DEVICE AND METHOD FOR PENILE TUMESCENCE MONITORING

The present application discloses a device (10), a system, and a method for monitoring the penile tumescence. The device comprises a loop (3) positioned around the base of the penis. The loop (3) consists of two string threads mutually attached on both ends. Said string threads are wound up on a reel (1) having the centrally positioned spring (la). The movement of the reel (1) and the rotation of the magnet (2) indicate the penis diameter and the intensity of the erection. The magnetic rotary encoder (5) outputs the digital form of acquired data to a microprocessor (6). The data are preferably forwarded over a BLE communication module (7) to the mobile app, installed on a smart device that communicates with a remote computer.

FIELD OF THE INVENTION

The present disclosure relates, in general, to the field of penile tumescence monitoring. Additionally, the present invention relates to providing a record of the penile rigidity and time intervals of the rigidity during a tumescence event. More particularly, the disclosure relates to a portable and wearable device for obtaining nocturnal penile tumescence data, a system comprising said device and a method for use thereof.

BACKGROUND OF THE INVENTION

Monitoring of penile tumescence is known in the art. The device such as RigiScan Plus Monitor is an ambulatory monitor and a data logging device for measuring and recording penile rigidity and tumescence. The device is linked by cable to a Windows PC, which downloads and processes the data, stores it for review, and prints it on command. The ambulatory monitor-Rigi Scan Plus uses tip and base penile loops that are adjustable by tightening slightly, at discrete time intervals, and allow measuring and recording penile rigidity and tumescence. Each loop contains a cable that moves freely inside a conduit. Each loop takes a measurement every 15 seconds. The loops gently tighten with a linear force of 4 ounces (114 g) and then immediately releases and the tissue rebounds to its unloaded state, thereby taking a tumescence measurement. After the tumescence measurement is taken, it is compared to the previous measurements. When a 6 mm increase in tumescence is detected, representing possible erectile activity, the Rigi Scan Plus Monitor starts taking measurements in 30 seconds intervals. When tumescence is measured, the loops tighten one more time around the circumference of the penis, with a linear force of 10 ounces (283.5 g). The Rigi Scan Plus Monitor takes a measurement when this force is applied, to record a cross-sectional response to radial compression which allows measuring of the rigidity.

Therefore, the Rigi Scan uses two sensors connected to the PC by cables. Due to its complexity, it requires calibration, extensive training of the user as well as interpretation of the results by the physician. Moreover, it requires that the user spends a night in a supervised environment, such as a sleeping room, or a hospital. In addition, due to the application of the two loops and the forces applied, the user may feel discomfort when wearing the device.

Document U.S. Pat. No. 5,782,778 discloses an apparatus and a method for detecting and monitoring the sexual arousal of an individual. The apparatus includes a physiological sensor for sensing the physiological changes of an individual, that correspond to sexual arousal. Generated sensor signals represent the physiological changes. The described apparatus further includes a microprocessor coupled with the sensor for receiving the sensor signals, for converting the sensor signals to control signals, and for storing the control signals. The device further includes a transmitter coupled with and responsive to the microprocessor, for transmitting the stored control signals to a device and for analyzing the control signals in order to monitor the sexual arousal of an individual.

U.S. Pat. No. 4,848,361 A relates to a penile rigidity and tumescence monitoring apparatus comprising transducer means for providing output signals, that indicate penile rigidity and tumescence. The disclosed apparatus further comprises the control means for providing control of the transducer means, for the acquisition and storage of penile rigidity and tumescence data. The transducer means includes readily interchangeable loop-like portions adapted for releasably encircling a penis about the circumference thereof.

Therefore, there is a need for a simple to use, i.e., user-friendly way of automatic tumescence monitoring and recording data indicative of penile tumescence and rigidity. Said data may be further used for obtaining penile health parameters, which can be performed by the user and do not require a physician's presence.

The system according to the present invention operates via wireless i.e. cable-free communication between the components of said system.

The above-mentioned drawbacks of the prior art are solved by the device according to the present invention i.e., by the wearable and non-obstructive device for measuring and monitoring nocturnal penile tumescence in home conditions, without a need to perform the measurement in a supervised environment.

