Abstract:
A vaginal rehabilitative device comprising: a vaginal electrical stimulation applicator; and a control module connectable by a wire to said applicator and comprising a user interface for controlling electrical stimuli by said applicator and a display module configured to display data received from said applicator.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. patent application Ser. No. 13/862,555, filed Apr. 15, 2013 and entitled “Vaginal Rehabilitative Device”, which is a Continuation-in-Part of U.S. patent application Ser. No. 13/063,949, now U.S. Pat. No. 8,634,920, filed May 6, 2011, and entitled “Device for Perineum Reeducation”. These documents are incorporated herein by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates to the field of vaginal rehabilitation devices. 
       BACKGROUND 
       [0003]    Urinary incontinence is often divided to two main types: stress incontinence and urge incontinence. Stress incontinence corresponds to loss of urine as a result of an increase in abdominal pressure on the bladder. This increase in pressure may be caused due to coughing, sneezing, laughing, or making a movement, in particular lifting a heavy object. Stress incontinence is the most common type of incontinence and it mainly affects women. It takes place in general when the perineal muscles and the muscles of the floor of the pelvis are weakened, e.g. by pregnancies, childbirth, or menopause. 
         [0004]    Urge incontinence corresponds to a sudden need to urinate, followed by an immediate contraction of the bladder. This contraction results in an involuntary loss of urine. Both men and women may be affected by this type of incontinence, in particular among older people. One of the reasons for such incontinence is a failure in the operation of the nervous system controlling the bladder. 
         [0005]    Mixed incontinence is a combination of stress incontinence and of urge incontinence. 
         [0006]    The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures. 
       SUMMARY 
       [0007]    The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. 
         [0008]    There is provided, in accordance with some embodiments, a perineal rehabilitation device comprising: an electrical stimulation applicator; and a control module connectable by a wire to said applicator, and configured to control said applicator, the control module comprising a user interface for controlling said applicator and a display module configured to display data received from said applicator. 
         [0009]    In some embodiments, said applicator is shaped as an elongated rounded cylinder, for endocavity use. 
         [0010]    In some embodiments, said applicator is shaped as an annular band, for external use. 
         [0011]    In some embodiments, said applicator further comprises at least one energy storage unit. 
         [0012]    In some embodiments, said applicator further comprises at least one microprocessor, configured to manage said applicator operation. 
         [0013]    In some embodiments, said applicator further comprises at least two stimulation electrodes, configured to apply voltage for executing electrical stimulation. 
         [0014]    In some embodiments, said applicator further comprises at least two charging electrodes, configured to be connected to power source while said applicator is charging. 
         [0015]    In some embodiments, said applicator further comprises a dedicated electrode configured to detect if said applicator is positioned correctly to allow stimulation activation. 
         [0016]    In some embodiments, said applicator further comprises a sensor configured to detect body reaction to electrical stimulation, for allowing adaptive stimulation and feedback of treatment effectiveness. 
         [0017]    In some embodiments, said sensor is a pressure sensor, configured to sense muscle contraction. 
         [0018]    In some embodiments, said control module further comprises at least one energy storage unit. 
         [0019]    In some embodiments, said control module further comprises at least one microprocessor, configured to manage said control module operation. 
         [0020]    In some embodiments, said control module further comprises a memory for storing data regarding the treatment history. 
         [0021]    In some embodiments, said applicator and said control module are configured to communicate via bidirectional wired communication protocol. 
         [0022]    In some embodiments, said control module is further configured to communicate with a computer via wired communication protocol, for further viewing and analyzing. 
         [0023]    In some embodiments, said control module is further configured to communicate with a computer via wireless communication protocol, for further viewing and analyzing. 
         [0024]    There is further provided, in accordance with some embodiments, a method for perineal rehabilitation comprising: selecting desired stimulation program using a control module; selecting desired treatment duration using said control panel; applying stimulation applicator to suitable body part and waiting for confirmation of correct applying on said control module; performing sensitivity test to define user sensitivity threshold; running the selected stimulation program; receiving feedback from user body by a sensor installed in said applicator; adjusting stimulation parameters while said program is running, if needed; extracting said applicator after treatment end; viewing data on said control module; and optionally connecting said control module to a computer, for viewing data stored on said control module. 
         [0025]    In some embodiments, said program is selected from multiple programs, pre-determined and dedicated for treatment of different medical diagnosis, programmed in said control module. 
         [0026]    In some embodiments, said sensitivity test is done by applying stimulation at zero intensity level and increasing stimulation manually by user, stopping the stimulation by the user when it is initially felt, and storing the corresponding intensity level on said control module memory. 
         [0027]    In some embodiments, said sensitivity test is done by applying stimulation at zero intensity level and increasing stimulation automatically by said control module, stopping the stimulation by the user when it is initially felt, and storing the corresponding intensity level on said control module memory. 
         [0028]    In some embodiments, said selected stimulation program parameters are displayed to the user on said control module, while said program is running. 
         [0029]    In some embodiments, said selected stimulation program parameters can be changed and said program can be stopped by the user at any time, while said program is running. 
         [0030]    In some embodiments, said selected stimulation program can be stopped automatically at any time if the applicator misplaced from its correct location on suitable body part, while said program is running. 
         [0031]    In some embodiments, said receiving feedback from user body is done by measuring muscle contraction, and used for adaptive stimulation. 
         [0032]    In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0033]    Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below. 
           [0034]      FIG. 1A  shows an illustration of an endocavity applicator of a rehabilitation device, in accordance with some embodiments; 
           [0035]      FIG. 1B  shows an illustration of a control module of a rehabilitation device, in accordance with some embodiments; 
           [0036]      FIG. 1C  shows an illustration of an endocavity applicator with a detection electrode, in accordance with some embodiments; 
           [0037]      FIG. 2  shows an illustration of a perineal rehabilitation device during a charging stage, in accordance with some embodiments; 
           [0038]      FIG. 3  shows an example of a display on the screen of the control module, in accordance with some embodiments; 
           [0039]      FIG. 4  shows a flow chart of the system operation, in accordance with some embodiments; 
           [0040]      FIG. 5  shows an illustration of the optional connection of the control module to a computer, in accordance with some embodiments; 
           [0041]      FIG. 6A  shows an example of a compact window displayed on a computer screen, in accordance with some embodiments; 
           [0042]      FIG. 6B  shows an example of a detailed window displayed on a computer screen, in accordance with some embodiments; and 
           [0043]      FIG. 6C  shows an example of another detailed window displayed on a computer screen. 
       
