HK1128081B - Self contained device with treatment cycle for electrostimulation - Google Patents

Description

Self-contained device with electrical stimulation treatment cycle

Technical Field

The present invention relates to electrical nerve and muscle stimulation and to electrical stimulation apparatus and methods of such stimulation and in particular, though not exclusively, to electrical stimulation apparatus and methods for the electrotherapy treatment and electrical stimulation of muscles or nerve groups associated with pelvic floor muscle dysfunction including urinary and/or fecal incontinence.

Background

Women concerned with pelvic floor dysfunction have gradually become an important part of women's health care. These disorders, including urinary and fecal incontinence, sexual dysfunction, pelvic organ prolapse, affect a large proportion of adult women. One common cause is injury during vaginal delivery (vaginal delivery) which can lead to a variety of pelvic floor disorders; stress and urge urinary and fecal incontinence are the most frequent and long lasting.

Women have been encouraged to perform pelvic floor muscle exercises in order to restore pelvic floor muscle function after childbirth. Pelvic floor muscle exercise (PFMC) is a common treatment for muscles that exercise control of the function of urination. The rationale for using pelvic floor muscle motion for the treatment and prevention of stress incontinence is based on the fact that muscle changes can be produced after special strength training (strength training). A strong and well functioning pelvic floor can establish structural support for the bladder (bladder) and urethra (urethra). The effectiveness of postnatal (postpartum) pelvic floor muscle exercise in preventing and treating stress urinary incontinence during the immediate postpartum period has been demonstrated. The results also show that the success of postpartum pelvic floor muscle exercise depends on the frequency and intensity of the training efforts.

Pelvic floor muscle exercises, also known as Kegel exercises (Kegel exercises), are the method proposed by physicians dr. The muscles involved in strengthening PFME (pelvic floor muscle movement) are Levator Ani muscles (Levator Ani), which include the pubococcygeus (pubococcygeus), the pubovaginalis, the puborectalis, the iliococcygeus (iliococcygeus), and the iliococcygeus muscle, which are collectively referred to as the "deep muscles" of the pelvic floor complex. Under the direction of the patient, these muscles relax to allow storage and discharge of urine and feces at socially acceptable times and places. PFME also stimulates "superficial muscles", including the ischiocavernosus muscles (ischiocarposus), the bulbocangiosus (bulbospongiosus), the transverse peroneii, and the urethral sphincter. Regular exercise is necessary to increase the function of the pelvic floor muscles. Muscle stimulation improves pelvic floor muscle function.

This exercise requires the relevant muscles to be contracted and relaxed regularly during the day or over a period of many weeks, usually months. Known devices for this movement comprise a prefabricated core of rigid plastic material. This device is provided in the form of a set of graduated weights that require the (female) patient to insert them into the vagina and hold them in place. However, this is difficult for some women. The minimum available weight is too heavy or not properly sized. For many women, accurate placement (positioning) of the device is a problem. Women with moderate or severe genitourinary prolapse are not suitable for using these devices.

A variety of non-surgical approaches have been investigated as treatments for urinary incontinence, including PFME, biofeedback, other behavioral therapies, and pelvic floor stimulation. Pelvic Floor Stimulation (PFS) involves electrical stimulation of the pelvic floor muscles using probes or skin electrodes that are wired to a device that controls the electrical stimulation. It is believed that pelvic floor stimulation via the pudendal and levator ani nerves will improve urethral closure by stimulating pelvic floor musculature. In addition, PFS is thought to be able to partially improve denervating urethral and pelvic floor musculature by enhancing the nerve transplantation (reinnervation) process. PFS is also thought to improve the neuromuscular coordination of patients to enable them to perform appropriate voluntary contractions in the future. Patients receiving PFS can receive treatment at a doctor's office or physiotherapy equipment, or patients can receive initial exercises at a doctor's office and later undergo home treatment using a rented or purchased pelvic floor stimulator.

Traditional electrical stimulation treatment of urinary and fecal incontinence requires the patient to apply stimulation by making electrical contact with the body through an intracorporeal electrode or multiple skin electrodes. Electrical stimulation devices for home or office use are programmed to deliver stimulation at a pre-set frequency. Conventional electrical stimulation systems include a pulse generator housed in a portable battery case, connected to electrodes by appropriate leads.

Conventionally, electrical stimulation systems use drive signals for electrodes. Different drive signal types are used to achieve different therapeutic effects. Traditionally, such stimulation systems allow the patient to vary the drive signal pulse width or frequency. However, each such known portable stimulation system has electronics dedicated to providing specific predetermined drive signals having geometries and other characteristics that are consistent with the desired therapeutic effect. Traditionally, the adjustment of the control signal is provided by an electronic push button switch or a rotary control button. The switches and buttons are often compromised (tampered with) by the patient, thereby making it difficult for the practitioner prescribing the electrical stimulation therapy to control the therapy when the patient leaves the clinic.

Other known electro-stimulators include a device-based microprocessor, however, traditionally, they have a problem that a special pre-programmed device must be used in the clinic in order to set the signal parameters. Such equipment is very expensive and often difficult to use.

In EP0411632 an expandable vaginal electrode adapted for insertion into a woman's vagina is described for use with a controller external to the device and woman's body.

In WO98/34677 a tampon (tampon) specific for women suffering from urinary incontinence is described, which tampon consists of a sponge-like material and is used in the wet state. The tampon is used with a non-insulated electrode and an external control source to treat incontinence.

An electrical stimulator for treating incontinence is described in NL 8902023. The stimulator is rigid and self-contained.

Despite the existence of various devices that are technically and commercially available for the treatment of urinary and/or fecal incontinence, there remains a need for new devices that can provide effective, low cost treatment. Although a number of low cost, even disposable solutions have been proposed, none of them meets the requirements of most users in need of treatment. The devices are either cumbersome, require careful control over the treatment cycle, and are designed to be reprogrammable to create a wide range of treatment conditions to be used, or provide inadequate vaginal contact for effective treatment. A particular need for a disposable solution is to be able to meet the needs of the mass market and to provide the patient with the possibility to effectively self-treat without medical intervention and/or without physician guidance.

Disclosure of Invention

The present invention and its specific embodiments aim to address the above-mentioned needs and problems associated with conventional plug-type electrodes, electro-stimulation devices and procedures known in the art, as well as the problems arising in the treatment of anterior and posterior pelvic floor muscle dysfunction, including prolapse, difficult defecation, sexual dysfunction and incontinence using such electro-stimulation devices and procedures.

According to the present invention, in a first aspect, there is provided a vaginal or anal electro-stimulation device for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex, comprising: a body, and at least two electrodes located on or on an outer surface of the body, an internal power source and an internal device that generates and controls electrical pulses for neuromuscular electrical stimulation, the apparatus being self-contained and being pre-programmed to provide a waveform electrical stimulation treatment cycle, the treatment cycle including an initial phase in which current is gradually ramped from an initial level to a higher level, a second phase in which current is gradually ramped from the higher level in the first phase to a second higher level, and a third phase in which current is maintained at the second higher level.

In another aspect, the present invention provides a vaginal or anal electro-stimulation device for neuromuscular electro-stimulation of the musculature of the pelvic floor complex, comprising: a body, and at least two electrically conductive elements located at or on an outer surface of the body, an internal power source and internal means for generating and controlling electrical pulses for neuromuscular electrical stimulation, the electrical stimulation apparatus being self-contained and programmed to provide a waveform electrical stimulation treatment cycle, the waveform comprising two or more components, each component being a sequence of regularly spaced pulses.

In a third aspect, the present invention provides a vaginal or anal electro-stimulation device for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex, comprising a body, and at least two electrically conductive elements located at or on the outer surface of the body, an internal power source and internal means for generating and controlling electrical pulses for the neuromuscular electro-stimulation, the electro-stimulation device being self-contained and being pre-programmed to provide an electro-stimulation treatment cycle of a waveform including an initial phase in which current is gradually increased from an initial level to a higher level, a second phase in which current is gradually increased from the higher level in the first phase to a second higher level, and a third phase in which current is maintained at the second higher level and the waveform has two or more components, each component is a sequence of regularly spaced pulses.

In use, the apparatus of the invention is operated in use by a user to provide electrical pulses of a predetermined waveform which provide neuromuscular electrical stimulation of the muscles of the pelvic floor complex. The waveform characteristics of the electrical stimulation signal are not changeable by, for example, the patient's user, and the waveform can be predetermined and preprogrammed on a microprocessor located on a PCB internal to the device.

In the following disclosure, the description relates to all aspects of the invention, which can be used in combination of each aspect with each other aspect.

