WO2023053148A1

WO2023053148A1 - Wearable device to provide simultaneous relief from menstrual pain and cramp discomfort using dual frequency

Info

Publication number: WO2023053148A1
Application number: PCT/IN2022/051004
Authority: WO
Inventors: Rahul Chopra; Preksha CHOPRA
Original assignee: Camex Wellness Limited
Priority date: 2022-07-26
Filing date: 2022-11-16
Publication date: 2023-04-06

Abstract

The present invention discloses device to provide relief from menstrual pain and cramp discomfort in women simultaneously by automatic and alternative switching between two frequencies at preset time. The complete device consist of Li-polymer rechargeable battery, battery charging section, controller section with preprogrammed 8 bit microprocessor with memory to control the output current and voltage, frequency, phase and width of pulses, user interface section, high voltage section (including power inverter using H Bridge), 2.5mm Jack cable pair of self-adhesive Electrodes (Patches) connected with the 2.5mm Jack female port. The electrode patches are reusable for 20 to 30 times. The device is capable of switching between dual frequencies of 50-120 Hz (defined as Program A) and 1 to 4 Hz (defined as Program B) at preset intervals of time, without user intervention.

Description

WEARABLE DEVICE TO PROVIDE SIMULTANEOUS RELIEF FROM

MENSTRUAL PAIN AND CRAMP DISCOMFORT USING DUAL

FREQUENCY

FIELD OF INVENTION

The present invention relates to wearable electronic devices for women. More specifically it is wearable device to provide simultaneous relief from menstrual pain and cramp discomfort using dual frequency.

BACKGROUND OF THE INVENTION

Most of the women suffer with Primary dysmenorrhea (menstrual pain) especially if they are in the age group of 20 to 42. Primary dysmenorrhea (PD) defined as the recurrent, cramping pain, which occurs during menses, and lacks any identifiable reproductive system pathology.

This monthly pain disrupts their normal routine and they either tolerate it or try to manage it by way of various pain management strategies which include: pain medicines physical therapies (such as heat or cold packs, massage, hydrotherapy and exercise) psychological therapies (such as cognitive behavioral therapy, relaxation techniques and meditation) mind and body techniques (such as acupuncture)

- pain relieving devices

The present invention will be confined to non- invasive electronic pain relieving devices. Some of such devices are categorized as Electrotherapy Units.

Electrotherapy units usually consist of a battery-powered device connected by wires to adhesive electrode pads which are placed on the skin. The electrode pads are sticky, so they will adhere to the skin. Once the electrodes are attached and the unit is turned on, a mild electric current is sent to the skin via the electrode.

A number of newer electrotherapy devices bypass the wires, combining electrodes and battery power into a single unit that can be worn inconspicuously on the back, arm, leg, or elsewhere during work or other daily activities. A hand-held controller is used to adjust the level of stimulation.

While a large number of people find electrotherapy helpful, others do not. The medical literature on electrotherapy's effectiveness has been mixed, and not all electrotherapy treatments are supported by research.

Types of Electrotherapy

All electrotherapy devices have certain similarities, such as using battery power to apply current to electrodes. The therapies vary in frequencies, waveforms, and effects, however. These are some of the most commonly used kinds of electrotherapy:

• Transcutaneous electrical nerve stimulation (TENS)

• Percutaneous electrical nerve stimulation (PENS)

• Electrical muscle stimulation (EMS)

Interferential current (IFC) Pulsed electromagnetic field therapy (PEMF)

• Galvanic stimulation (GS)

Electrotherapy Side Effects

The most common side effect with electrotherapy is skin irritation or rash, caused by the adhesives in the electrodes or the tape holding the electrodes in place. Overusing electrotherapy may cause a burning feeling in the skin. Directions about the duration of therapy should be followed closely to avoid a problem.

Electrical stimulation should not be applied over malignancies or areas with broken skin or an infection. Bruising, bleeding, or infections are possible with the types of electrotherapy that penetrate the skin.

Placing the pads over the heart or over pacemaker leads could cause cardiac arrhythmia and placing them over a pregnant woman's abdomen could cause fetal damage. In fact, people with pacemakers and pregnant women are generally advised to avoid electrotherapy altogether.

In recent years, a number of TENS products have been marketed as wearable devices. Some of these devices deliver current directly from electrodes in a battery-powered unit worn on the body. The unit may be strapped to a leg or attached to the back, shoulder, knee, or other part of the body. These devices are typically not visible under clothing.

Therapy may be done in 30-minute segments or run continuously. Overnight therapy is possible in some cases.

The response to TENS varies widely. While many individuals consider TENS a key part of their treatment, TENS does not relieve pain for everyone. Conditions Treated with TENS include neck pain and stiffness, low back pain, diabetic nerve pain. Fibromyalgia pain.

TENS is typically applied at the site of the pain, but is sometimes effective when used in other areas as well.

Percutaneous electrical nerve stimulation (PENS) and electrical muscle stimulation (EMS)

These are two therapies that may be recommended if transcutaneous electrical nerve stimulation (TENS) has not been successful as percutaneous Electrical Nerve Stimulation goes deeper. Percutaneous electrical nerve stimulation refers to applying electrical stimulation through small needles which penetrate the skin.

Small wires are attached to a battery-powered electrical stimulator. A key difference is that needle electrodes deliver current closer to the nerves or the muscles beneath the skin, making the nerves less sensitive to pain. PENS therapy is likely to be used first in a health care or physical therapy setting, but can also be used at home.

