Ejaculation control system and method

Abstract

A system for ejaculation control of a male user is provided. The system comprises stimulation assembly comprising a stimulator configured to generate a varying electric current, and an electrode pad configured to be adhesively affixed, at a proximal side thereof, to the perineum of the user. The electrode pad comprises one or more electrodes configured to contact the perineum of the user when the electrode pad is affixed thereto, and one or more electrical connectors each associated with one of the electrodes. The electrical connectors are configured to facilitate bringing their respective electrodes into electrical communication with the stimulator, and to detachably attach the stimulator to the electrode pad.

Description

EJACULATION CONTROL SYSTEM AND METHODFIELD OF THE INVENTION

[0001] The presently disclosed subject matter relates to systems for controlling male ejaculation during sexual intercourse, and in particular to systems which are configured to deliver a varying electric current to the user.BACKGROUND TO THE INVENTION

[0002] There are many known therapies which are designed to address premature ejaculation. Oral pharmaceuticals are often a first line of treatment. However, they are often prescribed off-label, and may be associated with high rates of adverse events and limited efficacy.SUMMARY

[0003] According to an aspect of the presently disclosed subject matter, there is provided a system for ejaculation control of a male user, the system comprising a stimulation assembly comprising: a stimulator configured to generate a varying electric current; and an electrode pad configured to be adhesively affixed, at a proximal side thereof, to the perineum of a user, the electrode pad comprising one or more electrodes configured to contact the perineum of the user when the electrode pad is affixed thereto, and one or more electrical connectors each associated with one of the electrodes, the electrical connectors being configured to facilitate bringing their respective electrodes into electrical communication with the stimulator, and to detachably attach the stimulator to the electrode pad.

[0004] The varying electric current may be suitable to delay an ejaculation by the user during sexual intercourse when applied to the perineum.

[0005] The electrode pad may be shaped so as to facilitate positioning on the user’s perineum such that the electrodes are positioned substantially over the user’s bulbospongiosus muscle and / or innervating nerves thereof.

[0006] The electrode pad may be shaped so as to facilitate positioning on the user’s perineum such that the electrodes are substantially not positioned over the user’s ischiocavernosus muscle.

[0007] Each of the electrodes may comprise an adhesive skin-contact layer at a proximal side thereof.

[0008] The skin-contact layer may comprise a hydrogel.

[0009] The system may further comprise a liner removably adhered to the skin-contact layer.

[0010] Each of the electrodes may comprise a conductive layer made of a metallic material.

[0011] Each of the electrodes may comprise a conductive carbon film layer.

[0012] Each of the electrodes may further comprise a base layer (which may be, e.g., the conductive carbon film) and a conductive structure formed on a proximal side of the base layer and exhibiting a significantly higher electrical conductivity than the base layer.

[0013] Each of the conductive structures may be in contact with the electrical connector associated with its respective electrode.

[0014] The surface area of the conductive structure may be less than about 50% of the surface area of its respective electrode.

[0015] The conductive structure may be formed as a reticulated pattern of lines defining gaps free of material thereof.

[0016] The average length of the gaps may be between about 4 mm and about 10 mm, for example between about 4 mm and about 6 mm or between about 8 mm and about 10 mm.

[0017] The conductive structure may be formed by depositing a conductive paste, which may comprise silver, on the base layer.

[0018] The electrode pad may further comprise a substrate film connected to the electrodes, the substrate film having sufficient stiffness to resist folding of the electrode pad, thereby preventing the electrodes from contacting each other during use of the system.

[0019] The substrate film may comprise a polyester material.

[0020] The electrical connectors may be configured to snipingly engage corresponding electrical connectors of the stimulator, thereby facilitating the detachable attachment of the stimulator to the electrode pad.

[0021] The system may further comprise a docking station configured for receiving the stimulator.

[0022] The docking station may be configured to be electrically connected to the stimulator to facilitate recharging a power source thereof.

[0023] The docking station may be configured to provide storage for at least two of the electrode pads when the stimulator is received thereby.

[0024] The docking station may be configured to remotely control the stimulator at least in part over a wireless connection.

[0025] The docking station may be configured to remotely control the stimulator to begin / cease generating the varying electric current and / or to vary the intensity of the varying electric current.

[0026] The docking station may comprise one or more buttons configured to facilitate being identified tactilely, the docking station being configured to remotely operate the stimulator upon engagement of one or more of the (tactilely-identifiable) buttons.

[0027] The system may comprise a plurality of the electrode pads, for example stored within the docking station.

[0028] The electrode pads may be provided within sealed pouches.

[0029] Each of the sealed pouches may contain no more than one of the electrode pads.

[0030] According to an aspect of the presently disclosed subject matter, there is provided a method of ejaculation control, the method comprising: providing a system according to any one of the preceding claims; detachably attaching an electrode pad of the system to the stimulator of the system, thereby bringing the electrodes of the electrode pad into electrical communication with the stimulator and assembling the stimulation assembly; adhesively affixing the stimulation assembly to the perineum of a user such that the electrodes thereof lie in registration over the user’s bulbospongiosus muscle; and activating, while the user is engaged in sexual intercourse, the stimulator to generate a varying electric current, thereby eliciting an electrical muscle stimulation in the user.