The circuit has a microprocessor that is pre-programmed to provide the required waveform prior to assembly of the electro-stimulation device. Suitable waveforms may be used as described in WO97/47357 or US6865423, the contents of WO97/47357 and US6865423 being incorporated herein by reference in their entirety. In one embodiment, the second component is combined with the first component, but the interval between successive pulses of the second component is smaller than the interval between successive pulses of the first component. In another embodiment, there is a third component having intervals between successive pulses that are smaller than the intervals between successive pulses of the second component. In yet another embodiment, there are periods of relaxation (periods of relaxation) between the sets of pulse sequences. In this embodiment, the period of relaxation is preferably at least equal to the period of stimulation. The treatment cycle may be carried out for a total time of 3 hours or less than 3 hours, preferably 2 hours or less than 2 hours, preferably 1 hour or less than 1 hour, most preferably less than 1 hour. In a particularly preferred embodiment, the treatment period is 45 minutes or less than 45 minutes. Typically, the treatment is provided by a combination of a stimulation period and a relaxation period. Typically, each combination is 2 minutes or less, preferably 1 minute or less. In one embodiment, the stimulation phase is about 10 seconds and the recovery phase is about 50 seconds. In a preferred embodiment, the recovery phase is approximately equal to or greater than the stimulation phase, preferably both phases are 5 to 10 seconds. The first component may have a pulse repetition frequency of between 1 and 15Hz, more preferably between 1 and 6Hz or between 5 and 15Hz, and the second component may have a pulse repetition frequency of between 30 and 60Hz, more preferably between 40 and 60 Hz. The third component may have a frequency of the pulse component between 80 and 300Hz, more preferably between 80 and 200 Hz. The pulse may have a pulse width of 50 to 350 microseconds. The pulse amplitude for each component may be the same amplitude or different amplitudes. The pulse width may be narrow at an early stage of the treatment cycle and then gradually increased or paced throughout the treatment cycle. The variation of the pulse width in this way can be used as an alternative to or in addition to the variation of the pulse amplitude during the treatment cycle. The pulse amplitude for each component may be the same amplitude or may be different amplitudes for each component. The pulse amplitude of each component may be a fixed amplitude throughout the treatment cycle, or preferably the pulse amplitude may be set to one or more amplitudes over one or more periods of time within the treatment cycle. The pulse may be between 0 and 90 mA. In a preferred embodiment, the pulse amplitude is initially set at a lower level and then gradually ramped up to a higher amplitude over a treatment period. In a preferred embodiment, the waveform consists of a series of pulses with a pulse width of 150 to 350 microseconds at a maximum voltage of 60 volts. The electro-stimulation device is programmed to automatically adjust the output level of the device from zero volts up to a therapeutic maximum over a period of approximately 45 minutes. Thereby ensuring a safe and comfortable start of the treatment cycle and enabling comfortable attainment of the maximum output value by initially adapting to the low intensity pulses. The current is preferably applied in regulated and increased amounts over a treatment time of about 20 to 50 minutes, preferably over a treatment time of 20 to 45 minutes, more preferably over a treatment time of 20 to 40 minutes. Preferably, the treatment cycle starts at 45mA or less, preferably 40mA or less, and rises to 40mA or more preferably 45mA or more with a ramp sequence therebetween for the last ten minutes of the treatment cycle. In one embodiment, the current is applied at 6mA after insertion and rises to 12mA in the first ten minutes, then gradually rises from 12mA to 40mA in the next ten minutes, and then remains at 40mA for the next ten to fifteen minutes, depending on the pulse frequency of, for example, 35Hz and the pulse width of 250 microseconds. Thus, within a treatment period of 30 to 45 minutes, the regimen (profile) starts with a lower impact on the user and then increases in intensity. The use of this cycle is particularly useful in the electro-stimulation device of the present invention.

Self-contained means that the electro-stimulation device does not require or use an external power source, an external electronic pulse generator or an external control unit. No intervention or manipulation by a physician or other medical professional is required. Each electro-stimulation device of the present invention contains all the necessary elements necessary to perform a single electro-stimulation treatment session for the treatment of anterior and posterior pelvic floor muscle dysfunction. Preferably the electro-stimulation device does not have any means to replace or recharge the enclosed battery or batteries. Although not preferred, the device may have a power source external thereto and power is supplied to the device by an electrical cord. In another embodiment, the apparatus may not include an internal power source, but instead receive sufficient power for the required treatment cycle through an external device during or just prior to use. There is no means to provide reprogramming of the internal microprocessor control circuitry, e.g. the control unit and/or signal generator, to provide different electrical stimulation patterns when the device is pre-programmed. The electro-stimulation device may be disposable after its use and is designed as a disposable electro-stimulation device, meaning that the device is used for a single treatment cycle and then discarded.

The body of the device may be rigid, or semi-rigid, e.g. soft but not soft enough to be compressed. The material used may be any compatible material such as a biocompatible plastic or a metal such as stainless steel.

In a preferred embodiment, the device and the device body are substantially compressible in at least one dimension. The electro-stimulation device in its non-compressed form is of a size such that one or more of its outer surfaces and one or more electrically conductive elements located on or on the electro-stimulation device body are in contact with one or more surfaces of the vaginal or anal endocavity. Typically, the device is in a partially compressed state when in-situ. This condition is caused by contact of the device with the vaginal or anal endocavity. In this state, one or more external surfaces of the electro-stimulation device and one or more electrically conductive elements located on or in the electro-stimulation device body are in intimate contact with one or more surfaces of the internal chamber. They are forced into contact with one or more surfaces of the lumen by elastic forces caused by the material used to manufacture the device body and/or due to the internal structure of the device. In general, electro-stimulation devices of these sizes are not easily inserted into the vagina or anus for use. However, when the dimensions of the electro-stimulation device of the present invention are reversibly compressible, the dimensions of the electro-stimulation device may be reduced to the required dimensions for ease of insertion. The range of compressibility is such that the device can be compressed to a size such that the device can be easily inserted into the vaginal or anal endocavity. Preferably the dimensions of the body of the electro-stimulation device, the material from which the body of the electro-stimulation device is made and/or the structure of the body of the electro-stimulation device are such that when the electro-stimulation device is in place, the surface of the electro-stimulation device body and the electrically conductive elements located on or on the surface of the device body are forced, for example under pressure, towards one or more surfaces of the lumen. Preferably, the electro-stimulation device body is manufactured with one or more resiliently deformable materials. Thus, the body of the electro-stimulation device, which is resiliently deformable when inserted, can expand to conform to the shape of the vaginal or anal endocavity after insertion into place. The electro-stimulation device in place is able to change its shape to substantially conform to the change in shape of the lumen during use of the device, so the device is comfortable during use. It should be understood that the dimensions described in detail below are those of the device designed for use in the vaginal cavity. Devices suitable for use in the anal endocavity will have smaller dimensions due to the smaller dimensions of the anal endocavity compared to the vaginal endocavity.

In another embodiment, the electro-stimulation device body may be compressed due to the choice of materials from which the device is made in combination with due to the structure of the device. For example, the electro-stimulation device body may be made of an elastically deformable material, and the interior of the electro-stimulation device body may be hollow. In this embodiment, when the electro-stimulation device is compressed, the body material deforms and the hollow interior is compressed or collapsed to a smaller volume. This combination may provide a highly reversible compressibility to the electro-stimulation device, so that the electro-stimulation device may be compressed to a significantly smaller volume than in the non-compressed state.

Preferably, the material used for the electro-stimulation device body is an elastically deformable/compressible biocompatible material and may be formed as a solid or semi-solid block of an elastically compressible biocompatible material so as to allow the electro-stimulation device body to elastically deform and conform to the shape of the object deforming the device, for example the vaginal or anal endocavity, or the wall of the applicator when in use. The elastically deformable/compressible biocompatible material may be selected or tailored to provide any desired degree of deformability/compressibility and/or elastic properties. The material may be selected and adjusted to provide the desired softness and/or firmness qualities, and to select the level of support required for effective contact with the luminal wall while maintaining the ability to conform to the shape of the anal or vaginal wall. Preferably, the deformable/compressible device body comprises a biocompatible material in the form of a compressible/deformable foam. Examples of suitable materials include thermoplastic foam materials such as polyvinyl formal foam (PVF), polyurethane foam. In a preferred embodiment, the device body is made of polyurethane, most preferably molded polyurethane foam. These polyurethane foams may be prepared from polyols and isocyanates, which are mixed and injected into a molding tool where they foam and are cured. In an alternative embodiment, the apparatus body is provided in two moulded halves formed of a suitable polymer and then brought together to seal the other components of the apparatus; the two halves may be sealed together, for example by hot plate welding, to provide a hollow device body. In this embodiment, the device body does not contain foam.

The foam device body may comprise a closed cell foam or an open cell foam. Preferably, the foam is an open cell foam. The use of open cell foams is desirable to provide a high level of compressibility and deformability. In a preferred embodiment, the foam formulation (foam) selected is self-skinning. During the manufacture of the device body, a skin of material compositionally the same as that of the foam inside the body is formed on the surface of the device body by injecting a foamable composition into a suitable mould. Preferably, the foam of the device body has a relatively low density. Thereby ensuring maximum compressibility/deformability of the device simply inserted into the applicator, if an applicator is used, and the device inserted into the relevant body lumen. Preferably, the foam density is less than 250Kgm^-3Preferably less than 200Kgm^-3Most preferably less than 150Kgm^-3. Preferably, the foam density is from 250 to 80Kgm^-3More preferably, in the range of 200 to 80Kgm^-3In the range of, more preferably, 200 to 100Kgm^-3In the range of, most preferably, 150 to 100Kgm^-3Within the range. In addition to the relatively low density, it is preferred that the polymer system used in the foam manufacture does not produce a rigid foam material that is strongly resistant to deformation. Preferably, the polymer system is selected so as to produce a relatively soft foam materialThe foam material has a relatively low IDF (indentation deflection force measured according to astm d 3574) value. At the same time, the material used to make the device body should be selected so as to produce a device body foam that is sufficiently rigid that the skinned surface and foam volume remain intact during manufacture and use of the device.

Since the device of the invention may be stored in a compressed state, for example in an applicator, the material used to manufacture the device must be stable for an extended period of time and maintain the material properties during the normal shelf life of the device. In particular, the elastically deformable/compressible materials must retain their properties during storage so that when released from compression, for example when withdrawn from an applicator, they are able to expand to a normal, non-compressed state and to exert the required pressure on the anal and vaginal endocavity. It is also important that the materials used do not leach (leach) chemicals such as plasticizers and the like during storage. The resiliently deformable/compressible material used to prepare the device body will exhibit a relatively rapid change from the compressed to the uncompressed state, such that on insertion, the device rapidly expands from the compressed state to contact the associated lumen. The change from the compressed state to the uncompressed state will normally occur in a matter of seconds, preferably less than 10 seconds, more preferably less than 5 seconds, and most preferably less than 3 seconds.