SUMMARY OF THE INVENTION

The device according to the present invention comprises a casing encompassing a reel, the reel having wound up two string threads and a loop formed by two string threads that extend from and are mutually attached outside of the casing. Each string thread is fixed in an outer base channel of the reel by its one end. Further, both threads are partially wound up on said outer base channel of the reel. The opposite end of each of two string threads extends outside of the casing and these two ends of two string threads are connected outside of the device to form a loop to be placed on the base of the penis.

A system for obtaining penis circumference change data comprises a said device, wherein the device is wirelessly connected to a smart device which is further wirelessly connected to a remote computer. The system and the device according to the present invention are used for collecting penile health data and for penile health monitoring.

While the user is asleep, the wearable device continuously monitors changes in penile diameter i.e., the engorgement of the penis. The movement i.e. rotation of the reel, having a spring attached to the reel and a magnet disposed on a disc arranged on the top of the reel, is indicative of a penis diameter. The intensity of erection corresponds to a change in the angular position of a magnet which is detected by a magnetic encoder. Magnetic encoder further converts analog to digital form of data and outputs the digital data to a microprocessor (CPU). The magnetic encoder may be of AS5048A/AS5048B type. CPU calculates the extension of the loop on the basis of the received digital data. The calculated data are forwarded from the CPU to a Bluetooth Low Energy (BLE) communications module, i.e., a communication module that wirelessly transmits the data to a mobile app, installed on a remote BLE enabled-smart device. Optionally, a memory module may be provided on the printed circuit board of the device to store the values directly obtained from the CPU, which are further sent via Bluetooth module to the application installed on the smart device to be stored in the smart device memory. Further, data are downloaded and sent from the mobile app to the cloud, such as a cloud database, to be stored, analyzed, and used for the calculation of various parameters. Further, the analyzed data are sent to the smart device application to be displayed on the smart device in the form of a report. The report may comprise the following data: start and end time of the measurement, total measurement time, date of the measurement, and measurement graph, where the graph is a simple cm/time graph that illustrates the change in the circumference of the penis during the time of the measurement. Furthermore, the report may comprise additional data such as the number of valid erection episodes, total erection time, T score, and additional penile health parameters. T score represents the sum of all the measurements that surpass the erection threshold from the base measurement.

When the user wakes up, the measurement shall be ended on the smart device application, acquired data sent to the remote computer and the device may be removed.

Contrary to the ambulatory monitor disclosed in the prior art, which uses two penile loops, i.e., tip and base penile loops, that adjust by tightening slightly at discrete time intervals to measure and record penile rigidity and tumescence, where the loop gently tightens and then immediately releases and the tissue rebounds to its unloaded state the wearable device according to the present application only needs to be placed on the base of the penis in home conditions, just before going to sleep, in order to obtain the information related to the tumescence. The change of the penile circumference initiates the extension of the loop which causes the rotation of the reel and thereby the change of angular position of the magnet.

Hence, the involvement of a physician is not required. Moreover, there is no need for training the user of the device. The obtained data are analyzed automatically and reported to the user. The data extraction is fully digitalized, with wireless communication between the components of the system.

Furthermore, due to its simplicity and small dimensions realized in a miniaturized, one size fits all manner, a ring-like device is simply placed around the penis by the user himself, just before going to bed. It is non-obstructive and after a few minutes of wearing it, the user hardly feels the presence of the device. Thus, the sleep of the user is not affected.

DETAILED DESCRIPTION OF THE DISCLOSURE

Device10for penile tumescence measurement and monitoring is shown inFIGS.1to9. Device10according to the present application is ring-like, and may be worn by the user at the base of the penis, preferably just before going to bed. Device10is small in size, compact, and completely non-obstructive, in order to provide comfort while using it. The total dimension of the casing11, is 32.2×25.5×31.6 mm. The casing material is preferably selected from a biocompatible material having similar properties as the ones being used for dental care. Preferably, the material of the casing may be Nylon PA2200.

