Device and method for measuring and treating the rigidity and erection of a penis and arterial-venous flows

Abstract

A measuring method enables the strength of the erector muscles (EM) causing the rigidity of the penis (P) of a patient and the arterial and venous variation ensuring the erection of the penis (P) of the patient to be measured and reinforced by placing a sensor ( 2, 50 ) around the penis (P) includes elements to receive the intracavernous pressure (ICP) and pressure variations of the penis (P), and at least one transducer ( 21, 55 ) integrated into or offset from the sensor ( 2, 50 ) allowing the pressure signal from the elements for receiving the pressure to be transformed into an electrical signal, and by connecting the sensor ( 2, 50 ) to a housing ( 35 ) including elements for amplifying and recording the signal from the transducer ( 21, 55 ), elements for analyzing the signal by a microcontroller allowing the fatigue state of the erector muscles (EM) to be measured and the variations in muscle strength of the erector muscles (EM) to be measured.

1 . A method for measuring the strength of the erector muscles (EM) causing the rigidity of the penis (P) of a patient and for measuring the variations in arterial and venous flows ensuring the erection of the penis (P) of the patient, which comprises:
 Placing a sensor ( 2 ,  50 ) around the penis (P) comprising means to receive the intracavernous pressure (ICP) and pressure variations of the penis (P), and at least one transducer ( 21 ,  55 ) integrated into or offset from the sensor ( 2 ,  50 ) allowing the pressure signal issued from the means for receiving the pressure to be transformed into an electrical signal,   And connecting the sensor ( 2 ,  50 ) to a housing ( 35 ) comprising means for amplifying and recording the signal from the transducer ( 21 ,  55 ) and means for analyzing the signal by a microcontroller allowing the state of erector muscle (EM) fatigue to be measured and the variations in muscle strength of the erector muscles (EM) to be measured.   
   
   
       2 . The measuring method according to  claim 1 , further comprising measuring the variations in intracavernous pressure (ICP) of the penis (P) in order to quantify the detumescence, tumescence and rigidity of the penis (P) during both day and night. 
   
   
       3 . The measuring method according to  claim 2 , further comprising measuring the intracavernous pressure (ICP) when the pressure progressively reaches the mean systolic pressure of the penis (P). 
   
   
       4 . The measuring method according to  claim 1 , further comprising measuring the increase in arterial inflow in the corpus cavernosum (CC) and the reduction in venous outflow during the vascular phase, which is the first penis (P) erection phase. 
   
   
       5 . The measuring method according to  claim 1 , further comprising measuring variations in the contraction and rigidity of the erector muscles (EM) surrounding the corpus cavernosum (CC) during the muscular phase, which is the second penis (P) erection phase. 
   
   
       6 . The measuring method according to  claim 4 , further comprising continuously measuring, particularly when the patient is sleeping, the arterial inflow and the venous outflow by measuring the pulse pressure (PP), pulse volume (PV) and intracavernous pressure (ICP). 
   
   
       7 . The measuring method according to  claim 1 , further comprising measuring the Young's modulus of the corpus cavernosum (CC) allowing the compliance of said corpus cavernosum to be evaluated. 
   
   
       8 . The measuring method according to  claim 2 , further comprising measuring and quantifying the cavernosal-venous leak from the intracavernous pressure (ICP) curve. 
   
   
       9 . The measuring method according to  claim 1 , measuring the maximum contraction (Pmax), the pressure gradient (Delta P and mean delta), the surface under the curve resulting in the muscle work of each contraction, the number of peaks and the width of each peak. 
   
   
       10 . The measuring method according to  claim 1 , further comprising measuring the fatigue of the erector muscles (EM) by measuring the angle (α). 
   
   
       11 . The measuring method according to  claim 1 , further comprising measuring the peaks of the erector muscle (EM) contractions and the variations in pulse pressure (PP) while maintaining stable pressure in the sensor ( 2 ,  50 ) whatever the variations in the volume of the penis. 
   
   
       12 . A method for treating the erector muscles (EM) of a patient with either erectile dysfunction or premature ejaculation or both, said patient having been diagnosed thanks to the measurement of erections taken both day and night, said measurements consisting of measurements of the strength of the erector muscles (EM) causing the rigidity of the penis (P) of the patient and of the arterial and venous variation of the corpus cavernosum ensuring the erection of the penis (P), which comprises:
 Placing a sensor ( 2 ,  50 ) comprising means to receive the intracavernous pressure (ICP) and pressure variations of the penis (P), means for electro stimulating ( 22 ,  56 ) the erector muscles (EM), and at least one transducer ( 21 ,  55 ) integrated into or offset from the sensor ( 2 ,  50 ) allowing the pressure signal issued from the means for receiving the pressure to be transformed into an electrical signal,   And connecting the sensor ( 2 ,  50 ) to a housing ( 35 ) comprising means for amplifying and recording the signal from the transducer ( 21 ,  55 ), means for analyzing the signal by a microcontroller allowing the electro stimulation to be controlled as a function of the fatigue state of the erector muscles (EM) and for controlling the muscular rehabilitation through sound, visual or tactile patterns indicating to the patient the intensity, duration and muscle contraction to be produced and the duration of the rest period between two contractions.   
   
