Device and method for alleviating symptoms of endometriosis

Abstract

A device for alleviating symptoms of endometriosis includes an electrical stimulator comprising a plurality of electrodes configured to be positioned to make contact with the subject's skin at a distance. The device includes an electronic circuit for providing an electrical signal to be applied to the subject through the plurality of electrodes during the duration of a treatment session lasting at least 2 minutes, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprising a progression of pulsing cycles in which the frequency increases monotonically from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second.

Description

Technology Field

[0001] Cross-reference regarding related applications

[0002] This application claims priority to the UK patent application GB2314186.4, filed on September 18, 2023, titled “Device and method for alleviating symptoms of endometriosis,” which is incorporated herein by reference in its entirety.

[0003] The present invention relates to a non-invasive and non-hormonal treatment for alleviating one or more symptoms of endometriosis, in particular a treatment comprising transcutaneous electrical stimulation. Background Technology

[0004] Endometriosis is a non-malignant disease in which functional endometrial tissue exists outside the uterus. Endometrial tissue contains estrogen and progestogen receptors that cause it to grow and differentiate in response to changes in hormone levels during the menstrual cycle. Clinical symptoms of endometriosis may include pelvic pain, pelvic masses, menstrual changes, and infertility. Endometrial implants in ovarian or adnexal structures can form endometriomas (cystic masses localized to the ovary) or adnexal adhesions. Endometriosis is reported to be found in 10 to 15% of menstruating women aged 25 to 44 and in 25 to 50% of infertile women.

[0005] Treatment for endometriosis includes medical suppression of ovarian function to inhibit the growth and activity of endometrial implants, conservative surgical resection of as much endometrial tissue as possible, a combination of these two treatments, and a total hysterectomy involving the removal of the ovaries and fallopian tubes. Treatment additionally includes medical therapy including estrogen suppression.

[0006] The application of transcutaneous electrical pulses has been previously disclosed as effective in relieving pain in certain situations. Existing approaches have not been proven appropriate for relieving secondary dysmenorrhea pain or improving the organic removal of endometrial tissue.

[0007] An embodiment of the present invention relates to a device and a method for providing treatment for the alleviation of symptoms of endometriosis using transcutaneous electrical pulses.

[0008] According to an embodiment, a device for alleviating symptoms of endometriosis comprises: (a) an electrical stimulator comprising a plurality of electrodes configured to be positioned to make contact with the skin of a subject at a distance; and (b) an electronic circuit configured to provide an electrical signal to be applied to a subject through the plurality of electrodes when activated during a duration of a treatment session lasting at least 2 minutes, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprising a progression of pulsing cycles in which the frequency monotonically increases from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second, the maximum frequency being at least 40 pulsing cycles per second higher than the minimum frequency, and each pulsing cycle comprising at least one of a positive voltage pulse and a negative voltage pulse. In some embodiments, each individual progression has a duration of at least 3 seconds to a maximum of 20 seconds.

[0009] In some embodiments, a method for alleviating one or more symptoms of endometriosis may include: (a) providing a device of any one of the embodiments disclosed herein; (b) positioning a plurality of electrodes to be in contact with the skin of a subject spaced apart from it; and (c) providing an electrical signal during the duration of a treatment session lasting for several minutes, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprises a progression of pulsing cycles in which the frequency increases monotonically from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second, the maximum frequency being at least 40 pulsing cycles per second higher than the minimum frequency, each pulsing cycle comprising at least one of a positive voltage pulse and a negative voltage pulse, and each progression having a duration of at least 3 seconds to up to 20 seconds. In some embodiments of the method, the provision of the electrical signal may be effective during the treatment session in (i) alleviating pain of secondary dysmenorrhea and (ii) promoting, increasing, or increasing the amplitude of uterine contractions or increasing the frequency of uterine contractions.

[0010] According to an embodiment of the present invention, a method for alleviating one or more symptoms of endometriosis is disclosed. The method comprises the step of providing a device comprising (a) an electrical stimulator comprising a plurality of electrodes, and (ii) an electronic circuit configured to provide an electrical signal to a subject through the plurality of electrodes. The method further comprises the step of (b) positioning the plurality of electrodes to be in contact with the subject's skin at a distance; and (c) providing an electrical signal during the duration of a treatment session lasting for several minutes, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprising a progression of pulsing cycles in which the frequency monotonically increases from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second, the maximum frequency being at least 40 pulsing cycles per second higher than the minimum frequency, and each pulsing cycle comprising at least one of a positive voltage pulse and a negative voltage pulse. In some embodiments, each individual progression has a duration of at least 3 seconds to a maximum of 20 seconds. Brief explanation of the drawing