[0031] The method may further comprise ceasing the varying electric current.

[0032] The method may further comprise detaching the electrode pad from the stimulator.BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figs. 1A and IB are perspective views of a stimulation assembly, in disassembled and assembled arrangements, respectively, of an ejaculation control system according to the presently disclosed subject matter;

[0034] Fig. 2 illustrates a portion of a varying electric current generated by a stimulator of the stimulation assembly illustrated in Figs. 1 A and IB, according to some examples of the presently disclosed subject matter;

[0035] Fig. 3 is an exploded view of an electrode pad of the stimulation assembly illustrated in Figs. 1 A and IB, according to some examples of the presently disclosed subject matter;

[0036] Fig. 4 is a bottom view of the electrode pad illustrated in Fig. 3, according to some examples of the presently disclosed subject matter in which a skin-contact layer thereof is transparent;

[0037] Fig. 5 illustrates an example of positioning of the assembled stimulation assembly illustrated in Fig. IB with respect the muscles of a user, in which the user’s skin is not shown;

[0038] Fig. 6 illustrates an electrode packet according to some examples of the presently disclosed subject matter;

[0039] Figs. 7 is a perspective view of a docking station of the ejaculation control system according to some examples of the presently disclosed subject matter, in an open position thereof;

[0040] Fig. 8 illustrates a method for ejaculation control according to the presently disclosed subject matter.DETAILED DESCRIPTION

[0041] As illustrated in Figs. 1A and IB, there is provided stimulation assembly, which is generally indicated at 10, of an ejaculation control system. The stimulation assembly 10 comprises a stimulator 12 configured to facilitate generating a varying electric current, and an electrode pad 14 configured to be brought into electrical communication with the stimulator and to facilitate delivering the varying electric current to a user. The stimulator 12 and electrode pad 14 are detachably attachable to each other.

[0042] The stimulator 12 comprises a housing 16 defining a compartment therewithin for accommodating one or more components of the stimulator. According to some examples, the housing 16 has a length not exceeding about 35 mm. According to some examples, the housing 16 has a width not exceeding about 14 mm. According to some examples, the housing 16 has a height not exceeding about 8 mm. According to some examples, the weight of the stimulator 12 does not exceed about 5 grams, and / or the weight of the electrode does not exceed about 2.5 grams.

[0043] The stimulator comprises an electronics unit (not shown) within the housing, being configured to generate the varying electric current. The electronics unit may comprise suitable electronic components, for example at least some of which are mounted to a printed circuit board. The stimulator may further comprise a power source, for example comprising a rechargeable battery, configured to provide power for operation of the electronics unit and to provide the power for the varying electric current. According to some examples, the power source may be configured to provide suitable power for at least about 30 minutes. The varying electric current may be suitable to effect electrical muscle stimulation (EMS) when applied to a perineum of a user. According to some examples, the electronics unit is configured to facilitate current regulation of the varying electric current, for example as is known in the art.

[0044] The varying electric current may be pulsed. The pulses may be of any suitable duration. According to some examples, each cycle of the varying electric current may comprise a rest periodbetween pulses. The varying electric current may be of any suitable frequency. According to some examples, the frequency of the varying electric current may be between about 0.5 Hz and about 200 Hz, for example between about 20 Hz and about 50 Hz. According to some examples, the frequency of the varying electric current is 30 ± 10% Hz

[0045] As illustrated in Fig. 2, the pulses may be biphasic, i.e., wherein each pulse comprises alternating positive and negative phases, for example one of each. According to some examples, the pulses are symmetrical rectangular biphasic waveforms. The width of each of the pulse may be any suitable duration. According to some examples, the width of each of the pulses may be between about 10 ps and about 800 ps. According to some examples, the width of each of the pulses is 400 ± 10% ps. According to some examples, the width of each of the phases may be any suitable duration, for example 150 ± 10% ps. According to some examples, alternating positive and negative phases may be separated by an interphase interval which may be of any suitable duration, for example between about 10 ps to about 250 ps. According to some examples, the duration of the interphase interval is 100 ± 10% ps.

[0046] According to some examples, the intensity of the varying electric current (in the case of a pulsed electric current, the absolute value of the intensity of each phase) is less than about 50 mA, e.g., less than about 20 mA, for example between about 7 mA and about 18 mA. According to some examples, the intensity of the varying electric current is no lower than about 9.9 mA. According to some examples, the intensity of the varying electric current is no greater than about 14.3 mA.

[0047] The electronics unit may be configured to ramp up the intensity of the varying electric current, i.e., increase it, e.g., from zero, to its full intensity over a period of time. According to some examples, the ramping occurs over a period of time of up to about 30 seconds. The increase in the intensity of the varying electric current may follow any suitable profile, for example being substantially linear. According to some examples, the rate of increase of the intensity of the varying electric current during ramp-up is between about 0.3 mA to about 1 mA per second. According to some examples, the electronics unit may be configured to repeatedly ramp up the intensity of the varying electric current and reduce it, e.g., after a predetermined duration once the full intensity has been reached.

