Adjustable perineal dynamometer device

Abstract

A perineal contraction dynamometer device for providing accurate biofeedback, comprising: a cover (1) coupled to a tubular member (11); at least one first finger (9a) and at least one plate (18) or at least one second finger (9b) and at least one force sensing resistor (17), the at least one plate (18) or the force sensing resistor (17) being arranged inside and parallel to the at least one finger (9a, 9b); at least one battery (15) for applying a potential difference to the at least one first finger (9a) and the at least one plate (18); a device for measuring the capacitance generated thereby, or at least one force sensing capacitor (17) for measuring the force applied to the at least one second finger (9b); and a processor connected to the device for applying the potential difference and measuring the capacitance or to the at least one force sensing resistor (17).

Description

Technical Field

[0001] The present invention relates to a perineal dynamometer device for sphincter training. Background Art

[0002] Weakened pelvic floor muscles result in incomplete muscular support of the internal organs and lead to difficulty controlling the release of urine, stool, or flatus. Pelvic floor exercises are designed to strengthen the pelvic floor muscles and prevent the need for corrective surgery. Exercises to strengthen the pubic muscles can improve the function of the urethra and anal sphincter, thereby preventing urinary and anal incontinence.

[0003] US Patent No. 8,088,051 B2 discloses an adjustable sphincter exerciser (Kegel exerciser), which includes: a flexible tubular member; at least one sleeve, the at least one sleeve being mounted to the tubular member; a main body, the main body being inserted into the tubular member; a conductive device, the conductive device being connected to the main body and located in the tubular member, the conductive device being activated when the tubular member is compressed; a vibration unit, the vibration unit being electrically connected to the conductive device; and a power unit, the power unit providing power to the conductive device and the vibration unit. At least one sleeve can be replaced and has different hardness, and when the user squeezes at least one sleeve and the tubular member to activate the conductive device and the vibration unit, the user learns the force of the sphincter exercise. In this arrangement, when the tubular member is squeezed by the sphincter, the curved portion of the conductive plate contacts the metal portion to form a conductive loop so as to generate a biofeedback signal. This patent does not disclose a component for sensing and measuring the force when the tubular member is compressed.

[0004] US Patent No. 7628744 B2 discloses a multi-mode pelvic exercise probe including a pressure sensing circuit and a component for providing an audio / visual biofeedback signal. Conventional sphincter exercisers may include a device for sensing and measuring pressure when a tubular member is compressed. However, most pressure or force sensors are unable to detect sphincter contraction with high accuracy, repeatability, and sensitivity, and therefore produce inaccurate readings.

[0005] In view of this disadvantage, it is desirable to provide a perineal dynamometer device having a high-precision sensor to detect muscle contraction force. Summary of the invention

[0006] The present invention relates to a perineal contraction dynamometer device for providing accurate biofeedback signals regarding the condition of the sphincter, comprising: a cover connected to a tubular member; at least one finger; at least one beam plate or at least one force sensing resistor, the at least one beam plate or at least one force sensing resistor being coaxially arranged within the tubular member so that the at least one plate or force sensing resistor is located within the at least one finger; a device for applying a potential difference to the at least one finger and the at least one plate; a sensor for measuring the capacitance generated thereby, or the at least one force sensing resistor receiving the force applied to the at least one finger; and a processor connected to the sensor or at least one force sensing resistor for measuring the capacitance. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The present invention will be more fully understood from the detailed description given hereinafter and the accompanying drawings, which are given by way of illustration only and thus do not limit the present invention, in which:

[0008] In the attached picture:

[0009] Figure 1a A perspective front view of an adjustable perineal dynamometer device according to the present invention is shown.

[0010] Figure 1b A perspective rear view of an adjustable perineal dynamometer device according to the present invention is shown.

[0011] Figure 2a An exploded view of a first embodiment of a device featuring a parallel beam-plate mechanism is shown.

[0012] Figure 2b A perspective view of a device is shown with a conductive mesh replacing at least one finger.

[0013] Figure 3a A cross-sectional view of the present invention according to a first embodiment is shown.