The electro-stimulation device of the invention may comprise an electro-stimulation device body which has been moulded around the internal components of the electro-stimulation device to seal the internal components. Alternatively, the electro-stimulation device body may be manufactured with a hollow interior within which the internal components are placed during manufacture of the electro-stimulation device. In another embodiment, the device body is molded in two halves, preferably by overmolding (overmould) each conductive element; the two halves are then sealed around the inner member using a technique such as hot plate welding. The device may be manufactured by a combination of any of these methods. Preferably, however, the device body is integrally (one piece) pre-molded with a cavity accessible from the outside, the cavity being capable of receiving and housing the conductive element and the electronic accessory. In a preferred embodiment, the molded device body includes an electronic accessory chamber accessible from a distal end of the molded device body, and preferably includes a recess molded along each side of the device body for receiving a conductive element at each side of the device.

In another preferred embodiment, the electro-stimulation device of the present invention may have a defined shape, preferably indeed. In particular, the shape of the electro-stimulation device may be selected so as to exhibit certain characteristics relating to its symmetry. Preferably, the cross-sectional shape of the device perpendicular to the axis of insertion is not circular when viewed along the axis of insertion. Preferably, the perpendicular cross-section is taken at the midpoint of the device along the axis of insertion. Preferably, the shape of the electro-stimulation device is such that the shape of any cross-section perpendicular to the axis of insertion is: when the electro-stimulation device is in place, it may not be freely rotatable about the axis of insertion whilst at the same time being in the greatest possible contact with the wall of the anal or vaginal endocavity. In one embodiment, this perpendicular cross-sectional shape may not exhibit any plane of reflective symmetry or rotational axis symmetry, e.g., the shape is completely asymmetric. In one embodiment, although the cross-section is not circular, preferably the perpendicular cross-sectional shape exhibits at least one axis of reflective symmetry and/or rotational symmetry, rather than an infinite number of axes of reflective symmetry or rotational symmetry; the vertical cross-sectional shape may thus be any non-circular shape. In a preferred embodiment, the perpendicular cross-sectional shape approximates a rectangle or square, preferably with gently rounded corners that are not angular and do not define a right angle or any defined angle. The extent of rounding of these corners is such that when the device is viewed in a perpendicular cross-section along the axis of insertion, it is clearly seen that the perpendicular cross-sectional shape results from a generally rectangular or square shape. Preferably, the perpendicular cross-sectional shape is substantially square or rectangular in shape. Preferably, the perpendicular cross-sectional axis exhibits at least one axis of reflective symmetry, more preferably at least two axes of reflective symmetry. In embodiments of a substantially square or rectangular shape, the shape of the perpendicular cross-section exhibits at least two axes of reflective symmetry and at least one axis of rotational symmetry; the substantially square shaped embodiment has four axes of reflective symmetry and one axis of rotational symmetry, and the substantially rectangular shaped embodiment has two axes of reflective symmetry and one axis of rotational symmetry. The device of the invention may have a shape such that the shape of the side, i.e. in a cross-section along the insertion axis of the device, when the device is seen from the side, is substantially similar to the shape of the device when seen along the insertion axis of the device, e.g. from the front of the device. When viewed from above (at an angle of about 90 degrees from the side view), the device assumes a shape that is similar to or different from the shape and size of the side or front view. In a preferred embodiment, the side and top views of the device are of different shapes and/or sizes from each other and from the front view of the device. In one embodiment, the side view may not exhibit any rotational or reflective symmetry axis. In one embodiment, the side view may exhibit one axis of rotational symmetry and two axes of reflective symmetry; in a preferred embodiment, one axis of reflective symmetry is present, and no axis of rotational symmetry is present. In another embodiment, the top view may not exhibit any rotational or reflective symmetry axis. In yet another embodiment, the top view may exhibit one axis of rotational symmetry and two axes of reflective symmetry; in a preferred embodiment, one axis of reflective symmetry is present and no axis of rotational symmetry is present. The device may have two different ends. The first end is adjacent to the insertion point into the anus or vagina and the second end is distal to the proximal end or insertion point. In one embodiment, the proximal end is larger in size than the distal end of the device; thus, the device has a conical or pear-shaped profile when viewed from the side or top of the device and from two perspective views. Preferably, the device is larger in size when viewed from the top than when viewed from the side of the device, so that the device may have a somewhat flattened profile when inserted. Alternatively, the dimensions may be opposite to the proximal end, which has a somewhat smaller dimension than the distal end of the device.

In one embodiment, the dimension of the electro-stimulation device body along the axis of insertion is greater than the dimension perpendicular to the axis, e.g. cross-section. In an alternative embodiment, the dimensions of the body may be similar in both views.

The compressibility of the device allows for easy insertion of the device into the associated lumen. The limits of compressibility are set by the material properties of the elastically deformable material used, for example for the body, the internal structural properties, for example the presence of hollow cavities, and the dimensions of the electronic components used internally. Ideally, these are selected so as to provide the maximum amount of compressibility for the device. In one embodiment, the electro-stimulation device may be compressible to a plurality of sizes that are scaled differently from each other compared to the corresponding sizes of the device in the non-compressed state. In another embodiment, the device may be compressed to the same and similar extent in all its dimensions. In yet another embodiment, the device has greater compressibility in a plane perpendicular to an insertion axis of the device. The electro-stimulation device may have two dimensions perpendicular to the axis of insertion, the two dimensions having different degrees of compressibility. For example, in the non-compressed state, the electro-stimulation device may have a length of about 60 to 65mm, a height of about 30 to 45mm and a width of about 30 to 45 mm. In the compressed state, the compressed electro-stimulation device may have a length of about 60 to 65mm, a height of about 25mm and a width of about 15 mm. In the non-compressed state, the electro-stimulation device may have a length in the range of from about 30 to 120mm, preferably in the range of about 40 to 100mm, more preferably in the range of about 45 to 75mm, most preferably in the range of about 45 to 65 mm. In the non-compressed state, the electro-stimulation device may have at least two equal dimensions or at least two unequal dimensions perpendicular to the axis of insertion, the dimensions being in the range of about 30 to 60mm, preferably about 35 to 55mm, most preferably about 35 to 50 mm. Preferably the length of the electro-stimulation device in the non-compressed state is equal to the length of the electro-stimulation device in the compressed state. The materials selected for the manufacture of the electro-stimulation device and/or the structure of the electro-stimulation device are such that at least one of the dimensions of the electro-stimulation device perpendicular to the axis of insertion is reduced in compression by at least 20%, more preferably by at least 40%, more preferably by at least 50%, most preferably by at least 60%. All dimensions of the electro-stimulation device perpendicular to the axis of insertion may be reduced in compression by at least 15%, preferably by at least 25%, more preferably by at least 35%, most preferably by at least 40%. In the compressed state, the dimensions of the electro-stimulation device perpendicular to the axis of insertion may be such that the width of the device is in the range 10 to 35mm, preferably 10 to 30mm, preferably 10 to 25mm, most preferably 15 to 20mm, such that the height of the electro-stimulation device is in the range 10 to 40mm, preferably 10 to 35mm, preferably 10 to 30mm, most preferably 15 to 30 mm. Preferably, the device has sufficient compressibility such that the volume of the device in the compressed state is reduced by at least 20%, preferably at least 25%, more preferably at least 30%, more preferably at least 40%, more preferably at least 50%, most preferably at least 75% compared to its volume in the uncompressed state.

In yet another embodiment, the electro-stimulation device of the present invention may be composed of a variety of materials and constructed such that the device may be compressed into a shape approximating a tampon form. In this form, the device is easier to insert into the vagina or anus. Once the electro-stimulation device in the form of a tampon is inserted and placed in position, the device will expand and come into contact with the walls of the vaginal or anal endocavity.

Thus, by using an applicator, the electro-stimulation device of the present invention may be adapted to be deployed into the anal or vaginal endocavity. The applicator may for example be a hollow tubular applicator containing the electro-stimulation device in its bore in a compressed state. The device is deployed from the applicator into the vagina or anus. Typically, the applicator, including the compressed device, is positioned at the vaginal orifice (opening) or anal sphincter and then, by operating the piston, the device is expelled from the applicator into the anus or vagina. The compressed electro-stimulation device may be expanded once the device is within the vagina or anus.

The invention also provides an electro-stimulation device for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex, for example for the treatment of anterior or posterior pelvic floor muscle dysfunction, the device comprising an electro-stimulation device according to the invention in combination with an applicator. Preferably the applicator comprises an outer member and an inner member, the electro-stimulation device being located within the outer member.

In this embodiment, the outer member is adapted to house the electro-stimulation device and the inner member. The inner member is located and movable within the bore of the outer member and cooperates with the outer member to force the electro-stimulation device out of the bore of the outer member after the applicator has been positioned at the vaginal orifice (opening) or anal sphincter.

