Title of Invention

"A DEVICE FOR THE TREATMENT OF FEMALE URINARY INCONTINENCE"

Abstract

A device (1.1) with a body adapted to be inserted in women's vagina to electrically stimulate the pelvic floor musculature and surrounding structures, comprising: a stimulator body having a first set of conductors (1.2,1.3), to transmit electrical pulses to the pelvic floor musculature, in combination with a second set of conductors (1.4), which, jointly with the first one, is adapted to transmit the instructions of the operator to the device microcontroller (2.2), both sets of conductors being on the surface of the device body, said device comprising a battery (2.1) as power supply located inside the device body, and means for applying preprogrammed instructions concerning the current frequency adapted to the type of incontinence to be treated, and the treatment duration, and a carrying and control case for housing said device body during non use of the stimulator body, without cable linking the device and the carrying and control case, the case comprising a transformer (3.1) with charge circuitry to charge the device battery (2.1), an electronic control system to transmit the instructions given by the operator, having two metal contacts adapted to charge the rechargeable battery through said both set of conductors of the stimulator body, and a second set of three metal contacts (3.17, 3.18, 3.19), located in the bottom of the case, which are connected to three specific conductors on the surface of the device body to transmit the instructions of the operator to the device controller, through this connection.

Full Text

The present invention relates to a device for the treatment of female urinary incontinence. BACKGROUND OF THE INVENTION Field of the invention The present invention relates to a device for the treatment of female urinary incontinence by the way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. DESCRIPTION OF THE PRIOR ART Female urinary incontinence is a condition with severe economic and psychosocial impact. There are several types of urinary incontinence but all are characterized by an inability to restrain urinary voiding. The three most frequent types of urinary incontinence are the stress incontinence, characterized by the involuntary loss of urine from the urethra during physical exertion, the urge incontinence or involuntary loss of urine associated with an abrupt and strong desire to void, and the mixed urinary incontinence which results from both urge incontinence and stress incontinence. Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. In particular, there are five major categories of urinary incontinence: overflow, stress, urge, functional, and reflex. Overflow incontinence: Overflow incontinence is caused by bladder dysfunction. Individuals with this type of incontinence have an obstruction to the bladder or urethra, or a bladder that doesn't contract properly. As a result their bladders do not empty completely, and they have problems with frequent urine leakage. Stress incontinence: Stress incontinence occurs when an individual involuntarily loses urine after pressure is placed on the abdomen (i.e. during exercise, sexual activity, sneezing, coughing, laughing, or hugging). Urge incontinence: Urge incontinence occurs when an individual fees a sudden need to urinate, and cannot control the urge to do so. As a consequence, urine is involuntarily lost before the individual can get to the toilet. Functional incontinence: Individuals who have control over their own urination and have a fully functioning urinary tract, but cannot make it to the bathroom in time due to a physical or cognitive disability, are functionally incontinenet. These individuals may suffer from arthritis, parkinson's disease, multiple sclerosis, or Alzheimer's disease. Relex incontinence: Individuals with reflex incontinence lose control of their bladder without warning. They typically suffer from neurological impairment. In some cases, an individual may develop short-term or acute incontinence. Acute incontinence may occur as a symptom or by-product of illness, as a side effect of medication, or as a result of dietary intake. The condition is typically easily resolved once the cause is determined and addressed. 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 in stress incontinence and invented a set of exercises to strengthen and support the pelvic floor. The purpose of the Kegel exercises is to increase volume and to develop stronger reflex contractions following quick rise in intra-abdominal pressure. Many women find these Kegel exercises difficult and uncomfortable to perforin 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 early 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 urinary incontinence, women had to go in a medical setting to undergo electrical stimulation session of their pelvic floor muscle. Later electrical stimulators for home treatment appeared. These devices are usually in two parts: an inside vagina part which is a vaginal plug with electrodes intended to be in 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 inside vagina part and the outside vagina part. Moreover, hygiene problems are encountered when the vaginal plug has not been completely cleaned before its insertion in 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 they 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, convenient to use and easy to insert, extract and clean. SUMMARY OF THE INVENTION The present invention is directed to a device 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 applying preprogrammed instructions concerning the current frequency adapted to the type 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 by an outer electronic control system. In a preferred embodiment of the invention, said electronic control system is located in a case comprising a housing for said stimulator, when not in use. Preferably, said device body 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 device microcontroller. Said device is advantageously watertight. It is convenient that an eyelet be provided at one end of the device 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 device as above defined and a carrying and control case, without cable linking one to the other. In a preferred embodiment, the carrying and control case comprises a housing for said device, a transformer with charge circuitry to charge the device battery, an electronic control system to transmit the instructions given by the operator. Said housing is advantageously provided with metal contacts arranged to be in contact with the conductors of the device when put into the housing. It further comprises a wedge adapted to go into the device eyelet and intended to secure the position of the device in the housing so that the conductors of the device be always in contact with the corresponding metal contacts of the housing. The above instructions are given by the operator to the device microcontroller through control knobs. The programmable device of the present invention is very convenient and easy to use. Between each use the rechargeable battery of the device is recharging when the device is in 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 device with the help of the guide string, the user can lubricate the device to make easier its insertion in the vagina. Then the device is inserted into the vagina like a tampon, just so it disappears into the vaginal opening. When the use time is passed, the device user takes out the device from the vagina, cuts the string, throws it away, cleans the device 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 device according to the invention. FIG. 2 is an exploded view of the inside of the device . FIG. 3 is a view from the inside of a carrying and control case, intended for containing a device . FIG. 4A is a block diagram illustrating the inside 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 device according to the invention. Said device (1. 1) is composed of a cylinder-shaped, polymer material body with two rounded ends. Such a stimulator may, for example, have the following dimensions : length 8 centimeters, diameter 2.5 centimeters. The device (1.1), which comprises a division floor (2. 