DEVICE AND METHOD FOR PENILE TUMESCENCE MONITORING

Abstract

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.

Claims

1. A device (10) for obtaining penis circumference change data during penile tumescence monitoring comprising: a casing (11) comprising holes (15, 16, 17, 18) and a reel (1) which is arranged within the casing (11) and rotatably connected to the casing (11), a spring (la) arranged in the reel (1) and operably connected to the reel (1) by one end (26) thereof and to the casing by an opposite end (25) thereof, a magnet (2) centrally positioned on a disc (14), the disc (14) covering the reel (1), a printed circuit board 4 (PCB) arranged in the casing (11) comprising a magnetic rotary encoder (5) and a microprocessor (6), the magnetic rotary encoder (5) operably arranged to measure the position of the rotation angle of the magnet (2) and to output the measured data to the microprocessor (6) for processing the received data, the magnetic rotary encoder (5) being adjacent to and facing the magnet (2), said PCB (4) further comprising a communication module (7) arranged to transmit data, a loop (3), formed by two string threads (23, 24), wherein the two string threads (23, 24) being mutually attached within the reel (1) at a fixing point (20) by one end of each string thread, and both string threads (23, 24) entering into an outer base channel (1b) of the reel (1), are partially wound up on said outer base channel (1b) of the reel (1), while the opposite ends of the string threads (23, 24) extend outside of the casing (11) through the respective holes (15, 16, 17, 18) and said threads (23, 24) are mutually attached outside of the device (10) forming the loop (3).

2. The device (10) according to claim 1, wherein the PCB (4) further comprises a memory module configured to store the data received from the microprocessor (6).

3. The device (10) according to claim 1, wherein the casing (11) comprises a top part (11b) having a protrusion (22) and a bottom part (11a).

4. The device (10) according to claim 3, wherein the spring (la) is connected by one end (25) thereof to the protrusion (22) centrally arranged on the inner side of the top part (11b) of the casing (11) and the opposite end (26) of the spring (la) passes through the base channel (1b) of the reel (1), and protrudes via a reel hole (21) back to the inner side of the reel (1).

5. The device (10) according to claim 3, wherein the protrusion (22) comprises a slit (22a) connected with the end (25) of the spring (la).

6. The device (10) according to claim 1, wherein the magnetic rotary encoder (5) is programmed with algorithms, said algorithms being Analog-to-Digital Converter (ADC) and Digital Signal-Processing (DSP) algorithms.

7. The device (10) according to claim 1, wherein the magnetic rotary encoder (5) contains integrated Hall sensors.

8. The device (10) according to claim 1, wherein said device (10) comprises a power supply unit (8), the power supply unit (80) preferably including a battery (8a) and a micro-USB port (8b).

9. The device (10) according to claim 1, wherein the holes (15, 16, 17, 18) are arranged at the top part (11b) of the casing (11) the holes (15,16) being positioned on one side of the top part (11b) of the casing (11), providing passage for the string thread (23) and the holes (17, 18) being positioned on the opposite side of the top part (11b) of the casing (11), providing passage for the string thread (24).

10. The device (10) according to claim 1, wherein the magnet (5) 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 magnet (2).

11. A system for obtaining penis circumference change data, the system comprising the device (10) according to claim 1, wherein the device (10) is wirelessly connected to a cloud database for recording, storing, and analyzing the received data.

12. The system according to claim 11, wherein the device (10) is wirelessly connected to a smart device for storing the data, which is wirelessly connected to a cloud database for recording, storing, and analyzing the received data.

13. A method of application of the device (10) according to claim 1, the method comprising the following steps: positioning the device (10) on the base of the penis; registering and measurement of the change of angular position of the magnet (2) by the magnetic encoder (5); generating digital format of the measurement data by the magnetic encoder (5); communicating the data from the magnetic encoder (5) to the microprocessor (6); processing the digital data by the microprocessor (6) by calculating the extension of the loop based on the degree of the rotation of the magnet (2) and the diameter of the outer base channel (1b); wirelessly transmitting the processed data from the microprocessor 6 to the memory module provided on the PCB of device 10 or to a smart device; storing the processed data; uploading the stored data to a cloud, such as a cloud database for storing and analyzing the data; receiving a generated report on the smart device and displaying the report on the smart device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 represents a perspective view of the bottom part of the casing

[0017] FIG. 2 represents the inner view of the top part of the casing

[0018] FIG. 3 represents the outer view of the top part of the casing showing indentation

[0019] FIG. 4 represents the top view of the reel

[0020] FIG. 5 represents a side view of the reel

[0021] FIG. 6 represents a block diagram of the monitoring system

[0022] FIG. 7 represents the block diagram, i.e. the cross-sectional view of the wearable device.

