about 3 inches (7.62 cm) or about 1 inch (2.54 cm) to about 2 inches (5.08 cm)).

[0087] In other examples, device 200 may define additional complex, curved, or planar surfaces intersecting the at least one curved solid surface 202. The additional complex, curved, or planar surfaces may be shaped to facilitate manipulation of device 200 by a user, such as, for example, by the fingers or hand of a user, including to facilitate device 200 being held in place. In some examples, the additional complex, curved, or planar surfaces mayinclude crowned surfaces, fins, tails, or other features extending from at least one curved solid surface 202. Such features may be integrally formed with (i.e., unitary) device 200 or coupled to device 200 (e.g., via adhesive bonding, ultrasonic welding, or other methods of coupling two plastic components). In some examples, the additional complex, curved, or planar surfaces may be defined by a shell extending from a core of the device.

[0088] Device 200 is shaped to conform to a person’s anal region. By means of its own shape and the natural dermal and muscular contours of the human body, device 200 remains in place without the use or application of any external support or fastening mechanism to secure it against said body portion. The peripheral modulation device 200 shown here is presented in the presently preferred spherical form and is, in its presently preferred form, made from a polymeric plastic material, namely, in the form of an elastomer that consists of a bio-safe and bio-compatible material such as medical- or food-grade silicone. Preferably, the device has uniform proportions, smoothness, and firmness and may or may not be adorned or in some artistic or sculptural form. Device 200 in the preferred embodiment is sufficiently flexible so as to most comfortably fit within or conform to the shape of the body, yet it is solid enough to largely maintain its shape when manual pressure is applied to it by use of the fingers or by the flexing of adjacent musculature.

[0089] The projection of the curved side edges, such as curved solid surface 202, facilitates both ease of accomplishing such conformation and comfort. The firm mass of device 200 provides sufficient mass and rigidity so that the projections of the curved side edges of device 200 inward towards the surrounding flesh, muscles, and body can perform their intended modulative function upon the nearby acupoints. Device 202 is preferably constructed of material having uniform proportions, smoothness, and firmness so as to provide both better modulation and comfort. Thus, when pressed with a finger or fingers or squeezed by adjacent musculature, device 200, such as curved solid surface 202, is configured to generate a modulating and consistent pressure via the device in relation to the body portion against which it is placed in order to better stimulate said acupoints, GV1 and CV1, located within said body portion.

[0090] The surface of device 200 may be further posited with and contain uniformly or randomly shaped protrusions or uniformly or randomly placed indentations in order to better or more comfortably hold the device in place, to better concentrate pressure and stimulation upon the user’s body portion, and to act even as avenues to provide and outlet for moisture and sweat from the user’s skin. In the presently preferred embodiment, device 200 has anapproximate total diameter ranging from about 0.75 inches (19 mm) to about 1.1811 inches (30 millimeters). Device 200 may be produced in varying sizes of any dimension or range to best accommodate the differing sizes of the human body and, thereby, to best accomplish the purpose of the disclosure. That said, the presently preferred spherical embodiment has a total diameter measuring about 1.125 inch (28.6 mm).

[0091] To relieve or extinguish sensatory signals that characterize the urge to urinate that arise in the lower pelvic area and bladder area, device 200 is placed in the described area so that the device’s all or in substantial part convex side edges 202 will create, preferably with, but also, in certain cases, without manual activation, a stimulation adequate to elicit the neural feedback to the brainstem and analgesia-producing areas referred to above.

[0092] Device 200 is designed so as to stimulate the general and specific areas of the acupoints, GV1 and CV1, as the user presses on device 200 inward toward the human body. These independent stimuli prevent accommodation of the nervous system to the pressure of its projection.

[0093] Uniform pressure is aided by both the firmness and flexibility of the device and the security with which device 200 is held in place by the surrounding skin and musculature. The reaction of the body to the uniform pressure tends to improve extension within the lower pelvic region and trunk and, therefore, the return of function at the apophyseal level. When device 200 is constructed as described herein it is both tolerable to and comfortable for the user, while the generally smooth surface prevents any abrasion, agitation, or puncturing of the skin. The symmetry of the projection of the curved side edges, such as curved solid surface 202, is in accordance with the psychophysical phenomenon of two-point discrimination. Thus, multi-directional adjacent pressure feels only to be single-directional although all directions are active in stimulating the acupoints, GV1 and CV1, via the surrounding skin and musculature.

[0094] Device 200 may not substantially interfere with freedom of body motion or otherwise encumber the body, which may reduce or prevent disruptions of the user’s sleep cycle and dormant state. Device 200 is simple in its construction so as to be able to be efficiently produced in differing sizes such as small, medium, and large for different sized persons. When the user is finished sleeping and leaves the bed, the user may easily remove device 200 or may continue to wear device 200 for additional therapeutic effect, if desired.

[0095] Additionally, or alternatively, device 200 may be used as is, alone or in plurality, as required or desired, for use as a device intended to provide anal, perinium, prostate, and genital stimulation and arousal. This alternative embodiment of the disclosure relates to a device that relies upon the pressure while held in place, without the use or application of any support or fastening mechanism, as may be brought to bear upon acupoints GV1 and CV1 and the anus, sphincter muscles, perineum, and prostate causing these to react to the device, thus creating a massage action, causing, for example, the sphincter’s contraction and relaxation to cause the prostate itself, in men, or, in women, the vaginal muscles to begin, in alternating motions, to contract and relax.

[0096] By its mere placement over the center of the anus or over the perineum, as held in place by the body’s own musculature and dermal folds, device 200 can provide pressure within the perineum region and a region midway between the anus and the lower end of the coccyx (tailbone) capable of, itself, producing acupressure therapeutic effects that stimulate both these areas as well as the prostate, externally, for therapeutic purposes. This embodiment and use of device 200 is based in peripheral findings that showed that pressuring the two acupressure points in question here, GV1 and CV1, while engaged in activities that encourage arousal, can provide the user with a multiplicity of additional therapeutic experiences. More specifically, compression at or in the vicinity of these two acupressure points with simultaneous stimulation of the anus or perineum was additionally found to provide comfortable and pleasant feelings of arousal to the user. Pleasant feelings of arousal can encourage the use of the device and, in this way, can cause additional and more active use of the device, thus, having the important additional effect of strengthening those muscles within the pelvic region and related to the urinary tract that further make possible a decrease in urges to urinate as well as an increase in the body’s general ability to withstand such urges.

[0097] To this end, directly or remotely controlled vibrating technologies can be included into device 200 to increase stimulation. Similarly, other components can be integrated with device 200, such as, for example, one or more sensors or other electronic devices that are capable of recording and storing the details of the user’s bodily sleep cycle, circadian cycle, bladder status, urinary habits, regional muscular tensions, muscular movements, bodily movements, skin and body temperature, time details, cardio and respiratory performance, and other relevant health-related data and patterns.

[0098] FIGS. 3A and 3B are top and side views of a peripheral modulation device 300 (hereinafter, device 300) including an off-center core and a shell. Device 300 may be thesame as or substantially similar to device 200 described above in reference to FIGS. 2A and 2B, except for the differences described herein. For example, device 300 defines, or largely consists of, all or in substantial part, convex side edges including at least one curved solid surface 302.

