Abstract:
The present invention relates to a method for measuring the elasticity of the anterior walls of the human vagina. The elasticity of the vagina walls degrade as women age. When a condition occurs called pelvic organ prolapse, the vaginal walls have lost much of the visco-elastic properties. The ability to measure the elasticity in healthy women at an early age and track the changes over time will give researchers the chance to develop new therapies to manage this growing problem. The present invention makes multiple data measurements of vacuum pressures and proximity measurement, by the use of a small insertable, user friendly and quickly sterilizable vaginal device. The proximity sensor not only measures the deformation of the skin pulled into a small hole of the vaginal probe but also measures the skin deformation after the skin has retracted out of the probe hole.

Description:
REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of 35 U.S.C. 111(b) Provisional Patent Application Ser. No. 61/574,290 which was filed on Aug. 1, 2011 and entitled “Electronic Skin Elasticity Meter”. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to an apparatus that measures the elasticity of skin. Skin elasticity is measured to determine the effects of medications, skin creams, surgery procedures and the effects of aging. The present invention is designed to measure the skin elasticity of the inner walls of the vagina to detect changes in the integrity of connective tissues in the vagina. The present includes a small probe that allows a physician to easily perform elasticity measurements on patients during a regular office exam. The present invention provides the physician with a medical device to determine, among other conditions, if a woman is susceptible to prolapse, a condition that happens when the bladder falls down into the vagina. 
         [0003]    Skin elasticity is calculated from the data derived from the combination of vacuum pressure, time, the amount of skin pulled by the vacuum, the length of time the skin returns to the original shape, and the recoil reaction of the skin. The values are collected, calculated, and stored by the microcontroller and then down loaded to a computer through a data port or USB port. The data can be compiled by a computer program to display tables, plot graphs, indicate changes in the vaginal wall elasticity and assist physicians diagnose any change of elasticity and the probability of prolapse and other conditions related to vaginal disease. 
         [0004]    The present invention is not limited to the vagina skin elasticity measurement. The present invention can test elasticity of any skin on any area of the body of any living animal. The present invention will also test the elasticity of flexible materials such as rubber, vinyl, foams or other elastic materials 
       BACKGROUND OF THE INVENTION 
       [0005]    The present invention relates to an electro mechanical device that measures skin elasticity for assessing the viscoelastic properties of the anterior wall of the vagina. Vaginal wall tissue deterioration can cause pelvic organ prolapse (POP), a hernia of the pelvic organs to or through the vaginal opening. POP affects a large number of aging women that often necessitates surgical repair and tends to recur over time. Approximately 200,000 operations are performed yearly in the United States for POP. Although not life threatening, POP is life altering and results in significant quality of life changes in women. 
         [0006]    Medical researchers have studied vaginal wall properties in fresh excised tissue, at the time of surgery, using an Instron tensile testing machine but this is limited by its applicability, namely patients requiring surgery. Currently, evaluation of the vaginal wall is limited to physical examination and imaging modalities. There are no quantitative and practical devices that a physician can use during an office visit to measure the unique viscoelastic properties of the vagina to objectively determine tissue deterioration. The ability to measure the elasticity of the inner walls of the vagina in healthy patients for study controls, patients in less advanced degrees of POP, patients before and after surgical repair and patients on hormonal therapy will lead to a myriad of common vaginal interventions, from pelvic floor therapy to reconstructive surgery. Like the thermometer to determine how sick a patient is, the present invention will serve as a diagnostic resource for clinicians and researchers interested in the management of POP. 
         [0007]    Skin elasticity measurement devices that were found in the patent search include US2008/0234607 A1. It applies a vacuum to a chamber that is placed over an area of the skin. When the vacuum draws the skin through an opening a video camera in an adjacent chamber captures light reflected from the skin. U.S. Pat. No. 7,955,278 B1 creates a vacuum that draws the skin into a chamber until the skin reaches the vacuum tube in the chamber. The vacuum pressures are measured and pressure changes are used to calculate elasticity. U.S. Pat. No. 5,278,776, describes the use of a camera that monitors the movement of dots placed on the skin. When the vacuum is applied the skin moves into the chamber causing the dots to move. The elasticity is determined by the dot separation. 
