Patent Description:
Ejaculation control is divided into three main conditions, premature ejaculation (PE), delayed ejaculation (DE), and retrograde ejaculation. PE is classified as a sexual disorder in the DSM-<NUM> (Diagnostic and Statistical Manual of Mental Disorders, fifth edition). Its diagnosis is assigned to men who ejaculate prematurely during vaginal intercourse. PE can occur during other sexual activity, however it is only defined as a disorder in the case of vaginal intercourse, as a time duration for oral or manual stimulation has not been determined. Premature or early ejaculation is defined as the man feels unable to control their orgasm, and climaxes in less than one minute after vaginal penetration.

DE is also a DSM -<NUM> sexual disorder in which a man is unable to ejaculate during sexual activity (American Psychiatric Association, <NUM>), specifically after <NUM> minutes to <NUM> minutes of continuous sexual stimulation (Case-lo, <NUM>; Nelson, <NUM>). This disorder is also known as DO (Delayed Orgasm) retarded ejaculation, or inhibited ejaculation (Nelson, <NUM>).

Retrograde ejaculation occurs when semen instead of being ejaculated through the urethra, is redirected to the urinary bladder.

Additional background art includes <CIT>, <CIT> and <CIT>.

<CIT> describes a device, comprising a skin patch, configured to attach to the skin surface of the perineum of a subject suffering from premature ejaculation, wherein the skin patch contains electrodes configured to deliver electrical impulses transcutaneously to the bulbcavernosus muscle of the subject, wherein the transcutaneously delivered electrical impulses are configured to treat premature ejaculation.

The present invention provides a device for electrifying nerves and/or muscles of the perineum with the features of the independent claim. Further advantageous embodiments are subject-matter of the dependent claims. Any embodiment, which is in contradiction to the subject-matter of claim <NUM>, is not part of the invention.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the disclosure, exemplary methods and/or materials are described below.

As will be appreciated by one skilled in the art, some embodiments of the present disclosure may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present disclosure may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a "circuit," "module" or "system. " Furthermore, some embodiments of the present disclosure may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and/or system of some embodiments of the disclosure can involve performing and/or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and/or system of the disclosure, several selected tasks could be implemented by hardware, by software or by firmware and/or by a combination thereof, e.g., using an operating system.

For example, hardware for performing selected tasks according to some embodiments of the disclosure could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the disclosure could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions.

Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the disclosure.

Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof.

Program code embodied on a computer readable medium and/or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

Computer program code for carrying out operations for some embodiments of the present disclosure may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages.

Some embodiments of the present disclosure may be described below with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the disclosure.

Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such as measuring electric field parameters, might be expected to use completely different methods, e.g., making use of expert knowledge and/or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.

The present invention relates to a device for electrifying nerves and/or muscles and, more particularly, to a device for electrifying nerves and/or muscles of the perineum.

An aspect of some embodiments relates to selectively delivery of an electric field to at least one desired target in the perineal tissue of a subject. In some embodiments, the perineal tissue is a tissue located between the perineum skin the pelvic diagram, optionally up to a depth of <NUM> from the perineum skin. Additionally or optionally, the perineal tissue is defined as the tissue between the scrotum and the anus. In some embodiments, the electric field is directed to a desired target in the perineal tissue by positioning electrodes at selected locations, by using electrodes with selected shape and/or surface, and/or by adjusting the electric field parameters to reach the desired targets without causing pain or discomfort.

According to some embodiments, the electric field is directed to selected targets in the perineal tissue comprising the Bulbospongiosus muscle (formerly known as the Bulbocavernosus muscle) or nerves innervating Bulbospongiosus muscle, for example the motor branch of the pudendal nerve, and/or to the Ischiocavernosus muscle or nerves innervating the Ischiocavernosus muscle, for example the perineal branch of the pudendal nerve. Additionally or optionally, the electric field is delivered while reducing the electrification of undesired targets in the perineal tissue comprising (<NUM>) the Superficial Transverse Perineal muscle, innervated by the Perineal branch of the Pudendal nerve, (<NUM>) Levator Ani muscle, innervated by the Pudendal nerve, Perineal nerve and Inferior Rectal nerve, the (<NUM>) Cremaster muscle, innervated by the Genital Branch of the Genitofemoral nerve and, and/or the (<NUM>) External Anal Sphincter, innervated by the Perineal Branch of the Pudendal nerve and the Inferior Hemorrhoidal nerves. In some embodiments, the delivery of the electric field inhibits the rhythmic contractions of the bulbospongiosus muscle, which are typical to ejaculation. Alternatively, the electric field relaxes the bulbospongiosus muscle. A possible advantage of inhibiting those rhythmic contractions is that it may postpone ejaculation and prolong sexual intercourse. In some embodiments, the delivered electric field interacts, optionally directly interacts, with the muscles and/or nerved described above.

According to some embodiments, the electric field at a desired target is at least <NUM>% larger than the electric field at an undesired target, for example <NUM>% larger, <NUM>% larger, <NUM>% larger, <NUM>% larger or any intermediate, smaller or larger value. In some embodiments, the electric field at an undesired target is at least <NUM>% smaller than the electric field at the desired target, for example <NUM>% smaller, <NUM>% smaller, <NUM>% smaller, <NUM>% smaller or any intermediate, smaller or larger value.

According to some embodiments, the delivered electric field is used in the treatment of PE by interaction of the electric field with the muscles and/or nerves listed above. In some embodiments, the delivered electric field is used in the treatment of DE and/or retrograde ejaculation by interacting with the same muscles and/or nerves. Alternatively, the delivered electric field is used in the treatment of DE and/or retrograde ejaculation by interacting with other muscles and/or nerves located in the perineal tissue.

According to some embodiments, the delivered electric field is used in the treatment of erectile dysfunction (ED) disorders, optionally in combination with medications for the treatment of ED, for example Viagra ®, Stendra, Cialis, Levitra and/or Staxyn. In some embodiments, the delivered electric field is used in the treatment of PE and ED. In some embodiments, patients that use the device for delivery of electric field to selected targets in the perineal tissue and also take medications, for example for the treatment of ED use a lower dose of the medications and/or different administration regime compared to subjects that do not use the device.

According to some embodiments, the electric field is delivered prior to and/or during the excitement phase of the sexual response cycle. Additionally or optionally, the electric field is delivered during the plateau phase and/or the orgasm phase and/or the resolution phase of the sexual response cycle. In some embodiments, the delivered electric field desensitizes nerves and/or muscles in the perineal tissue. In some embodiments, the desensitization of the muscles and/or nerves innervating the muscles leads to relaxation of the muscles. Alternatively or additionally, desensitization of nerves reduces pain sensation, for example pain sensation due to the delivered electric field. In some embodiments, the delivered electric field leads to ramp up of tension and/or contraction of muscles. In some embodiments, the electric field delivered to the selected targets in the perineal tissue prolongs the duration of the time from full erection to ejaculation, also termed the Ejaculatory Latency Time (ELT). In some embodiments, the delivered electric field prolongs ELT in at least <NUM> fold compared to the ELT duration without electric field delivery, for example <NUM> fold, <NUM> fold, <NUM> fold, <NUM> fold, <NUM> fold or any intermediate, smaller or larger increase ratio.

According to some embodiments the electric field is delivered by at least two electrodes that are shaped and sized to direct the electric field, optionally transcutaneous to the desired targets in the perineal tissue without causing a user to feel pain and/or discomfort. In some embodiments, the electrodes comprise rectangular electrodes, arc-shaped electrodes, oval or circular-shaped electrodes or any combination thereof. In some embodiments, the at least two electrodes differ in their surface area, for example one electrode has a larger surface area compared to the second electrode. Alternatively, the at least two electrodes have the same surface area. In some embodiments, the surface area is at least <NUM><NUM>, for example <NUM><NUM>, <NUM><NUM>, <NUM><NUM>, <NUM><NUM>, <NUM><NUM> or any other intermediate smaller or larger surface area. In some embodiments, the distance between the at least two electrodes is adjusted to deliver the directed electric field. In some embodiments, the distance between the at least two electrodes is at least <NUM>, for example <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or any intermediate or larger distance. In some embodiments, the distance between the at least two electrodes is in a range of <NUM> to <NUM>, for example <NUM>, <NUM>, <NUM> or any intermediate, smaller or larger value.

According to some embodiments, the electric field is directed to the desired target by selecting a pair of electrodes that are positioned at desired locations on the perineum skin. In some embodiments, the electrodes are positioned in different locations between the scrotum and the anus. Alternatively, one or more of the electrodes of the device are positioned near or adjacent to the anus, but are configured to deliver the electric field to a target tissue located away, for example at least <NUM> from the anus. In some embodiments, the position of the electrodes is selected when using an electrode array, and optionally pairing electrodes that are located at desired positions to deliver the electric field to the desired targets. In some embodiments, the selected pair of electrodes generates an electric field that can penetrate through the perineal tissue to the desired target.

According to some embodiments, at least one parameter of the electric field and/or at least one parameter of the treatment protocol are adjusted to allow delivery of the electric field to the desired targets. In some embodiments, the at least one parameter of the electric field comprises intensity, voltage and/or frequency of the electric field. In some embodiments, the at least one parameter of the treatment protocol comprises the duration of each electric field application, the number of electric field applications in each treatment session, the duration of each treatment session, interphase interval, pulse width and/or ramp time.

