VAGINAL STIMULATOR AND DEVICE FOR THE TREATMENT OF FEMALE URINARY INCONTINENCE

Abstract: The invention relates to a programmable vaginal stimulator and to a device comprising said vaginal stimulator with a carrying and control case, without cable linking one to the other.

Description: V aginal stimulator and device for the treatment of female urinar\ incontinence BACKGROUND OF THE INVENTION 1 Field of the invention The present invention relates to a vagmal stimulator and a device tor the treatment of female urinary incontinence by the way of electrical stimulation applied to the pelvic floor musculature and surrounding structures 2 Descπption of the Prior Art Female urinarv incontinence is a condition with severe economic and psychosocial impact There are several types of urinary incontinence but all are characteπzed by an inability to restram urinary voiding The three most frequent types of urinary incontinence are the stress incontinence, characteπzed by the involuntary loss of urme from the urethra during physical exertion, the urge mcontmence or involuntary loss of urme associated with an abrupt and strong desire to void, and the mixed urinary mcontmence which results from both urge incontinence and stress incontinence Various methods have been propesed for improving the strength and tone of the pelvic floor muscle group In 1948, Arnold Kegel described pelvic floor exercises as a treatment option m stress mcontmence and invented a set of exercises to strengthen and support the pelvic floor The purpose of the Kegel exercises is to mcrease volume and to develop stronger reflex contractions following quick rise m intra-abdominal pressure Manv women find these Kegel exercises difficult and uncomfortable to perform and the major obstacle to success with Kegel exercises is the tendency among women to give up or forget how to correctly do the exercises Electrical stimulation of the pelvic floor is an effective therapy both for stress incontinence and urge incontinence Electrical stimulation of the pelvic floor automates Kegel exercises through the use of direct electrical stimulation of the vagina and bladder muscle Electrical stimulation of the pelvic floor to treat stress incontinence and urge incontinence was first studied in the earl 1960 ' s and clinical studies from the 70 ' s through 90 's have reaffirmed its effectiveness With the first electrical stimulation methods used to treat female urinarv incontinence, women had to go in a medical setting to undergo electrical stimulation session of their pelvic floor muscle Later electπcal stimulators for home treatment appeared These devices are usually in two parts an mside vagina part which is a vaginal plug with electrodes intended to be m contact with the vagina wall and an outside vagina part which can be the pulse generator and a power supply or a power supply only if the pulse generator is inside the vaginal plug Such devices are not convenient because of the cable(s) between the mside vagina part and the outside vagina part Moreover, hygiene problems are encountered when the vaginal plug has not been completelv cleaned before its insertion m the vagina Other devices are used with a special condom which must be disposed of and changed after each use Said devices of the prior art are not well accepted by the women because thev are exacting and difficult to use With some devices the insertion and the extraction of the plug are not easy, the presence of cables and/or cumbersome equipment is not comfortable, the plugs are difficult to clean, the user must have batteries in advance, and in the case of devices used with condoms the user must have condoms in advance There is then a need for a pelvic floor muscle electrical stimulation device effective, convement to use and easy to insert, extract and clean SUMMARY OF THE INVENTION The present invention is directed to a vaginal stimulator with a body adapted to be inserted in women's vagina to electncally stimulate the pelvic floor musculature and surrounding structures, compπsmg a battery as power supplv means for applying preprogrammed instructions concerning the current frequency adapted to the t pe of incontinence to be treated and the treatment duration Advantageously, said means for applying preprogrammed instructions comprise a microcontroller to select the pulse frequency and the working time given bv an outer electronic control system In a preferred embodiment of the invention said electromc control system is located in a case comprising a housing for said stimulator, when not m use Preferably said vaginal stimulator bodv comprises on its surface, at least two sets of conductors, a first set being used as electrodes to transmit electrical pulses to the pelvic floor musculature, and a second set, which , jointly