FLOOR MUSCULATURE

FIELD

[0001] Embodiments described herein relate to a gear for electromyostimulation of a pelvic floor musculature of a human body, to an electromyostimulation current generator and an electromyostimulation system for this purpose, and to a wireless communication device and computer program product to control the electromyostimulation of the pelvic floor musculature. In more specific embodiments, the gear, electromyostimulation current generator, electromyostimulation system, wireless communication device and computer program can serve for electromyostimulation of the pelvic floor musculature to treat incontinence.

BACKGROUND

[0002] Incontinence is the inability to hold urine in or at least to hold it in completely. Even the loss of a few drops of urine is enough for an adequate diagnosis. The international continence society (ICS) defines different types of incontinence. Stress incontinence means that urine often leaks when stress is put on the bladder, such as when sneezing, laughing or exercising. The underlying cause is a weakness of pelvic floor musculature, especially the Musculus bulbospongiosus, Musculus ischiocavernosus and Musculus transversus perinei superficialis (superficial transverse perineal muscle). Another form of incontinence is urge incontinence, with sudden and intense urge to urinate, followed by an uncontrolled loss of urine. The main causes may be an infection or may be neurological. There is also overflow incontinence as a third form, which is caused by a bladder, that does not empty completely. All of these forms may occur combined in a mixed form.

[0003] According to official numbers more than 200 million people worldwide are affected by incontinence. About 11% of men suffer from urine incontinence, and prevalence rates differ between 11% to up to 55% in 15 to 64 year old women. Incontinence often goes along with social stigmatization, up to the point of social exclusion and ostracism. The psychological strain and level of suffering induced by incontinence is therefore extremely high, and the quality of life correspondingly low.

[0004] To strengthen the pelvic floor musculature and treat incontinence, anal probes and vaginal probes are known and commercially available. These probes have electrodes which, when inserted, can be used for pelvic floor training by electromyostimulation, also known as electro muscle stimulation or EMS. However, this kind of treatment may not be accessible for all patients, in particular the elderly. Further, many patients may feel psychologically repelled due to a sense of shame, which can lower compliance with a treatment plan. Even if a treatment plan is kept, patients may feel discomfort during the treatment, and improper handling and insufficient hygiene may lead to infections and inflammations of the rectum or the vagina.

[0005] EP 3 131 622 Bl describes an incontinence treatment device that utilizes transcutaneous electrical muscle stimulation to train and tone the muscle groups that control continence. This incontinence treatment device shall improve patient compliance, eliminating the need for anal or vaginal probes. More specifically, EP 3 131 622 Bl describes an electrode of hourglass shape that is temporarily affixed to an undergarment by plastically deformable tabs, much like a slip liner. This electrode has an egress for bodily fluids that is to be centered over the urethral opening, vagina and anus. The electrode is worn for an extended time, such as a treatment block of eight hours, a day, or several days, with several active treatment sessions and periods of inactivity in between. The electrode is connected to a wearable control unit that may be concealed under the user’s clothing. However, achieving the correct positioning of the electrode against the skin can be difficult for the user. The extended time of the treatment block of up to several days can cause discomfort. The reusability of the electrode is limited even if it can be cleaned. According to EP 3 131 622 Bl, the electrode might be used for more than one week, but is then disposed.

[0006] Therefore, there is need for improvement.

SUMMARY

[0007] According to an embodiment, a gear for electromyostimulation of pelvic floor musculature through a perineum of a human body is provided. The gear includes a positioning support, and a first contact electrode coupled at a predefined position with the positioning support. The positioning support is shaped to be worn on the human body and configured to position the first contact electrode on the perineum of the human body. The gear includes a first conductor connected to the first contact electrode, and an electrical connector comprising a first electrical terminal. The first conductor is connected the first electrical terminal. The electrical connector is configured for connecting to an electromyostimulation current generator that generates an electrical stimulation current to be applied by the first contact electrode to the perineum for the electromyostimulation of the pelvic floor musculature.

According to another embodiment, an electromyostimulation system for electromyostimulation of pelvic floor musculature through a perineum of a human body. The electromyostimulation system includes a gear for electromyostimulation of the pelvic floor musculature through the perineum of the human body. The gear includes a positioning support, and a first contact electrode coupled at a predefined position with the positioning support. The positioning support is shaped to be worn on the human body and configured to position the first contact electrode on the perineum of the human body. The gear includes a first conductor connected to the first contact electrode, and an electrical connector comprising a first electrical terminal. The first conductor is connected the first electrical terminal. The electromyostimulation system includes an electromyostimulation current generator configured to generate an electrical stimulation current to be applied by the first contact electrode to the perineum for the electromyostimulation of the pelvic floor musculature. The electromyostimulation current generator is connected to the electrical connector of the gear. The electromyostimulation current generator may be either a part of the gear or a separate, detachable unit.

[0008] Embodiments are also directed to methods for preparing the electromyostimulation system described herein to make it ready for use, and to the use of a gear and an electromyostimulation current generator to manufacture the electromyostimulation system for the treatment of incontinence.

[0009] An embodiment of the gear and electromyostimulation system with electromyostimulation current generator described herein has been tested in a clinical trial for the treatment of incontinence, particular stress incontinence, with promising results that are elsewhere described herein.

[0010] Further advantages, features, aspects and details that can be combined with embodiments described herein are evident from the dependent claims, the description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] A full and enabling disclosure to one of ordinary skill in the art is set forth more particularly in the remainder of the specification including reference to the accompanying drawings wherein:

Figi, shows a gear for electromyostimulation of a pelvic floor musculature according to embodiments described herein;

Fig. 2 shows an electromyostimulation current generator for providing an electrical stimulation current to the gear, particularly to its contact electrode(s);

Fig. 3 shows an electromyostimulation system according to embodiments described herein;

Fig. 4 illustrates a method for manufacturing or readying the electromyostimulation system;

Figs. 5-8 show a gear and electromyostimulation system according to embodiments described herein that has been used in a clinical trial to treat incontinence;

Figs. 9-10 show results of the clinical trial;

Figs. 11-12 schematically illustrate a human body and parts thereof.