         [0008]    Prior art is designed to test the elasticity of skin on the surface of the body. The present invention is a safe, easily insertable, user-friendly, and quickly sterilizable vaginal device that would allow rapid and reproducible measurements of different areas of the vagina, in the office setting. The present invention is simple to use but extremely accurate. The probe design is small enough to be inserted in the vagina, yet measure precisely the tissue deflection and recovery under mild suction and vacuum release. The stored data for each patient can be compared to previously collected data to detect the changes in tissue elasticity. For the first time, the present invention allows for a direct in-vivo measurement of vaginal wall tissue properties. 
       OBJECT OF THE INVENTION 
       [0009]    The present invention is used as a medical device to give physicians data to diagnose, predict and repair various conditions associated with skin due ageing or disease. The present invention is a small and portable unit consisting of a vacuum canister, a vacuum pump, an electronic control unit with a liquid crystal display, and an elasticity measuring wand assembly. The wand,  FIGS. 1 and 2 , is a hollow oval tube approximately six inches in length by approximately three quarters of an inch wide. A 10 millimeter hole is located on the edge of the wand approximately one half inch from the sealed end. The wand handle  FIG. 2 , has a circuit board that contains an electronic proximity sensor and connections for the data cable and vacuum line. When the handle is attached to the wand the sensor is positioned under the 10 millimeter hole. The wand assembly is inserted into the vagina to measure the elasticity of the anterior walls of the vagina. A vacuum is applied to the wand assembly making a seal through the hole in the wand. The vacuum causes the skin to be pulled into the hole of the wand assembly. When the vacuum reaches a preset level, the microcontroller reads the proximity sensor values. The proximity sensor measures the distance from the proximity sensor to the skin pulled into the hole. The microcontroller computes the distance measured to determine how much skin was pulled in from the vacuum. Skin elasticity is calculated from the data derived from the combination of vacuum pressure, time, the amount of skin pulled in by the vacuum, and the shape of the curve plotted from the data. The values are calculated and stored by the microcontroller and are transferred to a computer through a data port. The data is compiled and stored in a program that plots graphs for the physician to analyze. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention is a medical device that analyzes skin elasticity of the inner walls of the vagina. The Vaginal Bio-Mechanics Analyzer is a small and portable unit consisting of a vacuum canister, a vacuum pump, an electronic control unit with a liquid crystal display, remote computer connection, and an elasticity measuring wand assembly depicted in  FIG. 3 . The wand assembly consists of two parts, the probe  FIG. 1  and the handle,  FIG. 2 . The probe is removable from the handle for sterilization before each patient exam. The probe of  FIG. 1  is a hollow tube approximately six inches in length by approximately three quarters of an inch wide in an oval shape with a hole located on the wide edge of the probe and approximately three quarters of an inch from the rounded closed end of the probe. The handle of  FIG. 2  has a sensor board that slides into the probe and is positioned precisely beneath the hole in the probe. The vacuum line and data cable in  FIG. 3  connect to the handle of  FIG. 2 . The patient exam begins with the physician inserting the probe into the vagina. A low preprogramed vacuum is applied by the control unit of  FIG. 3  causing the skin of the vagina to be pulled into the hole in the probe. As the skin moves into the hole the proximity sensor measures the distance between the sensor and the moving skin. The data representing the skin movement, the changes in vacuum pressure and the increments of time are stored by the microcontroller of  FIG. 6  located in the control unit. The data port in  FIG. 6  connects to a computer that receives the stored data that is downloaded from the control unit. The physician compiles the data to analyze and store for future comparisons. Graphs can be produced such as  FIGS. 7 ,  8 , and  9  in common computer programs that represent a visual representation of the vaginal wall elasticity. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  shows a preferred embodiment of the probe that is inserted into the vagina. 
