WO2012079127A1

WO2012079127A1 - An apparatus for pelvic floor management

Info

Publication number: WO2012079127A1
Application number: PCT/AU2011/001626
Authority: WO
Inventors: David Drew Inglis Croft
Original assignee: Omega Medical Design Pty Ltd
Priority date: 2010-12-15
Filing date: 2011-12-15
Publication date: 2012-06-21

Abstract

An apparatus for pelvic floor management includes an electronic processor for executing tangible instructions stored in an associated electronic memory. A contraction sensor interface is provided that is in communication with the microprocessor. A human interface, in the form of an LCD screen and various button switches is included in the apparatus and placed in communication with the microprocessor. The instructions stored in the electronic processor and executed by the processor in use include instructions to operate the human interface to indicate a contraction strength level based on signals from the contraction sensor interface and a pre-selected base firmness level for a pelvic floor of a user of the apparatus. The memory may also include instructions to operate the human interface to indicate performance of the contraction strength level for a predetermined hold time.

Description

AN APPARATUS FOR PELVIC FLOOR MANAGEMENT TECHNICAL FIELD

The present invention relates to an apparatus for the prevention, treatment arid remedy of pelvic floor muscle disorders. A preferred embodiment of the device relates to a device for the management of pelvic floor exercises.

BACKGROUND

The discussion of any prior art documents, techniques, methods or apparatus is not to be taken to constitute any admission or evidence that such prior art forms, or ever formed, part of the common general knowledge.

Incontinence is defined as the complaint of any involuntary leakage of urine. Urinary incontinence is more common in women than in men and affects women of all ages. Prevalence rates vary between 9% and 72% of women aged 17 to 79 years living in the community. The most common type of urinary incontinence in women is stress urinary incontinence. Stress Urinary Incontinence is defined as the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing, or on sudden abdominal muscle use.

Urinary incontinence is a socially embarrassing condition, causing withdrawal from social situations and reduced quality of life. Stress urinary incontinence may be an important barrier to regular physical and fitness activities in women. This withdrawal may threaten women's general health and well-being because regular moderate physical activity is important in prevention of osteoporosis, obesity, diabetes, high blood pressure, coronary heart disease or ischemic heart disease.

Loss of personal and financial productivity is known to be a significant affect to the lives of people with the condition of incontinence. Figure 1 shows a side view (sagittal) view of the female pelvic floor. The pelvic viscera (basin) contain the rectum 104, the uterus 106, cervix 108 and the bladder 100 amongst other less dominant structures such as organs and glands. The pelvic muscle 118 extends from the base of the pubic bone 112 at the front of the body to the base of the spine at the rear of the body. It has three openings in it, allowing function of the urethra 114, vagina 116, and anal canal 120. The tone, strength, size and shape of the pelvic floor muscle 118 has a significant effect on the function of the urethra 114, vagina 116 and anal canal 120. Consequently, a therapeutic approach that has found a degree of success in alleviating the problems discussed above is regulated and prescribed pelvic floor exercise first devised by Dr Arnold Kegel.

An acknowledged method of female incontinence remedy is through the use of a perineometer, a device inserted into the vagina to measure the strength of muscular contractions when kegel exercises are performed. It is also frequently used to monitor the patient's progress in bladder re-education programs. For the purposes of medical device classification, the present invention may be classed as a perineometer.

Indicating and giving feedback to women and clinicians undertaking or monitoring pelvic floor muscle exercises is important not only in the identification of impaired pelvic floor muscle function but also to assist in the recovery of pelvic floor muscle function during and after therapeutic intervention.

It is an object of the present invention to address one or more of the above- described problems or to at least provide a useful alternative to those apparatus for pelvic floor treatment that have hitherto been known in the prior art. SUMMARY OF THE INVENTION

According to a first aspect of the present invention there is provided an apparatus for pelvic floor management including:

an interface for a user to input a pelvic floor firmness base level; and at least one indicator for indicating contraction pressure generated during a pelvic floor exercise with reference to the selected pelvic floor firmness base level.

Preferably the apparatus includes a communication transmission interface and display application for presenting an exercise history of the user via a remote computer.

In a preferred embodiment the apparatus is arranged for the at least one indicator to indicate contraction pressure over the course of the pelvic floor exercise as a function of the selected pelvic floor firmness base level.

For example, the at least one indicator may include a plurality of LEDs or other visual display elements that each correspond to a predetermined contraction pressure level to be reached over the course of the pelvic floor exercise.

Alternatively, the at least one indicator may include one or more light sources, or indicators on a visual display unit. Preferably the one or more light sources or indicators are arranged to increase in amplitude or visually progresse as contraction pressure increases, accompanied by an audible source.

Preferably the predetermined contraction pressure levels are based on the Modified Oxford Grading Scale of grading muscle strength. For example, the contraction pressure levels based on the Modified Oxford Grading Scale may comprise five levels corresponding to "flicker", "weak", "moderate", firm (or good) and "strong".