[0099] Device 300 includes a core 304 and a shell 306. Core 304 defines an inner support body having a first diameter DI . Shell 306 defines an outer cover having a diameter D2 and enveloping at least a portion of core 304. First diameter DI is less than second diameter D2. Each of first and second diameters DI and D2 may be within a range from about 0.5 inches (1.27 cm) to about 5 inches (12.7 cm) such as within range from about 1 inch (2.54 cm) to about 3 inches (7.62 cm).

[0100] In some examples, shell 306 may be perfectly-fitting on at least a portion of core 306, i.e., shell 306 may be directly adjacent to core 306. In other examples, shell 1306 may be adjacent to core 304 with one or more material layers disposed therebetween, such as for example, an adhesive or another material configured to interface between shell 306 and core 304.

[0101] In some examples, core 304 may include a firmer grade material relative to a softer grade material of shell 306. For example, core 304 may include a first material having a first durometer, and shell 306 may include a second material having a second durometer, where the first durometer is greater than the second durometer. In this way, shell 306 may be configured to provide, while being maintained by the harder inner support body, a softening or dampening effect when device 300 is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0102] As illustrated in FIG. 3A, at least a portion 308 of core 304 extends from shell 306. The portion 308 of core 304 may define a second curved solid surface 310 configured to be manipulated by a user. When a force is applied to surface 310 by a user, core 304 transmits the force to shell 306. Shell 306 then transmits the force through surface 302 to the body of the user. In this way, device 300 is configured to disperse a force applied by a finger to a relatively smaller surface area at surface 310 to the body over a relatively larger surface area at surface 302. The distribution of force may improve user comfort during use. Additionally, or alternatively, the distribution of force may enable the user to apply a force to the anus and, whether directly or indirectly, both CV1 and GV1, and optionally, indirectly, the prostate, allsimultaneously, with manipulation by as few as one finger, by contracting the gluteus maximus muscles, by contracting the anal sphincter, or combinations thereof.

[0103] Although core 304 is illustrated as partially extending from shell 306, in other examples, a core may be completely encapsulated within a shell.

[0104] FIGS. 4 A and 4B are top and side views of a peripheral modulation device 400 (hereinafter, device 400) including a core 404 and a shell 406 that completely encapsulates the core. Device 400 may be the same as or substantially similar to devices 200 or 300 described above, except for the differences described herein. For example, device 400 defines, or largely consists of, all or in substantial part, convex side edges including at least one curved solid surface 402 defined by shell 406 which encapsulates core 404.

[0105] In some examples, forming device 400 with core 404 and shell 406 may be less expensive compared to a device consisting essentially of the material of shell 406. Additionally, the position of core 404 within shell 406 may be selected to provide selected firmness at predetermined portions of device 400, such as at surface 402, to facilitate application and handling of device 400, to control a weight or center of mass of device 400, or the like.

[0106] FIGS. 5A and 5B are top and side views of a peripheral modulation device 500 (hereinafter, device 500) including a button 512. Button 512 may define, or largely consist of, a convex, concave, or flat surface, or any combination thereof. Device 500 may be the same as or substantially similar to any of devices 200, 300, or 400 described above, except for the differences described herein. For example, device 500 includes a body 504 that defines, or largely consists of, all or in substantial part, convex side edges including at least one curved solid surface 502. In some examples, device 500 may include a core and a shell as described above in reference to FIGS. 3A, 3B, 4A, and 4B.

[0107] Device 500 includes button 512 defining a surface 514 that is configured to receive a force. Surface 514 may define a convex, concave, or flat surface. In some examples, surface 514 may define a shape complementary to the curvature of one or more fingers.

[0108] Button 512 may be coupled to body 504 using an anchoring mechanism, mechanical affixment, glue or cement, chemical bonding, molecular bonding, or any combination thereof.

[0109] Button may include a firmer grade material relative to a softer grade material of body 504. In this way, body 504 may be configured to provide a softening or dampening effect when device 500 is pressed via button 512 inward toward the human body, thereby increasinguser comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0110] When a force is applied to surface 514 by a user, button 512 transmits the force through body 504 to surface 502 to the body of the user. In this way, device 500 is configured to disperse a force applied by a finger to a relatively smaller surface area at surface 514 to the body of the user over a relatively larger surface area at surface 502. The distribution of force may improve user comfort during use. Additionally, or alternatively, the distribution of force may enable the user to apply a force to the anus and, whether directly or indirectly, both CV1 and GV1 and optionally, indirectly, the prostate, all simultaneously, with manipulation by as few as one finger, by contracting the gluteus maximus muscles, by contracting the anal sphincter, or combinations thereof.[OHl] FIGS. 6 A and 6B are top and side views of a peripheral modulation device 600 including an anchored button. Device 600 may be the same as or substantially similar to device 500 described above in reference to FIGS. 5A and 5B, except for the differences described herein. For example, device 600 includes a body 604 and a button 612. Body 604 defines, or largely consists of, all or in substantial part, convex side edges including at least one curved solid surface 602. Button 612 defines a surface 614 configured to transmit a force applied thereto through body 604 to surface 602.

[0112] Button 612 also includes an anchor 616 extending from surface 614 into at least a portion of body 604. Anchor 616 may serve to affix button 612 to body 604. Additionally, or alternatively, anchor 616 may aid in transmitting a force applied to button 612 to body 604.

[0113] FIG. 7 is a conceptual diagram illustrating a system 701 including a peripheral modulation device 700 (hereinafter, device 700) having controller 720 that is operably coupled to a remote device 722 and an external power source 724. Device 700 may be the same as or substantially similar to the peripheral modulation devices described above, e.g., device 700 may include the construction or configuration of any one device 200, 300, 400, 500, or 600, except for the differences described herein. For example, device 700 includes a core 704 and a shell 706 defining a surface 702. Device 700 is configured to be received in the intergluteal cleft of the human body and at least partially surrounded by a musculature and a skin of the human body to remain in place without any external support to secure it against the portion of the human body. In response to a force applied to device 700 urgingdevice toward the anus, surface 702 is configured to stimulate at least the CV1 and GV1 acupoints, whether directly or indirectly.

[0114] Device 700 includes controller 720. Controller 720 may be at least partially encapsulated by at least one of core 704 and shell 706. Controller 720 may be configured to control an operation of device 700. For example, controller 720 may include one or more devices configured to control a vibration, movement, temperature, or combinations thereof of device 700. In some examples, the vibration, movement, temperature, or combinations thereof of device 700 may provide or amplify an effect of device 700 to stimulate at least the CV1 and GV1 acupoints, whether directly or indirectly.

[0115] Additionally, or alternatively, controller 720 may be configured to collect and, optionally, analyze sensor data indicative of physiological parameters of the user. For example, controller 720 may be coupled to one or more sensors suitable to determine physiological parameters of the user including but not limited to, at least one of pulse rate, blood oxygen saturation, movement, respiration rate, skin and body temperature, and muscle contraction or relaxation. Controller 720 may determine, based on select physiological parameters, one or more biological events associated with the user, including but not limited to, at least one of urges to urinate, sleep states and patterns, wake states and patterns, heart patterns, and breathing patterns.