[0014] Figure 3b A capacitive sensing electronics arrangement according to a first embodiment is shown.

[0015] Figure 4 shows that when at least one finger is fully extended Figure 3a A cross-sectional view of the invention of the described embodiment.

[0016] Figure 5 An exploded view of a second embodiment of the present invention is shown in which force sensing resistors are used instead of the parallel beam and plate mechanism.

[0017] Figure 6a A cross-sectional view of the present invention according to a second embodiment is shown.

[0018] Figure 6b A force sensing electronics arrangement according to a second embodiment is shown.

[0019] Figure 7 The figure shows the situation when the fingers are fully retracted and a force sensing resistor is used instead of the parallel plate. Figure 6a A cross-sectional view of the invention of the described embodiment.

[0020] Figure 8 A cross-sectional front view of the cover in either embodiment is shown.

[0021] Fig. 9 A force diagram for a user with healthy sphincter is shown.

[0022] Fig.10 A force diagram of a user showing a partial tear of the sphincter.

[0023] Fig.11 Force graphs for users with more extensive muscle or nerve impairments are shown.

[0024] Fig.12 Shown is a force graph of a user after performing an exercise routine using the adjustable perineal dynamometer device.

[0025] Fig.13 A force diagram of a user with involuntary contractions (vaginismus) is shown.

[0026] Fig.14 Shown is a graph of a force curve of a user performing an exercise routine for two months using the adjustable perineal dynamometer device.

[0027] Fig.15 Shown is a force graph of a user with vaginismus after two months. DETAILED DESCRIPTION

[0028] A detailed description of preferred embodiments of the present invention is disclosed herein. However, it should be understood that these embodiments are only examples of the present invention, which can be embodied in various forms. Therefore, the details disclosed herein should not be interpreted as limiting, but only as a basis for claims and teachings to those skilled in the art of the present invention. The numerical data or ranges used in the specification should not be interpreted as limiting. The following detailed description of the preferred embodiments will now be described according to the accompanying drawings.

[0029] The sphincter is a special circular muscle that should contract evenly and the resulting force from that contraction should be radially consistent. Damage to the muscle in the form of a tear or other physical trauma or nerve damage can cause the muscle to contract inconsistently and therefore the radially applied force when the muscle contracts. Collecting force data during training and exercise sessions will help understand the underlying physiology of women with incontinence or related conditions. This data provides feedback to the user or medical personnel on the condition of the sphincter.

[0030] The present invention relates to an adjustable perineal dynamometer device for providing accurate biofeedback on the condition of the sphincter muscles, particularly the female pubococcygeus and associated perineal sphincter musculature. The biofeedback helps the user identify, develop, train, and condition and rehabilitate the sphincter muscles.

[0031] The adjustable perineal dynamometer device features a self-contained perineal dynamometer probe for intravaginal use that communicates with a user device by wireless means, such as radio frequency (RF), using an RF transmitter and an RF receiver, wherein the user device includes software or an application that processes and displays biofeedback based on data received from the device. The software or application provides the data to the user in an analyzed format for the user to review. In addition, it also provides the ability to customize exercise routines. The adjustable perineal dynamometer device will be explained primarily in the following two embodiments: a first embodiment with parallel beam plates as the sensing mechanism and a second embodiment with a force sensing resistor as the sensing mechanism.

[0032] Figure 1 to Figure 8 The invention is shown in multiple embodiments from various angles. The invention includes: a cover (1), a setting indicator (2), a power switch (3), a status light (4), a pawl (5), a planetary gear set (6), an adjustment screw (7), a first anchor (8a), a second anchor (10a), a tubular member (11), a sub-knurled thread (12), a circuit board (13), a housing (14), at least one battery (15), a biasing device (16), at least one first finger (9a) and a parallel plate (18) for a first embodiment, and a third anchor (8b), a fourth anchor (10b), at least one second finger (9b) and a force sensing resistor (17) for a second embodiment.