           [0012]      FIG. 2  shows a preferred embodiment of the handle which attaches to the probe. 
           [0013]      FIG. 3  is an illustration of the components of the present invention. 
           [0014]      FIGS. 4A and 4B  set forth a flow chart of the control unit of the preferred embodiment. 
           [0015]      FIG. 5  is a schematic of pneumatic vacuum system of the present invention. 
           [0016]      FIG. 6  is a block diagram of the microcontroller and the electrical components of the present invention. 
           [0017]      FIG. 7  is a graph representing the data of a patient with prolapse. 
           [0018]      FIG. 8  is a graph representing the data of a patient without prolapse. 
           [0019]      FIG. 9  is a graph representing the data of the cheek of a patient&#39;s face. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0020]      FIG. 1  depicts a hollow tube that is oval. The wide part of the oval is 0.75 inches while the narrow part of the oval is 0.625 inches. The probe  1  is 5.5 inches in length and is the outer part of the wand assembly. A hole  2  has a 10 millimeter diameter and is on the 0.75 inch surface of the probe. Hole 2 centerline is 0.75 inches from the rounded end of the probe  1 . The hole  2  allows the skin that is under test to pull down into the hole when a vacuum is applied. As the skin is pulled in the hole, the proximity sensor of  FIG. 2  makes measurements as described later here in. The probe  1  has a flange that allows for a vacuum seal when connected to the handle of  FIG. 2 . The probe  1  is removed from the handle of  FIG. 2  to clean and sterilize after use. 
         [0021]      FIG. 2  shows the handle  3  with the proximity sensor  4  attached to a circuit board. The handle  3 , is 2.75 inches in length and is 2.25 inches in diameter. The probe  1  of  FIG. 1  attaches to the handle  3  by the threads  5  to securely hold the probe of  FIG. 1  to the handle  3  and make a seal to prevent vacuum leaks. The proximity sensor  4  is precisely positioned beneath the 10 millimeter hole of  FIG. 1  when the handle  3  and probe  1  are attached. The sensor circuit board  6  makes an electrical and data connection to the proximity sensor  4 . 
         [0022]      FIG. 3  is an illustration of the components used by the present invention to test skin elasticity. Vacuum canister  14  is evacuated to approximately negative 400 millimeters of mercury by an electrical vacuum pump  15 . A vacuum line  16  is connected to the electronic control unit  20 . Electronic control unit  20  has a liquid crystal display  24 , and switches  21 ,  22 , and  23 . The switches  21 ,  22 ,  23 , and LCD  24  are used to perform menu selections displayed on the LCD screen  24  as described later in  FIGS. 4A and 4B . The data cable  19  of wand assembly  18  provides electrical and data connection between the wand assembly and the electronic control unit  20 . Data cable  19  is used to transmit serial data from the proximity sensor  4  of  FIG. 2  to the microcontroller  62  described later in  FIG. 5 . Vacuum line  17  is connected to the wand assembly  18  and to the electronic control unit  20 . The vacuum line  17  allows a vacuum that is regulated by the control unit  20 . The vacuum pump  15  and vacuum storage canister  14  are contained in the control unit  20 . The electronic control valves of  FIG. 5  are located in the control unit  20 . 
