Modular portable device and method for simultaneous electrotherapy and thermotherapy in menstrual pain relief

Abstract

Aspects of present disclosure relate to a portable, versatile, and modular electronic device designed as a non-invasive solution for alleviating menstrual pain. Its modular design is a key feature, allowing the device to be separated into two distinct, standalone modules (Fig 2C), as an independent electrical nerve stimulator and as a thermal stimulator or in hybrid mode. The device incorporates a Battery Management Unit with various protection features, ensuring safe operation during charge and discharge cycles, and supports wireless charging. The Arbitrary Waveform Generator within the device produces customizable signal patterns, offering a frequency range from 1Hz to 200Hz and adjustable intensity levels from 0V to ±60V with no load across electrode gel pads, controlled by the processing unit. This system allows precise control over therapy intensity and frequency, enabling an adaptable and cost effective solution for menstrual pain management.

Description

DESCRIPTIONMODULAR PORTABLE DEVICE AND METHOD FOR SIMULTANEOUS ELECTROTHERAPY AND THERMOTHERAPY IN MENSTRUAL PAIN RELIEFTECHNICAL FIELD

[0001] The present invention relates to a portable, versatile, and modular electronic device. More particularly the present disclosure relates to its modular design, which divides the device into two distinct, standalone modules. The first module serves as an independent electrical nerve stimulator, delivering precise electrical pulses, while the second functions as a dedicated thermal stimulator, providing controlled heat therapy, offering a versatile and cost-effective solution solution for alleviating menstrual pain, including conditions such as dysmenorrhea.BACKGROUND ART

[0002] Menstrual pain and sciatic nerve pain are prevalent health concerns, often causes discomfort in the nerves associated with the female reproductive tract (FRT). These conditions can significantly disrupt daily life, leading to both physical and mental distress, particularly for women who are handling professional responsibilities alongside personal challenges. The management of such pain typically involves conservative methods, with many women relying on painkillers for relief. However, prolonged use of painkillers is associated with serious side effects, including gastrointestinal issues and potential long-term health risks.

[0003] In response to these concerns, thermal hot bag therapy has emerged as a popular alternative in recent years. By providing localized heat to the affected areas, this method helps relax muscles and improve blood circulation, offering temporary relief from pain. Despite its advantages, hot bag therapy has certain limitations, including inconsistent heat application, the need for frequent reheating, and the potential risk of bums if not used cautiously. Additionally, it may not address deeper nerve-related pain effectively.

[0004] As an innovative alternative, electric stimuli-based therapy has gained attention for its potential to alleviate pelvic nerve pain. This therapy uses controlled electrical impulses to target pain pathways, providing a more precise and effective solution for managing discomfort. It can help reduce pain intensity, relax muscles, and improve nerve function without the side effects associated with medications or the drawbacks of traditional heat therapy. Furthermore, electric stimuli-based devices are often portable, easy to use, and designed for sustainedtherapeutic effects, making them a promising option for women seeking safe and efficient pain relief.

[0005] Prior art US20170232260A1 describes that a medical device is designed to administer electrical stimulation therapy. It features a stimulation driver integrated with a microcontroller. The stimulation driver is responsible for amplifying electrical pulses into enhanced electrical signals, which are then delivered to the patient as part of the therapeutic process. Additionally, the device is equipped with a battery that provides a primary voltage supply to power its components. As compared to the cited prior art, the present invention, there is no requirement for an implantable pulse generator or peripheral neuro-stimulator device, which is typically coupled to one end of the lead in conventional systems. Instead, the micro-controller in this invention generates a high-frequency PWM (Pulse Width Modulation) signal, which directly drives the voltage converter circuit. This innovative approach simplifies the design, reduces dependency on additional pulse generator ICs, and ensures efficient generation of stimulation signals for therapeutic use. In addition, the present invention introduces a versatile and user- friendly medical device for electrical stimulation therapy. It offers multiple voltage levels, allowing users to select the most suitable level based on the intensity of their pain. The device requires only two electrodes to deliver either biphasic or monophasic electrical signals, eliminating the need for a multiplexer to control the electrodes.