DETAILED DESCRIPTION

[0012] Reference will now be made in detail to the various exemplary embodiments, one or more examples of which are illustrated in each figure. Each example is provided by way of explanation and is not meant as a limitation. For example, features illustrated or described as part of one embodiment can be used on or in conjunction with other embodiments to yield yet further embodiments. It is intended that the present disclosure includes such modifications and variations.

[0013] Within the description of the drawings, the same reference numbers refer to the same or similar components. Generally, only the differences with respect to the individual embodiments are described. The structures shown in the drawings are not necessarily depicted true to scale, and may contain details drawn in an exaggerated way to allow for a better understanding of the embodiments.

[0014] An embodiment described herein relates to a gear for electromyostimulation of pelvic floor musculature. The pelvic floor musculature can include a pelvic floor muscle or pelvic floor muscles, such as Musculus bulbospongiosus, Musculus ischiocavemosus and Musculus transversus perinei superficialis. The gear can be configured for transcutaneous electromyostimulation of the pelvic floor musculature. Therein, transcutaneous electromyostimulation is understood as electromyostimulation through the skin on the outside of a human body, without the need to insert the gear into a body opening such as the anus or vagina. The gear may be wearable on the human body, like clothing, in particular like pants or like a suit. The gear can be configured for electromyostimulation of the pelvic floor musculature through a perineum of a human body. The gear may be configured for electromyostimulation of the pelvic floor musculature exclusively through the perineum of a human body. Generally, an electrical stimulation current may be applied to the skin of other body areas as well, e.g., anterior, posterior or lateral to the perineum. The gear can be configured for electromyostimulation of the pelvic floor musculature exclusively through the perineum of the human body. The gear can be configured to stimulate the pelvic floor musculature by electromyostimulation for the treatment of incontinence, particularly stress incontinence and mixed-type incontinence including stress incontinence. The gear can be configured for non- invasive treatment of incontinence. A non-invasive treatment is a treatment not necessitating insertion of a treatment device into a body opening.

[0015] The gear includes a positioning support. The positioning support is shaped to be worn on the human body. The positioning support may be, or be in the likeness of, pants or a suit, e.g. cycling shorts. The positioning support may be a pull-on piece of clothing, i.e., it may be pulled on over the legs like pants. Alternatively, the positioning support may include, or be, a strap system, e.g. including a waistband that can be buckled and a string or strand running around the underside of the torso. The positioning support may be a combination thereof. The positioning support may have an inside and an outside, the inside being the body-side when the positioning support is worn on the human body, and the outside being the opposite side. The positioning support may be shaped to cover at least the perineum of the human body when worn, or the underside of the torso of the human body. The positioning support can be shaped and configured to tightly surround the perineum and/or apply pressure at least to the perineum when worn. The positioning support can be self-supporting when worn on the human body. That means, its shape, when worn, is such that the positioning support supports itself in place relative to the human body by mechanical forces, such as friction. The gear may be self- supporting. [0016] The positioning support can include more than one opening, particularly at least three openings. At least two openings can be sized to fit a leg of the human body. At least one opening can be sized to fit the waist of the human body. Therein, the human body may be an average adult human body. Typically, the positioning support can have three openings, of which two are sized to fit the two legs of the human body, and one opening is sized to fit the waist of the human body. At least one of the openings, such as three openings, may have a largest diameter of more than 15 cm and a smallest diameter of more than 10 cm. A least one of the openings, such as three openings, may have substantially circular or oval shape. The positioning support may invariably exhibit the openings. For instance, a positioning support in the form of pants innately and immutably includes three openings, of which there is one for the waist and two for the legs. The positioning support may exhibit the openings at least in the state in which it is worn (equipped state). For instance, if a part of the positioning support, such as a waistband, is configured to be buckled, then the positioning support may exhibit an opening for the waist only after that part has been buckled.

[0017] The positioning support may be a textile positioning support. A textile positioning support may include, or be made of, textile fabric. The textile fabric can be a flat fabric, such as a flat woven fabric. The textile fabric may be a knitted fabric, such as a flat-knitted fabric. The positioning support may include supporting parts such as a waistband or girdle, which may be connected around the underside of the torso by one or more strings, e.g., from waistband center front to waistband center back. The positioning support, or at least its supporting parts or some of its supporting parts, may be made of elastic textile fabric. The positioning support, or at least its supporting parts or some of its supporting parts, may ensure a tight fit and pressure to the perineum when worn. The positioning support may be elastic or include elastic material.

[0018] The gear includes a first contact electrode. The first contact electrode is coupled with the positioning support at a predefined position. The first contact electrode may be coupled with the positioning support on the inside of the positioning support. The positioning support is configured to position the first contact electrode on the perineum of the human body. Specifically, the positioning support may be shaped and configured to position the first contact electrode on the perineum when the positioning support is worn. The predefined position where the first contact electrode is coupled can be such that the first contact electrode comes into contact with the perineum when the gear is worn on the human body. The coupling at the predefined position may ensure that the first contact electrode is positioned properly for applying the electrical stimulation current to the perineum for electromyostimulation of the pelvic floor musculature. The positioning support may be configured to support the first contact electrode to be pressed against the perineum. The first contact electrode may be integrated with or mounted on the positioning support at the predefined position.