There is considerable variation in the duration of pain relief from PENS. The therapy is long- lasting for many individuals, but others need repeated visits.

Diabetic peripheral neuropathy is one of the conditions in which PENS is often advised. In fact PENS is electronic version of acupuncture. The theory of acupuncture is that there are over 2,000 points on the human body that connect with 20 pathways (meridians). These pathways conduct the qi throughout the body. With acupuncture, hair-thin metallic needles are inserted into specific combinations of these 2,000 points in an attempt to correct and/or maintain a normal flow of qi. The electrical acupuncture can be used with needles or through the use of a non -penetrating probe which is in other words PENS technology.

Acupuncture or PENS is thought to operate by following mechanisms:

• Release of opioid peptides. Opioids are naturally occurring chemicals in the brain that have an analgesic effect. The release of these opioids plays a significant role in the reduction of pain. There has been considerable evidence to support that acupuncture stimulates the central nervous system, releasing these chemicals.

• Alteration in the secretion of neurotransmitters and neurohormones. Acupuncture is said to activate the hypothalamus and pituitary gland and thereby alter secretion of these chemicals. These particular chemicals play a direct role in the sensation of pain as well as the activity of an organ or organs. Evidence has shown that acupuncture alters this secretion in a manner that reduces pain. Documentation has also shown that acupuncture positively affects immune functions in the body.

• Stimulation of electromagnetic points on the body. The 2,000 points of the body that acupuncture focuses on are theorized to be strategic conductors of electromagnetic signals. Stimulation of these areas is believed to start the flow of endorphins — the body's natural painkillers.

Electrical Muscle Stimulation (EMS) is used to rebuild muscle tissue.

An electrical muscle stimulator appears similar to a typical TENS unit, with electrodes attached by wires to the small, battery-powered stimulator. In EMS, the current is directed at weakened muscles, rather than nerves, prompting the muscles to contract and gradually regain their strength.

EMS can be helpful for rehabilitation after muscles have been weakened substantially or for less serious conditions, such as a pulled muscle. EMS may be helpful in gradually strengthening muscle.

(Ref: https://www.spine-health.com/treatment/pain-management/all-ahout-electrotherapy- and-pain-relief)

Based on the above, numerous number of devices are available in various forms. Most of them utilizing TENS as the base technology in the devices. Researchers are always aspiring to find out the best possible frequency and waveform which can provide pain relief using TENS as TENS device can operate at a frequency ranging from 1 to 5 Hz and 50 to 150 Hz. Pains of different parts of body may require different waveform and frequency to provide relief, e.g a device which works for knee pain may have to be altered in frequency to make it work for abdomen pain. Clinical trials and their results make the basis if such technical specifications as these are patient feedbacks. Similarly for muscle rejuvenation and strengthening, TENS is used at a frequency of 1 to 5 Hz.

Using TENS for relieving menstrual pain and cramps is also an upcoming application in women health. Sensory-level TENS frequencies are classified in two types: 1) HF (>50 Hz) or 2) LF (2- 5 Hz).

HF and LF mainly differ with regard to the type of sensory fibers that the current activates.

HF TENS activates large diameter, non-noxious cutaneous afferent (AP) mechanoreceptors, while the small diameter nerves are not stimulated (such as c fibers, muscle efferent, or A5 fibers). HF is used more often. Accordingly, it is referred as conventional TENS, and is applied at low intensities. The pattern of pulse delivery is usually continuous, although it can be delivered in “bursts” or “trains.” The patient experiences an intense, comfortable, nonpainful paresthesia over the site of pain dermatomes.

LF TENS consists of high-intensity pulses delivered in a range of frequencies from 1 Hz to 4 Hz, and activates motor efferent nerves to produce phasic muscle twitches. These events ultimately lead to the activation of small-diameter, noxious muscle afferent nerves (GUI, A5, ergoreceptors). It is experienced as a strong, painful pulsating sensation which is often accompanied by muscle twitching.

(Ref: Michal Elboim-Gabyzon , Leonid Kalichman: Transcutaneous Electrical Nerve Stimulation (TENS) for Primary Dysmenorrhea: An Overview- International Journal of Women's Health https://www.dovepress.com/ by 181.215.50.243 on 09-Jan-2020)

PROBLEM IN EXISTING TENS BASED DEVICES

Most of the existing TENS based devices work on HF and a single waveform. The frequency is set up at >50 Hz and multiple frequency ranges within the range can be selected. EMS based devices are used for muscle strengthening and are not effective in pain management. INNOVATIVE SOLUTION PROPOSED BY THE INVENTORS

The inventors of the present invention realized that along with abdominal pain, stomach muscle cramp is also one of the major discomforts for women during menstruation period. The available devices being of HF (ranging >50 Hz) can provide pain relief to some extent but these cause discomfort if used for longer time.

Only abdominal pain relief is not a complete relief for women as abdominal muscle cramps are also a major point of discomfort. Therefore, they developed a device which operates on dual frequency range (HF as well as LF) so that the wearer gets pain relief as well as cramp relief. Prototypes are prepared and given to family and friends for evaluation. Following the feedback received from wearers, the switching between HF and LF at set time period is developed. The said switching is provided automatically using specially designed and developed program implemented on microcontroller along with specially designed hardware circuit. Thus the heart of the invention lies in hardware and software to switch between HF and LF in the same device automatically.