[0011] The present invention will now be further explained by way of example with reference to the accompanying drawings, in which the dimensions of the components and features shown in the drawings are selected for convenience and clarity of explanation and are not necessarily selected to scale. In the drawings, FIG. 1 is a simplified block diagram of a device for alleviating one or more symptoms of endometriosis according to an embodiment of the present invention. FIG. 2 is a schematic diagram of a device for alleviating one or more symptoms of endometriosis according to an embodiment of the present invention. FIG. 3 is a schematic electrical diagram illustrating selected elements of a device for alleviating one or more symptoms of endometriosis according to an embodiment of the present invention. FIGS. 4a and 4b are schematic diagrams of an exemplary pulsing cycle according to an embodiment of the present invention. FIG. 5 illustrates a schematic diagram illustrating an exemplary progression of a pulsing frequency during a single sequence according to an embodiment of the present invention. Figure 6 illustrates a schematic diagram illustrating an exemplary progression of pulse frequency followed by an exemplary regression of pulse frequency during a single sequence. FIGS. 7a, FIGS. 7b, and FIGS. 7c are schematic diagrams of a pulsing cycle according to an embodiment of the present invention, illustrating the initial pulse width and amplitude of FIG. 4b in FIG. 7a, the extended pulse width of FIG. 7b, and the reduced pulse amplitude of FIG. 7c. FIGS. 8a and FIGS. 8b illustrate schematic diagrams illustrating, respectively, a continuous sequence of progression with and without an intervening user-selected rest period according to an embodiment of the present invention. FIGS. 9a and 9b illustrate schematic diagrams illustrating, respectively, a continuous sequence of progression followed by regression with and without a user-selected rest period between intervening sequences according to an embodiment of the present invention. FIGS. 10a, FIGS. 10b, and FIGS. 10c illustrate schematic diagrams illustrating an exemplary progression of FIG. 6, wherein, according to an embodiment of the present invention, the progression in FIG. 10a is applied according to an initial progression duration, the progression in FIG. 10b is applied according to a user-shortened progression duration, and the progression in FIG. 10c is applied according to a user-extended progression duration. FIGS. 11a, FIGS. 11b, and FIGS. 11c illustrate schematic diagrams illustrating an exemplary progression of FIG. 6, wherein, according to an embodiment of the present invention, in FIG. 11a, the frequency is monotonically increased in the number of initial steps, in FIG. 11b, the frequency is monotonically increased in the number of user-decreased steps, and in FIG. 11c, the frequency is monotonically increased in the number of user-increased steps. FIGS. 12, 13a, 13b, 13c, 13d, 13e and 13f illustrate a method and method steps for alleviating one or more symptoms of endometriosis according to an embodiment of the present invention. Specific details for implementing the invention

[0012] The present invention is described herein by way of example with reference to the accompanying drawings. Now, with detailed reference to the drawings, it is emphasized that the details depicted are presented only by way of example and for the purpose of discussion that serve as examples of preferred embodiments of the invention, and are intended to provide what is considered to be the most useful and easily understandable description of the principles and conceptual aspects of the invention. In this regard, there is no attempt to depict the structural details of the invention in more detail than is necessary for a basic understanding of the invention, and the description made together with the drawings makes it clear to those skilled in the art how various forms of the invention can actually be implemented. Throughout the drawings, similar reference numerals are generally used to denote similar elements.

[0013] Some embodiments of the present invention relate to a device and method for applying transcutaneous electrical pulses to a user's torso to alleviate symptoms of endometriosis. Where the term 'alleviation of symptoms' (or similar) is used herein, the term should be understood to include at least partial alleviation and at least temporary alleviation, as well as complete alleviation and / or long-term alleviation. Some symptoms believed to be alleviated by the device and / or method of the present embodiment include painful menstruation, secondary dysmenorrhea, and insufficient removal of endometrial tissue during menstruation. The inventors hold the opinion that inducing uterine contractions, including increasing the frequency and / or intensity of uterine contractions, may contribute to more effective removal or expulsion of endometrial tissue during menstruation. Accordingly, inducing uterine contractions is associated with alleviating one or more symptoms of endometriosis along with pain relief. Without being bound by theory, uterine contractions may be induced in response to periodic electrical stimulation, for example, by the peristaltic action of selected muscle groups triggered by the chemical production of acetylcholine in a progression of electrical pulses of monotonically increasing frequency as disclosed herein. The contractions induced or affected by periodic electrical stimulation may then replace or supplement the 'natural' contractions of menstruation to aid in the shedding of endometrial tissue.

[0014] The inventors have discovered that the alleviation of one or more symptoms of endometriosis can be achieved by applying electrical pulses to the user's torso in a continuous sequence comprising each progression of a pulsing cycle. Each pulsing cycle comprises at least one of a positive voltage pulse and a negative voltage pulse, namely, at least one positive voltage pulse and / or at least one negative voltage pulse. In a first non-limiting example, the pulsing cycle comprises exactly one positive voltage pulse and does not include a negative voltage pulse. In a second non-limiting example, the pulsing cycle comprises exactly one positive voltage pulse and exactly one negative voltage pulse of substantially the same intensity, width (duration), and / or electrical energy as the aforementioned positive voltage pulse. Alternating positive and negative voltage pulses are known to avoid polarization.

[0015] 'Progress' includes pulsing cycles in which the frequency increases over the progression, for example, pulsing cycles in which the frequency increases monotonically. In an exemplary example, the progression starts with a pulsing cycle applied at a frequency of 50 pulsing cycles per second and ends with a pulsing cycle applied at a frequency of 150 pulsing cycles per second. In another example, the starting (minimum) frequency for the progression can be as low as 30 pulsing cycles per second and as high as 60 pulsing cycles per second. The ending (maximum) frequency for the progression can be as low as 100 pulsing cycles per second and as high as 200 pulsing cycles per second. In an embodiment, during the progression, there is an increase in frequency from the start or minimum frequency to the end or maximum frequency of at least 40 pulsing cycles per second, or at least 45 pulsing cycles per second, or at least 50 pulsing cycles per second, or at least 60 pulsing cycles per second, or at least 70 pulsing cycles per second, or at least 80 pulsing cycles per second, or at least 90 pulsing cycles per second, or at least 100 pulsing cycles per second. In an embodiment, the user may adjust one or more parameters of the progression for comfort and / or efficacy that induce or control the frequency and / or intensity of the contractions.

[0016] An exemplary progression may last as little as 3 seconds or as long as 20 seconds. The progression may include at least 20 steps (frequency increases) or as many as 200 steps. The minimum step is an increase of at least 1 pulsing cycle per second; the steps may include as many as 10 pulsing cycles per second. In an embodiment, the treatment section may include at least 10, or at least 20, or at least 50 consecutive sequences. The device according to the embodiment may be programmed to provide progression for a selected duration of the treatment session and / or may be preset to a default duration.