[0019] The positioning support may include an electrode coupling portion. The electrode coupling portion may be, or include, a padding. The first contact electrode may be woven or knitted into the electrode coupling portion, sewn on the electrode coupling portion, or laminated on the electrode coupling portion, or otherwise fastened or mounted on the electrode coupling portion. The positioning support may be shaped so that the electrode coupling portion, or at least the area of the electrode coupling portion contacting the first contact electrode, rests opposite to the perineum when the gear/position support is worn in its intended way. The positioning support can self-positioning. That means, when the positioning support is worn in its intended way, it positions itself in a particular position, and the first contact electrode is thereby automatically positioned properly to be in contact with the perineum due to being coupled at a predefined position relative to the positioning support. The electrode coupling portion and/or the first contact electrode may be located in the crotch area of a positioning support having the shape of pants or shorts. For instance, when pulling on the positioning support in the form of pants, the first contact electrode that is coupled with the positioning support at a predefined position in the crotch area of the pants, will automatically be positioned properly without the user needing to make any placement or adjustment of the first contact electrode.

[0020] The first contact electrode is configured to apply an electrical stimulation current to the perineum for the electromyostimulation of the pelvic floor musculature. Specifically, when the positioning support is worn on the human body, the first contact electrode is contacting the skin of the perineum, and the first contact electrode is configured to apply the electrical stimulation current to the skin of the perineal area. The electrical stimulation current can pass through the skin of the perineal area, i.e., into and out of it, and stimulate the pelvic floor musculature. The first contact electrode may be a dry electrode. The first contact electrode preferably may have an inward, body-side, electrically conducting surface layer including a conductive polymer for passive hydration of a contact area with the perineum of the human body. The polymer may be or include caoutchouc or another vulcanized polymer material.

[0021] The gear may include a second contact electrode. The second contact electrode may be coupled with the positioning support. The second contact electrode may be coupled with the positioning support on the inside of the positioning support. The positioning support may be configured to position the second contact electrode on the perineum of the human body. Specifically, the positioning support may be shaped and configured to position the second contact electrode on the perineum when the positioning support is worn. The positioning support may be configured to support the second contact electrode to be pressed against the perineum. The second contact electrode may be integrated with or mounted on the positioning support. The second contact electrode may be woven or knitted into the electrode coupling portion of the positioning support, sewn on the electrode coupling portion, or laminated on the electrode coupling portion, or otherwise fastened or mounted on the electrode coupling portion. The positioning support may be shaped so that at least the area of the electrode coupling portion contacting the second contact electrode rests opposite to the perineum when the gear/position support is worn in its intended way. The second contact electrode may be located in the crotch area of a positioning support having the shape of pants or shorts. The second contact electrode may be arranged parallel to the first contact electrode in a lengthwise direction.

[0022] The second contact electrode may be configured to apply an electrical stimulation current to the perineum for the electromyostimulation of the pelvic floor musculature. Specifically, when the positioning support is worn on the human body, the second contact electrode may be contacting the skin of the perineum, and the second contact electrode may be configured to apply the electrical stimulation current to the skin of the perineal area. The electrical stimulation current can pass into the skin through the first contact electrode and out of the skin through the second contact electrode in a first half cycle of the electrical stimulation current, and vice versa in a second half cycle. The second contact electrode may be a dry electrode. The second contact electrode preferably may have an outward, body-side, electrically conducting surface layer including a polymer for passive hydration of a contact area with the perineum of the human body. The polymer may be caoutchouc or another vulcanized polymer material. The first contact electrode may be an anode. The second contact electrode may be a cathode. The roles may be reversed. Depending on the waveform of the electrical stimulation current, the first contact electrode and the second contact electrode can change their roles dynamically.

[0023] The first contact electrode and/or second contact electrode may be flexible. The first contact electrode and/or second contact electrode may be configured to adapt itself to the shape of the human body in the contact area between the human body and the first contact electrode and/or second contact electrode, specifically to the shape of the perineal area. The first contact electrode and/or the second contact electrode can have a length, a width, and a height. When the gear is worn, the length can extend in a direction in a sagittal plane and the width can extend in a direction in a coronal plane (frontal plane). The length of the first contact electrode and/or of the second contact electrode may be at least as long as the median anogenital distance. The length of the first and/or second contact electrode may be in the range from 5.5 cm to 12 cm, such as from 6 cm to 10 cm, e.g. about 9.5 cm. The width of the first contact electrode and/or second contact electrode may be in the range from 1 cm to 4 cm, such as from 2 cm to 3.5 cm, e.g., about 3 cm. The height of the first contact electrode and/or the second contact electrode may be in the range from 0.5 mm to 10 mm, such as from 1 mm to 8 mm, for instance about 2 mm. The first contact electrode and/or second contact electrode may include a current conductor, such as a wire or wire mesh or other form of a conductor, and may be metallic. The current conductor may be disposed on a carrier material, wherein the carrier material may be insulating. The metallic part may be covered by the conductive polymer. The gear may include more than two contact electrodes, such as a third contact electrode, fourth contact electrode, etc.

[0024] The gear includes a first conductor connected to the first contact electrode. The first conductor may be configured to provide the electrical stimulation current to the first contact electrode. In addition to being in electrical contact with the first contact electrode, the first conductor may be mechanically coupled to the positioning support. The first conductor may include, or be made of, electrically conducting textile fibers, or may include an electrical cable. The electrical cable may be insulated. The first conductor may be woven or knitted into the positioning support, sewn on the positioning support, or laminated on the positioning support, or otherwise fastened or mounted on the positioning support. The first conductor may be integrated with the textile fabric of the positioning support. The first conductor may be mechanically coupled to the positioning support on the inside, or may lead through the positioning support from the inside, where it may contact the first contact electrode, to the outside.