[0048] The voltage applied to generate the varying electric current may be fixed or variable. According to some examples, the voltage of the varying electric current is at least about 50V, for example about 60V. According to some examples, the voltage applied to generate the varying electric current is no more than about 120V, for example about 90V.

[0049] The stimulator 12 further comprises an output interface (not illustrated) via which the varying electric current is provided to the electrode pad 14, i.e., it is configured to facilitate the electrical communication between the stimulator and the electrode pad 14, as will be described below. The output interface is electrically connected to the electronics unit to receive the varying electric current therefrom. According to some examples, the output interface is exposed at the exterior of the housing 16, thereby facilitating direct electrical connection to the electrode pad 14. According to some examples, the output interface comprises two electrical connectors.

[0050] According to some examples, the electronics unit comprises an impedance monitor configured to measure the impedance across the output interface, e.g., between the two electrical connectors thereof. The electronics unit may be configured to perform one or more actions in response to the measured impedance.

[0051] The electronics unit may be configured to monitor the impedance across the output interface as suitable, e.g., upon powering on the electronics unit, immediately prior to beginning providing the varying electric current, at predetermined intervals while providing the varying electric current, continuously while providing the varying electric current, etc.

[0052] According to some examples, the electronics unit may be configured to take a suitable action if the impedance monitor measures an impedance across the output interface which exceeds a predetermined critical threshold. The critical threshold may be, e.g., between about 25 kQ and about 40 k , for example about 35 kQ. The critical threshold may be selected to indicate that the electrode pad 14 is not sufficiently contacting the skin of the user. In such a case, the suitable action may comprise producing an audible alert, producing a visual alert, and / or ceasing (or not beginning) the varying electric current.

[0053] According to some examples, the electronics unit may be configured to take a suitable action if the impedance monitor measures an impedance across the output interface which is below the critical threshold (for example as described above) but above a predetermined non-critical threshold. The non-critical threshold may be, e.g., between about 5 kQ and about 7 kQ, e.g., about 6 kQ or about 7 kQ. In such a case, the suitable action may comprise producing an audible alert, producing a visual alert, and / or providing a reduced varying electric current.

[0054] According to some examples, when the impedance monitor measures an impedance which is below the non-critical threshold, the visual alert may comprise a green light; when the impedance monitor measures an impedance which is above the non-critical threshold and below the critical threshold, the visual alert may comprise an orange light or an alternating orange / green light; when the impedance monitor measures an impedance which is above the critical threshold, the visual alert may be the same as when the impedance monitor measures an impedance which isbelow the non-critical threshold, or it may be different, for example comprising an orange light, an alternating orange / green light, or a red light. According to any of the above examples, the light may be blinking. It will be appreciated that the above are by way of example only, and in practice the visual alert corresponding to each of the ranges measured by the impedance monitor may comprise a light of any one or more suitable colors.

[0055] The electronics unit may be configured to vary the voltage applied to generate the varying electric current based on the impedance measure by the impedance monitor. According to some examples, the electronics unit may be configured to vary the voltage in accordance with the measured impedance in order to maintain a constant current (as per Ohm’s law) when the impedance monitor measures an impedance which is below the non-critical threshold.

[0056] According to some examples, the electronics unit may be configured to maintain the voltage at or below a predetermined voltage (e.g., about 90V) when the impedance monitor measures an impedance which is above the non-critical threshold and below the critical threshold, thereby reducing the current when the impedance is in this range.

[0057] According to some examples, the electronics unit may be configured to maintain the voltage at or below a reduced predetermined voltage (e.g., about 20V) and / or stop generating the varying electric current within a predetermined amount of time (e.g., about 30 sec.) when the impedance monitor measures an impedance which is above the critical threshold.

[0058] The stimulator 12 may comprise a power button 18, configured to allow a user to selectively turn the stimulator on or off and / or to selectively begin and / or cease providing the varying electric current. According to some examples, the stimulator 12 may be configured to provide an indication, e.g., haptic, visual, and / or audial feedback, when the power button 18 is engaged. According to some examples, the stimulator 12 may be configured to power off and / or cease providing the varying electric current after a predetermined period of time, e.g., after 30 minutes of providing a varying electric current.

[0059] The stimulator 12 may further comprise an indicator light 19, which may be a light-emitting diode (LED), for example a multi-color LED. The stimulator 12 may be configured to operate the indicator light 19 to signify that operation of the stimulator has commenced, e.g., blinking in a predetermined sequence (such as a single double-blink) at the beginning of stimulation. According to some examples, after commencement of operation of the stimulator 12 has been indicated, the indicator light 19 does not illuminate for the duration of use, e.g., under normal conditions, so as not to create a distraction which may be unwelcome to the user and / or others who may be present during use of the system.

[0060] According to some examples, the indicator light 19 may be configured to indicate the range of impedance measured by the impedance monitor, for example as described above.

