Labor pain relief device and method

Abstract

A pain relief device and method for managing labor pain. The device includes a housing with one or more vibrating elements suitable for placement on specific anatomical regions such as the abdomen, clitoris, and / or pubis of a human female subject. The device is configured to be used by applying vibrations to targeted pain points during the various stages of labor. The device and method allow non-invasive, customizable pain management during labor.

Description

[0001] LABOR PAIN RELIEF DEVICE AND METHOD

[0002] FIELD OF INVENTION

[0003] The present disclosure relates to pain relief devices for use during labor. More particularly, the invention pertains to a device and method for managing labor pain using vibration applied to specific anatomical regions.

[0004] BACKGROUND OF THE INVENTION

[0005] Epidural administration has long been a common method for managing labor pain during childbirth. In the western world, epidural anesthesia is widely utilized during childbirth, with a substantial percentage of women receiving this form of pain relief Statistics indicate that approximately 60-70% of women in the western world receive epidural anesthesia during labor and delivery.

[0006] While effective in providing substantial pain relief, epidural administration also presents a range of drawbacks and potential complications that make them less than ideal for all patients.

[0007] Firstly, epidural administration involves the insertion of a needle into the epidural space surrounding the spinal cord. This invasive procedure carries inherent risks such as accidental punctures, nerve damage, and infections. Moreover, the process requires skilled healthcare professionals for accurate placement, which may not always be readily available or feasible in certain healthcare settings.

[0008] Furthermore, the use of epidural administration can result in a loss of sensation and motor function in the lower body, potentially prolonging labor and increasing the likelihood of instrumental delivery (e.g., using forceps, vacuum extraction) or cesarean section, thereby impeding the labor.

[0009] These interventions carry their own set of risks and recovery challenges for both the mother and the newborn. Additionally, epidural administration may not be suitable for all women due to contraindications, medical conditions, the risks brought above, or personal preferences. Some women may prefer to avoid pharmacological interventions during labor, seeking more natural and non-invasive pain relief alternatives.

[0010] In response to these concerns and limitations associated with epidural use, there is growing interest and demand for non-pharmacological methods of pain management during childbirth. Devices designed specifically for labor pain relief offer a promising alternative, providing women with greater autonomy and control over their birthing experiences while minimizing the need for invasive medical interventions like epidurals.

[0011] The Gate Control Theory of Pain, proposed by Melzack and Wall in 1965 (Science, 1965 Nov 19;150(3699):971-9), suggests that pain perception is regulated by a "gate" mechanism in which activation of nerves that do not transmit pain signals, called nonnociceptive fibers, can override and reduce painful sensations, thereby inhibiting pain. Factors like touch and emotions can modulate this gate. Implications of the theory include the use of non-pharmacological interventions, like massage and Transcutaneous Electrical Nerve Stimulation (TENS).

[0012] TENS therapy is a non-invasive pain relief method that uses low- voltage electrical currents to alleviate discomfort. It works by stimulating nerves through electrodes placed on the skin, modulating pain signals before they reach the brain. TENS therapy is commonly used for various types of acute and chronic pain, including labor pain. However, its effectiveness varies based on factors like the type and severity of pain. While TENS therapy offers a drug-free alternative for pain management, it may not be suitable and effective for everyone, and proper electrode placement is crucial. Further, evidence suggests that TENS’s effectiveness is apparent only in early stages of childbirth and is not suitable for use in highly humid environments, such as water births. Various further labor assisting tools are known. CN105496523 discloses an abdominal pressure midwifery instrument for the whole labor process, comprising a main control device and an abdominal pressure belt device electrically connected to the main control device, including an abdominal pressure airbag device, and an abdominal pressure belt vibration device. The device is used to add abdominal pressure during labor, and the abdominal pressure belt vibration device is used to prevent and reduce postpartum hemorrhaging. An external operation device is used to input control commands for controlling the working state of the abdominal pressure belt device and the working state of the abdominal pressure belt vibration device.

[0013] There is a benefit for effective, and safe devices for alleviating labor pain without the side effects and risks associated with the aforementioned pain-relieving options.

[0014] SUMMARY OF THE INVENTION

[0015] An aspect of the invention pertains to a pain relief device comprising: a housing suitable to be placed about the abdomen and / or the clitoris, and / or a pubic region of the anatomy of a human subject; one or more vibrating elements integrated within the housing; and a power source.

[0016] An aspect of the invention pertains to a labor pain relief device comprising: a housing suitable to be placed about a body region comprising the lower abdomen, and any one or both of the clitoris, and pubis, or a region thereof, of a female subject; a plurality of vibrating elements integrated within the housing and positioned to provide vibration therapy to said body region of the female subject; a control unit in communication with the plurality of vibrating elements and configured to activate and / or adjust vibration parameters of the plurality of vibrating elements; and a power source.

[0017] An aspect of the invention provides a labor pain relief device comprising: a plurality of vibrating elements positioned to provide vibration therapy to a body region of a female subject comprising the lower abdomen, and any one or both of the clitoris, and pubis, or a region thereof, of a female subject; a control unit in communication with the plurality of vibrating elements and configured to activate and / or adjust vibration parameters of the plurality of vibrating elements; and a power source.

[0018] An aspect of the invention pertains to a labor pain relief device. In one or more embodiments, the device comprises a housing. In one or more embodiments, the housing is suitable to be placed about a body region. In one or more embodiments, the body region comprises the lower abdomen, the clitoris, the pubis, or the lower back, or a region thereof. In one or more embodiments, the body region comprises at least two regions selected from the lower abdomen, the clitoris, the pubis, or the lower back or a region thereof. In one or more embodiments, the body region comprises the lower abdomen, and any one or both of the clitoris, and pubis, or a region thereof, of a female subject.

[0019] In one or more embodiments, the device comprises a plurality of vibrating elements. In one or more embodiments, the device comprises a plurality of vibrating elements integrated within the housing and positioned to provide vibration therapy to the body region of the female subject. In one or more embodiments, the device or system comprises multiple housings each comprising at least one vibrating element. In one or more embodiments, the device comprises a control unit in communication with the plurality of vibrating elements and configured to activate and / or adjust vibration parameters of the plurality of vibrating elements. The device further comprises a power source.

[0020] In one or more embodiments, the housing is configured as a hand-held device, a belt for wrapping the lower abdomen and lumbar region (waist or pelvic), a panty with a waist or pelvic extension for covering the lower abdomen region, a glove, a patch, an adhesive based sticker or a hand-held cylinder, or a rounded structure. In one or more embodiments, the housing comprises a belt-like structure suitable to be placed around an abdomen and / or the clitoris, and / or the pubic region.

[0021] In one or more embodiments, the housing is configured as an inverted triangle. In one or more embodiments, the housing comprises a pocket for accommodating a subject’s hand. In one or more embodiments, the housing is suitable for accommodating a user’s hand. In one or more embodiments, the housing has a pocket structure or a glove-like structure. In one or more embodiments, the device adapts the lower abdomen anatomy of a pregnant human subject.

[0022] In one or more embodiments, the vibrating element is being operated by the subject. In one or more embodiments, the vibrating element is operated by the female through pressing or releasing pressure. In one or more embodiments, when the female subject presses the vibrating element on a painful area, it activates it, and when the female subject stops pressing, the vibrating element stops operating. Optionally, the pressure intensity can affect the activation intensity.

[0023] In one or more embodiments, the housing is configured as an inverted triangle. In one or more embodiments, the housing comprises a pocket for accommodating a subject’s hand.

[0024] In one or more embodiments, the device further comprising a heating element embedded within the housing. In one or more embodiments, the heating elements generate controlled heat or cooling to provide additional comfort and relaxation during labor. In one or more embodiments, the device does not include a heating element.