In a preferred embodiment of the invention the apparatus is arranged to indicate the passage of a selected hold time for performance of the specific pelvic floor exercise.

Preferably the user interface is arranged for the user to select a prescribed contraction hold time from amongst a number of predetermined hold times. For example, the user may select from between preselected hold times of 1 second, 2 seconds, 5 seconds and 10 seconds. It will be realized that other hold times may also be provided for in other embodiments of the invention.

Preferably the apparatus includes an audible indicator for indicating the passage of the selected hold time: However, other indicators, for example a visual indicator such as an LED, or other visual display methods might also be used.

Preferably the apparatus is arranged to indicate successful performance of the pelvic floor exercise upon said exercise being carried out at a predetermined contraction strength for the selected hold time.

For example the apparatus may be arranged to indicate the successful performance of the pelvic floor exercise by operation of an audible source, such as a loudspeaker or electronic buzzer.

In a preferred embodiment the apparatus is arranged to indicate rest times between periods for performing the pelvic floor exercises. In one embodiment the rest times correspond to the predetermined contraction hold times. Preferably the apparatus is arranged to log data generated during the pelvic floor exercises. In a preferred embodiment a data port, which may be a wired or wireless port, is provided for downloading the logged results to another computational device. For example the logged results may be downloaded for reviewing with a data management or graphical display program.

The data port may comprise a USB port that is configured to also provide for charging of a battery of the apparatus.

According to a further aspect of the present invention there is provided a sensor for sensing contractions during pelvic floor exercise sessions, wherein the sensor is provided with placement features corresponding to human anatomy for consistently retaining the sensor in place during said sessions.

In a preferred embodiment the placement features comprises external ridges spaced apart a distance corresponding to a portion of the vaginal canal.

In one embodiment the sensor includes a housing about which the ridges are disposed and a bladder proximate the housing for compression by the contractions of the pelvic floor muscles.

Preferably the housing receives a tube having a lumen in communication with an interior of the bladder.

The lumen may be in communication with the interior of the bladder by means one or more holes formed through a wall of the tube.

Preferably the tube receives a conduit for conveying pressure changes sensed by the bladder to a remote location. The housing may be provided in two portions with a rearward portion about which the ridges are disposed and a forward portion for penetration of the vaginal canal wherein the bladder is disposed intermediate between the forward portion and the rearward portion.

Preferably the forward portion receives an end of the tube opposite the conduit.

An apparatus for pelvic floor management including:

an electronic processor for executing tangible instructions stored in an associated electronic memory;

a contraction sensor interface in communication with the microprocessor; and

a human interface ih communication with the microprocessor;

wherein said instructions include:

instructions to operate the human interface to indicate a contraction strengt level based on signals from the contraction sensor interface and a pre-selected base firmness level for a pelvic floor of a user of the apparatus.

Preferably the apparatus further includes instructions to operate the human interface to indicate performance of the contraction strength level for a predetermined hold time.

Preferably the apparatus further includes instructions to indicate successful performance of a pelvic floor exercise upon the contraction strength level exceeding a predetermined threshold for a predetermined hold time.

In a preferred embodiment the human interface includes a switch in communication with the electronic processor to receive a user selection of the firmness level. Preferably the human interface includes a further switch in communication with the electronic processor to receive a user selection of the hold time.

In a preferred embodiment the apparatus further includes instructions for comparing the contraction strength level to a number of predetermined contraction pressure levels to thereby calculate when each of said predetermined levels has been attained during performance of the pelvic floor exercise.

The human interface preferably includes a number of light sources or visual indicators corresponding to the number of predetermined contraction pressure levels to for indicating when each of said levels has been attained during performance of the pelvic floor exercise.

Preferably the predetermined contraction pressure levels are based upon the Modified Oxford Grading Scale of grading muscle strength.

In a preferred embodiment the contraction sensor interface includes a pressure transducer for ^"converting air pressure from a pelvic floor muscle strength sensor into an electrical signal.

In a preferred embodiment the contraction sensor interface includes a port to receive the conduit of the previously described pelvic floor muscle strength sensor.

Preferably the apparatus includes instructions for the microprocessor to enter a sleep mode after a predetermined period of inactivity.

In a preferred embodiment the apparatus includes instructions to produce a data log of data generated during pelvic floor exercises. Preferably the apparatus includes a data port or wireless transmission capability for connection to a remote computational device for downloading of the data log.

The data port may comprise a wired or wireless communications port, for example a USB port. In one embodiment the apparatus includes a rechargeable battery and circuitry for recharging the battery via the USB communications port.

Preferably the apparatus includes instructions for monitoring battery status and reporting battery status via the human interface.