In other words, a combination of Transcutaneous Electrical Nerve Stimulation therapy along with Acupuncture TENS therapy technique is provided in the present invention. The difficulty of connecting the two therapies together was well removed by providing specific switching circuit and microcontroller programming in a way that the wearer feels most comfortable.

PRIOR ART PATENTS AND THEIR LIMITATIONS

Patent Application No. US 20200188663A (also PCT/IB2017/054965 and 201947009687) discloses “Electrical device for providing pain relief’

The above cited invention discloses an apparatus for relieving pain in region of body of a user by contacting electrodes to a surface of the body of the user at the region and providing a series of electrical impulses to the region. The apparatus disclosed in above cited invention comprises of 2 electrodes, which are in the contact of the body surface of user, a control unit and signal generator. Signal generator and control unit is connected to a power supply, to provide series of electrical impulses to body surface via electrodes. Series of current include plurality of cycles having positive voltage pulse and negative voltage pulse, wherein frequency of plurality of cycles is within a range of 60-150 cycles. The method of using of device comprises of steps of attaching the at least two electrodes to the surface of the body of the user; and activating the signal generator to operate in the operative mode to provide the series of electrical impulses to the surface of the body, via the electrodes.

Present invention also discloses wearable non- invasive wearable pain relief device particularly for relieving menstrual pain. But in present invention, combination TENS i.e., Transcutaneous Electrical Nerve Stimulation therapy along with EMS i.e., Electronic muscle stimulation physical therapy technique is used to control a specific frequency, which provides relief from menstrual pain. Only TENS is used in above prior art.

Patent Application No. US20160051817A1 discloses “Electrical Stimulation System with Pulse Control”

The above cited patent discloses an electrical stimulation system with pulse control. It discloses an electrical stimulation system to provide pulse stimulation to selected area of body by way of one or more electrode leads. The apparatus and system disclosed in present invention comprises of a pulse generating circuit having controllable output voltage to generate constant voltage pulses to one or more electrode leads. It further consists of a controller to estimate associated resistance element of the area, determine specific target steady state current value to be applied to the area and control pulse generating circuit to generate constant voltage pulse to one or more electrodes.

Present invention also discloses wearable non-invasive wearable pain relief device particularly for relieving menstrual pain. But in present invention, combination TENS i.e., Transcutaneous Electrical Nerve Stimulation therapy along with EMS i.e., Electronic muscle stimulation physical therapy technique is used to control a specific frequency, which provides relief from menstrual pain. Only TENS is used in above prior art.

Patent Application No. US 20060009820A1 discloses “Apparatus for application of electrical pulses to the human body”

The above cited invention discloses an apparatus for applying electrical pulses to patient’s body by at least two electrodes at specific body locations. The apparatus as disclosed in above cited invention comprises of a pulse generating unit connected to electrodes, which provides series of electrical impulses. Said series of electrical impulses comprises of plurality of first i.e., positive and plurality of second i.e., polarity impulses. Series of impulses is an intermittent series of pulses. In above cited invention, inventors has realised that, by appropriately changing the waveform applied to the patient, there can be an improvement in the performance of the electrical treatment. This can be achieved by providing positive and negative impulses with a spacing between impulses and optionally the Series of pulses may be changed to an intermittent Series.

Present invention discloses a device to provide intermittent series of impulse using combination TENS i.e., Transcutaneous Electrical Nerve Stimulation therapy along with EMS i.e., Electronic muscle stimulation physical therapy technique. Only TENS is used in above prior art.

Patent Application No. US6282443 Bl discloses “Method of Treatment of Dysmenorrhea or relieving menstrual cramps”

Above cited patent discloses a wristwatch like device to be worn on wrist and provide electrical stimulation to wrist. The device is non-invasive nerve stimulation device secured with strap to ventral side of wrist in such a way that pair of electrodes are dispersed over median nerve in contact with skin in vicinity of P6 acupuncture point. The electrodes are on the underside of the housing the required battery and control electronics are housed within the housing, and input mechanisms are located on the outer face of the housing. The electrodes stimulate the median nerve and collateral or associated nerve Structures.

Present invention does not discloses a wrist watch like apparatus, which is used to provide relief to menstrual pain, whereas non-invasive wearable device is discloses, which can be worn at the site of pain to provide pain relief. Further, present invention does not focus towards specific acupuncture points to provide pain relief whereas in present invention a device is disclosed, to provide intermittent series of impulse using combination TENS i.e., Transcutaneous Electrical Nerve Stimulation therapy along with EMS i.e., Electronic muscle stimulation physical therapy technique for treatment of pain. Only electronic acupuncture therapy is used in above prior art.

Patent Application No. US2010/0042180A1 discloses “Electrical stimulation device and method for therapeutic treatment and pain management” The above cited invention discloses an electrical stimulation device which comprises of TENS Based stimulator having first and second disposable, self-adhesive electrode potions, a control module attached to first electrode comprising a preprogramed treatment program and status indicator. Further the device comprises of flexible cable coupled to 1 ^st end of the control module and 2^nd end of the electrode portion and a power source is also housed in structure having control module to power the electrical stimulation device. Preprogramed treatment is selected from group consisting of TENS, Muscle stimulation program, massage program etc.

Present invention discloses a device to provide intermittent series of impulse using combination TENS i.e., Transcutaneous Electrical Nerve Stimulation therapy along with EMS i.e., Electronic muscle stimulation physical therapy technique. This cited prior art empowers the user to select either Muscle stimulation program or massage program but simultaneous application of TENS at HF AND LF and switching at preset intervals without intervention of wearer is not disclosed in the cited prior art.

