AU2004208669B1 - Medical device to electronically force the pelvic floor & associated muscles and muscles of the urogenital triangle to exercise - Google Patents

Description

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SPECIFICATION

TITLE OF INVENTION Medical device to electronically force the pelvic floor and associated muscles, and muscles of the urogenital triangle to exercise.

I MARGARET PHILLIPA TREANOR, of 50/121 Pacific Highway, Homrnsby 2077, New South Wales, Australia, an Australian resident, and a New Zealand Citizen HEREBY declare the invention, for which I pray that a patent may be granted to me and the method by which it is to be performed, to be particularly described in and by the following statement: described in and by the following statement: Page 2 0 THE FIELD OF THE INVENTION

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00 This invention is a medical device to electronically force the muscles of the C pelvic floor, vagina and muscles of the urogenital triangle to contract and release, causing the muscles to exercise.

SThis device would replace the need for pelvic floor exercises and the husband c1, stitch. The term husband stitch is used to describe an additional suture to tighten the vagina post childbirth and husbands usually directed the request to the administering doctor at the time of labour. This device would tone and tighten the vaginal muscles of the intravaginal cavity, strengthen the pelvic floor and urogenital triangle muscles by electronically exercising the area through electronic stimulation. Electronic stimulation has been readily available for many purposes and has proven to be a safe and effective method of treatment for many medical problems. This medical device electronically forces the contracting and releasing of the muscles which allows the user to relax, using no conscious effort to hold a contraction whilst exercising this area. It is small and compact making it portable and discreet allowing the user to have more dignity, privacy and control over these areas. The device has simplistic instructions, which allows the user to control the usage and dosage, making it user friendly and needing no previous medical background or professional help. Also has capability to cure and prevent medical problems associated with weak pelvic floor muscles like incontinence.

Page 3 0 PRIOR ART \O A previous attempt US Patent number 6086549 to overcome some of the 00 medical aspects was to provide a probe with x2 bands surrounding an 0 electrode shell of an electrode carrier being part of the probe. These were used Sto electronically stimulate the pudendal nerve via the itravaginal cavity to Streat incontinence. This solution has had some disadvantages. A handle was Sneeded to place the probe within the intravaginal cavity. The probe had x3 C alternative electrode carriers, which catered for the varying depths and size of the intravaginal cavity. The bands also relied on the width of the electrode carrier to retain the probe within the intravaginal cavity and converge with the walls of tile intravaginal cavity for sufficient electrical stimulation. The tip of the head of the probe had no electrodes to convey an electrical charge to electronically stimulate the pelvic floor directly, but relied on the stimulation of the pudendal nerve to treat the incontinence.

US Patent number 5662699 relied on a collapsible airtight sheath with a resilient skeleton which relied on air pumped into the sheath to expand enough for the outer conductive bands to relay the electrical charge to the intravaginal walls. US Patent number 4296760 also has an inflatable elongated element which comprises of a bladder prepared from an expandable material such as rubber to retain the device within the intravaginal cavity. Both of these patents rely on air to expand the carrier for the electrodes to make contact with the vaginal wall. Patent number FR2754717A 1 has an elongated carrier with a disposable sheath with two electrodes as part of the sheath that also aligns with rods that are connected to a band and used as electrodes of the carrier that extend to relay the electrical charge to the vaginal walls. The endings of the rod are detachable and make the device questionable as to whether these endings would become detached while in use. US Patent number 5046511 relies on a removable pad fastened by conductive snap fasteners and wrapped around and secured to a carrier before insertion into the vagina. The pad could easily become undone during insertion. European patent number 0411632A I relies on a nonconductive sheet of material with conductive electrode elements on the exterior surface of the sheet formed into a diametrically compressible spiral tending to unwind within the vagina, retaining the device. This device relies on the user to hold the vaginal electrode by hand to maintain the compressed spiral state for insertion into the vagina.