[0017] In some embodiments, each sequence comprises only the progression as disclosed herein, and then the sequence is repeated. In some embodiments, the progression may be separated for a rest period of any desired duration, i.e., without the application of an electrical pulse. In some embodiments, each progression is followed by a regression comprising a pulsing cycle in which the frequency decreases monotonically throughout the regression. The regression may be a mirror image of the progression and starts at a maximum pulsing cycle frequency equal to, or within ±5% of, or within ±10% of, or within ±15% of, the maximum pulsing cycle frequency of the progression, and decreases to a minimum pulsing cycle frequency equal to, or within ±5% of, or within ±10% of, or within ±15% of, the minimum pulsing cycle frequency of the progression. The regression may have the same duration as the progression or a duration within ±15% of the duration of the progression. In some embodiments, regression is implemented so as not to contribute to the therapeutic nature of the treatment, but rather to allow the user to feel greater comfort (or less discomfort) and have a smoother transition between progressions. In some embodiments, the user may choose not to apply electrical pulses during a rest period, i.e., between sequences, i.e., after each regression and before the start of the progression of the next sequence, or between consecutive progressions where regression is not included in the sequence.

[0018] A treatment session comprising the application of a continuous sequence of pulse cycles preferably has a duration long enough to yield some beneficial results for the user and is therefore not non-substantial. In an embodiment, the treatment session lasts for several minutes, e.g., at least 2 minutes, or at least 3 minutes, or at least 4 minutes, or at least 5 minutes, or at least 6 minutes, or at least 7 minutes, or at least 8 minutes, or at least 9 minutes, or at least 10 minutes.

[0019] Now, referring to the drawings and in particular FIG. 1, a device according to an embodiment ( 100A simplified block diagram of the device is shown. 100 ) is a device for alleviating one or more symptoms of endometriosis, and an electrical stimulator for generating and applying transcutaneous electrical pulses to a user ( 130 ), electric stimulator( 130 A control system for controlling ) 106 An electronic circuit including ) and a device (which not only provides information to a user or caregiver) 100 A user interface for communicating with a user or caregiver, comprising the step of receiving user input related to the operation of ) 109 Includes ). Electric stimulator ( 130 ) is power ( 112 ), a signal generator for generating an electrical signal including a plurality of consecutive sequences of electrical pulses according to an embodiment ( 104 ), and at least two electrodes ( 102 Includes ). Electrode ( 102 ) has electrodes ( 102 A wire is provided that is positioned to contact the subject's skin at a distance. Control system ( 106 ) is, for example, programmed, an electric stimulator ( 130 As described above, a plurality of electrodes ( 102 It is configured to provide an electrical signal to be applied to a subject through ), and the electrical signal comprises a plurality of consecutive sequences of pulsing cycle pulses, each sequence comprising at least each progression.

[0020] machinery and tools( 100 A schematic diagram of ) is illustrated in FIG. 2 in a portable configuration as a non-limiting example. In other examples not illustrated, the device may have a tabletop or carttop configuration or may be installed in a gauge cabinet. In the example of FIG. 2, the user interface ( 109 ) is a plurality of function-specific input mechanisms for receiving user input ( 108Includes )(e.g., physical / mechanical or on-screen buttons, switches, dials). For example:

[0021] Input mechanism ( 108 VA ) is the user( 90 It is intended to receive voltage adjustment input from ).

[0022] Input mechanism ( 108 PD ) is the user( 90 It is intended to receive input for adjusting the duration of progress from ).

[0023] Input mechanism ( 108 PUW ) is the user( 90 It is intended to receive pulse width adjustment input from ).

[0024] Input mechanism ( 108 PS ) is the user( 90 It is intended to receive input that adjusts the number of steps in the progress from ).

[0025] Input mechanism ( 108 BSR ) is the user( 90 It is intended to receive input that adds, deletes, or adjusts the rest period between sequences from ).

[0026] In the non-limiting example of FIG. 2, exactly two electrodes ( 102 ) is illustrated. In some embodiments, the device ( 100 ) is the electrode( 102 Includes a port (not shown) for attaching ).

[0027] Referring to FIG. 3, this is now an exemplary device according to an embodiment ( 100 Illustrates a simplified diagram of ). Power source( 112 ) is shown in FIG. 3 as a battery, e.g., a 3V primary or rechargeable battery, but any electrical source may be used. Control system ( 106) is indicated by a CPU and representative components, e.g., a variable resistor, for adjusting any one of the user-adjustable parameters disclosed above, including voltage adjustment, progression duration adjustment, pulse width adjustment, adjustment of the number of steps in the progression, and the addition or adjustment of rest periods between sequences. In a non-limiting example of FIG. 3, a voltage amplifier is provided for each output channel; in some designs, a separate CPU may be provided for each channel.

[0028] FIGS. 4a and 4b illustrate two examples of pulse cycle sequences as described above. FIG. 4a illustrates a pulse cycle containing only positive voltage pulses in a voltage versus time schematic. In contrast, FIG. 4b illustrates a pulse cycle containing a positive voltage pulse followed by a negative voltage pulse in a similar voltage versus time schematic. It may be desirable for the negative voltage pulse and the positive voltage pulse to be evenly spaced, for example, where the duration of the negative voltage pulse is approximately half the duration of the consecutive positive voltage pulse. FIGS. 4a and 4b are not drawn to scale, and both the pulse width (pulse duration) and the length of the pulsing cycle are variable. In one example, the pulse width is 100 to 300 microseconds, and the pulsing cycle duration is 5 to 33 milliseconds (corresponding to a maximum frequency range of 30 to 200 pulsing cycles per second).

[0029] FIG. 5 illustrates a pulsing cycle sequence comprising only a progression of pulsing cycles in which the frequency increases monotonically from a minimum frequency to a maximum frequency. In a non-limiting example of FIG. 5, which is a schematic diagram of frequency versus number of steps, the progression starts at a minimum frequency of 50 pulsing cycles per second and increases at 80 steps to 150 pulsing cycles per second (individual frequency increase). In the example, the progression may include at least 20 steps and up to 200 steps, or at least 40 steps and up to 150 steps, or at least 60 steps and up to 100 steps. The minimum frequency of the progression may be at least 30 pulsing cycles per second and up to 60 pulsing cycles per second, while the maximum frequency may be at least 100 pulsing cycles per second and up to 200 pulsing cycles per second.