[0025] In one or more embodiments, the device further comprises one or more sensors for sensing movements, body heat, and sounds. In one or more embodiments, the one or more sensor is selected from an accelerometer, a noise sensor, and a sonic sensor. In one or more embodiments, the one or more sensors is selected from the group consisting of: a pressure sensor, an accelerometer, a noise sensor, a sonic sensor, a tocodynamometer, a temperature sensor, an electrodermal activity sensor, a capacitive humidity sensor, an electric conductivity sensor, a biosensor, and a piezoelectric transducer. In one or more embodiments, the device further comprises an ultrasound. In one or more embodiments, the device is non-invasive. In one or more embodiments, the device is disposable. In one or more embodiments, the device is sterilized. In one or more embodiments, the device can be packed in medical packaging and sterilized.

[0026] In one or more embodiments, the vibrating elements include one or more motors, electromagnetic elements, and / or piezoelectrical actuator, and / or materials. In one or more embodiments, the vibrating elements are adjustable affording adjusting the speed, intensity, and patterns of vibrations. In one or more embodiments, the vibration parameter of the plurality of vibrating elements is selected from frequency, amplitude, vibration location in the body, and / or patterns of vibrations.

[0027] In one or more embodiments, the device comprising at least one vibrating element configured for placement on the lower abdomen, at least one vibrating element configured for placement on the pubic region, and at least one vibrating element configured for placement on a clitoral area. In one or more embodiments, the device further comprises one or more vibrating elements for placement about the lower back region.

[0028] In one or more embodiments, the device comprises three vibrating elements configured for placement on the lower abdomen, one vibrating element configured for placement on the pubic region, and one vibrating element configured for placement on a clitoral area.

[0029] In one or more embodiments, the control unit is configured to activate the lower abdomen vibrating element(s) and optionally the lower back vibrating element(s) during an initial latent labor phase, additionally or alternatively activate the pubic region vibrating element(s) during an active labor phase, and additionally or alternatively activate the clitoral region vibrating element(s) during a transition labor phase.

[0030] In one or more embodiments, the control unit is configured to adjust the vibration parameters based on the detected physiological parameters. In one or more embodiments, the control unit is configured to adjust the vibration parameters based on at least one external data entry comprising at least one physiological parameter associated with labor pain of said subject.

[0031] In one or more embodiments, the device further comprises a wireless communication module comprising Bluetooth or Wi-Fi, configured to convey data to a remote device.

[0032] In one or more embodiments, the remote device comprises a software algorithm comprising a machine learning algorithm configured to generate an output signal for adjusting the vibrating parameters based on one or more physiological parameters associated with labor pain of said subject.

[0033] In one or more embodiments, the one or more physiological parameters of the subject is selected from the group consisting of labor stage / phase, hormone levels (e.g., oxytocin), body movements, body heat, labor contractions, heart rate, skin humidity, and / or sounds.

[0034] In one or more embodiments, the device further comprises one or more straps, adhesives, and / or fixatures for allowing stable placing the device onto the abdomen and one or both the pubis region, and the clitoral region.

[0035] In one or more embodiments, the control unit is configured to receive commands from the subject for adjusting the vibration parameters, wherein the control unit comprises at least one of a touch screen, and buttons.

[0036] In one or more embodiments, the control unit further comprises a user interface comprising a display screen displaying feedback associated with the subject’s response to said vibration parameters, and / or provide real-time insights regarding the efficacy of the labor pain management device.

[0037] In one or more embodiments, the power source is a battery or electrical wire featuring an electric plug-in device. In one or more embodiments, the device further comprises a heating element, and wherein the pain management comprises managing the heat intensity.

[0038] In one or more embodiments, the vibrating elements are positioned within the housing structure to target specific pain points associated with labor pain.

[0039] In one or more embodiments, the device further comprises one or more straps. In one or more embodiments, the device further comprises one or more fixatures for allowing stable placing the device onto the abdomen and / or pubic region. In one or more embodiments, the one or more fixature comprises an adhesive.

[0040] In one or more embodiments, the device further comprises a control unit and an electrical connection for allowing communication between the vibrating element and the control unit.

[0041] In one or more embodiments, the device further comprises a Bluetooth connectivity, or a software integration for controlling functionality and customization.

[0042] In one or more embodiments, the device further comprises a feedback mechanism to monitor user responses and provide real-time insights to healthcare providers regarding pain management effectiveness.

[0043] In another aspect the invention provides a method of managing pain, comprising providing a device according to the herein invention; and placing the device around the abdomen and / or the clitoris, and / or the pubic region, and / or the lower back of a human subject. In one or more embodiments, the method is suitable for managing a gynecological pain of a female subject. In one or more embodiments, the method is suitable for managing labor pain of a female subject.

[0044] In one or more embodiments, the method comprises a first step of activating the vibrating elements around the abdomen at initial stages of labor. In one or more embodiments, the method comprises a second step of activating the vibrating elements around the clitoris, and / or the pubic region at final stages of labor. In one or more embodiments, the final stages of labor are when the cervix is almost fully or fully open.

[0045] In another aspect the invention provides a method of managing labor pain of a female subject, comprising: providing a device comprising one or more vibrating elements configured to rotate one or more regions of pain points associated with labor pain selected from a lower abdomen, a clitoris, and a pubis of a female subject in labor; placing the rotating elements of said device about said one or more regions of pain points associated with labor pain of the female subject; and activating the one or more vibrating elements to provide labor pain relief therapy to the female subject.

[0046] In one or more embodiments, the method comprising activating the one or more vibrating element about the lower abdomen or a region thereof at an initial latent labor phase. In one or more embodiments, the method comprising activating the one or more vibrating element about the pubis during an active labor phase. In one or more embodiments, the method comprising activating the one or more vibrating element about the clitoris during a transition labor phase.

[0047] In one or more embodiments, the method comprising activating the one or more vibrating element about the lower abdomen or a region thereof at an initial latent labor phase and additionally or alternatively activating the one or more vibrating elements about the pubis during an active labor phase. In one or more embodiments, the method further comprises a step of activating the one or more vibrating elements about the clitoris and optionally ceasing vibrating the lower abdomen region and / or the pubis during a transition labor phase.

[0048] In one or more embodiments, the method further comprising receiving one or more physiological parameters of the female subject. In one or more embodiments, the method further comprising detecting one or more physiological parameters of the female subject using one or more sensors. In one or more embodiments, the physiological parameter is selected from the group consisting of body movements, body temperature, labor contractions, heart rate, skin humidity, hormone levels (e.g., oxytocin), and bodily sounds.

[0049] In one or more embodiments, the method further comprising adjusting one or more vibration parameters of the at least one vibrating element based on the physiological parameters. In one or more embodiments, the method the one or more vibration parameters is selected from frequency, amplitude, and / or patterns of vibrations.

[0050] In another aspect there is provided a system for managing labor pain in a female subject, the system comprising a device according to the herein invention; and a data processing unit, adapted for processing one or more physiological parameters of a female subject in labor, wherein the data processing unit is configured for data communication with the device; wherein the data processing unit comprising data relating to at least one physiological parameter of the female subject and is adapted to provide an output signal for adjusting one or more vibration parameters required to relieve labor pain.

[0051] In one or more embodiments, the system comprising a computer program product, comprising a non-transitory computer-readable storage medium having program code embodied thereon, the program code executable by the data processing unit to adjust the one or more vibration parameters required to relieve labor pain.

[0052] In one or more embodiments, the data processing unit is configured to receive, and analyze the physiological parameter and provide an output based on said parameters to thereby adjust the vibration parameters.

[0053] In one or more embodiments, the system comprises a communication module configured for conveying data of the physiological parameter to an external computerized remote device configured to receive the data, to display, store, analyze the data, and / or provide an output signal for adjusting one or more vibration parameters required to relieve labor pain. In one or more embodiments, the computing device is selected from a smartphone, a laptop, a computer, a tablet and a smartwatch, the computing device comprising a designated application program for monitoring and displaying milk related parameters and data communicated from the monitoring device.