         [0023]    FIGS.  4 A and  4 B-illustrate a flow diagram of the present invention. The flow diagrams describe only two of a plurality of skin elasticity tests that the present invention can perform. A microcontroller of the present invention is programmed to read and write the control values of the proximity sensor  4  of  FIG. 2 , the vacuum pump  15 , the liquid crystal display of  FIG. 3 , and the electronic vacuum valves  54 ,  55  and  56  of  FIG. 5 . The power is switched on at the step  25 , vacuum pump at step  26  is energized and begins aspirating a vacuum in canister  14  of  FIG. 3 . At step  28 , digital vacuum sensor  53  of  FIG. 5  outputs an analog signal proportional to the vacuum pressure. The signal is converted to a digital value in the microcontroller. When the vacuum pressure reaches approximately 400 millimeters of mercury at step  28  the vacuum pump  15  of  FIG. 3  is switched off. In step  29  the liquid crystal display (LCD)  24  of  FIG. 3  displays a message to begin the test. In step  30  the physician presses the start button  23  of  FIG. 3 . The proximity sensor  4  of  FIG. 2  is energized. Internal circuitry in the proximity sensor stabilizes and at step  32  the physician presses select switch  22  of  FIG. 3  to choose the type of test to perform. When the test is selected, the physician inserts the wand assembly into the vagina of the patient at step  36 . At step  38  the physician presses the test switch  23  of  FIG. 3  to start the selected test. At step  39 , variable solenoid vacuum valve  55  of  FIG. 6  is opened and a vacuum is created in the wand assembly. A small portion the inner wall of the vagina begins to pull into the hole  2  of  FIG. 1 . At step  41  the vacuum is sensor  58  of  FIG. 5  begins sensing the change from atmospheric pressure to a vacuum. At step  41  the variable solenoid valve  55  of  FIG. 5  stays open until a predetermined vacuum pressure has been reached and then switched off at step  42 . The microcontroller  62  of  FIG. 6  receives the proximity value at step  43  from the proximity sensor  4  of  FIG. 2 . The values are computed and the results are displayed on LCD  24  of  FIG. 3  at step  44 . At step  45 , the results are stored in memory of the microcontroller  62  of  FIG. 6 . At step  46  the physician is given a choice to start the tests over or at step  48 , to download the test results to a computer through the data port  63  of  FIG. 6 . The type of test decision at step  32  is selected by pressing the switch  22  of  FIG. 3 . Test one is a test that requires the microcontroller to energize and open the electronic variable valve  56  of  FIG. 6  until the vacuum sensor  58  of  FIG. 5  senses a preset value. The proximity sensor  4  of  FIG. 2  measures the distance and outputs a digital number representing the zero point in distance at zero vacuum. The vacuum sensor  58  of  FIG. 5  begins detecting a change of negative pressure while the proximity sensor  4  of  FIG. 2  continues to make measurements. The microcontroller  62  of  FIG. 6  stores the values from the vacuum sensor  58  of  FIG. 5  and proximity sensor  4  of  FIG. 2  until the vacuum reaches a predetermined value. The electronic variable valve  56  of  FIG. 5  is closed ending the test. The microcontroller  62  of  FIG. 6  computes the proximity and vacuum values of the test and stores them in memory for evaluation of skin elasticity. Test 2 at step  34  uses the variable electronic valve  55  of  FIG. 6  to vary the vacuum pressure applied to the wand assembly. The test begins at a zero vacuum pressure and for a predetermined time, the vacuum increases to a predetermined level. During the pressure increase, the proximity sensor  4  of  FIG. 2  takes a predetermined amount of measurements which are stored in microcontroller  62  of  FIG. 6 . The sensor  4  of  FIG. 2  and vacuum sensor  58  of  FIG. 5  values are displayed on the LCD  24  of  FIG. 3  at step  44 . The values are downloaded to a computer through a data port  63  of  FIG. 6  at step  48 . The computer compiles the data to plot graphs showing the relationship of vacuum and the increase of skin being pulled through the hole  2  of  FIG. 1  vs. time. Test three at step  35  is designed to test the amount of skin pulled through the hole  2  of  FIG. 1  while a preset vacuum is held over a change in time. The proximity sensor  4  of  FIG. 2  measures the zero vacuum level then stores the value in microcontroller  62  of  FIG. 6 . The electronic variable vacuum valve  56  of  FIG. 5  is opened until a predetermined vacuum pressure is reached. The vacuum in held for a predetermined time. The proximity sensor  4  of  FIG. 2 , takes a predetermined number of readings that are stored in microcontroller  62  of  FIG. 6 . The values are downloaded to a computer through data port  63  of  FIG. 6  at step  48 . The computer compiles the data that can display graphs of time vs. increasing amount of skin pulled through hole  2  of  FIG. 1 . The present invention is not limited to the described three tests. A plurality of preprogrammed tests are possible to determine skin elasticity. 