[0030] FIG. 6 illustrates a pulsing cycle sequence comprising a progression of a pulsing cycle in which the frequency increases monotonically from a minimum frequency to a maximum frequency, followed by a regression of a pulsing cycle in which the frequency decreases monotonically from approximately the same maximum frequency to approximately the same minimum frequency. In a non-limiting example of FIG. 6, which is a schematic diagram of frequency versus number of steps, the progression starts at a minimum frequency of 50 pulsing cycles per second and increases to 150 pulsing cycles per second in 80 steps (individual frequency increase). The regression starts at a maximum frequency of 150 pulsing cycles per second and decreases to 50 pulsing cycles per second in 80 steps (individual frequency decrease). In other examples, the regression, which is not illustrated, may have a longer or shorter duration than the immediately preceding progression and / or may include more or fewer individual steps.

[0031] In an embodiment, the pulsing sequence is repeated without change for the duration of the treatment session when there is no user input changing one or more of the sequence parameters. The duration of the treatment session may be pre-set or may be shortened or extended by the user at any time.

[0032] Device for alleviating the symptoms of endometriosis ( 100 The user of ) has a user interface for adjusting any one of a number of treatment parameters ( 109 Access to ). Any adjustment may be effective in increasing comfort or reducing discomfort and / or increasing the perceived efficacy of the treatment. For example, any adjustment may be made in response to uterine contraction conditions that are, for example, too few or too many, too weak or too strong, and / or too frequent or too infrequent. Additionally or alternatively, any adjustment may be made in response to pain conditions of secondary dysmenorrhea. The following paragraphs describe user adjustments for individual parameters with reference to FIGS. 7a through c, 8a through b, 9a through b, 10a through c, and 11a through c. In some embodiments, any number of parameters, whether tandem or sequential, may be user adjusted to achieve desired results. All user adjustments shown or described are for illustrative purposes only and are not limited in any way to the range of possible user adjustments.

[0033] Now, referring to FIGS. 7a, 7b, and 7c, which illustrate a series of schematic diagrams of voltage versus time illustrating user adjustment of pulse width (duration) and / or pulse amplitude (intensity). FIG. 7a shows an initial treatment pattern having pulse amplitude, i.e., maximum voltage per pulse, and pulse width, i.e., pulse duration, according to the example of FIG. 4b. FIG. 7b illustrates a virtual adjustment, for example, user adjustment of pulse width. In one example, to double the pulse width from 100 microseconds (in FIG. 7a) to 200 microseconds, the device ( 100 The user interface of ) 109 Through ), for example, the input mechanism shown in FIG. 2 ( 108 PUW It is changed by user input received through ). FIG. 7c illustrates virtual adjustment, for example, user adjustment of pulse amplitude, which is the maximum absolute value of the pulse voltage. Typical maximum voltages are in the range of 60V to 80V. In the example of FIG. 7c, to reduce the maximum voltage of the pulse from 80V (in FIG. 7a) to 60V, the pulse amplitude is [adjusted] by the device ( 100 The user interface of ) 109 Through ), for example, the voltage regulation input mechanism shown in FIG. 2 ( 108 VA It is changed by user input received through ).

[0034] Now, refer to FIGS. 8a and 9b and FIGS. 9a and 9b. FIG. 8a illustrates a schematic diagram of frequency versus step number in which the exemplary pulsing cycle sequence of FIG. 5, comprising only the progression of a pulsing cycle with monotonically increasing frequency, is repeated. FIG. 8b illustrates virtual adjustment, e.g., user adjustment for a rest period between sequences. Specifically, FIG. 8b illustrates a user-adjusted rest period in contrast to FIG. 8a, which illustrates a pulsing sequence that repeats without an intervening rest period. In the example of FIG. 8b, the rest period is a user interface ( 109 Through ), for example, the inter-sequence rest input mechanism shown in FIG. 2 ( 108 BSR It was added by user input received through ). FIG. 9a illustrates a schematic diagram of frequency versus step number in which the exemplary pulsing cycle sequence of FIG. 6 is repeated, comprising the progression of a monotonically increasing frequency pulsing cycle followed by a corresponding regress of a monotonically decreasing frequency pulsing cycle. FIG. 9b illustrates virtual adjustment, e.g., user adjustment for a rest period between sequences. Specifically, FIG. 9b illustrates a user-adjusted rest period in contrast to FIG. 9a, which illustrates a sequence that repeats without an intervening rest period. In the example of FIG. 9b, the rest period is a user interface ( 109Through ), for example, the inter-sequence rest input mechanism shown in FIG. 2 ( 108 BSR It was added by user input received through ).

[0035] Now refer to FIGS. 10a to c and FIGS. 11a to c.