    
    
     DETAILED DESCRIPTION 
       [0044]    Disclosed herein are a device and a method for vaginal rehabilitation. The present device, according to some embodiments, may be a mobile, liquid-sealed, easy to use electrical stimulator for treating one or more conditions such as urine incontinence, organ prolapsed and/or the like. 
         [0045]    Present embodiments may be better understood with reference to the accompanying drawings. Reference is now made to  FIG. 1A , which shows an illustration of an endocavity applicator of a rehabilitation device, and to  FIG. 1B  which shows an illustration of a control module of a rehabilitation device. Depicted is an endocavity applicator  100  which may comprise an oblong portion  100   a  for inserting into the cavity (e.g. the vagina), and a long thin portion  100   b  which may comprise a handle for inserting and removing the applicator. The endocavity applicator may be sealed so as to be easy to clean. 
         [0046]    Oblong portion  100   a  may be equipped with multiple annular stimulation electrodes, by way of example herein two electrodes  102  and  104 . Other electrode shapes, in particular circular arcs may also be implemented. Stimulation electrodes  102  and  104  may be used to apply the electrical stimuli. The number of stimulation electrodes may be greater. Nevertheless, studies have shown that the ratio of the number of electrodes to the effectiveness of stimuli is very satisfactory when using two electrodes. 
         [0047]    Assuming the device may be designed for vaginal use in such manner that oblong portion  100   a  is inserted in full, stimulation electrodes  102  and  104  may occupy the first four centimeters of oblong portion  100   a , since it may be their optimal and most effective location. 
         [0048]    Applicator  100  may include at least one microprocessor for managing the stimuli, and a communication module, for wire communicating with a control module  108 . Control module  108  may function as a remote control for the user. Control module  108  may include a display screen  110  and multiple control buttons, by way of example herein five buttons  112 ,  114 ,  116 ,  118 ,  120 . Control module  108  may also include a battery, at least one microprocessor, at least one memory module for storing data, and a communication module for wire communicating with applicator  100 . 
         [0049]    Button  112  may serve to switch the device on and off. Button  112  may be also used for stopping the stimulation at any moment. Button  114  may enable the treatment to be started and paused momentarily. Buttons  116 ,  118  and  120  may serve as multi-functional keys, allowing controlling a variety of changing functionalities, such as validation of choices, selecting treatment, setting treatment duration and intensity, view session report, setting preferred language, date and time, etc. 
         [0050]    Applicator  100  and control module  108  may apply wired communication between them. Any type of wired communication protocol may be used, such as Ethernet, USB (Universal Serial Bus), etc. wired communication may be obtained via applicator connector  106  and control module connector  122 , by way of example herein DIN3 connectors, which may be connected with a wire suitable for the communication protocol of choice. Specifically, muscular contraction may weaken after several successive contractions. It may then become inefficient for the muscle that is fatigued or that is becoming fatigued to be stimulated strongly. 
         [0051]    Advantageously, applicator  100  may include a sensor for measuring the reactions of the user&#39;s body, e.g. a pressure sensor suitable for measuring muscle contraction, which may be implemented by a strain gauge. The measurement of this contraction may then be transmitted in real time to control module  108 , which may adjust the stimulation intensity according to measured muscle contraction, for creating an adapted use. Moreover, this data may be recorded on control module memory, to provide feedback of user advancement to the user and/or to health professional, in real time during treatment session and/or during report analysis after treatment. 
         [0052]    According to an advantageous characteristic of the invention, the applicator  100  includes a third electrode  103  for detecting that it has been inserted or installed in a body cavity, e.g. the vagina, to avoid electric shocks. Electrode  103  is suitable for detecting contact with the body, said electrode being suitable for sending a signal to the microprocessor installed within the applicator and/or the microprocessor installed within the control module, the microprocessor being such as to be suitable for causing stimulation to stop as soon as the applicator is no longer in contact with the body or when the applicator  100  is extracted from the vagina. 