[0061] The electrode pad 14 comprises a proximal side 14a configured to be affixed to the user’s perineum, and a distal surface 14b opposite thereto to which the stimulator 12 is attached. The electrode pad 14 may be shaped so as to conform to the shape of the user’s perineum, i.e., to the portion of the perineum to which it will be affixed. According to some examples, the electrode pad 14 is shaped so as to facilitate correct positioning on the user’s perineum, e.g., being formed with one or more indicia (e.g., a notch, a curved edge, etc.) corresponding to an anatomical landmark. For example, the electrode pad 14 may be shaped to conform to the anatomy around the perineum.

[0062] The electrode pad 14 may comprise a plurality of electrodes, e.g., two, for example as described below in reference to and illustrated in Figs. 3 and 4. The electrode pad 14 may further comprise electrical connectors 20 exposed at the distal surface 14b of the electrode pad 14, each being in electrical communication with one of the electrodes. The electrical connectors 20 are made of a conductive material e.g., a metal such as copper, steel, etc., and are configured to detachably attach to the electrical connectors of the output interface of the stimulator 12, thereby facilitating both attachment of the electrode pad 14 to the stimulator 12, and the electrical communication between the electronics unit of the stimulator and the electrodes.

[0063] The electrical connectors 20 and their counterpart electrical connectors of the output interface of the stimulator 12 may be of any suitable design. According to some examples, they comprise snap-on connectors for example as shown, wherein some of the electrical connectors comprise studs 22, and their counterpart electrical connectors comprise sockets (not illustrated), each configured to mate with one of the studs. According to some examples, the electrical connectors and their counterpart electrical connectors may comprise magnetically fastened connectors, slide-on connectors, twist-on or screw-on connectors, or be of any other suitable design for example as is known in the art, mutatis mutandis.

[0064] As illustrated in Fig. 3, the electrode pad 14 may comprise a support layer 24, and one or more electrodes 26 attached thereto.

[0065] The support layer 24 is configured to carry the electrical connectors 20, alone or together with the electrode 26. It may be made of any suitable material or materials, including, but not limited to, fabric, non-woven fabric, vinyl, rubber, etc. According to some examples, support layer 24 is made of a non-woven fabric with a pattern, for example a sesame dot pattern. The pattern may be selected for any one or more suitable purposes, including, but not limited to, to increase breathability, to increase strength, to increase the rate of drying, for aesthetic reasons, etc.

[0066] The electrodes 26 may be made of any suitable material and / or construction. They may be suitably spaced from each other, e.g., at least about 10 mm apart.

[0067] According to some examples, each of the electrodes may comprise a conductive layer 28, for example comprising a conductive carbon film. According to some examples, for example as illustrated in Fig. 4, the conductive layer 28 may comprise a base layer (e.g., the conductive carbon film, or a non-conductive film or planar layer) and a conductive structure 30 formed on its proximal side, e.g., by printing or any other suitable means for example as is known in the art.

[0068] The conductive structure 30 may be made of a material exhibiting a significantly (e.g., at least one order of magnitude) higher electrical conductivity than does the base layer. According to some examples, the conductive structure 30 comprises a conductive paste (e.g., a silver paste) and / or any other suitable material.

[0069] The surface area of the conductive structure 30 is much less than the surface area of the base layer of the electrode 28 on which it is formed. According to some examples, the surface area of the conductive structure 30 is no more than about 50% of the surface area of the base layer. According to some examples, the surface area of the conductive structure 30 is no more than about 25% of the surface area of the base layer. According to some examples, the surface area of the conductive structure 30 is no more than about 10% of the surface area of the base layer. According to some examples, the surface area of the conductive structure 30 is no more than about 5% of the surface area of the base layer.

[0070] The conductive structure 30 may be formed in any suitable design such that it constitutes a monolithic element to ensure that it constitutes a single conductive path. According to some examples, the conductive structure 30 comprises a reticulated pattern of lines, which may include straight and / or curved lines, defining gaps 30a therebetween being free of the material thereof. The gaps 30a may be polygonal in shape. According to some examples, the reticulated pattern may be a tessellation, e.g., a periodic tessellation. The average length of the gaps 30a (for example only including those gaps which are fully circumscribed by material of the conductive structure, i.e., excluding those which abut the edge of the base layer of the electrode 28) may be between about 4 mm and about 10 mm. According to some examples, the average length of the gaps 30a is between about 4 mm and about 6 mm, for example about 5 mm. According to some examples, the average length of the gaps 30a is between about 8 mm and about 10 mm, for example about 8 mm or about 9 mm.

[0071] According to some examples, the conductive structure 30 is in direct contact with the electrical connector 20 associated with the electrode 26, thereby providing a conductive path to the electronics unit of the stimulator 12 which does not include the base layer of the conductivelayer 28. According to some examples, the electrical connector 20 substantially overlaps (i.e., overlaps or is very close to) the geometric center of the electrode 26.

[0072] Since the varying electric current is provided to the electrode 26 at a single location, i.e., the electrical connector 20, the conductive structure 30 may facilitate reducing variation in the current density across the area of the electrode. Similarly, the conductive structure 30 may facilitate reducing the impedance of the electrode 26, for example increasing the accuracy of the impedance monitor. According to some examples, the sizes of the gaps 30a may be selected so as to reduce the impedance of the electrode 26 as much as possible.