[0006] Prior art US12076562B2, “Systems and methods for the treatment of pain through neural fiber stimulation” describes systems and methods for pain treatment by selectively activating neural fibers, including afferent and / or efferent fibers. When afferent fibers are stimulated, either alone or with efferent fibers, electrical stimulation mimics natural afferent activity and targets receptors like muscle spindles, Golgi tendon organs, joint receptors, and touch receptors. In comparison with the above prior art, present disclosure combines electrotherapy and thermotherapy in a modular design, with one module serving as an electrical nerve stimulator and the other as a thermal stimulator. The system delivers both electrical pulses and controlled heat therapy simultaneously for pain relief, specifically targeting menstrual pain. In addition, present disclosure allows for adjustable intensity and frequency of electrotherapy via the Arbitrary Waveform Generator, providing customization treatment parameters.

[0007] Lee; Won joon et al. US9421123B2 Patent on “Portable combined stimulation device for alleviating menstrual pain” describes a portable device for alleviating menstrual pain combines trans-cutaneous electrical nerve stimulation (TENS) and thermal stimulation. It features a patch-type electrode pad with an embedded planar heater, attachable to any pain- affected body part. The device includes a power unit, a processor for controlling the TENSelectrode and heater, a temperature sensor on the heater for monitoring heat levels, and an A / D converter to digitize temperature readings for precise control. Prior art patent offers a single patch-based system with integrated control over temperature and TENS, whereas present disclosure features a modular design with more flexibility in adjusting electrical signal parameters and offers a more detailed approach to pain management with fine control over both intensity and frequency.Present disclosure distinguishes itself by combining both electrotherapy and thermotherapy in a modular, portable design specifically for menstrual pain relief, while the other prior art invention are focused primarily on neural stimulation for general pain management through a more complex mechanism targeting neural fibers. The objectives, distinctive features, and benefits of the invention are comprehensively outlined in the accompanying detailed description.DISCLOSURE OF THE INVENTIONOBJECTS OF THE INVENTION

[0008] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.

[0009] The primary object of this invention is a cost-effective, portable and light weight device for relieving menstrual pain.

[0010] It is an object of this invention is to integrate a modular electrotherapy and thermotherapy component which can be configured between the single channel or dual channel.

[0011] It is an object of this invention is the Arbitrary Waveform Generator which can generate electric signal of varying frequency, pattern, pulse-width and intensity with or without user intervention.

[0012] It is an object of this invention to obtain interphase-free biphasic pulses in advancing non-invasive electrotherapeutic modalities.

[0013] It is an object of this invention for an uninterrupted biphasic electric pulses with dynamic amplitude to ensure effective charge balancing while reducing the risk of tissue damage.SUMMARY

[0014] In summary, the present disclosure relates to a menstrual pain relieving device which is portable, of light weight. More particularly, a unique feature of the device is its modularconfiguration, enabling independent operation of the two modules. The first module functions as a dedicated electrical nerve stimulator, delivering precise electrical pulses to the nerves, while the second module provides targeted heat therapy through a controlled thermal stimulation system. These modules can also be combined, allowing for simultaneous electrical and thermal therapy, which has been shown to enhance pain relief efficacy.

[0015] According to another aspect of the present disclosure, the device is composed of two distinct modules, each designed to cater to specific therapeutic functions, with compact and scalable dimensions to enhance usability and versatility.

[0016] In an embodiment, Electrotherapy Module is tailored for delivering electrical stimulation and operates with dimensions ranging from 35 mm x 35 mm x 6 mm to 80 mm x 80 mm x 35 mm. The compact size ensures portability while accommodating varying configurations of electrode gel pads. Its design allows it to deliver precise electrotherapy signals for pain relief and rehabilitation.

[0017] In an embodiment, Thermotherapy Module dedicated to providing heat-based therapy, this module is slightly larger, with dimensions ranging from 35 mm x 35 mm x 6 mm to 80 mm x 80 mm x 50 mm. The additional depth accommodates the heating element and thermal insulation, ensuring effective heat distribution while maintaining safety and durability.

[0018] In an embodiment, both modules are designed to seamlessly integrate with the device's control system, allowing users to select and personalize therapy modes as required. The scalable dimensions make the device suitable for various applications, from localized treatments to larger therapeutic areas.