[0025] The gear may include a second conductor connected with the second contact electrode. The second conductor may be configured to provide the electrical stimulation current to the second contact electrode. In addition to being in electrical contact with the second contact electrode, the second conductor may be mechanically coupled to the positioning support. The second conductor may include, or be made of, electrically conducting textile fibers, or may include an electrical cable. The electrical cable may be insulated. The second conductor may be woven or knitted into the positioning support, sewn on the positioning support, or laminated on the positioning support, or otherwise fastened or mounted on the positioning support. The second conductor may be integrated with the textile fabric of the positioning support. The second conductor may be mechanically coupled to the positioning support on the inside, or may lead through the positioning support from the inside, where it may contact the first contact electrode, to the outside. The second conductor may be grouped with, or mechanically coupled to, the first conductor, while being electrically insulated therefrom. The second conductor may be arranged to run parallel to the first conductor.

[0026] The gear includes an electrical connector. The electrical connector includes a first electrical terminal. The first conductor is connected to the first electrical terminal. The first conductor may have a first end and a second end. The first conductor may be connected to the first contact electrode at the first end and to the first electrical terminal at the second end. The electrical connector may include a second electrical terminal. The second conductor may be connected to the second electrical terminal. The second conductor may have a first end and a second end. The second conductor may be connected to the second contact electrode at the first end and to the second electrical terminal at the second end.

[0027] The electrical connector of the gear is configured for connecting to an electromyostimulation current generator that generates the electrical stimulation current to be applied by the first contact electrode, and preferably by the second contact electrode, to the perineum for the electromyostimulation of the pelvic floor musculature. The electromyostimulation current generator will be described later in detail. The electromyostimulation current generator may include an electrical connector. The electrical connector of the gear may be configured to mechanically couple to the electrical connector of the electromyostimulation current generator, such as releasably couple thereto. The first terminal and/or the second terminal of the electrical connector of the gear may be in the form of a plug (male terminal) or socket (female terminal). The electrical connector of the electromyostimulation current generator may have corresponding, but opposite terminals. For instance, the first terminal and/or second terminal of the electrical connector of the gear may include male sides of snap fasteners, and the terminals of the electrical connector of the electromyostimulation current generator may include female sides of the snap fasteners.

[0028] The gear may be washable or otherwise disinfectable. The gear may be made of materials such that the structure and functionality of the gear may not substantially deteriorate when the gear is washed or disinfected by disinfectants. The gear may be machine-washable. The gear may withstand the stresses induced by being washed and tumbled in a washing machine. The gear may be configured to withstand at least 100, at least 200, or at least 300 washing cycles. Electronics to generate or control the generation of the stimulation current may entirely be contained in the electromyostimulation current generator.

[0029] Fig. 1 shows an embodiment of a gear 100 in the form of pants or shorts, such as cycling shorts. More specifically, the gear 100 includes a positioning support 110 made of a textile fabric and having the shape of pants or shorts. The gear 100, respectively the positioning support 110, has an inside 112 and an outside 114. The inside 112 contacts the human body when the gear 100 is worn. The outside 114 is the opposite side, facing away from the human body when the gear 100 is worn.

[0030] Figs. 11-12 show schematic drawings of a human body 1, in this case, but without limitation thereto, a female body with the anus 2, the vagina 3, the urethra 4, the pubic bone 5, the bladder 6, the uterus 7, the bowl 8, the sacrum 9, the perineum 10 and the pelvic floor musculature 20. The anogenital distance is the distance AGD-AF between the anus and the vagina for females, and is the distance AGD-AS between the anus and the scrotum for males. The distance AGD-AF is shown in Fig. 12 with reference sign 12. When the human body or parts of it are referred to with reference signs, the reference is made to Figs. 11-12. A sagittal plane 14 and a coronal plane 16 are indicated.

[0031] Returning to the gear 100 of Fig. 1, a crotch region of the positioning support 110 includes an electrode coupling portion 115. The gear 100 includes a first contact electrode 122 and a second contact electrode 124, which are integrated with the electrode coupling portion 115. The first contact electrode 122 and the second contact electrode 124 are arranged on the inside 112 of the positioning support 100, specifically on an inside of the electrode coupling portion 115, and are therefore shown in dashed lines in Fig. 1 due to the external view on the gear 100. The first contact electrode 122 and the second contact electrode 124 are dry electrodes which include a polymer layer on the inward, body-side surface for passive hydration of a contact area with the perineum 10 of the human body 1. Additional moisture, such as a gel, is not needed on the contact electrodes to apply electric stimulation current to the perineum 10. The first contact electrode 122 is parallel to the second contact electrode 124 in a lengthwise direction of the electrodes, the lengthwise direction being the direction of a crotch seam of the positioning support in Fig. 1. The first contact electrode 122 and the second contact electrode 124 are separated from each other by a distance in the widthwise direction of the electrodes.

[0032] The gear 100 further includes a first terminal 142, a first conductor 132 connected to the first contact electrode 122 and to the first terminal 142, and includes a second terminal 144, a second conductor 134 connected to the second contact electrode 124 and to the second terminal 144. The first terminal 142 and the second terminal 144 belong to a connector 140 of the gear 100. The first conductor 132 and the second conductor 142 may be integrated in the textile fabric on the inside 112 of the positioning support 110, such as sewn in or knitted in, and lead to the outside 114 where the connector 140 is located.

[0033] In the intended use, the gear 100 of Fig. 1 is worn. The positioning support 110 in the form of pants or shorts can be pulled on so that the first contact electrode 122 and the second contact electrode 124 come into contact with the skin of the perineum 10. The positioning support 110 positions the first contact electrode 122 and the second contact electrode 124 in this way when it is pulled on, and further supports them so that they are pressed against the perineum 10. A passive hydration can be established between the perineum 10 contact electrodes 122, 124 by sweat. When the electrical stimulation current is coupled into the first terminal 142 and the second terminal 144, the first contact electrode 122 and the second contact electrode 124 apply this electrical stimulation current to the perineum 10. The electrical stimulation current enters into the human body 1 and stimulates the pelvic floor musculature 20. The training by electromyostimulation of the pelvic floor muscles can reduce or even eliminate problems with incontinence, particularly stress incontinence, but potentially also other types and mixed types.