[0033] Figure 1a and Figure 1bThe front perspective view and the rear perspective view of the adjustable perineal contraction dynamometer device according to the present invention are respectively shown. The device includes a cover (1) connected to a tubular member (11), and the tubular member (11) contains electronic devices such as sensor mechanisms and vibration devices located inside. The tubular member (11) includes a flange-like protrusion (11a) at one end, a tube (11b) at the other end, and a hemispherical end (11c), wherein when the adjustable perineal contraction dynamometer device is inserted into the vaginal cavity, the flange-like protrusion (11a) rests on the outer entrance of the vaginal cavity, and the hemispherical end (11c) is further introduced into the vaginal cavity. The tubular member (11) is a ductile sheath that can transmit force to internal components. The tubular member (11) is made of medical grade silicone rubber and has a detectable force range of 0.1N to 10N. Alternatively, any soft medical grade material can be used. In a non-limiting example, the sheath can be a material with high sensitivity to force, so that the sensitivity of the reading can be increased. The tubular member (11) is waterproof to prevent any liquid from entering the tubular member (11). The cover (1) contains basic functional features, such as but not limited to the setting indicator (2), the power switch (3) and the status light (4). The power switch (3) is used to turn the power on / off to the present invention. The status light (4) is used to indicate whether the present invention is powered on or off and possible other indications, such as but not limited to training and pause. The status light (4) is a multi-color LED light that indicates different colors for different states. The setting indicator (2) is used to indicate the type of setting the device is in, for example, the force range detected by the present invention. It is envisioned that the touch screen interface can replace the functional features, wherein the settings of the device are controlled by touch screen interaction. Optionally, the cover (1) includes a port for wired connection to the user device, so that if the functional features on the cover (1) and / or the wireless method of the present invention fail, data can be received via the wired connection and can be transmitted to the user device to control the adjustable sphincter settings, process the data and display it to the user.

[0034] Figure 2aAn exploded view of a first embodiment of a device featuring a parallel beam-plate mechanism is shown. A cover (1) houses a circuit board (13) that can be nested within a circuit board frame (13a). The circuit board (13) includes a processor for processing signals, an RF transmitter (not shown) and a receiver (not shown) for transmitting and receiving data. At least one battery (15) is used to power the electronics in the device and to apply a potential difference to at least one first finger (9a) and at least one plate (18) so that capacitance can be measured. A planetary gear set (6) is rotatable in response to rotation of the cover (1) and is used to rotate an adjustment screw (7) in which a first anchor (8a) straddles the adjustment screw (7). A pawl (5) is used to adjust the position of the first anchor (8a). Rotating the cover (1) in one direction rotatably pushes the first anchor (8a) toward the cover (1), and rotating the cover (1) in an opposite direction rotatably pushes the first anchor (8a) away from the cover (1). At least one first finger (9a) is coaxially secured to the housing (14) at one end and to the second anchor (10a) at the opposite end. When assembled, the first anchor (8a) is nestable in the housing (14). The at least one first finger (9a) is located within the tubular member (11) and preferably, the at least one first finger (9a) is contactable or securable to the inner surface of the tubular member (11). The at least one first finger (9a) may be a rigid or ductile structure, preferably composed of segments such as a chain, wherein it is held in place at its ends. Rotating the cap (1) in one direction retracts or extends the at least one first finger (9a), thereby reducing or increasing the relative stiffness of the at least one first finger (9a), thereby resulting in an increase or decrease in the force required to deflect the at least one finger (9a) by muscle contraction. The at least one first finger (9a) is covered in a ductile sheath that transmits the forces generated during muscle contraction to the finger assembly. In an alternative embodiment, a conductive means such as, but not limited to, a conductive mesh (20) is used instead of Figure 2b At least one first finger (9a) is shown, wherein the conductive mesh (20) encapsulates at least one plate (not shown) positioned inside the conductive mesh (20) when assembled.