[0019] According to another aspect of the present disclosure, the device can function in two distinct modes: wired and non-wired. In non-wired mode, the device attaches directly to the self-adhesive gel pads and can be worn on the body, allowing unrestricted mobility. In wired mode, the device is connected to the gel pads via lead wires; with the option, the user can wear the device on a garment or place it in a pocket, maintaining flexibility in positioning.

[0020] According to another aspect of the present disclosure, the Arbitrary Waveform Generator is designed to produce electric signals with adjustable frequency, pattern, pulse width, and intensity, operating either autonomously or under user control. It enables the creation of customizable signal patterns for electrotherapy applications and features a DC-to-DC voltage amplifier.

[0021] In an embodiment, the plurality of amplifier is powered by the Battery ManagementUnit, amplifies the input voltage with a processing unit-controlled gain of up to 14x. The devicesupports frequency modulation from 1 Hz to 200 Hz and generates output intensities ranging from 0V to ±60V with no load across electrode gel pads and the intensity can be adjusted in increments as small as 0.5V, offering precise control over the electrotherapy parameters.

[0022] According to another aspect of the present disclosure, the device includes an impedance analyzer designed to measure the impedance across the gel pads, ensuring their quality and functionality. These gel pads are self-adhesive and feature integrated heating capabilities and the device supports three types of patches.

[0023] In an embodiment, the plurality of Electrode Gel Pads equipped with an adhesive layer, these pads are exclusively for electrotherapy.

[0024] In an embodiment, the plurality of Heat Pads featuring a heating element, these pads are designed for thermotherapy.

[0025] In an embodiment, the plurality of Electrode Gel Pads with Heating combining an adhesive layer and an integrated heating element, these pads provide both electrotherapy and thermotherapy.

[0026] According to another aspect of the present disclosure, upon activation, users can personalize their therapy by selecting from a variety of electrical pulse patterns and adjusting both the frequency and intensity of the electrical and heat signals. The device also includes a dynamic mode, which mitigates tolerance buildup to short-term electrical stimulation by automatically altering the stimulation pattern, frequency, pulse width and intensity throughout the therapy session without user intervention.

[0027] According to another aspect of the present disclosure, the device includes an integrated memory unit that continuously records essential usage data and parameters, such as selected electrical and heat patterns, frequencies, intensity levels, and detailed usage information (date, time, and duration). This logged data can be shared with users, healthcare providers, or physiotherapists for in-depth analysis, enabling personalized adjustments to therapy for optimized pain relief outcomes. Additionally, the data serves as a diagnostic tool for evaluating and maintaining device performance.

[0028] According to yet another aspect of the present disclosure, the device offers fully customization of parameters, including stimulation patterns, frequency, and intensity, all of which can be controlled wireless through a paired computing device. This adaptability allows users to personalize their pain relief experience, ensuring maximum comfort and effectiveness tailored to their individual needs.

[0029] One should appreciate that although the present disclosure has been explained with respect to a defined set of functional modules, any other module or set of modules can be added / deleted / modified / combined and any such changes in architecture / construction of the proposed system are completely within the scope of the present disclosure. Each module can also be fragmented into one or more functional sub-modules, all of which also completely within the scope of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiment's of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0031] Fig 1 A, B, C illustrates the top view, side view and bottom view, respectively, of the outer enclosure of the electrotherapy module.

[0032] Fig 2A is the schematic block diagram of the electrotherapy module. It is configured in 2 channel mode. It explains all the functionality & working mechanism of the module.

[0033] Fig 2B is the schematic block diagram of the thermotherapy module.lt explains all the functionality & working mechanism of the module.

[0034] Fig 2C is the schematic block diagram of the device, the electrotherapy and thermotherapy modules are connected together. The electrotherapy is configured to operate in single channel mode. This embodiment explains all the functionality & working mechanism of the device.

[0035] Fig 2D illustrates the schematic block diagram of the Arbitrary Waveform Generator.

[0036] Fig 3A illustrates the lead wires with Male USB Type-C Port (301) which transmit the electrical signal to the adhesive electrode gel pads and Fig 3B is a pair of adhesive electrode gel pads.