According to a further aspect of the invention there is provided a method for pelvic floor management of a subject including:

sensing pelvic floor contractions;

calculating contraction pressure generated during said contractions as a function of a pelvic floor firmness base level corresponding to the subject; and

indicating successful performance of a pelvic floor exercise to the subject upon the calculated contraction pressure corresponding to said exercise exceeding a predetermined level.

Preferably the step of indicating successful performance of a pelvic floor exercise to the subject occurs upon the calculated contraction pressure corresponding to said exercise exceeding a predetermined level for a predetermined time.

According to a further aspect of the invention there is provided an apparatus arranged to implement the above described method. BRIEF DESCRIPTION OF THE DRAWINGS

Preferred features, embodiments and variations of the invention may be discerned from the following Detailed Description which provides sufficient information for those skilled in the art to perform the invention.

The Detailed Description is not to be regarded as limiting the scope of the preceding Summary of the Invention in any way. The Detailed Description will make reference to a number of drawings as follows:

Figure 1 shows a side (sagittal) cross sectional view of the female pelvic floor.

Figure 2 is a block diagram of an apparatus according to a preferred embodiment of the present invention.

Figure 3 is a view of a housing of the apparatus of Figure 2 with vaginal sensor connected.

Figure 4A depicts a vaginal sensor of the apparatus in a passive state.

Figure 4B depicts the vaginal sensor of Figure 4A in a compressed state.

Figure 5 depicts the vaginal sensor in-situ in a non-compressed state. Figure 6 depicts the vaginal sensor in-situ in a compressed state. Figure 7 is a first part of a flowchart illustrating the use of the apparatus.

Figure 8 is a second part of the flowchart illustrating the use of the apparatus.

Figure 9 is a third part of the flowchart illustrating the use of the apparatus.

Figure 10 is first part of a flowchart illustrating operation of the apparatus to perform a data download and review process.

Figure 11 is a second part of the flowchart illustrating operation of the apparatus to perform the data download and review process. Figure 12 is a flowchart illustrating a device power off process of the apparatus.

Figure 13 is a flowchart illustrating a battery charging process for the apparatus.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to Figure 2, there is depicted a block diagram of a perineometer 200, with a connected sensor 201, according to a preferred embodiment of the present invention.

Fig 2 indicates the primary components of the device 200 in connection with the vaginal sensor 201 but not including the enclosure, charging plug pack, and the Universal Serial Bus (USB) cable. In Figure 2 the item numbers are as set out in Table 1 as follows:

Item Description

201 Vaginal Sensor

202 Connector Tube

203 Pressure Transducer

204 Noise Filter Circuit

205 Firmness Range Select

206 Hold Time Select

207 Preset Calibration Module

208 Microcontroller or

"Microprocessor"

209 USB Interface Controller

210 USB Connector Port

211 Real Time Clock Module

212 Memory Module

213 USB Charging Circuit Earth

214 Battery Earth 215 Battery Charging Circuit

216 Display: Charging

217 Rechargeable Batteries

218 Display: Lo Batt

219 Power Switch

220 Display: POWER ON

221 Wireless Controller

222 WirelessTransmit Switch

223 WirelessTransmitter

224 Display: Wireless Transmit

225 Display: Hold Time

226 Display: Range

227 Display Module

228 Beeper - Sounder

229 Display: Exercise result

Table 1

The VAGINAL SENSOR (Item 201) is inserted into the vagina of the woman. A tightening of the Pelvic Floor Muscle is transmitted from the VAGINAL SENSOR through the PLASTIC TUBE (Item 202) to a PRESSURE TRANSDUCER (Item 203). An electrical signal is produced in the PRESSURE TRANSDUCER and transmitted to a NOISE FILTER CIRCUIT (Item 204) which filters out all extraneous electrical noise and then forwards the signal to an electronic processor in the form of MICROCONTROLLER (Item 208). Prior to use, the FIRMNESS selector (Item 205) is set to one of three levels or bands, essentially one of light, firm or strong. These bands indicate the basic tone category of the woman's pelvic floor muscle, i.e. the pelvic floor firmness base level.

The established constriction and elevation of the vaginal wall and the strength of (pelvic floor muscle) PFM were graded by the Oxford Grading Scale, an internationally accepted muscle grading system, modified by Laycock in 1994. The Modified Oxford Grading Scale is as set out in Table 2 as follows:

Table 2

The values on this scale are explained in the article Evaluation of pelvic floor muscle function in a random group of adult women in Austria by H. Talasz & G. Himmer-Perschak & E. Marth & J. Fischer-Colbrie & E. Hoefner & M. Lechleitner in Int Urogynecol J (2008) 19:131-135

"Grade 0 describes the complete lack of any discernible response in the perivaginal muscles, and Grade 1 corresponds to a minor fluttering of the muscles ("nonfunctioning" PFM according to the definition of the International Continence Society) Grade 2 means a weak muscle activity without a circular contraction, squeeze, or inward movement of the vagina ("underactive" PFM according to the definition of the ICS). Grade 3 describes a reproducible muscle contraction with moderate circular squeeze pressure around the examiner's finger and with an elevation and cranioventral displacement of the vagina ("normal" PFM contraction according to the definition of the ICS). Grades 4 and 5 describe a good or a strong muscle contraction even against a resistance by the examining finger and a significant inward movement of the vagina ("strong" PFM contraction according to the definition of the ICS). " The device is programmed to record a contraction of the pelvic floor muscle and categorize its strength within the selected firmness band against measurements based on levels 1 to 5 of the Modified Oxford System of muscle strength within that band that have been previously stored within the apparatus.