[0054] In one or more embodiments, the system comprises a learning algorithm designed to analyze and adapt the parameters of the vibrations. In one or more embodiments, the learning algorithm utilizes machine learning techniques to continuously adapt and optimize pain relief settings based on patient specific behavior, and / or preferences observed during labor, or the stage of the labor and birth, or the physiological parameter.

[0055] Further embodiments and the full scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

[0056] BRIEF DESCRIPTION OF THE DRAWINGS

[0057] The invention may be more clearly understood upon reading of the following detailed description of non-limiting exemplary embodiments thereof, with reference to the following drawings, in which:

[0058] Figure 1A is a schematic front view of an exemplary device for labor pain relief that comprises one or more vibrating elements about the lower abdomen and the pubic region, according to embodiments of the invention.

[0059] Figure IB is a front view of the device of figure 1A when worn by a female subject, according to embodiments of the invention. Figure 2 A is a schematic front view of another exemplary device for labor pain relief that comprises one or more vibrating elements about the lower abdomen, the pubic region, and the clitoral region, according to embodiments of the invention.

[0060] Figure 2B is a front view of the device of figure 2 A when worn by a female subject, according to embodiments of the invention.

[0061] Figures 3A-3C illustrate anatomy positions for activating the vibrating elements during the course of a childbirth, according to embodiments of the invention.

[0062] Figures 4A-4B are a front view and a side view of an exemplary device for labor pain relief that comprises a hand pocket and a top user interface, according to embodiments of the invention.

[0063] Figures 5A-5B are a front view and a side view of another exemplary device for labor pain relief that comprises a hand pocket and a front user interface, according to embodiments of the invention.

[0064] Figure 6 illustrates another exemplary device for labor pain relief having a glove-like structure, according to embodiments of the invention.

[0065] Figures 7A-7B illustrate another exemplary device for labor pain relief having an inverted triangle structure and comprising a set of adhesives, according to embodiments of the invention.

[0066] Figures 8A-8B illustrate another exemplary device for labor pain relief having a panty-like structure, according to embodiments of the invention.

[0067] Figures 9A-9B illustrate another exemplary device for labor pain relief having a plurality of vibrating elements, according to embodiments of the invention. DETAILED DESCRIPTION OF THE INVENTION

[0068] The following description sets forth exemplary aspects of the present disclosure. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure. Rather, the description also encompasses combinations and modifications to those exemplary aspects described herein.

[0069] The present disclosure relates to a method for managing labor pain and to a labor pain relief device designed to provide non-invasive pain management during childbirth.

[0070] By applying focused vibration to key anatomical areas associated with labor pain, such as the lower abdomen, the pubis, and the clitoris, the device may stimulate non-nociceptive nerve fibers whilst overriding or blocking other nerves associated with pain signals, potentially modulating pain perception during various phases of labor.

[0071] The device and method are configured to address pain in multiple anatomical regions commonly associated with labor discomfort and pain.

[0072] In some embodiments, the herein device comprises a housing, one or more vibrating elements integrated within the housing, a control unit in communication with the vibrating elements and configured to activate and / or adjust vibration parameters of the one or more vibrating elements; and a power source.

[0073] The housing may be adapted for placement on specific areas of a female subject's body. The housing may be shaped to conform to the contours of the lower abdomen, pubic region, and / or clitoral area of a pregnant female subject. In some cases, the device housing may be configured in various forms to suit different preferences and usage scenarios. For example, the device housing may be shaped as a hand-held device, a belt for placement around the abdomen, a panty with a lower abdomen extension, a glove, a patch, an inverted triangle, or a cylinder. In another embodiment, the housing is a plurality of separate vibrating elements, each configured to be placed in a specific area of a female subject's body comprising the lower abdomen, the pubis, the clitoris regions, and the lower back. The housing may be formed from various materials. For example, the housing may be formed for a material which has one or more of the following properties: hypoallergenic, non-heat conducting; high elasticity, biocompatibility, waterproof, non-porous material to prevent bacterial growth, and high flexible. For example, in one embodiment, the housing may be made from a plastic material. In an alternative embodiment, the housing may be made from a more malleable or pliable material, such as a gel, which transmits vibrations, but which is also soft and may shape itself, to an extent, e.g., to the shape of the outer surface of the anatomy of the lower abdomen of a pregnant female subject. Suitable materials include but are not limited to fabrics, soft silicone, Acrylonitrile Butadiene Styrene (ABS), rubber materials, Thermoplastic Elastomers (TPE), and / or various other polymers. The housing may be made from a material that is soft and flexible, exhibiting properties similar to gels or very soft rubbers.

[0074] The housing may be made from a material having up to Shore 60A hardness. For example, the housing may be made from a material having up to a Shore 40A hardness. This level of hardness may provide a balance between flexibility and durability, allowing the labor pain relief device to conform to the subject's body while maintaining its structural integrity. In an alternative embodiment, the housing may be made from a material having up to Shore 30A hardness. For example, the device may be made from a material having a Shore 20A hardness. The housing may be made from hydrophilic or hydrophobic materials or may be made from a combination of hydrophilic and hydrophobic material or may be coated with hydrophilic and / or hydrophobic materials. The housing may be suitable for use in an aqueous environment.

[0075] The labor pain relief device may incorporate multiple vibrating elements integrated within the housing structure. These vibrating elements may be positioned to deliver localized vibration therapy. In some implementations, the vibrating elements may be arranged to target the lower abdominal region. In some implementations, the vibrating elements may be arranged to target the pubic region. In some implementations, the vibrating elements may be arranged to target the clitoral region. In some implementations, the vibrating elements may be arranged to target the lower back region (or lumbar region). Optionally, all vibrating elements may be activated simultaneously or independently.

[0076] The device may for example include one or more vibrating elements that are configured to be placed about the lower abdomen region. The device may for example include one or more vibrating elements that are configured to be placed about the pubic region. The device may for example include one or more vibrating elements that are configured to be placed about the clitoral region. Optionally, the device includes, consists, or consists essentially of vibrating elements configured to be placed about the lower abdomen, the pubic region, and the clitoris. Optionally, the device includes, consists, or consists essentially of vibrating elements configured to be placed about the lower abdomen, the pubic region, the clitoris and the lower back (or lumbar region). Optionally, the device does not include vibrating elements configured to be placed about the lower back (or lumbar region). Optionally, the device includes, consists, or consists essentially of vibrating elements configured to be placed about the lower abdomen, and the pubic region. Optionally, the device includes, consists, or consists essentially of vibrating elements configured to be placed about the lower abdomen, and the clitoris. Optionally, the device includes, consists, or consists essentially of vibrating elements configured to be placed about the pubic region, and the clitoris.

[0077] The housing may include one central or main zone for vibrating elements. The housing may include various spaced apart vibrating elements positioned such that upon use the vibrating elements are positioned about the lower abdomen, the pubis, the clitoris, and / or the lower back. During use, the abdominal vibrating elements may be activated during the initial latent labor phase. As labor progresses, the pubis vibrating element may be activated during the active labor phase. In some cases, the clitoral vibrating element may be activated during the transition labor phase. In some cases, one or more lower back vibrating elements may be further activated during any one or more of the labor phases. For example, the lower back vibrating elements may be further activated during the latent phase. Alternatively, or additionally, the lower back vibrating elements may be further activated during the active phase. Alternatively, or additionally, the lower back vibrating elements may be further activated during the transition phase.

[0078] By providing vibration therapy to these specific anatomical regions, the labor pain relief device may offer an alternative or complementary approach to traditional pain management techniques during childbirth. As will be elaborated further, the device may be designed to be adjustable, allowing for customized therapy as labor progresses and pain patterns shift.