According to some embodiments, the electric field which is also termed herein as electric stimulation or stimulation, is delivered through the skin into the adjacent nerves and/or muscles, and causing the selected muscles to contract. Alternatively, the delivered electric field causes the selected muscle to relax. In some embodiments, the values of the electric field parameters are selected to allow efficient penetration of the electric field to the desired target without causing pain or discomfort. In some embodiments, the electric field parameters are selected to allow interaction with inner tissues of the perineum, for example inner muscles and inner nerves located at a depth of at least <NUM> inside the perineal tissue and optionally with minimal interaction with superficial tissues of the perineum, for example superficial nerves and/or superficial muscles located in a depth of <NUM>-<NUM> from the perineum skin. In some embodiments, the interaction of the electric field with the superficial tissues is less than <NUM>% of the interaction with the inner tissues of the perineum.

According to some embodiments, the electric field parameter values are selected to allow penetration of the electric field into the perineal tissue to a depth in a range of <NUM> to <NUM>, for example <NUM>, <NUM>, <NUM>, <NUM> or any intermediate, smaller or larger value. In some embodiments, the electric field parameter values are selected to allow penetration of at least <NUM> from the perineum outer surface or the perineum skin and into the perineal tissue.

According to some embodiments, the intensity of the delivered stimulation or the intensity of the electric field is in a range of <NUM> mA (milli-amper) to <NUM> mA, for example <NUM> mA to <NUM> mA, <NUM> mA to <NUM> mA, <NUM> mA to <NUM> mA or any other intermediate range of values. In some embodiments, the intensity of the electric field delivered to the perineal tissue is in a range of <NUM> mA to <NUM> mA, for example <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA or any intermediate, smaller or larger value.

According to some embodiments, the frequency of the delivered stimulation or the frequency of the delivered electric field is in a range of <NUM> (Hertz) to <NUM>, for example <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM> or any other intermediate range of values. In some embodiments, the electric field frequency is in a range of <NUM>- <NUM>, for example <NUM>, <NUM>, <NUM> or any intermediate smaller or larger value.

According to some embodiments, the electric field voltage is in a range of 50V (Volt) to 100V, for example 50V, 60V, 70V or any intermediate, smaller or larger value.

According to some embodiments, the interphase interval of the delivered stimulation or the delivered electric field is in a range of <NUM>µsec (micro-seconds) to <NUM>µsec, for example <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec or any other intermediate range of values. In some embodiments, the interphase interval is in a range of <NUM>µsec to <NUM>µsec, for example <NUM>µsec, <NUM>µsec, <NUM>µsec, <NUM>µsec, <NUM>µsec or any intermediate, smaller or larger value.

According to some embodiments, the stimulation pulse width or the delivered electric field pulse width is in a range of <NUM>µsec to <NUM>µsec, for example <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec or any other intermediate range of values. In some embodiments, the electric field pulse width is in a range of <NUM>µsec to <NUM>µsec, for example <NUM>µsec, <NUM>µsec, <NUM>µsec or any intermediate, smaller or larger value.

According to some embodiments, the ramp time of the stimulation or the delivered electric field is in a range of <NUM> sec to <NUM> sec, for example <NUM> sec to <NUM> sec, <NUM> sec to <NUM> sec, <NUM> sec to <NUM> sec or any other intermediate range of values. In some embodiments, the ramp time of the delivered electric field is in a range of <NUM> sec to <NUM> sec, for example <NUM> sec, <NUM> sec, <NUM> sec or any intermediate, smaller or larger value.

According to some embodiments, the stimulation duration is predetermined as continuous or accumulated, for example for safety reasons. In some embodiments, the continuous stimulation duration is set to at least <NUM> minute, for example <NUM> minutes, <NUM> minutes, <NUM> minutes or any intermediate or larger value. Optionally, after reaching the maximal stimulation duration, the stimulation is turned off. In some embodiments, the accumulated stimulation duration is set to at least <NUM> minute, for example <NUM> minutes, <NUM> minutes, <NUM> minutes or any intermediate value, if the stimulation is paused and continued.

According to some embodiments, the stimulation duration is predetermined and preprogrammed into a control circuitry of the device. In some embodiments, the control circuitry executes a command to turn the stimulation off, for example, after <NUM> minutes, <NUM> minutes, <NUM> minutes or any other intermediate smaller or larger value. In some embodiments, a user determines the stimulation duration. Optionally, the device delivers an electric field for a maximal period of <NUM> minutes, for example <NUM> minutes, <NUM> minutes, <NUM> minutes or any intermediate or shorter duration. Optionally, the device delivers an electric field for a maximal duration of <NUM> minutes.

According to some embodiments, the device is preprogrammed to stimulate at a certain intensity value, without the need of a software application controlling the device, for example an app, installed in a smartphone, a tablet or a smartwatch. In some embodiments, this intensity value may be 10mA, 15mA, 20mA or any intermediate, smaller or larger value.

According to some embodiments, the electric field is delivered to a depth between <NUM>-<NUM> inside the perineal tissue, for example into the sub-perineal tissue. In some embodiments, the electric field is delivered into the sub-perineal tissue without causing pain to a subject. In some embodiments, the electric field delivered to the sub-perineal tissue has a reduced effect on the skin of the perineum, for example on the foreskin and/or on the superficial perineal fascia. In some embodiments, the reduced effect is lower than the threshold of pain sensation in the skin of the perineum and/or in the superficial perineal fascia.

An aspect of some embodiments, relates to delivery of an electric field to the perineal tissue by a flexible device sized and shaped to be entirely attached to the outer surface of the perineum between the scrotum and the anus of a subject. In some embodiments, the electric field is generated based on programs and/or values of at least one electric field parameter stored in a readable and writable memory of the device.

According to some embodiments, the device is at least partly bendable, for example to conform to the anatomical curvature of the perineum. Alternatively or additionally, the device is at least partially bendable to conform to anatomical changes during sexual intercourse, for example anatomical changes in the perineum region during sexual intercourse. In some embodiments, the device housing comprise at least two axial bending lines, for example to direct the bending the device. Alternatively or additionally, the device comprises a flexible printed circuit board (fPCB) with cuts, for example to allow bending of the fPCB.

According to some embodiments, the device is shaped to allow accurate axial orientation and to reduce positioning errors when attaching the device to the perineum. In some embodiments, the device proximal region has a concave shape, for example to allow easy orientation and attachment of the device to the posterior aspect of the scrotum.

Reference is now made to <FIG> and <FIG> depicting at least two electrodes attached to the perineum outer surface, according to some exemplary embodiments of the invention. According to some exemplary embodiments, the electrodes, for example electrodes <NUM> and <NUM> are placed in contact with the outer surface of the perineum <NUM>. In some embodiments the electrodes are positioned between the posterior aspect <NUM> of the scrotum <NUM> and the anus <NUM>. In some embodiments, an anterior electrode, for example electrode <NUM> is positioned adjacent to the posterior aspect <NUM> of the scrotum <NUM>, for example at a distance of <NUM>, <NUM>, <NUM> or any intermediate, smaller or larger distance from the scrotum. In some embodiments, the posterior electrode, for example electrode <NUM>, is positioned at a distance of at least <NUM> away from the anus <NUM>. In some embodiments, positioning the posterior electrode too close to the anus <NUM> may cause discomfort and anal contraction upon electric field delivery.

According to some exemplary embodiments, the electrodes for example electrodes <NUM> and <NUM> are positioned at a desired distance between each other on the outer surface of the perineum, to direct an electric field <NUM> to selected regions in the perineal tissue, for example region <NUM>. In some embodiments region <NUM> comprise the Bulbospongiosus (formerly known as the Bulbocavernosus) and Ischiocavernosus muscles, and their innervating nerves, the motor branch of the pudendal nerve and perineal branch of the pudendal nerve, respectively. In some embodiments, the position of the electrodes allows to direct the electric field <NUM> away from undesired regions, for example regions <NUM>, <NUM> and <NUM>. In some embodiments, the undesired regions comprise, the Superficial Transverse Perineal muscle, innervated by the Perineal branch of the Pudendal nerve, the Levator Ani muscle, innervated by the Pudendal nerve, the Perineal nerve and the Inferior Rectal nerve, the Cremaster muscle, innervated by the Genital Branch of the Genitofemoral nerve and, the External Anal Sphincter, innervated by the Perineal Branch of the Pudendal nerve and the Inferior Hemorrhoidal nerves.

According to some embodiments, a device for the delivery of an electric field to the perineal tissue is attached entirely between the anus and the posterior aspect of the scrotum. In some embodiments, the device does not have any wires outside of the device housing, for example to reduce discomfort and/or to simplify device attachment.

Reference is now made to <FIG>, depicting the device components, according to some exemplary embodiments of the invention. According to some exemplary embodiments, device <NUM> comprises a thin housing <NUM> having an upper flat face and a lower face. In some embodiments, the width of the housing is between <NUM> and <NUM>, for example <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or any intermediate width. In some embodiments, the device and the housing <NUM> are shaped and sized to be positioned entirely between the posterior aspect of the scrotum and the anus.