In a preferred embodiment, the inner member is adapted to assist in activating the electro-stimulation device when the device is deployed from the applicator. The inner member in this embodiment may be adapted to assist in the activation of the electro-stimulation device may take the form of a particular shape or arrangement of the proximal end of the inner member such that the proximal end of the inner member is in contact with part of the activation mechanism of the electro-stimulation device. During deployment of the electro-stimulation device from the applicator, the inner member contacts and remains in contact with the activation mechanism until the device is deployed. It is the contact between the proximal end of the inner member and the activation mechanism combined with the necessary amount of stiction force between the electro-stimulation device and the outer member of the applicator that ensures that sufficient force is applied to the activation mechanism during deployment to activate the device. The force required to activate the activation mechanism by this contact is less than the force required to overcome the stiction force between the outer member and the encapsulated electro-stimulation device. This means that the force applied to the inner member during deployment will activate the activation mechanism before the inner member forces the electro-stimulation device out of the outer member into the lumen by the applied pressure. The preferred activation mechanism associated with the use of the applicator will be described in detail below. In a preferred embodiment, the applicator includes a detent position which helps to prevent inadvertent actuation of the electro-stimulation device during manufacture, storage or opening of the package by the end user. It is necessary to apply an appropriate force to the inner part in order to disengage the detent position described above and allow the inner part to move relative to the outer part. In another preferred embodiment, the inner member is in the form of a hollow tube. This arrangement has the advantage that when a retrieval cord is used, it can pass down through the bore of the tube, thereby avoiding being trapped between the inner and outer parts during deployment of the device. This arrangement also facilitates alignment during assembly of the applicator with the electro-stimulation device.

The applicator may be marked, serrated or grooved so that the direction of insertion is apparent to the user.

In addition to the device body, the electro-stimulation device comprises an electronic assembly comprising at least two conductive elements and a complete set of internal electrical components necessary to generate and control the electro-stimulation pulses to the musculature of the pelvic floor complex via the conductive elements. These components include, in particular, a power supply, a signal generating device and a microprocessor based control circuit. The circuit includes a voltage generator preferably having a voltage range of 0 to 60 volts, an amplitude control circuit, a control logic pulse table (control pulse table) and a pulse conversion circuit. Preferably, the internal electrical components are located on a Printed Circuit Board (PCB). In addition, means for activating the circuit electronics are associated with the internal electrical components.

The circuitry within the electro-stimulation device may house one or more batteries as its power source. When the electro-stimulation device is a single use device, the battery may be a small battery that is easily accommodated within the compressed dimensions of the electro-stimulation device. Suitable batteries include those with a low level of potentially harmful materials, such as low or zero mercury zinc cathode batteries or lithium manganese button cells. The device may be rechargeable or powered by an external power source, but preferably one or more batteries are the dedicated power source for the device.

The conductive elements may be provided on and connected to the surface of the electro-stimulation device and connected to the internal circuitry by suitable conductive paths, for example wiring. Alternatively, the conductive elements may be formed as part of the internal components of the electro-stimulation device and exposed on the surface of the electro-stimulation device body through suitably defined apertures in the device body. Preferably, the conductive element is preformed and not formed as part of the inner member, but the conductive element is connectable to the inner member or connectable to a conductive element in communication with the inner member. The conductive elements may be made of a biocompatible conductive material such as stainless steel, conductive rubber, conductive plastic, sputtered plastic, or plated plastic. Suitable examples of electrode materials are conductive styrene-butadiene-styrene (SBS) materials; the electrical conductivity is provided by a carbon filter. The conductive SBS electrodes can be manufactured by injection molding or extrusion. In one embodiment, the preferred electrode material is conductive Ethylene Vinyl Acetate (EVA); this material helps to reduce the stick-rub force between the device and applicator in use. Another suitable material is conductive silicone rubber. The conductive element may be sized and shaped such that the conductive element covers or is exposed on a majority of the exterior surface of the device body. The conductive elements may be of any shape or size, except that (save that) requires sufficient space between them to prevent shorting the device. In one embodiment, the conductive element is approximately rectangular in shape and has dimensions of approximately 28mm by 13 mm. In this embodiment the conductive elements are located at or on opposite surfaces of the electro-stimulation device, spaced apart by approximately 180 degrees. The purpose of these conductive elements is to conduct the waveform from the electro-stimulation device to the musculature of the pelvic floor complex. In a preferred embodiment, the conductive element is in the form of a flat plate. In yet another embodiment, the conductive element may be annular, so that there are two annular conductive elements forming two continuous bands around the circumference of the electro-stimulation device; preferably, this circumference is perpendicular to the insertion axis. The conductive element may be made of a material that is deformable to cooperate with the deformation of the device body. In an alternative embodiment, the electrically conductive element may be located on a resiliently deformable arm which communicates with the interior of the device and compresses the electrically conductive element when the electro-stimulation device is compressed. The conductive element may be sprung (sprung) to maintain proper pressure on the walls of the vagina or anus during use. In another embodiment, the conductive element includes a clamping mechanism that can clamp a conductive element, such as wiring, within the device to the conductive element, thereby electrically connecting the conductive element to the PCB. In one embodiment, the conductive element is molded as one piece with the conductive element.

In a preferred embodiment, all electronic components of the electronic assembly, except for the conductive elements and associated wiring, but including the activation mechanism, are sealed wholly or partially within the frame. The interior of the frame can receive a PCB and through appropriately located holes can allow conductive paths to pass from the device body into the frame to make electrical contact with the PCB. Preferably, at one end of the frame there is an opening that can receive an activation device for the apparatus. The activation mechanism may be partially sealed within the frame. In a preferred embodiment, the frame comprises two members reversibly engaging each other to provide a closed portion of the frame and to provide an open portion of the frame. Preferably, the PCB is located within the enclosure portion and the activation device is associated with the enclosure portion and the opening portion. The activation device will be described more fully below. An advantage of the closed portion of the frame is that it is possible to prevent liquid from entering sensitive components of the PCB during manufacturing of the device or during use of the device. Another advantage is that material is prevented or limited from flowing out of the member within the frame. Preferably, the frame is made of polypropylene or ABS (acrylonitrile butadiene styrene) polymer. During manufacture of the device, the frame includes a PCB and the actuating mechanism can be easily inserted and engaged into a pre-molded cavity within the molded device body. This chamber communicates with other smaller chambers that house surface exposed conductive elements and their conductive paths, such as wires. This arrangement provides a simple means for assembling the individual components into an apparatus, thereby providing a robust apparatus.

Thus, in a further embodiment, the invention provides an electro-stimulation device for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex, for example for the treatment of anterior or posterior pelvic floor muscle dysfunction, the device comprising a device body and at least two electrically conductive elements located on the surface of the device and secured to and resiliently biased against points located within the interior of the device such that the electrically conductive elements may be reversibly compressed towards the interior of the device. In a preferred embodiment, at least one of the conductive elements is part of a device component, as described below. Preferably, at least one of the conductive elements is fixed to an internal point of the device by an arcuate arm member composed of an elastically deformable material.

It is also envisaged that the electro-stimulation device may be provided as a kit providing a complete set of devices, with or without applicators, for example for the daily treatment of incontinence, in accordance with the present invention. In one embodiment, it is envisaged that the kit may include electro-stimulation devices having different therapeutic waveforms. In this case, the devices may be used sequentially to provide increasingly stronger treatment protocols as the user progresses through the treatment process.

The invention also provides a method of neuromuscular stimulation of the musculature of the pelvic floor complex, for example for the treatment of anterior or posterior pelvic floor muscle dysfunction, the method comprising the use of an electrical stimulation device according to the invention. In a preferred embodiment, the method comprises the use of a stimulation device according to the invention for the treatment of anterior or posterior pelvic floor muscle dysfunction.

It is envisaged that the electro-stimulation device of the present invention may be used in the presence of unknown dysfunction of the musculature of the pelvic floor complex resulting in any symptoms of dysfunction such as incontinence. In these cases, the device of the invention may be used to improve the performance of the musculature of the pelvic floor complex prior to its dysfunction or to help prevent dysfunction. As one example, women may use the device prior to pregnancy in order to strengthen or to ensure that the musculature of the pelvic floor is in a good physical condition prior to pregnancy or childbirth.

In one embodiment, the electro-stimulation device comprises a removable patch or cord attached to the device which facilitates removal of the device. This tab or wire may also cooperate with the internal components of the device to activate or deactivate (deactivate) the device in place. The cord may be in the form of a pull cord having the function of acting on an internal component, such as a battery, under the application of force/torque to the cord. In this embodiment, the device may be placed in position by using an applicator and then the string is pulled gently to activate the device.

In a preferred embodiment, the microprocessor controlled circuit includes a delay (delay) after activation to ensure that the conductive element surfaces are in place before the treatment cycle begins. In yet another embodiment, the electro-stimulation device may include a one-time start/stop mechanism associated with the inner member. Examples of such mechanisms include: means for detecting a change in impedance of the conductive element after insertion of the device; use of gel shorting (gel shorting) conductive elements; starting a zinc/air battery; detecting insertion using a light sensor; a pressure sensor to detect inflation upon deployment of the device and to detect compression of the device during removal; an in-base (inbase) relay switch activated by the applicator; a hall effect switch in the base activated by the applicator; removing the thin plastic insulator by the applicator to make contact with the battery; e.g., activated by expulsion from the applicator using a reed switch and magnet; and initial additional compression of the device upon expulsion from the applicator acts on the pressure switch.

In a preferred embodiment, the device includes an activation mechanism associated with internal circuitry of the device that is activated by a force applied to the activation mechanism by an inner member of an applicator that is external to the device. In this embodiment, the activation mechanism comprises a switch member associated with a microprocessor controlled circuit located within the body of the device and also contactable by internal components of the applicator, the activation mechanism further comprising at least two switch contacts associated with the circuit, the switch contacts contacting the switch member by interaction to activate the circuit. In one embodiment, the movable switch member may be in the form of a plug arrangement, and the switch contacts may be located within a socket arrangement of the device, the plug corresponding to the movable switch member. Movement of the switch member relative to the device body forces the switch member to be inserted into the socket housing the two switch contacts, forcing them into contact, thus activating the circuit.