Patent Application No. US20070270917A1 discloses “Method and device for promoting localized change in blood flow”

Present invention discloses a non-invasive method and device for promoting a localized change in blood flow through a limb segment by a series of electrically stimulated contractions of muscle tissue, the device comprises of at least a first electrode, a second electrode, and a third electrode, each of the electrodes for operatively contacting the limb segment of the body; (ii) a signal generator, operatively connected to each electrode, for producing a series of electrical impulses to the limb segment via electrodes, and (iii) a control unit, associated with the signal generator, for controlling the signal generator produce the series of electrical stimulation impulses.

The device disclosed in present invention is just limited to limb segment of body and aims to change in blood flow. Whereas device disclosed in present invention is based on combination of TENS and Electrical muscle stimulation technique to provide series of intermittent impulses, which helps in treatment of pain associated during menstrual cycle. Only EMS is used in above cited prior art. Simultaneous application of TENS at HF AND LF and switching at preset intervals without intervention of wearer is not disclosed in the cited prior art. Journals and Publications

Effects of different frequencies of transcutaneous electrical nerve stimulation on venous vascular reactivity

Ref: Brazilian Journal of Medical and Biological Research (2014) 47(5): 411-418, http://dx.doi.org/10.159G/1414~431X20143767, ISSN 1414-431X

Transcutaneous electrical nerve stimulation (TENS) is a type of therapy used primarily for analgesia, but also presents changes in the cardiovascular system responses; its effects are dependent upon application parameters. Alterations to the cardiovascular system suggest that TENS may modify venous vascular response. The objective of this study was to evaluate the effects of TENS at different frequencies (10 and 100 Hz) on venous vascular reactivity in healthy subjects. Twenty- nine healthy male volunteers were randomized into three groups: placebo (n=10), low-frequency TENS (10 Hz, n=9) and high frequency TENS (100 Hz, n=10). TENS was applied for 30 min in the nervous plexus trajectory from the superior member (from cervical to dorsal region of the fist) at low (10 Hz/200 ms) and high frequency (100 Hz/200 ms) with its intensity adjusted below the motor threshold and intensified every 5 min, intending to avoid accommodation. Venous vascular reactivity in response to phenylephrine, acetylcholine (endothelium-dependent) and sodium nitroprusside (endothelium-independent) was assessed by the dorsal hand vein technique. The phenylephrine effective dose to achieve 70% vasoconstriction was reduced 53% (P,0.01) using low-frequency TENS (10 Hz), while in high-frequency stimulation (100 Hz), a 47% increased dose was needed (P,0.01). The endothelium-dependent (acetylcholine) and independent (sodium nitroprusside) responses were not modified by TENS, which modifies venous responsiveness, and increases the low-frequency sensitivity of al -adrenergic receptors and shows high-frequency opposite effects. These changes represent an important vascular effect caused by TENS with implications for hemodynamics, inflammation and analgesia.

The objective of above prior art is to evaluate the effects of TENS at different frequencies (10 and 100 Hz) on venous vascular reactivity in healthy subjects.

No constructional features of the TENS based device and the circuit hardware and software is disclosed. No mechanism of switching between Low frequencies to High frequencies is disclosed in the cited prior art. Just that TENS works at 10 to 100 Hz is disclosed in this article which is already known.

Transcutaneous Electrical Nerve Stimulation (TENS) for Primary Dysmenorrhea: An Overview- Michal Elboim-Gabyzon, Leonid Kalichman

Ref: International Journal of Women's Health downloaded from https://www.dovepress.com/ by 181.215.50.243 on 09-Jan-2020

Primary dysmenorrhea is a chronic health condition that affects primarily young women. Transcutaneous electrical nerve stimulation (TENS) has been suggested as an effective pain reduction modality in primary dysmenorrhea. TENS is a noninvasive, inexpensive, portable method with minimal risks and a few contraindications. When necessary, it can be self-administered on a daily basis during everyday activities. Several studies have investigated the effectiveness of TENS in reducing pain, decreasing the use of analgesics, and improving the quality of life in primary dysmenorrhea patients. These studies have some limitations in methodological quality and therapeutic validation. However, the overall positive effects of TENS in primary dysmenorrhea encountered in all prior studies indicated its potential value. This review presents the clinical recommendations for TENS parameters for treating primary dysmenorrhea symptoms based on previously published studies.

This study indicates the use of either LF or HF and their various parameters and effectiveness.

But nowhere is a device disclosed which has hardware and circuit as disclosed in present invention with a switching possibility at preset intervals from LF to HF and vice versa.

Commercial Information a) Ova Period Pain reliever:

Ref: https://www.tenscare.com.au/wp-content/uploads/2019/07/OVA-manual-Australia _Pub

Ref-3.0_12.05.16-TGA.pdf

The device disclosed herein is used to treat menstrual pain using gentle electrical stimulation i.e., TENS (Transcutaneous electrical Nerve stimulation). The “Ova+” machine delivers small electrical pulses to the body via electrode patches placed on the lower abdomen. It works in three ways: - It blocks pain signals from reaching the brain through a mechanism called the ‘PainGate’. - It stimulates the natural production of endorphins which raise the threshold for pain perception. - Finally, it helps to relax the contracted muscles. Prior art Fig 1