For example, if the user selects the lowest base firmness range, i.e. the lowest pelvic floor firmness base level, then the strength of the pelvic floor contraction that she will need to apply for the device to record a grade 3, i.e. "moderate" contraction, will be less than if she had selected the highest base firmness range. This is because the device is programmed to indicate the strength of the contraction, i.e. levels 1 to 5 of the scale in Table 2, with reference to the user selected base firmness level.

The user selection nominated base firmness level will be indicated on the DISPLAY MODULE (Item 227) as words indicating that selection. In order to maintain a specific contraction hold time, the HOLD TIME SELECTOR SWITCH (Item 206) is set at either 1 second, 2 seconds, 5 seconds, or 10 seconds which will be indicated on the Display Module (Item 227) by a series of words or indicators, indicating 1 second, 2 seconds, 5 seconds, or 10 seconds (Item 225). The device is one-time calibrated using the PRESET CALIBRATION (Item 207) module. This is preset at manufacture to ensure the device operates within tolerance. A REAL TIME CLOCK (Item 211) tags the information from each successful contraction with time and date of each event. The tagged event, along with the firmness range and hold time settings, and information concerning the indicative pressure value of the contraction, is stored in the MEMORY MODULE (Item 212).

The USB INTERFACE CONTROLLER (Item 209) provides an interface between the MICROCONTROLLER and the USB Connector (item 210). As shown in Figure 3 a computer 231 may be coupled to USB port 210 by means of a USB cable. The computer 231 is fitted with an optical disk drive so that it can read optical disks and transfer data therefrom via USB cable 232 to the USB connector 210. The USB INTERFACE CONTROLLER (item 209) manages commands from the computer in order to download specific software and configurations. For example, a software product borne upon CD-ROM 230 comprising tangible machine readable instructions for execution by the microcontroller to thereby carry out the method that will be explained herein. The USB interface also provides a pathway for data downloading from the MEMORY MODULE (Item 211) to the Computer 231 for graphical or tabular output. The USB INTERFACE CONTROLLER (Item 209) is connected to the USB CONNECTER, (Item 210) which is of a female form to accept a USB type male form connector on a cable. The USB Cable can be connected to a computer or a suitable charging Plug-Pack. A low battery charge condition where the device will not operate efficiently will be indicated in a display element (Item 218) on the Display screen (Item 227). The USB CONNECTER is also connected to a USB CHARGING CIRCUIT (Item 215) which, in turn, is connected to a RECHARGEABLE BATTERY (Item 217). Whilst the battery is recharging, a BATTERY CHARGER INDICATOR (Item 216) illuminates on the DISPLAY MODULE (ITEM 227) and blinks when the battery is fully charged. The USB CHARGING CIRCUIT is earthed to the circuit board via a BATTERY CHARGER EARTH (Item 213)

The battery is connected to the circuit board BATTERY EARTH (Item 214) which in turn is connected to a POWER SWITCH (Item 219) and a POWER INDICATOR (Item 220) illuminates when the power is on or in sleep mode.

A WIRELESS CONTROLLER (Item 221) is connected to the Microcontroller (Item 208). A WIRELESS TRANSMIT SWITCH (Item 222) is connected to the wireless controller, and when depressed by the user activates the WIRELESS TRANSMITTER (Item 223) and causes a transmission of exercise history data to be transmitted to a computational device that is programmed to receive the data through the data wireless connection. Whilst the transmission is taking place, a display element indicating WIRELESS TRANSMIT or similar words, will be illuminated on the display module 227.

A set of software commands stored in memory module 212 and executed by the microcontroller 208 prevents the user using the device to record pelvic floor exercises when either the device is connected to either a computer, charging device, or transmitting data through the medium of wireless.

A series of five visual indicators (item 229 of Figures 2 and 3) on a visual display illuminate indicating the strength of the woman's contraction during the time of the contraction. These indicators progressively illuminate on the display panel preferably indicating equivalence to the Modified Oxford Grading Scale a grading system of muscle strength. Certain display elements indicating the equivalent pressure of the contraction indicators (Item 229) against the words indicated on the display module/'FLICKER", "WEAK", "MODERATE", "FIRM" (or "GOOD"), and "STRONG" in the same order

An audible BEEPER/SOUNDER (Item 228) beeps when the device is turned on indicating completion of the self-calibration cycle, once when a successful contraction occurs, and once when the relax time is completed. It also sounds once after approximately 10 minutes inactivity has elapsed. The device will then move to sleep mode to conserve battery power.