In a preferred embodiment, the movable switch member is captured by an associated internal member of the switch within the device while being exposed to the exterior of the device. This means that the movable switch member cannot be completely removed from the apparatus main body while being movable relative to the apparatus main body. The capture capability of the switch member within the device is important to be able to effectively stop the device. In a preferred embodiment, the movable switch member further comprises a cord located on or attached to an outer surface of the member. Using this cord, the device can be stopped before it is removed from the patient. When the device is in place and activated, the cord passes through the device and out of the patient where it can be easily accessed by the patient. When the patient requests that the device be stopped and removed, the patient pulls on the cord. The pulling force applied to the cord is transmitted to a movable switch member which, under the effect of the force applied thereto, is forced away from the two switch contacts to open the circuit. When the movable switch member is captured within the device, a point occurs at which the movable switch member cannot move any further relative to the device body, and at which the applied pulling force is applied to and presses against the entire device, now, under the continuous application of pulling force on the cord, the entire device can be removed. The relative force required to separate the switch member from the switch contacts is much less than the force required to remove the device from the patient. Because of the relative imbalance in force, the device is always stopped early in the removal cycle to ensure that the patient can remove the device comfortably. In a further embodiment the socket also comprises support means for supporting said plug in position within the socket. This support means may take the form of a low pressure spring arrangement which contacts the plug surface and clamps it in the engaged position. The force necessary to disengage the plug from these support means is significantly less than the force required to remove the entire device from the patient under the action of pulling the cord.

In a preferred embodiment, the capture function is imparted by the interaction between one or more protrusions on the movable switch member and one or more slots in the frame of the electronic accessory. The slot is closed at one end to ensure that the movable member cannot be disengaged from the frame when the protrusion of the movable switch member engages the slot in the assembled state. In one embodiment, the projection may take the form of a resiliently deformable arm connected towards the distal end of the member and aligned parallel to a line inserted into the device with the end of the arm at the proximal end of the member. The ends of the arms have outwardly facing barbs that extend beyond the outer circumference of the movable member. During assembly, when this movable member is inserted into the slit portion of the frame, the barbed arms are forced inwardly towards the centerline of the member so that the barbed surfaces no longer extend beyond the circumference of the movable member. When inserted, the barbed arms are held in this position until the closed slit meets the barbed end engaged in the slit of the frame at a point when the barbed arms are able to move into the resting position. This arrangement allows deformation of the movable member at the time of assembly while preventing removal of the movable member after assembly. In yet another embodiment, it is contemplated that the frame body may further include guides for the barbed arms to facilitate assembly; these guides may take the form of grooves on the inner surface of the frame body and communicate with the outside of the frame body and the closed slit of the frame.

Thus, in another embodiment, an electro-stimulation device of the invention may further comprise an activation mechanism comprising a movable switch member captured within the device and having at least one of its surfaces exposed to the exterior of the device, the activation mechanism being activatable by movement of the switch member by the applicator upon expulsion of the device from the applicator. Preferably, the switch member is exposed towards the distal end of the device. Preferably, the switch member is moved or activated by the impact of the proximal end of the inner member, most preferably the switch member is moved or activated by the proximal end of the inner member impacting on the distal face of the switch member.

Drawings

For a better understanding of the present invention, and to show how the same may be carried into effect, various specific embodiments thereof are illustrated by way of example in the accompanying drawings, in which:

figure 1(a) shows a perspective view of an electro-stimulation device according to the present invention; figure 1(b) (i) shows a cross-sectional view of the device perpendicular to the insertion axis (x) of the device; FIG. 1(b) (ii) shows a side view of the apparatus and FIG. 1(b) (iii) shows a top view of the apparatus;

figures 2(a) and 2(b) show perspective views of an electro-stimulation device according to the present invention in an uncompressed state and a compressed state;

figures 3(a) and 3(b) show an application device (or applicator arrangement) using the electro-stimulation apparatus of the present invention;

figures 4(a), 4(b) and 4(c) show the assembly of an electro-stimulation device and the internal components and conductive elements used in an electro-stimulation device according to the invention;

FIG. 5 shows a schematic and circuit diagram of the internal circuitry used in the electro-stimulation device of the present invention;

figure 6 shows a perspective view of an electro-stimulation device according to the present invention;

figure 7 shows a perspective view of the device body of the electro-stimulation device of figure 6;

FIG. 8 shows a perspective view of an electronic accessory of the device shown in FIG. 6;

FIG. 9 shows a perspective view of the electronics assembly of FIG. 8 with the frame (chassis) removed;

figure 10a shows a perspective view of an electro-stimulation device according to the present invention; FIG. 10b shows various front views of the device of FIG. 10 a;

FIG. 11a shows an exploded perspective view of the components of the apparatus of FIG. 10a prior to their assembly; FIG. 11b shows an electronic accessory of the device of FIG. 10 a; and

fig. 12(a) and 12(b) show an applicator using the electro-stimulation device of fig. 6 and 10 a.

Detailed Description

Referring to fig. 1(a), there is shown an electro-stimulation device (1) in an uncompressed, fully expanded state. The device (1) has a body (2), the body (2) being constructed from a biocompatible resiliently compressible foam. The electrode members, also referred to above and hereinafter as conductive elements (3 and 3 ' not shown), emerge from the inside of the body (2) of the device and are located on the surfaces (4 and 4 ' not shown) of the sides (5 and 5 ' not shown) of the device (1). The conductive elements (3 and 3' not shown) are relatively flat. In this particular embodiment, the electrode members (3 and 3') communicate with internal members (not shown) of the device (1) via internal conductive pathways. They pass from inside the device (1) so as to provide electrode surfaces (6 and 6 'not shown), said electrode surfaces (6 and 6' not shown) lying in substantially the same plane as the surfaces (4 and 4 ') of the sides (5 and 5') of said device. The bodies of the flat electrode members (3 and 3 ') are located below the surfaces (4 and 4') of the body (2) within a cavity (not shown) within the body (2) of the device (1). The surfaces (6 and 6 ' not shown) of the electrode members (3 and 3 ') emerge through these openings (7 and 7 ' not shown) of the body (2). In one embodiment, the electrode members (3 and 3') may be surface mounted on the body (2) of the device (1); in this embodiment, the surface-mounted electrode members (3 and 3') may be in contact with a conductive path communicating with the inside of the main body (2). The internal components of the device (1) are not shown in this figure, but are described in more detail below. The apparatus (1) has a cord (8), the cord (8) passing through a hole (not shown) in the main body (2) of the apparatus and communicating with and being connected to internal components of the apparatus (1). The cord (8) may be connected to an internal member, enabling the cord (8) to act on internal mechanisms of the apparatus (1) to start or stop the apparatus (1) during use. The cord (8) may be made of wire or similar material, plastic material or e.g. biocompatible metal.

The dimensions of the device (1) in the non-compressed state are length (L), greater than width (W), which in turn is greater than height (h). This device (1) is therefore an example according to the invention, wherein the device (1) has a non-uniform symmetrical cross-section, when seen in a cross-sectional view along the axis of insertion (X), said cross-section having two symmetrical surfaces. Said non-uniform symmetry means that the device (1) is less prone to rotation or displacement with respect to the axis of insertion (X) during use of the device (1). The device (1) does not have sharp edges but rather has clearly defined planes connected to each other by gradually curved regions. The compressible nature of the device (1) ensures resilient contact with the lumen during its use, the overall size and shape of the device (1) and the smooth curvature of the associated surfaces combine to enable easy and comfortable insertion of the device (1) during use while limiting or preventing unwanted rotation and displacement during use. Referring to fig. 1(b), the cross-sectional shape of the device is shown in (i); the cross-section is perpendicular to an insertion axis (x) of the device. Here it can be seen that the cross-sectional shape is a wide rectangle with soft rounded corners. The perpendicular cross-sectional shape exhibits two reflective symmetry axes (a and B) and one axis of rotational symmetry along the insertion axis. Referring to fig. 1(b), in (ii) a side perspective view of the apparatus is shown; it can be seen here that in a side sectional view, the device has one axis of reflection symmetry C, which is an axis along the insertion axis X of the device. In side view, there is no axis of rotational symmetry. Referring to fig. 1(b), the apparatus is shown in top perspective view in (iii); it can be seen here that in top view the device has one axis of reflection symmetry D, which is an axis along the insertion axis X of the device. In a top view, there is no axis of rotational symmetry.

Fig. 2(a) and 2(b) show a device (10) which has a more uniform cross-section and overall profile, although the device (10) is very similar in structure to the device (1) illustrated in fig. 1. Thus, the device (10) has a body (11), electrode members (12 and 12 ' not shown), body surfaces (13 and 13 ' not shown) on the sides (14 and 14 ' not shown) of the device, electrode surfaces (15 and 15 ' not shown), body openings (16 and 16 ' not shown), and a cord (17). Fig. 2(a) shows the device (10) in an uncompressed state. The device (10) has a width (W) of approximately 45mm at its widest point and a height (H) of approximately 45mm at its highest point. The length (L) is approximately 60 mm. Thereby, the device (10) has a relatively uniform cross-section at any point along the insertion axis (X). However, despite the substantially uniform cross-sectional dimensions, the device (10) has a shape as a whole with different surfaces linked to each other by smooth curves; this shape provides a non-circular cross-section along the insertion axis (X). Fig. 2(b) shows the same device (10) as shown in fig. 1(a), but after being compressed (10). Here, it can be clearly seen that the length (L) of the device (10) remains substantially constant at 60mm, whereas the height (H) has been reduced to 25mm and the width has been reduced to 15 mm. The compressed device has the overall shape and size of a tampon (tampon). In this embodiment, the volume of the device in the compressed state is 20% less than the volume of the device in the uncompressed state.