[0034] The gear described herein has advantages over the known ways to treat incontinence by electromyostimulation. The gear can be used by nearly all patients, also those patients who cannot insert such anal probes or vaginal probes for medical reasons. The gear can be worn inconspicuously, for instance just like cycling pants when the positioning support has the form of pants, or under normal clothing when the positioning support is a strap system that can be strapped on. Incontinence treatment with the gear described may cause much less feelings of shame as compared to probes that need to be inserted into the anus or vagina. The treatment is comfortable and easy to use, with little risk of improper handling that could itself cause medical problems. The gear may not need any lubricants/gels in contrast to anal probes and vaginal probes, particularly when dry electrodes are used in the gear. If the electromyostimulation current generator is separable from the gear, there is no need to encapsulate electronics to shield them from water and tensides during washing or from disinfectants during disinfecting. Both the gear and the electromyostimulation current generator can be built simpler and still have increased lifetimes.

[0035] Moreover, the gear is simple to put on, e.g., putting it on can be as simple as pulling up regular pants, and the gear is comfortable to wear. Unlike the electrode described in EP 3 131 622 Bl, the contact electrodes of the gear are in a predetermined spatial relationship to the positioning support, which in turn is in a predetermined spatial relationship to the human body when worn due to its shape. The contact electrodes can therefore be automatically brought into the correct position just by putting the gear on in the intended way. The contact electrodes can also automatically adapt their form to the anatomy of the body in the process of putting on the gear. These characteristics of the gear make it easier for users to follow a treatment plan all by themselves without any aid to position the contact electrodes properly. In addition, the gear is also easy to remove and reapply. The gear can be reusable many times, and can have the lifetime of regular sportswear. The gear may be disinfectable without any special procedure or special cleaning agent, such as by machine-washing it with regular detergents. The gear is not only easy to clean, sustainable and environment friendly, but also does not need to be worn for any prolonged period of time going beyond the current treatment period. The gear can taken off by the user, cleaned/washed where necessary, and later put on again only for the next treatment period. The comfort for the user is therefore improved, and a potential feeling of shame is reduced that may be associated with having to wear a device for a prolonged period of time, possibly also in public.

[0036] According to further embodiments, an electromyostimulation current generator is provided. The term “electromyostimulation” is abbreviated as “EMS” herein for conciseness. The EMS current generator can be configured for providing an electrical stimulation current, particularly for providing the electrical stimulation current to the gear described herein. The EMS current generator may be configured for cooperation with the gear described herein to provide the electrical stimulation current to the first contact electrode and/or the second contact electrode of the gear.

[0037] The EMS current generator includes a controller and a pulse generator. The controller is configured to control the pulse generator to generate the electrical stimulation current. The pulse generator can be configured to provide an electrical stimulation current having at least one of the following characteristics: a nominal current strength (amplitude) of 1-100 mA, a voltage of 1-350 V, a frequency of 30-90 Hz (which may be the modulation/inteference frequency of currents with 1000 to 4000 Hz frequency), an impulse period of 100 ps to 1000 ps, a pattern/ envelope with a 2-60 seconds stimulation time (on-time) and a 2-60 seconds pause (off-time), a pattern/envelope of rectangular form or trapezoid or pyramidal form, wherein the trapezoid or pyramidal form may have a rising flank ramping up current strength from zero to the nominal current strength within 0.01 to 2 seconds and may have a falling flank ramping down current strength from the nominal current strength to zero within 0.1 to 2 seconds. The pulse generator can be configured to generate the electrical stimulation current for a treatment period of 5-45 minutes, particularly of 10-25 min, such as about 10 min or about 15 min or about 20 min. The frequency may particularly be in the range from 30-50 Hz, such as 40 Hz. The pattern may have a stimulation time of 4 seconds and a pause of 4 seconds, and the treatment period may be 10 or 20 min. The electrical stimulation current can have characteristics such that it stimulates the pelvic floor muscles when applied to the perineum. The controller may be configured to control the pulse generator to generate the electrical stimulation current with at least one of said characteristics and/or to generate the electrical stimulation current for said treatment period.

[0038] The controller may include a processor, a memory, which may store firmware, and other hardware or software for performing said functions.

[0039] The EMS current generator may be a separate entity, and may be releasably connectable to the gear. The EMS current generator may include an electrical connector. The electrical connector may be connected to the pulse generator. The electrical connector of the EMS current generator may be configured to mechanically couple to the electrical connector of the gear. The electrical connector of the EMS current generator may be configured to electrically connect the EMS current generator to the first contact electrode and/or the second contact electrode of the gear for application of the stimulation current to the perineum of the human body wearing the gear. The electrical connector of the EMS current generator may include a first terminal and a second terminal. The first terminal and/or the second terminal of the electrical connector of the EMS current generator may be in the form of a socket (female terminal) or plug (male terminal). The electrical connector of the EMS current generator may have corresponding, but opposite terminals as compare to the terminals of the gear. For instance, the first terminal and/or second terminal of the electrical connector of the EMS current generator may include female sides of snap fasteners, and the terminals of the electrical connector of the gear may include male sides of the snap fasteners. The EMS current generator may include a first conductor and/or a second conductor for connecting the electrical connector to the pulse generator. The first conductor and/or the second conductor of the EMS current generator may be included in a cable. The first conductor may be connected to the first terminal, and the second conductor may be connected to the second terminal of the electrical connector of the EMS current generator.