It will be realized that the apparatus includes a user human interface comprised of the firmness selector 205, hold time selector 206, beeper (or as it may variously be called "loudspeaker') 225, power indicator and battery charging indicator 216. Furthermore, the human interface comprises at least one indicator for indicating contraction pressure generated during a pelvic floor exercise is provided by contraction strength LED indicators or indicated on a visual display screen (item 227of Figure 3).

Referring now to Figures 4a and 4b, there is shown a cross section of the vaginal sensor 201 , according to a preferred embodiment of the present invention, in a passive state (Fig 4a), and secondly, a state where it is being compressed (Fig 4b). The sensor comprises of an internal inflexible tube 401 with a medial lumen 402. A number of holes 403 are formed through the wall of the tube so that the lumen communicates with an air space or bladder 404 that is defined by an outer sheath 409. When the outside sheath 409 is compressed by a contraction of, say, the pelvic floor muscles, the lumen transmits the resulting change in pressure through a connected conduit 202 to a sensor interface 203 of the measurement and recording device. The vaginal sensor 201 includes a forward housing portion 405 having a tapered bow at one end to allow for easy penetration into the vagina. Placement features are provided in the form of two rounded radial ridges on the shaft of the rearward portion of the sensor housing, namely an outer sensor placement ridge 406 and an inner sensor placement ridge 407. These ridges allow correct placement of the sensor in the vagina thus positioning the sensor in the region there it will most accurately measure the pelvic muscle strength during a contraction.

The sheath 409, a portion of which is located intermediate the forward 405 and rear 410 housing portions, along with the housing portions defines the bladder 404, which is sensitive to pressure from contracting muscles of the pelvic floor.

Figure 4B shows how, when the muscles of the pelvic floor are constricted about the sensor 201 , the sheath 409 is squeezed so that air 411 flows from bladder 404 through holes 403 and into lumen 402. This action consequently causes a pressure wave 413 to flow through pipe 202 that is converted into an electrical signal by pressure transducer 203 for subsequent processing by the microcontroller 208. Figure 5 illustrates the positioning of the sensor in use in-situ within the vagina held in position by the sensor placement ridges and guides. The pelvic floor is in a relaxed state in this diagram so that negligible pressure is exerted on the vaginal sensor.

Figure 6 indicates the vaginal sensor in a contracted state. In a contracted state the vaginal muscles 501 compresses the sides of the vaginal sensor 201. The resulting change in pressure 413 (Figure 4B) is transmitted through the plastic tube 202 (Figure 4B) to the device for bio-feedback, measurement and recording by the device as previously mentioned.

Referring now to Figures 7 to 11 , there is shown a flowchart for a method of performing a pelvic floor muscle exercise by means of the apparatus 200. This flowchart, and the subsequent flowcharts, includes steps that are programmed as instructions into the memory module 212 of the apparatus 200 or borne upon optical disk 230 (Figure 3). For example, boxes 714 to 718 refer to operations that the apparatus 200 is programmed to implement.

Commencing at Box 702, the vaginal sensor connector tube 202 is connected to the device (Box 704) by a user. Then it is recommended that the sensor be lubricated with water based lubricant (Box 706). The vaginal sensor is then inserted into the vagina (Box 708) and correctly positioned so the positioning ridge is just outside and adjacent to the introitus of the vagina and not juxtapositioned with the outer labia. The device 200 is then turned on (Box 712) by actuating the power switch 219. The user will then relax their pelvic floor muscles (Box 718). The device is programmed so that it baselines to intra-vaginal rest pressure. The user will then select the appropriate firmness level (Box 714) and the required hold time (Box 716) using the selector button switches 205, 206 (Figure 3). The device is programmed so that in response a corresponding visual indicator will illuminate (Box 801 Figure 8). The device will then beep via buzzer 218, and at the same time the LEDS or indicators will flash more than once (Box 720) to indicate that the device has now recalibrated current readings to read from zero reflecting normal relaxed internal pressure inside the vagina (Box 718).

The device 200 is programmed so that If the user needs to change the base firmness level (i.e. the base firmness range with reference to which their contractions will be measured) or hold time setting they can do this task at this stage. The user can set base Firmness (Box 904, Fig 9), and Hold time setting (Box 906).