[0116] Additionally, or alternatively, controller 720 may be communicatively couplable to remote device 722 that is configured to collect and, optionally, analyze physiological parameters, biological events, additional user input data, or combinations thereof. Remote device 722 may include a smart phone, a tablet, a personal computer, a dedicated physiological parameter monitoring device, or another electronic device suitable to receive and or process data. In some examples, remote device 722 may define a user interface (or other machine-human interface) configured to receive input from a user and transmit output to the user. The input and output may include data associated with any one or more of audio, visual, or tactile information. Example user input data may include, but is not limited to, amount of and time of urine being voided as well as food, drink, and nutrition consumption information.

[0117] In some examples, the user may interface with remote device 722 via a mobile application stored on remote device 722. The mobile application may include graphical userinterfaces enabling a user to view and interact with the content described herein related to data provided by device 700, functionality of device 700, or both.

[0118] In some examples, controller 720 may be wirelessly coupled to remote device 722 via any suitable wireless communication protocol, such as, for example, Bluetooth, Bluetooth Low Energy, Wi-Fi, Zigbee, Z-wave, or the like. In other examples, controller 720 may be configured to, at least temporarily, couple to remote device 722 via a wired connection, such as, for example, a universal serial bus (USB) connection or other connector suitable to transfer data and optionally supply power. In some examples, remote device 722 may include or be communicatively coupled to a remote or cloud-based server configured to store and, optionally, process data. By communicatively coupling to remote device 722, at least a portion of data processing or the functions described in reference to controller 720 may occur on remote device 722.

[0119] Controller 720 includes a power source suitable to operate processing circuitry and other electronic or electro-mechanical devices associated with controller 720. The power source may include primary batteries, such as alkaline or lithium batteries, secondary batteries, such as lithium-ion, lithium-ion polymer, lithium-iron-phosphate, or nickel metal hydride batteries. In examples in which the power source includes a secondary battery, controller 720 (i.e., the power source) may be configured to receive an electrical charge from an external power source 724.

[0120] In some examples, external power source 724 may include a voltage converter (e.g., outputting 5 volts (V), 9V, 12V, or the like) coupled to household power (e.g., from about 110V to about 240V). The voltage converter may be configured to receive a USB connector and controller 720 may be configured to receive a USB connector or a direct current (DC) connector. In some examples, a female receptacle of a DC connector may be substantially encapsulated within shell 706 to form a substantially water-resistant port that may receive therethrough a male DC connector. In this way, device 700 may be used in moist environments, washed, or otherwise submersed in water without water infiltrating toward controller 720 or interior cavities of device 700.

[0121] In other examples, external power source 724 may include an inductive charging device. For example, external power source 724 may include a primary coil in a charging plate configured to receive thereon device 700. Device 700 may include a secondary coil coupled to controller 720 (i.e., the power source). When the secondary coil is within apredetermined distance and orientation relative to the primary coil, an electric current applied to the primary coil may generate a magnetic field to induce a current in the secondary coil, thereby charging the secondary battery of device 700.

[0122] FIG. 8 is a conceptual diagram illustrating a system 801 including peripheral modulation device 800 (hereinafter, device 800) having a controller 820 that is operably coupled to a remote device 822. Device 800 may be the same as or substantially similar to device 700 described above in reference to FIG. 7, except for the differences described herein. For example, device 800 includes a core 804 and a shell 806 (the boundaries of which are illustrated as dashed lines). Device 800 is configured to be received in the intergluteal cleft of the human body and at least partially surrounded by a musculature and a skin of the human body to remain in place without any external support to secure it against the portion of the human body. In response to a force applied to device 800 urging device toward the anus, a surface of shell 806 is configured to stimulate at least the CV1 and GV1 acupoints, whether directly or indirectly.

[0123] Device 800 includes controller 820. Controller 820 may be the same as or substantially similar to controller 720 described above in reference to FIG. 7, except for the differences described herein. For example, controller 820 may be configured to control an operation of device 800, collect and, optionally, analyze sensor data, communicate with remote device 822, and a battery 825 that is configured to receive power from an external power source (e.g., power source 724).

[0124] Controller 820 includes processing circuitry 830 that is operably coupled to each of battery 825, a memory 832, communication circuitry 834, sensors 836A through 836N (collectively, sensors 836), motor 838, vibration motor 840, and thermoelectric device 842. The components of controller 820 are contained within device 800, but may be positioned within core 804, shell 806, or portions of both to facilitate functionality of the component. For example, sensor 836A may not require near or direct physical contact with a body of the user to function and thus may be positioned outside of core 804 and within shell 806, whereas sensor 836N may best function when in near or direct physical contact with a body of the user and thus may at least partially protrude from shell 806. These and other physical configurations of the components of controller 820 within core 804, shell 806, or portions of both are contemplated.

[0125] Processing circuitry 830 is configured to perform various functions of device 800, including but not limited to, transmitting data, receiving data, or both from remote device 822 via communications circuitry 834, receiving data from sensors 836, controlling a power state of motor 838, vibration motor 840, and thermoelectric device 842, and monitoring a power state of battery 825. Additionally, processing circuitry 830 may determine based on physiological data received from one or more of remote device 822 and sensors 836 a biological event associated with the user. Functions of processing circuitry 830 may be performed by hardware, computer instructions saved on memory 832 (or retrieved from remote device 822), or combinations of hardware and software.

[0126] Memory 832 is configured to store various types of data and executable computerprogram instructions. Memory 832 includes computer-readable media in the form of volatile memory, nonvolatile memory, or combinations of both and may be removable or nonremovable. For example, memory 834 may include random access memory (RAM), read only memory (ROM), electronically erasable programmable read only memory (EE-PROM), flash memory, optical or magnetic storage devices, or other medium that can be used to store information and can be accessed by electronic devices.

[0127] Battery 825 may include primary batteries, such as alkaline or lithium batteries, secondary batteries, such as lithium-ion, lithium-ion polymer, lithium-iron-phosphate, or nickel metal hydride batteries. In some examples battery 825 may be configured to receive an electrical charge from an external power source via a wired or wireless connection.

[0128] Communications circuitry 834 may include one or more receivers, transmitters, or transceivers, such as, for example, a cellular receiver, a Wi-Fi receiver, a Bluetooth receiver, a radio receiver, a nearfield communication receiver, or the like. Communication circuitry 834 is operably coupled to processing circuitry 830 and configured to transmit data, receive data, or both from remote device 822, such as user input data or other data. In some examples, the data may include physiological data received from sensors 836, biological events (determined by processing circuitry 830 based on physiological data received from sensors 836) associated with the user, user input data, or combinations thereof. Additionally, or alternatively, communication circuitry 834 may be configured to receive from remote device 822 data indicative of commands to control an operation of device 800. For example, remote device 822 may transmit to communication circuit a signal indicative of a command to control a power state (i.e., on / off state) of motor 838, vibration motor 840, thermoelectric device 842, or other devices of combinations of devices. In this way, remote device 822 maycommunicate with controller 820 such that various functions of device 800 may be turned on or turned off remotely.

[0129] Sensors 836 are configured to generate data indicative of detected physiological parameters (referred to as physiological data) that may be used to determine biological events associated with the user. Sensors 836 may include but are not limited to accelerometers, gyroscopes, inertia monitor, thermometers, respiratory monitors, pulse (heart rate) monitors, pulse oximeters, photoplethysmography monitors, blood pressure monitors, electromyography sensors, electroencephalogram sensor, electrocardiogram sensors, or other sensors configured to measure a physiological parameter of the user. Each of sensors 836 may be disposed on or within core 804, shell 806, portions of core 408 and shell 806, or located remotely from and communicatively coupled to processing circuitry 830 (e.g., via communication circuitry 834).