Page 4 c, 0 OBJECTS OF THE INVENTION NThe object of the present invention is to provide an insert that will in some o ways prevent the above disadvantages, and utilise existing technology to replace pelvic floor exercises and the need for the husband stitch. The device uses spring-loaded domes in an active state to retain the device whilst making contact with the intravaginal cavity and pelvic floor. This enables the device to O relay an electrical current to these areas to electronically exercise the muscles.

i Because of this there is no need to change the electrode carriers to fit the contours of the intravaginal cavity. The device is long enough to insert into the vagina without any other assistance like a handle. The domes are strategically placed to allow stimulation directly to the vagina, pelvic floor and urogenital muscles. Electronically forcing the muscles of the vagina, pelvic floor and urogenital triangle to contract and release causes the muscle to exercise without any conscious effort by the user to hold the contraction. This would forcefully strengthen, tone and tighten these areas for prevention of any future medical and sexual problems associated with these areas. The basic design and technology of the device makes it simplistic and user friendly and the compact nature of the device enables it to be used discreetly and privately needing no professional help or instruction. This would allow the user to have more dignity and control over these areas as they age.

BRIEF DESCRIPTION OF THE DRAWINGS One preferred form of the invention will now be described with reference to the accompanying drawings, of which; Figure 1 shows the medical device assembled as one unit in an inactive form according to the invention, shown as separate items; Figure 2 shows the same device in an active form.

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o DETAILED DESCRIPTION OF THE INVENTION N In the form shown, it is an insert, cylindrical in shape of 20mm in width x 00 140mm in length, which consists of a head, shaft and base (Figure The O outer layer is non-conductive rubber (Fig. The head of the insert has x2 spring-loaded metal domes of 10mm in circumference each made of Sconductive metal material; each surrounded by non-conductive rubber 0 (Fig. The domes are the electrodes of the device and are controlled by the N on/off dial to expand to touch walls of the intravaginal cavity. The shaft of the insert has x4 metal, spring-loaded domes; the electrodes are 10mm in circumference (Fig. 1.9) made from conductive metal material. These are strategically placed around the length of the shaft and surrounded by nonconductive rubber. The base of the insert protrudes 20mm out from the vulva.

The base consists of an ON and OFF dial (Fig. 1.8) to turn the power of the device on and off and to control the expansion of the domes. An INTENSITY dial (Fig. 1.7) which is controlled by the user to regulate the intensity of the electrical charge, 0=OFF, l=lowest intensity of electrical charge to intensity (strongest contraction). A HOLD dial (Fig. 1.6) controls the time the contraction lasts 0=OFF, l=shortest time contraction lasts, 5=longest time contraction held. The base also houses the AA battery, which is the conductor of the electrical charge (Fig. The insulated wiring is the conveyor of the electrical charge from the conductor to the domes (Fig. The contact points are used with the intensity dial to regulate and direct the electrical charge (Fig. The device can include a circuit breaker (Fig 1.10) to automatically break the electrical current, which then causes the muscles to relax, however this can also be controlled manually by the HOLD dial. After insertion during active use of the device (Figure the spring-loaded metal domes expand to touch the walls of the intravaginal cavity and pelvic floor (Fig.2.1) which retains the insert while transmitting the electrical charge within the intravaginal cavity, there is no need to adjust the shaft or head to the varying sizes of the intravaginal cavity. The electrical charge, controlled by the dials is relayed to the intravaginal walls through the metals domes forcing them to contract and release, this forces the muscles of the pelvic floor, vagina and urogenital triangle to exercise, to tone and strengthen and tighten these areas.

Page 6 0 DESCRIPTION OF THE OPERATION OF THE INVENTION

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NOIn operation, during active use, the device uses the dials to control the O electrical current from the AA battery, which is the power source. This Selectrical current is relayed via the insulated wiring to the domes of the insert, O which are the electrodes. The electrical current is then relayed from the domes, Swhich during active use converges with the contours of the intravaginal cavity i walls and pelvic floor. The electrical current causes the muscles of the vagina and pelvic floor to contract. The intensity dial and contact points control how much electrical current is relayed at any one time through the insulated wiring, to the electrodes/domes, and then to the vagina and pelvic floor which causes the muscles to contract. The circuit breaker is optional and is controlled/preset by the hold dial, which breaks the electrical current causing the muscles to relax. This electronically controlled contracting and relaxing of the muscles causes them to exercise. The use of AA batteries instead of the main household power supply is for safety reasons. If the unit malfunctions for some reason, the user could experience a slight shock like that of a bee sting but would do no serious long term damage compared to the risks involved with using the main household power supply.

It will be appreciated that the invention broadly consists in the parts, elements and features described in this specification, and is deemed to include any equivalents known in the art which, if substituted for the described integers, would not materially alter the substance of the invention