Confirming the hold time and firmness levels are set to the correct values ^• (Box 902), the user then contractions her pelvic floor muscles and holds the contraction at the strongest level for the time set by the user, (Box 908). At Box 912, if the contraction fulfils the time and pressure settings, (Box 910) LEDs or visual indicators, i.e. display 225 (Figure 3) up illuminate on the visual display consistent with the pressure held within the fimness range, indicating the highest pressure maintained for the elapsed hold time (Box 914) will light up or otherwise indicate. An audible beep (Box 916) will be heard from beeper 228 and the event will be recorded by the device (Box 918) in its internal memory 212 (Figure 2).

The device 200 is programmed so that if there is approximately 10 minutes of inactivity, the device beeps, then all active components go into sleep mode (Box 802, Fig. 8). In this mode the visual display elements remain activated on the visual display (Box 804) and all active components within the device power off to conserve battery energy (Box 806). If the user wishes to turn the device on (Box 808) the user turns the power off using the button switch 219, then turns it on, (Box 810), or if they want to turn it off completely, the user mast hold it down for a few seconds (Box 814). Figures 10 and 11 describe the Data download and Review process that the device 200 is programmed to implement. Commencing at Box 1002, the person wanting to review the accumulated data held in 'the MEMORY MODULE of the device (Box 1004) ensures the device is turned on (Box 1008) and that the device is not in "Sleep" mode. The computer to which the data is to be downloaded must be turned on (Box 1010) and have preferable suitable data management and display program installed on it in working order. The user has the choice of either transmitting the data to the computer via a USB connection or through a wireless connection to a suitable computer. (Box 1012). For a USB connection the user then plugs the supplied USB cable into the device (Box 1014) and then plugs the other end of the USB cable into the USB inlet on the computer (1014). The computer must have the supplied software installed. The user then opens up the supplied software and executes a command to download the software log file (Box 1016) from the MEMORY MODULE onto the computer memory system (Box 1102).

If the user chooses to transfer the data in the device to the computer through a wireless ^' connection, they must ensure that the computer recognizes the wireless signal from the device through a suitable protocol for example an ADVERTISING - DISCOVERY protocol (Box 1018). The user then depresses the wireless transmit button 222 (Figure 3) on the device (Box 1020) and then all available data is transmitted to the computer.

The data is copied onto the memory system of the computer and given a filename associated with the date and time of the download (Box 1104). The device can be disconnected from the computer at this stage of the process (Box 1106). The user has the option of including a suffix name or identifier to the filename prior to the save action (Box 1108). The data is automatically converted to a format that can be used by the data management and display software. The data is then opened using the software and it displays the exercise history data in graphical form (Box 1112). The user may elect to transmit the data file via a web application to a secure server for viewing by a user nominated health provider (Box 1110). This then completes the Data Download and review process.

Fig 12 indicates the Device Power Off Process (Box 1202). If the user nominates to manually turn the device off (Box 1204), the user then switches the device off using the power switch (Box 1206). If the user decides to choose to turn off the device using the "sleep mode" process, then they need to ensure the device is not subject to any activity for about ten (10) minutes (Box 1208). After approximately ten (10) minutes, the device will automatically go into "sleep" mode (Box 1210). The device will beep once and the "Power" indicator will stay on, (Box 1212). All the active devices will turn off (Box 1214). The Power off process then ends (Box 1210).

Fig 3 details the battery charging process. If the user nominates to charge the battery in the device (Box 1302) they can either plug the USB cable into the device (Box 1304), then plug the other end of the USB cable into a computer (Box 1306). If the computer is turned on, then the battery in the device is charged via the connection (Box 1308). The user may also choose to charge the device through the plug pack charger.

The user then connects the USB cable to a suitable plug pack, (Box 1310) and plugs the other end of the USB cable into the device (Box 1312). The battery in the device then commences charging (Box 1314). When the device is charging, the charging display element illuminates, (Box 1316) and when the battery is fully charged, the Charging display element flashes (Box 1318)

It will be realized that the previously described device, being an apparatus that is a preferred embodiment of the invention provides a number of advantages as follows. The device is programmable by the user to three (3) levels of "firmness". These levels of firmness are indicative of the three broad firmness levels of female pelvic floors. This takes into account the fact that a pelvic floor in any two subjects is not the same. A woman of senior years may exhibit a pelvic floor pressure that can be classified as excellent for that age bracket, but the same pelvic floor pressure exhibited by a young nulliparous (no births) woman may be considered as needing immediate pelvic floor muscle remedy even though it could rated as in the strongest level in the lowest category of "firmness". The measurement of absolute pelvic floor pressure, without taking into account the age, vaginal geometry, and medical symptoms such as faecal and urinary incontinence, childbearing status,, former injuries and physio-psychological status of the subject renders a measurement of pelvic floor pressure of nominal therapeutic value. The three (or more) programmable levels of pelvic floor firmness base levels, i.e. the "Firmness Range" parameter that is entered at box 714 of Figure 7, accommodate the three broad ranges of female pelvic floor muscle strength. The appropriate base firmness value entered at box 714 may be provided to the user by a clinician or settled on by the user after some trial and error.