[0037] Fig. 4A illustrates the electrode gel pads (402), snap button for heating element (401), snap button for electrotherapy (403) with an adhesive layer and an integrated heating element to provide both electro and thermo therapy.

[0038] Fig. 4B illustrates the lead wires with Male USB Type-C Port (404) which transmit the electrical signal and power from the device to the adhesive electrode gel pads and thermal pads, respectively, through the snap buttons (405,406).

[0039] Fig. 5A depicts the adhesive electrode gel pads positioned near the lower abdomen, as worn by the user during dysmenorrhea, Fig 5 B describes the wear detection functionality of the device and Figure 5C shows the gel pads adhered to a thin sheet of fixed-value resistive material.

[0040] Fig. 6A is a visual representation of the top view of the electrotherapy module without the use of a wire, and Fig. 6B is top view of the device when electrotherapy(604) and thermotherapy(605) modules are connected together.

[0041] Fig. 7A, 7B, 7C, 7D, 7E illustrates Dynamic Amplitude, Dynamic Phase, Dynamic Frequency, Dynamic Pattern, Dynamic Pulse Width, respectively.

[0042] Fig.7F illustrates an asymmetric biphasic electric pulses for electrotherapy.

[0043] Fig. 8A illustrates biphasic electric pulses with an inter-phase for electrotherapy, where (180) represents Inter-phase between phase change.

[0044] Fig. 8B illustrates biphasic electric pulses without an inter-phase for electrotherapy.

[0045] Fig. 8C illustrates an uninterrupted biphasic electric pulse with dynamic amplitude for electrotherapy.

[0046] Fig. 8D illustrates a biphasic square wave for electrotherapy.DETAILED DESCRIPTION

[0047] The following is a detailed description of embodiment's of the disclosure. The embodiment's are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiment's; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0048] Aspects of the present disclosure relate to a portable and modular menstrual pain management device combining electrotherapy and thermotherapy (Fig. 2C). It consists of two distinct, separable modules: the first serves as an independent electrical nerve stimulator, while the second operates as a standalone thermal stimulator, delivering controlled heat therapy.

[0049] The electrotherapy module consists of a plastic enclosure, battery, battery management unit, processing unit, user interface unit, telemetry unit, arbitrary waveform generators, impedance analyser, clock unit, memory unit, lead wire & adhesive electrode gel pads.

[0050] Fig. 1 illustrates embodiment’s of outer enclosure of the electrotherapy module which may consists of an Power LED (101) for indicating the state of the device, power mode switch (102,103,104), interactive keypad and display unit (105), USB Type-C port (106) and a output port (107)for TENS signals made up of female snap buttons to attach electrode gel pads.

[0051] The embodiment's of Fig. 3 A & 3B may be used to deliver the electrotherapy on the skin.The components involved are listed in the table below.

[0052] The embodiment's of Fig. 5A and 5B, illustrates the state when the electrode gel pads (501) are positioned near the lower abdomen and the wear detection functionality of the device like changes in human body impedance (502) which are connected through the lead wires (503).

[0053] In another aspect, the Battery Management Unit (Fig. 2A) may be used for regulating and monitoring battery operations during charging and discharging processes. It may include multiple protection features, including safeguards against over current, over voltage, under voltage, over charging, over discharging, short circuits, and excessive temperatures. It is configurable for various cell types with nominal voltages such as Li-Po, LFP, NMC, and NiCd. The BMU supports both USB Type-C and Inductive charging.

[0054] In another aspect, User Interface Unit (Fig. 1A) is divided into two parts, display unit and keypad. The display unit is an alphanumeric interface that provides essential device information, such as intensity levels, operating modes, battery status, and more. It can beimplemented using various technologies, including 7-segment displays, LCDs, or OLED displays, depending on design requirements. The keypad serves as the user input interface, allowing the user to control the device. It can be designed with mechanical switches or integrated into a touchscreen display, offering flexibility in usability and design. Clock unit is made up of oscillators or RTC modules. One can also utilize the builtin oscillator of a micro-controller, which is used by the processing unit to calculate time.