In present invention, intermittent series of impulse is provided using combination of TENS and Electrical muscle stimulation technique, whereas in OVA device, only TENS technology is being used. Simultaneous application of TENS at HF AND LF and switching at preset intervals without intervention of wearer is not disclosed in the cited prior art. b) A device that can ‘turn off” your period cramps, India Today Web Desk, May 3, 2016

Ref: https ://www. indiatoday. in/lifestyle/welhiess/story/a-device-that-can-turn-off-your- period- cramps-livia-israel-period-pain-remedy-for-period-cramps-321368-2016-05-03

US 20200188663A (also as Indian patent application no. 201947009687) is converted as commercial product by the name of “Livia” which is a pain management device made for women. The device uses physiotherapy tech to block pain receptors through electrical pulses. Based on nerve "Gate Control Theory" Livia transmits a pulse that keeps the nerves "busy", so that pain messages that should be accepted by nerve receptors and transmitted to the brain— which concludes that a woman is in pain— aren't sent out. With those messages lost in transmission, there is no feeling of pain. Prior art Fig 2

Only TENS technology is being used. Simultaneous application of TENS at HF AND LF and switching at preset intervals without intervention of wearer is not disclosed in the cited product. c) TENS Unit and EMS Combination Muscle Stimulator by Quad Stim Plus - 4 Channels for Pain Management - OTC Combo Device

(https://www.amazon.in/Combination-Muscle-Stimulator-Quad-Stim/dp/B07BBV6F6Z)

Quad-Stim is a combination EMS unit (Electro Muscle Stimulator) and TENS machine (Transcutaneous Electrical Nerve Stimulation). A TENS EMS unit is used for pain management, massage, relaxation, and as an electric pulse muscle stimulator. Quad Stim has 24 preprogrammed cycles for quick and easy selection on your estim unit. Additionally, 5 TENS machine modes and 3 EMS muscle stimulator modes and adjustable Pulse Rate and Width make for an extremely versatile tenz massage unit and stim machine.

• COMBO UNIT: Quad-Stim is a combination EMS unit (Electro Muscle Stimulator) and TENS machine (Transcutaneous Electrical Nerve Stimulation). A TENS EMS unit is used for pain management, massage, relaxation, and as an electric pulse muscle stimulator.

• 4 CHANNELS: This EMS TENS unit is unique with four controllable and independent output channels, each with its own intensity level adjustment connect to an electrode pair, totaling 8 electrodes.

24 PROGRAMS: Quad Stim has 24 preprogrammed cycles for quick and easy selection on your estim unit. Additionally, 5 TENS machine modes and 3 EMS muscle stimulator modes and adjustable Pulse Rate and Width make for an extremely versatile tenz massage unit and stim machine. Prior art Fig 3 d) AGARO Dual Channel TENS Massager TM2421, 24 Modes, 20 Intensity Levels,

Rechargeable, Muscle/Nerve Stimulator for Pain Relief Therapy, 10 Gel Pads, Storage Bag, for physiotherapy, Battery Powered, Rechargeable Prior art Fig 4 e) Dr Physio Electrical Nerve Stimulation Pulse Massager- Digital Massage Machine for Body Prior art Fig 5 f) Ultra Care PRO TENS - 1.0 Rechargeable Dual Channel Digital TENS Unit/TENS Device/TENS Machine Physiotherapy Pulse Massager Equipment for Nerve Stimulation, Full Body Pain Relief Prior art Fig 6 All the above commercial products have user selected mode setting whereby the user can select and choose whether to use TENS OR EMS through 24 programs. Some of the above cited devices are bulky and aesthetically not appealing also.

In addition to these disadvantages, simultaneous application of TENS at HF AND LF and automatic switching at preset intervals without intervention of wearer is not disclosed in any of the cited product.

Therefore as is obvious from above, the present invention is technologically inventive over existing prior art devices. The same is described in more detail below.

OBJECT OF THE PRESENT INVENTION

The primary object of the present invention is to disclose a wearable dual frequency operable electronic device to provide relief from menstrual pain and cramp discomfort in women simultaneously.

Another object of the present invention is to disclose a wearable dual frequency operable electronic device to provide relief from menstrual pain and cramp discomfort in women wherein the switching between two frequencies is automatic.

Yet another object of the present invention is to disclose a wearable dual frequency operable electronic device to provide relief from menstrual pain and cramp discomfort in women wherein the switching between two frequencies is at preset time.

SUMMARY OF THE INVENTION

The complete device of the present invention consist of Hardware including battery, battery charging section, controller section with memory and preprogrammed 8 bit microprocessor, user interface section, high voltage section (including power inverter using H Bridge , MOSFETs and Timers), USB port, a pair of self-adhesive Electrodes (Patches) connected with the 2.5mm Jack port through 2.5mm Jack cable connector . The device is capable of switching automatically between dual frequencies of 50-120 Hz (defined as Program A) and 1 to 4 Hz (defined as Program B) at preset intervals of time using timer and without user intervention to provide pain relief in menstrual pain and cramp discomfort simultaneously.

DESCRIPTION OF DRAWINGS

Fig 1 to Fig 6: Prior art figure

Fig 7: Hardware Circuit diagram of present invention

Fig 8: Schematic of H Bridge

Fig 9: Output Waveform of present device

Fig 10: Complete device prototype

Fig 11: Block diagram of complete device from user perspective

DETAILED DESCRIPTION OF THE INVENTION

The following description is the best-contemplated mode of carrying out the invention.

The description is made for the purpose of illustrating the general principles of the invention and should not be taken in a limiting sense.