Device10comprises compact and ergonomic casing11having a top part11band a bottom part11a. The device10further comprises a reel1within casing11, having a spring1apositioned in the center of reel1. One end25of spring1ais in connection with the inner side of the top part11bof casing11. This end25of the spring1ais connected to a protrusion22, preferably a slit22aof a protrusion22, the protrusion22being centrally arranged on the inner side of the top part11bof the casing11. The opposite end26of spring1apasses through the base channel1bof reel1, and protrudes via reel hole21back to the inner side of reel1, thus stabilizing the spring to reel1. The device10further comprises a magnet2centrally attached to disc14, the disc14covering the top side1cof the reel. The device10according to the present invention further comprises a printed circuit board4(PCB) having a magnetic rotary encoder5disposed on the PCB, a microprocessor6(CPU), and a communication module7, such as Bluetooth Low Energy communications module (BLE). Furthermore, device10comprises loop3, formed by two string threads23and24. Both string threads23,24, by one end thereof, are fixed at the fixing point20of the reel1and both threads are partially wound on the outer base channel1bof the reel1. The opposite end of each of the string threads extends outside of the top part11bof the casing11and these two ends are mutually attached outside of the device10to form a loop3.

The bottom part11aof casing11comprises the printed circuit board (PCB)4. PCB may be differently shaped, for example, may be ellipsoidal, square, or round-shaped. PCB is preferably round-shaped, with a 2.5 cm diameter, and has double-sided component placement, i.e., bottom side4band top side4acomponent placement on the PCB. The magnetic rotary encoder5is positioned at the top side4aof the printed circuit board4adjacent to and facing magnet2when both parts (11a,11b) of casing11are assembled together. The magnetic rotary encoder5is a special integrated circuit (I.C.) arranged to measure the position of the rotation angle of the magnet2i.e., the angular position of the magnet2. Furthermore, the I.C. contains integrated Hall sensors and is placed at the center of the PCB. The I.C. is programmed with algorithms, the algorithms being Analog-to-Digital Converter (ADC) and Digital Signal-Processing (DSP) algorithms. Based on these algorithms the I. C. is arranged to provide an accurate high-resolution absolute angular position information in a digital format to a microprocessor6(CPU) placed on the bottom side4bof the printed circuit board4. The microprocessor6and the communication module7, such as the Bluetooth Low Energy communications module, are arranged at the bottom side4bof the printed circuit board4. Additionally, device10has a power supply unit8that may include a battery8aand a micro-USB port8b. Device10further includes an on/off switch12.

The top part11bof the casing11has an indentation13in the middle of the outer surface i.e., the surface which is in contact with the penis (seeFIG.3andFIG.9). Said indentation13ensures comfortable use by the user when the device10is in contact with the user's penis. The top part11bof casing11, as previously disclosed, houses reel1, rotatably attached to protrusion22of casing11.

The top part11bof the casing11is further provided with holes15,17,18(FIG.2) and16(FIG.3). The holes15,16,17,18are arranged to provide the passage for the string threads23and24coming out from the casing11and being attached outside of the casing11to form the loop3. The holes15and16, are positioned on one side of the top part11bof the casing11, providing passage for the string thread23while the holes17and18are located on the opposite side of the top part11bof the casing11, providing passage for the string thread24(FIG.2).

Each of the two string threads is fixed in the outer base channel1bof reel1at the fixing point20. Both threads are at least partially wound on said outer base channel1bof reel1. One string thread23passes through the holes15and16, while the other string thread24passes through the holes17and18and both string threads reach the outside of the top part11bof the casing11. String threads are attached by their ends and at least partially covered by a covering strap27, preferably a silicon tube, outside of the casing11to form a loop3, which shall be placed around the penis.

The string threads23and24, and consequently the loop3, may be differently shaped. The string threads23and24, and consequently the loop3are preferably tube-shaped and made of soft material, preferably silicon.

Both threads23,24are attached to one another at the fixing point20, for example by being tied in a knot. Further, the opposite ends of each string thread23,24are partially wound around reel1and subsequently extended to the outside of the top part11b.

The reel hole21on reel1(FIG.4) may be differently shaped. The reel hole21, preferably ellipsoidal in shape, stabilizes spring1a, i.e., the opposite end26of spring1a, which is opposite to the end25of spring1a. The term stabilizing means that said opposite end26of spring1arotates together with reel1(it is pulled by the reel), thus having no degree of freedom to move without the movement of reel1.

Reel1of device10has two sides: top side1cand bottom side1d. The top side1cof the1faces the top side4aof the printed circuit board4. The top side1cof reel1has a disk14attached to it, with centrally positioned magnet2on disc14, facing the magnetic rotary encoder5. The size of the magnet is preferably between 6 and 8 mm in diameter, and the height of the magnet is preferably ≥2.5 mm, the height being measured from the base of the magnet2.