         [0053]    In addition to sensor  103 , the electric current or intensity can be reduced to zero at any moment so as to allow removing the applicator at any moment. The sensor  103  then serves to verify that the applicator  100  is indeed inserted before beginning the treatment. The signal issued by the sensor  103  is sent to the control module. 
         [0054]    According to the invention, it is also advantageous for the software managing the operation of the applicator  100  to stop the stimulation as soon as the sensor  103  detects that the applicator  100  is no longer in contact with the body. This stopping of stimulation may be under the control of the control module to which the signal issued by the sensor  103  is returned, or indeed it may be stopped internally by the applicator itself, with the microprocessor installed therein being suitable for processing the data issued by the sensor  103  and for stopping stimulation. 
         [0055]    Reference is now made to  FIG. 2 , which shows an illustration of the device charging. Control module  108  may be connected to a charger  200  using a charging cable  202 , which may be a USB cable. Charger  200  in turn, may be connected to a mains outlet  204 , to allow charging. 
         [0056]    Reference is now made to  FIG. 3 , which shows an example of a display on the screen of the control module. An indicator  300  may indicate whether connection with applicator  100  may be established or not (e.g. green indicator for communication and red indicator for no communication). An indicator  302  may indicate the stimulation intensity level graphically. An indicator  304  may indicate the stimulation intensity level numerically. An indicator  306  may specify the stimulation program (in this example “EFFORT P 1 ”) that may be running or may have been selected. An indicator  308  may display a timer showing the elapsed or remaining duration of the treatment. An indicator  310  may indicate that stimulation is currently operating. In this example, it may be depicted by a circle with a disk at its center that is lighted only when stimulation is active. Indicators  312  and  314  may indicate that multi-functional buttons  118  and  120  are now configured to increase or decrease stimulation intensity level, respectively. An indicator  316  may indicate the device battery level. 
         [0057]    Reference is now made to  FIG. 4 , which shows a flow chart of the system operation. Control module  108  may be switched on using button  112 , and screen  110  may display a “wake-up” indication, in step S 1 . Screen  110  may then invite the user to press on button  116  (herein button  1 ) in order to select a treatment option, in step S 2 . The user may be invited to select treatment program from a list of programs, using buttons  116 ,  118 , and  120  (herein buttons  1 ,  2 , and  3 ), in step S 3 . Specifically, the user may select from the following programs: Programs P 1  and P 2  may be dedicated for treating stress incontinence, and program P 3  may be dedicated for treating mixed incontinence. The programs specific parameters may be given by the following table: 
         [0000]    
       
         
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                   
               
               
                   
                   
                 Pulse 
                 Stimulation 
                 Rest 
                   
               
               
                   
                 Frequency 
                 duration 
                 time 
                 time 
                 Recommended  
               
               
                 Program 
                 [Hz] 
                 [μsec] 
                 [sec] 
                 [sec] 
                 use 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 P1 
                 50 
                 400 
                 3 
                 6 
                 30 min, 3-5 
               
               
                   
                   
                   
                   
                   
                 times/week 
               
               
                 P2 
                 50 
                 400 
                 5 
                 10 
                 30 min, 3-5 
               
               
                   
                   
                   