[0036] In an embodiment, the user may be provided with either or both of two options for changing the parameters of progression (and, by extension, the corresponding regression after progression). FIGS. 10a through c are schematic diagrams of frequency versus number of steps and relate to changing the duration of progression of a pulsing cycle (regardless of whether the number of steps per progression is adjusted). In some embodiments, the minimum duration of progression is 3 seconds, and the maximum duration is 20 seconds, or 19 seconds, or 18 seconds, or 17 seconds, or 16 seconds, or 15 seconds, or 14 seconds, or 13 seconds, or 12 seconds. The ‘minimum duration’ of progression refers to the minimum duration considered effective in alleviating one or more symptoms of endometriosis. In some embodiments, the minimum duration of progression is 4 seconds, and the maximum duration is 20 seconds, or 19 seconds, or 18 seconds, or 17 seconds, or 16 seconds, or 15 seconds, or 14 seconds, or 13 seconds, or 12 seconds. According to some embodiments, the minimum duration of progression is 5 seconds, and the maximum duration is 20 seconds, or 19 seconds, or 18 seconds, or 17 seconds, or 16 seconds, or 15 seconds, or 14 seconds, or 13 seconds, or 12 seconds. According to some embodiments, the minimum duration of progression is 6 seconds, and the maximum duration is 20 seconds, or 19 seconds, or 18 seconds, or 17 seconds, or 16 seconds, or 15 seconds, or 14 seconds, or 13 seconds, or 12 seconds. FIG. 10a illustrates a progression from a minimum frequency of 50 pulsing cycles per second to a maximum frequency of 150 pulsing cycles per second in 80 steps, as in FIG. 5. FIG. 10b illustrates a decrease in the duration (in seconds) of the progression in FIG. 10a, and FIG. 10c illustrates an increase in the duration (in seconds) of the progression in FIG. 10a. In an exemplary and non-limiting example, the initial duration of the progression in FIG. 10a is 10 seconds, the shortened duration illustrated in FIG. 10b is 6 seconds, and the extended duration illustrated in FIG. 10c is 13 seconds. In the examples of FIG. 10b and 10c, the progression duration is a user interface (109 Through ), for example, the progression duration adjustment input mechanism (illustrated in FIG. 2) 108 PD It was adjusted by user input received through ).

[0037] FIGS. 11a through c are schematic diagrams of frequency versus number of steps and relate to changing the number of steps per progression (regardless of whether the progression duration is adjusted). According to some embodiments, the monotonic increase of progression consists of at least one pulsing cycle step per second and is limited to a maximum of 10 pulsing cycles per second. In some embodiments, the total monotonic increase of progression requires at least 20 individual steps, or at least 30 individual steps, or at least 40 individual steps, or at least 50 individual steps, or at least 60 individual steps, and a maximum of 200 steps. The minimum number of steps of progression refers to the minimum number of steps considered effective for alleviating one or more symptoms of endometriosis. In some embodiments, the total monotonic increase of progression requires at least 20 individual steps, or at least 30 individual steps, or at least 40 individual steps, or at least 50 individual steps, or at least 60 individual steps, and a maximum of 150 steps. In some embodiments, the monotonic increase of the total progression requires at least 20 individual steps, or at least 30 individual steps, or at least 40 individual steps, or at least 50 individual steps, or at least 60 individual steps, and up to 100 steps. FIG. 11a illustrates a progression from a minimum frequency of 50 pulsing cycles per second to a maximum frequency of 150 pulsing cycles per second in 80 steps, as in FIG. 5. FIG. 11b illustrates a decrease in the number of steps to 60 steps (compared to FIG. 11a), and FIG. 11c illustrates an increase in the number of steps to 100 steps (compared to FIG. 11a). In the examples of FIG. 11b and 11c, the number of steps is a user interface (109 Through ), for example, the progress step adjustment input mechanism (Figure 2) 108 PS It was adjusted by user input received through ).

[0038] Now, referring to FIG. 12, a method for alleviating one or more symptoms of endometriosis is disclosed. As illustrated by the flowchart of FIG. 12, the method comprises at least three method steps. S01 , S02 and S03 Includes:

[0039] step S01 The device according to any one of the embodiments disclosed herein ( 100 Includes the step of providing ).

[0040] step S02 is a plurality of electrodes ( 102 ) the subject( 90 It includes arranging it to be in contact with the skin of ) spaced apart.

[0041] step S03 The method comprises the step of providing an electrical signal during the duration of a treatment session lasting for a plurality of minutes. The electrical signal comprises a continuous sequence of a plurality of pulses, each sequence comprising a progression of pulsing cycles in which the frequency increases monotonically from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second. Each pulsing cycle comprises at least one of a positive voltage pulse and a negative voltage pulse. Each individual progression has a duration of at least 3 seconds to a maximum of 20 seconds. In some embodiments, the step S03 Performing this is effective during treatment sessions to (i) relieve the pain of secondary dysmenorrhea and (ii) promote, increase, and / or increase the amplitude and frequency of uterine contractions.

[0042] Now, referring to FIG. 13a, a method for alleviating one or more symptoms of endometriosis is disclosed. As illustrated by the flowchart of FIG. 12, the method comprises at least three method steps. S11 , S12 and S13 Includes:

[0043] step S11 (i) a plurality of electrodes ( 102 Electric stimulator including ) 130 ), and (ii) a plurality of electrodes ( 102 Through ) the subject( 90 An electronic circuit configured to provide an electrical signal to ) 106 Device including ) 100 Includes the step of providing ).

[0044] step S12 is a plurality of electrodes ( 102 ) the subject( 90 It includes arranging it to be in contact with the skin of ) spaced apart.

[0045] step S13The method comprises the step of providing an electrical signal during the duration of a treatment session lasting for a plurality of minutes. The electrical signal comprises a continuous sequence of a plurality of pulses, each sequence comprising a progression of a pulsing cycle in which the frequency monotonically increases from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second. Each pulsing cycle comprises at least one of a positive voltage pulse and a negative voltage pulse. Each individual progression has a duration of at least 3 seconds to a maximum of 20 seconds. In some embodiments, each pulsing cycle comprises exactly one positive voltage pulse and exactly one negative voltage pulse. In some embodiments, each sequence further comprises, after the progression of the pulsing cycle in which the frequency monotonically increases, a regression of a pulsing cycle in which the frequency monotonically decreases from a frequency up to 15% lower than the maximum frequency to a frequency up to 15% higher than the minimum frequency, each regression having a duration of at least 3 seconds and a maximum of 20 seconds. In some embodiments, the duration of each regression is within ±15% of the duration of each aforementioned progression.