FIG.9represents the top part11bof casing11showing indentation13and loop3of the string threads23and24. In this figure, the covering strap27is also shown. The covering strap27, covers the attachment of the string threads23and24, i.e., the point where both strings are attached, in order to form the loop3. The covering strap27is of a protective soft material that protects the soft outer tissue of the penis from an injury, which can be caused by the attachment point of the two string threads23and24. The covering strap27, preferably covers at least the attachment point of the two string threads23and24, i.e. only partially covers the loop3.

The operation of device10is described as follows. In order to provide the tumescence monitoring, loop3formed by the two string threads23,24, which extend from the casing11, shall be placed around the penis encompassing the base of the penis. At the occurrence of night erections, the penis changes its diameter, which leads to the extension or shortening of the loop3, formed by the two string threads23,24, which extend out from the casing11. Inside of casing11, these two string threads23,24are partially wound up on the outer base channel1bof reel1.

During the engorgement of the penis, loop3extends, i.e. the two string threads23,24extend outside the casing11, causing the reel1to rotate. The string threads23,24are wound on the reel1in the same direction. During the extension of loop3, string threads23,24are unwinding from the outer base channel1b, and reel1rotates in one direction, while during the retraction of loop3, string threads23,24are winding on the outer base channel1band the reel1rotates in opposite direction.

The rotation of reel1at the same time causes rotation of the disk14and thus the rotation of magnet2. As stated before, magnet2is attached and centrally positioned on disk14, said disk being further attached on the top side1cof the1. The alternating magnetic field is monitored by the magnetic rotary encoder5which is placed at the top side4aof the printed circuit board4adjacent to and facing the magnet2. The magnetic rotary encoder5outputs the corresponding alternating magnetic field data to the microprocessor6placed on the bottom side4bof the printed circuit board4. Said data are indicative of the time and value of the loop extension. The received data are then processed by microprocessor6, and the extension of loop3is calculated using algorithms implemented in the microprocessor6firmware, i.e. based on the degree of rotation of the magnet2and the diameter of the outer base channel1b. Thus, device10provides information reflecting the circumference change of the penis every second in real time.

In order to start the monitoring of the circumference change of the penis, the user shall extend loop3, and place the casing11on the base of the penis with loop3, embracing the penile base. Loop3encircles the penis, and in cooperation with spring-loaded reel1holds device10in place.

Optionally, the device may be accompanied by a cover, in order to further protect the penis and hold the device10in one position.

The data collected by device10reflect the values of the diameter of the penis when in a flaccid state and when in an erect state, whereby said values of the diameter correspond further to erection intensity during the erection episodes. In one aspect, the communication module7is in constant communication with the smart device in order to transmit the data processed by the microprocessor6. Namely, the data is transmitted each second via communication module7, such as Bluetooth Low Energy communications module, to a user's smart device, i.e., smartphone. The smart device contains the application which acquires the data from the device10. The acquired data are stored locally in the memory of the smart device.

Upon completion of monitoring of the circumference change of the penis, the application installed on the smart device uploads all the recorded data to the remote computer such as a cloud database, where the data are analyzed by an algorithm. The remote computer may store, calculate and analyze various parameters and generate various reports to be provided to the user.

In another aspect, the acquired data are stored locally by the memory module provided in the PCB of device10.

Upon completion of monitoring of the circumference change of the penis, the recorded data are uploaded to a cloud database, preferably to a remote computer, where the data are analyzed by an algorithm. The remote computer may store, calculate and analyze various parameters and generate various reports to be provided to the user.

Device10according to the present invention may be applied for obtaining data on the circumference change of the penis. The method for application of the device10and the system comprises the following steps:positioning the device10according to the present invention on the base of the penis;detection and measurement of the change of angular position of magnet2by the magnetic encoder5;generating digital format of the measurement data by the magnetic encoder5;communicating the digital format of the measurement data from the magnetic encoder5to the microprocessor6;processing the data received by the microprocessor6by calculating the extension of the loop based on the degree of the rotation of magnet2and the diameter of the outer base channel1b;wirelessly transmitting the processed data from the microprocessor6to the memory module provided on the PCB of device10or to the smart device;storing the processed data;uploading the stored data to a cloud, such as a cloud database for storing, analyzing, and using for the calculation of various parameters;generating the report;transmitting the generated report to the smart device anddisplaying the report on the smart device.