The device (10) in this compressed form is preferably inserted into the vagina or anus by means of an applicator. Figure 3 illustrates one suitable form of applicator. Referring to fig. 3(a) and 3(b), an applicator (30) having an outer member (31) and an inner member (32) is shown. The inner part (32) has a head (33) connected to a handle (34). The inner part (32) has a hole (35) penetrating the inner part (32) and opening at an end (36) of the handle (34). The inner part (32) can fit comfortably within the bore (37) of the outer part (31). The outer member (31) has an indicator (38) for indicating the proper direction of use of the applicator. When assembled, the inner member (32) is located within the bore (37) of the outer member (31), as illustrated in figures 1 and 2(a) and (b), and the compressed electro-stimulation device according to the invention is located within the bore (37) of the outer member (31) and adjacent the opening (39) of the outer member (31). The compressed device remains in a compressed state after being positioned within the bore (37). The device is oriented within the applicator such that a cord (not shown) of the device can pass through the bore of the inner member (32) along the bore (37) of the outer member (31) and then out the end (36) of the inner member (32). Once the applicator is assembled with the apparatus, it is ready for use. To place the device in the vagina or anus of a user, the outer member (31) of the applicator (30) is placed at the vaginal entrance (orifice) or anal sphincter (anal sphincter), and then the inner member (32) is used to apply pressure to the end of the compressed device within the bore (37) of the outer member (32) and force the device out of the bore (37) into the lumen of the vagina or anus. When the device exits the bore (37) of the outer member (31), the device is no longer held in compression and can expand and contact the vaginal or anal endocavity walls. The cord passes out of the vagina or anus and can be held or pulled by the user to remove the device from the vagina or anus once the treatment cycle is complete. In this embodiment, the cross-section of the bore of the outer member in the axis of insertion (X) is substantially similar in shape to the cross-section of the device in the compressed state.

Referring to fig. 4(a), 4(b) and 4(c), the internal components of the apparatus of fig. 2 are shown prior to assembly. The internal components are housed within a frame (40) and/or connected to a frame (40), in this embodiment the frame (40) is injection moulded integrally with a wire/cord (41) for removal of the device at the completion of a treatment cycle. The electrode member (42, 42 ') has an electrode pad (43, 43') substantially rectangular in shape. Each plate has an electrode surface (44 and 44 'not shown) which, as shown in fig. 4(c), is exposed through an opening (45 and 45' not shown) of the device body housing (53) when the device is assembled. Each electrode member (42, 42 ') has a resilient arcuate arm (46, 46 '), the resilient arcuate arm (46, 46 ') being connected at one end (47, 47 ') thereof to or formed with the electrode plate (43, 43 '), and being connected at an opposite end (48, 48 ') thereof to or formed with a plate portion (49, 49 '), the plate portion (49, 49 ') being in a plane (a) substantially parallel to a plane (B) of the electrode plate (43, 43 '). In this embodiment, the arcuate arms (46, 46 ') are connected to the plates (43, 43') at one of their narrower edges. As shown in fig. 4(b), the flat plates (49, 49 ') may be attached to the frame (40) or located within the frame (40) such that the electrode surfaces (44 and 44') are distally opposite each other and distally opposite the frame (40). In this embodiment, by applying pressure to the electrode pads (43, 43 '), the electrode members (42 and 42') can be compressed and moved toward the frame (40). When the pressure is released, the electrode members (42 and 42 ') return to their non-compressed state due to the spring-like nature imparted to the members by the resilient deformation nature of the arcuate arms (46 and 46') and their spatial disposition relative to the frame (40). A printed circuit board (50) is snap fitted into the frame (40) and associated contacts on the PCB are sprung (spring) connected to the ends of the electrode plates (49, 49'). In one embodiment, the electrode members (42, 42') may be molded as one element with the frame (40) and the cords (41).

To assemble the electro-stimulation device, the electrode members (42, 42 ') are attached to the frame (40), and then the printed circuit board (50) is snap-fitted into the frame (40) and spring-connected to the ends of the electrode plates (49, 49'). A power source (not shown) may be located on the printed circuit board (50) or may be located within the frame (40) and connected to the printed circuit board (50). Once these components are combined, a unitary device assembly (51) is provided as shown in fig. 4(b), which unitary device assembly (51) can then be readily used to manufacture the final device. The assembly of the final device is completed by grasping the device assembly (51) and compressing the electrode members (42, 42') towards the frame (40) such that the device assembly (51) is in a compressed state. In this state, the device assembly (51) is then inserted into a device body housing (53), the device body housing (53) being made of a biocompatible material such as a biocompatible foam or a compressed material such as a thermoplastic elastomer (thermoplastic elastomer). The device body housing (53) has a cavity (52), the cavity (52) being molded such that it can accommodate the device component (51). The device body housing (53) has an opening (45 and 45 ' not shown) through which the electrode pad (43, 43 ') can be exposed to the exterior of the device once the device assembly (51) is inserted into the cavity (52) of the device body housing (53) and the electrode member (42, 42 ') is no longer under compression. Once the device assembly (51) is inserted into the cavity (52) of the device body housing (53), it can then be welded closed along the open edges to the cavity and the housing welded around the openings (45 and 45 ') and electrode pads (44, 44'). In an alternative embodiment, the device assembly (51) in the uncompressed state may be placed in a suitable mold and the device body (53) may then be formed around the assembly (51) by injection molding or similar process. By design and arrangement, the components are easy to assemble, and the compression electrostimulation device is easy to assemble.

Referring to fig. 5, there is shown an example of a circuit and circuit diagram that may be used in the apparatus of the present invention. This circuitry and the necessary components can be housed on a relatively small printed circuit board that can be easily housed within the body of the device. The circuit comprises a voltage generator, an amplitude control device, a pulse conversion device and a logic control component (a control logic pulse table).

Referring to fig. 6, the electro-stimulation device (60) is shown in an uncompressed, fully expanded state. The device (60) has a body (61), the body (61) being constructed of a resiliently compressible polyurethane foam. The electrically conductive elements (62 and 62', not shown) are bonded to the surface of the body (61) of the device (60) using a suitable adhesive, for example a cyanoacrylate-based adhesive. The electro-stimulation elements (62 and 62 'not shown) are located within moulded recesses (63 and 63' not shown). Each conductive element (62 and 62 ' not shown) has an arm portion (64 and 64 ' not shown) located within the arcuate recess (65 and 65 ' not shown). The ends of the arm portions (not shown) are bent and enter the interior of the body (61) of the device (60) towards the front of the device (60) in order to make contact with a suitable connector on a PCB located inside the device. In this embodiment, the ends (not shown) of the arms are held partially in their position by a plug (66) located at the front of the device (60). The plug (66) also serves to protect the end of the arm (not shown). A switch member (67) to which the cord is connected is located towards the rear of the apparatus. The dimensions of this device (60) have the same relationship to the device (1) illustrated in fig. 1 and 1(a) discussed in detail. In this embodiment, the exposed surface of the arcuate arm is electrically insulated from the user by a suitable polymer film or mask applied to its surface and within the recess.

Referring to figure 7, there is shown a moulded electro-stimulation device body (70), the moulded electro-stimulation device body (70) being in a non-compressed, fully expanded state and having no internal components or electrically conductive elements. The moulded recesses (71) and (72) for the conductive element and the arms of the conductive element respectively can be clearly seen. Also shown is an internal mold cavity (73), the internal mold cavity (73) being used to house internal electronic accessories and switching mechanisms (not shown). It can be seen that the cavity passes through a moulded device body having openings at both ends thereof.

Referring to fig. 8, the electronic assembly (80) of the device of fig. 6 is shown without the molded device body. The electronic assembly (80) is composed of a frame (81), a PCB (82), a switching mechanism composed of a switching member (83) and a switching socket (84) having two switching contacts (not shown). The conductive elements (85 and 86) have arm ends (87 and 88) that pass through openings (89 and 90) of the frame (81) to make contact with terminals (not shown) on the PCB (82). The frame (81) has two distinct regions (81a) and (81 b). The switch member (83) is movable relative to the assembly (80) in the direction indicated by the double arrow X. The opening member (83) is captured within an end frame member (81 b). This is achieved by engaging the barbed arms (91) of the switch member (83) within the closed slits of the end frame member (81 b). The barbed arms (91) are free to move in the direction indicated by X under the constraint of the closed slit. The plug end (not shown) of the switch member is engageable with a switch contact of a switch receptacle (84). The cord (93) is also illustrated in the figure.

Referring to fig. 9, the electronic assembly (80) of the device of fig. 6 is shown without showing the molded device body or frame illustrated in fig. 8. In this figure, the spatial arrangement of the ends (101 and 102) of the conductive elements (103 and 104) can be clearly seen. In addition, without a frame, it is clear that the plug end (105) of the switching member (106) engages in the socket of the switching socket (107). One of the barbed arms of the switch member (106) can also be clearly seen. The other components are the same as described in fig. 8.

Referring to fig. 10a and 10b, an electro-stimulation device (200) is shown in an uncompressed, fully expanded state. The device (200) has a body (201), the body (201) being composed of injection moulded resiliently compressible polyurethane foam. The electrically conductive elements (202 and 202' not shown) are bonded to the surface of the device body (201) using a suitable adhesive, for example a cyanoacrylate-based adhesive. The conductive elements (202 and 202 ', not shown) are located within molded recesses (203 and 203'). Each conductive element (202 and 202 ', not shown) is connected to an internal PCB (not shown) by a connector (not shown) that is connected to a clip (not shown) on the back side of the conductive element (202 and 202', not shown). A switch member (204) having a cord (205) connected thereto is positioned towards the rear of the apparatus. The device body also includes grooves (206, 207, 208 and 209) on the surface of the body. The grooves may increase the compressibility of the device. Fig. 10b illustrates the relative proportions of the device as viewed from the side, top and back of the device. The dimensions of this apparatus (200) are the same as the apparatus illustrated in figures 1 and 1(a) described in detail.