[0130] Sensors 836 may transmit physiological data to processing circuitry 830, remote device 822, or both, which may determine, based on one or more of the detected physiological data and user input data, biological events associated with the user, such as at least one of urges to urinate, sleep states and patterns, wake states and patterns, heart patterns, and breathing patterns. For example, sensors 836 may include sensors configured to detect movement of the user, a heart rate or respiratory rate of the user, and a skin and body temperature of the user, such that, based on this physiological data, processing circuitry 830 may determine that the level of movement, the heart rate or respiratory rate, and skin and body temperature of the user are indicative of the user being in a select sleep state or wake state.

[0131] Based on changes in these physiological parameters and, optionally, other received physiological data, including but not limited to, muscle contractions in proximity to device 800, processing circuitry 830 may determine that the user is experiencing an urge to urinate. In some examples, a sequential change in physiological data (i.e., a pattern in the physiological data) may be indicative of the user experiencing an urge to urinate. In such examples, system 801 may be configured to predict an urge to urinate prior to the user subjectively experiencing the urge to urinate.

[0132] In response to a determined urge to urinate, as determined by processing circuitry 830 based on physiological data received from sensors 836, processing circuitry 830 may cause operation of a component of device 800. The operation of a component of device 800 mayinclude controlling a power state of a component of device 800, analyzing and storing data indicative of the urge to urinate, generating data receivable by remote device 822 that is indicative of a notification that can be received by the user, or a combination thereof. For example, in response to a determined urge to urinate, processing circuitry 830 may control a power state (e.g., on / off state) of motor 833.

[0133] Additionally, or alternatively, in response to a determined urge to urinate, processing circuitry 830 may generate data receivable by remote device 822 that is indicative of the determined urge to urinate (i.e., urge data). In some examples, remote device 822 (or processing circuitry 830) may be configured to store the urge data in a memory (e.g., memory 832). Over time, storing urge data may enable system 801 to determine patterns in urination urges, associate urination urges with other user input data, associate urination urges with detected physiological data, or the like.

[0134] In some examples, in response to receiving urge data, remote device 822 may be configured to generate a notification via a user interface of remote device 822 that is receivable by the user, such as, for example, an audible alert (e.g., an alarm), a visual alert (e.g., a flashing light or short message service alert), or a tactile alert (e.g., a vibration of remote device 822). For example, system 801 may notify the user of an urge to urinate, in some instances, prior to the user subjectively experiencing the urge to urinate. In other examples, system 801 may be configured to notify user of a history of urges to urinate. For example, after waking, system 801 may generate a push alert to a mobile device of the user (e.g., remote device 822) that includes a history logging each detected urge to urinate during the previous night. In some examples, the user may be able to provide feedback in response to the push notification, for example, to indicate whether the device successfully reduced the urge to urinate. Such feedback or other user input data may be used to train device 800.

[0135] In some examples, processing circuitry 830 may be configured to select the operation of a component of device 800 based on feedback from the user collected in response to a previously selected operation of a component of device 800. For example, in response to a first detected urge to urinate, processing circuitry 830 may select a first operation of device 800 (e.g., turning on vibration motor 840 and turning on thermoelectric device 842). Processing circuitry 830 may receive first feedback data from user, either as user selected feedback data from a user interface associated with remote device 822 or as detected feedback data from sensors 836, that is indicative of a level of success of the first selected operation in reducing the first detected urge to urinate. Subsequently, in response to a seconddetected urge to urinate, processing circuitry 830 may select a second operation of device based on, at least in part, the first feedback data (e.g., only turning on thermoelectric device 842 and not turning on vibration motor 840). Processing circuitry 830 then may receive second feedback data from user that is indicative of a level of success of the second selected operation in reducing the second detected urge to urinate. This process may be iteratively repeated. In this way, device 800 may be configured to utilize machine learning to predictively select operations of device 800 that are more likely to successfully reduce urges to urinate compared to other possible operations of device 800.

[0136] Although the functions described above are in response to a detected urge to urinate, in other examples, different detected parameters may initiate a function of processing circuitry 830. For example, a function of processing circuitry 830 may be initiated in response to a detected force manually applied to device 800, such as a force urging device 800 toward the anus of the user or a tactile input to device 800 (e.g., a double tap, a triple tap, or the like). In some examples, a plurality of unique manual force inputs may be associated with corresponding functions of device 800. Additionally, or alternatively, functions may be based on a detected orientation or motion of device 800. For example, system 801 may be configured to alert the user that the device is positioned in the intergluteal cleft when processing circuitry 830 determines that the user is getting out of bed, approaching the toilet, or when device 800 may otherwise become displaced from the intergluteal cleft.

[0137] In some examples, a function of processing circuitry 830 may include generating a notification or other data for receipt by a user related to eating or drinking patterns of the user, including, for example, suggestions for eating or drinking patterns that may reduce urges to urinate during selected time, such as during sleep periods. In this way, device 800 may be configured to provide to the user and his or her physician real-time information, feedback, predictions, or the like about this so that the user could modify his or her eating and drinking patterns both during the day and in the evening before bed so that he or she could minimize the likelihood of having urges to urinate and, thereby, increase sleep quality. In some examples, processing circuitry 830 may be configured to generate a grocery shopping list that it would change and tailor-make with suggestions for the user for specific foods and beverages, including specfic brands or products, to help him or her to change more easily his or her habits and to find alternative foods that lessen agitation to or that do not agitate the bladder and prostate. For example, if the user orders groceries or tracks grocery purchases online, device 800 may be configured to interact accordingly, with permission from the user,with his or her chosen app or online grocery lists. Additionally, or alternatively, device 800 may be configured to retrieve food and beverage nutritional data from external sources such as the USDA or NIH websites or the like for the purpose of analyzing, determining, storing, and actively learning from said nutritional data, the user’s specific urinary voiding details and actual nutrient intake data (each as inputted by the user), and grocery shopping habit information, both historical and desired, so that device 800 may better guide and inform the user and the user and the user’s physician may best track, understand, and improve the user’s condition and symptoms based upon said information all for the purpose of seeing and discovering patterns of connection, including but not limited to, between the user’s amounts and types of nutrient, food, and beverage inake, timings of such nutrient, food, and beverage intake, urinary voiding timing, frequency, and amounts, and resultant disturbances or improvements in sleep patterns and increases or decreases in urges to urinate. Device 800 could, thereby, better predict and learn to better foresee the impending onset of urinary urge events, bladder and prostate agitation, sleep disturbances, as well as act to provide user and his or her physician with real-time data for the purposes of more accurately understanding and diagnosing the user’s condition and symptoms all while increasing the user’s general health and decreasing the user’s intake of those specific nutrients, foods, and beverages that especially agitate a user’s own bladder and, in the case of men, the prostate. Processing circuitry 830 may, in some examples, cross-reference food and beverage data with the USDA’s Daily Recommended Intake (DRI) data for the user or similar dietary needs data, the users reported food and drink intake, physiological parameters, biological events, or combinations thereof.