[0079] The device may comprise a plurality of vibrating elements. The device may include three or more vibrating elements. The device may include four or more vibrating elements. The device may include five or more vibrating elements. The device may include six or more vibrating elements. In one example, the device includes five or more vibrating elements. In an exemplary embodiment, the device includes two or more (e.g., three) vibrating elements that are configured to be placed about the lower abdomen. In an exemplary embodiment, the device includes one or more (e.g., two) vibrating elements configured to be placed about the pubic region. In an exemplary embodiment, the device includes one vibrating element configured to be placed about the clitoris. In an exemplary embodiment, the device includes or consists of three vibrating elements configured to be placed about the lower abdomen, one vibrating element configured to be placed about the pubis and one vibrating element configured to be placed about the clitoris. In another exemplary embodiment, the device includes or consists of three vibrating elements configured to be placed about the lower abdomen, one vibrating element configured to be placed about the pubis, one vibrating element configured to be placed about the clitoris, and two vibrating elements configured to be placed about the lower back.

[0080] As will be apparent to those skilled in the art, the vibrating element may include one or more motors (e.g., an Eccentric Rotating Mass (ERM) Motor, DC motors with eccentric weights), ac motors, or / and a piezoelectric actuator. The motor Round Per Meter (RPM) typically ranges from 1,200 to 12,000 rpm with power requirements of 3-6V DC. Motor speed may be regulated with variable speed control through PWM (Pulse Width Modulation) or Micro-control unit-based speed regulation. Soft start / stop functionality can be used to prevent sudden movements. Multiple pattern capabilities through programmed waveforms allow custom vibration or motion patterns. The motor may preferably be small and lightweight. It may also be preferable for such a motor to be capable of producing vibrations of variable frequency and amplitude. A low frequency of vibrations produced by the vibrating element may preferably be up to 50 Hz (Hertz), for example 20-50 Hz. Moderate frequency may range between 60 and 120 Hz. A high frequency of vibrations produced by the vibrating element may be up to 200 Hz, for example 120-200 Hz. The amplitude of the vibrations produced by the vibrating element may be up to 5 mm.

[0081] The vibrating elements may be controlled by a control unit, allowing the user or healthcare personnel to adjust the parameters of the vibrations. In some embodiments, the control unit may also be configured to allow the user to adjust the amplitude of the vibrations and / or a pattern / sequence of the vibrations and / or frequencies thereof. Optionally, the control unit may be separate from the housing and configured to facilitate remote access / use whilst the device is in use. The control unit may be attached to the housing via a wire. Optionally, the control unit is attached or integrated within the housing. In an alternative embodiment, the control unit may be totally detached from the housing (e.g. wirelessly connected to the housing and the vibrating elements), providing “remote control” of the device. Optionally, one central control unit may manage all vibrating elements in all locations independently. Alternatively, each vibrating element may have its own dedicated control unit.

[0082] In some cases, the control unit may be configured to adjust the vibration parameters based on the physiological parameters detected by the sensors. In some cases, the control unit may be configured to adjust the vibration parameters based on external data entry associated with the physiological parameters of subject. Such external physiological parameters may be any one or more of the childbirth stage, hormone levels, body movements, body temperature, labor contractions, heart rate, skin humidity, and body sound. Suitable pleasure hormones include, for example, dopamine, serotonin, endorphins, and oxytocin. Pain-related hormones include, for example, substance p, cortisol, and norepinephrine Each possibility is a separate embodiment.

[0083] The herein device further includes a power source which may be selected between a rechargeable (e.g., lithium-ion) or disposable battery, and a wired power supply, connected via electrical wiring to the main control unit. The device further includes control circuitry, i.e., an electronic module that regulates the vibration intensity, duration, and frequency. The device may further include microcontroller units (MCUs) or applicationspecific integrated circuits (ASICs) for processing input signals and adjusting vibration parameters.

[0084] In some embodiments, the housing may include one or more sensors. The sensors may be configured to detect physiological parameters of the female subject and optionally trigger vibration responses based on the detected physiological data.

[0085] Sensing capabilities may be achieved by utilizing any sensor known in the art. The sensor may be an electrical sensor, an optical sensor, a pressure force displacement or any other sensor. The sensors may be selected in accordance with the at least one physicochemical or physiological parameter to be measured and the sensitivity that is required for a particular physicochemical or physiological parameter. The term “sensor” refers, within the context of the present invention, to the components of a device configured to sense and transmit a data signal associated with any one or more physiological parameters of a female subject in labor. The physiological parameters may be related to labor. The physiological parameters may be related to labor pain. The physiological parameters may be one or more of body movements, body temperature, labor contractions, heart rate, skin electrical conductivity, levels of oxytocin, and / or body sounds. Additionally, an external auxiliary source, such as hospital equipment (e.g., ultrasound, monitors) or the clinical nursing team, may be utilized to measure the one or more physiological parameter.

[0086] The sensors may be configured to detect hand or fingers presses of the female subject. When using the device, the female subject may apply pressure on painful areas, which can be detected by one or more sensors. The pressure detected may trigger the activation of one or more vibrating elements positioned around the painful regions. Optionally, when the pressure is no longer applied, the vibrating elements are turned off.

[0087] Suitable sensors may be selected from a pressure sensor, an accelerometer, a noise sensor, a sonic sensor, a tocodynamometer, a temperature sensor, electrodermal activity, capacitive humidity, a pH sensor, a body conductivity sensor, a biosensor (e.g., for measuring oxytocin levels in a biological sample), an Electromyography (EMG) Sensor and a piezoelectric transducer.

[0088] Excessive movement may indicate pain. Thus, measuring body movements can be applicable to measure a level of labor pain. Suitable sensors for measuring body movements include, for example, accelerometers, piezoelectric sensors, EMG, Gyroscopes and force sensors. Each possibility is a separate embodiment of the invention.

[0089] Labor contractions cause labor pain. Suitable sensors for measuring labor contractions, include, for example, strain gauges, piezoelectric sensors, electromyography (EMG) sensors, tensile force sensors and accelerometers. Each possibility is a separate embodiment of the invention.

[0090] Heart rate can be indicative of labor pain. During labor, pain and physical exertion can cause the body to release stress hormones like adrenaline (epinephrine), which can lead to an increase in heart rate. Suitable sensors for measuring heart rate, include for example, Photoplethysmogram (PPG) sensors, Electrocardiogram (ECG) sensors, ballistocardiogram sensors (BCG), Microwave radar, and capacitive sensors. Each possibility is a separate embodiment of the invention.

[0091] Skin conductivity (or skin conductance, which is related to sweating) can be indicative of labor pain. When a person experiences pain, the body activates its sympathetic nervous system (part of the autonomic nervous system), leading to an increase in sweating. Suitable sensors for measuring skin humidity, include, for example, electric conductivity, Galvanic Skin Response (GSR) Sensors, Humidity Sensors, Capacitive Sensors, Optical Sensors, and Piezoelectric Sensors. Each possibility is a separate embodiment of the invention.

[0092] Oxytocin is a hormone and neurotransmitter that plays a key role in stimulating uterine contractions during labor. Oxytocin can stimulate the release of pain-relieving endorphins. Oxytocin is usually measured through laboratory tests such as an Enzyme-Linked Immunosorbent Assay (ELISA), or any other assay using antibodies that detect and quantify oxytocin in a blood sample, a saliva sample, or urine sample using antibodies. Nevertheless, recent developments use biosensors to measure levels of oxytocin. Suitable sensors for measuring levels or trend over time (e.g., increase or decrease) of oxytocin may include biosensors such as electrochemical sensors.

[0093] The herein device may further comprise an ultrasound to monitor fetal health and maternal well-being. Suitable sensors for measuring body sounds include Fetal Doppler, electronic stethoscopes, microphone-based sensors, and capacitive sensors. Each possibility is a separate embodiment of the invention.

[0094] The herein device may further comprise a heating or cooling element embedded within the housing and configured to generate controlled heat to provide additional comfort and relaxation to the subject during labor. Optionally a temperature sensor is provided to regulate the heat produced by the device. Suitable sensors for measuring body temperature, include Infrared sensors, Thermistors, Thermocouples and semiconductor sensors. Each possibility is a separate embodiment of the invention.