[0035] Figure 3aA cross-sectional view of the present invention according to a first embodiment is shown. When assembled, at least one plate (18) is positioned coaxially with and parallel to at least one first finger (9a) inside at least one first finger (9a) such that at least one first finger (9a) and at least one plate (18) are spaced apart when no force is applied to at least one first finger (9a). Alternatively, a conductive means such as, but not limited to, a conductive plate grid may be used in place of at least one plate (18). Preferably, at least one conductive protrusion is disposed perpendicular to at least one first finger (9a) and at least one plate (18) with a small gap between the protrusions, wherein the protrusions facilitate more accurate capacitance measurement. A battery (15) applies a potential difference to at least one first finger (9a) and at least one plate (18) such that capacitance can be measured. An Analog Systems AD7746 microchip is used to measure the capacitance between at least one first finger (9a) and at least one plate (18). Figure 3b A capacitive sensing electronic configuration according to a first embodiment is shown. A microchip (19) is used as a capacitive sensor in combination with at least one first finger (9a) and at least one plate (18). In non-limiting examples, other types of capacitive measuring microchips known in the industry may be used. Back to Reference Figure 3a, the capacitive sensor forms each segment connected end to end. Preferably, each end of each segment is supported by one or more biasing devices (not shown), wherein the biasing device (not shown) is a spring or spring-like material. The biasing device (not shown) provides physical resistance in its essence. The biasing device (not shown) is attached to each end of at least one plate (18) via a slidable guide so that the biasing device (not shown) can slide up and down to apply different amounts of physical resistance from 0N to the desired amount of force to at least one plate (18) through an extension and retraction mechanism. Multiple biasing devices (not shown) can be used to provide more control by increasing the physical resistance. The strain measurement of the spring can be combined with the capacitance measurement to calculate the force, and the position of the force applied to the electrode can also be derived. Alternatively, at least one first finger (9a) and at least one plate (18) can have a soft material between them, such as but not limited to foam, rubber, soft plastic and other soft materials known in the art. The soft material helps at least one first finger (9a) return to its original position. The at least one finger (9a) causes a force generated by muscle contraction to cause a deflection on the at least one finger (9a). Deflecting the at least one first finger (9a) reduces the gap between the at least one first finger (9a) and the at least one plate (18), thereby changing the capacitance, wherein a greater deflection produces a greater capacitance change. The capacitance is calibrated, wherein the capacitance between the at least one first finger (9a) and the at least one plate (18) is recorded before no force is applied to the at least one first finger (9a) as a reference point for measuring the difference from when force is applied to the at least one first finger (9a). The capacitance measured by the capacitive sensor is recorded by a processor.

[0036] Figure 4 It is shown that when at least one first finger (9a) is fully extended Figure 3a A cross-sectional view of the present invention of the embodiment described. At least one first finger (9a) is fixed to the second anchor (10a) through the fourth anchor (10b) and fixed to a housing (not shown) connected to the circuit board (13). The circuit board (13) nested on the circuit board frame extends from the cover (1) and the at least one first finger (9a) is hardened.

[0037] Figure 5 An exploded view of a second embodiment of the present invention is shown. Using a force sensing resistor ( Figure 6a) instead of a parallel beam-plate mechanism. Unlike the first embodiment using a planetary gear set, the cover (1) includes an acrometic thread (12) on which a circuit board frame (13a) straddles. The circuit board (13) can be nested within the circuit board frame (13a). Rotating the cover (1) in one direction pushes the circuit board (13) toward the cover (1), and rotating the cover (1) in the opposite direction pushes the circuit board (13) away from the cover (1) via the adjustment screw (7) and the first anchor (8a). Note that for either embodiment, the moving mechanism may be interchangeable and is not described herein with respect to the parallel beam-plate mechanism or the force sensing resistor mechanism. At least one battery (15) powers the electronics in the device. At least one second finger (9b) is coaxially secured to the circuit board (13) at one end and to a fourth anchor (10b) at the other end. When assembled, the at least one second finger (9b) passes through the fourth anchor (10b) which is used to hold the at least one second finger (9b) in place. Withdrawing the circuit board (13) toward the cover (1) retracts the at least one second finger (9b), thereby reducing the relative stiffness and resulting in a reduction in the force required to deflect the at least one second finger (9b). Similar to the first embodiment, the at least one second finger (9b) is located within the tubular member (11) and preferably, the at least one second finger (9b) can contact or be fixed to the inner surface of the tubular member (11) for transmitting the force from the muscle contraction to the finger assembly. The force range can be calibrated according to the position of the first anchor (8a) so that longer fingers shift the sensing sensitivity to a low range and shorter fingers shift the sensing sensitivity to a high range.

