WO2012016005A2

WO2012016005A2 - Pelvic muscle trainer

Info

Publication number: WO2012016005A2
Application number: PCT/US2011/045667
Authority: WO
Inventors: William G. Mccoy; Matthew W. Hoskins; Michael S. Wax
Original assignee: Sunbeam Products, Inc.
Priority date: 2010-07-28
Filing date: 2011-07-28
Publication date: 2012-02-02
Also published as: WO2012016005A3; US20130130871A1; EP2598215A2; EP2598215A4

Abstract

A training device is disclosed for exercising the pubococcygeal or pelvic floor muscles, for example in the treatment of incontinence. The device includes a cylindrical, deformable probe for insertion into the vagina or rectum of a user. The probe is connected to a pressure transducer, which detects the pressure applied to the probe by contraction of the pelvic floor muscles and displays a-pressure indicator to the user to help direct the contraction of the appropriate muscles. The pressure indicator may take the form of a series of nested figures, such as curves or concentric semi-circles, that incrementally converge toward a common point as pressure on the probe increases. The nested figures incrementally retreat from the common point as pressure on the probe decreases. The training unit guides a user through an exercise routine by tracking the overall exercise time and the timing between flexing and relaxation cycles. The training unit can include a controller, such as a microcontroller, that is coupled to the inflatable probe for detecting the pressure within the probe. The controller tracks the timing of exercises performed by the user and guides the user through alternating cycles of muscular contraction and relaxation to provide a safe and effective biofeedback regimen

Description

PELVIC MUSCLE TRAINER

FIELD OF THE INVENTION

The present invention relates generally to an apparatus for strengthening the

pubococcygeal muscles (i.e., pelvic floor muscles) for improved sphincter or urinary control, and improving erectile dysfunction. More particularly, this invention relates to a biofeedback device that guides a user through an exercise program for the pelvic floor muscles.

BACKGROUND OF THE INVENTION

Over 18 million people in the US suffer from urinary incontinence. Many forms of incontinence have been linked to poor muscle tone in the pubococcygeus or pelvic floor muscles.

The pelvic floor muscles originate from the symphysis pubis and extend posteriorly

encompassing the urethra, the vagina, and the rectum. The pelvic floor muscles often work in conjunction with other muscles, such as the sphincter urethrae, to control urination. Many pathological conditions, such as cystocoel (hernial protrusion of the urinary bladder through the vaginal wall), rectocoel (hernial protrusion of part of the rectum into the vagina), uterine prolapse (protrusion of the uterus through the vaginal orifice), and bladder and sexual dysfunctions, may be caused by a weakened condition of the pelvic floor muscles. It is widely known that treatment of these pathological conditions generally includes development of muscle tone in the pelvic floor muscles.

One procedure for improving tone in the pelvic floor muscles is for the patient to exercise these muscles through voluntary contractions. Many patients find it difficult to perform such exercises because of an unfamiliarity with how to control the pelvic floor muscles or due to the weakened state of the muscles. Some types of voluntary exercises have been prescribed, such as the exercises developed by Dr. Arnold Kegel. To perform these exercises properly requires instruction, such as the insertion of an instructor's finger into the vagina or anus to determine when the correct muscles have been contracted. Once the patient has learned to contract the correct muscle group, the patient repeats the contractions many times per day. The requirement for personal instruction is often an impediment to a patient seeking care for incontinence or other conditions caused by pelvic muscular dysfunction.

Many training devices have therefore been developed for assistance in exercising the pelvic floor muscles. For example, U.S. Pat. No. 4,167,938 to Remih discloses a vaginal muscle exerciser having an inflatable, compressible body connected to an air cell. The air cell houses a piston connected to a tongue which raises and lowers a U-shaped pointer riding along a numerical scale to indicate the pressure. As a user applies pressure to the body by contraction of the pelvic muscles, air is forced out of the body, through a tube and into the air cell. As air enters or leaves the air cell, the piston moves upwardly or downwardly to approximately indicate on the scale the amount of applied pressure. A digital readout of the total pressure applied to the compressible body is also disclosed.

U.S. Pat. No. 2,541,520 to Kegel discloses another device for exercising injured sphincter muscles. The device includes a resilient member that is inserted within a sphincter muscle. A hose connects the device to a mechanical pressure gauge and an externally located pump. As pressure is applied to the inflatable member by the user's sphincter muscles, air is forced from the resilient member, through the hose and toward the mechanical pressure gauge, where the pressure is approximately indicated by a needle on the pressure gauge. SUMMARY OF THE INVENTION

The present disclosure provides a device for assisting in an exercise routine of pelvic floor muscles of a user. The device includes an inflatable probe for insertion into an orifice of the user. The inflatable has a reference pressure prior to the initiation of the exercise routine. A training unit operably connected to the inflatable probe. The training unit includes a controller for determining the reference pressure and pressures applied to the inflatable probe by flexure and relaxation of the pelvic floor muscles by the user. A display is coupled to the controller and has a pressure indicator portion for displaying information associated with the flexure and relaxation of the pelvic floor muscles. The controller indicating on the display alternating flexing and relaxation cycles for guiding the user through the exercise routine of the pelvic floor muscles. During the flexing cycle an actual pressure applied to the inflatable probe is displayed incrementally, the actual pressure being determined in relation to the reference pressure, and

The controller further including a leak monitor system for detecting changes in the reference pressure in the inflatable probe. The incremental display of the actual pressure is adjusted to compensate for changes in the reference pressure.