The device has four user programmable hold times (item 225 Figure 3). These are 1 second, 2 seconds, 5 seconds, and 10 seconds. The 1 second and 2 second set hold times generally assist the woman in exercising the fast twitch pelvic muscles) more generally aiding in the management of Stress Urinary Incontinence, and slow twitch muscles (5 second and 10 second hold times) assist more generally in building up a strong base level pelvic floor to avoid pelvic organ prolapse. The device beeps after the woman has squeezed and held at a particular level for the preset time thereby providing a high level of user feedback to enable consistent targeting of the different muscle sets or symptoms. This feature meets a significant need to differentiate between the muscle sets based on the different muscle types using different exercises and different symptoms. The device has five (5) preset levels of pressure indicators (item 229 Figure 3) within each base firmness level. These are based on the Modified Oxford Grading Scale of muscle strength (flicker, weak moderate, firm (or good), and strong). These levels are consistent with the current physiotherapist method of grading muscle strength. This addresses the issue of having results consistent with current clinical methodology of measuring muscle strength. This feature is preferable because it specifically indicates the muscle pelvic muscle strengths and indicates such with feedback consistent with the Modified Oxford Grading Scale.

The device has programmable preset relax times built into the device allow for an 'enforced rest' time between exercises, equivalent to the pre-set hold time. This addresses a need to the woman to complete her exercises in a regular and repeatable manner. The device will beep when the rest time is elapsed thus ensuring results across all devices and all users are consistent with general clinician practice. It allows an exercise set to be reproduced reasonably accurately and with reasonable repeatability of results in the home as well as in the clinic.

The vaginal sensor has two ridges (inner and outer) enabling correct positioning and position hold functionality. The measurement of the female pelvic floor muscle pressure commences at approximately 15mm from the introitus or entrance to the vagina. Current sensors rely on the woman or clinician placing it into the vagina and holding it in place to obtain the best and consistent measurements during the exercise routine. An incorrect exercise, such as an abdominal 'bearing down' action, will provide a 'pushing out' force on the sensor. Testing has shown that a variation of 10mm in the placement of the sensor in the vagina can change the pressure reading of up to 20%. The vaginal sensor has two ridges on the shaft distanced so the that the soft flesh component of the vaginal entrance 'holds' the sensor in place and ensures the pressure sensitive area of the sensor is consistent from squeeze to squeeze, and only measures the pelvic floor muscles, and not vaginal entrance pressure. The correct positioning of the sensor during a squeeze will ensure that correct information is available to the clinician for more accurate assessment of the state of the subject's pelvic floor. The sensor is designed to allow for correct and repeatable self- positioning and position hold capability in the vagina.

The exercise history may be automatically and clearly represented graphically, for example in a graphical format. This enables quick and accurate assessment of exercise history. Every exercise event is electronically tagged with time/date so the reviewer can assess frequency and timing of all events. This allows quick and accurate assessment of the exercise history enabling progress to be monitored and perhaps adjusted or refined for the next set of exercises. This feature addresses the issue of not being able to monitor past exercise history clearly and easily. This ability to recall historical activity, over 8000 events, with graphs representing each event according to date/time, hold time settings, firmness level and pressure level reached is highly advantageous. These indicators give the woman or clinician the ability to monitor progress in pelvic floor exercise and remedy accurately and logically.

The device is built with a rechargeable power supply that recharges the installed battery through either a plug pack that is plugged into mains power, or through the USB (Universal Service Bus) cable when connected to a powered on computer. This negates the issue of needing to change batteries when the battery charge depletes. The battery and circuitry has been made generally inaccessible to the general user.

Many variations and further embodiments may be provided that are encompassed by the present invention. Some additional options that may be provided are as follows: 1 Addition of a vibrating alert

i. A vibrating alert may be included.

ii. It responds when the beeper/buzzer sounds to assist hearing impaired

2 Addition of touch screen capability to display all the features (as a minimum) as the colour screen, and;

1. Touch screen controls

2. Verbal "training" and assistance

3. Programmed pelvic exercise routines

3 Ability to connect to the device over the internet for calibration, results download or downloading software updates.

4 Adaption for an Anal Sensor thus being suitable for the remedy of male faecal and urinary incontinence.

5 Multiple sampling of a single pelvic floor contraction making available an additional tool for clinical research and also enabling a better level of pelvic care and/or management.

6 Web based download and review of data may be achieved through automatic download of the data from the device to a computer and automatically to a secure web site that can be accessed through password by the clinician and subject through the Internet. This facility is available now, and may be incorporated in the design of the device on first release or subsequent versions dependent on costing/timing and/development required to institute the feature.

In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. The term "comprises" and its variations, 'such as "comprising" and "comprised of is used throughout in an inclusive sense and not to the exclusion of any additional features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted by those skilled in the art.