4), includes the following elements : 1. Three conductors (1.2), (1.3), (1.4) which are included in the exterior 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 device microcontroller (Fig. 2: (2.2)) to the vaginal musculature when the device is operating. Two of the three conductors (1.2), (1.4) are used to charge the inside device rechargeable battery (Fig. 2 : (2.1)) and said three conductors (1.2), (1.3), (1.4) are used to transmit instructions to the inside device microcontroller (Fig. 2: (2.2)) when the device user is programming the device. 2. An eyelet (1.5) for string connection. An about 20 centimeters bit of string is threaded through the device eyelet (1.5) and the two ends of the string are knotted before the use of the device. This bit of string enables an, easier extraction of the device at the end of the use time. 3. A string guide (1.6) to easier thread the string in the device eyelet (1. 5). 4. A rechargeable battery (2.1) which is the power supply of the device (1. 1). This rechargeable battery is charged through two conductors (1. 2), (1.4) of the device (1. 1) and two corresponding metal contacts of an outside device, advantageously of a carrying and control case adapted for housing the device. 5. A microcontroller (2.2) with microprocessor, random access memory and input output system, to generate the electric pulses necessary to make working the device (1. 1) and execute the different orders given by the operator. 6. An inside round seal (2.3) which permits to make the device watertight and easy to clean with mild soap, alcohol or other disinfectants. The block diagram of the inside stimulator electronic 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. ), (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 device is provided with a carrying and control case. The carrying and control case may have a rectangle parallepipede shape and comprises 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 main body includes the following elements illustrated on FIG. 3 : 1. A transformer with charge circuitry located in compartiment (3.1) of the main body which receives equally input current of 110 or 220 volts and will transform it in an adequate output current able to charge the inside device rechargeable battery for example in 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 electronic 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 device microcontroller or to recharge the inside device 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 incontinence position (3.9) corresponds to 50 Hz pulse frequency coming from the inside device microcontroller. The orders given by the device user through this control knob (3.6) are sent to the electronic control system of the carrying and control case. 5. Control knob (3.7) permits to the device user to select the use time of the device: 15 minutes (3.10), 30 minutes (3.11), 45 minutes (3.12) or 60 minutes (3.13). The orders given by the device user to the control knob (3.7) are sent to the electronic control system of the carrying and control case. 6. A green control light (3.14) which indicate to the device user that the inside device rechargeable battery is fully charged and that the device 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 inside device rechargeable battery is always in charge and that the device cannot yet be used. When this red control light (3. 15) is on, the green control light (3.14) is off. 8. A housing (3.16) wherein the device (1.1) can be put between each use. Said housing has the same shape than the device but a slight upper size to permit to the device to fit easily into the housing. The bottom of housing (3.16) comprises three metal contacts (3.17), (3.18), (3.19) intended for transmitting to the three device 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 carrying and control case cover. A wedge (3.20) is provided at one end of the housing (3.16) and is adapted to fit into the device eyelet (1.5)) when the device is put into the housing (3.16). The wedge (3.20) is intended to maintain the device in 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 device conductors (1. 2), (1.3), (1.4) when the device is in the housing. 9. A string spool niche (3. 21) with a cover (3.22) intended to keep a string spool (3.23). A cutting system (3. 24) is provided with the string pool niche to cut the string before the use or after the use of the device. 10. In the hinge joining the cover to the main body of the carrying and control case there is a switch which gives orders to the electronic control system. The opening of the cover stops automatically the charge of the inside stimulator rechargeable battery and starts the working of the device, when the device is in its housing. The closing of the cover stops automatically the working of the device and starts the charge of the inside device rechargeable battery, when the device is in its housing. The block diagram of the inside carrying and control case electronic control 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 device 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 inside device rechargeable battery (6 hours). To use the device there is only to open the carrying and control case, remove the device from its housing, thread a 20 centimeters bit of string in the eyelet, knot the two ends of the string, lubricate the device and insert it into the vagina. The device is working. At the end of the session, take the device out of the vagina, cut and throw away the bit of string, clean the device, place it back in its resting nest and close the cover of the carrying and control case. The battery will be charge automatically. WE CLAIM: 1. A device (1.1) with a body adapted to be inserted in women's vagina to electrically stimulate the pelvic floor musculature and surrounding structures, comprising: - a stimulator body having a first set of conductors (1.2,1.3), to transmit electrical pulses to the pelvic floor musculature, in combination with a second set of conductors (1.4), which, jointly with the first one, is adapted to transmit the instructions of the operator to the device microcontroller (2.2), both sets of conductors being on the surface of the device body, said device comprising a battery (2.1) as power supply located inside the device body, and means for applying preprogrammed instructions concerning the current frequency adapted to the type of incontinence to be treated, and the treatment duration, and - a carrying and control case for housing said device body during non use of the stimulator body, without cable linking the device and the carrying and control case, the case comprising a transformer (3.1) with charge circuitry to charge the device battery (2.1), an electronic control system to transmit the instructions given by the operator, having two metal contacts adapted to charge the rechargeable battery through said both set of conductors of the stimulator body, and a second set of three metal contacts (3.17, 3.18, 3.19), located in the bottom of the case, which are connected to three specific conductors on the surface of the device body to transmit the instructions of the operator to the device controller, through this connection. 2. The device as claimed in claim 1, wherein said means for applying preprogrammed instructions comprise a microcontroller (2.2) to select the pulse frequency and the working time given by an outer electronic control system. 3. The device as claimed in claim 1 or 2, which is watertight. 4. The device as claimed in anyone of claims 1 to 3, wherein said device body comprises an eyelet (1.5) at one end, with a guide to thread a string into the eyelet (1.5). 5. The device as claimed in anyone of claims 1 to 4, wherein said housing for the device is provided with said metal contacts arranged to be in contact with the conductors of the device when put into the housing (3.16). 6. The device as claimed in anyone of claims 1 to 5, wherein said housing (3.16) comprises a wedge (3.20) adapted to go into the device eyelet (1.5) and intended to secure the position of the device in the housing so that the conductors of the device be always in contact with the corresponding metal contacts of the housing. 7. The device as claimed in anyone of claims 1 to 6, wherein said instructions are given by the operator to the microcontroller through control knobs.

