Restoration device with male tissue growth method

Abstract

The device of the present invention enables a method of promoting penile tissue growth and enhancing male urinary incontinence. An activation module surrounding a vacuum chamber is operatively connected to a vacuum pump and a vibrator. A control module directs operation of the vacuum pump and vibration module such that vacuum and vibration are applied to the user's penis within the vacuum chamber. Application of appropriate sequences of vacuum and vibration intervals over a plurality of cycles characterizes the performance of the method of the present invention. Application of appropriate levels of vacuum and vibration over cycles and intervals within cycles also characterizes the present invention.

Description

Technical Field

[0001] The present invention relates to an apparatus and method for promoting the regrowth or repair of the penis after surgery or injury. organization

Background Art

[0002] Some types of urological surgery or genital injuries may induce loss of penile mass as a side effect. Various approaches have been tried to achieve growth or regrowth of penile tissue mass or what is known as male enhancement in a normal male. Four approaches have been taken in attempts for male enhancement.

[0003] Tablets, creams and lotions are widely commercially available and sold. However, there is no direct force to produce penile growth. organization There is no pharmaceutical means to direct drugs or compounds to grow specific parts of the body similar to other parts against the penis. For example, products for hair growth are designed to act specifically on very specific cells. Despite the inefficiency of such products, they are still sold because they are easy to use and many men believe they are effective. organization

[0004] Traction devices are attached to the penile end and apply a predetermined tensile force up to several hours a day. Such devices can be theorized to operate because cells die and are replaced naturally, so that dead cells no longer firmly fix adjacent cells and replaced cells adapt to the elongated configuration of local cells. It is difficult to find conclusive studies that this is effective in the long term.

[0005] ​​Traction devices are undesirable for at least three reasons. First, they are dangerous, painful, and difficult to use for long-term traction without cutting off blood supply. Second, the traction device must be worn for several hours a day to see results. Third, it takes too long to increase length, causing users to give up.

[0006] There are surgeries to lengthen the penis. However, these surgeries only increase the length in a flaccid state; therefore, while the penis may appear larger when flaccid, it will not be longer than before the surgery when erect. Such surgeries have three disadvantages. Firstly, the surgery does not provide a functional increase in length. A penis modified by surgery can still become erect, but it should not protrude from the body. This means that the penis may have to be manually adjusted during sexual intercourse, and the erection may appear as if it were flaccid. Secondly, there are surgical risks, including not only common surgical risks such as infection, but also risks of erectile dysfunction and loss of sensation. Thirdly, the cost is excessively high.

[0007] A vacuum device includes a chamber for inserting the penis, along with a type of pump. The chamber is positioned to fit the groin and often uses a soft gasket to help seal the chamber against the groin. Most pumps are manually driven or battery-powered. The user slides the chamber over the penis and pumps until the desired vacuum is achieved, and the vacuum is maintained as long as the user holds the vacuum state.

[0008] While vacuum devices are claimed to be effective, there is a general consensus in the medical community that they do not provide lasting effects. The only medically approved use of a vacuum device is one in which, once fully inflated by the vacuum, the action of an O-ring applied to the base of the penis creates an erection suitable for insertion. Vacuum devices are all failures due to usage and physiological problems. In particular, vacuum devices are inconvenient because they require a vacuum level necessary to generate maximum elasticity. Human skin is especially unsuitable for exposure to applied vacuum. Blood flows into the area beneath the skin, which causes immediate pain at high vacuum and eventually pain at low vacuum. Vacuum is actually organization Regardless of whether it leads to growth or not, it is not possible to apply the required vacuum level for a sufficiently long duration without unbearable pain.

[0009] As a result, the penis organization In this context, means are needed to induce long-term, sustained growth or regrowth.

[0010] The extension generated by the vacuum device is organization Not enough to permanently extend it. organization The cells can be imagined as a set of connected spheres. Consequently, when a tensile force is applied, the cells can be imagined to take on an elliptical shape, with all the bonds between the cells remaining perfectly intact. This elliptical deformation can be maintained as long as the tensile force is held. However, when the tensile force is released, the cells will slowly return to their original spherical shape without any growth by elongation.

[0011] organization An increase in volume can occur through one of three methods. Enlargement of existing cells occurs, for example, in fat cells, but in the penis. organization It does not occur in cells. Scars resulting from wound healing. organization , an additional collagen organization The accumulation of such substances is undesirable for this purpose.

[0012] Instead, penis organizationThe best way to induce regrowth is thought to be by inducing micro-tears. Simply put, this involves inducing micro-tears by exceeding the binding strength between adjacent cells, thereby allowing new cells to grow between them.

[0013] As mentioned above, this effect cannot be achieved by applying tensile force. Various adjustments and strategies for applying and limiting the vacuum level were attempted but were ineffective. Using water instead of air as a means of applying vacuum is also ineffective. [Overview of the project] [Problems that the invention aims to solve]

[0014] When a vacuum tensile force is applied to the penis, two things happen as the penis stretches to its natural length. First, the penis is filled with blood. Second, the cells stretch into an oval shape. Once the cells are oval-shaped, they can withstand deformation indefinitely.

[0015] In the test, it was able to withstand the deformation in this way. organization In this study, it was found that the cause of microruptures at the most deformed areas was the application of vibration. Elliptic cells move with vibration and can simply stretch or relax the small parts necessary to withstand deformation, so microruptures did not occur with light vibration. organization Applying vibration before it receives full tensile force was also ineffective. An effective method is to use a vacuum. organization This involves applying vibration after fully stretching the object. [Means for solving the problem]

[0016] The present invention applies strong vibrations to a chamber that pulls on the user's penis in each of a vacuum pull interval, a vibration pull interval, and a recovery interval of reduced vacuum recovery. Multiple cycles of the intervals are controlled for interval duration, vacuum level, and vibration intensity.