[0073] It will be appreciated that the length of a gap 30a is a characteristic length thereof. According to some examples, e.g., wherein the gaps 30a are formed as one or more convex shapes such as polygons, circles, ellipses, etc., the characteristic dimension may be the largest diameter (e.g., the major axis) thereof, the maximum diameter in a direction perpendicular to the largest diameter (e.g., the minor axis), or the average thereof; the largest distance between two linear sides thereof, the maximum distance in a direction perpendicular thereto, or the average thereof; the major and / or minor diameter of an inscribed and / or circumscribed ellipse and / or oval, and / or the average of two or more thereof; etc.

[0074] Each of the electrodes 26 may further comprise an adhesive skin-contact layer 32 at a proximal side thereof, configured to facilitate affixing the electrode pad to the user’s skin.

[0075] The skin-contact layer 32 may be made of material which is adhesible to the perineum skin surface of the user, and which provides sufficient adhesion for the duration of use, e.g., from when it is affixed and at least throughout the duration of sexual intercourse. Moreover, in particular when provided on the proximal surfaces of the electrodes, the skin-contact layer may be made of a material which permits delivery of the varying electric current generated by the stimulator 12 to be delivered therethrough to the user.

[0076] According to some examples, the skin-contact layer 32 comprises a hydrogel, such as a high-tack hydrogel, which is suitable for electrical muscle stimulation. An example of a suitable material is an AG2500 Series hydrogel, e.g., AG2550, sold by Axelgaard Manufacturing Co., Ltd.

[0077] According to some examples, material properties, e.g., the viscoelasticity, of the skincontact layer 32 increases the conformability of the electrode pad 14 to the skin of the user, e.g., by filling of irregularities (e.g., bumps, crevices, etc.) on user’s skin surface. The increased conformability may provide increased electrical contact between the electrodes 26 and the user’s skin. In addition, the skin-contact layer 32 may provide greater comfort to the user than do other elements of the electrode 26.

[0078] It will be appreciated that the electrodes 26 may comprise additional layers besides those described herein, for example as is known in the art.

[0079] According to some examples, the electrode pad 14 may further comprise a strengthening layer 34, configured to provide additional strength and / or rigidity between the electrodes. The strengthening layer 34 is configured to resist folding of the electrode pad 14, thereby preventing the electrodes 26 from contacting each other during use — i.e., mitigating the possibility of the electrodes contacting each other — and causing an electrical short. The strengthening layer 34 may be made of any suitable material or materials, including, but not limited to, fabric, non-woven fabric, vinyl, rubber, etc. According to some examples, support layer 24 is made of a non-woven fabric with a pattern, for example a sesame dot pattern. The pattern may be selected for any one or more suitable purposes, including, but not limited to, to increase breathability, to increase strength, to increase the rate of drying, for aesthetic reasons, etc.

[0080] According to some examples, a liner 36 is provided, removably adhered to the proximal surface 14a of the electrode pad 14, e.g., to the skin-contact layer 32. The liner 36 is disposable, and is configured to be removed from the electrode pad 14 prior to use, thereby exposing the adhesive skin-contact layer 32. The liner 36 may be configured to be easily gripped (e.g., by pinching) by a user when attached to the electrode pad 14, for example overhanging the skincontact layer 32 as shown, comprising one or more tabs protruding proximally therefrom, etc.

[0081] Each of the electrical connectors 20 may comprise a stud 22 and a post 38 snappingly receivable by the stud and passing through apertures formed in the electrodes 26 — e.g., through the conductive layer 28 thereof — and the support layer 24, for example as is known in the art, thereby facilitating the electrical communication between the electrical connectors 20 and the electrodes 26.

[0082] It will be appreciated that while an electrode pad 14 with two electrodes 26 is illustrated in the accompanying drawings, this is by way of example only, and in practice an electrode pad may be provided with suitable number of electrodes, mutatis mutandis.

[0083] The electrode pad 14 may be configured to facilitate delivery of a majority or substantially all of the energy of the varying electric current to the bulbospongiosus muscle and / or the innervating nerves thereof when correctly positioned on the user’s perineum, for example as described above. For example, as illustrated in Fig. 5, the electrode pad 14 may be configured, when affixed to the user, to facilitate positioning of the electrodes 26 over the bulbospongiosus muscle. According to some examples, the electrode pad 14 may be sized so as to limit application of the electrical to the bulbospongiosus muscle, for example being configured to facilitate beingaffixed to the user such that the electrodes 26 do not overlie a portion of the user’s perineum which overlies either branch of the ischiocavernosus muscle.

[0084] According to some examples, the electrode pad 14 may have a length not exceeding about 41 mm and / or a width not exceeding about 40 mm. According to some examples, the surface area of each of the electrodes is at least 480 mm2. Different sized electrode pads 14 may be provided, for example for use by users of different sizes.