                   
                   
                 times/week 
               
               
                 P3 
                 20 
                 400 
                 3 
                 6 
                 30 min, 3-5 
               
               
                   
                   
                   
                   
                   
                 times/week 
               
               
                   
               
             
          
         
       
     
         [0058]    Afterwards, the system may invite the user to select the duration of the treatment, using buttons  116 ,  118 , and  120  (herein buttons  1 ,  2 , and  3 ), in step S 4 . The system may then invite the user to insert applicator  100  into the vagina, in step S 5 . The sensor  103  then serves to verify that the applicator  100  is indeed inserted before beginning the treatment. Advantageously, the signal issued by the sensor  103  is sent to the control module. The screen can then indicate whether or not the applicator  100  has been inserted correctly, and when the applicator is inserted correctly, the screen invites the user to press on the key in order to start the stimulation program. 
         [0059]    After applicator  100  may have been inserted correctly, the system may invite the user to press on button  114  in order to start the stimulation program, in step S 6 . Screen  110  may then display a message announcing of stimulation test start, in step T 1 . In step T 2 , the test sequence may begin with stimulation at zero intensity level, to ensure that the patient does not suffer any electric shock, and the user may be invited to increase stimulation intensity level by pressing on “+”, using button  118  (herein button  2 ). When she might feel a convenient level of stimulation, she may press “OK” using button  120  (herein button  3 ). Alternatively, the intensity level may be adjusted automatically by control module  108 , according to body feedback (e.g. muscle contraction) measured by a sensor embedded in applicator  100  and transmitted to control module  108 . The test may be performed at the beginning of each session, and allow obtaining important medical data, namely the user&#39;s sensitivity threshold and advancement level. A health professional may then measure the effectiveness of the treatment, knowing such data. The selected stimulation program may then put into operation in step P 1 . A timer counting down may appear and the user may increase and/or decrease the intensity level, using buttons  118  and  120  (herein buttons  2  and  3 ). Alternatively, the intensity level may be adjusted automatically by control module  108 , according to body feedback (e.g. muscle contraction) measured by a sensor embedded in applicator  100  and transmitted to control module  108 . While the program is running, indicator  310  may light up when a stimulation starts and may turn off when it stops. This may enable the user to know when stimulation is taking place in order to contract her muscles at the same time. In application of Kegel exercises, such contraction may encourage treatment and restoration or reinforcement of muscular structures. The user may also pause and/or resume the program momentarily, using button  114 . The duration of stimulation and its intensity may be stored automatically in the memory of control module  108 . After the treatment session has finished, screen  110  may display an “end of session” indication, in step P 2 . Executed treatment session parameters may be automatically stored in control module memory. Thus, after session ending, screen  110  may automatically display a “report” indication, in step R 1 , immediately followed by a summary report of the executed treatment, in step R 2 . The report may include treatment session time and date, selected program, duration, average intensity level, stimulation test value, status of the session (completed successfully or not), etc. Treatment session history for all executed treatment sessions may be available to the user and/or health professional, by selecting the “Reports” option with button  120  (herein button  3 ), in step S 2 . 
         [0060]    Reference is now made to  FIG. 5 , which shows an illustration of the optional connection of the control module to a computer. The connection between control module  108  and a computer  500  (e.g. the computer of the user or of a health professional) may be done by a USB cable  502 . The data stored in memory of control module  108  may then be accessible by computer  500 . It may also be possible to transfer the stored data to computer  500 . Under such circumstances, the data may be subsequently presented using a format that may be suitable for reading that data by common software (e.g. Excel). In the context of biofeedback applications, it is advantageous also to store a so called “fitness” test showing the automatic adaptation of the intensity of stimulation as a function of progress during the application of the treatment. This may provide information about the fatigability of the muscle and about its training. 
         [0061]    Reference is now made to  FIG. 6A  which shows an example of a compact window displayed on a computer screen. Compact window  600  may include a summary report of a specific session stored in the control module. Reference is now made to  FIG. 6B  which shows an example of a detailed window displayed on a computer screen. Detailed window  602  may include additional data regarding the session (e.g. user name, graphical stimulation test summary, etc.) stored in the control module. Reference is now made to  FIG. 6C  which shows an example of another detailed window displayed on a computer screen. Detailed window  604  may include a list of treatment sessions performed by the user, stored in the control module. The summary of the sensitivity tests in window  602  may be in the form of a curve of sensitivity threshold intensities detected by the user over the set of treatment sessions listed in window  604 . 
         [0062]    In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. In addition, where there are inconsistencies between this application and any document incorporated by reference, it is hereby intended that the present application controls.