[0138] Motor 838 may include an electric motor operably coupled to processing circuitry 830 (and battery 825) that is configured to control motion of one or more features of device 800. In some examples, motor 838 may be coupled to a cog or lobed gear positioned at or below a surface of shell 806 such that actuation of the cog or lobed gear by motor 838 causes the surface of shell 806 to undulate or otherwise move. When positioned against the body of the user, the undulations provide a massaging action. In some examples, a position of the cog or lobed gear may be selected to provide the massaging action at or near CV1 and GV1 to enhance stimulation of the CV1 and GV1 acupoints and, optionally, the prostate. In other examples, motor 838 may cause at least partial rotational motion about an axis of device 800.

[0139] Vibration motor 840 may include an electric motor operably coupled to processing circuitry 830 (and battery 825) that is configured to cause vibration of device 800. Forexample, vibration motor 838 may be coupled to counter- weighted bearing such that actuation of the motor causes the counter-weighted bearing to rotate and cause small displacements in weight that are experienced by the user as a vibration. In some examples, the counter-weight bearing may be enclosed in a case fixed to a body of the vibration motor such that rotation of the counter-weighted bearing causes a portion of the counter-weighted bearing to contact the case. In this way, the vibration may be amplified compared to a vibration motor and counter-weighted bearing system without a case. In some examples, the vibration motor 840 may be positioned within core 804 to produce a substantially consistent vibration throughout device 800. In other examples, vibration motor 840 may be positioned within shell 806 (e.g., at or near a surface of shell 806) such that vibrations are focused at the CV1 and GV1 acupoints and, optionally, the prostate.

[0140] Thermoelectric device 842 may include a resistive heater or thermoelectric heat pump coupled to processing circuitry 830 (and battery 825) that is configured to cause heating or cooling of device 800. A resistive heater may cause heating of one or more selected portions of device 800. A thermoelectric heat pump may cause heating or cooling of one or more selected portions of device 800. In some examples, thermoelectric device 842 may be thermally coupled to a heat sink. For example, to affect cooling of at least a portion of shell 806, core 804 may be configured as a heat sink thermally coupled to a hot side of a thermoelectric heat pump. In this way, a portion of shell 806 adjacent to a cold side of the thermoelectric heat pump may be at least temporarily cooled. In some examples, the heating or cooling of select portions of device 800 may enhance stimulation of the CV1 and GV1 acupoints and, optionally, the prostate.

[0141] Although described as being included in device 800, in other examples, one or more components of device 800 may be included in separate device. For example, device 800 may not include a vibration motor 840, rather device 800 may be communicatively coupled to a second auxiliary device including vibration motor 840 such that processing circuitry 830 of device 800 may control the vibration motor 840 included in the second auxiliary device. In this way, the described devices may be paired with auxiliary devices to perform one or more of the device functions described herein.

[0142] FIG. 9 is a flow diagram illustrating an example technique of reducing an urge to urinate using a peripheral modulation device. The technique is described in reference to device 800 illustrated in FIG.8, although the technique may be used with other devicesdescribed herein. Additionally, the devices described herein may be used to perform other techniques for reducing an urge to urinate.

[0143] The technique illustrated in FIG. 9 includes positioning device 800 in proximity to a selected acupoint (902). The selected acupoint may include the CV1 and GV1 acupoints. For example, the technique may include positioning device 800 in the intergluteal cleft of a user, optionally centered on the anus.

[0144] The technique illustrated in FIG. 9 also includes applying pressure to at least a portion of device 800 to urge at least one surface of device 800 toward the at least a portion of the body of the user (904). The pressure may be applied by any suitable means, such as the fingers of the user, contraction of muscles (e.g., gluteus maximus and sphincter muscles) of the user, actuation of a component of device 800 (e.g., motor 838), actuation of a tool (e.g., a wand controlled by a hand of the user) in contact with device 800. The at least one surface of device 800 may include at least one curved solid surface defined by a body of device 800. The at least portion of the body of the user may include at least one of the anus, the CV1 acupoint, the GV1 acupoint, and the prostate. In some examples, the at least portion of device 800 may include a button or cap, which may define a curvature corresponding to a shape of one or more fingers, to distribute pressure applied to the button or cap throughout a larger surface of device 800 compared to applying pressure to device 800 without a button or cap.

[0145] In some examples, the technique may include detecting by device 800, e.g., one or more sensors 836, at least one physiological parameter to generate physiological data (912). Optionally, the technique may include controlling, by processing circuitry 830, sensors 836 to power-on or otherwise activate sensors 836 or prompt sensor 836 to retrieve the at least one physiological parameter.

[0146] The technique also may include, determining, by processing circuitry 830, based on the physiological data, at least one biological event associated with the user (914). In some examples, the biological event may include an urge to urinate. In some examples, the technique may include compiling two or more biological events (or physiological data sets) to determine, by processing circuitry 830, one or more patterns associated with the biological events (or physiological data sets). In some examples, the technique may include predicting, by processing circuitry 830, based on the one or more patterns and second physiological data, at least one future biological event.

[0147] The technique also may include controlling, by processing circuitry 830, in response to a determined or predicted biological event, at least one component of device 800 (916). The at least one component of device 800 may include at least one of sensors 836, motor 838, vibration motor 840, and thermoelectric device 842. Additionally, or alternatively, the technique may include controlling, by processing circuitry 830, in response to a detected force manually applied to device 800, at least one component of device 800.

[0148] FIG. 10 is an example kit 1000 including a peripheral modulation device 1002 (hereinafter, device 1002), a reminder token 1004, and an instruction manual 1006. Device 1002 may be the same as or substantially similar to any one or more of devices 200, 300, 400, 500, 600, 700, or 800 described herein. Reminder token 1004 is configured to remind the user to remove the worn device 1002 prior to sitting down on the toilet to prevent loss of the device 1002 in the toilet water or sewage system. In some examples, reminder token 1004 may include a multi-use container for cleaning and storage, which reminds the user both to remove the device prior to sitting down on the toilet and to reinsert the device upon returning to bed. In other examples, device 1002 may include a body defining reminder token 1004 in any shape or form and of any material configured to be placed within sight of the user, for example and without limitation, that can be hung, balanced, placed, or set in or upon any place and in any manner or location that confronts the user. Instruction manual 1006 may include instructions for using device 1002 consistent with any device or technique described herein.

[0149] FIGS. 11 A and 1 IB are conceptual diagrams illustrating peripheral modulation device 1100 (hereinafter, device 1100) having an orienting tail 1150 coupled to a body 1102 of device 1100. Device 1100 may be the same as or substantially similar to devices 200, 300, 400, 500, 600, 700, or 800 described above, except for the differences described herein. Orienting tail 1150 may include the same material as body 1102 (e.g., a shell of the device) and be shaped to fit within at least a portion of the intergluteal cleft to orient device 1100 relative to the anatomy of the user. In some examples, orienting device 1100 relative to the anatomy of the user may facilitate a function of device 1100. For example, in examples in which device 1100 includes a component configured to enhance stimulation of the CV1 and GV1 acupoints and, optionally, the prostate, orienting device 1100 with orienting tail 1150 extending along a portion of the intergluteal cleft may position the component more accurately at the CV1 and GV1 acupoints compared to a device that does not include an orienting tail 1150. Additional, or alternative, orienting features may be configured to orientdevice 110 based on a removable coupling to the scrotum or penis, in males, or the vaginal opening in females.