[0055] In another embodiment, Arbitrary Waveform Generator (Fig. 2D) generates the electrical signal for electrotherapy, it consists of 3 parts: DC to DC voltage amplifier unit, signal generator unit and signal amplifier unit. The electrotherapy module can have two arbitrary waveform generators for dual channel mode. Number of channels may be configured at hardware level or software level. This unit can generate monophasic or biphasic electrical signals like pulse, square wave, sine, ramp etc. It can dynamically adjust stimulation patterns, frequency, pulse width and intensity without user intervention. It can generate symmetrical and asymmetrical patterns.

[0056] In another embodiment, a DC-to-DC voltage amplifier (Fig. 2D) may be employed to draw power from the Battery Management Unit and step up the voltage to meet specific requirements. The amplification gain, ranging from 1 to 14.5 times the battery voltage, may be dynamically controlled by the processing unit. This system utilizes a step-up converter circuit — a direct DC-to-DC conversion method comprising transistors, resistors, an inductor, a capacitor, and a diode. Unlike traditional methods, it does not rely on a transformer or convert the battery's DC voltage into AC. Additionally, the design allows for precise control over intensity adjustments, enabling fine-tuned increments and decrements.

[0057] In another embodiment, Signal Generator Unit consists of DAC which can generate different patterns of monophasic or biphasic electrical signals like pulse , ramp, sine wave. The signal may be controlled by the processing unit which generates different patterns for electrotherapy. In order to obtain electrical pulses, General-purpose input / output (GPIO) of the micro-controller can be used instead of DAC.

[0058] In another embodiment, Signal Amplifier Unit amplifies the signal of the signal generator. It takes input from a signal generator and power from DC to DC voltage amplifier. The amplified signal may be used in electrotherapy.

[0059] In another embodiment, the Telemetry Unit enables seamless communication between the device and external computing devices, such as smartphones, tablets, or computers. Supporting both wired and wireless protocols, it allows users to remotely control the device andmonitor therapy sessions in real-time. Wireless connectivity is achieved through Bluetooth Low Energy (BLE), operating in the 2.4 GHz ISM band. BLE ensures ultra-low power consumption for prolonged battery life, a data transfer rate of 1 Mbps, and security features such as AES-128 encryption and pairing authentication. The unit is compatible with Over-the-Air (OTA) firmware updates. Additionally, a USB-C port provides a wired option for data transfer and device control.

[0060] In another embodiment, the electrode gel pads feature an adhesive layer, allowing them to securely attach to the skin during electrotherapy. There are two types of gel pads available: one with integrated heating elements for simultaneous thermotherapy, and the other without, designed solely for electrotherapy.

[0061] The embodiment of Fig. 7A functions as Dynamic Amplitude, that is a modulation of amplitude characteristics of the electric pulse for electrotherapy. The user can set the maximum amplitude, and the amplitude oscillates without requiring user intervention. The characteristics of pulse is marked in Fig. 7A and it is tabulated in the below table.

[0062] The embodiment’s of Fig.7B functions as Dynamic Phase, the modulation involves altering the phase characteristics of the electric pulse used for electrotherapy. The phase oscillates periodically or periodically without requiring user intervention.The characteristics of pulse is marked in Fig. 7B and it is tabulated in the below table.

[0063] The embodiment's in Fig. 7C illustrates modulation of frequency characteristics of the electric pulse for electrotherapy. The frequency of the pattern changes without requiring user intervention and the frequencies of the signal (F701, F702, F703) changes with time as F701 > F702 > F703.

[0064] The embodiment’s of Fig. 7D illustrates Dynamic Pattern, which is a modulation of pattern characteristics of the electric pulse for electrotherapy. The pattern changes without requiring user intervention. In the embodiment, Pattern of the TENS signal, S701is biphasic pulse, S702 Monophasic pulse, and the Pattern changes with time.

[0065] The embodiment's in Fig. 7E, pulse width changes without requiring user intervention and the characteristics is tabulated in the below table.

[0066] Various embodiment’s in Fig. 7F illustrates an asymmetric biphasic electric pulses for electrotherapy. The change in amplitude, phase , frequency and pulse width is simultaneous and the detailed characteristics is tabulated below.