         [0024]      FIG. 5  is a schematic of the pneumatic vacuum system of the present invention. The vacuum pump  50  is connected by vacuum tubing to a check valve  51  to prevent air from flowing back into the vacuum canister  52  after the vacuum pump is switched off. The vacuum canister  52  is used as a vacuum reservoir for fast evacuation of air through the vacuum system. An electronic vacuum sensor  53  is connected by tubing the vacuum canister  52  and senses the vacuum which outputs an analog voltage proportional to the vacuum pressure. The analog voltage is used by the microcontroller  62  of  FIG. 6  to determine the vacuum pressure and keep a constant vacuum pressure in the vacuum canister  52  by switching the vacuum pump  50  on at a preset low value and off for a preset high value. Solenoid pressure valve  54  is connected by tubing to electronic vacuum sensor  53  and is an emergency release valve that is opened to bring the vacuum system to atmospheric pressure. If the vacuum pressure reaches a predetermined level or the physician presses the emergency release switch  21  of  FIG. 4 , solenoid pressure valve  54  will open to allow the system to come to atmospheric pressure. Electronic variable solenoid valve  55  is connected by tubing to the solenoid valve  54 , and restricts the vacuum pressure level that is proportional to the current applied to the solenoid by the microcontroller  62  of  FIG. 6 . Flow restriction is one of the parameters used in an elasticity test. Solenoid valve  56  is connected by tubing to electronic variable valve  55  and when opened releases the vacuum pressure in the wand assembly. Pressure sensor  58  is connected by tubing to the solenoid valve  56  and sends an analog voltage proportional to the vacuum pressure of the wand assembly to microcontroller  62  of  FIG. 6 . The microcontroller opens electronic variable valve  55  at the beginning of a test and closes it at a predetermined vacuum level measured by the vacuum sensor  58 . 
         [0025]      FIG. 6  is a block diagram that illustrates the electronic components of the present invention. Microcontroller  62  is programmed to perform the tasks required to control all the required functions of the flow charts,  FIGS. 4A and 4B . The power is preferably a 12 volt direct current power supply  60 . The power switch  61  switches on the power to the microcontroller  62 . Vacuum solenoid valve  54  is electrically connected to an I/O port that provides power to open the valve to release the vacuum in vacuum canister  14  of  FIG. 3 . Vacuum sensor  53  is electrically connected to an ND port on microcontroller  62  that reads the analog voltage output from the sensor and converts it to a digital signal used by the microcontroller  62  to switch on and off the vacuum pump  15 . Solenoid variable valve  55  is electrically connected to an I/O port that outputs a pulse width modulated signal to vary the current through the solenoid. As the current increases through the valve&#39;s solenoid, valve  55  opens wider, allowing more airflow. Solenoid valve  56  is electrically connected to an I/O port on microcontroller  62  and energizes the solenoid at a programmed point to release the vacuum pressure on the wand assembly. Vacuum sensor  58  monitors the vacuum pressure on the vacuum line connected to the wand assembly by outputting an analog voltage to a second A/D input of microcontroller  62 . The A/D input converts the analog signal to a digital value proportional to the analog voltage. The microcontroller  62  is programmed to open solenoid valve  56  at a predetermined vacuum pressure. Proximity sensor  4  is electrically connected to an I2C data port on microcontroller  62 . Data from proximity sensor  4  is used in the microcontroller  62  to determine the distance from the sensor  4  to the surface of the skin pulled through the hole  2  in  FIG. 1  by the vacuum applied. Liquid crystal display  24  is connected to I/O ports to display the various menu options and test results that are computed by the microcontroller  62 . Push button switch  23  is electrically connected to microcontroller  62  and when pressed starts the test program to begin collecting data from the pressure sensors  53  and  58  and proximity sensor  4 . Push button  22  is electrically connected to microcontroller  62  and when pressed causes the liquid crystal display to display programmed menu choices available for performing the tests. Push button switch  21  is electrically connected to microcontroller  62  and when pressed causes all functions to stop and open the solenoid valve  54 , to release the pressure in vacuum canister  14  of  FIG. 3  and then open solenoid valve  56  to relieve vacuum pressure on the wand assembly. Data port  63  is electrically connected to microcontroller  62  to allow the data from the microcontroller  62  to transfer to a computer that is programmed to compute, graph and store the skin elasticity data for analysis. 