Additionally, the axial length of the device and the housing is shorter than the anogenital distance. In some embodiments, the housing comprises axial bending lines, for example to direct the bending of the housing to conform to the anatomical curvature of the perineum, and to allow, for example to attach the device and the housing of the device between the left and right creases of the thighs. In some embodiments, the housing <NUM> comprises an attachment element <NUM> for attaching the upper flat face of the housing <NUM> to the outer surface of the perineum. In some embodiments, the attachment element comprises a sticker with glue, optionally a reusable sticker which allows for example to remove and re-attach the device to the perineum outer surface several times. In some embodiments, the attachment element <NUM>, optionally at the interface between the device and the skin comprises a conductive and optionally an adhesive hydrogel, for example to allow better conductance when attaching the device to a hairy perineal skin.

According to some exemplary embodiments, the device comprises at least two electrodes, for example electrodes <NUM> and electrodes <NUM> positioned at least partly on the upper face of the housing <NUM>. Alternatively, the at least two electrodes are positioned inside the housing, and deliver the electric field through a conductive layer positioned on top of the housing. In some embodiments, the electrodes are positioned along the anogenital distance and/or in parallel to each other. In some embodiments, the electrodes comprise <NUM>, <NUM>, <NUM>, <NUM>, <NUM> electrodes or any smaller or larger number of electrodes.

In some embodiments, at least some of the electrodes are unipolar.

Optionally some of the electrodes are bipolar. In some embodiments, the electrodes comprise at least one sensing electrode positioned at the upper face of the housing, for example to measure at least one physiological parameter of the body, for example heart rate and/or electrical conductivity of one or more muscles. In some embodiments, the electrodes, for example electrodes <NUM> and/or electrodes <NUM> have a surface area in a range between <NUM><NUM> and <NUM><NUM>, for example <NUM><NUM>, <NUM><NUM>, <NUM><NUM>, <NUM><NUM> or any intermediate, larger or smaller value. In some embodiments, using electrodes with a surface area smaller than <NUM><NUM> may yield large current and power density which may cause pain and discomfort to the user. In some embodiments, using electrodes with surface area larger than <NUM><NUM> may result with large current distribution and inefficient stimulation. According to some exemplary embodiments, the electrodes for example electrodes <NUM> and electrodes <NUM> are positioned at a distance of at least <NUM> between each other, for example <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or any intermediate or larger distance.

The device <NUM> comprises a pulse generator positioned inside the housing <NUM>. The pulse generator is electrically connected to at least some of the electrodes <NUM>. A control circuitry, for example control circuitry <NUM> is electrically connected to the pulse generator <NUM>. The control circuitry <NUM> signals the pulse generator <NUM> to generate an electric field according to at least one protocol and/or according to electric field parameter values stored in a memory <NUM>, which is a readable and writable memory. In some embodiments, the electric field parameters comprise intensity, voltage, frequency, interphase interval, pulse width and/or ramp time.

According to some exemplary embodiments, the device <NUM> comprises an interface <NUM>, for example for receiving input from a user and/or for delivery of indications to the user. In some embodiments, the interface comprises at least one light source, for example a light emitting diode (LED) and/or at least one sound producing element. In some embodiments, the interface <NUM> delivers indications related to the treatment protocol and/or the electric field. Alternatively or additionally, the interface <NUM> delivered indications related to the status of the device <NUM>, for example when the device is turned on, when the device delivers an electric field, and/or when the device is in a non-stimulating mode. In some embodiments, the interface delivers alerts to a user, for example a low battery alert and/or alerts related to device malfunctioning.

The device <NUM> comprises a communication circuitry <NUM> electrically connected to the control circuitry <NUM> inside the housing <NUM>. The embedimentethe communication circuitry receives and/or transmits wireless signals, for example Bluetooth signals, WiFi or any other wireless signals. The control circuitry comprises a receiver for receiving the wireless signals from a remote device, for example a wearable device or a mobile device. Optionally, the receiver receives the wireless signals from a computer. The communication circuitry comprises a transmitter for transmitting the wireless signals to a remote device, for example a wearable device or a mobile device. Optionally, the transmitter transmits the wireless signals to computer.

The device <NUM> comprises at least one battery <NUM> inside the housing <NUM>. In some embodiments the battery <NUM> is a rechargeable battery, for example a lithium ion battery. In some embodiments, the battery <NUM> is remotely charged. Alternatively, the battery <NUM> is a non-rechargeable battery. Optionally, the battery is a thin battery, for example a coin or a disc shaped battery. In some embodiments, the battery <NUM> is a replaceable battery, for example a battery that can be replaced by the removal of a cover in the housing <NUM>.

According to some exemplary embodiments, the device <NUM> measures and/or calculates at least one electrical parameter of the skin, for example impedance. In some embodiments, the electrical parameter of the skin is measured by at least one electrode or at least one sensor of the device which is in an electrical contact with the skin. In some embodiments, the electrical impedance monitoring is used to determine the quality of adhesion of the device to the skin, prior to the delivery of the electric field and/or during the delivery of the electric field. In some embodiments, high impedance values, for example impedance values of at least <NUM> ohm, for example <NUM> ohm, <NUM> ohm, <NUM> ohm or any intermediate or larger value indicates that the device has no contact with the skin.

In some embodiments, in this case, the device would automatically cease stimulation and optionally signals a mobile device, for example a smartphone to deliver an alert to the user. In some embodiments, gradually decreasing impedance values, for example at a rate of at least <NUM> ohm per second, for example <NUM> ohm per second, <NUM> ohm per second, <NUM> ohm per second or any intermediate or larger rate may indicate of nerve activity which may indicate of approaching ejaculation and/or urination.

According to some exemplary embodiments, low impedance values, for example impedance values of <NUM> ohm and lower, for example <NUM> ohm, <NUM> ohm, <NUM> ohm or any intermediate or smaller value would indicate that the device is properly contacting the skin. In some embodiments, in this case, the device would signal the smartphone to deliver an indication to the user that the device is properly attached to the skin.

According to some exemplary embodiments, measured impedance values in a range between <NUM> ohm and <NUM> ohm indicates that the device is sub-optimally applied to the skin. In some embodiments, in this case, the device would signal the smartphone to generate a warning indication to the user.

According to some embodiments, if the measured or calculated impedance values indicate an insufficient contact between electrodes of the device and the perineum surface or perineum skin, the device stops generation of the electric field and/or delivers an indication to a user. Optionally, the indication to the user is delivered by a mobile device wirelessly coupled to the device.

According to some exemplary embodiments, the device is shaped and sized to be positioned between the scrotum and the anus, and to be flexible enough to bend according to the anatomical curves of the perineum. Reference is now made to <FIG> depicting the device design, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, the device housing has an inward notch, for example an inward arch cut <NUM> in the proximal region <NUM> of the device <NUM>, for example to easily fit and attach the device to the posterior aspect of a subject scrotum. In some embodiments, the inward arch cut <NUM> is according to a cut in a PCB inner layer of the device <NUM>. In some embodiments, the inward notch has a width in a range of <NUM>-<NUM>, for example <NUM>, <NUM>, <NUM>, <NUM> or any intermediate, smaller or larger value. In some embodiments, on both sides of the inward curve <NUM>, the device <NUM> comprises two removal grasp tips <NUM>, one on each side of the inward curve <NUM>. In some embodiments, the device <NUM> comprises two lateral notches, for example curve cuts <NUM>, one cut on each side of the device <NUM>, for example to allow easy torsion of the device <NUM>. In some embodiments, device <NUM> comprises at least one distal notch, for example distal cut <NUM> in the distal region <NUM> of the device <NUM>. Optionally, the arch cut <NUM> conforms to the shape and/or position of the anus, for example to allow the accurate positioning of the device <NUM> without covering the anus. In some embodiments, positioning the device in a distance from the anus and the proximal tissue surrounding the anus will allow for example to avoid undesired stimulation of the External Anal Sphincter and innervations.

Reference is now made to <FIG> depicting the bending of the device to fit the anatomical curvature in the perineum region, according to some exemplary embodiments of the invention. <FIG> shows an exaggerated representation of the perineum <NUM>. According to some exemplary embodiments, the device <NUM> is bent is attached to the outer surface of the perineum <NUM>, for example to the skin of the perineum <NUM>, and is bent to conform to the anatomical curves of the perineum <NUM> between the two legs <NUM>. In some embodiments, the device is bent along the scrotum-anus axis until the distance <NUM> between the lateral sides of the device <NUM> is minimum <NUM>, for example <NUM>, <NUM>, <NUM> or any intermediate or larger distance.

Reference is now made to <FIG> depicting the device external design and dimensions, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, the device comprises at least one longitudinal bending line, for example a longitudinal bending line <NUM> which optionally passes through the inward curve <NUM> and the distal cut <NUM>. In some embodiments, the device comprises at least one transverse bending line, for example transverse bending line <NUM>, which optionally passes through the lateral curve cuts <NUM>.

According to some exemplary embodiments of the invention, the device length, for example length <NUM> is in a range of <NUM>-<NUM>, for example <NUM>, <NUM>, <NUM>, <NUM> or any intermediate smaller or larger value. In some embodiments, the device length <NUM> is shorter than the anogenital distance between the posterior aspect of the scrotum and the anus.

According to some exemplary embodiments, the device and/or housing width, for example width <NUM> is in a range of <NUM>-<NUM>, for example <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or any intermediate smaller or larger value. In some embodiments, the device width is smaller than the distance between the creases of the left and right thighs.