[0017] Using the present invention involves sliding the vacuum chamber of the activation module over the penis and sealing it against the body. Pressing a button starts the cycling process. The preferred process in best mode is to perform the following steps 40 cycles: [[ID=??]]

[0018] - A vacuum is applied to the penis during the pull interval. The amount of vacuum is specific to the number of cycles within a session. The first cycle starts at 20% vacuum.

[0019] - Vibration is applied to the penis of the activation module during the vibration interval. Such a combination of vacuum and vibration is held for about 10 seconds.

[0020] - The vibration is stopped and the vacuum is reduced to a very low level to create a time with no little vacuum stress. The vacuum is not completely released so that the chamber remains sealed against the body. Such a recovery interval is held for 5 seconds.

[0021] - The process is repeated up to 40 cycles. The vacuum level in the pull interval increases by 4% per cycle. The maximum vacuum applied to all cycles is 17 inHg or 56.8%.

[0022] Such an increase per cycle can be restricted by user input via the touch screen of the control module. The user selects a target vacuum at which the increase stops. The user can also select the number of cycles.

[0023] It should be noted that the text contains some medical and personal device-related content which may be sensitive. Also, there seems to be a missing number in the "

[0018] " line in the original text. This translation is done based on the available content following the given rules. The length of the penis within the chamber is electronically measured using an ultrasonic sensor inside the end of the activation module. Using the ultrasonic sensor, it is possible to determine when the penis reaches its final length due to the vacuum tensile force and the additional length due to the vacuum along with the vibration. This allows for recording of the progress data for each cycle.

[0024] A vacuum is applied to the activation module by a vacuum pump, and vibration is applied by a vibrator attached to the activation module. The electrical components are controlled by an electronic control module that can receive user input via a touch screen.

[0025] Growth measurable using a device with such steps organization is achieved. And since the effect does not depend on an excessive vacuum level, the discomfort is mild.

[0026] Therefore, the device of the present invention enables a method of promoting penis organization growth, promoting penile blood flow, and strengthening male urinary continence. The vacuum level used according to the present invention has been found to be able to act as resistance to exercise. Such exercise resistance provides the user with an opportunity to easily practice pelvic floor muscle exercises, and further improves recovery from pelvic surgery or injury. The movement of the pelvic muscles can be sensed and measured using the sensors of the device, which improves the user's confidence in difficult exercises. Such promoted pelvic floor muscle exercises are expected to reduce urinary incontinence due to pelvic surgery.

Brief Description of the Drawings

[0027] [Figure 1] Shows an overview of the device. [Figure 2] Shows a chart of exemplary results from a single course of 14 weeks using the device of the present invention. [Figure 3] Is a detailed view of the activation module of the device. [Figure 4] This is an external perspective view of the activation module portion of the present invention. [Figure 5] This is a perspective view showing three external views of the activation module of the present invention. [Figure 6] This is a perspective view of the internal range measuring instrument components used in the present invention. [Figure 7] This is an additional external perspective view of the activation module portion of the present invention. [Figure 8] This is an external perspective view of the activation module, showing a cutout diagram of the activation module. [Figure 9] This is a side view of a preferred embodiment of the apparatus in the initial steps of use. [Figure 10] This is a side view of a preferred embodiment of the apparatus in the tensile interval step of a cycle using the present invention. [Figure 11] This is a side view of a preferred embodiment of the apparatus in the first vibration interval step of the present invention. [Figure 12] This is a side view of a preferred embodiment of the apparatus in the recovery interval step of the usage cycle of the present invention. [Figure 13] A flowchart illustrating the operation of the apparatus in an exemplary embodiment of the present invention is shown. [Figure 14] A wiring diagram illustrating possible electrical connections in an exemplary embodiment of the present invention is shown. [Figure 15] A diagram of the components shows the arrangement of components, power and control elements in an exemplary embodiment of the present invention. [Modes for carrying out the invention]

[0028] Figure 1 shows an overview of the device. The components are arranged around the activation module 1 and are combined sequentially to transmit vacuum and vibration. The vacuum chamber 2 forms a nearly cylindrical space inside the activation module with a circumference large enough to comfortably accommodate a human penis. The proximal end 3 of the activation module has a fluted opening 5 that is adjacent to the user's torso 4 and can be placed at the same height as the user's torso. A stylized depiction of a human penis 6a occupying the proximal portion of the vacuum chamber is illustrated.

[0029] The distal end 7 of the activation module is further away from the user's torso during use. The distal portion 8 of the chamber has a narrower internal circumference than the proximal portion 9 of the chamber. Therefore, there is always a chamber transition portion 10 from the proximal to the distal portion of the vacuum chamber where the internal circumference gradually narrows.

[0030] The distal portion of the chamber is used to form a vacuum and features a vacuum opening 11 through which a vacuum pump 12 operates. In the drawing, the vacuum pump is connected via a vacuum hose 13 through the vacuum opening. A sensor opening 14, indicated at the end of the activation module, corresponds to a similar type of sensor such as an internal range meter, proximity sensor, radiation sensor, or distance sensor 15. A sensor ranging target puck 16 is positioned in the distal portion of the vacuum chamber to provide a flat surface for the internal range meter.

[0031] Furthermore, a vibrator 17 with controllable frequency and amplitude is positioned around the activation module. In the drawing, the vibrator is mounted directly to the outside of the activation module by a mounting bracket 18 integrated into the activation module.

[0032] The vacuum pump and vibrator operate together as an integrated system by a control module 19, which here shows an electronic device with a touchscreen control unit 20.