[0067] Thus, the scope of the present disclosure is defined by the appended claims and includes both combinations and sub-combinations of the various features described herein-above as well as variations and modifications thereof, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

CLAIMSWe Claim:

1. A portable, lightweight device for providing relief from menstrual pain, comprising: a modular electrotherapy and thermotherapy component which can be configured between the single channel or dual channel; a battery management unit integrated with processing, memory, and telemetry functionalities, Real-Time Clock (RTC) / Oscillator, display, and keypad;An Arbitrary Waveform Generator can generate electric signal of varying frequency, pattern, pulse-width and intensity with or without user intervention.

2. The device according to claim 1 comprising of: a battery management unit provides inductive charging, over voltage (OV), over current (OC), and under voltage (UV) protection to ensure safe operation; a processing unit includes a micro controller configured to manage and control all device functionalities; a memory unit continuously logs device operations and user session data; an Arbitrary Waveform Generator creates signal patterns for electrotherapy, includes a DC-to-DC voltage amplifier, which receives power from the Battery Management Unit and amplifies the voltage. The amplification gain, controlled by the processing unit, can achieve a maximum gain of up to 14 times the input voltage and generator is capable of producing a frequency range from 1Hz to 200Hz and can output an intensity of 0V to ±60V with no load across electrode gel pads and the intensity can be adjusted in increments as small as 0.5V, offering precise control over the electrotherapy parameters; an impedance analyzer configured to measure the impedance across the gel pads. The analyzer is used to assess the quality of the gel pads, which are self-adhesive gel pads integrated with heating functionality;an telemetry unit communicates with external computing devices, allowing the sharing of device information and receiving operational commands; a RTC / Oscillator records time for device operation and user session tracking; a display unit is an alphanumeric interface to present device information such as mode and intensity, may be implemented using a 7-segment display, LCD, or OLED screen with a size ranging from 0.9 inches to 1.5 inches; a keypad is used for device operation, including power control, intensity adjustment, and pattern selection, may be implemented as a mechanical switch-based keypad or as a touchscreen interface.

3. The device according to claim 1, wherein the thermotherapy component comprises of a thermal management unit, which includes a switching circuit implemented using a transistor and a temperature sensor for real-time monitoring and continuously regulates the temperature of the heating element by monitoring inputs from the temperature sensor and adjusting the output accordingly.

4. The device as claimed in claim 1, wherein the device is separable into two distinct modules: a first module configured to function independently as an electrical nerve stimulator with dimensions ranging from 35 mm * 35 mm * 6 mm to 80 mm * 80 mm * 35 mm; and a second module configured to operate independently as a standalone thermal stimulator with dimensions ranging from 35 mm * 35 mm * 6 mm to 80 mm * 80 mm * 50 mm.

5. The device as claimed in claim 1 supports three types of patches, i) Electrode Gel Pads with a adhesive layer for only electrotherapy iijHeat Pad, it has a heating element for thermotherapy iiijElectrode Gel Pads with a adhesive layer and an integrated heating element to provide therapy.

6. The device as claimed in claim 1, wherein the device includes a programmable auto-shutdown feature, which detects user inactivity and automatically powers off after a predefined period of time, and the duration, denoted as x, can be set by the user, with selectable options such as 20 minutes or 30 minutes.

7. The device as claimed in claim 1, wherein the device includes a memory unit configured to store and retrieve device information, user settings, and data related to therapy sessions, and the he processing unit continuously logs relevant information to the memory unit, and may comprise an SD card, EPROM, or internal memory of the microcontroller.

8. The device as claimed in claim 1, wherein the device operates in two distinct modes: a non-wired mode, in which the device directly attaches to snap-button self-adhesive gel pads and can be worn on the body; and a wired mode, in which the device is connected to the gel pads via lead wires.

9. The device as claimed in claim 1, wherein the pulses operate at frequencies ranging from 1 Hz to 200 Hz, may include: a biphasic electric pulses without an inter phase in electrotherapy, exhibit a pulse peak of ±60V for potential interphase-free biphasic pulses in advancing non-invasive electrotherapeutic modalities. an uninterrupted biphasic electric pulses with dynamic amplitude delivering a pulse peak of ±60V, there by ensures effective charge balancing while reducing the risk of tissue damage.

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