According to some exemplary embodiments, the device thickness, for example thickness <NUM> is in a range of <NUM>-<NUM>, for example <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or any intermediate smaller or larger value. In some embodiments, the thickness is designed to be as minimal as possible, for example to avoid any discomfort and/or pain when the device is attached to the perineum skin during sexual intercourse.

Reference is now made to <FIG> depicting bending of the device, according to some exemplary embodiments of the invention. According to some exemplary embodiments, the device is bent along the transverse bending line <NUM>, for example to conform to the perineum anatomical curvature between the creases of the left and right thighs. Additionally or optionally, the device is bent along the longitudinal bending line <NUM>, for example to conform to the perineum anatomical curvature between the posterior aspect of the scrotum and the anus.

Device <NUM> delivers a directed electric field to selected targets in the perineal tissue. In some embodiments, the electrodes of the device are shaped and/or are spatially arranged for directing the electric field.

Reference is now made to <FIG>, depicting different spatial rearrangements and/or shapes of the electrodes on the upper surface of the device housing which faces the perineum skin.

The electrodes comprise at least two electrodes positioned between the scrotum and the anus. In some embodiments, for example as shown in <FIG>, the electrodes comprise a proximal electrode <NUM> positioned near the scrotum <NUM>, and a distal electrode <NUM> positioned at a distance from the anus <NUM>. In some embodiments, the proximal electrode and/or the distal electrode <NUM> are shaped as rectangles. In some embodiments, for example as shown in <FIG> the device comprises at least two proximal electrodes <NUM> and <NUM> positioned near the scrotum <NUM>, and at least two distal electrodes <NUM> and <NUM> positioned at a distance from the anus <NUM>. In some embodiments, the at least two proximal electrodes and/or the at least two distal electrodes are shaped as rectangles.

According to some exemplary embodiments, for example as shown in <FIG>, the device comprises at least two arc-shaped electrodes <NUM> and <NUM>. In some embodiments, the electrodes <NUM> and <NUM> are shaped as an arc subtending an angle between <NUM>-<NUM> degrees, for example <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees or any intermediate smaller or larger angle. In some embodiments, a proximal arc electrode <NUM> is positioned near the scrotum <NUM> and the distal arc <NUM> is positioned in a distance from the anus <NUM>. In some embodiments, for example as shown in <FIG>, the device comprises at least two proximal arc-shaped electrodes <NUM> and <NUM> positioned near the scrotum <NUM>, and at least two distal arc-shaped electrodes <NUM> and <NUM> positioned in a distance from the anus <NUM>.

In some embodiments, at least some of the at least two proximal electrodes <NUM> and <NUM> and the at least two distal electrodes <NUM> and <NUM> are shaped as an arc subtending an angle between <NUM>-<NUM> degrees. In some embodiments, the convex face of arc-shaped electrode <NUM> or arc shaped electrodes <NUM> and <NUM> faces the scrotum and/or the convex face of arc shaped electrode <NUM> or electrodes <NUM> and <NUM> faces the anus. In some embodiments, the concave face of arc-shaped electrode <NUM> or electrodes <NUM> and <NUM> faces the scrotum and/or the concave face of arc-shaped electrode <NUM> or electrodes <NUM> and <NUM> faces the anus.

According to some exemplary embodiments, for example as shown in <FIG>, the device comprises at least two round electrodes <NUM> and <NUM>. In some embodiments, the at least two round electrodes are shaped as a circle or as an ellipse. In some embodiments, the round or circular electrodes have a diameter in the range of <NUM>-<NUM>, for example <NUM>, <NUM>, <NUM>, <NUM> or any intermediate smaller or larger diameter. In some embodiments, the proximal round electrode <NUM> is positioned near the scrotum <NUM> and the distal round electrode is positioned in a distance from the anus <NUM>.

In some embodiments, for example as shown in <FIG>, the device comprises at least two round-shaped proximal electrodes <NUM> and <NUM>, and at least two round-shaped distal electrodes <NUM> and <NUM>. In some embodiments, the at least two round shaped proximal electrodes are positioned near the scrotum <NUM>, and the at least two round shaped distal electrodes <NUM> and <NUM> are positioned at a distance from the anus <NUM>. In some embodiments, the minimal distance between the two proximal electrodes, for example electrodes <NUM> and <NUM>, electrodes <NUM> and <NUM>, or electrodes <NUM> and <NUM> is at least <NUM>, for example <NUM>, <NUM>, <NUM> or any intermediate or larger distance. In some embodiments, the minimal distance between the two distal electrodes, for example electrodes <NUM> and <NUM>, electrodes <NUM> and <NUM>, or electrodes <NUM> and <NUM> is at least <NUM>, for example <NUM>, <NUM>, <NUM> or any intermediate or larger distance.

Reference is now made to <FIG> depicting electrodes arranged in electrode arrays, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, at least one electrode array, for example electrode array <NUM> is positioned near the scrotum <NUM> and/or at least one electrode array, for example electrode array <NUM> is positioned near or at a distance from the anus <NUM>. In some embodiments, for example as shown in <FIG>, at least one pair of electrodes, one electrode from electrode array <NUM> and one from electrode array <NUM> is selected, for example to provide a directed electric field to selected targets in the perineal tissue.

According to some exemplary embodiments, the device receives and/or transmits wireless signals to remote devices. Reference is now made to <FIG> depicting the connectivity of a device, for example device <NUM> attached to the perineum of a subject <NUM>, according to some exemplary embodiments of the invention.

Device <NUM> communicated by wireless signals, for example Bluetooth and/or WiFi s signals with remote device. In some embodiments, the device <NUM> communicates with a wearable device <NUM>, for example a smartwatch or a fitness bracelet. Alternatively or additionally, the device <NUM> communicates with a mobile device <NUM>, for example a smartphone or any other mobile device. In some embodiments, a software application or a software program installed in a memory of the wearable device <NUM> and/or the mobile device <NUM> controls and/or monitors the operation of the device <NUM>.

According to some exemplary embodiments, the device <NUM> is under a control and/or in communication with a device which comprises one or more microphones and a remote virtual assistant stored in a memory of the device, for example Alexa™ by amazon™. Alternatively or additionally, the remote virtual assistant is stored in a remote memory cloud. In some embodiments, the virtual assistant activates and/or controls the activation of the device <NUM>. In some embodiments, the virtual assistant controls the activation of the device <NUM> according to values of one or more parameters stored in a remote memory storage, for example a memory cloud, in communication with the virtual assistant. Alternatively or additionally, the virtual assistant receives data, for example activation log files of the device <NUM> and/or one or more clinical parameters. Optionally, the virtual assistant stores the data in the memory cloud.

According to some exemplary embodiments, the remote virtual assistant analyzes audio signals, for example sound, received by the one or more microphones. Optionally, the audio signals comprise voices of a user of the device <NUM> and/or voices of the user's partner before, during and/or after intercourse. In some embodiments, the audio signals comprise background sounds, for example sounds generated by clothes, and/or shoes.

According to some exemplary embodiments, the remote virtual assistant controls the activation, for example activates and/or deactivates the device <NUM> according to the analyzed audio signals. In some embodiments, the remote virtual assistant activates the device when sounds of clothes removal are identified. In some embodiments, the remote virtual assistant controls the activation of the device <NUM> based on audio signals received during intercourse. In some embodiments, the remote virtual assistant identifies stages in the intercourse based on the received audio signals and modifies the activation of the device <NUM> accordingly, for example when specific audio signals are received the remote virtual assistant stops the pulse generation by the device <NUM> to allow ejaculation.

According to some exemplary embodiments, the device <NUM> is voice activated, for example based on voice commands received by a microphone within the device <NUM> and/or based on voices commands received by an external microphone, for example the remote virtual assistant-associated microphone. Optionally, the device <NUM> and/or the virtual assistant identify a pre-determined voice pattern, for example a voice pattern of a user and/or a voice pattern of a user partner. In some embodiments, the device <NUM> is activated or the activation of the device <NUM> is controlled only in response to voice commands of a one or more pre-determined voice patterns, for example personalized voice patterns.

In some embodiments, the software application or the software program allow to modify at least one parameter of the delivered electric field, for example intensity, voltage, frequency, pulse width and/or at least one treatment parameter, for example timing of the treatment, interphase interval, ramp time. In some embodiments, the device <NUM> receives measured values of at least one physiological parameter, for example heart rate from the wearable device <NUM> by wireless signals.

According to some exemplary embodiments, the device <NUM> is in communication with an information storage cloud, for example cloud <NUM> by the wireless signals. In some embodiments, the device <NUM> receives from the cloud <NUM> values of at least one electric field parameter and/or values of at least one treatment parameter. In some embodiments, the device <NUM> transmits to the cloud <NUM> and/or to the wearable device <NUM> or mobile device <NUM> log files and/or measured values of at least one physiological parameter, for example heart rate or electrical activity of perineal muscles.

Optionally, the cloud comprises at least one table and/or at least one algorithm that modifies at least one parameter of the delivered electric field based on the information received from the device <NUM>. In some embodiments, the cloud <NUM> then delivered the modified parameter values to the device <NUM>. In some embodiments, software applications or programs installed in the wearable device <NUM> and/or the mobile device <NUM> comprise at least one table and/or at least one algorithm. In some embodiments, the wearable device <NUM> and/or the mobile device <NUM> modify values of at least one electric field parameter values based on the information received from the device <NUM>.