[0038] Figure 6a A cross-sectional view of the invention according to a second embodiment is shown. When assembled, at least one force sensing resistor (17) is grounded on the component and connected to a circuit board (not shown). The at least one force sensing resistor (17) is contactable and coaxial with at least one second finger (9b) internally so that a force applied to the at least one second finger (9b) will be transferred to the at least one force sensing resistor (17) and measured as resistance by the at least one force sensing resistor (17). Figure 6b A force sensing electronics arrangement according to a second embodiment is shown. The resistance is recorded by a processor on a circuit board (not shown). The force sensing resistor (17) used is a TekscanFlexiforce A201. Alternatively, the force sensing resistor (17) may be replaced by an accelerometer sensor (such as the NXP MMA8451) or an eddy current sensor (such as the Micro-Epsilon eddyNCDT 3005). Return to reference Figure 6a, a biasing device (not shown) is attached between at least one second finger (9b) and the force sensing resistor (17) via a slidable guide, so that the biasing device (not shown) can slide up and down to apply different amounts of physical resistance from 0N to a desired amount of force to at least one plate (18) through an extension and retraction mechanism. Alternatively, there is a soft material between at least one second finger (9b) and the force sensing resistor (17), such as but not limited to foam, rubber, soft plastic and other soft materials known in the art. The soft material helps the at least one second finger (9b) return to its original position. A calibrated resistor, wherein the force sensing resistor (17) measures the resistance before no force is applied to the at least one second finger (9b) as a reference point for measuring the resistance difference when a force is applied to the at least one second finger (9b).

[0039] Figure 7 The figure shows the situation when the fingers are fully retracted and the force sensing resistor (17) is used instead of the parallel plate (18). Figure 6a Cross-sectional view of the invention of the described embodiment. The finger is retracted between the third anchor (8b) and the fourth anchor (10b).

[0040] Figure 8 A cross-sectional front view of the cover (1) in any of the embodiments is shown. The cover (1) has three possible stiffness settings, positions 1-3, providing three possible force ranges. It is contemplated that more than three rotatable positions may be provided, with each position providing a different force range or a different finger stiffness. When using phosphor bronze fingers and a maximum effective length of 0.35 mm thick x 10 mm wide x 50 mm, the force range for position 1 is between 0.3N-2.5N, position 2 is between 0.5N-5.0N, and position 3 is between 1.2N-12N.

[0041] It is contemplated that reducing and increasing the relative stiffness of the at least one first finger (9a) may be achieved by other means such as but not limited to a push-pull locking mechanism, wherein the at least one first finger (9a) is connected to the connecting device via the cover (1). The retraction and extension of the at least one first finger (9a) is manipulated by moving the at least one first finger (9a) towards or away from the cover (1), respectively. When the desired length is reached, the position of the connecting device may be locked by rotating the at least one first finger (9a), wherein by rotating the at least one first finger (9a), a ridge provided on the connecting device sinks into a corresponding ridge from the corresponding component. The corresponding component may have a plurality of corresponding ridges, wherein a ridge on the connecting device may be locked to a specific corresponding ridge of the corresponding component, depending on the length of the at least one first finger (9a) to be achieved. It is also contemplated that reducing and increasing the relative stiffness of the at least one first finger (9a) may be achieved by replacing fingers having different stiffnesses.

[0042] Preferably, in both embodiments, four fingers are coaxially arranged in the device with four plates / force sensing resistors arranged inside at least one finger, wherein the plurality of sensors are capacitive sensors or resistive sensors to measure the capacitance or resistance of at least one deflected finger when subjected to force. Each sensor is positioned to sense force from a specific radial region of the vaginal cavity. It is contemplated that a greater number of fingers may be used to detect contractions from multiple radial regions within the vagina and not just limited to the x-axis and y-axis.