[0033] Figure 2 shows a chart of exemplary results from a single 14-week course using the apparatus of the present invention. The chart shows the lengths measured by the method of the present invention with appropriate vacuum and vibration combinations. After the length is reached by pre-vibration or tensile, the measured penile length increases by applying vibration intervals with appropriate vibration parameters. By using increasing cycle vacuum parameters, additional lengthening begins immediately when the next cycle resumes. The illustrative results shown are the average of the measurements obtained in the last cycle of each usage session in each cycle of a week.

[0034] The chart shows that the measured length increased by an average of 1.7 inches after 14 weeks of use. The measured increased average length occurs under appropriate vacuum tensile force and vibration according to the present invention. Once the tensile force and vibration are removed, approximately 25% of the increased length is retained for an extended period. As an example of this, a new penis organization A length of 0.425 inches is maintained as growth.

[0035] Figure 3 is a detailed view of the activation module 1 of the device. The case wall 21 of the activation module has sufficient strength to form an internal vacuum of at least 56% under standard external atmospheric pressure. The case wall at the proximal end extends toward a grooved or flanged opening. The proximal portion 9 of the vacuum chamber, shown here empty, narrows toward the distal portion 8 of the vacuum chamber via the vacuum chamber transition portion 10. The sensor target pack 16, positioned in the vacuum chamber of the activation module, has a circumference only a few thousandths of an inch smaller than the circumference of the distal portion 8 to prevent rattling or displacement.

[0036] The distal portion 8 of the vacuum chamber needs to be extended beyond the expected distance to which the human penis can be stretched using the device, and sufficient space is required to form a vacuum beyond the expected distance. Thus, embodiments of the device may have a proximal vacuum chamber portion 9 that is 14 inches or longer. The distal vacuum portion 8 of the chamber is extended by sufficient chamber volume so that at least 56% vacuum can be generated in the vacuum chamber using a connected vacuum pump.

[0037] In this example, the vacuum opening 11, which connects to the distal portion 8 of the chamber, is shown to pass through the dorsal side of the activation module case wall 21. The sensor hole 14 is shown to pass through the closed distal end 7 of the activation module case wall. In an alternative embodiment, such a hole may be located at another position in the activation module case wall to connect to the distal portion of the chamber.

[0038] The vibrator mounting bracket 18 is exemplified as being mounted dorsally, at the upper end, on the outside of the activation module, but may be located ventrally, below, or elsewhere. In the illustrated embodiment, the chamber transition portion 10 shows the internal chamber circumference narrowing together with the outside of the chamber case wall, but in other embodiments, the outside of the case does not reflect the shape of the internal vacuum chamber.

[0039] In one embodiment of the present invention, the activation module 1 is made of a transparent polycarbonate tube with ruler markings so that the user can observe the progress. In this embodiment, the proximal end 3 and distal end 7 of the activation module are manufactured as separate parts and assembled together. In this embodiment, the closure portion of the distal end is manufactured as a threaded end cap, in which a machined lock slot and lock button attach the end cap to the distal end. A gasket between the mounting surface of the distal end and the end cap is used to prevent vacuum leakage.

[0040] Figure 4 is a perspective view of the exterior of the activation module of the present invention. In the illustrated embodiment, the exterior of the activation module 1 is essentially cylindrical, and the flange opening 5 is circular.

[0041] The mounting bracket 18 for the vibrator is shown to have an I-beam shape to accommodate the mounting bolts. The lower end of the mounting bracket 22 is bent to the same height as the cylindrical exterior of the activation module to transmit vibrations to the chamber.

[0042] The manual vacuum release valve 23 is located outside the activation module through the case wall 21. Such a release valve does not stop the operation of the vacuum pump, but rather allows air to escape into the activation module more quickly than the vacuum pump can generate vacuum, thus serving as a manual emergency pressure release unit. Two additional user-operated vacuum release control units are located on the control module, as described below with reference to Figure 11.

[0043] Figure 5 is a perspective view showing three external views of the activation module of the present invention. A controllable vibrator 17 is mounted on a mounting bracket to transmit vibrations through the activation module case wall. A pulse-width modulated controllable vibrator, a pneumatic vibrator, or any other suitable vibrator capable of supplying an amplitude within a specified range may be used. Secondly, it is shown that an internal range measuring sensor 15 occupies a sensor hole 14 at the distal end 7 of the activation module and is in use. Thirdly, the flanged opening 5 is at the same height as the user's torso 4 to allow for vacuum sealing.

[0044] Figure 6 is a perspective view of the components of the internal range measuring device used in the present invention. The internal range measuring device, also called a proximity sensor, is a sensor used to measure the distance between the end of the activation module and the tip of the user's penis. In a preferred embodiment, this sensor is used by the user organization This is an ultrasonic proximity sensor that does not generate enough energy to have an effect. In other embodiments, an infrared sensor, laser, or other radiation sensor may be used. The proximal end 24 of this component is sized to fit the sensor aperture. The distal end 25 of the component houses a wire for connection to a control module.

[0045] Figure 7 is an additional external perspective view of the activation module portion of the present invention. The proximity sensor 15 is located within the sensor opening 14 when viewed from the outside. Also shown is a mounting bracket having mounting bolt holes 26 that extend through a horizontal extension portion of the mounting bracket. In a preferred embodiment, the activation module is constructed of cured plastic using injection molding or 3D printing technology to achieve the required shape.

[0046] Figure 8 is an external perspective view of the activation module with a cutout of the activation module. The vibration engine 17 is positioned on the mounting bracket 18. The distance sensor 15 is positioned in the sensor hole. The flanged opening 5 is at the same height as the user's torso.