According to some exemplary embodiments, the device is configured to be easily applied and activated in order to reduce discomfort and undesired stress of a subject. Reference is now made to <FIG>, depicting a process for application and/or initial calibration of the device, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, the device is removed from a package at <NUM>. In some embodiments, the device is a single-use device that is used, for example for several hours, and then it is discarded. Alternatively, the device is removed from the perineum and is stored in the package for further usage.

According to some exemplary embodiments, the device is activated at <NUM>. In some embodiments, the device is activated by pressing an activating button. Alternatively, the device is activated by removing a separating insulator between a battery and electrical conductors. In some embodiments, the device is activated by inserting the battery into the device. In some embodiments, the device is activated while removing the device from the package at <NUM>. Optionally, the device delivers an indication by light and/or sound when the device is activated.

According to some exemplary embodiments, an application program installed on a mobile device, for example a smartphone, a tablet and/or a smartwatch delivers an indication to a user to activate the device. In some embodiments, the mobile device delivers the indication based on an algorithm and/or tables stored in the memory of the mobile device.

According to some exemplary embodiments, the device is paired with a remote controller at <NUM>. In some embodiments, the device is paired with a wearable device and/or a mobile device using Bluetooth wireless signals. Alternatively, the device is paired by WiFi wireless signals with the wearable device and/or the mobile device. In some embodiments, when pairing is complete, the device delivers an indication to the subject. In some embodiments, the indication is delivered by the mobile device and/or the wearable device. In some embodiments, the indication is delivered by sound, light or vibration.

According to some exemplary embodiments, a treatment program or values of at least one electric field parameter are selected at <NUM>. In some embodiments, the selection is made by pressing at least one button on the device. Alternatively or additionally, the selection is made using the application or software program installed on the mobile device or on the wearable device.

According to some exemplary embodiments, the device is attached to the perineum at <NUM>. In some embodiments, the device is attached after the removal of a sticker cover, for example to expose a region covered with glue. In some embodiments, the device is oriented to a desired position using the curves and the cuts, as shown in <FIG>.

According to some exemplary embodiments, an application program installed on a mobile device, for example a smartphone, a tablet and/or a smartwatch delivers an indication to a user to attach the device to the perineum. In some embodiments, the mobile device delivers the indication based on an algorithm and/or tables stored in the memory of the mobile device.

According to some exemplary embodiments, the device is paired with a remote controller at <NUM>, after the device is attached to the perineum. In some embodiments, the pairing is performed as described at <NUM>.

According to some exemplary embodiments, a treatment program or values of at least one electric field parameter are selected at <NUM>, after the device is attached to the perineum. In some embodiments, the treatment program or values of at least one electric field parameter are selected as described at <NUM>.

According to some exemplary embodiments, the device is calibrated at <NUM>. In some embodiments, the device is calibrated, for example by intermittently or continuously increasing the electric field intensity until the subject feels uncomfortable and/or pain. The electric field intensity level that causes pain or discomfort is determined as a threshold level. In some embodiments, the electric field intensity is then lowered to a sub-threshold level.

In some embodiments, an automatic calibration process is performed. In some embodiments, in the automatic calibration process, the electric field intensity is increased while monitoring at least one physiological parameter related to the electric field effect. In some embodiments, the electric field intensity is set when a desired effect is reached. In some embodiments, the electric field intensity that was used in prior treatment sessions in the same subject is used.

According to some exemplary embodiments, the device is placed in a non-stimulating mode at <NUM>, for example to save battery power. In some embodiments, the device and/or a mobile device coupled to the device measures and/or calculates at least one physiological parameter. In some embodiments, the at least one physiological parameter is an indicator of the arousal level, excitement level and/or is an ejaculation-indicative parameter. In some embodiments, the at least one physiological parameter comprises the erection level of the penis, blood flow in the penis, heart rate, blood pressure and/or movement of the scrotum or testis.

Reference is now made to <FIG> depicting a process for delivery of an electric field to the perineal tissue, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, the device receives a remote signal from a coupled remote device at <NUM>. In some embodiments, the device receives a remote signal from a mobile device and/or the wearable device, optionally using an installed application or program software. In some embodiments, the subject presses a button on the coupled remote device.

According to some exemplary embodiments, an electric field is generated at <NUM>. In some embodiments, the electric field is generated based on the signals received at <NUM>. Alternatively or additionally, the electric field is generated based on a treatment program installed in the memory of the device, for example the memory <NUM> shown in <FIG> or in the memory of the remote controller device, for example a mobile device and/or a wearable device. In some embodiments, the signals received at <NUM> include values of at least one electric field parameter, used to generate that electric field at <NUM> based on these values.

According to some exemplary embodiments, the electric field is generated when values of the at least one physiological parameter measured and/or calculated at <NUM> are larger than predetermined values or are in a range of desired values. In some embodiments, the measured and/or calculated values of the at least one physiological parameter are stored in the memory of the device, for example memory <NUM> or in a memory of the mobile device. In some embodiments, the predetermined values and/or the range of desired values are stored in the memory of the device, for example memory <NUM> or in a memory of the mobile device.

According to some exemplary embodiments, the generated electric field is delivered to the perineal tissue at <NUM>. In some embodiments, the electric field is delivered through the electrodes of the device that are placed in contact with the perineal tissue. In some embodiments, the electric field is delivered through selected electrodes of a plurality of electrodes. In some embodiments, the electrodes for the delivery of the electric field are selected based on the desired target type, for example muscles and/or nerves, and the positioned of the desired target inside the perineal tissue, for example the depth of the desired target inside the perineal tissue. In some embodiments, the electric field is delivered for a pre-determined time period, optionally according to the treatment program. In some embodiments, the pre-determined time period is adjusted by a user prior to activation or attachment of the device. Alternatively, the pre-determined time period is adjusted during the activation of the device, for example during the delivery of the electric field. In some embodiments, when the electric field is stopped, the device returns to a non-stimulating mode at <NUM>.

According to some embodiments, the electric field generated at <NUM> have parameter values selected to allow penetration of the electric field into the perineal tissue to a depth in a range of <NUM> to <NUM>, for example <NUM>, <NUM>, <NUM>, <NUM> or any intermediate, smaller or larger value. In some embodiments, the electric field parameter values are selected to allow penetration of at least <NUM> from the perineum outer surface or the perineum skin and into the perineal tissue.

According to some embodiments, the intensity of the electric field generated at <NUM> is in a range of <NUM> mA (milli-amper) to <NUM> mA, for example <NUM> mA to <NUM> mA, <NUM> mA to <NUM> mA, <NUM> mA to <NUM> mA or any other intermediate range of values. In some embodiments, the intensity of the electric field delivered to the perineal tissue is in a range of <NUM> mA to <NUM> mA, for example <NUM> mA, <NUM> mA, <NUM> mA, <NUM> mA or any intermediate, smaller or larger value.

According to some embodiments, the frequency of the electric field generated at <NUM> is in a range of <NUM> (Hertz) to <NUM>, for example <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM> or any other intermediate range of values. In some embodiments, the electric field frequency is in a range of <NUM>- <NUM>, for example <NUM>, <NUM>, <NUM> or any intermediate smaller or larger value.

According to some embodiments, the voltage of the electric field generated at <NUM> is in a range of 50V (Volt) to 100V, for example 50V, 60V, 70V or any intermediate, smaller or larger value.

According to some embodiments, the interphase interval of the electric field generated at <NUM> is in a range of <NUM>µsec to <NUM>µsec, for example <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec or any other intermediate range of values. In some embodiments, the interphase interval is in a range of <NUM>µsec to <NUM>µsec, for example <NUM>µsec, <NUM>µsec, <NUM>µsec, <NUM>µsec, <NUM>µsec or any intermediate, smaller or larger value.

According to some embodiments, the pulse width of the electric field generated at <NUM> is in a range of <NUM>µsec to <NUM>µsec, for example <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec, <NUM>µsec to <NUM>µsec or any other intermediate range of values. In some embodiments, the electric field pulse width is in a range of <NUM>µsec to <NUM>µsec, for example <NUM>µsec, <NUM>µsec, <NUM>µsec or any intermediate, smaller or larger value.

According to some embodiments, the ramp time of a stimulation or the electric field delivered at <NUM> is in a range of <NUM> sec to <NUM> sec, for example <NUM> sec to <NUM> sec, <NUM> sec to <NUM> sec, <NUM> sec to <NUM> sec or any other intermediate range of values. In some embodiments, the ramp time of the delivered electric field is in a range of <NUM> sec to <NUM> sec, for example <NUM> sec, <NUM> sec, <NUM> sec or any intermediate, smaller or larger value.

According to some embodiments, the duration of the electric field delivery at <NUM> is predetermined as continuous or accumulated, for example for safety reasons. In some embodiments, the continuous electric field delivery duration is set to at least <NUM> minute, for example <NUM> minutes, <NUM> minutes, <NUM> minutes or any intermediate or larger value. Optionally, after reaching the maximal electric field delivery duration, the electric field delivery is stopped. In some embodiments, the accumulated electric field delivery duration is set to at least <NUM> minute, for example <NUM> minutes, <NUM> minutes, <NUM> minutes or any intermediate value, if the electric field delivery is paused and continued.

Reference is now made to <FIG> depicting a process for modifying a treatment program and/or values of at least one electric field parameter based on a measured efficacy parameter, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, the electric field is delivered at <NUM>, or example as previously described at <FIG>. In some embodiments, the electric field is generated and delivered according to a treatment program and/or based on electric field parameter values stored in a readable writable memory of the device, for example memory <NUM>.