Referring to figure 11a, there is shown a developed (or exploded) view of the main components of the electro-stimulation device (300) of figures 10a and 10b prior to assembly. Unlike the device illustrated in fig. 6 to 9, the device (300) is assembled through openings towards the rear (302) and the sides (303 and 303', not shown) of the device body (304). Unlike the embodiment in fig. 6, the opening (302) does not open into the opening towards the front of the device (300). The conductive elements (305 and 305 ') are clearly shown with the wires (306 and 306') clipped to the back of each conductive element (305 and 305 ') by clips (307 and 307'). During assembly, the wires (306 and 306 ') are connected through the openings (303 and 303', not shown) to the PCB components within a fully enclosed frame (308), the fully enclosed frame (308) being two parts (308a) and (308b) that are glued or snap-fitted to each other. The PCB member (not shown) is located within the front frame member (308 a). The switch member (309) shown here may be moved relative to the end frame member (308b) in the direction indicated by the double arrow X before it is inserted into that member. Is captured within the end frame member (308b) upon insertion of the switch member (309). This is achieved by engaging the barbed arms (310 and 310 ') of the switch member (309) within the closed slots (311 and 311') of the end frame member (308 b). The barbed arms (310 and 310') may be free to move in the direction indicated by X, under the constraint of a closed slit. Fig. 11a also illustrates a plug end (312) of the switch member (309), the plug end (312) being engageable with a switch contact (not shown) of the switch socket (not shown, located within the frame (308)). Fig. 11a also illustrates cords (313). Fig. 11a also illustrates guides (314 and 314 ') located within the chamber of the end frame member (308b), which guides (314 and 314') engage the barbed arms (310 and 310 ') during assembly to facilitate engagement of those arms with the closed slots (311 and 311'). The conductive elements (305 and 305') and frame (308) are bonded in place to the surface of the device body (304) using a suitable adhesive, such as a cyanoacrylate-based adhesive. The conductive members (305 and 305 ') are made of conductive SBS or EVA and are located and bonded within molded recesses (315 and 315' not shown). Fig. 11b illustrates the spatial relationship of the main components of the electronic accessory after assembly of the apparatus shown in fig. 11a, but the apparatus body and frame are omitted for clarity. The description for the numerically designated components in FIG. 11b is the same as the description for the similarly numbered components in FIG. 11 a. Fig. 11b shows point contacts of PCB (400) and wires (306 and 306') to PCB (400). Fig. 11b shows the plug end (312) of the switching member (309), said plug end (312) engaging with a switching contact (not shown) of the switching socket (401).

The device of fig. 6 to 11 in its compressed form is preferably inserted into the vagina or anus by means of an applicator. In both of these devices, the activation mechanism is designed to be activated by means of an applicator during deployment of the device. To this end, one suitable form of applicator is illustrated in fig. 12a to 12 c. Referring to fig. 12a, an applicator (500) having an outer member (501) and an inner member (502) is shown. The inner member (502) is in the form of a hollow cylinder and is engaged with the distal end (503) of the outer member (501). The applicator in this state has an electro-stimulation device (not shown) within a bore (not shown) of the outer member (501). A switch member (not shown) of the apparatus is aligned with a head (not shown) of the inner member (502) and is either adjacent to the head of the inner member (502) or in contacting engagement with the head of the inner member (502). In this state, the apparatus and applicator (500) are in a standby state. The cord (504) of the device is shown in fig. 12a passing through the hole of the inner part (502) and out through the hole-like opening (505) of the outer part (501). The outer member (501) has a grip region (506), the grip region (506) being shaped to facilitate gripping and manipulation of the applicator (500) by a human hand. The inner member (502) has a flanged end (507), said flanged end (507) presenting a large surface area to facilitate the application of pressure to the inner member (502) by a human hand during use of said applicator (500). This applicator (500) is operated in the same way as described in fig. 3a and 3 b. Referring to fig. 12b, the outer part (501) is shown without the inner part. This figure clearly shows the locator (508) exposed towards the rear of the component (501). The retainer (508) is formed by a series of spaced apart tabs (509), each of said tabs (509) being attached to the distal end (510) of the outer member at the inner radial surface thereof. The tab (509) protrudes toward the central axis (Y) of the outer member (501). Each sheet (509) has ridges (512) on its inner surface (513), in this embodiment the ridges (512) are aligned with the ridges (512) on each adjacent sheet (509). In addition, there is a chamfer (514) at the junction of the adjacent edges (515) of each sheet with their inner surfaces. The arrangement of the tabs (509), ridges (512) and ramps (514) provides a locator with corresponding features on the inner member (502) and a narrow bore in the outer member (501) for receiving, securing and holding the inner member (502) within the outer member (502) once the applicator is assembled. Referring to fig. 12c, the inner member (502) has an annular ridge (516) on its proximal end (517) around its outer circumference and an annular groove (518) on the same surface and adjacent to said annular ridge (516). The distance between the annular ridge (516) and the annular groove (518) on the inner part (512) corresponds to the distance between the ridge (512) and the ramp (514) on each segment of the outer part (501). Thus, when the inner part (502) is inserted into the outer part (501), the inner part (502) is held in the correct axial position by the arrangement of the radial tabs (509) and the inner part (502) is held securely by the engagement of the grooves (518) and ridges (516) of the inner part (502) with the corresponding ridges (512) and ramps (514) of the tabs (509) of the outer part. In an alternative embodiment, the radial slot (518) of the inner member (502) may be replaced with a distal radial ridge. In this embodiment, the distance between adjacent radial ridges of the inner part (502) is just greater than the distance between the ramp (514) and the ridge (512) arrangement of the outer part (501). When assembled, the proximal ridge (516) of the inner member (502) engages the ramp (514) and the distal radial ridge (518', not shown) rides up the frusto-conical surface on the ridge (512) of the plate (509). For both embodiments, the arrangement of the ridges and notches engaging each other provides the required detent action when the inner member (502) is inserted into the outer member (501).

All of the features disclosed in this specification for each embodiment (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, as long as the features and/or steps in the combinations are not mutually inconsistent (or contradictory).

Claims (90)

1. A vaginal or anal electro-stimulation device for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex comprising: a body, and at least two conductive elements located on or on an outer surface of the body, an internal power source and an internal device that controls the generation of electrical pulses through the conductive elements to electrically stimulate musculature of the pelvic floor complex, characterized in that:

the electro-stimulation device is self-contained and programmed to provide a waveform electro-stimulation treatment cycle including an initial phase in which current is gradually increased from an initial level to a second level higher than the initial level, a second phase in which current is gradually increased from the second level in the initial phase to a third level higher than the second level, and a third phase in which current is maintained at the third level.

2. An electro-stimulation device as claimed in claim 1 wherein the waveform used comprises two or more components, each component being a sequence of regularly spaced pulses.

3. An electro-stimulation device as claimed in claim 2 wherein the second component is combined with the first component but the spacing between successive pulses of the second component is less than the spacing between successive pulses of the first component.

4. An electro-stimulation device as claimed in claim 2 wherein a third component is present, the spacing between successive pulses of the third component being less than the spacing between successive pulses of the second component.

5. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein there is a period of relaxation between sets of pulse sequences.

6. An electro-stimulation device as claimed in claim 5 wherein the period of relaxation is equal to or greater than the period of stimulation.

7. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the treatment period is 3 hours or less than 3 hours.

8. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the treatment period is 2 hours or less than 2 hours.

9. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the treatment cycle is 1 hour or less than 1 hour.

10. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the treatment cycle is less than 1 hour.

11. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the treatment period is 45 minutes or less than 45 minutes.

12. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse repetition frequency of the first component is between 1 and 15 Hz.

13. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse repetition frequency of the first component is between 1 and 6 Hz.

14. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse repetition frequency of the first component is between 5 and 15 Hz.

15. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse repetition frequency of the second component is between 30 and 60 Hz.

16. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse repetition frequency of the second component is between 40 and 60 Hz.

17. An electro-stimulation device as claimed in claim 4 wherein the pulse repetition frequency of the third component, when present, is between 80 and 300 Hz.

18. An electro-stimulation device as claimed in claim 4 wherein the pulse repetition frequency of the third component, when present, is between 80 and 200 Hz.

19. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the pulses have a pulse width of 50 to 350 microseconds.

20. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the pulse width of the pulses is variable during use of the device.

21. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse amplitude of each component is the same amplitude.

22. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse amplitude of each component is a different amplitude.

23. An electro-stimulation device as claimed in any one of claims 2 to 4 wherein the pulse amplitude of one or more of the components can be varied at one or more points in time throughout the treatment cycle.

24. An electro-stimulation device as claimed in claim 2 wherein at least one component consists of a series of pulses having a pulse width of 150 to 350 microseconds at a maximum voltage of 60 volts and between each series of pulses there is a rest period of 5 to 10 seconds.

25. An electro-stimulation device as claimed in claim 1 wherein the applied current is adjusted and increased throughout the treatment cycle.

26. An electro-stimulation device as claimed in claim 1 wherein the treatment cycle starts at 45mA or less and rises to 45mA or more over the last ten minutes of the treatment cycle with a ramp sequence in between.

27. An electro-stimulation device as claimed in claim 1 wherein the treatment cycle starts at 40mA or less and rises to 40mA or more over the last ten minutes of the treatment cycle with a ramp sequence in between.

28. An electro-stimulation device as claimed in claim 1 wherein at a pulse frequency of 35Hz and a pulse width of 250 microseconds, the current is applied at 6mA and rises to 12mA in the first ten minutes, then gradually rises from 12mA to 40mA in the next ten minutes, then remains at 40mA in the next ten to fifteen minutes.