[0047] A cutaway view through the case wall 21 of the activation module shows a stylized human penis in a relaxed state 6b, reaching the proximal portion 9 of the vacuum chamber. Since the penis is not vacuumed within the chamber, it does not expand. Because it is not expanded, it does not come into contact with the abdominal interior of the case wall. This allows for an unobstructed view of the transitional portion inside the activation module.

[0048] Figure 9 is a side view of a preferred embodiment or best mode of the apparatus in the first step of use. First, a set of control parameters is stored in a control module 19 having persistent non-volatile memory. In the preferred embodiment shown herein, the control module features a touchscreen 20 for user input and is called a control panel. In other embodiments, the control module may use buttons, dials or other common inputs. In other embodiments, the control module may receive user input via a paired smartphone, computer, or other smart device.

[0049] The control parameters stored in the control module are used to determine how the control module controls the vibrator 17 and the vacuum pump 12. The control parameters stored in the control module may include: a vacuum parameter that sets the vacuum level generated by the vacuum pump; a vibration frequency parameter that sets the vibration frequency generated by the vibration pump; a vibration amplitude parameter that sets the magnitude of the vibration generated by the vibrator; a time parameter that can determine the duration of the vacuum generated by the vacuum pump; a time parameter that can determine the duration of the vibration generated by the vibrator; increase and decrease parameters that set how much to periodically increase or decrease the other parameters; and maximum or minimum parameters that set maximum or minimum limits for the other control parameters.

[0050] For such a step of setting a value for at least one control parameter of the device, the set of control parameters for which a value can be set may include: First tensile interval vacuum parameter; First tension interval duration parameter; First oscillation interval frequency parameter; First vibration interval amplitude parameter; First oscillation interval duration parameter; First recovery interval vacuum parameter; First recovery interval duration parameter, Second tensile interval vacuum parameter; Second tensile interval duration parameter; Second vibration interval frequency parameter; Second vibration interval amplitude parameter; Second oscillation interval duration parameter; Second recovery interval vacuum parameter; Second recovery interval duration parameter; Vacuum increase parameter; Duration increase parameter; Duration reduction parameter; Oscillation frequency increase parameter; Vibration frequency reduction parameter; Vibration amplitude increase parameter; Vibration amplitude reduction parameter; Sealing parameters; Maximum vacuum parameter; User target vacuum parameters.

[0051] In a preferred embodiment of the present invention, the maximum vacuum level parameter is set to a vacuum of 56.8% or near that level. This is the maximum vacuum level permissible for the activation module for safety reasons.

[0052] Furthermore, in a preferred embodiment of the present invention, a plurality of control parameters can be set by the user. The user-defined control parameters are received from the user to the control module via a touchscreen, buttons, dials, a paired device, or other suitable input means. In a preferred embodiment, the user can input a user-target vacuum parameter lower than the maximum vacuum parameter. Regardless of the settings for the maximum vacuum parameter and the user-target vacuum parameter, it should be noted that there will always be a cycle in which the first tension interval vacuum parameter is lower than the highest vacuum parameter reached in the next cycle. The maximum vacuum parameter is either the maximum vacuum parameter or the user-target parameter.

[0053] In the method using the device, the user's penis is housed within the proximal opening of the device's vacuum chamber. Here, the user's flaccid penis 6c is shown. Since the user's penis is stationary, it is shown that it has not yet come into contact with the sensor distance measuring target packet 16 located in the distal portion 8 of the vacuum chamber. In a preferred embodiment, the user activates the activation module using the control panel. In an alternative embodiment, the control module activates the activation module by sensing that the user's penis is in the proximal portion of the vacuum chamber using an internal range measuring instrument.

[0054] When the activation module is activated, the vacuum pump 12 is set to generate enough vacuum in the activation module to form a vacuum seal between the user's torso 4 and the proximal opening 5 and / or around the base of the user's penis within the activation module. In a preferred embodiment, the vacuum pump generates the vacuum effect by an air pumping method rather than by water or liquid pumping. The amount of vacuum required to form a vacuum seal is stored in the control module as a sealing parameter. It has been found that a sufficient value for the sealing parameter is approximately 20% vacuum.

[0055] Figure 10 is a side view of a preferred embodiment of the apparatus or the best mode of the present invention in a tensile interval step in a cycle using the present invention. In this stage of use, a tensile interval occurs in the vacuum chamber, and the tensile interval has a first tensile interval vacuum parameter and a first tensile interval duration parameter.

[0056] During the first tension interval, the control module 19 controls the vacuum pump 12 to generate a vacuum level in the activation module according to the first tension interval vacuum parameter. The generated vacuum is sufficient to cause the user's penis to be pulled, expand, and fill with blood. In the pulled state, the length and circumference of the user's penis increase.

[0057] The drawing shows the user's penis fully stretched to a first length by the vacuum 6d. As shown, the penis is longer than in Figure 9. Also, the circumference of the penis is larger than in Figure 9. The narrowing transition of the vacuum chamber, which leads to the narrowing end of the vacuum chamber, prevents the user's penile skin below the glans from being pulled forward by the vacuum. As a tensile force is applied to the user's penis, it comes into contact with the sensor ranging target pack 16 located at the end 8 of the vacuum chamber.

[0058] In a preferred embodiment, the user's penis is held for 10 seconds during this tension interval. The vibration interval begins at or immediately after the tension interval and is performed in a vacuum state along with vibration during this cycle, as described below with reference to Figure 11.

[0059] Such a first tension interval has the same duration as the first tension interval duration parameter stored in the control module. In an alternative embodiment, this first tension interval has a duration parameter received from the user.