with the first one, is able to transmit the instructions of the operator to the vaginal stimulator microcontroller Said vaginal stimulator is advantageously watertight It is convement that an eyelet be provided at one end of the vaginal stimulator body, with a guide to thread a string into the eyelet The invention is also directed to a device for the treatment of female urinary incontinence by electrical stimulation applied to the pelvic floor musculature and surrounding structures, comprising a vaginal stimulator as above defined and a carrying and control case, without cable linking one to the other In a preferred embodιment,the carrying and control case comprises a housing for said vaginal stimulator, a transformer with charge circuitry to charge the vaginal stimulator battery, an electromc control system to transmit the instructions given by the operator Said housmg is advantageously provided with metal contacts arranged to be m contact with the conductors of the vaginal stimulator when put into the housing It further compπses a wedge adapted to go into the vagmal stimulator eyelet and intended to secure the position of the vaginal stimulator in the housing so that the conductors of the vagmal stimulator be always m contact with the corresponding metal contacts of the housing The above instructions are given by the operator to the vaginal stimulator microcontroller through control knobs The programmable vaginal stimulator of the present invention is very convenient and easy to use Between each use the rechargeable battery of the vaginal stimulator is recharging when the vagmal stimulator is m its housing and the cover of the carrying and control case is closed Before each use the user has only to select the type of incontinence and program the use time Usually, this programming is done once and for all before the first use After having thread a piece of string through the eyelet of the vagmal stimulator with the help of the guide string, the user can lubricate the vagmal stimulator to make easier its insertion m the vagma Then the vagmal stimulator is inserted into the vag a like a tampon, just so it disappears into the vagmal opening When the use time is passed, the device user takes out the vagmal stimulator from the vagma, cuts the string, throws it away, cleans the vagmal stimulator with mild soap or alcohol, or other disinfectants, wipes it, places it back in its resting nest and closes the cover of the carrying and control case The battery will recharge automatically BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is a view of the vaginal stimulator according to the invention. FIG. 2 is an exploded view of the inside of the vagmal stimulator. FIG. 3 is a view from the inside of a carrying and control case, intended for contaimng a vagmal stimulator. FIG. 4A is a block diagram illustrating the mside stimulator electronic circuit. and FIG. 4B is a block diagram illustrating the inside carrying and control case electronoc control system. DETAILED DESCRIPTION Figure 1 illustrates a vaginal stimulator according to the invention. Said vaginal stimulator (1.1) is composed of a cylinder-shaped, polymer matenal body with two rounded ends. Such a stimulator may, for example, have the following dimensions: length 8 centimeters, diameter 2.5 centimeters. The vaginal stimulator (1.1), which comprises a division floor (2.4), includes the following elements: 1. Three conductors (1.2), (1.3), (1.4) which are mcluded in the exteπor polymer material body surface. Two of the three conductors are used as electrode + (1.2) and electrode - (1.3) to carry the electric pulses coming from an inside vaginal stimulator microcontroller (Fig. 2 : (2.2)) to the vagmal musculature when the vaginal stimulator is operating. Two of the three conductors (1.2), (1.4) are used to charge the mside vaginal stimulator rechargeable battery (Fig. 2 : (2.1)) and said three conductors (1.2), (1.3), (1.4) are used to transmit instructions to the inside vaginal stimulator microcontroller (Fig. 2 : (2.2)) when the device user is programming the vaginal stimulator. 