[0023] FIG. 8 represents the inner view of the top and bottom parts of the casing of the device.

[0024] FIG. 9 represents the outer view of the top part of the casing showing indentation and an extended loop of the string threads with the covering strap covering the attachment point.

[0025] FIG. 10 represents the outer view of the top part of the casing showing indentation and a loop of the string threads with a covering strap covering the attachment point.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0026] Device 10 for penile tumescence measurement and monitoring is shown in FIGS. 1 to 9. Device 10 according 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. Device 10 is small in size, compact, and completely non-obstructive, in order to provide comfort while using it. The total dimension of the casing 11, is 32.225.531.6 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.

[0027] Device 10 comprises compact and ergonomic casing 11 having a top part 11b and a bottom part 11a. The device 10 further comprises a reel 1 within casing 11, having a spring 1a positioned in the center of reel 1. One end 25 of spring 1a is in connection with the inner side of the top part 11b of casing 11. This end 25 of the spring 1a is connected to a protrusion 22, preferably a slit 22a of a protrusion 22, the protrusion 22 being centrally arranged on the inner side of the top part 11b of the casing 11. The opposite end 26 of spring 1a passes through the base channel 1b of reel 1, and protrudes via reel hole 21 back to the inner side of reel 1, thus stabilizing the spring to reel 1. The device 10 further comprises a magnet 2 centrally attached to disc 14, the disc 14 covering the top side 1c of the reel. The device 10 according to the present invention further comprises a printed circuit board 4 (PCB) having a magnetic rotary encoder 5 disposed on the PCB, a microprocessor 6 (CPU), and a communication module 7, such as Bluetooth Low Energy communications module (BLE). Furthermore, device 10 comprises loop 3, formed by two string threads 23 and 24. Both string threads 23, 24, by one end thereof, are fixed at the fixing point 20 of the reel 1 and both threads are partially wound on the outer base channel 1b of the reel 1. The opposite end of each of the string threads extends outside of the top part 11b of the casing 11 and these two ends are mutually attached outside of the device 10 to form a loop 3.

[0028] The bottom part 11a of casing 11 comprises 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 side 4b and top side 4a component placement on the PCB. The magnetic rotary encoder 5 is positioned at the top side 4a of the printed circuit board 4 adjacent to and facing magnet 2 when both parts (11a, 11b) of casing 11 are assembled together. The magnetic rotary encoder 5 is a special integrated circuit (I.C.) arranged to measure the position of the rotation angle of the magnet 2 i.e., the angular position of the magnet 2. 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 microprocessor 6 (CPU) placed on the bottom side 4b of the printed circuit board 4. The microprocessor 6 and the communication module 7, such as the Bluetooth Low Energy communications module, are arranged at the bottom side 4b of the printed circuit board 4. Additionally, device 10 has a power supply unit 8 that may include a battery 8a and a micro-USB port 8b. Device 10 further includes an on/off switch 12.

[0029] The top part 11b of the casing 11 has an indentation 13 in the middle of the outer surface i.e., the surface which is in contact with the penis (see FIG. 3 and FIG. 9). Said indentation 13 ensures comfortable use by the user when the device 10 is in contact with the user's penis. The top part 11b of casing 11, as previously disclosed, houses reel 1, rotatably attached to protrusion 22 of casing 11.