[0060] In an alternative embodiment, the user's penis is held for a sufficiently long tensile interval so that the internal range measuring sensor 15 can determine that the length increase has been interrupted by the vacuum, thereby determining that the penis has been fully subjected to tensile force by the vacuum during this cycle. The vibration interval begins after the first determination by the sensor that the penis has been fully subjected to tensile force. The length measured by the sensing is stored in the control module as tensile length data for this cycle. The time required to reach this length is recorded in the control module as tensile time data for this cycle. Subsequent tensile intervals are stored in the control module and may have the same duration as the tensile time data increased by a parameter for a stepwise increase in the duration of the tensile force.

[0061] The tensile tension interval in this step of the method of the present invention is the user's penis organization It is understood that the cells here enter a state referred to as being stretched. As mentioned above, the penis is stretched during this stretching period. organization Cells can be conceived to be pulled or stretched in the vacuum direction or to have an elliptical shape while all the connections between cells remain completely intact. Such an elliptical distortion can be maintained as long as the tensile force is held. Therefore, the step of generating a first tensile interval in the vacuum chamber uses sufficient vacuum parameters so that at least some of the cells of the user's penis are stretched into an elliptical shape by the vacuum tensile force.

[0062] Two user-activated vacuum release control devices are located in the control module. One such user-activated vacuum release control device is a manually operated electric button or switch 27 located in the casing 28 of the control module, configured to actuate the vacuum pump 12. The other user-activated vacuum release control device is a screen button 29 located on the interface screen of the control module, configured to actuate the vacuum pump.

[0063] The control module is wired to hold solenoids and release solenoids that open and close the vacuum pumps, respectively. As a safety measure, the solenoids are normally configured to be open. When the device is powered off, the existing vacuum is released. An electric discharge control device is also wired to the solenoids and, when triggered, immediately releases the existing vacuum.

[0064] As an additional vacuum safety measure, a first vacuum sensor 30 and an auxiliary vacuum sensor 31 are positioned in the vacuum chamber or operably connected to the vacuum chamber or vacuum line. These two vacuum sensors are operably connected to a control module and provide the control module with vacuum readings. If the vacuum sensor readings indicate that the target vacuum for the current cycle has been reached, the vacuum pump is stopped and the vacuum state is maintained. If the vacuum sensor readings indicate that the maximum vacuum has been exceeded, the vacuum pump is stopped and released, and air flows into the vacuum chamber. Also, if the readings of the first vacuum sensor and the auxiliary vacuum sensor reach 3% or more, the vacuum pump is stopped and released, air flows into the vacuum chamber, and the vibrator is stopped.

[0065] Figure 11 is a side view of a preferred embodiment of the apparatus in the first vibration interval step used in best mode. In the preferred embodiment, the step to induce the vibration interval begins approximately simultaneously with or immediately after the start of the tension interval. In an alternative embodiment, the vibration interval begins after the user's penis has reached the tension length, as described with respect to Figure 10, in which case the step to induce the first vibration interval begins after at least some cells of the user's penis have been fully stretched by the first tension interval. It is also possible to start the vibration before starting the vacuum tension, but the goal is to coincide the tension interval and the vibration interval so that at least a portion of the duration of the vacuum tension interval overlaps with at least a portion of the duration of the vacuum interval.

[0066] During such a first vibration interval, the control module controls the vibrator to generate vibrations in the activation module, along with vacuum from a tensile interval whose duration overlaps. In a preferred embodiment, the vibrations are generated by a first vibration interval vibration frequency parameter and a first vibration interval vibration amplitude parameter. The vibration amplitude may be set to distance per second of the activation module, to "G" as gravitational acceleration, or to other terms used in the art to measure acceleration force or vibration power.

[0067] According to research by the National Institute of Health, a standing adult can withstand whole-body vibrations of approximately 2.0 g for up to one minute (see "Safety and severity of accelerations delivered from whole-body vibration exercise devices to standing adults" at https: / / www.ncbi.nlm.nih.gov / pmc / articles / PMC36886421). A vibrator that moves an eccentric mass of 0.94 inches per revolution at 3600 RPM imparts a vibration amplitude of approximately 123 G relative to the motor's eccentric mass, where G (or g) is the acceleration due to gravity, or 9.8 m / s². 2 This is the amplitude measured relative to the user's penis. When applying the vibrator to a 4kg mass consisting of the motor, activation module, and the user's penis, a vibration amplitude of approximately 9.2G RMS (root mean square) can be expected. According to tests, this is close to the maximum vibration amplitude that the user's penis can withstand, with a vibration interval of 7 to 10 seconds. organization It is effective in increasing it. Similarly, the lowest vibration amplitude of the mass consisting of the motor, activation module, and the user's penis, which is expected to exhibit useful effects in the present invention, is about 2.1 G RMS.

[0068] In a preferred embodiment, the effective vibration should have a minimum peak-to-peak amplitude of approximately 0.69 mm at 3600 RPM, i.e., 3.5 g RMS. Also in a preferred embodiment, the effective vibration should have a maximum peak-to-peak amplitude of approximately 1.7 mm at 3600 RPM, or 8.7 g RMS for a short interval of approximately 10 seconds. The best-mode effective amplitude in a preferred embodiment is 6.1 g RMS for a peak-to-peak amplitude of 1.2 mm at 3600 RPM, or for an vibration interval. A variety of vibration amplitudes and frequency settings may be used to achieve similar effects.

[0069] Therefore, a first vibration interval is applied to the vacuum chamber simultaneously with a first tension interval, and the first vibration interval has a first vibration interval duration parameter, a first vibration interval frequency, and a first vibration interval amplitude, and is applied by a vibrator.