[0095] The vibrating device offers a portable and user-friendly solution that can be easily integrated into existing labor and delivery protocols. Unlike epidurals, which require specialized equipment and trained personnel for administration, the vibrating device allows women to actively participate in their pain management process, promoting a sense of empowerment and satisfaction during childbirth. The device advantageously offers a safe, effective, and non-invasive alternative to epidural administration, and has the potential to enhance the birthing experience. The device may be sterilized prior to use and may be placed in a package that maintains sterility thereof.

[0096] In some cases, the labor pain relief device may be used to manage pain during different stages of labor. The labor pain relief device may include various vibrating elements positioned to target specific anatomical regions associated with labor pain.

[0097] In some cases, the labor pain relief device may include a wireless communication module for remote control or integration with a digital health monitoring system or a remote device. The wireless communication module may comprise Bluetooth or Wi-Fi. This wireless communication module may be configured to send data to a remote device. The remote device may comprise a software algorithm including a machine learning algorithm. These algorithms may be configured to generate an output signal for adjusting the vibrating parameters based on data received from the labor pain relief device or based on external data entry associated with physiological parameters of the subject. Data set of stored previous cases of a large population of women in labor can be utilized as reference population for determining the vibration parameters such as frequency, amplitude, pattern, and location.

[0098] By another aspect, there is provided a computer program product, comprising a non- transitory computer-readable storage medium having program code embodied thereon, the program code executable by at least one hardware processing unit to perform a method of the invention.

[0099] By another aspect, there is provided a computer program product, comprising a non- transitory computer-readable storage medium having program code embodied thereon, the program code executable by at least one hardware processing unit to receive data associated with one or more physiological parameters of a female subject in labor; determine the level of labor pain based on the physiological parameters; and determine the vibration parameters and / or location required to manage / relief the labor pain of the female subject in labor. The data associated with one or more physiological parameters of a female subject may correlated with labor pain, i.e., the physiological parameter(s) indicate the level of labor pain experienced by the female subject is. The data associated with one or more physiological parameters of a female subject includes any one or more of the childbirth stage, oxytocin levels, body movements, body temperature, labor contractions, heart rate, skin humidity, and bodily sound.

[0100] In some cases, the computer program product may include machine learning techniques to continuously (in real time) adapt and optimize the vibration parameters based on data associated with labor pain or based on real time data associated with the physiological parameters a female subject. This algorithm may allow for personalized pain relief throughout the labor process.

[0101] In some embodiments, the computer program product outputs the vibration amplitude required to relief the labor pain. In some embodiments, the computer program product outputs the vibration frequency required to relief the labor pain. In some embodiments, the computer program product outputs the vibration pattern required to relief the labor pain.

[0102] The labor pain relief device may include an ultrasound feature. This feature may provide additional information about the progress of labor or the position of the fetus.

[0103] Utilizing the vibrating elements, and optionally the various sensors, and / or dedicated algorithm, the herein labor pain relief device may provide customized pain management throughout the different stages of labor. The device may adjust its settings based on realtime physiological data and user preferences, potentially offering a more personalized and effective approach to managing labor pain.

[0104] Figs. 1A-1B illustrate schematically an exemplary labor pain relief device 10 as herein disclosed that includes a housing 11 and one or more vibrating elements 18. The housing 11 is configured to be placed and cover areas of the lower abdomen and the pubic region of a female subject. In some cases, the housing 11 may be configured as a handheld device. In some cases, the housing 11 may be configured as a belt for placement around the lower abdomen. In some cases, the housing 11 may be configured as a panty with a waist extension for covering the lower abdomen region. In some cases, the housing 11 may be configured as a glove. In some cases, the housing 11 may be configured as a patch or adhesive. In some cases, the housing 11 may be configured as a cylinder or a rounded structure. In some cases, the housing 11 may be configured as an inverted triangle.

[0105] The labor pain relief device 10 may comprise three or more abdominal vibrating elements 18 arranged across the lower abdomen in an upper region 1 of the device 10 as illustrated. However, one or two vibrating elements 18 are also applicable. The vibrating elements 18 may be dispersed at various positions in the lower abdomen region 1. For example, the vibrating elements 18 may be arranged along a longitudinal axis in lower abdomen region 1.

[0106] One or more of a pubis vibrating element 18 may be positioned in a lower pubic region 2 of the labor pain relief device 10. The labor pain relief device 10 may comprise one pubis abdominal vibrating element 18 in a pubis region 2 of the device 10 as illustrated. However, two vibrating elements 18 or more are also applicable. The vibrating elements 18 may be disposed at various positions in the pubis region 2. For example, the vibrating elements 18 may be arranged along a longitudinal axis in pubis region 2.

[0107] The labor pain relief device 10 may be suitable to be worn by a subject, when the abdominal vibrating elements 18 are positioned over the lower abdomen region 1 and the pubis vibrating element 18 is positioned over the pubic region 2. The arrangement of the vibrating elements 18 may allow for targeted vibration therapy to specific anatomical areas associated with labor pain.

[0108] The labor pain relief device 10 may further comprise one or more straps, adhesives, and / or fixatures for allowing stable placement of the device 10 onto the abdomen 1 and pubic region 2. These features may help ensure that the labor pain relief device 10 remains securely positioned during use, maintaining consistent contact between the vibrating elements 18 and the intended anatomical regions.

[0109] Figs. 2A and 2B illustrate a labor pain relief device 20 that further includes clitoris vibrating element 18. Similarly to device 10, the labor pain relief device 20 may comprise a plurality of abdominal vibrating elements 18 arranged in the upper abdominal region 1 of device 20. Pubis vibrating element 18 may be positioned below the abdominal vibrating elements 18, in the pubis region 2. A clitoris vibrating element 18 may be located in a lower region 3 of the labor pain relief device 20. The vibrating elements 18 may be integrated within the housing 11 of the labor pain relief device 20. Alternatively, the vibrating elements 18 may be provided as separate components when each is configured to be placed on a different anatomical position, as mentioned above.

[0110] The abdominal vibrating elements 18 may be configured for placement on the lower abdomen region 1. The pubis vibrating element 18 may be configured for placement on the pubic region 2. Clitoris vibrating element 3 may be configured for placement on the clitoral region 3. In some cases, the labor pain relief device 20 may further comprise one or more vibrating elements 18 at various positions along the lower back region. These additional lower back region vibrating elements 18 may further provide targeted vibration therapy to the lower back area, which may experience discomfort during labor.

[0111] Fig. 3 shows the arrangement of vibrating elements 18 in labor pain relief devices 10 and 20. These may allow for simultaneous or independent activation of different anatomical regions. This configuration may provide flexibility in addressing pain and discomfort in various areas during different stages of labor.

[0112] The abdominal vibrating elements 18 may be configured for placement on the lower abdomen region 1. The abdominal vibrating elements 18 may be activated during any stage / phase of the labor. For example, the abdominal vibrating elements 18 may be activated during the initial / early latent labor phase. The latent labor phase may be characterized by mild and commonly irregular contractions with gradual cervical dilation. During the latent labor phase, the cervix starts thinning (effacement) and dilating (usually up to 3-4 cm). The latent labor phase can last hours or even days, especially in first-time mothers.

[0113] The pubis vibrating element 18 may be configured for placement on the pubic region 2. The pubis vibrating elements 18 may be activated during any stage / phase of the labor. For example, the pubis vibrating element 18 may be activated during the active labor phase. The active phase may involve stronger, more frequent contractions with increased cervical dilation, and stronger, and more regular contractions (typically every 3-5 minutes) and the cervix dilates from about 4 cm to about 7 cm.