29. An electro-stimulation device as claimed in claim 1 wherein the body of the electro-stimulation device is rigid or semi-rigid in structure.

30. An electro-stimulation device as claimed in claim 1 wherein the device is compressible.

31. An electro-stimulation device as claimed in claim 1 wherein the dimensions of the device in its non-compressed form are such that when the device is in place in the desired location in the vagina or anus, the outer surface of the device and the electrically conductive elements located at or on the surface of the body of the device are in contact with one or more surfaces of the vagina or anus.

32. An electro-stimulation device as claimed in claim 1 wherein the device is made of an elastically deformable/compressible material.

33. An electro-stimulation device as claimed in claim 1 wherein the body is compressible due to the combination of the use of resiliently deformable/compressible material in the manufacture of the body and the characteristics of the device structure.

34. An electro-stimulation device as claimed in claim 1 wherein the body is made of an elastically deformable/compressible material and the interior of the electro-stimulation device body is hollow.

35. An electro-stimulation device as claimed in claim 1 wherein the body of the device is moulded around to encapsulate the internal components of the electro-stimulation device.

36. An electro-stimulation device as claimed in claim 1 wherein the body has a hollow interior within which the internal components are placed during manufacture of the electro-stimulation device.

37. An electro-stimulation device as claimed in claim 1 wherein the shape of the electro-stimulation device when viewed in cross-section perpendicular to the axis of insertion into the vagina or anus is such that the electro-stimulation device is not free to rotate about said axis when in position.

38. An electro-stimulation device as claimed in claim 1 wherein the shape of the electro-stimulation device is not circular when viewed in cross-section perpendicular to the axis of insertion into the vagina or anus.

39. An electro-stimulation device as claimed in claim 1 wherein the dimension of the electro-stimulation device body along the axis of insertion is greater than the dimension perpendicular to that axis.

40. An electro-stimulation device as claimed in claim 1 wherein the electro-stimulation device is compressible to different dimensions in proportion to the dimensions in the non-compressed state.

41. An electro-stimulation device as claimed in claim 1 wherein the device has at least two dimensions perpendicular to the axis of insertion with different degrees of compressibility.

42. An electro-stimulation device as claimed in claim 1 wherein in the non-compressed state the electro-stimulation device has a length in the range of from 30mm to 120 mm.

43. An electro-stimulation device as claimed in claim 1 wherein in the non-compressed state the electro-stimulation device has a length in the range of from 40mm to 100 mm.

44. An electro-stimulation device as claimed in claim 1 wherein in the non-compressed state the electro-stimulation device has a length in the range from 45mm to 75 mm.

45. An electro-stimulation device as claimed in claim 1 wherein in the non-compressed state the electro-stimulation device has a length in the range from 50mm to 65 mm.

46. An electro-stimulation device as claimed in claim 1 wherein in the non-compressed state the electro-stimulation device has at least two equal dimensions or at least two unequal dimensions perpendicular to the axis of insertion, the dimensions being in the range 30mm to 60 mm.

47. An electro-stimulation device as claimed in claim 1 wherein in the non-compressed state the electro-stimulation device has at least two equal or at least two unequal dimensions perpendicular to the axis of insertion, the dimensions being in the range 35mm to 55 mm.

48. An electro-stimulation device as claimed in claim 1 wherein in the non-compressed state the electro-stimulation device has at least two equal dimensions or at least two unequal dimensions perpendicular to the axis of insertion, the dimensions being in the range 35mm to 50 mm.

49. An electro-stimulation device as claimed in claim 1 wherein the length of the electro-stimulation device in the non-compressed state is equal to the length of the electro-stimulation device in the compressed state.

50. An electro-stimulation device as claimed in claim 1 wherein at least one of the dimensions of the electro-stimulation device perpendicular to the axis of insertion is capable of being reduced by at least 20% when compressed.

51. An electro-stimulation device as claimed in claim 1 wherein at least one of the dimensions of the electro-stimulation device perpendicular to the axis of insertion is capable of being reduced by at least 40% on compression.

52. An electro-stimulation device as claimed in claim 1 wherein at least one of the dimensions of the electro-stimulation device perpendicular to the axis of insertion is capable of being reduced by 50% when compressed.

53. An electro-stimulation device as claimed in claim 1 wherein at least one of the dimensions of the electro-stimulation device perpendicular to the axis of insertion is capable of being reduced by at least 60% when compressed.

54. An electro-stimulation device as claimed in claim 1 wherein all dimensions of the electro-stimulation device perpendicular to the axis of insertion can be reduced by at least 15% on compression.

55. An electro-stimulation device as claimed in claim 1 wherein all dimensions of the electro-stimulation device perpendicular to the axis of insertion are capable of being reduced by at least 25% when compressed.

56. An electro-stimulation device as claimed in claim 1 wherein all dimensions of the electro-stimulation device perpendicular to the axis of insertion can be reduced by at least 35% on compression.

57. An electro-stimulation device as claimed in claim 1 wherein all dimensions of the electro-stimulation device perpendicular to the axis of insertion can be reduced by at least 40% on compression.

58. An electro-stimulation device as claimed in claim 1 wherein the volume of the device in the compressed state is reduced by at least 20% compared to the volume in the non-compressed state.

59. An electro-stimulation device as claimed in claim 1 wherein the volume of the device in the compressed state is reduced by at least 25% compared to the volume in the non-compressed state.

60. An electro-stimulation device as claimed in claim 1 wherein the volume of the device in the compressed state is reduced by at least 30% compared to the volume in the non-compressed state.

61. An electro-stimulation device as claimed in claim 1 wherein the volume of the device in the compressed state is reduced by at least 40% compared to the volume in the non-compressed state.

62. An electro-stimulation device as claimed in claim 1 wherein the volume of the device in the compressed state is reduced by at least 50% compared to the volume in the non-compressed state.

63. An electro-stimulation device as claimed in claim 1 wherein the volume of the device in the compressed state is reduced by at least 75% compared to the volume in the non-compressed state.

64. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 35mm in width and 10mm to 40mm in height after compression.

65. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 35mm in width and 10mm to 35mm in height of the electro-stimulation device after compression.

66. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 35mm in width and 10mm to 30mm in height after compression.

67. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 35mm in width and the height of the electro-stimulation device after compression is in the range 15mm to 30 mm.

68. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 30mm in width and 10mm to 40mm in height after compression.

69. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 30mm in width and 10mm to 35mm in height of the electro-stimulation device after compression.

70. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 30mm in width and 10mm to 30mm in height after compression.

71. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 10mm to 30mm in width and the height of the electro-stimulation device after compression is in the range 15mm to 30 mm.

72. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 15mm to 20mm in width and 10mm to 40mm in height of the electro-stimulation device after compression.

73. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 15mm to 20mm in width and 10mm to 35mm in height of the electro-stimulation device after compression.

74. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 15mm to 20mm in width and 10mm to 30mm in height of the electro-stimulation device after compression.

75. An electro-stimulation device as claimed in claim 1 wherein in the compressed state the dimension of the electro-stimulation device perpendicular to the axis of insertion may be in the range 15mm to 20mm in width and the height of the electro-stimulation device after compression is in the range 15mm to 30 mm.

76. An electro-stimulation device as claimed in claim 1 wherein the shape of the electro-stimulation device in the compressed state is that of a tampon.

77. An electro-stimulation device as claimed in claim 1 wherein the stimulation is by

a. Positioning an applicator containing an electro-stimulation device in a compressed state at the opening of the vagina or anus, and

b. expelling the electro-stimulation device from the applicator, passing the electro-stimulation device into the vagina or anus and allowing it to expand within the vagina or anus,

the electro-stimulation device is adapted to be deployed into the vaginal or anal endocavity.

78. An electro-stimulation device as claimed in claim 77 wherein the applicator has a hollow body for receiving the device after compression.

79. The device according to claim 1, wherein the stimulation is used to treat anterior and posterior pelvic floor muscle dysfunction.

80. An electro-stimulation device as claimed in claim 1 wherein the electrically conductive element is capable of being located on and connected to a surface of the electro-stimulation device and connected to the internal circuitry by a conductive path.

81. An electro-stimulation device as claimed in claim 1 wherein the conductive element may be formed as part of an internal component of the electro-stimulation device and may be exposed on the surface of the body of the electro-stimulation device through an aperture defined in the body.

82. An electro-stimulation device as claimed in claim 1 wherein the conductive elements are rectangular in shape and are 28mm x 13mm in size and are located at or on opposite surfaces of the electro-stimulation device, spaced apart by 180 degrees.

83. An electro-stimulation device as claimed in any one of claims 1 to 4 wherein the conductive element is annular.

84. An electro-stimulation device as claimed in claim 1 wherein the electrically conductive element is sprung to maintain correct pressure on the walls of the vagina or anus during use.

85. An electro-stimulation device as claimed in claim 1 wherein the internal circuitry includes a delay after activation to ensure that the conductive element surface is in position before the start of a treatment cycle.

86. An electro-stimulation device as claimed in claim 1 wherein the electro-stimulation device includes a one-time start/stop mechanism associated with the internal means of controlling the generation of the electrical pulses.

87. A device for stimulating musculature of the pelvic floor complex comprising an electro-stimulation device according to claim 1 in combination with an applicator comprising an outer member and an inner member, the electro-stimulation device being located within the outer member.

88. A kit comprising a plurality of electro-stimulation devices as claimed in any one of the preceding claims.

89. The kit of claim 88, wherein the plurality of electro-stimulation devices are all identical.

90. The kit of claim 88, wherein the kit comprises a plurality of electrostimulation devices capable of producing different therapeutic waveforms.