[0070] The vibrations generated along with the vacuum are intended to be sufficient to further inflate the user's penis with the activation module. When the vacuum is applied along with the described vibrations, the user's penis length will extend beyond what would be induced by the vacuum alone. Similarly, the application of vibrations of the present invention along with the vacuum promotes the user's penis to expand around beyond the expansion caused by the vacuum alone as described by Figure 10. The user's penis is promoted to lengthen further so that it comes into contact with the sensor. A target pack, positioned at the end of the vacuum chamber, is measured and pushed forward. The proximity sensor target pack provides a flat surface that the internal range measuring instrument uses as a target for measuring penile elongation in the appropriate step of the present invention. In an alternative embodiment, the present invention was made without a target pack. This offers the advantage of having fewer moving parts, but the measurement accuracy is lower.

[0071] Figure 11 shows the user's penis 6e inflated under vacuum and vibration. In a preferred embodiment, the vibration interval lasts approximately 7 seconds and ends 3 seconds before the simultaneously progressing tension interval ends. The 3 seconds without vibration stop the movement of the measurement target packet 16 so that the internal range measuring instrument 15 can accurately determine the length reached by the user's penis during the vibration interval. Such a length is stored in the control module as vibration length data for this cycle.

[0072] In an alternative embodiment, the user's penis is held in such a vibration interval for a sufficiently long time so that the internal range measuring instrument determines that the penis has been fully tensed to a predetermined length by the vacuum combined with vibration, at which point the increase in length by vibration and vacuum is interrupted, and a recovery interval begins. Such a vacuum tensile length is stored in the control module's persistent non-volatile memory as vibration length data for this cycle. The time required to reach this length is recorded in the control module as vibration time data for this cycle. Subsequent vibration intervals are stored in the control module and may have the same duration as vibration time data increased by a stepwise duration increase parameter of vibration.

[0073] In an alternative embodiment, changes in vibration parameters, such as vibration frequency or vibration amplitude, can be set by a control module or from user input. Once the changes in vibration parameters are used, they can be stored as vibration interval frequency data and amplitude data. Along with vacuum data, tensile length data, vibration length data, interval duration, and numerous cycle analyses of such data, the most effective combination of vacuum, vibration amplitude, vibration frequency, interval duration, and number of cycles can be determined.

[0074] organization Applying vibration before the penis is pulled by vacuum is ineffective. The vibration interval step of the present invention, which is performed simultaneously with the tensile interval step of the method of the present invention, is effective for the penis organization It plays a role in inducing expected micro-ruptures between cells, thereby creating space for new cell growth in the rupture zone. Therefore, the step of generating the first tension interval, along with the step of generating the first vibration interval, is performed on at least a portion of the user's penis. organization This is sufficient to induce micro-ruptures.

[0075] As a result of this tension, rupture, and formation of new cells, the user's penis organization Growth, enlargement, and / or regrowth can be expected. Therefore, the step of inducing the first tension interval along with the step of inducing the first vibration interval is performed on the user's penis. organization This is sufficient to promote the formation or addition of at least some new cells.

[0076] Figure 12 is a side view of a preferred embodiment of the apparatus during the recovery interval phase of the service cycle. After the tensile interval duration parameter has elapsed, the vibration due to the vibration interval is interrupted or reduced, and the vacuum level of the vacuum chamber is reduced to a level lower than the previous tensile interval level, causing a first recovery interval to occur in the vacuum chamber. The recovery interval has a recovery interval vacuum parameter and a recovery interval duration parameter, where the recovery interval vacuum parameter is lower than the previous tensile interval vacuum parameter. In such a preferred embodiment, this recovery interval vacuum is about 20%, or sufficient to maintain the vacuum seal. In an alternative embodiment, the recovery interval vacuum parameter may be as low as 10%, or as high as 30%.

[0077] The vacuum parameter for the recovery interval is the user's penis. organization The pressure is not high enough to induce micro-ruptures. In a preferred embodiment, the recovery interval is held for 5 seconds. The user's penis 6f shows a contracted state compared to the vibration interval in Figure 11, but also shows an expanded state compared to the previous interval in Figure 9. In a low vacuum state, this duration is such that the user's penis can reach the tensile length quickly during the tension interval of the next cycle. A period that does not effectively deviate from this effect may be used in alternative embodiments. The step of inducing the first tension interval, together with the step of inducing the first vibration interval and the resulting recovery interval step, the user's penis organizationThis is sufficient to promote the formation or addition of at least some new cells.

[0078] A new cycle of tension interval, vibration interval, and recovery interval begins by starting a new tension interval after the recovery interval. The vacuum for the new cycle is increased by the stepwise vacuum increase parameter as described above. In a preferred embodiment, the number of cycle parameters is 40. Also in a preferred embodiment, the stepwise vacuum increase parameter is 4%, so the tension interval vacuum moves from 20% to 56% in 9 cycles. This parameter may be modified or changed by the user in alternative embodiments.

[0079] Pelvic muscle exercises In embodiments of the present invention, including (pelvic floor muscle stretching exercise), the exercise is performed with sufficient vacuum to keep the vacuum chamber of the activation module sealed to the user's body, with a stretching interval having high vacuum and a recovery interval having lower vacuum. Pelvic muscle exercises ( Pelvic floor muscle exercises ) It can be executed during specific intervals for that purpose.