According to some exemplary embodiments, values of at least one efficacy related physiological parameter are measured and/or calculated at <NUM>. In some embodiments, the values are measured during the application of the electric field. In some embodiments, the efficacy-related physiological parameter comprises electrical activity of muscles and/or nerves at selected regions in the perineal tissue, for example muscles and nerves at regions between the posterior aspect of the scrotum, between the thigh creases skin and in depth of up to <NUM>. Alternatively or additionally, the efficacy-related physiological parameter comprises contraction level of selected muscles in the perineal tissue, for example contraction of the Bulbospongiosus muscle and/or the Ischiocavernosus muscle. In some embodiments, the values are sensed by at least one electrode and/or sensor of the device, for example device <NUM>. In some embodiments, the at least one electrode and/or sensor of the device delivers the sensed values to a control circuitry of the device, for example control circuitry <NUM>. Additionally or optionally, the sensed values are stored in a readable writable memory, for example memory <NUM> of the device.

According to some embodiments, at least one electrical parameter of the skin, for example impedance is measured, for example by dividing voltage with current at <NUM>. In some embodiments, the electrical parameter of the skin is measured by at least one electrode or at least one sensor of the device which is in an electrical contact with the skin. In some embodiments, the electrical impedance monitoring is used to determine the quality of adhesion of the device to the skin, prior to the delivery of the electric field and/or during the delivery of the electric field. In some embodiments, high impedance values, for example impedance values of at least <NUM> ohm, for example <NUM> ohm, <NUM> ohm, <NUM> ohm or any intermediate or larger value indicates that the device has no contact with the skin. In some embodiments, in this case, the device would automatically cease stimulation and optionally signals a mobile device, for example a smartphone to deliver an alert to the user.

According to some exemplary embodiments, measured impedance values in a range between <NUM> ohm and <NUM> ohm indicates that the device is sub-optimally applied to the skin. In some embodiments, in this case, the device would signal the smartphone to generate a warning indication to the user. In some embodiments, a gradual decrease in impedance values, for example at a rate of at least <NUM> ohm per second, for example <NUM> ohm per second, <NUM> ohm per second, <NUM> ohm per second or any intermediate lower or higher decrease rate is an indicator of nerve activity which may indicate of approaching ejaculation and/or urination.

According to some exemplary embodiments, the device determines if the measured values of the efficacy related physiological parameter are in a desired range of values, at <NUM>. In some embodiments, the control circuitry of the device determines if the measured values are in a desired range of values by comparing the measured values to at least one table or to pre-determined values stored in the memory. Alternatively or additionally, the control circuitry of the device determines if the measured values are in a desired range of values using at least one algorithm and/or software program stored in the memory of the device. In some embodiments, the control circuitry of the device determines if the measured values are in a desired range of values by transmitting the measured values to a cloud, for example cloud <NUM>, and optionally using at least one table, algorithm and/or a software program stored in the cloud. Alternatively, the control circuitry of the device determines if the measured values are in a desired range of values by transmitting the measured values to an external device, for example mobile device <NUM> or wearable device <NUM> and optionally using at least one table, algorithm and/or a software program stored in the external device.

According to some exemplary embodiments, if the measured values are not in a desired range of values, then the treatment program or at least one parameter of the treatment program is modified at <NUM>, optionally automatically, by the device. In some embodiments, if the measured values are not in a desired range of values then a different treatment program is selected, optionally by the control circuitry, from a plurality of treatment programs stored in the memory of the device. Alternatively or additionally, at least one parameter of the electric field is modified, for example the frequency and/or the intensity of the electric field. Optionally, the control circuitry of the device increases or decreases the frequency and/or the intensity levels of the electric field. In some embodiments, the treatment program and/or the at least one electric field parameter are modified while delivering the electric field to the tissue. Alternatively, the electric field delivery is stopped and continues after the treatment program and/or the at least one electric field parameter are modified.

According to some exemplary embodiments, if the measured values are in a desired range of values than the electric field is delivered to the perineal tissue at <NUM>, according to the treatment program or based on the electric field parameter values used at <NUM>.

According to some exemplary embodiments, the electric field delivery is stopped at <NUM>. In some embodiments, the electric field delivery is stopped according to the treatment program. Alternatively, the electric field delivery is stopped when a signal is received from a user of the device, for example using the mobile device or a wearable device wirelessly connected to the device. In some embodiments, the electric field delivery is stopped based on measured physiological signals, for example when the device detects physiological signals related to the desire of a user to ejaculate. Optionally, the electric field delivery is stopped when the device, the mobile device and/or wearable device receives a voice command for stopping the delivery of the electric field.

According to some exemplary embodiments, when the electric field is stopped, the device moves to a non-stimulating mode at <NUM>. In some embodiments, in a non-stimulating mode the device waits to receive an activating wireless signal to resume the generation and the delivery of the electric field. Optionally, if an activating wireless signal is received, the device delivers an electric field to the tissue based on the last program and/or last electric field parameter values used, that are stored in the readable writable memory of the device. In some embodiments, the device is a single-use device, therefore the last program and/or last electric field parameter values are stored on the mobile device, for example in the application program installed on the mobile device.

Reference is now made to <FIG> depicting a process for delivery of an electric field while monitoring safety related parameters, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, the electric field is delivered at <NUM>, or example as previously described in <FIG> and <FIG>. In some embodiments, the electric field is generated and delivered according to a treatment program and/or based on electric field parameter values stored in a readable writable memory of the device, for example memory <NUM>.

According to some exemplary embodiments, values of at least one safety related parameter, for example a physiological parameter is measured and/or calculated at <NUM>. In some embodiments, the values are measured during the application of the electric field. In some embodiments, the safety-related physiological parameter comprises electrical activity of muscles and/or nerves at selected regions in the perineal tissue, for example regions proximal to posterior aspect of the scrotum, and/or regions proximal to the anus, and/or regions proximal to each of the creases of the thighs. Alternatively or additionally, the safety-related physiological parameter comprises contraction level of selected muscles in the perineal tissue, for example the bulbospongiosus muscle and/or the, ischiocavernosus.

In some embodiments, the values are sensed by at least one electrode and/or sensor of the device, for example device <NUM>. In some embodiments, the at least one electrode and/or sensor of the device delivers the sensed values to a control circuitry of the device, for example control circuitry <NUM>. Additionally or optionally, the sensed values are stored in a readable writable memory, for example memory <NUM> of the device.

According to some exemplary embodiments, the device measures at least one electrical parameter of the skin, for example impedance during application of the electric field and/or electrical parameters related to the generate electric field. In some embodiments, removing the device from the skin during electric field delivery causes an increase, optionally a rapid increase in current and/or power density and/or impedance. In some embodiments, the device stops the electric field delivery if such an increase is detected.

According to some exemplary embodiments, the device determines if the measured values of the safety related parameter are in a desired range of values, at <NUM>. In some embodiments, the control circuitry of the device determines if the measured values are in a desired range of values by comparing the measured values to at least one table or to pre-determined values stored in the memory. Alternatively or additionally, the control circuitry of the device determines if the measured values are in a desired range of values using at least one algorithm and/or software program stored in the memory of the device. In some embodiments, the control circuitry of the device determines if the measured values are in a desired range of values by transmitting the measured values to a cloud, for example cloud <NUM>, and optionally using at least one table, algorithm and/or a software program stored in the cloud.

Alternatively, the control circuitry of the device determines if the measured values are in a desired range of values by transmitting the measured values to an external device, for example mobile device <NUM> or wearable device <NUM> and optionally using at least one table, algorithm and/or a software program stored in the external device.

According to some exemplary embodiments, if the measured values are not in a desired range of values or are higher or lower compared to a predetermined safety threshold, then the electric field delivery is sopped at <NUM>, optionally automatically, by the device.

According to some exemplary embodiments, if the measured values are in a desired range of values or lower or higher from a predetermined safety threshold then the electric field is delivered to the perineal tissue at <NUM>, according to the treatment program or based on the electric field parameter values used at <NUM>.

According to some exemplary embodiments, a signal is received from a user at <NUM>. In some embodiments, the signal is received from the user during the delivery of the electric field to the perineal tissue of the user. Alternatively, a signal is received from a user between the delivery of electric field pulses or after the delivery of the electric field. In some embodiments, the signal is received from an external device, for example a mobile device and/or a wearable device. In some embodiments, the user delivers the signal in response to a pain sensation at the perineal tissue or in other parts of the body. Alternatively or additionally, the user delivers the signal in response to discomfort sensation.

According to some exemplary embodiments, when a signal related to pain or discomfort is received by the device, the electric field delivery is stopped at <NUM>. Alternatively, at least one parameter of the electric field is modified, for example the intensity of the electric field is lowered.

According to some exemplary embodiments, an indication is delivered by the device to the user at <NUM>, for example when the electric field delivery is stopped. In some embodiments, the indication comprises a sound indication and/or a vibration indication. Alternatively, the device signals an external device, for example a mobile device or a wearable device to generate the indication. In some embodiments, the indication generated by the external device comprises a sound indication and/or a light indication. Optionally all indications by the device or by the external devices are human detectable indications.