   
       13 . The method for treating a patient with erectile dysfunction or premature ejaculation according to  claim 12 , characterized in that the electro stimulation means are constituted of electrodes ( 22 ,  56 ) controlled by the microcontroller and by the patient in order to vary the intensity. 
   
   
       14 . The method for treating a patient with erectile dysfunction according to  claim 12 , characterized in that the diagnosis of organic impotence is established during the night by the measuring device ( 1 ). 
   
   
       15 . The method for treating a patient with erectile dysfunction according to  claim 12 , characterized in that the rehabilitation is specially indicated for patients presenting a muscular pathology having a normal vascular phase, but also for those having a mixed vascular pathology of arterial or venous and muscular origin. 
   
   
       16 . The method for treating a patient with erectile dysfunction according to  claim 12 , characterized in that the patient is placed on an examination bed or on his bed, electrodes ( 22 ,  56 ) are connected to the housing ( 35 ) and are placed on the middle part of the penis (P), one at the right and the other at the left, the electrode may also be placed on various regions of the penis, particularly along the dorsal nerve apart from the sensor ( 2 ,  50 ). 
   
   
       17 . The method for treating a patient with erectile dysfunction according to  claim 16 , characterized in that the patient starts the electro stimulation system of the housing ( 35 ) and adjusts the intensity of the stimulation either by using a potentiometer placed on the housing ( 35 ) or by using a virtual button situated on the screen, of either the computer ( 18 ), or a PDA or a portable telephone. 
   
   
       18 . The method for treating a patient with erectile dysfunction according to  claim 17 , characterized in that the electro stimulation is continued until the end of the session, as with all muscle rehabilitation, since it improves the performance of the erector muscle (EM) rehabilitation, as well as the vasodilation of the cavernosal arteries. 
   
   
       19 . The method for treating a patient with erectile dysfunction according to  claim 18 , characterized in that the patient verifies that his voluntary contractions cause an elevation in intracavernous pressure (ICP), which proves that the right muscles are contracted, since only the erector muscles (EM) raise the intracavernous pressure (ICP). 
   
   
       20 . The method for treating a patient with erectile dysfunction according to  claim 19 , characterized in that the patient then sees a mask of muscle contractions appear on the screen that he is invited to follow, indicating the optimum duration and height of the contraction that must be made as well as the duration of the rest phase. 
   
   
       21 . The method for treating a patient with erectile dysfunction according to  claim 20 , characterized in that the mask of muscle contractions is adjustable and established from the fatigue curve of the erector muscle (EM). 
   
   
       22 . The method for treating a patient with erectile dysfunction according to  claim 21 , characterized in that modifications in the pattern indicating the modalities of the contraction to be performed will be calculated either in real time by the microcontroller during the session or between two sessions when this analysis will be done by the analysis and telecontrol center (ATC). 
   
   
       23 . A method for treating a patient with premature ejaculation according to  claim 12 , further comprising perineal rehabilitation, which is obtained by means of the measuring device ( 1 ) with electro stimulation of the penis (P) through electrodes ( 22 ,  56 ) positioned under sensor ( 2 ,  50 ), the electro stimulation of the penis P allowing the erector muscles (EM) surrounding the corpus cavernosum (CC) to be strengthened and the increase in arterial circulation and thus the erection necessary for rehabilitation to be promoted. 
   
   
       24 . The method for treating a patient with premature ejaculation according to  claim 23 , characterized in that the patient may do this rehabilitation at home according to the same method as that described for erectile dysfunction rehabilitation. 
   
   
       25 . The method for rehabilitating a patient with premature ejaculation according to  claim 23 , characterized in that the stimulation of the vascular reflex is obtained when the patient acts by a pressure variation on the gland by small compressions between the thumb and index finger to produce an increase in the arterial flow of the cavernosal arteries such that this stimulation of the vascular reflex combined with electro stimulation of the erector muscles (EM) most often produces a rigid erection of the penis (P) necessary for rehabilitation. 
   