[0080] The user resists the vacuum tension without vibration. Pelvic muscles ( Pelvic floor muscles )When pulling, the movement of the sensor target pack 16 can be captured by the internal range measuring sensor 15 while measuring pelvic tension. In such embodiments, the internal range measuring sensor may also be referred to as a pelvic tensile force sensor operably coupled to a control module portion capable of detecting pelvic muscle movement by the user of the device and located on or inside the activation module portion. Alternatively, the weight of the activation module sealed in the user's body by vacuum can act as resistance to the user's pelvic tensile movement. In such use cases, the movement of the activation module can act as a pelvic tensile force sensor in the activation module and control module, or it can be measured using an accelerometer 32 operably coupled to the activation module and control module. In both cases, the sensor measurement is stored in the control module's memory. Pelvic muscles This can be stored as exercise data. Pelvic muscles Exercise data, Pelvic muscles This may include the number of contractions, the speed or acceleration of the contraction, and the distance contracted. Pelvic muscles Exercise data can be compared over one usage cycle to other usage cycles, which is how the user of the present invention performs exercise using the device of the present invention. Pelvic muscles Provides an indication of enhancement.

[0081] Figure 13 shows a flowchart illustrating the operation of the apparatus in an exemplary embodiment of the present invention. When the user presses the start button connected to the control module with the penis still inside the activation module, the activation module is depressurized by the vacuum sealing parameter in step 33.

[0082] In step 34, the control module sets the cycle count to 1 to start the first cycle when the device is put into use. The cycle vacuum level is set to a predetermined minimum value by the control module. The cycle vacuum level may be referred to as the first tension interval vacuum parameter for the purpose of initiation.

[0083] In step 35, the vacuum pump is driven by the activation module until it reaches cycle vacuum, initiating the first tensile interval in this first use cycle. In step 36, it is determined using an internal range meter whether the tensile length has been achieved. The tensile length is the length of the user's penis stretched by the current cycle vacuum level.

[0084] Next, in step 37, when the user's penis reaches the tensile length, the vibrator operates at the amplitude and frequency set by the user, or at a predetermined amplitude and frequency. The vacuum pump waits for 10 seconds in step 38. In the embodiment shown in this flowchart, it can be seen that the vibrator operates for 10 seconds in step 38 because the user's penis quickly reaches the tensile length after the vacuum has started. In other embodiments, the vibration starts easily with or immediately after the vacuum, regardless of the vacuum-induced tensile length.

[0085] During this time, the combination of vacuum and vibration induces an additional increase in the length and / or circumference of the user's penis beyond the tensile length. In step 39, the vibrational length of the penis during this vibration interval is determined using an internal range measuring instrument. The tensile length and vibrational length are recorded as data in the control module along with the cycle vacuum, vibration parameters, and other parameters used in such a cycle of the present invention.

[0086] In this step, the vibrator is turned off, the vacuum level is reduced to a relaxation level, and a recovery interval begins for a predetermined period. The recovery interval is the final step of the cycle, and the cycle count parameter is incremented in the control module.

[0087] Next, control module stage 40 determines whether the maximum cycle count has been reached. If so, the process is stopped and no further cycles are executed.

[0088] Otherwise, in the next step 41, the cycle vacuum is increased, resulting in a higher tensile interval vacuum for the next cycle. The amount by which the cycle vacuum increases may be a predetermined control module parameter or a user-defined parameter. The amount of the cycle vacuum increase may alternatively vary by a formula in some embodiments. For example, the cycle vacuum increase decreases as the number of cycles increases or as it approaches the previously recorded maximum length of the user's penis recorded during the interval in which tensile force is applied to a given cycle.

[0089] If the newly increased cycle vacuum does not exceed the vacuum limit in step 42, the process returns to step 35 to start a new cycle. In a preferred embodiment, there is a safety vacuum limit of approximately 56.8% vacuum or approximately 334 Torr. If the newly increased vacuum cycle exceeds the limit, the vacuum cycle is reduced to the limit in step 43 before the new cycle begins.

[0090] Figure 14 shows a wiring diagram illustrating an electrical connection usable in an exemplary embodiment of the present invention. The Click Plus branded C2-08-DR6C I / O module is shown as an operable option for the wiring harness 44. The wiring harness is characterized by a set of channels 45 for individual inputs, a set of channels 46 for individual outputs, a set of analog input channels 47 with analog-to-digital converters, and a set of analog output channels 48 with digital-to-analog converters.

[0091] The four individual inputs can be wired with noise-canceling capacitors to receive state signals from signalable components. Here, the individual signal outputs are reserved for the vibrator control signal 49, the vacuum pump control signal 50, the hold solenoid signal 51, and the release solenoid signal 52. The four individual outputs are wired in common to 120V or 240V AC.

[0092] The analog input channel receives current sensor signals to reduce motor noise. Available analog current inputs are used for range measuring instrument or proximity sensor signals 53, the first vacuum sensor 54, and the auxiliary vacuum sensor 55.

[0093] Figure 15 shows a component diagram illustrating the arrangement of components, power, and control elements in an exemplary embodiment of the present invention. The diagram is stylized to include all wired components and PCB-mounted components.

[0094] The wiring harness 44, described in detail in Figure 13, is connected to the printed circuit board (PCB) 56 via a multi-pin connector. As described above, the wiring harness directs I / O connections from the individual vibrator relay 57, the individual vacuum pump relay 58, the hold solenoid 59, the release solenoid 60, the proximity sensor analog current input 61, the first vacuum sensor analog current input 62, and the auxiliary vacuum sensor analog current input 63. The hold solenoid, release solenoid, proximity sensor, first vacuum sensor analog current input, and second vacuum sensor are individual components connected to the wiring harness by wires.

[0095] Individual relays for the vibrator and vacuum pump are mounted on the PCB. The PCB also includes a power supply unit that drives 64V to 120VAC or 240VAC, providing 24VDC at 3 amps to the vacuum pump, vibrator, solenoid, and proximity sensor. An Ethernet switch 65 for external communication with the control module is also mounted on the PCB.