[0150] FIGS. 12A through 12C are conceptual diagrams illustrating peripheral modulation device 1200 having a concave button 1214 flanked by orienting fins 1250A and 1250B (collectively, orienting fins 1250) extending from a body 1202 of device 1200. Device 1200 may be the same as or substantially similar to devices 200, 300, 400, 500, 600, 700, 800, or 1100 described above, except for the differences described herein.

[0151] Orienting fins 1250 may include the same material as body 1202 (e.g., a shell of the device) and be shaped to fit within at least a portion of the intergluteal cleft to orient device 1200 relative to the anatomy of the user. In other examples, orienting fins 1250 may include the same material as and, optionally, extend from core 1204. In some examples, orienting device 1200 relative to the anatomy of the user may facilitate a function of device 1200. For example, in examples in which device 1200 includes a component configured to enhance stimulation of the CV1 and GV1 acupoints and, optionally, the prostate, orienting device 1200 with orienting fins 1250 extending along a portion of the intergluteal cleft may position the component more accurately at the CV1 and GV1 acupoints compared to a device that does not include orienting fins 1250. In some examples, at least one of orienting fins 1250 may be configured to be grasped between a finger and thumb of the user to manipulate or remove device 1200.

[0152] Concave button 1214 may be positioned adjacent to orienting fins 1250 such that, when device 1200 is positioned adjacent the anus in the intergluteal cleft, concave button 1214 is oriented outward (e.g., opposite the anus) to facilitate manipulation of device 1200 by the user. In some examples, a depth D of concave button 1214 may be selected to facilitate manipulation by the user, e.g., using a single finger to interface with and manipulate device 1200. Depth D may be between about 0.125 inch (0.32 cm) to about 0.5 inch (1.27 cm). In some examples, concave button 1214 may extend at least partially into a region of a core 1204. In this way, concave button may improve directional control, pressure control, or both applied by the user to device 1200 compared to, for example, a device without a button, a button that is not concave, or a concave button that does not have a depth D.

[0153] FIG. 13a through 13C are conceptual diagrams illustrating peripheral modulation device 1300 having a concave button 1314 surrounded by a raised crown structure 1350 extending from a body 1302 of the device 1300. Device 1300 may be the same as orsubstantially similar to devices 200, 300, 400, 500, 600, 700, 800, 1100, or 1200 described above, except for the differences described herein.

[0154] Crown 1350 may include the same material as body 1302 (e.g., a shell of the device) and be shaped to fit within at least a portion of the intergluteal cleft to orient device 1300 relative to the anatomy of the user. In other examples crown 1350 may include the same material as and, optionally, extend from core 1304. Crown 1350 may at least partially surround concave button 1314. When device 1300 is positioned adjacent to the anus in the intergluteal cleft, concave button 1314 is oriented outward (e.g., opposite the anus) to facilitate manipulation of device 1300 by the user. In some examples, a depth D of concave button 1314 may be selected to facilitate manipulation by the user. Depth D may be between about 0.125 inch (0.32 cm) to about 0.5 inch (1.27 cm). For example, the user may use a single finger to interface with and manipulate device 1300, grasp device 1330 between a finger positioned within a region defined by concave button 1314 and thumb positioned along an exterior portion of crown, or both. In some examples, crown 1350 may extend outside a spherical plane defined by body 1302. The distance crown 1350 extends outside of the spherical plane may be selected to make it less able to tickle or be felt.

[0155] In some examples, concave button 1314 may be defined, at least in part, by anchor 1316. Anchor 1316 may be at least partially embedded in body 1302. In some examples, at least a portion of anchor 1316 may be defined by at least a portion of core 1304 or may be mechanically coupled or otherwise fixed to core 1304. The concave shape of anchor 1316 may improve directional control, pressure control, or both applied by the user to device 1300 compared to, for example, a device without a button, a button that is not concave, or a concave button that does not have a depth D or anchor.

[0156] The devices described herein may be formed using any suitable technique. In some examples, forming the device may include forming a core. The core may define a cavity configured to house a controller. Alternatively, core may be overmolded onto the controller. In some examples, the shell may be separately formed, e.g., by a conventional molding process, and subsequently adhered to or otherwise coupled to the core. In other examples, the shell may be overmolded onto the core. In some examples, the shell may be molded based on a formed defined by an anatomy of the user. For example, a mold may be used to create a positive impression of the intergluteal cleft of the user. The positive impression may be used for forming a negative impression or mold from which the shell may be formed to define a shape that corresponds directly to the anatomy of the user.

[0157] The devices described herein may, in some examples, be used to enhance bladder training techniques. Bladder training, also known as timed voiding or bladder reeducation, is a behavioral therapy that helps people regain control of their bladder. Bladder training may include at least practicing urge suppression by using the devices described herein by pressing the device toward the CV1 and GV1 pressure points and optionally lifting the diaphragm muscle to suppress the urge to urinate before the scheduled interval. In some examples, bladder training may further include one or more of: (1) Scheduling voiding by using the bathroom at set times, even when there is no urge to urinate; (2) Increasing intervals between voiding to gradually increasing the time between bathroom breaks; (3) Patient education such as learning about bladder function and how to maintain continence; and (4) Positive reinforcement via psychological support to encourage patients to continue the practice. Bladder training can help with urinary incontinence, overactive bladder, reduce leakage, and the sense of urgency as well as other benefits described herein. Bladder training is usually provided by healthcare providers, but it can also be done in groups or individually. It typically lasts 8 to 12 weeks. In some examples, using the devices described herein may reduce the duration of bladder training. After going through bladder training, you should be able to: Go longer periods of time between bathroom visits; Hold more liquid in your bladder; and Have more control over the urge to go.

[0158] In this disclosure, whenever an indicator of gender is noted, it is intended to apply to and include each the male and female genders. And where a body function or part of a certain gender is noted, such is intended to apply to the corresponding body function or part of the opposite gender, to the full extent such exists. Moreover, whenever the singular is used, it is also intended to include the plural.

[0159] The following clauses illustrate example subject matter described herein.

[0160] Clause 1. A device for temporarily blocking or relieving a body’s sensatory feelings of an urge or a need to urinate comprising a flexible or inflexible peripheral acupressure modulation device adapted to conform to the shape of a portion of a person’s body, being a means for providing adequate stimulation to activate a neural feedback loop through brainstem analgesia-producing areas to provide relief from the urge to urinate when said device, located and centered over said body portion, and so that, when the urge to urinate presents, is pressed inward toward the human body, causing the acupressure points GV1 and CV1, and, as desired, in men, the prostate, to be stimulated and the urge to urinate, accordingly, to recede and dissipate upon each occasion.

[0161] Clause 2. A device as defined in Clause 1 wherein said device has means for being capable of remaining in place without the use or application of any external support or fastening mechanism to secure it against said body portion.

[0162] Clause 3. A device as defined in Clause 1 wherein said device consists of, or largely consists of, all or in substantial part, convex side edges so that the top and bottom portions can be positioned comfortably within the dermal folds and musculature of the lower pelvic region.

[0163] Clause 4. A device as defined in Clause 1 wherein said device consists of a complete and singular solitary unit in its form, firmness, and composition that is characterized by, or largely consists of, all or in substantial part, convex side edges.