[0030] The top part 11b of the casing 11 is further provided with holes 15, 17, 18 (FIG. 2) and 16 (FIG. 3). The holes 15, 16, 17, 18 are arranged to provide the passage for the string threads 23 and 24 coming out from the casing 11 and being attached outside of the casing 11 to form the loop 3. The holes 15 and 16, are positioned on one side of the top part 11b of the casing 11, providing passage for the string thread 23 while the holes 17 and 18 are located on the opposite side of the top part 11b of the casing 11, providing passage for the string thread 24 (FIG. 2).

[0031] Each of the two string threads is fixed in the outer base channel 1b of reel 1 at the fixing point 20. Both threads are at least partially wound on said outer base channel 1b of reel 1. One string thread 23 passes through the holes 15 and 16, while the other string thread 24 passes through the holes 17 and 18 and both string threads reach the outside of the top part 11b of the casing 11. String threads are attached by their ends and at least partially covered by a covering strap 27, preferably a silicon tube, outside of the casing 11 to form a loop 3, which shall be placed around the penis.

[0032] The string threads 23 and 24, and consequently the loop 3, may be differently shaped. The string threads 23 and 24, and consequently the loop 3 are preferably tube-shaped and made of soft material, preferably silicon.

[0033] Both threads 23, 24 are attached to one another at the fixing point 20, for example by being tied in a knot. Further, the opposite ends of each string thread 23, 24 are partially wound around reel 1 and subsequently extended to the outside of the top part 11b.

[0034] The reel hole 21 on reel 1 (FIG. 4) may be differently shaped. The reel hole 21, preferably ellipsoidal in shape, stabilizes spring 1a, i.e., the opposite end 26 of spring 1a, which is opposite to the end 25 of spring 1a. The term stabilizing means that said opposite end 26 of spring 1a rotates together with reel 1 (it is pulled by the reel), thus having no degree of freedom to move without the movement of reel 1.

[0035] Reel 1 of device 10 has two sides: top side 1c and bottom side 1d. The top side 1c of the 1 faces the top side 4a of the printed circuit board 4. The top side 1c of reel 1 has a disk 14 attached to it, with centrally positioned magnet 2 on disc 14, facing the magnetic rotary encoder 5. 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 magnet 2.

[0036] FIG. 9 represents the top part 11b of casing 11 showing indentation 13 and loop 3 of the string threads 23 and 24. In this figure, the covering strap 27 is also shown. The covering strap 27, covers the attachment of the string threads 23 and 24, i.e., the point where both strings are attached, in order to form the loop 3. The covering strap 27 is 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 threads 23 and 24. The covering strap 27, preferably covers at least the attachment point of the two string threads 23 and 24, i.e. only partially covers the loop 3.

[0037] The operation of device 10 is described as follows. In order to provide the tumescence monitoring, loop 3 formed by the two string threads 23, 24, which extend from the casing 11, 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 loop 3, formed by the two string threads 23, 24, which extend out from the casing 11. Inside of casing 11, these two string threads 23, 24 are partially wound up on the outer base channel 1b of reel 1.

[0038] During the engorgement of the penis, loop 3 extends, i.e. the two string threads 23, 24 extend outside the casing 11, causing the reel 1 to rotate. The string threads 23, 24 are wound on the reel 1 in the same direction. During the extension of loop 3, string threads 23, 24 are unwinding from the outer base channel 1b, and reel 1 rotates in one direction, while during the retraction of loop 3, string threads 23, 24 are winding on the outer base channel 1b and the reel 1 rotates in opposite direction.

[0039] The rotation of reel 1 at the same time causes rotation of the disk 14 and thus the rotation of magnet 2. As stated before, magnet 2 is attached and centrally positioned on disk 14, said disk being further attached on the top side 1c of the 1. The alternating magnetic field is monitored by the magnetic rotary encoder 5 which is placed at the top side 4a of the printed circuit board 4 adjacent to and facing the magnet 2. The magnetic rotary encoder 5 outputs the corresponding alternating magnetic field data to the microprocessor 6 placed on the bottom side 4b of the printed circuit board 4. Said data are indicative of the time and value of the loop extension. The received data are then processed by microprocessor 6, and the extension of loop 3 is calculated using algorithms implemented in the microprocessor 6 firmware, i.e. based on the degree of rotation of the magnet 2 and the diameter of the outer base channel 1b. Thus, device 10 provides information reflecting the circumference change of the penis every second in real time.