[0114] The clitoris vibrating element 18 may be configured for placement on the clitoral region 3. The clitoris vibrating elements 18 may be activated during any stage / phase of the labor. In some cases, the clitoris vibrating element 18 may be activated during the transition labor phase. The transition phase may be the most intense part of labor, occurring just before pushing begins, and characterized by contractions every 2-3 minutes and the cervix dilates from about 7 cm to about 10 cm.

[0115] The abdominal vibrating elements 18 may be non-active in the active and transition phases. Alternatively, the abdominal vibrating elements 18 may be maintained active during the active phase and further optionally during the transition stage. In an exemplary embodiment, the abdominal vibrating elements 18 are active during the latent and the active phases and deactivated during the transition stage.

[0116] The pubis vibrating elements 18 may be deactivated or non-active in the latent and / or transition phases. Optionally, the pubis vibrating elements 18 are maintained active during the active stage and further optionally during the transition stage. The clitoris vibrating elements 18 may be deactivated or non-active in the latent and active phases. Optionally, the clitoris vibrating elements 18 are maintained active during the transition stage.

[0117] Figs. 4A-4B illustrate an exemplary labor pain relief device 100. Labor pain relief device 100 comprises a housing 111 having an inverted triangle shape that fits the lower abdomen anatomy of a pregnant female subject. The housing 111 of the labor pain relief device 100 may be made from a material having up to Shore 60A hardness. For example, the housing 111 of the labor pain relief device 100 may be made from a material having a Shore 40A hardness. This level of hardness may provide a balance between flexibility and durability, allowing the labor pain relief device 100 to conform to the subject's body while maintaining its structural integrity. In an alternative embodiment, the housing 111 of the labor pain relief device 100 may be made from a material having up to Shore 30A hardness. For example, Shore 20A hardness. In some cases, the housing 111 of the labor pain relief device 100 may be made from materials such as fabric, soft silicone, rubber materials, Thermoplastic Elastomers (TPE), or various other polymers. These materials may contribute to the comfort and flexibility of the labor pain relief device 100, potentially enhancing the user experience during labor.

[0118] Housing 111 may comprise a hand pocket 112, control unit with a user interface 114, and a curved portion 116. The hand pocket 112 may be configured to accommodate the subject's hand. The hand pocket 112 may allow the subject to hold and maneuver the labor pain relief device 100 comfortably during use. In cases wherein the device includes sensors, such as pressure sensors, the hand pocket 112 may allow maneuvering movements of the device and activating the vibrations elements by finger pressing in locations where pain is present. The user interface 114 may be positioned on a top surface of the labor pain relief device 100 as illustrated.

[0119] The user interface 114 activates a control unit (not shown) integrated within the housing 111 and allows the subject to control various functions of the labor pain relief device 100, such as adjusting vibration parameters or activating different vibrating elements and / or patterns / sequences. The control unit is configured to activate different vibrating elements 18 based on the phase of labor. The control unit may activate the abdominal vibrating elements 18 during the initial latent labor phase. Additionally, or alternatively, the control unit may activate the pubis vibrating element 18 during the active labor phase. Additionally, or alternatively, the control unit may activate the clitoris vibrating element 18 during the transition labor phase.

[0120] The configuration of the labor pain relief device may allow for targeted vibration therapy as labor progresses. In some cases, the activation of different vibrating elements 18 at various stages of labor may provide customized pain relief based on the changing needs of the subject during childbirth.

[0121] The curved portion 116 of the labor pain relief device 100 may be configured to adapt to the lower abdomen 1, the pubis 2 and the clitoris 3 of a pregnant woman. This curved portion 116 may allow for better contact between the labor pain relief device 100 and the subject's body, improving the effectiveness of the vibration therapy.

[0122] In some cases, the labor pain relief device 100 may further comprise a heating element (not shown) embedded within the housing 111. The heating element may be configured to generate controlled heat to provide additional comfort and relaxation to the subject during labor.

[0123] In some cases, the labor pain relief device 100 may further comprise one or more sensors (not shown) embedded within the housing 111. The sensors may be configured to detect physiological parameters of the subject, such as movements, body temperature, labor contractions, heart rate, skin humidity, and / or sounds.

[0124] Figs. 5A-5B illustrate yet another exemplary labor pain relief device 200. The labor pain relief device 200 may comprise a hand pocket 212 and a user interface 214. In some cases, the labor pain relief device 200 may differ from the labor pain relief device 100 in the position of the user interface 214 which can be a front position as illustrated. The hand pocket 212 of the labor pain relief device 200 may be configured to accommodate a user's hand. In some cases, the hand pocket 212 may allow for comfortable holding and maneuvering of the labor pain relief device 200 during use.

[0125] The user interface 214 may be positioned on an upper portion of the labor pain relief device 200. This positioning may allow for control of device functions while the labor pain relief device 200 is being held. In some cases, the user interface 214 may be configured to receive commands from the subject for activating the one or more vibration elements 18, and or heating element. In some cases, the user interface 214 may be configured to receive commands from the subject for adjusting vibration parameters and / or location of the labor pain relief device 200.

[0126] The user interface 214 may comprise a touch screen or buttons. In some cases, the labor pain relief device 200 may include intuitive touch-sensing dynamics. These dynamics may enable users to easily adjust vibration intensity, frequency, and / or patterns.

[0127] In some cases, the user interface 214 may comprise a display screen which may be a cellular screen (not shown). The display screen may display one or more of the vibration parameters. In cases where the device 200 includes one or more sensors the display screen may optionally display one or more of the detected physiological parameters of the female subject. In cases where the device 200 includes one or more sensors the display screen may optionally provide feedback associated with the subject's response to vibrations generated by the labor pain relief device 200. Additionally, the display screen may provide real-time insights regarding the effectiveness of labor pain management.

[0128] Fig. 6 illustrates yet another exemplary labor pain relief device 300 having a glove-like structure. The device 300 comprises a plurality of vibrating elements (not shown) integrated within the device. When a user presses vibrating elements at the lower abdomen region, the lower abdomen vibrating elements may be activated. Similarly, alternatively or additionally, when a user presses vibrating elements at the pubic region, the pubis vibrating elements may be activated. Similarly, alternatively or additionally, when a user presses vibrating elements at the clitoral region, the clitoris vibrating elements may be activated.

[0129] Figs. 7A-7B illustrate yet another exemplary labor pain relief device 400 comprising a plurality of adhesive housings 411, each comprising one or more vibrating elements for placing on the lower abdomen 411a, the pubis 411b, and / or the clitoris 411c. The device may include adhesives with vibrating elements for placement at the lower back.

[0130] Figs. 8A-8B illustrate yet another exemplary labor pain relief device 500 having a panty- like structure. The device comprises three lower abdomen vibrating elements 518a, one pubis vibrating element 518b, one clitoris vibrating element 518c and two lower abdomen vibrating elements 518d. Vibrating elements at certain locations may be activated by a user by pressing vibrating elements at painful regions. When a user ceases pressing the vibrating element at the location, the vibration element may be turned off.

[0131] Figs. 9A-9B illustrate yet another exemplary labor pain relief device 600. Device 600 features a plurality of vibrating elements 618, i.e., more than the three lower abdomen vibrating elements or one pubis and clitoris vibrating elements, that together may form a panty like structure and are being operated by the female subject’s presses. The plurality of vibrating elements may be interconnected or may be provided as separate elements. Each vibrating element 618 may be disposed in a separate housing. The vibrating elements 618 may be operated by the female subject. The vibrating elements are operated by the female through pressing and / or releasing pressure. When the female subject presses the vibrating element on a certain location of painful area, it activates it, and when the female subject stops pressing, the vibrating element stops operating. Optionally, the pressure intensity can affect the activation intensity.