Preferred embodiment of the present invention

Constructional features:

The complete device consist of: a) Hardware including power section consisting of battery, battery charging section, controller section with memory and preprogrammed 8 bit microprocessor, user interface section, high voltage section (including power inverter using H Bridge), USB port. b) Pair of self-adhesive Electrodes (Patches) and connected to the device using 2.5mm Jack connector cable (6) to the device jack female port (7);

The Hardware (Fig 7) consists of:

- Power section (1) consisting of Li -polymer rechargeable battery (3.7V) and battery charging section to provide power to the device. As the product is a battery operated device, the rechargeable battery (3.7V) is charged via a 5V USB charger and cable. The charge rate is controlled by this part of the circuit and it informs the control section about whether the battery is being charged or fully charged.

- Controller section (2) - This section consists of an 8 bit processor with internal memory. The processor generates the positive and negative pulses, controls the output current and voltage, decides the frequency of pulses, the pulse phase, the pulse width as well as when it should change so as to deliver a pleasant experience to the user. The controller also manages the intensity from a button input to increase the current / power delivered to the H bridge and to the user. It also gets feedback about the battery from the charger and the buttons and accordingly changes the intensity of the current or else puts itself into deep power down mode.

- High voltage section (3) - This section consists of pulse generator with power inverter using H Bridge, USB port; jack female port. The H-bridge circuit converts or amplifies the signals from the controller to bi-phased high voltage pulses using the high voltage DC from boost power supply section.

- User interface section (4) - the device has 7 LEDs in a pattern that denote that the device is delivering output current as well as it depicts the intensity of the current, the LEDs are controlled directly by the controller. Apart from this the device has 2 buttons, one + and one - to increase or decrease the intensity of the current delivered in incremental steps. In addition to this there is an emergency switch that will disable the device in case the user needs to turn it OLE. The device has an auto-off feature that puts it in deep power down mode to preserve battery for the long term. A White color led in the center depicts the Blinking status of the charging mode of battery so that the user can understand whether it needs to be charged / disconnected. To summarize, the controller performs the following tasks:

1) Takes the information from the charger about the battery and its status and depicts it on the LEDs

2) Takes the input from the buttons and increases or decreases the voltage of the high voltage section by controlling the pulse width of the voltage boost switch.

3) Takes the feedback of the output voltage from the high-voltage section using its internal analog to digital converter and controls the output voltage and thus power in a close loop fashion.

4) Controls the direction of the current through the electrodes using the high-voltage H-bridge, by selecting which of the half-bridges will activate the high side switch and which will activate the low side switch.

5) Controls the T_on (on-time) of the H-bridge which in turn controls the length of the pulse.

6) Controls the cycle time or frequency of pulses using its internal timers software to maintain the accurate pulse cycle time.

7) Uses a predefined scheduled program map decided based on elapsed time of user when it should switch the frequency and pulse width of its outputs.

8) Uses a frequency shifting formula f_out (Hz) = 80 + 30*sin(6.284) which gives a slow frequency shifting between 50Hz to 110Hz that covers the range of TENS

High voltage section (Pulse generator with H-bridge):

This section has an inductor based voltage boost circuit. A high speed MOSFET is switched by the controller to generate higher voltages which are in turn measured and thus controlled by a feedback loop by the software on the controller.

Based on the intensity setting, the voltage output from this boost circuit is generated. This voltage in the range of 9V to 40V is delivered to the H-bridge that is composed of two half bridges. This section consists of a boost power supply section that uses a closed loop feedback to generate 50VDC from li-ion battery voltage.

An H-bridge is an electronic circuit that switches the polarity of a voltage applied to a load. These circuits are often used in applications to allow DC motors to run forwards or backwards. The name is derived from its common schematic diagram representation, with four switching elements configured as the branches of a letter "H" and the load connected as the cross-bar.

Most DC-to-AC converters (power inverters), most AC/ AC converters, the DC-to-DC push-pull converter, isolated DC-to-DC converter, most motor controllers, and many other kinds of power electronics use H bridges.

(Ref: https://en. wikipedia.org/wiki/H-bridge)

The H-bridge amplifies the pulse signal and its phase using the high voltage input from the boost circuit and low voltage signals from the controller. It is designed with high speed transistors that can accurately mimic the pulse duration, pulse width and rise and fall times while amplifying the voltage and current of the pulses.

The existing similar devices use set frequency as they use transformers which can change the amplitude but are designed for set frequency range which the user can not alter. To overcome this problem and to allow the frequency of sinusoidal waveform to vary between frequency range of 1 -4 Hz and 50- 120 Hz, without user intervention, H Bridge is used in the present invention. This bridge helps in converting the sinusoidal waveform in Bi phasic pulse form with pulse width ranging from 100 microsecond to 200 microsecond in the voltage range of range of + - 40 V.

The existing devices use Transformer for voltage up or down but the frequency of waveform cannot vary much and remains in a short range only of approx. 40 to 60 Hz. The waveform is sinusoidal in existing devices. The input and output currents are both AC, since transformer works for AC voltages only.

The present invention has used “INVERTER” technology which converts DC voltage from battery to AC. Transformerless inverters use a computerized multi-step process and electronic components to convert DC to high frequency AC, back to DC, and ultimately to standard-frequency AC. The waveform is bi-phased pulses and not sinusoidal in the present device.

Working of the pulse generator with H-bridge

1) the controller has a couple of in -build timer counters that generate events at fixed time periods. These timers are used to set an event at the frequency decided by the program in microcontroller.