[0085] As illustrated in Fig. 6, there is provided an electrode packet 40, comprising one or more electrode pads 14 (illustrated in broken lines) in a hermetically sealed pouch 42. According to some examples, each electrode packet 40 comprises a single electrode pad 14, as illustrated. According to some examples the pouch 42 is sealed, and may optionally comprise one or more notches 42a to facilitate opening, for example as is known in the art. According to some examples, the pouch 42 comprises a mechanical sealing mechanism (not illustrated), for example comprising interlocking plastic strips, such as is known in the art. The pouch 42 may be made of any suitable material, for example being configured, when sealed, to provide for humidity protection for the electrode pad 14 stored therein. According to some examples, the pouch 42 is made of an aluminized material. According to some examples, e.g., wherein the electrode pad 14 is not provided with a liner for example as described above, an interior surface of the pouch may be, or be coated with, a non-adhesive or removably adhesive material, to facilitate removal of the skincontact layer 32 therefrom.

[0086] According to some examples, the system comprises a plurality of electrode packets 40, e.g., to encourage single usage of the electrode pads 14. According to some examples, one or more electrode packets 40 may be provided separate from other elements of the system.

[0087] As illustrated in Fig. 7, the system may further comprise a docking station 44. The docking station 44 may be configured, inter alia, to facilitate charging of the stimulator 12, and / or to facilitate remote operation of the stimulator. According to some examples, the docking station 44 comprises a base portion 46 and a cover 48 hingedly articulated thereto to facilitate closing of the docking station 44. It may further comprise a controller (not illustrated) configured to direct its operation.

[0088] The base portion 46 of the docking station 44 may comprise a cradle 50 configured for receiving therein the stimulator 12, in particular be correspondingly formed with the shape of the housing 16 of the stimulator to constitute a seat therefor. The cradle 50 may comprise one or more charging contacts 52 configured to facilitate charging of the stimulator 12. According to some examples, the charging contacts 52 are configured to contact the electrical connectors of the output interface of the stimulator 12 when the stimulator is received within the cradle 50, therebyfacilitating charging via the electrical connectors. The charging contacts 52 may comprise studs (not shown) configured to mate with sockets of the electrical connectors. According to some examples, the docking station 44 is configured to indicate to a user when the charging contacts 52 are in electrical contact with the electrical connectors of the output interface of the stimulator 12, for example by providing a haptic, visual, and / or audial indication.

[0089] The docking station 44 may be configured to detect the level of charge of the battery of the stimulator 12. Accordingly, it may comprise a stimulator-status indicator 63 configured to display an indication of the detected level of charge of the battery of the stimulator 12. According to some examples, stimulator-status indicator 63 comprises an LED, for example a multi-color LED. The stimulator-status indicator 63 may be configured to indicate the detected level of charge and or charging state by its illumination state (i.e., on / off), sequence of blinking, color (e.g., orange to indicate low battery), etc., for example as is known in the art.

[0090] The stimulator-status indicator 63 may be further configured to display an indication of the stimulation status of the stimulator 12, for example blinking in a predetermined sequence to indicated that the stimulator is operating to generate an electric current, for example as is known in the art. According to some examples, the stimulator-status indicator 63 may be configured to indicate the range of impedance measured by the impedance monitor, for example as described above.

[0091] The docking station 44 may comprise a power source such as an internal rechargeable battery (not illustrated). A cable connector 56 — e.g., comprising a receptacle according to the USB-C standard, according to a modified design based on the USB-C standard, or according to any other suitable design — may be provided to facilitate charging the battery. An internal battery indicator 54, for example comprising one or more LEDs, may be provided to display an indication of the level of charge and / or charging state of the internal rechargeable battery, for example wherein the number of LEDs illuminated indicates the charging level, and / or wherein active charging is indicated by the blinking state of one or more of the LEDs.

[0092] According to some examples, the docking station 44 provides storage for one or more electrode pads 14 and / or electrode packets 40, for example in the cover 48. The cover 48 may comprise one or more grips 58, defining a storage space, disposed on an inner side thereof. According to some examples, the storage space provides storage for two electrode pads 14 or electrode packets 40.

[0093] According to some examples, the docking station 44 is configured to facilitate remote control of the stimulator 12, e.g., when the stimulator is removed from the cradle 50, e.g., during use. According to some examples, the docking station 44 comprises a remote power toggle button60 and / or remote current-intensity control buttons 62. Some or all of the buttons may be raised, thereby facilitating tactile identification thereof by a user without seeing them, for example during intercourse.

[0094] According to some examples, the docking station 44 may further comprise a currentintensity indicator 64, for example comprising a plurality of LEDs, configured to provide a visual indication of the relative intensity of the varying electric current as it is delivered.

[0095] The docking station 44 may be configured to provide the user with a haptic, visual, and / or audial indication when a button is pressed. The docking station may be configured to remotely operate the stimulator 12 to vary the intensity of the varying electric current, e.g., incrementally, for example wherein the intensity of the varying electric current is increased to a full intensity level at increments.

[0096] It will be appreciated that while indicators, buttons, etc., are depicted as being on the base portion 46 or cover 48 of the docking station 44, this is by way of example only, and in practice each may be provided in any suitable location on the docking station, mutatis mutandis.