[0132] The invention further provides a method for managing labor pain. The method includes one or more steps of applying vibration on one or more painful regions in the body of a pregnant woman. The method step includes providing a device that comprises one or more vibrating elements configured to rotate one or more regions of pain points associated with labor pain. The method further comprises placing one or more vibrating element on painful region. The painful region may be one or various regions. The region may be a lower abdomen region 1 (as shown in Fig. 3A). The region may be pubic region 2 (as shown in Fig. 3B). The region may be clitoris region 3 (as shown in Fig. 3C). The region may be a region within the back. The region may be a lower back. The method further comprises activating the one or more vibrating elements to provide labor pain relief therapy to the female subject in painful regions associated with labor.

[0133] The female subject may be a mammal. The female subject may be a human female subject. In one or more embodiments, the method comprises activating the vibrating elements about the lower abdomen or a region thereof at an initial latent labor phase. In one or more embodiments, the method comprises activating the vibrating elements about the pubis during an active labor phase. In one or more embodiments, the method comprises activating the vibrating elements about the clitoris during a transition labor phase. In one or more embodiments, the method comprises activating the vibrating elements about the lower abdomen or a region thereof at an initial latent labor phase and additionally or alternatively activating the vibrating elements about the pubis during an active labor phase. In one or more embodiments, the method comprises a step of activating the vibrating elements about the clitoris and optionally ceasing vibrating the lower abdomen region and / or the pubis during a transition labor phase.

[0134] In one or more embodiments, the method further comprises detecting one or more physiological parameters of the female subject, optionally, using one or more sensors integrated within the housing. The method may comprise a step of providing data associated with one or more physiological parameters of the female subject to the herein device or system. For example, the levels of oxytocin may be detected by the system. Optionally, the levels of oxytocin may be independently detected, and data associated with these levels may be entered into the device / system of the invention. The device / system may provide output signals for activating or adjusting the vibrating elements according to the levels of oxytocin. Oxytocin levels may be measured in saliva, blood or urine by collecting a sample thereof and performing a test (e.g., an enzyme-linked immunosorbent assays (ELISAs) or any other antibody color reaction) to quantify the hormone, or by utilizing a suitable biosensor).

[0135] In one or more embodiments, the method comprises adjusting one or more vibration parameters of at least one vibrating element based on the detected physiological parameters. The one or more vibration parameter is selected from frequency, amplitude, vibration location or body area, and / or patterns of vibrations.

[0136] In one or more embodiments, when the levels of oxytocin exceed a predetermined threshold or are rising, the device may turn off or deactivate the vibration element or decrease its frequency or amplitude or change its location, amplitude, or power. In one or more embodiments, when the levels of oxytocin are below a predetermined threshold or are decreasing, the device may activate the vibration element or increase its frequency or amplitude or change its location, amplitude, and / or power.

[0137] Similarly, any alternative or additional physiological parameters may be measured, such as skin humidity, body temperature, bodily sound, heart rate (of the female subject or its fetus), labor contractions, and body movements, and the system may adjust the vibration parameters accordingly, to thereby relief the labor pain. For example, when the parameter tested indicates of pain exacerbation, the device may activate the vibration element at a location or decrease its frequency or amplitude or change its pattern. When the parameter tested indicates of a decrease in pain the device may turn off or deactivate the vibration element at a location or decrease its frequency or amplitude or change its, amplitude, or power.

[0138] The invention further provides a system for managing labor pain in a female subject, the system comprising a data processing unit for processing one or more physiological parameters associated with labor or pregnancy of a female subject. The data processing unit is configured for data communication with one or more sensors integrated in the herein device according to the invention. The one or more sensors of the herein device is further configured for data communication with / conveying sensed signals to the data processing unit; wherein the data processing unit comprises data relating to one or more physiological parameters associated with labor at one or at various time points and is adapted to receiving from the sensors information relating to the physiological parameters obtained at a time point(s), and provide an indication of the vibration parameters required to relieve childbirth pain.

[0139] In some embodiments, the herein device further contains a signal transmitting module adapted for conveying sensed signals to a data processing unit. The date processing unit may be part of the housing and / or may be contained in a remote computerized device. A user interface, e.g., screen or any other visualization means, may be provided on an external surface of either part of the device or on a remote device (cellphone and / or computer). In some embodiments, the device may be adapted for presenting the physiological parameters and / or detected pain parameters.

[0140] The processing unit may be at a remote location, e.g., a cloud, and comprising data relating to the at least one physiological parameters, as disclosed herein, at various time points of labor and is adapted to receiving from the sensors (via the signal transmitting module) information relating to the measured physiological parameters, and provide through the user interface an indication related to the labor pain. The remote device may be an electronic device such as a cellphone, a computer or any portable device.

[0141] The labor relief device may feature artificial intelligent elements that comprise, for example, machine learning algorithms that can determine and control the performance of the device according to preferences of the user, i.e., patient specific performance. The device may include one or more sensors that afford transmitting one or more physiological parameters of the female subject to machine learning algorithms that in turn automatically adjust parameters of frequency, intensity, and locations of the vibrations. Thus, there is further provided a computer program product, comprising a non-transitory computer-readable storage medium having program code embodied thereon, the program code executable by at least one hardware data processing unit to perform a method of the invention. The herein computer program product, comprises a non-transitory computer- readable storage medium having program code embodied thereon, the program code executable by at least one hardware processing unit to receive data associated with one or more physiological parameters of a female subject in labor; determine the level of labor pain based on the physiological parameters; and determine the vibration parameters required to manage the labor pain of the female subject in labor.

[0142] The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, = a, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.

[0143] Computer readable program instructions described herein can be downloaded to respective computing / processing devices from a computer readable storage medium or to an external computer or an external storage device via a network, for example, the Internet, a local area network, a wide area network and / or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface in each computing / processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing / processing device.

[0144] Definitions

[0145] Each of the following terms: 'includes', 'including', 'has', 'having', 'comprises', and 'comprising', and their linguistic equivalents, as used herein, means 'including, but not limited to', and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof.

[0146] The term 'consisting essentially of’ as used herein means that the scope of the claim is limited to the specified elements and those that do not materially affect the basic and novel characteristic(s) of the claimed device and materials.

[0147] Each of the phrases 'consisting of and 'consists of, as used herein, means 'including and limited to'.

[0148] The term 'method', as used herein, refers to steps, procedures, manners, means, or / and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or / and techniques, either known to, or readily developed from known steps, procedures, manners, means, or / and techniques, by practitioners in the relevant field(s) of the disclosed invention.

[0149] Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range 'from 1 to 6' also refers to, and encompasses, all possible subranges, such as 'from 1 to 3', 'from 1 to 4', 'from 1 to 5', 'from 2 to 4', 'from 2 to 6', 'from 3 to 6', etc., and individual numerical values, such as '1', '1.3', '2', '2.8', '3', '3.5', '4', '4.6', '5', '5.2', and '6', within the stated or described numerical range of 'from 1 to 6'. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.

[0150] All ranges disclosed herein include the endpoints. The use of the term “or” shall be construed to mean “and / or” unless the specific context indicates otherwise.

[0151] Moreover, for stating or describing a numerical range, the phrase 'in a range of between about a first numerical value and about a second numerical value', is considered equivalent to, and meaning the same as, the phrase 'in a range of from about a first numerical value to about a second numerical value', and thus, the two equivalently meaning phrases may be used interchangeably. The term 'about', is some embodiments, refers to ±30 % of the stated numerical value. In further embodiments, the term refers to ±20 % of the stated numerical value. In yet further embodiments, the term refers to ±10 % of the stated numerical value.

[0152] It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or subcombination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the broad scope of the appended claims.

[0153] All publications, patents, and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation, or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

[0154] It should be understood that the above description is merely exemplary and various embodiments of the present invention may be devised, mutatis mutandis, and that the features described in the above-described embodiments, and those not described herein, may be used separately or in any suitable combination; and the invention can be devised in accordance with embodiments not necessarily described above.

[0155] EXAMPLES

[0156] Case studies using the herein device

[0157] Two women were subjected to labor pain when giving birth and used the herein device. The device illustrated to be effective in relieving labor pain as described below.