[0046] In some embodiments, step S13 It is effective in promoting uterine contractions during a treatment session and / or increasing the amplitude of one or more uterine contractions during a treatment session and / or increasing the frequency of consecutive uterine contractions during a treatment session. In some embodiments, step S13 It is effective in relieving the pain of secondary dysmenorrhea during the treatment section.

[0047] In some embodiments, the device ( 100 ) is a voltage regulation input element ( 108 VA The method additionally includes the step as illustrated by the flowchart in FIG. 13b. S14 Includes additionally.

[0048] step S14is the above voltage adjustment input element ( 108 VA It includes a step of adjusting the absolute value of the voltage of the pulse in response to user input received through ).

[0049] In some embodiments, the device ( 100 ) is the progress duration adjustment input element( 108 PD The method additionally includes the step as illustrated by the flowchart in FIG. 13c. S15 Includes additionally.

[0050] step S15 The above-mentioned progress duration adjustment input element ( 108 PD It includes a step of adjusting the duration of the process in response to user input received through ).

[0051] In some embodiments, the device ( 100 ) is a rest input element between sequences ( 108 BSR The method additionally includes the step as illustrated by the flowchart of FIG. 13d. S16 Includes additionally.

[0052] step S16 is a rest input element between the above sequences ( 108 BSR It includes the step of adding or modifying a rest period between consecutive sequences in response to user input received through ).

[0053] In some embodiments, the device ( 100 ) is the pulse width input element ( 108 PUW The method additionally includes the step as illustrated by the flowchart in FIG. 13e. S17 Includes additionally.

[0054] step S17 The above pulse width adjustment input element ( 108 PUW It includes a step of adjusting the pulse width in response to user input received through ).

[0055] In some embodiments, the device ( 100 ) is a progress step adjustment input element ( 108 PS The method additionally includes the step as illustrated by the flowchart in FIG. 13f. S18 Includes additionally.

[0056] step S18 The above progress step adjustment input element ( 108 PS It includes a step of adjusting the number of steps in progress in response to user input received through ).

[0057] The following is a non-comprehensive and non-limiting list of inventive concepts according to some embodiments of the present disclosure. Embodiments of the present invention may include any combination of any one or more of the inventive concepts.

[0058] Invention Concept 1: A device for alleviating symptoms of endometriosis, wherein the device comprises: (a) an electrical stimulator comprising a plurality of electrodes configured to be positioned to make contact with the skin of a subject at a distance; and (b) an electronic circuit configured to provide an electrical signal to be applied to the subject through the plurality of electrodes when activated, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprising a progression of pulsing cycles in which the frequency increases monotonically from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second.

[0059] Invention Concept 2: In invention concept 1, the device, wherein each process has a duration of at least 3 seconds and up to 20 seconds.

[0060] Invention Concept 3: In either concept of invention 1 or 2, the electronic circuit is programmed or programmable to provide the electrical signal during the duration of a treatment session lasting for several minutes.

[0061] Invention Concept 4: A device, wherein in any one of invention concepts 1 to 3, the electronic circuit is programmed or programmable to provide the electrical signal for a duration of at least 10, at least 20, or at least 50 consecutive sequences.

[0062] Inventive Concept 4A: A device in any one of Inventive Concepts 1 to 4, wherein each pulsing cycle comprises at least one of a positive voltage pulse and a negative voltage pulse.

[0063] Invention Concept 5: A device in any one of invention concepts 1 to 4A, wherein each sequence further comprises, after the progression of a pulsing cycle in which the frequency monotonically increases, a regression of a pulsing cycle in which the frequency monotonically decreases from a frequency up to 15% lower than the maximum frequency to a frequency up to 15% higher than the minimum frequency, and each regression having a duration of at least 3 seconds and up to 20 seconds.

[0064] Invention Concept 6: A device according to invention concept 5, wherein the duration of each regression is within ±15% of the duration of each aforementioned progression.

[0065] Invention Concept 7: A device in any one of invention concepts 1 to 6, wherein the duration of each individual process is at least 4 seconds.

[0066] Invention Concept 8: A device in any one of invention concepts 1 to 7, wherein the duration of each individual process is a maximum of 15 seconds.

[0067] Invention Concept 9: A device in any one of invention concepts 1 to 8, wherein the duration of each individual process is a maximum of 13 seconds.

[0068] Invention Concept 10: A device in any one of invention concepts 1 to 9, wherein the monotonic increase is composed of steps of at least one pulsing cycle per second and up to 10 pulsing cycles per second.

[0069] Invention Concept 11: A device in any one of invention concepts 1 to 10, wherein the monotonic increase comprises at least 20 steps and up to 200 steps.

[0070] Invention Concept 12: A device in any one of invention concepts 1 to 11, wherein the monotonic increase comprises at least 40 steps and up to 150 steps.

[0071] Invention Concept 13: A device in any one of invention concepts 1 to 12, wherein the monotonic increase comprises at least 60 steps and up to 100 steps.

[0072] Invention Concept 14: A device in any one of invention concepts 1 to 13, wherein the maximum absolute value of the voltage of the pulse is 80V or less.

[0073] Invention Concept 15: A device in any one of invention concepts 1 to 14, wherein the maximum absolute value of the voltage of the pulse is 60V or less.

[0074] Invention Concept 16: A device in any one of invention concepts 1 to 15, wherein the minimum frequency is at least 30 pulsing cycles per second and a maximum of 60 pulsing cycles per second.

[0075] Invention Concept 17: A device in any one of invention concepts 1 to 16, wherein the maximum frequency is at least 100 pulsing cycles per second and up to 200 pulsing cycles per second.

[0076] Invention Concept 18: In any one of invention concepts 1 to 17, a plurality of consecutive sequences in a treatment session are identical when there is no user input, the device.

[0077] Invention Concept 19: A device in any one of invention concepts 1 to 18, further comprising a voltage adjustment input element, wherein the electronic circuit is configured to adjust the absolute value of the voltage of the pulse in response to user input received through the voltage adjustment input element.