[0043] In a first embodiment, deflection is sensed by energizing the first finger (9a) and the parallel plate (18) with a potential difference from a battery (15), and the capacitance is measured by the sensor. Deflection of the first finger (9a) changes the spacing between the first finger (9a) and the parallel plate (18) and thus changes the capacitance. Characterizing the deflection versus capacitance curve allows accurate determination of the finger-to-plate spacing and, therefore, the applied force.

[0044] In a second embodiment, the second finger (9b) is calibrated by using a force sensing resistor (17) positioned below the second finger (9b) to produce accurate and repeatable force measurements, wherein when a force is applied to the second finger (9b), the second finger (9b) deflects, wherein the resistance force is related to the amount of deflection. The finger deflection for a simple support is a known quantity based on the following formula:

[0045] △=PL 3 / 48EI

[0046] Where: △ refers to the deflection of the object

[0047] P is the concentrated load applied to the center of the finger

[0048] L is the length of the fingers between the supports

[0049] E is the Young's modulus of the material of the finger, and

[0050] I refers to the moment of inertia of the object

[0051] Since the amount of deflection is proportional to the cube of the finger length, retracting the finger by a small amount also changes the force range significantly. The present invention contemplates that retracting the finger into the cover effectively retracts the finger and significantly changes the force range of the sensor.

[0052] It is contemplated that the deflection of the fingers from both embodiments may be detected by sensors such as, but not limited to, ultrasonic sensors, infrared range finding sensors, laser sensors, inductive sensors, and other deflection measuring sensors known in the art.

[0053] The described invention can be developed into a pre-programmed routine operation in the software / application and provide the user with the option to customize the exercise routine to suit their training regimen. In one non-limiting example, the pre-programmed routine can be an exercise routine for prompting contraction and relaxation cycles and selectable resistance for strengthening the sphincter and sensing the contracted state of the sphincter and prompting relaxation, including lowering the resistance so that women with vaginismus can feel the fully relaxed muscles. Prior to training, the user can select the appropriate force range that can suit their condition by turning the cap to a specific position.

[0054] The capacitive sensors and force sensing resistors have a sensitivity of up to 0.1N and provide good repeatability and accuracy. The RF transmitter transmits data such as force calculations received from the processor to the user device. The user device includes a display unit and runs software / applications that process the force data and convert it into a force map, which is stored in the user device for viewing by the user. In a non-limiting example, the force data stored in the user device includes time-stamped data from each sensor during the routine and training routine used. The force map generated by the collected data shows weak areas of the muscle, such as but not limited to torn and damaged tissue. The force map helps design training routines and the results of the map over time to record compliance with the prescribed program and encourage use by showing progress over time. The force map can also assist practitioners in designing specific treatment methods for users. Since the sensitive sensors provide good repeatability and accuracy for the measured data, the present invention is able to provide accurate biofeedback.

[0055] The present invention includes an internal vibrator device, such as but not limited to a motor driven vibrator or a piezoelectric vibrator, that provides tactile feedback to reinforce the user's learned control. The tactile feedback may provide a vibration signal, such as but not limited to an alarm for notifying the user of the training routine timeline and stages, such as but not limited to program start, program end, and continuing to the next training routine stage.

[0056] In a working example, four phosphor bronze fingers of 0.35 mm thickness x 10 mm width x 50 mm maximum effective length are coaxially arranged in a tubular member (11), wherein four phosphor bronze plates are arranged inside corresponding to each finger. A potential difference is applied from a battery (15) to at least one first finger (9a) and at least one plate (18). Four capacitive sensors are arranged in the tubular member (11) to measure the initial capacitance and the capacitance of at least one deflected finger when subjected to force. The device is turned on by a power switch (3), wherein a status light (4) will indicate that the device is turned on. The cover (1) can be rotated to any position to achieve a specific force range, for example, position 1 between 0.3N-2.5N, position 2 between 0.5N-5.0N, and position 3 between 1.2N-12N. The cover (1) is opened in position 1, wherein an indicator (2) is arranged to indicate that the device is in position 1. The user device is paired with the device via radio frequency (specifically Bluetooth). Once connected, the device transmits force data to the user device and the data is stored in the user device. The force data is displayed on the user device as a force graph and a force curve graph.