Documents:

IN-PCT-2002-00808-DEL-Abstract-(07-10-2008).pdf

in-pct-2002-00808-del-abstract.pdf

in-pct-2002-00808-del-assignments.pdf

IN-PCT-2002-00808-DEL-Claims-(07-10-2008).pdf

in-pct-2002-00808-del-claims.pdf

in-pct-2002-00808-del-complete specification (granded).pdf

IN-PCT-2002-00808-DEL-Correspondence-Others-(08-08-2008).pdf

in-pct-2002-00808-del-correspondence-others.pdf

IN-PCT-2002-00808-DEL-Description (Complete)-(07-10-2008).pdf

in-pct-2002-00808-del-description (complete).pdf

in-pct-2002-00808-del-drawings.pdf

in-pct-2002-00808-del-form-1.pdf

in-pct-2002-00808-del-form-13.pdf

in-pct-2002-00808-del-form-18.pdf

IN-PCT-2002-00808-DEL-Form-2-(07-10-2008).pdf

in-pct-2002-00808-del-form-2.pdf

IN-PCT-2002-00808-DEL-Form-3-(08-08-2008).pdf

in-pct-2002-00808-del-form-3.pdf

in-pct-2002-00808-del-form-5.pdf

in-pct-2002-00808-del-form-6.pdf

in-pct-2002-00808-del-gpa.pdf

in-pct-2002-00808-del-pct-210.pdf

in-pct-2002-00808-del-pct-304.pdf

in-pct-2002-00808-del-pct-409.pdf

in-pct-2002-00808-del-pct-416.pdf

IN-PCT-2002-00808-DEL-Petition-137-(08-08-2008).pdf

IN-PCT-2002-00808-DEL-Petition-138-(08-08-2008).pdf