[0078] Invention Concept 20: A device according to any one of invention concepts 1 to 19, further comprising a progression duration adjustment input element, wherein the electronic circuit is configured to adjust the progression duration in response to user input received through the progression duration adjustment input element.

[0079] Invention Concept 21: A device according to any one of invention concepts 1 to 20, further comprising a sequence-interval rest input element, wherein the electronic circuit is configured to add or modify a rest period between consecutive sequences in response to user input received through the sequence-interval rest input element.

[0080] Invention Concept 22: A device in any one of invention concepts 1 to 21, further comprising a pulse width input element, wherein the electronic circuit is configured to adjust the pulse width in response to user input received through the pulse width input element.

[0081] Invention Concept 23: A device according to any one of invention concepts 1 to 22, wherein (i) the plurality of electrodes are arranged to be spaced apart from and in contact with the skin of the subject, and (ii) the electronic circuit is activated to provide the electrical signal, and when the electrical signal is applied to the subject through the plurality of electrodes, the electrical signal is effective during a treatment session in (i) alleviating the pain of secondary dysmenorrhea and / or (ii) promoting, increasing the amplitude of uterine contractions and / or increasing the frequency of uterine contractions.

[0082] Invention Concept 24: A method for alleviating one or more symptoms of endometriosis, wherein the method comprises: (a) providing a device of any one of Inventive Concepts 1 to 23; (b) arranging the plurality of electrodes to be in contact with the skin of the subject at a distance; and (c) providing the electrical signal during the duration of a treatment session lasting for several minutes, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprises a progression of pulsing cycles in which the frequency monotonically increases from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second, wherein the maximum frequency is at least 40 pulsing cycles per second higher than the minimum frequency, each pulsing cycle comprises at least one of a positive voltage pulse and a negative voltage pulse, and each progression has a duration of at least 3 seconds to a maximum of 20 seconds.

[0083] Invention Concept 25: In invention concept 23, the provision of the electrical signal is effective during a treatment session in (i) relieving pain of secondary dysmenorrhea and (ii) promoting, increasing, and / or increasing the frequency of uterine contractions.

[0084] Invention Concept 26: As a method for alleviating one or more symptoms of endometriosis, the above method is (a) (i) A method comprising: (ii) providing a device comprising an electrical stimulator including a plurality of electrodes, and an electronic circuit configured to provide an electrical signal to a subject through the plurality of electrodes; (b) arranging the plurality of electrodes to be in contact with the subject's skin at a distance; and (c) providing the electrical signal during the duration of a treatment session lasting for several minutes, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprises a progression of pulsing cycles in which the frequency increases monotonically from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second, the maximum frequency being at least 40 pulsing cycles per second higher than the minimum frequency, and each pulsing cycle comprising at least one of a positive voltage pulse and a negative voltage pulse.

[0085] Invention Concept 27: In the invention concept 26, the step of providing the electrical signal comprises providing the electrical signal for a duration of at least 10, at least 20, or at least 50 consecutive sequences.

[0086] Invention Concept 28: In the invention concept 27, each process has a duration of at least 3 seconds to a maximum of 20 seconds.

[0087] Invention Concept 29: A method according to concept 27 or 28, wherein each sequence further comprises, after the progression of a pulsing cycle in which the frequency monotonically increases, a regression of a pulsing cycle in which the frequency monotonically decreases from a frequency up to 15% lower than the maximum frequency to a frequency up to 15% higher than the minimum frequency, and each regression having a duration of at least 3 seconds and up to 20 seconds.

[0088] Invention Concept 30: In the invention concept 29, the method wherein the duration of each regression is within ±15% of the duration of each aforementioned progression.

[0089] Invention Concept 31: A method in any one of invention concepts 26 to 30, wherein the step of providing the electrical signal is effective in promoting uterine contractions during a treatment session.

[0090] Invention Concept 32: A method in any one of invention concepts 26 to 30, wherein the step of providing the electrical signal is effective in increasing one or more uterine contraction amplitudes during a treatment session.

[0091] Invention Concept 33: A method in any one of invention concepts 26 to 30, wherein the step of providing the electrical signal is effective in increasing the frequency of continuous uterine contractions during a treatment session.

[0092] Invention Concept 34: A method in any one of invention concepts 26 to 30, wherein the step of providing the electrical signal is effective in relieving pain of secondary dysmenorrhea during a treatment session.

[0093] Invention Concept 35: A method in any one of invention concepts 30 to 33, wherein the step of providing the electrical signal is also effective in relieving pain of secondary dysmenorrhea during a treatment session.

[0094] Invention Concept 36: A method in any one of invention concepts 26 to 35, wherein the duration of each individual process is at least 4 seconds.

[0095] Invention Concept 37: A method in any one of invention concepts 26 to 36, wherein the duration of each individual process is a maximum of 15 seconds.

[0096] Invention Concept 38: A method in any one of invention concepts 26 to 36, wherein the duration of each individual process is a maximum of 13 seconds.

[0097] Invention Concept 39: A method in any one of invention concepts 26 to 38, wherein the monotonic increase is formed by steps of at least one pulsing cycle per second and up to 10 pulsing cycles per second.

[0098] Invention Concept 40: A method in any one of invention concepts 26 to 39, wherein the monotonic increase comprises at least 20 steps and up to 200 steps.

[0099] Invention Concept 41: A method in any one of invention concepts 26 to 39, wherein the monotonic increase comprises at least 40 steps and up to 150 steps.

[0100] Invention Concept 42: A method in any one of invention concepts 25 to 39, wherein the monotonic increase comprises at least 60 steps and up to 100 steps.

[0101] Invention Concept 43: A method in any one of invention concepts 26 to 42, wherein the maximum absolute value of the voltage of the pulse is 80V or less.

[0102] Invention Concept 44: A method in any one of invention concepts 26 to 42, wherein the maximum absolute value of the voltage of the pulse is 60V or less.