[0097] The docking station 44 may be configured to pair with the stimulator 12 using any suitable wireless technology. The technology may be configured to establish a wireless personal area network interconnecting the docking station 44 and the stimulator 12. Examples of such technologies may include, but are not limited to, Bluetooth, Bluetooth Low Energy, Wi-Fi (i.e., based on an IEEE 802.11 standard), and modulated electromagnetic waves such as radio waves.

[0098] According to some examples, the docking station 44 and / or stimulator 12 are configured to communicate with an external device, for example wirelessly, e.g., using an application installed on a mobile or standalone wearable device.

[0099] As illustrated in Fig. 8, the system may be configured to facilitate a method, which is generally indicated at 100, for ejaculation control.

[0100] In step 110 of the method 100, an ejaculation control system as described above is provided. The system comprises a stimulation assembly 10, and optionally comprises a docking station 44.

[0101] In step 120 of the method 100, the stimulation assembly 10 is assembled by electrically attaching an electrode pad 14 to a stimulator 12, for example as described above. According to some examples, the electrode pad 14 is intended for a single use. The electrode pad 14 may be electrically connected to the stimulator 12 by attaching electrical connectors of the stimulator 12 to corresponding electrical connectors 20 of the electrode pad. According to examples in which the electrode pad 14 is provided in an electrode packet 40, it is removed from the pouch 42 before being connected to the stimulator 12.

[0102] In step 130 of the method 100, the electrode pad 14 is affixed to the perineum of the user, by adhering the skin-contact layer 32 with the user’s skin. According to examples in which a liner 36 is provided, it is removed prior to adhering the electrode pad 14 to the user’s skin. The electrode pad 14 may be positioned such that it’s electrodes 26 lie in registration over the user’s bulbospongiosus muscle. According to some examples, this step is performed prior to commencement of sexual intercourse.

[0103] In step 140 of the method 100, the stimulator 12 is activated to generate a varying electric current. The varying electric current is delivered to the user via the electrodes 26 of the electrode pad 14, for example to a neuro-muscular junction, such as of the bulbospongiosus muscle. An electrical muscle stimulation may be elicited in the user, for example causing the muscles to contract and inhibiting the muscles from producing the rhythmic contractions associated with the ejaculation process induced. According to some examples, the varying electric current is delivered to the user during the neural ejaculatory stimulus phase of intercourse.

[0104] According to some examples, operation of the stimulator 12 to generate the varying electric current may be effected by the user. For example, the user may press a button, e.g., the power button on the stimulator 12 or the remote power toggle button 60 on the docking station 44. According to some examples, the user may use an external device, e.g., using an application installed on a mobile or standalone wearable device, to facilitate the operation of the stimulator 12.

[0105] According to some examples, the stimulator 12 is operated autonomously to generate the varying electric current. For example, the stimulator 12 and / or docking station 44 may be configured to generate the varying electric current in response to one or more detected events before and / or during sexual intercourse, for example as described in US 2021 / 0361941, the contents of which are incorporated herein by reference.

[0106] In step 150 of the method 100, the stimulator 12 ceases to generate the varying electric current. Ceasing to generate the varying electric current may be effected by the user, e.g., by pressing a button, e.g., the power button on the stimulator 12 or the remote power toggle button 60 on the docking station. According to some examples, the stimulator 12 is operated autonomously to cease generating the one or more varying electric current, for example in response to detection of one or more events during sexual intercourse, for example as described in US 2021 / 0361941. According to some examples, the stimulator 12 ceases to generate the varying electric current when its battery no longer contains sufficient charge to power its operation. According to some examples, the user ejaculates after the varying electric current is no longer delivered.

[0107] In optional step 160 of the method 100, the electrode pad 14 is detached from the stimulator 12 and discarded.

[0108] Unless otherwise described herein, one or more features of the system may be as described in one or both of US 10,773,072 and US 12,017,067, the contents of which are incorporated herein by reference.

[0109] While the term “controller” is used herein the specification and appended claims with reference to a single element, it may comprise a combination of elements, which may or may not be in physical proximity to one another, without departing from the scope of the presently disclosed subject matter, mutatis mutandis. In addition, disclosure herein (including recitation in the appended claims) of a controller carrying out, being configured to carry out, or other similar language, implicitly includes other elements of the system carrying out, being configured to carry out, etc., those functions — alone, in concert with the controller, in concert with other elements of the system, in concert with one or more external devices, etc. — without departing from the scope of the presently disclosed subject matter, mutatis mutandis.

[0110] The term “sexual intercourse” as used herein the specification and appended claims refers to a sexual act in which the user will experience penile stimulation leading to ejaculation. Such a sexual act may be performed immediately following other sexual activity, and may include penetrative and / or non-penetrative sexual acts, mutatis mutandis.[OHl] It will be recognized that examples, embodiments, modifications, options, etc., described herein are to be construed as inclusive and non-limiting, i.e., two or more examples, etc., described separately herein are not to be construed as being mutually exclusive of one another or in any other way limiting, unless such is explicitly stated and / or is otherwise clear. Those skilled in the art to which this invention pertains will readily appreciate that numerous changes, variations, and modifications can be made without departing from the scope of the presently disclosed subject matter, mutatis mutandis.