The device10shall be placed on the base of the penis, turned on, and connected over BLE to the smart device. The magnetic encoder5shall measure the change of angular position of magnet2and generate the digital format of the measured data. The digital data shall be communicated from the magnetic encoder5to a microprocessor6, and data received by the microprocessor6shall be processed and the extension of the loop calculated based on the degree of the rotation of the magnet2and the diameter of the outer base channel1b. The data may be further stored directly from the CPU in the memory module provided on the PCB. The calculated data shall be wirelessly transmitted from the microprocessor6to the smart device, such as a smartphone, and the acquired data stored in the smart device's memory. Such stored data shall be transmitted to the remote computer for storing, analyzing, and using for the calculation of various parameters. The various parameters shall be transmitted from the remote computer to the smart device and represented in the form of the report sent to the user.

Preferably, 1 sample per second is acquired, i.e. so during 8h of sleep, 28800 samples may be acquired. Preferably, the first 5 mins (300 samples) of the measurement of the change of angular position of the magnet2by the magnetic encoder5is discarded, to avoid loop extension adjustment errors created by the user during the positioning of the device.

The minimum and maximum tumescence levels measured are used for the determination of an erection threshold.

A valid erection episode is detected if the value of the change of angular position of the magnet2is above the erection threshold and lasts during a particular period of time, which is the first period of time, i.e. valid erection episode. Particularly, if during the first period of time, which may last for example for 5 min, the value of the change of angular position of magnet2falls below the erection threshold once or more than once, depending on the length of the first erection time, and where such value lasts for a predetermined period of time i.e. second period of time, for example for 1 min during the 5 min long first period of time, the second period of time will be omitted from the data analyses. Otherwise, if during the first period of time, the value of the change of angular position of magnet2falls below the erection threshold for longer than the predetermined period of time, for example for longer than 1 min, preferably 2-3 min, then the second period of time shall not be omitted from the data analyses and shall be accounted as an end of the first erection episode.

During an overnight sleep, most healthy men will experience3-5erections episodes. It is important to keep the erection mechanism healthy in order to provide highly oxygenated blood to the erectile tissue. Conversely, impaired night erections reduce tissue oxygenation and increase penile fibrosis (formation of scar tissue in the penis) which leads to further worsening of night erections. This may result in progressive erectile dysfunction (ED).

Device10according to the present application enables tracking of the additional markers for erection health, i.e. the total duration of all recorded erection episodes. Most men will have a total erection time of at least 45 min after an overnight sleep i.e., during 7-8 hours. The total duration of the erection correlates with the penile condition. Thus, device10enables monitoring the total erection time during an overnight sleep.

The score is used to evaluate the overall quality of night erections during the measurement. Every man will have a different initial score, so there is no normal range. However, an increase in the total erection time will indicate that night erections are improving. The total erection time is measured as a sum of all the measurements that surpass the erection threshold.

Thus, the present application discloses a monitoring system comprising the device wirelessly connected to a smart device, wherein the smart device is wirelessly connected to a remote computer. The smart device is configured to receive the data from the device over the BLE and to perform recording, storing, and transmitting the measurement data to the remote computer and further displaying the report obtained from the remote computer. The remote computer is configured to store and analyze the received data and to calculate the penile health parameters.

Using the parameters to measure and track the night erections, it can be determined whether the user has erectile dysfunction or erectile dysfunction-like symptoms or a psychological issue.

REFERENCE SIGNS

1Reel1aSpring1bOuter base channel1cThe top side of the reel1dBottom side of the reel2Magnet3Loop4PCB (Printed circuit board)4aTop side of the PCB4bBottom side of the PCB5Magnetic rotary encoder6Microprocessor (CPU)7Communication module (Bluetooth Low Energy communications module (BLE))8Power supply unit8aBattery8bMicro USB charge port10Device11Casing11aBottom part of the casing1111bTop part of the casing1112On/off switch13Indentation14A disk having the magnet15,16Holes on one side of the top part of the casing17,18Holes on the opposite side of the top part of the casing20Fixing point21Reel hole22Protrusion22: Slit23.24String threads25.26Ends of the spring27Covering strap