[0103] Invention Concept 45: A method in any one of invention concepts 26 to 44, wherein the minimum frequency is at least 30 pulsing cycles per second and up to 60 pulsing cycles per second.

[0104] Invention Concept 46: A method in any one of invention concepts 26 to 45, wherein the maximum frequency is at least 100 pulsing cycles per second and up to 200 pulsing cycles per second.

[0105] Invention Concept 47: In any one of invention concepts 26 to 46, a plurality of consecutive sequences are identical when there is no user input.

[0106] Invention Concept 48: A method in any one of invention concepts 26 to 47, wherein the device further comprises a voltage adjustment input element, and the method further comprises the step of adjusting the absolute value of the voltage of the pulse in response to user input received through the voltage adjustment input element.

[0107] Invention Concept 49: A method in any one of invention concepts 26 to 48, wherein the device further comprises a progression duration adjustment input element, and the method further comprises a step of adjusting the progression duration in response to user input received through the progression duration adjustment input element.

[0108] 50 Invention Concepts: A method in any one of invention concepts 26 to 49, wherein the device further comprises a sequence-interval rest input element, and the method further comprises the step of adding or modifying a rest period between consecutive sequences in response to user input received through the sequence-interval rest input element.

[0109] Invention Concept 51: A method in any one of invention concepts 26 to 50, wherein the device further comprises a pulse width input element, and the method further comprises the step of adjusting the pulse width in response to user input received through the pulse width input element.

[0110] Invention Concept 52: A method in any one of invention concepts 46 to 51, wherein the user input responds to a uterine contraction state.

[0111] Invention Concept 53: A method in any one of invention concepts 46 to 51, wherein the user input responds to a pain state of secondary dysmenorrhea.

[0112] The present invention has been described using the detailed description of embodiments of the invention provided as examples and is not intended to limit the scope of the invention. The described embodiments include different features, and not all of these are required in all embodiments of the invention. Some embodiments of the invention utilize only some of the features or possible combinations of features. Variations of the embodiments of the invention, including different combinations of features mentioned in the described embodiments, will occur to those skilled in the art to which the invention pertains.

Claims

Claim 1 As a device for alleviating the symptoms of endometriosis, the device is a. an electric stimulator comprising a plurality of electrodes configured to be positioned to make contact with the subject's skin at a distance; and b. A device comprising an electronic circuit configured to provide an electrical signal to be applied to a subject through a plurality of electrodes when activated, wherein the electrical signal comprises a plurality of consecutive sequences of pulses, each sequence comprising a progression of pulsing cycles in which the frequency monotonically increases from a minimum frequency of at least 30 pulsing cycles per second to a maximum frequency of up to 200 pulsing cycles per second, the maximum frequency being at least 40 pulsing cycles per second higher than the minimum frequency, and each pulsing cycle comprising at least one of a positive voltage pulse and a negative voltage pulse. Claim 2 A device according to claim 1, wherein each individual process has a duration of at least 3 seconds to a maximum of 20 seconds. Claim 3 A device according to claim 1 or 2, wherein the electronic circuit is programmed or programmable to provide the electrical signal during the duration of a treatment session lasting at least 2 minutes. Claim 4 A device according to any one of claims 1 to 3, wherein the electronic circuit is programmed or programmable to provide the electrical signal for a duration of at least 10, at least 20, or at least 50 consecutive sequences. Claim 5 A device according to any one of claims 1 to 4, wherein each sequence further comprises, after the progression of a pulsing cycle in which the frequency monotonically increases, a regression of a pulsing cycle in which the frequency monotonically decreases from a frequency up to 15% lower than the maximum frequency to a frequency up to 15% higher than the minimum frequency, and each regression has a duration of at least 3 seconds and up to 20 seconds. Claim 6 In paragraph 5, the device wherein the duration of each regression is within ±15% of the duration of each aforementioned progression. Claim 7 A device according to any one of claims 1 to 6, wherein the duration of each individual process is at least 4 seconds and at most 15 seconds, or at least 4 seconds and at most 13 seconds. Claim 8 A device according to any one of claims 1 to 7, wherein the monotonic increase consists of steps of at least one pulsing cycle per second and up to 10 pulsing cycles per second. Claim 9 A device according to any one of claims 1 to 8, wherein the monotonic increase comprises at least 20 steps and up to 200 steps, or at least 40 steps and up to 150 steps, or at least 60 steps and up to 100 steps. Claim 10 A device according to any one of claims 1 to 9, wherein the maximum absolute value of the voltage of the pulse is 80V or less, or 60V or less. Claim 11 A device according to any one of claims 1 to 10, wherein the minimum frequency is at least 30 pulsing cycles per second and a maximum of 60 pulsing cycles per second, and the maximum frequency is at least 100 pulsing cycles per second and a maximum of 200 pulsing cycles per second. Claim 12 In any one of claims 1 to 11, a plurality of consecutive sequences in a treatment session are the same device when there is no user input. Claim 13 In any one of paragraphs 1 through 12, i. ii. A voltage adjustment input element for adjusting the absolute value of the voltage of the above pulse, iii. Input element for adjusting the duration of progress to adjust the above duration of progress, Inter-sequence rest input elements for adding or modifying rest periods between consecutive sequences, and iv. A device further comprising at least one of input elements, such as a pulse width input element for adjusting the pulse width. Claim 14 A device according to any one of claims 1 to 13, wherein (i) the plurality of electrodes are arranged to be spaced apart from and in contact with the skin of the subject, and (ii) the electronic circuit is activated to provide the electrical signal, and when the electrical signal is applied to the subject through the plurality of electrodes, the electrical signal is effective during a treatment session in (i) alleviating the pain of secondary dysmenorrhea and / or (ii) promoting, increasing the amplitude of uterine contractions and / or increasing the frequency of uterine contractions.

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