[0040] In order to start the monitoring of the circumference change of the penis, the user shall extend loop 3, and place the casing 11 on the base of the penis with loop 3, embracing the penile base. Loop 3 encircles the penis, and in cooperation with spring-loaded reel 1 holds device 10 in place.

[0041] Optionally, the device may be accompanied by a cover, in order to further protect the penis and hold the device 10 in one position.

[0042] The data collected by device 10 reflect 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 module 7 is in constant communication with the smart device in order to transmit the data processed by the microprocessor 6. Namely, the data is transmitted each second via communication module 7, 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 device 10. The acquired data are stored locally in the memory of the smart device.

[0043] 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.

[0044] In another aspect, the acquired data are stored locally by the memory module provided in the PCB of device 10.

[0045] 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.

[0046] Device 10 according to the present invention may be applied for obtaining data on the circumference change of the penis. The method for application of the device 10 and the system comprises the following steps: [0047] positioning the device 10 according to the present invention on the base of the penis; [0048] detection and measurement of the change of angular position of magnet 2 by the magnetic encoder 5; [0049] generating digital format of the measurement data by the magnetic encoder 5; [0050] communicating the digital format of the measurement data from the magnetic encoder 5 to the microprocessor 6; [0051] processing the data received by the microprocessor 6 by calculating the extension of the loop based on the degree of the rotation of magnet 2 and the diameter of the outer base channel 1b; [0052] wirelessly transmitting the processed data from the microprocessor 6 to the memory module provided on the PCB of device 10 or to the smart device; [0053] storing the processed data; [0054] uploading the stored data to a cloud, such as a cloud database for storing, analyzing, and using for the calculation of various parameters; [0055] generating the report; [0056] transmitting the generated report to the smart device and [0057] displaying the report on the smart device.

[0058] The device 10 shall be placed on the base of the penis, turned on, and connected over BLE to the smart device. The magnetic encoder 5 shall measure the change of angular position of magnet 2 and generate the digital format of the measured data. The digital data shall be communicated from the magnetic encoder 5 to a microprocessor 6, and data received by the microprocessor 6 shall be processed and the extension of the loop calculated based on the degree of the rotation of the magnet 2 and the diameter of the outer base channel 1b. 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 microprocessor 6 to 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.

[0059] 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 magnet 2 by the magnetic encoder 5 is discarded, to avoid loop extension adjustment errors created by the user during the positioning of the device.

[0060] The minimum and maximum tumescence levels measured are used for the determination of an erection threshold.

[0061] A valid erection episode is detected if the value of the change of angular position of the magnet 2 is 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 magnet 2 falls 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 magnet 2 falls 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.

[0062] During an overnight sleep, most healthy men will experience 3-5 erections 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).

[0063] Device 10 according 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, device 10 enables monitoring the total erection time during an overnight sleep.

[0064] 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.

[0065] 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.

[0066] 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

[0067] 1 Reel [0068] 1a Spring [0069] 1b Outer base channel [0070] 1c The top side of the reel [0071] 1d Bottom side of the reel [0072] 2 Magnet [0073] 3 Loop [0074] 4 PCB (Printed circuit board) [0075] 4a Top side of the PCB [0076] 4b Bottom side of the PCB [0077] 5 Magnetic rotary encoder [0078] 6 Microprocessor (CPU) [0079] 7 Communication module (Bluetooth Low Energy communications module (BLE)) [0080] 8 Power supply unit [0081] 8a Battery [0082] 8b Micro USB charge port [0083] 10 Device [0084] 11 Casing [0085] 11a Bottom part of the casing 11 [0086] 11b Top part of the casing 11 [0087] 12 On/off switch [0088] 13 Indentation [0089] 14 A disk having the magnet [0090] 15,16 Holes on one side of the top part of the casing [0091] 17,18 Holes on the opposite side of the top part of the casing [0092] 20 Fixing point [0093] 21 Reel hole [0094] 22 Protrusion [0095] 22: Slit [0096] 23.24 String threads [0097] 25.26 Ends of the spring [0098] 27 Covering strap