Claims

The claims defining the invention are as follows:

1. An apparatus for pelvic floor management including:

2. An apparatus according to claim 1 , wherein said user interface is arranged for the user to nominate a contraction hold time for the pelvic floor exercise.

3. An apparatus according to claim 2, arranged to indicate passage of the nominated contraction hold time for performance of the pelvic floor exercise.

4. An apparatus according to claim 3, arranged for the at least one indicator to indicate contraction pressure over the course of the pelvic floor exercise with reference to the selected pelvic floor firmness base level.

5. An apparatus according to any one of the preceding claims, wherein the at least one indicator comprises a plurality of visual display elements that each correspond to a predetermined contraction pressure level to be reached over the course of the pelvic floor exercise.

6. An apparatus according to claim 5, wherein the plurality of visual display elements indicate predetermined contraction pressure levels based on a Modified Oxford Grading Scale of grading muscle strength.

7. An apparatus according to claim 6 wherein the visual display elements indicate five contraction pressure levels corresponding to "flicker", "weak", "moderate", "firm" or "good" and "strong".

8. An apparatus according to any one of the preceding claims, including a communication transmission interface and display application for presenting an exercise history via a remote computer.

9. An apparatus according to any one of claims 2, 3, 6 and 7, arranged to indicate successful performance of the pelvic floor exercise upon said exercise being carried out at the predetermined contraction strength for the user nominated contraction hold time.

10. An apparatus according to claim 9, arranged to indicate the successful performance of the pelvic floor exercise by operation of an audible source, such as a loudspeaker or electronic buzzer.

11. An apparatus according to any one of the preceding claims, arranged to indicate rest times between periods for performing the pelvic floor exercises.

12. An apparatus for pelvic floor management including:

a contraction sensor interface in communication with the microprocessor; and

a human interface in communication with the microprocessor;

wherein said instructions include:

instructions to operate the human interface to indicate a contraction strength level based on signals from the contraction sensor interface and a pre-selected base firmness level for a pelvic floor of a user of the apparatus.

13. An apparatus according to claim. 12, wherein the memory includes instructions to operate the human interface to indicate performance of the contraction strength level for a predetermined hold time.

14. An apparatus according to claim 13, wherein the memory includes instructions to indicate successful performance of a pelvic floor exercise upon the contraction strength level exceeding a predetermined threshold for a predetermined hold time.

15. An apparatus according any one of claims 12 to 14, wherein the human interface includes a switch in communication with the electronic processor to receive a user selection of the firmness level.

16. An apparatus according to any one of claims 12 to 15, wherein the human interface includes a further switch in communication with the electronic processor for a user to select the hold time.

17. An apparatus according to claims 12 to 16, wherein the memory includes instructions for comparing the contraction strength level to a number of predetermined contraction strength levels to thereby calculate when each of said predetermined levels has been attained during performance of the pelvic floor exercise.

18. An apparatus according to claim 17 wherein the human interface includes a number of light sources pr visual indicators corresponding to the number of predetermined contraction pressure levels to for indicating when each of said levels has been attained during performance of the pelvic floor exercise.

19. An apparatus according to claim 18 wherein the predetermined contraction pressure levels are based upon the Modified Oxford Grading Scale of grading muscle strength.

20. An apparatus according to any one of claims 12 to 19, wherein the contraction sensor interface includes a pressure transducer for converting air pressure from a pelvic floor muscle strength sensor into an electrical signal.

21. A method for pelvic floor management of a subject including:

sensing pelvic floor contractions;

22. A method according to claim 21 , wherein the step of indicating successful performance of a pelvic floor exercise to the subject occurs upon the calculated contraction pressure corresponding to said exercise exceeding a predetermined level for a predetermined time.

23. A method according to claim 22, wherein the step of indicating successful performance includes indicating strength of the contraction with a visual indicator to display the words "Flicker", "Low", "Moderate" "Firm" or "Good", or "Strong".

24. A sensor for sensing contractions during pelvic floor exercise sessions, wherein an exterior of the sensor bears placement features comprising external ridges spaced apart a distance corresponding to a portion of a vaginal canal of a user for consistently retaining the sensor in place during said sessions.

25. A sensor according to claim 24, wherein the sensor includes a housing about which the ridges are disposed and an air bladder proximate the housing for compression by the contractions of the pelvic floor muscles.

26. A sensor according to claim 25, wherein the housing receives a tube having a lumen in communication with an interior of the bladder.

27. A sensor according to claim 26, wherein the lumen communicates with the interior of the bladder by means one or more holes formed through a wall of the tube.

28. A sensor according to claim 27 wherein the tube receives a conduit for conveying pressure changes sensed by the bladder to a remote location.

29. A sensor according to claim 28 wherein the housing is provided in two portions with a rearward portion about which the ridges are disposed and a forward portion for penetration of the vaginal canal wherein the bladder is disposed intermediate between the forward portion and the rearward portion.

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