[0164] Clause 5. A device as defined in Clause 1 wherein said device consists of, or largely consists of, all or in substantial part, convex side edges, wherein said device is made up of a smaller inner support body that consists of a firmer grade material that is, itself, all or substantially enveloped within a perfectly-fitting larger outer cover body shell made up of a softer grade material, the cover body shell thereby providing, while being maintained by the harder inner support body, a softening or dampening effect when the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0165] Clause 6. A device as defined in Clause 1 wherein said device consists of, or largely consists of, all or in substantial part, convex side edges, wherein the portion of the device interacting directly with the anus itself consists of a main body that is made up of a softer grade material, to which a round convex or flat cap or button that consists of a harder grade material is affixed upon the opposite side, whether by using an anchoring mechanism, medical-grade glue or cement, chemical bonding, molecular bonding, or any combination of the aforegoing, said harder cap or button, thus, providing for an increased focus of all force manually applied to the device, while the larger and softer portion below provides a softening or dampening effect when the entirety of the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0166] Clause 7. A device as defined in Clause 1 wherein said device has means for being capable of collecting the device user’s physiological and health data specifically relating to the need or urge to urinate by the building into said device minute micro-sensors and memorycapable of recording, storing, and transmitting the details of the user’s bodily sleep cycle, circadian cycle, urinary habits, movements, time details, cardio performance, and other relevant heal th -related data and patterns.

[0167] Clause 8. A device for massaging and stimulating the anus, sphincter muscles, perineum, and, in men, the prostate, or, in women, the vaginal muscles, by means of placement of a device on or adjacent to acupoints GV1 and CV1 comprising a flexible or inflexible peripheral acupressure modulation device adapted to conform to the shape of a portion of a person’s body, being a means for providing adequate stimulation to activate neural pleasure centers through the brainstem when pressure is applied upon the anus, sphincter muscles, perineum, and prostate causing these to react to the device, thus creating a massage action, causing, for example, the sphincter’s contraction and relaxation to cause, in men, the prostate itself, or, in women, the vaginal muscles to begin, in alternating motions, to contract and relax, thus, producing acupressure therapeutic effects that stimulate these areas for therapeutic purposes.

[0168] Clause 9. A device as defined in Clause 8, wherein said device has means for being capable of remaining in place without the use or application of any external support or fastening mechanism to secure it against said body portion.

[0169] Clause 10. A device as defined in Clause 8, wherein said device consists of, or largely consists of, all or in substantial part, convex side edges so that the top and bottom portions can be positioned within the dermal folds and musculature of the lower pelvic region.

[0170] Clause 11. A device as defined in Clause 8, wherein said device consists of a complete and singular solitary unit in its form, firmness, and composition that is characterized by, or largely consists of, all or in substantial part, convex side edges.

[0171] Clause 12. A device as defined in Clause 8, wherein said device consists of, or largely consists of, all or in substantial part, convex side edges, wherein said device is made up of a smaller inner support body that consists of a firmer grade material that is, itself, all or substantially enveloped within a perfectly-fitting larger outer cover body shell made up of a softer grade material, the cover body shell thereby providing, while being maintained by the harder inner support body, a softening or dampening effect when the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0172] Clause 13. A device as defined in Clause 8, wherein said device consists of, or largely consists of, all or in substantial part, convex side edges, wherein the portion of the device interacting directly with the anus itself consists of a main body that is made up of a softer grade material, to which a round convex or flat cap or button that consists of a harder grade material is affixed upon the opposite side, whether by using an anchoring mechanism, glue or cement, chemical bonding, molecular bonding, or any combination of the aforegoing, said harder cap or button, thus, providing for an increased focus of all force manually applied to the device, while the larger and softer portion below provides a softening or dampening effect when the entirety of the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

[0173] Clause 14. A device as defined in Clause 8, wherein said device has means for being capable of applying micro vibrating technology capable of stimulating the anus, sphincter muscles, perineum, and, in men, the prostate, or, in women, the vaginal muscles, by means of building into said device of a minute directly or remotely controlled vibrating technology that can be included into the device to increase therapeutic stimulation.

[0174] Clause 15. A method for suppressing the urge to urinate, comprising: providing a device configured in accordance with any one of claim 1 through 14 to contact a first acupressure point, GV1, located on the lower outer periphery of the anus about midway between the center of the anus and the lower end of the coccyx, and a second acupressure point, CV1, located in the perineum region between the anus and the scrotum, in males, and between the anus and the posterior labial commissure, in females; placing the device over and centered upon the anus and the sphincter, including the internal and external sphincter, wherein the device when so placed has a convex section substantially in contact with the entirety of the anus; manually pressing and holding the device inward toward the anus and sphincter while directing the device upward, forward, or backward whereby, via the device, pressure is applied, whether directly or indirectly, to the first acupressure point (GV1) and the second acupressure point (CV1), or as desired, in males, also to the prostate, depending upon the amount of force upon and trajectory of that force upon the device when manually pressed inward towards the human body.

[0175] Clause 16. The method of Clause 15, further comprising stimulating of the large transmitter fibers of the nervous impulses to the spinal cord by activating the first acupressure point (GV1) and the second acupressure point (CV1), thus, resulting in the closure of theoveractive nerve impulse transmission gates and, thereby, achieving a dissipation or lessening, in each instance, of the nerve impulse that causes the feeling of an urge or need to urinate.

[0176] Clause 17. The method of Clause 15, further comprising: lifting upward and inward of the uppermost pairs of rectus abdominis muscles as well as the diaphragm muscles and holding this position, thus, relieving pressure on the bladder below, refocusing the body’s attention away from the muscles involved in the urge to urinate, and, in this way, further dispensing with and suppressing any remaining urge.

[0177] Clause 18. The method of Clause 15, wherein the device comprises: a body consisting of, or largely consisting of, all or in substantial part, convex side edges, and sized to fit over the anus and the sphincter, which includes the internal and external sphincters, wherein the body is configured to contact the first acupressure point (GV1) and the second acupressure point (CV1), directly or indirectly, depending upon the amount of force upon and trajectory of that force upon the device when manually pressed inward towards the human body.

[0178] Clause 19. A method for reminding the user of his or her wearing of the device as described in any one of Clauses 1 through 14, comprising providing an additional device in the form of a token reminder piece to remind the user to remove the worn device prior to sitting down on the toilet to prevent loss of the device in the toilet water or sewage system.

[0179] Clause 20. The method of Clause 19, further comprising providing a token reminder piece, in the preferred embodiment a multi-use container for cleaning and storage, that reminds the user both to remove the device prior to sitting down on the toilet and to reinsert the device upon returning to bed.

[0180] Clause 21. The method of Clause 19, wherein the device comprises a body comprising a token reminder piece in any shape or form and of any material configured to be placed within sight of the device user, for example and without limitation, that can be hung, balanced, placed, or set in or upon any place and in any manner or location that confronts the device user.

Claims

CLAIMSWhat is claimed is:

1. A peripheral modulation device for temporarily relieving an urge to urinate, the device comprising a body configured to be received by a portion of a human body, wherein the body defines at least one curved solid surface shaped to provide, in response to a pressure toward the portion of the human body, acupressure stimulation of at least one or a GV1 acupressure point, a CV1 acupressure point, and a prostate.

2. The peripheral modulation device of claim 1, wherein the body is configured to be received in the intergluteal cleft and at least partially surrounded by a musculature and a skin of the human body to remain in place without any external support to secure it against the portion of the human body.

3. The peripheral modulation device of claim 1 or 2, wherein the at least one curved solid surface comprises a continuous convex surface defining a sphere or a spheroid.