[0040] In an alternative embodiment, the gear includes the EMS current generator, and the EMS current generator may be permanently connected to the first and second contact electrodes and/or permanently coupled to the positioning support of the gear. The electrical connector of the gear may be configured for connecting to the pulse generator in this case, e.g., and may just be a soldering or the like, while the EMS current generator may not need an electrical connector of its own. The controller, the pulse generator, other electronics, if any, and a power supply may be encapsulated in a waterproof manner. The EMS current generator may be integrated into a waistband of the gear.

[0041] The EMS current generator may include a power supply. The power supply may be supply electrical power to the components of the EMS current generator, e.g., to the controller and the pulse generator. The power supply may include a battery. The battery may be replaceable, e.g., by opening a battery cover. The battery may be rechargeable. The battery may be fixedly installed in the EMS current generator. The battery may be wirelessly rechargeable, e.g. in accordance with the Qi standard of the Wireless Power Consortium (WPC).

[0042] The EMS current generator may include a memory storing one or more EMS training programs. An EMS training program can contain a collection of characteristics of the electrical stimulation and of a treatment period. The characteristics and treatment periods may be selected from the ranges specified above. Alternatively, the EMS current generator may include means for externally receiving the EMS training program(s), such as a wireless communication interface described later. The EMS current generator may include a user interface for selecting an EMS training program. The user interface may include at least one of buttons, a display and a touchscreen for allowing a user to make that selection and/or for receiving feedback about it. The controller of the EMS current generator may be configured to control the pulse generator to generate the electrical stimulation current according to the characteristics and the treatment period of a selected EMS training program. The EMS current generator may be configured to carry out different EMS training programs. The EMS training programs may be pre-configured or may be configurable, such as via the user interface. [0043] The EMS current generator may include a feedback loop for reporting proper flow of the stimulation current. The feedback loop may include hardware components, such as sensors, and/or software components. For instance, the EMS training program(s) stored in the EMS current generator may register if the nominal current strength (amplitude) of the stimulation current flows, at least within a tolerance interval, when the operating voltage is set. If not, the EMS training program may be halted, and output of the stimulation current be interrupted. The improper working condition may be indicated to a user, e.g., via the user interface. Since this condition may indicate that the contact of the contact electrodes to the skin is not yet sufficient, the EMS current generator may output instructions how to properly put on the gear, or how to improve the contact, such as instructions to pull up the gear in form of pants more tightly or to use a separate pressure intensifier described later.

[0044] Fig. 2 shows an embodiment of an EMS current generator 200. The EMS current generator 200 includes a user interface 260. In Fig. 2, the user interface 260 is shown with several buttons and a display. A user, particularly a patient treated for incontinence or doctor, can chose an EMS training program for the treatment of incontinence. The EMS current generator 200 includes a controller 210 and a pulse generator 220, as schematically shown in Fig. 2. The electrical stimulation current is generated by the pulse generator 220 under the control of the controller 210 and in accordance with the chosen EMS training program, determining the characteristics and treatment period of the electrical stimulation current. The electrical stimulation current is passed through a cable 230 to the electrical connector 240. The electrical connector 240 includes a first terminal 242 in the form of a female side of a first snap fastener, and a second terminal 244 in the form of a female side of a second snap fastener. The first terminal 242 and the second terminal 244 are configured to engage corresponding first and second terminals 142, 144 of the electrical connector 140 of the gear 100 having the form of male sides of the first and second snap fasteners, as shown in the enlarged portion in Fig. 2.

[0045] The EMS current generator may include a wireless communication interface for receiving communication signals from a wireless communication device, such as a smartphone or other mobile communication device. The wireless communication interface may include a receiver or may include a transceiver. A transceiver has receiving and transmitting functionality. The wireless communication interface may be configured for wireless communication according to the wireless communication standards known as Bluetooth, NFC, IEEE 802.11 (WLAN), or radio access technologies of the second to fifth generation (GMS, UMTS, LTE / LTE-advanced, NR). The wireless communication interface may be connected to the controller. The controller may be configured to control the pulse generator based on the communication signals received from the wireless communication device. The wireless communication interface may receive wireless communication signals containing information about an EMS training program. The controller may interpret the wireless communication signals, and cause the pulse generator to generate the electrical stimulation current in accordance with the characteristics and treatment period derived from the information about an EMS training program contained in the wireless communication signals.

[0046] According to further embodiments, a wireless communication device is provided. The wireless communication device may be smartphone, tablet, PC or other electronic device having wireless communication functionality. The wireless communication device may be configured for wireless communication according to the wireless communication standards known as Bluetooth, NFC, IEEE 802.11 (WLAN), or radio access technologies of the second to fifth generation (GMS, UMTS, LTE / LTE-advanced, NR). The wireless communication device may be configured to for supporting or using the same wireless communication technology as the wireless communication interface of the EMS current generator.

[0047] The wireless communication device includes a transmitter or a transceiver for wireless communication. The wireless communication device includes a processor and a memory. The memory stores computer-executable instructions which, when executed by the processor, cause the transmitter or transceiver to transmit communication signals encoding information about an electrical stimulation current. Therein, the electrical stimulation current is to be generated by the EMS current generator according to embodiments described herein, and to be applied, by the gear according to embodiments described herein, to the perineum of a human body for electromyostimulation of the pelvic floor musculature. The communication signals may encode information about an EMS training program. The information about the electrical stimulation current or the EMS training program may specify electrical characteristics of the electrical stimulation current and/or the treatment period. The electrical characteristics and treatment period may be selected from the quantities and their ranges described herein.