Claims

CLAIMS1. A system for ejaculation control of a male user, the system comprising a stimulation assembly comprising: a stimulator configured to generate a varying electric current; and an electrode pad configured to be adhesively affixed, at a proximal side thereof, to the perineum of a user, the electrode pad comprising one or more electrodes configured to contact the perineum of the user when the electrode pad is affixed thereto, and one or more electrical connectors each associated with one of the electrodes, the electrical connectors being configured to facilitate bringing their respective electrodes into electrical communication with the stimulator, and to detachably attach the stimulator to the electrode pad.

2. The system according to claim 1, wherein the varying electric current is suited to delay an ejaculation by the user during sexual intercourse when applied to the perineum.

3. A system according to claim 1, wherein the electrode pad is shaped so as to facilitate positioning on the user’s perineum such that the electrodes are positioned substantially over the user’s bulbospongiosus muscle and / or innervating nerves thereof.

4. The system according to claim 3, wherein the electrode pad is shaped so as to facilitate positioning on the user’s perineum such that the electrodes are substantially not positioned over the user’s ischiocavernosus muscle.

5. The system according to any one of the preceding claims, each of the electrodes comprising an adhesive skin-contact layer at a proximal side thereof.

6. The system according to claim 5, wherein the skin-contact layer comprises a hydrogel.

7. The system according to any one of claims 5 and 6, further comprising a liner removably adhered to the skin-contact layer.

8. The system according to any one of the preceding claims, wherein each of the electrodes comprises a conductive layer made of a metallic material.

9. The system according to any one of the preceding claims, wherein each of the electrodes comprises a conductive carbon film layer.

10. The system according to any one of the preceding claims, each of the electrodes comprising a base layer and a conductive structure formed on a proximal side of the base layer and exhibiting a significantly higher electrical conductivity than the base layer.

11. The system according to claim 10, wherein each of the conductive structures is in contact with the electrical connector associated with its respective electrode.

12. The system according to any one of claims 10 and 11, wherein the surface area of the conductive structure is less than about 50% of the surface area of its respective electrode.

13. The system according to any one of claims 10 through 12, wherein the conductive structure is formed as a reticulated pattern of lines defining gaps free of material thereof.

14. The system according to any one of claims 10 through 13, wherein the average length of the gaps is between about 4 mm and about 10 mm.

15. The system according to claim 14, wherein the average length of the gaps is between about 4 mm and about 6 mm.

16. The system according to claim 14, wherein the average length of the gaps is between about 8 mm and about 10 mm.

17. The system according to any one of claims 10 through 16, wherein the conductive structure is formed by depositing a conductive paste on the base layer.

18. The system according to claim 17, wherein the conductive paste comprises silver.

19. The system according to any one of the preceding claims, the electrode pad further comprising a substrate film connected to the electrodes, the substrate film having sufficient stiffness to resist folding of the electrode pad, thereby preventing the electrodes from contacting each other during use of the system.

20. The system according to claim 19, wherein the substrate film comprises a polyester material.

21. The system according to any one of the preceding claims, wherein the electrical connectors are configured to snappingly engage corresponding electrical connectors of the stimulator, thereby facilitating the detachable attachment of the stimulator to the electrode pad.

22. The system according to any one of the preceding claims, further comprising a docking station configured for receiving the stimulator.

23. The system according to claim 22, wherein the docking station is configured to be electrically connected to the stimulator to facilitate recharging a power source thereof.

24. The system according to any one of claims 22 and 23, wherein the docking station is configured to provide storage for at least two of the electrode pads when the stimulator is received thereby.

25. The system according to any one of claims 22 through 24, wherein the docking station is configured to remotely control the stimulator at least in part over a wireless connection.

26. The system according to 25, wherein the docking station is configured to remotely control the stimulator to begin / cease generating the varying electric current and / or to vary the intensity of the varying electric current.

27. The system according to any one of 25 and 26, the docking station comprising one or more buttons configured to facilitate being identified tactilely, the docking station being configured to remotely operate the stimulator upon engagement of one or more of the buttons.

28. The system according to any one of the preceding claims, comprising a plurality of the electrode pads.

29. The system according to claim 28, wherein the plurality of the electrode pads are stored within the docking station.

30. The system according to any one of claims 28 and 29, wherein the electrode pads are provided within sealed pouches.

31. The system according to claim 30, wherein each of the sealed pouches contains no more than one of the electrode pads.

32. A method of ejaculation control, the method comprising: providing a system according to any one of the preceding claims; detachably attaching an electrode pad of the system to the stimulator of the system, thereby bringing the electrodes of the electrode pad into electrical communication with the stimulator and assembling the stimulation assembly; adhesively affixing the stimulation assembly to the perineum of a user such that the electrodes thereof lie in registration over the user’s bulbospongiosus muscle; and activating, while the user is engaged in sexual intercourse, the stimulator to generate a varying electric current, thereby eliciting an electrical muscle stimulation in the user.

33. The method according to claim 32, further comprising ceasing the varying electric current.

34. The method according to any one of claims 32 and 33, further comprising detaching the electrode pad from the stimulator.

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