4. The peripheral modulation device of any one of claims 1 through 3, wherein the body consists of a complete and singular solitary unit in its form, firmness, and composition.

5. The peripheral modulation device of any one of claims 1 through 4, wherein body comprises a core and a shell, wherein the core comprises a first material having a first durometer, wherein the shell comprises a second material having a second durometer, wherein the first durometer is greater than the second durometer.

6. The peripheral modulation device of any one of claims 1 through 5, wherein the body defines a first portion defining the at least one curved solid surface shaped configured to profile the acupressure stimulation and a second portion defining at least one of a cap or a button configured to receive a manual manipulation including the pressure toward the portion of the human body, wherein the first portion comprises a first material having a first durometer, wherein the second comprises a second material having a second durometer, wherein the second durometer is greater than the first durometer.

7. The peripheral modulation device of any one of claims 1 through 6, further comprising processing circuitry operatively coupled to at least one physiological sensor, a memory device, and a power source, wherein the processing circuitry is configured to at least one of record, store, and transmit physiological data indicative of the urge to urinate, and wherein the physiological data comprises at least one of a sleep cycle, circadian cycle, bladder status, urinary habits, regional muscular tensions, muscular movements, bodily movements, skin or body temperature, time details, cardio and respiratory performance.

8. A device for massaging and stimulating acupoints GV1 and CV1 and the anus, sphincter muscles, perineum, and, in men, the prostate, or, in women, the vaginal muscles, by means of placement of a device on or adjacent to acupoints GV1 and CV1 comprising a flexible or inflexible peripheral acupressure modulation device adapted to conform to the shape of a portion of a person’s body, being a means for providing adequate stimulation to activate neural pleasure centers through the brainstem when pressure is applied upon at least one of acupoints GV1 and CV1, the anus, sphincter muscles, perineum, and prostate causing these to react to the device, thus creating a massage action, causing, for example, the sphincter’s contraction and relaxation to cause, in men, the prostate itself, or, in women, thevaginal muscles to begin, in alternating motions, to contract and relax, thus, producing acupressure therapeutic effects that stimulate these areas for therapeutic purposes.

9. A device as defined in claim 8, wherein said device has means for being capable of remaining in place without the use or application of any external support or fastening mechanism to secure it against said body portion.

10. A device as defined in claim 8, wherein said device consists of, or largely consists of, all or in substantial part, convex side edges so that the top and bottom portions can be positioned within the dermal folds and musculature of the lower pelvic region.

11. A device as defined in claim 8, wherein said device consists of a complete and singular solitary unit in its form, firmness, and composition that is characterized by, or largely consists of, all or in substantial part, convex side edges.

12. A device as defined in claim 8, wherein said device consists of, or largely consists of, all or in substantial part, convex side edges, wherein said device is made up of a smaller inner support body that consists of a firmer grade material that is, itself, all or substantially enveloped within a perfectly-fitting larger outer cover body shell made up of a softer grade material, the cover body shell thereby providing, while being maintained by the harder inner support body, a softening or dampening effect when the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

13. A device as defined in claim 8, wherein said device consists of, or largely consists of, all or in substantial part, convex side edges, wherein the portion of the device interacting directly with the anus itself consists of a main body that is made up of a softer grade material, to which a round convex, concave, or flat cap or button, or a cap or button that is made up of a combination of convex, concave, or flat surfaces, that consists of a harder grade material is affixed upon the opposite side, whether by using an anchoring mechanism, mechanical affixment, glue or cement, chemical bonding, molecular bonding, or any combination of the aforegoing, said harder cap or button, thus, providing for an increased focus of all force manually applied to the device, while the larger and softer portion below provides a softening or dampening effect when the entirety of the device is pressed inward toward the human body, thereby increasing user comfort and preventing injury or damage to the anus and surrounding epidermis and dermis.

14. A device as defined in claim 8, wherein said device has means for being capable of applying micro vibrating technology capable of stimulating acupoints GV1 and CV1 and the anus, sphincter muscles, perineum, and, in men, the prostate, or, in women, the vaginal muscles, by means of building into said device of a minute directly or remotely controlled vibrating technology that can be included into the device to at least one of increase therapeutic stimulation and increase prostate, genital, and pelvic floor muscle strength.

15. A method for suppressing the urge to urinate, comprising: providing a device configured in accordance with any one of claim 1 through 14 to contact a first acupressure point, GV1, located on the lower outer periphery of the anus about midway between the center of the anus and the lower end of the coccyx, and a secondacupressure point, CV1, located in the perineum region between the anus and the scrotum, in males, and between the anus and the posterior labial commissure, in females; placing the device over and centered upon the anus and the sphincter, including the internal and external sphincter, wherein the device when so placed has a convex section substantially in contact with the entirety of the anus; manually pressing and holding the device inward toward the anus and sphincter while directing the device upward, forward, or backward whereby, via the device, pressure is applied, whether directly or indirectly, to the first acupressure point (GV1) and the second acupressure point (CV1), or as desired, in males, also to the prostate, depending upon the amount of force upon and trajectory of that force upon the device when manually pressed inward towards the human body.

16. The method of claim 15, further comprising stimulating of the large transmitter fibers of the nervous impulses to the spinal cord by activating the first acupressure point (GV1) and the second acupressure point (CV1), thus, resulting in the closure of the overactive nerve impulse transmission gates and, thereby, achieving a dissipation or lessening, in each instance, of the nerve impulse that causes the feeling of an urge or need to urinate.

17. The method of claim 15, further comprising: lifting upward and inward of the uppermost pairs of rectus abdominis muscles as well as the diaphragm muscles and holding this position, thus, relieving pressure on the bladder below, refocusing the body’s attention away from the muscles involved in the urge to urinate, and, in this way, further dispensing with and suppressing any remaining urge.

18. The method of claim 15, wherein the device comprises: a body consisting of, or largely consisting of, all or in substantial part, convex side edges, and sized to fit over the anus and the sphincter, which includes the internal and external sphincters, wherein the body is configured to contact the first acupressure point (GV1) and the second acupressure point (CV1), directly or indirectly, depending upon the amount of force upon and trajectory of that force upon the device when manually pressed inward towards the human body.

19. A method for reminding the user of his or her wearing of the device as described in any one of claims 1 through 14, comprising providing an additional device in the form of a token reminder piece to remind the user to remove the worn device prior to sitting down on the toilet to prevent loss of the device in the toilet water or sewage system.

20. The method of claim 19, further comprising providing a token reminder piece, in the preferred embodiment a multi-use container for cleaning and storage, that reminds the user both to remove the device prior to sitting down on the toilet and to reinsert the device upon returning to bed.

21. The method of claim 19, wherein the device comprises a body comprising a token reminder piece in any shape or form and of any material configured to be placed within sight of the device user, for example and without limitation, that can be hung, balanced, placed, or set in or upon any place and in any manner or location that confronts the device user.

22. The method of claim 15, wherein the method further comprises suppressing the urge to urinate for purposes of bladder training and optionally lifting upward and inward of the uppermost pairs of rectus abdominis muscles as well as the diaphragm muscles and holding this position, thus, relieving pressure on the bladder below, refocusing the body’s attention away from the muscles involved in the urge to urinate, and, in this way, further dispensing with and suppressing any remaining urge.

Images