2. An eyelet (1.5) for string connection. An about 20 centimeters bit of stnng is threaded through the vagmal stimulator eyelet (1.5) and the two ends of the string are knotted before the use of the vaginal stimulator. This bit of string enables an, easier extraction of the vaginal stimulator at the end of the use time. 3 A stnng guide (1 6) to easier thread the string in the vaginal stimulator ey elet ( 1 5) 4 A rechargeable battery (2 1 ) which is the power supply of the vagmal stimulator (1 1) This rechargeable battery is charged through two conductors (1 2). (1 4) of the vagmal stimulator (1 1) and two corresponding metal contacts of an outside device, advantageously of a carrying and control case adapted for housina the va 'Bgm' al stimulator 5 A microcontroller (2 2) with microprocessor, random access memory and input output system, to generate the electric pulses necessary to make working the vagmal stιmulator(l 1) and execute the different orders given by the operator 6 An mside round seal (2 3) which permits to make the vagmal stimulator watertight and easy to clean with mild soap, alcohol or other disinfectants The block diagram of the mside stimulator electromc circuit is given on Fig 4A As above-mentioned, the microcontroller (2 2), supplied by the battery (2 1) and in connection with a charge and command control (4 1), generates electric pulses which through a pulse modulation system (4 1 ) and a safety control system (4 3) are transmitted to the electrodes (1 2), (1 3) and the third conductor (1 4) Said electrodes and conductor are then used to charge the battery (2 1) In a preferred embodiment, said vagmal stimulato is provided with a carrying and control case The carrymg and control case may have a rectangle parallepipede shape and composes a main body with a cover, which may be together joined by a hinge Said case has, for example, the following dimensions 10 centimeters long, 10 centimeters wide and 5 centimeters high It is divided in two parts the main body (3) which may be 10 centimeters long, 10 centimeters wide and 4 centimeters high and the cover (not represented) which may have, for example, the following dimensions 10 centimeters long, 10 centimeters wide and 1 centimeter high The mam body includes the following elements illustrated on FIG 3 1 A transformer with charge circuitry located in compartiment (3 1 ) of the mam body which receives equally input current of 1 10 or 220 volts and will transform it in an adequate output current able to charge the mside v aginal stimulator rechargeable battery for example m 4 to 6 hours 2 A power cord (3 2) to link the transformer to the supply area This power cord is located in compartiment (3 3) and is directly connected to the transformer The power cord can be easily gotten out of its location (3 3) to be connected with the mains supply Once the power cord out of its location and the power cord location cover (3 5) closed, the power cord will be hold in a passage (3 4) and the cover of the carrying and control case can be closed 3 An electromc control system (not represented) permitting to the device user, through the two control knobs (3 6), (3 7) and the carrying and control case cover, to transmit orders to the vagmal stimulator microcontroller or to recharge the mside vaginal stimulator rechargeable battery 4 Control knob (3 6) permits to the device user to select the type of urinary incontinence urge incontinence (3 8) or stress incontinence (3 9) The urge incontinence position (3 8) corresponds to 12 5 Hz pulse frequency and the stress mcontmence position (3 9) corresponds to 50 Hz pulse frequency coming from the mside vagmal stimulator microcontroller The orders given by the device user through this control knob (3 6) are sent to the electromc control system of the carrymg and control case 5 Control knob (3 7) permits to the device user to select the use time of the vaginal stimulator 15 mmutes (3 10), 30 mmutes (3 1 1), 45 mmutes (3 12) or 60 mmutes (3 13) The orders given by the device user to the control knob (3 7) are sent to the electromc control system of the carrying and control case 6 A green control light (3 14) which indicate to the device user that the mside vagmal stimulator rechargeable battery is fully charged and that the vagmal stimulator can be used When this green control light (3 14) is on, the red control light (3 15) is off 7 A red control light (3 15) which indicates to the device user that the mside vagmal stimulator rechargeable battery is always in charge and that the vag al stimulator cannot yet be used When this red control light (3 15) is on the 3 green control light (3 14) is off 8 A housing (3 16) wherein the vagmal stimulator (1 1 ) can be put between each use Said housing has the same shape than the vagmal stimulator but a slight upper size to permit to the vagmal stimulator to fit easily into the housing 10 The bottom of housing (3 16) comprises three metal contacts (3 17), (3 1 8). (3 19) intended for transmitting to the three vagmal stimulator conductors (Fig 1 (1 2), (1 3), (1 4)), orders coming from the electronic control system and given by the device user through the control knobs (3 6), (3 17) or through the carrymg and control case cover A wedge (3 20) is provided at one end of the ID housing (3 16) and is adapted to fit into the vagmal stimulator eyelet (1 5)) when the vagmal stimulator is put into the housing (3 16) The wedge (3 20) is intended to maintain the vagmal stimulator