2) when this event is triggered the H-bridge is activated in one direction by sending a signal to one of its transistors. This signal is held for the pulse width desired. The H-bridge delivers current during this pulse-width time to the output patches / load.

3) at the end of this pulse, the input to the H-bridge is removed so it is deactivated and stops delivering the high-voltage and current, this again is held for the pulse width

4) now the H-bridge is again activated for the pulse width time but by signaling the other transistor so that the current is now flowing in the opposite director for the pulse width time

5) at the end of the pulse width time once again the H-bridge is de-activated and thus it stops delivering current to the patches / load

6) this process generates the high-voltage and current bi-phaser signal that is required to excite the nerve and deliver TENS therapy 7) in the desired frequency / cycle time the timer of the controller again triggers an event and the steps (2) to (6) are repeated again

8) as the transistors in the H-bridge are all high-speed and there is no limitation in it operating the range of 1Hz - lOKhz which is sufficient to generate the required signals for TENS therapy

9) to switch over to the acupuncture frequency range, the frequency and pulse width are only altered as desired and the hardware does the rest.

10) the slow rate frequency shifting is also possible by changing the frequency within the desired range every second. We adopt a sin function based frequency shifting within the l-5Hz for acupuncture and 50-120Hz for tens

Flow chart of the working of the present invention Technical specifications of the device of the present invention

1) Frequency of bi -phased pulses 1Hz to 110Hz depending on the program (cycles)

2) Vap = +/-40V for no load condition and about +/-8V on a 220ohm resistor load, human body load is variable and so the voltage amplitude is user to user dependent. Maximum average current on Tpositive is 40mA

3) Ramp up voltage is 500V/ ps

4) 80% of time averaged voltage is attained in 40ns

5) Positive voltage pulse is increase by 20V in 60ns

6) Ton (on-time) of the H-bridge to control the length of the pulse is 100 s and 200 ps as per two programs.

The device of the present invention is capable of switching between frequency range of 50-120 Hz (Defined as Program A) and 1 to 4 Hz (Defined as Program B) as shown in Table 1 and at set intervals of time as shown in Table 2 below:

Table 2

The intensity in terms of voltage can be increased or decreased by the user and will follow the following pattern of Intensity Vs Voltage and Program Sequence (Table 3)

Table 3

The user can increase or decrease the intensity of current using 2 buttons, one + and one - to increase or decrease the intensity of the current delivered in incremental steps.

The said time intervals are preset as per user feedback during testing of the device prototype.

ELECTRODE PATCHES:

There are several types of electrodes used in electrotherapy, i.e., metal, silicone, self-adhesive, special purpose, and textile ones. The present invention utilizes self-adhesive electrodes of any shape preferably round have special gels that ensure good adherence to the skin during electro stimulation treatments, as well as gels that enable proper joining of subsequent layers of the electrode.

Block diagram of the present invention

The user connects the pair of electrodes using 2.5mm Jack connector cable to the jack female device connector.

Method of use of the present invention consists of following steps:

- the user connects the pair of electrodes using 2.5mm Jack connector cable to the jack female device connector;

- the user attaches the pair of electrodes to the menstrual pain points in the abdomen;

- the user switches the power ON which indicated by the LED ;

- the user increases or decreases the intensity of current by pressing the push buttons indicated by the LED pattern;

- the device automatically switches between dual frequencies of 50-120 Hz (defined as Program A) and 1 to 4 Hz (defined as Program B) at preset intervals of time.

- the device automatically switches off after 15 minutes.

Block diagram of working

The present invention is named as “WELME” and due clinical studies have been carried out by the applicant under study title “A Randomized, Controlled, Two-arm, Parallel, Sham-controlled clinical study to assess the performance and safety of Welme menstrual pain relief device in women suffering from primary dysmenorrhea.” on 60 subjects.

The results in terms of effective pain management were measured over many parameters and are remarkable.

EFFICACY RESULTS:

PAIN INTENSITY USING VAS SCORE Cycle 1

The average VAS score in Welme group before using the device was 7.16±1.82. After using the device it was 2.10±0.66. The average VAS score in Sham group before using the device was 7.2±1.83. After using the device it was 6.83±1.88. The VAS score in Welme group was significantly decreased when compared to the Sham group (p<0.05).

Cycle 2

The average VAS score in Welme group after using the device was 1.6±1.07. The average VAS score in Sham group after using the device was 5.87±2.24. The VAS score in Welme group was significantly decreased than in the Sham group (p<0.05).

ANALGESIC USAGE (NUMBER OF TABLETS USED PER DAY)

Cycle 1

The average analgesic usage (number of tablets per day) in Welme group at baseline was 2.53 ± 0.51. After using the device was 0.57±0.77. The average analgesic usage in Sham group before using the device was 2.51±0.51. After using the device it was 2.27±0.87. The analgesic usage in Welme group was significantly decreased than in the Sham group (p<0.05).

Cycle 2

The average analgesic usage in Welme group after using the device was .50±0.73. The average analgesic usage in Sham group after using the device was 2.20±1.13.

The analgesic usage in Welme group was significantly decreased than in the Sham group (p<0.05).

The device also showed better efficacy in terms of “COX MENSTRUAL SYMPTOM SCALE”, PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE. VAS SCORE OF WELME VS SHAM (MEAN CYCLE 1 and CYCLE 2)

The said study was concluded on July 15, 2022 with the following remarks:

The results of this study led us to conclude that Welme menstrual pain relief device was very effective in managing primary dysmenorrhea. It was free from the adverse effects of analgesics, gives immediate pain relief and had no adverse effects.