         [0026]      FIG. 7  is a graph of the deformation of the skin in the anterior wall of the vagina of a patient with prolapse. The probe was inserted 5 centimeters with the hole  2  of  FIG. 1  pointing up. The test parameters were selected by choosing a menu displayed on the LCD screen  24  of  FIG. 3 . The test was set to a 20 second time period. The test parameters consisted of a vacuum linearly increased from 0 to 150 millimeters of mercury over a 6 second period while data measurements were recorded in 1/10 of a second intervals. At the end of 6 seconds the vacuum was released. The data was continuously collected for 14 more seconds. The skin deformed to 2.9 millimeters and dropped to 0.9 millimeters in 2/10 ef a second. Over the last 14 seconds the skin gradually rose to 1.5 millimeters. The chart indicates that the vagina&#39;s anterior wall of a prolapsed patient lacked elasticity when compared to the chart of  FIG. 8 , a patient without prolapse. 
         [0027]      FIG. 8  is a graph of the deformation of the skin in the anterior wall of the vagina of a patient without prolapse. The test parameters were the same as in  FIG. 7 . The vacuum was increased from 0 to 150 millimeters of mercury over 6 seconds while data measurements recorded every 1/10 of a second of the proximity sensor  4  of  FIG. 2  and the vacuum measurements from the sensor  58  of  FIG. 5 . The test continued for 14 seconds longer still collecting data each 1/10 of a second. 200 data points from the proximity sensor and 200 data points from the vacuum sensor were transferred to a computer through the data port  63  of  FIG. 6 . The plotted data show the elasticity of a patient&#39;s vagina without prolapse. The peak deformation at 150 millimeters of mercury was 2.1 millimeters with a relaxation from 0.75 millimeters that continued down to 0.25 millimeters at the end of 20 seconds. The chart indicates the skin deformation and elastic properties are significantly different than the patient with a prolapsed bladder. 
         [0028]      FIG. 9  is a chart of the skin deformation of the cheek on a patient&#39;s face. The same parameters and procedures were followed as in  FIGS. 7 and 8 . The data produced a very different graph that represents the versatility of the present invention. At the peak when the vacuum reached 150 millimeters of mercury the skin deformed to 0.55 millimeters. The vacuum was released and the skin pulled back past zero to −0.15 millimeters. At 14 seconds into the test the skin moved from 0.15 millimeters to 0. Then the skin began moving up until the test was completed at 20 seconds where the skin reached a 0.1 millimeter deflection. The patient under the test was a male approximately 60 year old. The graph indicates the skin bouncing back and passing through zero creating a concave effect on the skin surface. Tests performed on tighter skin surfaces showed a smaller skin deformation but not passing through zero. Another feature the graph depicts is the representation of the patient&#39;s heart beat. The groupings of the spikes in the graph at 6 seconds equals to 7 indicating a slightly faster rate of 1 per second. At 20 seconds the groupings of spikes 22 beats or a slightly faster rate than 1 beat per second.