   
       26 . A measuring and/or rehabilitation device for implementing the method according to  claim 1 , characterized in that the sensor ( 2 ) is constituted of:
 A cuff ( 12 ) integral on its inner face with a reservoir ( 3 ) filled with a liquid allowing the intracavernous pressure (ICP) and pressure variations to be received,   Stimulation electrodes ( 22 ) positioned between the reservoir ( 3 ) and the outer wall of the penis of the patient,   And tubing connection parts ( 10 ,  11 ,  14 ,  20 ) connecting the reservoir ( 3 ) to a photoplethysmograph ( 16 ) and to a pressure transducer ( 21 ) that are connected to the housing ( 35 ).   
   
   
       27 . The measuring and/or rehabilitation device according to  claim 26 , characterized in that the cuff ( 12 ) is connected through a first three-way valve ( 9 ) to the photoplethysmograph ( 16 ) measuring the displacements of a flexible membrane ( 15 ) integral with the connection tubing ( 14 ) in order to measure the penile pulse volume coming from the cavernosal arteries. 
   
   
       28 . The measuring and/or rehabilitation device according to  claim 26 , characterized in that the cuff ( 12 ) is connected through the second connection tubing ( 11 ) and a second three-way valve ( 13 ) to a pressure regulator ( 23 ) to ensure stable pressure inside the reservoir ( 3 ) of the cuff ( 12 ). 
   
   
       29 . The measuring and/or rehabilitation device according to  claim 28 , characterized in that the pressure regulator ( 23 ) is constituted of a cylinder ( 24 ) comprising two chambers ( 25 ,  26 ) filled with a fluid, separated by a wall ( 27 ) pierced with a calibrated orifice ( 28 ) connecting said chambers between each other, said first chamber ( 25 ) being connected to the three-way valve ( 13 ) while said second chamber ( 26 ) comprises a piston ( 29 ) allowing the pressure of the fluid to be varied by means of a micrometer setting device ( 30 ). 
   
   
       30 . The measuring and/or rehabilitation device according to  claim 29 , characterized in that the micrometer setting device ( 30 ) comprises a spring ( 31 ) disposed around the operating rod of the piston ( 29 ) in order to adjust the tension of said spring and to maintain stable pressure in the cuff ( 12 ) while allowing high, short-duration pressure variations. 
   
   
       31 . The measuring and/or rehabilitation device according to  claim 26 , characterized in that the cuff ( 12 ) is held and closed around the penis of the patient by a non-elastic tie ( 6 ). 
   
   
       32 . The measuring and/or rehabilitation device according to  claim 26 , characterized in that the housing ( 35 ) contains an amplifier, an analog to digital converter, a microprocessor and a removable memory card. 
   
   
       33 . The measuring and/or rehabilitation device according to  claim 32 , characterized in that the housing ( 35 ) comprises an electro stimulation system. 
   
   
       34 . The measuring and/or rehabilitation device according to  claim 26 , characterized in that, as the photoplethysmograph ( 16 ) is sensitive to pressure, the latter is positioned at a certain distance from the reservoir ( 3 ) to prevent the pressure variations from said reservoir from disturbing said photoplethysmograph ( 16 ). 
   
   
       35 . The measuring and/or rehabilitation device according to  claim 26 , characterized in that the photoplethysmograph ( 16 ) comprises a light emitting diode and a photoelectric cell allowing a light ray to be sent in the direction of the flexible membrane ( 15 ) and the reflected ray captured by the cell to be received, while said signal emitted by the photoplethysmograph ( 16 ) is transmitted to the housing ( 35 ) that enables said signal to be amplified and recorded. 
   
   
       36 . A measuring and/or rehabilitation device for implementing the method according to  claim 1 , characterized in that the sensor is constituted of:
 An open or half-open ring ( 50 ) comprising two branches ( 51 ,  52 ) in an arc of circumference interconnected by a flexible element ( 53 ),   A strain gauge ( 55 ) integral with the flexible element ( 53 ) and connected to the housing ( 35 ).   
   
   
       37 . The measuring and/or rehabilitation device according to  claim 36 , characterized in that the branches ( 51 ,  52 ) are plate-shaped flat branches made in a material with high elastic deformation strength, or a material that is said to be not very deformable. 
   
   
       38 . The measuring and/or rehabilitation device according to  claim 36 , characterized in that the flexible element ( 53 ) connecting the branches ( 51 ,  52 ) is constituted of a thin plate of metal presenting significant elastic deformation characteristics. 
   
   
       39 . The measuring and/or rehabilitation device according to  claim 36 , characterized in that the ring ( 50 ) comprises, on the inner face of the branches ( 51 ,  52 ), contact areas constituted of rubber dots ( 54 ) presenting low elastic deformation and pressing against the penis (P) of the patient so as to slightly offset the inner face of said ring branches. 
   
   
       40 . The measuring and/or rehabilitation device according to  claim 36 , characterized in that the ring ( 50 ) comprises electro stimulation means that are constituted of electrodes ( 56 ) disposed on the rubber dots ( 54 ).