According to some exemplary embodiments, at least one treatment program parameter is modified at <NUM>. In some embodiments, at least one parameter of the delivered electric field is modified, for example lowering the intensity of the electric field and/or modifying the frequency of the delivered electric field. Alternatively or additionally, the delivery duration of the electric field is modified, for example shortening the delivery duration of the electric field to the perineal tissue.

According to some exemplary embodiments, the device moves to a non-stimulating mode at <NUM>. In some embodiments, in a non-stimulating mode the device waits to receive a signal from a user in order to generate and/or to deliver an electric field to the user.

According to some exemplary embodiments, the device is designed to be applied by a user to the perineum before sexual intercourse. In some embodiments, the device is removed from the perineum and discarded after the sexual intercourse or can be re-used by the user. Reference is now made to <FIG> depicting a process of using the device by a user, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a user removes the devise from a package at <NUM>. In some embodiments, when unpacking the device, the user tears the package along marked lines, for example not to damage the device. Alternatively or additionally, the user tears the package at specific marked location which are distant from the packed device.

According to some exemplary embodiments, the user switches a power mode of the device to a standby mode, at <NUM>. In some embodiments, the power mode is switched by a switch or a selection button positioned on the housing of device, for example housing <NUM> shown in <FIG>. Optionally the switch or the selection button is part of the interface <NUM> of the device. In some embodiments, removal of an isolator between at least one battery, for example battery <NUM>, shifts the power mode to a stand-by mode. In some embodiments, the power switch or button switches the power mode between OFF, Standby and ON. Optionally, the power switch or button is mechanical, magnetic or an isolation tab which exposes contacts and close circuit when removed.

According to some exemplary embodiments, a software application (app) installed in a mobile device, for example a smartphone is activated at <NUM>. In some embodiments, a user couples the device with a smartphone at <NUM>. Alternatively or additionally, the device is coupled with a tablet or a smartwatch. In some embodiments, the device is coupled with smartphone only after an identification process is completed. In some embodiments, to prevent unauthorized coupling, an identification process, which optionally comprises insertion of a password to allow coupling, is performed.

According to some exemplary embodiments, the device is applied to the perineum at <NUM>. In some embodiments, the device is applied to the perineum by exposing at least one adhesive tape located on the device housing, and attaching the at least one adhesive tape to the perineum skin. In some embodiments, the device is oriented during application according to markings or geometrical shapes or geometrical cuts or curves in the device housing. In some embodiments, the device is bent along axial bending lines in the device housing to conform to the anatomical curves of the perineum, for example to conform to the anatomical curve of the perineum between the two legs, for example as shown in <FIG>. Alternatively or additionally, the device is bent along axial bending lines in the device housing to conform to the anatomical curve of the perineum between the scrotum and the anus.

According to some exemplary embodiments, the stimulation parameters, for example stimulation intensity are set at <NUM>. In some embodiments, the stimulation parameters set using the software program installed in the mobile device coupled to the device, for example the smartphone and/or tablet and/or smartwatch. In some embodiments, the stimulation parameters are set based on the parameters values stored in the memory of the mobile device. In some embodiments, a device calibration is performed by increasing the stimulation intensity until a user senses discomfort and/or pain, and then reducing the intensity level in at least <NUM>. 1mA, for example <NUM>. 1mA, <NUM>. 2mA, <NUM>. 3mA, <NUM>. 5mA or any intermediate or larger reduction value, to reach for example a subthreshold intensity level. Alternatively, the stimulation intensity is set to previously used intensity levels.

According to some exemplary embodiments, stimulation is activated at <NUM>. In some embodiments, stimulation is activated by delivering the electric field to selected targets in the perineal tissue. In some embodiments, the intensity increases after stimulation is activated to a pre-determined level, for example the intensity level set at <NUM>. In some embodiments, when the stimulation is activated, for example when the electric field is delivered to perineal tissue, selected muscles are affected and delay ejaculation, for example the Bulbospongiosus muscle and/or the Ischiocavernosus muscle.

According to some exemplary embodiments, after ejaculation or after the sexual intercourse, the device is removed from the perineum at <NUM>. In some embodiments, the device is discarded. Alternatively, the device is stored for an additional use.

According to some exemplary embodiments, usage information and/or log files are uploaded, optionally automatically, to a cloud based storage, for example cloud <NUM> shown in <FIG>, at <NUM>. Alternatively or additionally, the usage information and/or log files are stored in the writable readable memory, for example memory <NUM> shown in <FIG> of the device. In some embodiments, the usage information and/or log files are stored in a memory of an external device, for example mobile device <NUM> and/or wearable device <NUM> shown in <FIG>.

According to some exemplary embodiments and without being bound to any theory, premature ejaculation is characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration. In some embodiments, application of an electric field for example, for stimulation of selected targets in the perineal tissue delays ejaculation in at least <NUM> seconds, for example <NUM> seconds, <NUM> seconds, <NUM> seconds, <NUM> minute, <NUM> minutes, <NUM> minutes or any intermediate or larger value. Optionally, application of an electric field delays ejaculation in at least <NUM> fold from the base line duration until ejaculation, for example <NUM> fold, <NUM> fold, <NUM> fold or any intermediate smaller or larger value. In some embodiments, a device for delivery of the electric field measures values of at least one ejaculation indicative parameter and optionally sets the timing for delivery of the electric field to the desired tissue. In some embodiments, a gradual decrease in impedance values, for example at a rate of at least <NUM> ohm per second, for example <NUM> ohm per second, <NUM> ohm per second, <NUM> ohm per second or any intermediate lower or higher decrease rate is an indicator of nerve activity which may indicate of approaching ejaculation and/or urination.

Reference is now made to <FIG> depicting changes in time of values of an ejaculation indicative parameter under premature ejaculation conditions and in response to application of an electric field as described in this application, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, values of at least one ejaculation parameter are increased at <NUM>. In some embodiments, when an electric field is not applied to the perineal tissue, ejaculation occurs at <NUM> and ends at T1. In some embodiments, in order to delay ejaculation, an electric field is applied at T0. In some embodiments, the electric field is applied prior to reaching the point of controlled ejaculation initiation <NUM>. In some embodiments, the applied electric field delays ejaculation until point <NUM> and therefore ejaculation ends at T3. Optionally, the device reduces or stops the electric field at T2 to initiate controlled ejaculation at point <NUM>.

According to some exemplary embodiments, the applied electric field temporarily inhibits the rhythmic contractions of the bulbospongiosus muscle. In some embodiments, the ejaculation indicative parameter comprises the contraction level of the Bulbospongiosus muscle or a gradual decrease in impedance values, as described above. In some embodiments, the device measures the ejaculation indicative parameter values by at least one electrode or sensor in the device. In some embodiments, the control circuitry of the device, for example control circuitry <NUM> shown in <FIG>, signals to generate and to deliver the electric field based on the measured values. Optionally, the control circuitry determined the timing for application of the electric field and/or at least one parameter of the electric field, for example the intensity, based on the measured values.

Reference is now made to <FIG> and <FIG> depicting changes in arousal levels in healthy subjects, subjects suffering from premature ejaculation and in response to electric field application by the device, according to some exemplary embodiments of the invention.

According to some exemplary embodiments and without being bound by any theory, the sexual response cycle in humans is divided into <NUM> main phases, an excitement phase <NUM>, a plateau phase <NUM>, an orgasm phase <NUM> and a resolution phase <NUM>, for example as shown in <FIG> and as described, for example, in <NPL>. In subjects suffering from premature ejaculation (PE), for example as shown in <FIG> graph <NUM>, the plateau phase is shorter compared to the plateau phase in healthy subjects shown in graph <NUM>. Additionally or optionally, the excitement phase is also shorter in PE subjects compared to the excitement phase in healthy subjects. According to some exemplary embodiments, application of an electric field in PE subjects during the excitement phase, for example as shown in <FIG> graph <NUM>, prolongs the plateau phase in at least <NUM> seconds, for example <NUM> seconds, <NUM> seconds, <NUM> seconds, <NUM> minutes, <NUM> minutes or any intermediate smaller or larger value.

According to some exemplary embodiments, the device delivers an electric field in response to signals received from a mobile device, for example a smartphone, tablet or smartwatch. In some embodiments, the electric field is delivered and/or stopped in response to a voice command delivered by a user of the device. In some embodiments, the voice command is received by the device and/or by the mobile device.

According to some exemplary embodiments, the electric field onset is determined based on the duration of the excitement phase in each PE subject. In some embodiments, the electric field onset is determined by a user of the device or an expert, for example a physician or a surrogate. In some embodiments, the expert determines the electric field parameters, for example stimulation intensity, stimulation duration and/or stimulation onset. In some embodiments, the device measures at least one physiological parameter during the sexual response cycle in a subject, for example during the excitement phase, during the plateau phase and/or during the orgasm phase to determine the stimulation (electric field) onset, stimulation duration, stimulation intensity or any other parameter related to the stimulation or the treatment delivered by the device.

According to some exemplary embodiments, the electric field is delivered prior to the excitement phase. Alternatively, the electric field is delivered automatically by the device during the excitement phase, for example when values of at least one physiological parameter are higher than a pre-determined value or are in a range of desired values. In some embodiments, the at least one physiological parameter is measured by the device and/or by at least one sensor connected to the device or to the mobile device. Alternatively or additionally, the at least one physiological parameter is measured by the mobile device.