[0096] The user touchscreen 66 and the CPU 67 for the control module are also connected by wires. Finally, the vacuum pump 12 and the vibrator 17 are shown connected by wires to the vacuum pump relay and the vibrator relay, respectively.

[0097] Although the present invention has been described in relation to specific embodiments for illustrative purposes, the present invention is not limited thereto. Therefore, various modifications, adaptations, and combinations of the various features of the described embodiments can be carried out without departing from the scope of the present invention.

Claims

1. A device for promoting at least one of the following: tissue growth of the user's penis, enhancement of male urinary incontinence, and / or enhancement of penile blood flow, A vacuum chamber portion, wherein the vacuum chamber portion is part of the activation module of the apparatus, and the vacuum chamber portion has a proximal opening and is configured to accommodate a human penis; A vacuum pump operably connected to the vacuum chamber portion; vibrator; and A control module configured to store control parameters; including, The aforementioned control module is: A step of controlling the vacuum pump so that a first tension interval occurs in the vacuum chamber portion; A step of controlling the vibrator so that a first vibration interval occurs that is superimposed on the first tension interval; A step of controlling the vacuum pump so that a first recovery interval occurs; A step of controlling the vacuum pump to generate a second tension interval; A step of controlling the vibrator so that a second vibration interval occurs that overlaps with the second tension interval; and The system is configured to perform the step of controlling the vacuum pump so that a second recovery interval occurs; The control module is configured to receive input via a user interface configured to receive control parameters, the user interface being part of the apparatus or part of a separate device operably coupled to the apparatus. The control module is operably coupled to a sensor located within the vacuum chamber, which is configured to sense the expansion of the user's penis within the vacuum chamber. The control module is During the first stretching interval, a first determination is made using the sensor that the user's penis has been fully stretched to a first length by vacuum; and An apparatus configured to further perform the step of initiating the first vibration interval after the first determination.

2. A device for promoting at least one of the following: tissue growth of the user's penis, enhancement of male urinary incontinence, and / or enhancement of penile blood flow, A vacuum chamber portion, wherein the vacuum chamber portion is part of the activation module of the apparatus, and the vacuum chamber portion has a proximal opening and is configured to accommodate a human penis; A vacuum pump operably connected to the vacuum chamber portion; vibrator; and A control module configured to store control parameters; including, The aforementioned control module is: A step of controlling the vacuum pump so that a first tension interval occurs in the vacuum chamber portion; A step of controlling the vibrator so that a first vibration interval occurs that is superimposed on the first tension interval; A step of controlling the vacuum pump so that a first recovery interval occurs; A step of controlling the vacuum pump to generate a second tension interval; A step of controlling the vibrator so that a second vibration interval occurs that overlaps with the second tension interval; and The system is configured to perform the step of controlling the vacuum pump so that a second recovery interval occurs; The control module is configured to receive input via a user interface configured to receive control parameters, the user interface being part of the apparatus or part of a separate device operably coupled to the apparatus. The system further includes a sensor located inside the vacuum chamber portion, which is operably coupled to the control module and configured to sense the expansion of the user's penis inside the vacuum chamber portion. The control module is During the first stretching interval, the sensor is used to make a first determination that the user's penis has been fully stretched to a first length by vacuum; A step of starting the first vibration interval after the first decision; A second step of determining, during the first vibration interval, that the penis has been fully stretched to a second length by a vacuum coupled with vibration using the sensor; and An apparatus configured to further perform the step of starting the first recovery interval after the second decision.

3. The first tensile interval has a vacuum parameter and a duration parameter; The first vibration interval has a vibration frequency parameter, a vibration amplitude parameter, and a duration parameter, wherein the first vibration interval duration parameter is less than or equal to the first tension interval duration parameter; The apparatus according to claim 1 or 2, characterized in that the first recovery interval has a vacuum parameter and a duration parameter, and the first recovery interval vacuum parameter is lower than the first tension interval vacuum parameter.

4. The system further includes a sensor located inside the vacuum chamber portion, which is operably coupled to the control module and configured to sense the expansion of the user's penis inside the vacuum chamber portion; The control module is A step of determining the length of the user's penis using the sensor after the first vibration interval; and The system is configured to further perform the step of recording the first decision as data, The apparatus according to claim 1 or 2.

5. The device further includes an internal range measuring sensor located on or inside the activation module, operably coupled to the control module, and capable of detecting pelvic muscle movement by the user of the device. The control module is The apparatus according to claim 1 or 2, characterized in that, after the first vibration interval, an additional step is performed to perform a first measurement of pelvic muscle movement by the user of the apparatus using the internal range measuring sensor.

6. Along with the second vibration interval, the vacuum parameter of the second tension interval is set to induce micro-ruptures in the user's penile tissue. The apparatus according to claim 1 or 2, characterized in that the vacuum parameter for the second recovery interval is set so as not to induce microruptures in the user's penile tissue.

7. The vacuum chamber portion is cylindrical, having an outer diameter, a first inner diameter, and a closed end opposite the proximal opening; The first inner diameter gradually narrows toward a second inner diameter which is smaller than the first inner diameter; The first inner diameter is closer to the proximal opening; The second inner diameter is closer to the closed end; The first tensile interval has a tensile interval vacuum parameter; The first recovery interval has a recovery interval vacuum parameter; The first vibration interval has a vibration interval amplitude parameter; The first tensile interval vacuum parameter has a minimum vacuum of approximately 20% and a maximum vacuum of approximately 56.8%; The first recovery interval vacuum parameter has a minimum vacuum of approximately 10% and a maximum vacuum of approximately 30%; The apparatus according to claim 1 or 2, characterized in that the vibration amplitude parameter of the first vibration interval has a minimum of approximately 2.1 G RMS and a maximum of approximately 9.2 G RMS.

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