[0057] Figures 9 to 13 A force diagram of the sphincter is shown, wherein the y-axis and x-axis represent the forces applied to the sensor in the vertical and horizontal directions, respectively, or in the corresponding directions of the sensor. A healthy sphincter contraction will indicate an equal force distribution in both the y-axis and the x-axis.

[0058] Fig. 9 A force graph for a user with healthy sphincter muscles is shown. In this graph, it can be seen that the forces are roughly equal across the circumference of the device (all four sensor outputs are roughly equal), indicating that the user's sphincter muscles are unlikely to have any nerve or muscle damage.

[0059] Fig.10 A force graph is shown for a user with a partial tear of the sphincter. The forces on three of the four sides are consistent, while the force recorded from the fourth sensor is significantly lower. This type of muscle trauma may be associated with childbirth or other traumatic events, and knowledge of this condition may guide the clinician in the appropriate care of this user throughout the recovery process.

[0060] Fig.11 A force graph for a user with more extensive muscle or nerve damage is shown. In this example, it appears that half of the sphincter muscles are either not contracting or performing significantly poorly during contraction.

[0061] Fig.12 A force graph is shown after a user performs an exercise routine using the adjustable perineal dynamometer device. The data shows similar contraction force for each contraction, with a small drop as the muscle fatigues.

[0062] Fig.13A force graph of a user with involuntary contractions (vaginismus) is shown. The graph shows sustained high forces, but also shows the relative health of the sphincter (as indicated by radial consistency). As the user learns to consciously control the muscles and learns to relax the muscles, the data from the device will help show their progress and control during recovery from this condition.

[0063] Fig.14 A force graph is shown after a user performed an exercise routine with the adjustable perineal dynamometer device for two months. Each data series is related to data from a different sensor of the device. The data collected over time can help the user see progress even though symptoms may still be present, to encourage continued use during recovery from their condition. In this graph, the data shows continued use and significant improvements in the strength and elasticity of the sphincter.

[0064] Fig.15 A force graph is shown for a user with vaginismus after two months. Each series indicates data from a different sensor. The graph shows data from continued use, and shows that the user is learning to relax the sphincter and recovering from the condition.

[0065] The terms used herein are only used for the purpose of describing specific exemplary embodiments and are not intended to be limiting. As used herein, the singular forms "a", "an", and "the" may also be intended to include the plural forms unless the context clearly indicates otherwise. The terms "comprise", "include", "contain", and "have" are inclusive and therefore specify the presence of the features, integers, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, parts, and / or groups thereof.

[0066] The method steps, processes, and operations described herein should not be construed as necessarily requiring execution in the particular order discussed or described, unless specifically indicated as an order of execution. It should also be understood that additional or alternative steps may be employed. The use of the expression "at least" or "at least one" implies the use of one or more elements because the use may achieve one or more desired purposes or results in one of the embodiments.

Claims

1. A perineal dynamometer device for providing biofeedback regarding sphincter condition, comprising: a cover (1) coupled to the tubular member (11); at least one first finger (9a), the at least one first finger (9a) being coaxially disposed within the tubular member (11); at least one plate (18), the at least one plate (18) being disposed inside the at least one first finger (9a) and parallel to the at least one first finger (9a), the at least one plate (18) being spaced apart from the at least one first finger (9a); at least one battery (15) for applying a potential difference to the at least one first finger (9a) and the at least one plate (18); a capacitance measuring microchip (19) for measuring the capacitance between the at least one first finger (9a) and the at least one plate (18); a processor for recording the capacitance measured by the capacitance measuring microchip (19); in: The processor is capable of communicating with a radio transmitter for transmitting the capacitance value or force data to the user interface device via a wireless manner; as well as When rotated in one direction, the at least one first finger (9a) can be retracted or extended toward the cover (1), wherein the stiffness of the at least one first finger (9a) is adjustable.