[0048] The wireless communication device may include a user interface, e.g. a graphical user interface. The user interface may include a touchscreen or buttons and a display. The user interface may be configured to display information about one or more EMS training programs, and allow starting and/or selecting and starting an EMS training program. The computerexecutable instructions may include code to cause the display or touchscreen to display this information, and to accept user input from the buttons or the touchscreen to configure or start an EMS training program. The user of the user interface may be a patient treated for incontinence, same as the user of the gear or EMS system, or may be medical staff such as a medical doctor configuring the EMS training program for the patient.

[0049] The computer-executable instructions may include code which, when executed by the processor, allows the wireless communication device to detect, identify and/or authenticate the EMS current generator, the gear or both. The wireless communication device, through the computer-executable instructions stored in its memory, may be configured for cooperation specifically with the EMS current generator and/or gear according to embodiments described herein, such as by being able to detect, identify and/or authenticate the EMS current generator, the gear or both, and is distinguished from other wireless communication not having the computer-executable instructions stored in their memory.

[0050] The computer-executable instructions may be included in a computer program, such as an application (app), or computer program product. For simplicity, reference is made to an app hereinafter. The app may be stored and thus embodied in the memory of the wireless communication device. Further embodiments are directed to the app that includes the computerexecutable instructions described herein. The computer-executable instructions may cause, when executed by the processor of the wireless communication device, potentially after having been configured by input from a user (e.g. selection or configuration of an EMS training program), a wireless communication signal encoding information about an electrical stimulation current to be transmitted to the EMS current generator. The electrical stimulation current may have the characteristics and treatment period described herein. The wireless communication signal may cause the EMS current generator to generate the electrical stimulation current, and provide it the gear for electromyostimulation of the pelvic floor musculature through the perineum. The app may be stored on a remote memory, such as cloud memory, or on a CD or DVD. The app may be downloadable from an app store.

[0051] According to further embodiments, an electromyostimulation system (EMS system) is provided. The EMS system can be configured for electromyostimulation of pelvic floor musculature through a perineum of a human body. The EMS system includes the gear according to embodiments described herein. The EMS system includes the EMS current generator according to embodiments described herein. The EMS current generator can be connected to the electrical connector of the gear to generate the electrical stimulation current to be applied by the first contact electrode to the perineum for the electromyostimulation of the pelvic floor musculature when the positioning support is worn on the body. The EMS system may include the wireless communication device according to embodiments described herein.

[0052] The EMS system may further include a separate pressure intensifier to increase the pressure of the contact electrodes against the skin in the perineal area. The separate pressure intensifier may be a seating object on which the user of the EMS system, particularly a patient treated for incontinence, can sit while wearing the gear. The seating object may be anatomically shaped to conform to the underside of the torso, particularly to the perineal area. The seating object may include a seating surface (upper surface) with substantially cylindrical shape or saddle shape. The seating object may be soft to achieve conformity to the underside of the torso. The seating object may be a cushion. The seating object may be used if the EMS system determines that the contact of the contact electrodes is not yet sufficiently good, which may be indicated on the user interface.

[0053] Fig. 3 shows an electromyostimulation system 300. The EMS system 300 includes the gear 100 described with respect to Fig. 1. A patient can put on the gear 100, pulling it up over the legs until it has a tight fit to the body. The positioning support 110 in the form of pants then automatically positions the first and second contact electrodes 122, 124 so that they contact the skin of the perineal area, and supports the first and second contact electrodes 122, 124 so that they are pressed against the skin. The EMS system 300 includes an EMS current generator 200 with connector 240 and cable 230. The EMS current generator 200 of Fig. 3 is a variant of the EMS current generator shown in Fig. 2. Here, the EMS current generator 200 includes the controller 210 and the pulse generator 200, and additionally the wireless communication interface 250. The EMS system can include a reduced user interface, e.g., a user interface 260 with few buttons or only one button. The EMS training program is not set, configured and/or started from the user interface 260 in the embodiment shown in Fig. 3, but by a wireless communication signal received by the wireless communication interface 250. The EMS current generator can thus be made smaller and cheaper. The EMS system includes the wireless communication device 400, here in the form of a smartphone with touchscreen 460. The wireless communication device 400 includes a wireless interface with a transceiver 450, a processor 410, and memory 430 with the computer-executable instructions 435 stored therein, for example as part of an app, as schematically shown in Fig. 3. The EMS training program is chosen by a user on the touchscreen, and corresponding information is encoded in the wireless communication signal transmitted by the transceiver 450 to the wireless communication interface 250 of the EMS current generator 200, possibly after the app has verified that the EMS current generator 200 is a compatible device. The EMS current generator 200 generates the electrical stimulation current in accordance with the EMS training program, and provides it to the first and second contact electrodes 122, 124. The electrical stimulation current applied at least to the perineum stimulates the pelvic floor musculature in accordance with the EMS training program to treat the incontinence condition of the patient. The EMS system 300 may include a pressure intensifier cushion 510 as a separate element. The pressure intensifier cushion 510 may be have an anatomically shaped upper surface, such as a cylindrical or saddle- shaped upper surface, which, when a user wearing the gear 100 sits thereon, matches the anatomical form of the underside of the torso, in particular of the perineal area, and intensifies the pressure of the contact electrodes 122, 124 against the skin of the user.

[0054] According to further embodiments, as schematically illustrated in Fig. 4, a method 600 of manufacturing an EMS system or readying the EMS system is provided. The method 600 may include washing 610 and/or disinfecting a gear that is in accordance with embodiments described herein, particularly machine-washing the gear. The method 600 includes mechanically coupling 620 and/or electrically connecting the gear and an EMS current generator that is in accordance with embodiments described herein. The method 600 may include downloading 605 an app that is in accordance with embodiments described herein to a wireless communication device that is in accordance with embodiments described herein. The method 600 may include establishing 630 a wireless communication channel between the wireless communication device and the EMS current generator. The method 600 may include providing the pressure intensifier cushion. The EMS system that includes the gear and the EMS current generator, and that may include the wireless communication device and/or the pressure intensifier cushion, can thus be manufactured or readied for use.