m its location and to secure that the three metal contacts (3 17), (3 18), (3 19) of the housing (3 16) be in connection with the three vaginal stimulator conductors (1 2), (1 3), (1 4) when 0 the vagmal stimulator is m the housing 9 A string spool mche (3 21) with a cover (3 22) intended to keep a stπng spool (3 23) A cutting system (3 24) is provided with the string pool mche to cut the stπnag before the use or after the use of the vasinal stimulator D 10 In the hinge joining the cover to the mam body of the carrying and control case there is a switch which gives orders to the electromc control system The opening of the cover stops automatically the charge of the mside stimulator rechargeable battery and starts the working of the vagmal stimulator, when the 0 vagmal stimulator is in its housmg The closmg of the cover stops automatically the working of the vaginal stimulator and starts the charge of the mside vagmal stimulator rechargeable battery, when the vagmal stimulator is in its housing The block diagram of the mside carrymg and control case electromc control 5 system is given on Fig 4B The charge circuit (4 4) receives input current of 110 or 220 volts which is transmitted through the command control (4 5) to the metal contacts of the housing Advantageously, the device of the invention is free from cable linking the carrying and control case to the vagmal stimulator and is then pratical to use Prior the first use, the device user has only to select the type of incontinence and the wished use time He has also to make a first charge of the mside vagmal stimulator rechargeable battery (6 hours) To use the vagmal stimulator there is only to open the carrying and control case, remove the vagmal stimulator from its housing, thread a 20 centimeters bit of string m the ey elet. knot the two ends of the string, lubricate the vaginal stimulator and insert it mto the vagina. The vagmal stimulator is working. At the end of the session, take the vaginal stimulator out of the vagma, cut and throw away the bit of string. clean the vaginal stimulator, place it back in its resting nest and close the cover of the carrying and control case. The batterv will be charge automaticalh

Claims: Claims A vaginal stimulator with a body adapted to be inserted in women's vagina to electrically stimulate the pelvic floor musculature and surrounding structures, comprising a battery as power supply , means for apply ing preprogrammed instructions concerning the current frequency adapted to the type of incontinence to be treated . and the treatment duration The vagmal stimulator according to claim 1, wherem said means foi applying preprogrammed instructions comprise a microcontroller to select the pulse frequency and the working time given by an outer electronic control system The vagmal stimulator according to claim 1 or 2. wherem said vaginal stimulator body comprises on its surface, at least two sets of conductors, a first set being used as electrodes to transmit electπcal pulses to the pelvic floor musculature, and a second set. which , jointly with the first one, is able to transmit to the vaginal stimulator microcontroller the instructions of the operator The vagmal stimulator according to anyone of claims 1 to 3, which is watertight The vagmal stimulator according to anyone of claims 1 to 4, wherein said vagmal stimulator body compπses an eyelet at one end, with a guide to thread a string mto the eyelet The device for the treatment of female urinary mcontmence by electπcal stimulation applied to the pelvic floor musculature and surrounding structures, comprising a vaginal stimulator according to claim 1 and a carrying and control case, without cable linking one to the other The device of claim 6, wherem the carrymg and control case comprises a housing for said vagmal stimulator, a transformer with charge circuitry to charge the vagmal stimulator battery, an electronic control system to transmit the instructions given by the operator _ The device of claim 6 or 7, wherem said housing is provided with metal contacts arranged to be in contact with the conductors of the v ag al stimulator when put into the housing ) The device according to claim 7, wherem said housing comprises a wedge adapted to go into the vaginal stimulator eyelet and intended to secure the position of the vagmal stimulator in the housing so that the conductors of the vagmal stimulator be always in contact with the corresponding metal contacts of the housinog 0 The device according to claim 7, wherem said instructions are given by the operator to the vagmal stimulator microcontroller through control knobs

Inventors: MARTY JEAN-CLAUDE, MARTY, JEAN-CLAUDE
Applicants: MARTY JEAN CLAUDE, MARTY, JEAN-CLAUDE
Application year: 2001
Main classification: A61N1
IPC codes: A61N1