Reference is now made to <FIG> depicting a process for applying, optionally automatically, an electric field to the inhibit ejaculation based on measurements of an ejaculation-indicative parameter, according to some exemplary embodiments of the invention. In some embodiments, the process is optionally a fully automatic process, where, for example the device determines when to deliver and when to stop delivering the electric field based on ejaculation-indicative physiological parameters measured by at least one electrode and/or at least one sensor of the device.

According to some exemplary embodiments, the device monitors values of at least one ejaculation indicative parameter at <NUM>. In some embodiments, the values of the ejaculation indicative parameter are sensed by at least one electrode or at least one sensor of the device, placed in contact with the perineum. In some embodiments, the device monitors at least one physiological parameter prior to and/or during the excitement phase, for example excitement phase <NUM>. In some embodiments, the at least one physiological parameter indicates the progression of the excitement phase. In some embodiments, the at least one physiological parameters comprises arousal level, erection level, blood flow inside the penis, movement of the scrotum or testis.

According to some exemplary embodiments, the device delivers an electric field to selected targets in the perineal tissue at <NUM>. In some embodiments, the device initiates the delivery of the electric field when values of the at least one ejaculation indicative parameter reach a pre-determined level, stored for example in the readable writable memory, for example memory <NUM> of the device. In some embodiments, the device delivers an electric field to the perineal tissue if values of the at least one physiological parameter measured prior to and/or during the excitement phase are higher than a pre-determined value or are in a desired range of values. In some embodiments, the measured values and/or the pre-determined values and/or the desired range of values are stored in the readable writable memory of the device or in the memory of the mobile device coupled to the device.

According to some exemplary embodiments, the ejaculation-indicative parameter is monitored while the electric field is delivered at <NUM>. In some embodiments, the control circuitry of the device measures the values of the parameter and determines when to stop the delivery of the electric field at <NUM> based on said measured values and using at least one algorithm, at least one table and/or at least one software program in memory <NUM>. Optionally, the control circuitry compares the measured values to values stored in the memory <NUM>. In some embodiments, the ejaculation-indicative parameter and/or the at least one physiological parameter and/or other one or more physiological parameters are measured during the plateau phase <NUM> and/or during the orgasm phase <NUM> and optionally during the resolution phase <NUM>. In some embodiments, the ejaculation-indicative parameter and/or the at least one physiological parameter are measured during the entire sexual response cycle, for example the sexual response cycle described in <FIG>.

According to some exemplary embodiments, the device stops the electric field at <NUM>, based on the determining results at <NUM>. In some embodiments, when the electric field delivery stops, the device is placed in a non-stimulating mode at <NUM>.

According to some exemplary embodiments, the device is set to a learning mode, where an electric field is not applied. In some embodiments, when the device is in a learning mode, the device measures at least one ejaculation indicative parameter or any other physiological parameter that allows to determine when to deliver an electric field and optionally when to stop the delivery of the electric field. In some embodiments, based on the measured parameter, the device generates a personalized treatment plan, which includes timing and/or electric field parameter values that are adjusted to a specific user. In some embodiments, the personalized treatment plan is generated by a software application installed in the mobile device, for example mobile device <NUM> and/or by at least one algorithm and/or software program installed in the cloud, for example cloud <NUM>.

According to some exemplary embodiments, the device is controlled by an app installed in a mobile device, for example a smartphone. In some embodiments, the app delivers indications and alerts to a user of the device, for example by sound, by light or by vibration. In some embodiments the app deliver indications, for example visual indications related to the battery of the device, the activation state of the device, the electric field parameter values or any other parameter related to the device or the treatment program.

In some embodiments, the app serves to control the parameters of the delivered electric field and/or the parameters of the treatment, for example by selecting values of the parameters. Additionally, the app allows to initiate and/or to terminate the delivery of an electric field, optionally by a user or any other subject.

According to some exemplary embodiments, the app presents historical usage information of a single user, as well as comparative information of multiple users, optionally anonymous users. In some embodiments, the app enables the user to upload his usage information, for example date and time of use, stimulation intensity, duration of use and/or electrical impedance to a cloud based storage, for example cloud <NUM>. In some embodiments, each individual device is identified using a Device ID - a visible alphanumeric series for device identification and, Encrypted ID - alphanumeric series for device identification while transferring usage information. In some embodiments, in this way, the identity and privacy of the user are maintained. In some embodiments, the app stores in a memory the intensity value of the last stimulation session or an average stimulation intensity value, and allow the user easier and quicker stimulation activation. In some embodiments, when the device comprises an array of electrodes, the app stores the combination of electrodes used for the last stimulation.

According to some exemplary embodiments, launching the app and/or when the device is in a non-stimulating mode and/or when the device delivers the electric field, activates the smartphone's Kiosk Mode, meaning only emergency functions are operational and all other functions are temporarily disabled for the duration of stimulation. In some embodiments, this feature is used for safety reasons and/or to help the user avoid distractions during sexual intercourse.

According to some exemplary embodiments, in case the smartphone's battery is not charged enough, the app may render the activation of the device disabled. In some embodiments this feature can be preprogrammed into the processor and be preset to <NUM>% or <NUM>% or <NUM>% of the current capacity/charge status of the battery of the smartphone. In some embodiments, the device automatically pauses stimulation in case connectivity between device and smartphone/app is lost. Alternatively, when the connection between the smartphone and the device is lost, the device continues to deliver the electric field based on a program and/or on electric field parameter values stored in the memory of the device. Optionally, when setting the electric field parameters or any treatment parameter by the app, the settings are wirelessly transmitted to the device and are stored in the memory, for example memory <NUM> of the device. In some embodiments, storing the settings in the memory <NUM> allows, for example to deliver the electric field to the perineal tissue when the connection between the device and the smartphone is lost.

According to some exemplary embodiments, when the app is coupled to the device, the software program and/or algorithms and/or tables stored in the memory <NUM> of the device are updated.

According to some exemplary embodiments, the application program, for example the app, delivers usage instructions stored in the memory of the mobile device and/or in a cloud storage, to the user.

According to some exemplary embodiments, the application program recommends a treatment protocol and/or electric field parameter values and/or modifies a treatment protocol based on data received from the user and/or from an expert, for example clinical data of the user, list of diseases, list of medications taken by the user, and/or estimated time to sexual intercourse. In some embodiments, the clinical data comprises weight, body-mass index (BMI), age and/or clinical history of the subject. In some embodiments, the treatment protocol comprises the activation time of the device, attachment time of the device and/or other parameters related to the electric field delivery.

In some embodiments, the application program recommends a treatment protocol and/or electric field parameter values and/or modifies a treatment protocol using at least one table or at least one algorithm included in the application program or in a memory of the mobile device, for example in the memory of the smartphone, tablet and/or smartwatch. In some embodiments, the application program suggests a modified treatment protocol with optionally modified electric field parameter values if a subject is treated for ED, for example by Viagra ®, Stendra, Cialis, Levitra and/or Staxyn. In some embodiments, the application program determines which treatment protocol to select and/or which electric field parameter values to select using at least one table and/or at least one algorithm stored in the memory of the mobile device, for example smartphone, tablet and/or smartwatch.

According to some exemplary embodiments, data provided by manufactures of other products can allow a user of the device to access premium features in the application program. In some embodiments, manufacturers can place an access code/barcode/QR code on the packaging of their relevant products, for example condoms, erectile dysfunction drugs, lubricants, etc. In some embodiments, these codes are identified by the app controlling the device and offer the user of the patch premium features, for example additional features that are not included in his program application. In some embodiments, for example, a user who purchases both Viagra pills and the device, can use access codes or any data on the package of the pills to access premium features in the application program, for example his personal usage history of the devices.

In some embodiments, premium features the device are application program/software based and comprise personal usage history, for example number of uses, duration of use, improvement rate, on-line ordering of patches, on-line prescription delivery. Optionally, the premium features are software/hardware embedded features, for example extending the delivery duration of the electric field relative to an existing treatment protocol, for example from <NUM> minutes to <NUM> minutes or to <NUM> minute.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

Claim 1:
A device (<NUM>) suitable to be used during sexual intercourse and for electrifying nerves and/or muscles of the perineum, comprising:
a housing (<NUM>) shaped and sized to be attached to a perineum surface of a subject between a posterior aspect of the scrotum and the anus of said subject;
at least two electrodes (<NUM>) in said housing configured to deliver an electric field to a perineal tissue, wherein said electrodes are positioned entirely between the scrotum and the anus of said subject;
a pulse generator (<NUM>) in said housing electrically connected to said at least two electrodes, wherein said pulse generator generates an electric field with parameter values selected to affect at least one selected target within said perineal tissue;
a control circuitry (<NUM>) in said housing electrically connected to said pulse generator;
a readable and writable memory circuit (<NUM>) in said housing electrically connected to said control circuitry, wherein said readable and writable memory stores indications of at least one electric field parameter and/or at least one treatment program;
at least one battery (<NUM>) in said housing electrically connected to said pulse generator, characterized in that said device comprises
a communication circuitry (<NUM>) in said housing electrically connected to said control circuitry, configured to:
(a) transmit values of at least one physiological parameter of said subject to a remote device;
(b) receive wireless signals from said remote device which include values of at least one parameter of said electric field;
wherein said control circuitry stores said received wireless signals in said memory and signals said pulse generator to generate said electric field based on said stored received wireless signals.