2. A perineal contraction force meter device as described in claim 1, wherein when in use, the force applied to the tubular member (11) can be translated to the at least one first finger (9a), and the at least one first finger (9a) can be deflected under the force, and the processor records the capacitance under deflection and calculates the force applied to the at least one first finger (9a).

3. The perineal dynamometer device of claim 1, wherein the wireless method is radio frequency.

4. The perineal dynamometer device according to claim 1, wherein said at least one first finger (9a) is capable of contacting or being fixed to an inner surface of said tubular member (11).

5. The perineal dynamometer device of claim 1, wherein the device comprises a plurality of first fingers (9a) and a corresponding number of plates (18).

6. The perineal dynamometer device of claim 1, wherein the force data is a force calculation result used to create a force map corresponding to a muscle contraction.

7. A perineal contraction force meter device as described in claim 1, wherein the capacitance measuring microchip (19), the at least one first finger (9a) and the at least one plate (18) are combined to act as a capacitance sensor, and retracting or extending the at least one first finger (9a) changes the force range measured by the capacitance sensor.

8. A perineal contraction dynamometer device as described in claim 1, wherein the at least one first finger (9a) and the at least one plate (18) form respective segments connected end to end, and the respective segments are supported by a biasing device (16), and the biasing device (16) can be attached to each end of the at least one plate (18) via a slidable guide so that the biasing device (16) can slide up and down to apply various amounts of physical resistance ranging from 0N to a desired amount of force to the at least one plate (18) through an extension and retraction mechanism.

9. A perineal dynamometer device as described in claim 1, wherein the cover (1) includes a port for connecting to a user device via a wired connection, so that if the user interface and / or wireless method on the cover (1) fails, data can be received and transmitted to the connected user device.

10. A perineal dynamometer device for providing biofeedback regarding sphincter condition, comprising: a cover (1) coupled to the tubular member (11); at least one second finger (9b), said at least one second finger (9b) being coaxially disposed within said tubular member (11); at least one force sensing resistor (17), the at least one force sensing resistor (17) being contactable with the at least one second finger (9b) such that a force applied to the at least one second finger (9b) is measured by the at least one force sensing resistor (17); and a processor that records the resistance measured by the at least one force sensing resistor (17), wherein the processor is connected to a radio transmitter for transmitting the resistance value or force data to the user interface device via a wireless manner; as well as When rotated in one direction, the at least one first finger (9a) can be retracted or extended toward the cover (1), wherein the stiffness of the at least one first finger (9a) is adjustable.

11. A perineal contraction force meter device as described in claim 10, wherein when in use, the force applied to the tubular member (11) can be translated to the at least one second finger (9b), and the at least one second finger (9b) can be deflected under the force, and the processor records the resistance under the force and calculates the force applied to the at least one second finger (9b).

12. The perineal dynamometer device of claim 10, wherein the wireless method is radio frequency.

13. The perineal contraction dynamometer device according to claim 10, wherein the force sensing resistor (17) is replaceable with an accelerometer or an eddy current sensor.

14. The perineal dynamometer device according to claim 10, wherein said at least one second finger (9b) is capable of contacting or being fixed to an inner surface of said tubular member (11).

15. The perineal dynamometer device of claim 10, wherein the device comprises a plurality of second fingers (9b) and a corresponding number of force sensing resistors (17).

16. The perineal dynamometer device of claim 10, wherein the force data is a force calculation result used to create a force map corresponding to a muscle contraction.

17. The perineal dynamometer device of claim 10, wherein retracting or extending the at least one second finger (9b) changes the force range measured by the force sensing resistor (17).

18. A perineal contraction dynamometer device as described in claim 10, wherein the biasing device (16) can be attached between the at least one second finger (9b) and the force sensing resistor (17) via a slidable guide, so that the biasing device (16) can slide up and down to apply different amounts of physical resistance from 0N to a desired amount of force to the at least one plate (18) through an extension and retraction mechanism.

19. A perineal dynamometer device as described in claim 10, wherein the cover (1) includes a port for connecting to a user device via a wired connection, so that if the user interface and / or wireless method on the cover (1) fails, data can be received and transmitted to the connected user device.

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