[0158] Case description - No. 1 :

[0159] A woman with a second delivery at 41+3 weeks gestation. Spontaneous onset of contractions occurred. The device was applied to the lower abdomen during the ride to the hospital, effectively alleviating pain and allowing for relaxation during contractions. The contractions were not very painful. Upon examination, cervical dilation was found to be 4 cm, followed by coalescing contractions and a rapid progression to 8 cm dilation. The device was intermittently used on the clitoral area during intense contractions. No pain was experienced during crowning and delivery of the baby.

[0160] Case description - No. 2: The subject arrived at the hospital with full dilation (10 cm). Labor halted for two hours with no contractions whatsoever. The device was applied to the clitoral area for 5 minutes. Contractions then resumed regularly and effectively, and the device continued to be used during these contractions. Approximately 15 minutes later, the delivery was successfully completed.

Claims

CLAIMS1. A labor pain relief device comprising: a housing suitable to be placed about a body region comprising the lower abdomen, and any one or both of the clitoris, and pubis, or a region thereof, of a female subject; a plurality of vibrating elements integrated within the housing and positioned to provide vibration therapy to said body region of the female subject; a control unit in communication with the plurality of vibrating elements and configured to activate and / or adjust one or more vibration parameters of the plurality of vibrating elements; and a power source.

2. The labor pain relief device of claim 1 , wherein the housing is configured as a hand held device, a belt for wrapping the waist, a panty with a waist extension for covering the lower abdomen region, a glove, a patch, a sticker or a hand held cylinder.

3. The labor pain relief device of any one of claims 1-2, wherein the housing is configured as an inverted triangle.

4. The labor pain device of any one of claims 1-3, wherein the housing comprises a pocket for accommodating the subject’s hand.

5. The labor pain device of any one of claims 1-4, further comprising a heating element embedded within the housing and configured to generate controlled heat to provide additional comfort and relaxation to the subject during labor.

6. The labor pain device of any one of claims 1-5, wherein the vibrating elements include a motor, electromagnetic elements, and / or a piezoelectrical actuator and / or materials.

7. The labor pain device of any one of claims 1 -6, wherein the vibration parameter of the plurality of vibrating elements is selected from the group consisting of frequency, amplitude, vibration location, and patterns of vibrations.

8. The labor pain device of any one of claims 1-7, comprising at least one vibrating element configured for placement on the lower abdomen, at least one vibrating element configured for placement on the pubic region, and at least one vibrating element configured for placement on a clitoral area.

9. The labor pain device of any one of claims 1-8, further comprises one or more vibrating elements for placement about the lower back region.

10. The labor pain device of any one of claims 1 -9, comprising three vibrating elements configured for placement on the lower abdomen, one vibrating element configured for placement on the pubic region, and one vibrating element configured for placement on a clitoral area.

11. The labor pain device of any one of claims 1-10, wherein the control unit is configured to activate the lower abdomen vibrating elements and optionally the lower back vibrating elements during an initial latent labor phase, additionally or alternatively activate the pubic region vibrating elements during an active labor phase, and additionally or alternatively activate the clitoral region vibrating elements during a transition labor phase.

12. The labor device of any one of claims 1-11, further comprising one or more sensors configured to detect at least one physiological parameter of said subject selected from the group consisting of body movements, body temperature, labor contractions, heart rate, skin humidity, hormone levels, and sounds.

13. The labor pain device of claim 12, wherein the one or more sensors is selected from the group consisting of: a pressure sensor, an accelerometer, a noise sensor, a sonic sensor, a tocodynamometer, a temperature sensor, an electrodermal activity sensor, a capacitivehumidity sensor, an electric conductivity sensor, a biosensor, and a piezoelectric transducer.

14. The labor pain device of claim 12, wherein the control unit is configured to adjust the vibration parameters based on the detected physiological parameters.

15. The labor pain device of any one of claims 1-15, wherein the control unit is configured to adjust the vibration parameters based on at least one external data entry comprising at least one physiological parameter associated with labor pain of said subject.

16. The labor pain device of any one of claims 1-15, further comprises a wireless communication module comprising Bluetooth or Wi-Fi, configured to convey data to a remote device.

17. The labor pain device of claim 16, wherein the remote device comprises a software algorithm comprising a machine learning algorithm configured to generate an output signal for adjusting the vibrating parameters based on one or more physiological parameters associated with labor pain of said subject.

18. The labor pain device of claim 17, wherein said one or more physiological parameters is selected from the group consisting of childbirth stage, hormone levels, body movements, body heat, labor contractions, heart rate, skin humidity, and sounds.

19. The labor pain device of any one of claims 1-18, further comprising one or more straps, adhesives, and / or fixatures for allowing stable placing the device onto the abdomen and one or both the pubis region, and the clitoral region.

20. The labor pain device of any one of claims 1-19, wherein the control unit is configured to receive commands from the subject for adjusting the vibration parameters, wherein the control unit comprises at least one of a touch screen, and buttons.

21. The labor pain device of any one of claims 1-21, wherein the control unit further comprises a user interface comprising a display screen displaying feedback associated with the subject’s response to said vibration parameters, and / or provide real-time insights regarding the efficacy of the labor pain management device.

22. The labor pain device of any one of claims 1-20, wherein the device is non- invasive.

23. The labor pain device of any one of claims 1-22, wherein the device is disposable.

24. The labor pain device of any one of claims 1-23, wherein the device can be packed in medical packaging and sterilized.

25. The labor pain device of any one of claims 1-25, wherein the power source is a battery or electrical wires featuring an electric plug-in device.

26. A method of managing labor pain of a female subject, comprising: providing a device comprising one or more vibrating elements configured to rotate one or more region of pain points associated with labor pain selected from a lower abdomen, a clitoris, or a pubis of a female subject in labor; placing the one or more rotating elements of said device about said one or more regions of pain points associated with labor pain of the female subject; and activating the one or more vibrating elements to provide labor pain relief therapy to the female subject.

27. The method of claim 26, comprising activating the one or more vibrating elements about the lower abdomen or a region thereof at an initial latent labor phase.

28. The method of claim 26 or 27, comprising activating the one or more vibrating elements about the pubis during an active labor phase.

29. The method of any one of claims 26-28, comprising activating the one or more vibrating elements about the clitoris during a transition labor phase.

30. The method of any one of claims 26-29, comprising activating the one or more vibrating elements about the lower abdomen or a region thereof at an initial latent labor phase and additionally or alternatively activating the one or more vibrating element about the pubis during an active labor phase.

31. The method of claim 30, further comprises a step of activating the one or more vibrating element about the clitoris and optionally ceasing vibrating the one or more lower abdomen region and / or the pubis during a transition labor phase.

32. The method of any one of claims 26-31 , further comprising receiving one or more physiological parameters of the female subject.

33. The method of claim 32, wherein the physiological parameter is selected from the group consisting of body movements, body temperature, labor contractions, heart rate, skin humidity, hormone levels, and bodily sounds.

34. The method of claim 33, further comprising adjusting one or more vibration parameters of the at least one vibrating element based on the physiological parameters.

35. The method of claim 34, wherein the one or more vibration parameters is selected from frequency, amplitude, body location, and / or patterns of vibrations.

36. A system for managing labor pain in a female subject, the system comprising a device according to any one of claims 1 to 25; and a data processing unit, adapted for processing one or more physiological parameters of a female subject in labor, wherein the data processing unit is configured for data communication with the device;wherein the data processing unit comprising data relating to at least one physiological parameter of the female subject and is adapted to provide an output signal for adjusting one or more vibration parameters required to relieve labor pain.

37. The system of claim 36, comprising a computer program product, comprising a non-transitory computer-readable storage medium having program code embodied thereon, the program code executable by the data processing unit to adjust the one or more vibration parameters required to relieve labor pain.

38. The system of claim 37, Wherein the data processing unit is configured to receive, and analyze the physiological parameter and provide an output based on said parameters to thereby adjust the vibration parameters.

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