Comparison of results with existing similar device (Livia)

The clinical trial data of similar product as available in public domain (https://www.accessdata.fda.gov/cdrh_docs/pdfl8/K183110.pdf) indicates the following results

VAS SCORE OF LIVIA VS SHAM

The use of product of present invention succeeded in reducing the VAS score by an average of 53.6. The use of the Sham device reduced the VAS score by 8.5 points. The difference between the groups is 44.6.

Whereas the use of similar product succeeded in reducing the VAS score by an average of 28.1(29 points). The use of sham device is (17.6). The difference is 10.5 between the groups. In conclusion, the device of the present invention (Welme) has shown good performance and better in reducing the Pain scores when compared to existing product (Livia) in Primary Dysmenorrhea.

The present invention as described by the preferred embodiment is novel as the device of the present invention is capable of switching between frequency range of 50-120 Hz (Defined as Program A) and 1 to 4 Hz (Defined as Program B) and provides simultaneous relief from menstrual pain and cramp discomfort using dual frequency. None of the presently available devices have an automatic system of changing to two frequencies at preset time intervals. One of the said frequencies provides relief in menstrual pain and the other in cramp discomfort.

The technological advancement lies in designing a circuit and developing the device using inverter technology based H bridge circuit for providing dual frequency ranges without any noise and timers to provide switching between two frequencies at set time intervals. The said improvement over existing devices led to better efficacy in pain management on various parameters as is clear from the clinical study also.

The industrial application is obvious as the device is consumer based and can be manufactured easily at industrial scale. The device will be much in demand as menstrual pain and cramps are common problems in women worldwide.

Claims

WE CLAIM:

1. A device to provide simultaneous relief from menstrual pain and cramp discomfort using dual frequency consisting of : a) Power section (1) consisting of Li-polymer rechargeable battery and battery charging section to provide power to the device; b) controller section (2) with preprogrammed 8 bit microprocessor with memory to control the output current and voltage, frequency, phase and width of pulses, c) high voltage section (3) consisting of pulse generator with power inverter using H Bridge, USB port; jack female port; d) user interface section (4), b) pair of self-adhesive Electrodes (Patches) (5) connected to the device using 2.5mm Jack connector cable (6) to the device jack female port (7); wherein the device is capable of automatic switching between dual frequencies of Program A (50-120 Hz) and Program B (1 to 4 Hz) at preset intervals of time by altering the Ton (on-time) of the H-bridge which controls the pulse width between 100 ps and 200 ps and using a sine function based frequency shifting within the l-5Hz for cramp discomfort and 50-120Hz for menstrual pain relief.

2. The device as claimed in claim 1 wherein final output waveform is sinusoidal bi phasic pulse width modulated waveform.

3. The device as claimed in claim 1 wherein :

Vap - +/-40V for no load condition and about +/-8V on a 220ohm resistor load;

Maximum average current on Tpositive is 40mA;

Ramp up voltage is 500V/us;

80% of time averaged voltage is attained in 40ns; and positive voltage pulse increases by 20V in 60ns;

T on (on-time) of the H-bridge to control the length of the pulse is 100 ps and 200 ps for program A and B respectively. The device as claimed in claim 1 wherein the sinusoidal pulse width modulated pulse waveform has pulse width of 50 to 100 ps and output voltage amplitude ranging from 9 to 40 VDC at current intensity ranging from 1 mA to 40mA. The device as claimed in claim 1 wherein pair of self-adhesive Electrodes (Patches) (5) are reusable for 20 to 30 times. The device as claimed in claim 1 wherein the user interface section consists of:

6 LEDs (8) to indicate output current and intensity;

2 push buttons (9) to increase or decrease the intensity of the current in incremental steps; an emergency switch to turn the device OFF (10); center white color LED (11) blink in the center to indicate the status of the device and battery so that the user can understand whether it needs to be charged / disconnected. The device as claimed in claim 1 wherein the method of working of the pulse generator with H-bridge consist of following steps:

- a couple of in-build timer counters in the controller are used to set an event at the Frequency decided by the program in microcontroller;

- when this event is triggered the H-bridge is activated in one direction by sending a signal to one of its transistors; this signal is held for the pulse width desired and the H-bridge delivers current during this pulse-width time to the output patches / load; at the end of this pulse, the input to the H-bridge is removed so it is deactivated and stops deliveringthe high-voltage and current, this again is held forthe pulse width;

- the H-bridge is again activated for the pulse width time but by signaling the other transistor so that the current is now flowing in the opposite director for the pulse width time;

- at the end of the pulse width time once again the H-bridge is de-activated and thus it stops delivering current to the patches / load; this process generates the high-voltage and current bi-phaser signal that is required to excite the nerve and deliver TENS therapy; in the desired frequency / cycle time, the timer of the controller again triggers an event and the steps are repeated again. he device as claimed in claim 1 wherein the method of use consists of following steps: the user connects the pair of electrodes (5) 2.5mm Jack connector cable (6) to the device jack female port (7); the user attaches the pair of electrodes (5) to the menstrual pain points in the abdomen; the user switches the power ON which indicated by the LED ; the user increases or decreases the intensity of current by pressing the push buttons indicated by the LED pattern; the device automatically switches between dual frequencies of 50-120 Hz (defined as Program A) and 1 to 4 Hz (defined as Program B) at preset intervals of time. the device automatically switches off after 15 minutes.