[0055] A further embodiment is directed to the use of a gear and of an EMS current generator for the manufacture of an EMS system for the treatment of incontinence. The manufacture may include mechanically coupling and/or electrically connecting the gear and the EMS current generator. Other embodiments are directed to the gear for use in the treatment of incontinence, or the EMS current generator, the wireless communication device, or the computer program/the app for use in the treatment of incontinence. Therein, the gear can be in accordance with embodiments described herein. The EMS current generator and the wireless communication device can be in accordance with embodiments described herein. The EMS system can be in accordance with embodiments described herein. [0056] A clinical trial has been conducted to study the benefits of the gear described herein, particularly a gear with a positioning support in the form of pants. Figs. 5-8 show different illustrations of the gear 100 used in the study. The gear 100 includes the pant-shaped positioning support 110 made of a flat woven textile fabric and having two leg openings and one waist opening, i.e., a total of three openings. The pant-shaped positioning support includes, in a crotch area, an electrode coupling portion 115 in the form of a padding. The gear includes the first conductor 132 and the second conductor 134 which are commonly sewn in with the center back seam and extend beyond the waistband, and which electrically connect the first contact electrode 122 with the first electrical terminal 142 of the electrical connector 140 and the second contact electrode 124 with the second terminal 144 of the electrical connector 140. In Figs. 5 and 6, the gear 100 is shown right side out, i.e., with the outside 114 facing outward, and inside 112 facing inward. Since the contact electrodes are not visible in this state, Figs. 6 and 7 show the gear 100 inside out, i.e., with the inside 112 facing outward, and the outside 114 facing inward. Therein, Figs. 5 and 8 show the front part of the gear 100, and Figs. 6 and 7 the rear part of the gear 100. As can be seen best in Fig. 7, the first contact electrode 122 and the second contact electrode 124 are fixedly arranged on the electrode coupling portion 115, are parallel to each other in a lengthwise direction. The lengthwise direction lies in a sagittal plane when the positioning support is worn regularly, i.e. in the intended way and right side out. The first and second contact electrodes are 9.5 cm long and 3 cm wide, and arranged to contact the perineal area when the gear 100 is worn, i.e., when the positioning support is pulled on like any other regular pants. Fig. 8 also shows the EMS current generator 200, which was a stand-alone device with user interface 260, without control/ support from a wireless communication device.

[0057] The focus of the study of the clinical trial was on patients with stress incontinence. A total of sixty patients were initially included, of which thirty-five concluded the study. The mean age was 71 years. They were informed of the study design, and their consent was obtained. All included patients were diagnosed with stress incontinence by a urologist. Before starting any treatment, patients performed an incontinence questionnaire, designed by the ICS (Gaudenz questionnaire). Initial stress and urge scores were obtained from the answers. Urge incontinence was an exclusion criterion. The patients followed a treatment plan with the gear 100 stimulating the pelvic floor musculature. One to two treatments, each twenty minutes long, were performed per week. After a treatment course of fifteen treatments, the ICS questionnaire was repeated, and final stress and urge scores were obtained from the answers. Statistical analysis was performed using IBM SPSS statistics version 27.0. The data was tested with paired t-tests. [0058] At the timepoint of inclusion to the study the initial mean urge score was at 16.63 ± 6.75, as shown in Fig. 9 with reference sign 910. Within a time range of six to ten weeks, this initial mean urge score was reduced to a final mean urge score of 4.01 ± 4.99, as shown in Fig.

9 with reference sign 920. These results were significant with a p-value <0.001. Re-evaluation with the “Revised urinary Incontinence Score” of the ICS, which eliminates an ambiguity of the Gaudenz questionnaire relating to nightly visits to the restrooms without urine loss, leads to an initial score of 13.14 ± 3.11 and a final score of 2.92 ± 3.94. When broken down into male and female patients, scores differed slightly. The clinical trial included twenty-eight male patients who concluded the study, with an initial mean urge score of 13.75 ± 7.38, shown in Fig. 10 with reference sign 950, and with a final mean urge score of 3.21 ± 4.99, shown in Fig.

10 with reference sign 960. The twenty-eight male patients underwent radical prostatectomy before starting the EMS treatment cycle. One patient suffering from Guillain-Barre-Syndrome was included in the clinical trial, and treated efficiently. Seven female patients concluded the study, who had an initial mean urge score of 23.12 ± 2.67, as shown in Fig. 10 with reference sign 930, and a final mean urge score of 7.00 ± 5.06, as show in Fig. 10 with reference sign 940.

[0059] The patients, although mostly being elderly, were able to put on the gear without difficulties and without external help. The contact electrodes of the gear automatically contacted the right areas of the perineum when the pant-shaped positioning support was pulled up and the gear was worn like regular pants. The EMS treatment was very well tolerated by patients. No side effects occurred. The gear was washed and reused for the fifteen treatments over the course of six to ten weeks. The data shows significant results for the improvement of incontinence due to non-invasive EMS treatment with the gear and the EMS system including it. This training possibility is likely to also improve the compliance of elderly patients and other patients who might not be comfortable with anal electrodes or the like. The EMS treatment is also a good support for conventional pelvic floor training, done at home. The gear and the EMS system have the prospect to improve the treatment outcome of incontinence at home, without supervision. The gear and EMS system can most likely also improve the quality of life of incontinence patients. Positive effects were demonstrated in both female and male patients, including patients who had undergone severe surgeries or had given birth before.

[0060] While the foregoing is directed to embodiments, other and further embodiments may be devised without departing from the scope determined by the claims.