In another embodiment, device for assisting in an exercise routine of pelvic floor muscles of a user is provided. The device includes an inflatable probe for insertion into an orifice of the user, the inflatable probe having a wireless transmitter. The device further includes a training unit. The training unit has a controller, display, and a wireless transmitter, the training unit being in wireless communication with the inflatable probe.

In further embodiment, a device for assisting in an exercise routine of pelvic floor muscles of a user. The device includes an inflatable probe for insertion into an orifice of the user. The inflatable probe has a replacement indicator. The device further includes training unit operable connected to the inflatable probe.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:

FIG. 1 is a view of a first embodiment of a training unit that includes a control/display unit in association with a rectal and a vaginal probe. FIG. 2 is an exploded perspective view of the control/display unit of FIG. 1.

FIG. 3 is an enlarged view taken along line 3—3 in FIG. 2.

FIG. 4 is a block diagram schematically illustrating the electrical components within the control/display unit of FIG. 1.

FIG. 5 is a schematic cross-sectional view showing the rectal probe in use in a male subject.

FIG. 6 is a schematic cross-sectional view showing the vaginal probe in use in a female subject.

FIG. 7 is a block diagram of electrical components for a training unit according to another embodiment of the present invention, which guides a user through an exercise routine of the pelvic floor muscles.

FIG. 8 is a flowchart of steps taken by the training unit of FIG. 7 prior to entering a workout phase. FIG. 9 is a top-level flowchart of steps taken by the training unit of FIG. 7 after entering a workout phase.

FIGS. 10A-10B are detailed flowcharts of steps taken by the training unit of FIG. 7 during a workout phase.

FIGS. 11 A-l IF are illustrations of information displayed on the training unit of FIG. 7 prior to entering a workout phase.

FIGS. 12A-12F are illustrations of information displayed on the training unit of FIG. 7 prior to and during a workout phase.

FIGS. 13A-13D are top, side and cross-sectional views of the embodiment of the training unit shown in FIG. 7.

FIG. 14 depicts an inflatable probe including a disabling soluble seal.

FIG. 15 depicts an inflatable probe including a visual replacement indictor.

FIG. 16 depicts an inflatable probe including a disabling soluble seal and a visual replacement indicator.

FIG. 17 depicts a training unit having a electronic replacement indicator.

FIG. 18 depicts a graphical representation of the pressure difference between a non- leaking and a leaking inflation probe.

FIG. 19 depicts a flow diagram of a leak correction system for use in the subject training device.

FIG. 20 depicts a wireless training unit and inflatable probe in a joined configuration. FIG. 21 depicts a wireless training unit and inflatable probe in a separated configuration. FIG. 22 depicts an exploded view of the inflatable probe.

FIG. 23 depicts the training unit in wireless communication with alternative wireless devices.

FIG. 24 depicts a block diagram of the sensing unit. FIG. 25 depicts a block diagram of the training unit.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawing figures in which like reference designators refer to like elements, there is shown in FIG. 1 a pubococcygeal muscular contraction sensing and feedback display apparatus (PMT) 10, for enabling a user to strengthen the pelvic floor muscles through biofeedback, in a way which will be described in more detail below. The user can be, for example, someone suffering from any condition associated with weakness of the muscles of the pelvic floor. Persons who have urinary stress incontmence are an example (without limitation) of a population of users that would benefit from use of the device. However, the apparatus 10 could also be used for any other condition that would benefit from exercising the pelvic floor muscles.

Apparatus 10 includes an inflatable probe 50, which is insertable into an orifice of the user. A male subject would use a relatively smaller probe 52, which is designed for insertion into the anus, with the tip residing in the rectum. A female subject would use a slightly larger probe 54 which is designed for insertion through the vaginal opening for retention in the vagina.

Because each probe is substantially the same except for the orifice in which its use is intended, only probe 52 will be described, it being understood that probe 54 is similarly constructed.

As shown in FIGS. 1 and 5, probe 52 is elongated and includes hemispherical end caps 56, 58 of molded plastic. A hollow, tubular structure 60 extends between caps 56, 58, and a series of openings 62 extend through the tube. Caps 56, 58 and tubular structure 60 are enveloped by any suitable non-toxic, elastic, heat shrink skin 64 suitable for use in the human body. A central, compressible portion of probe 52 (between caps 56, 58) is yieldable in response to contraction and relaxation of the user's muscles, as described in more detail below. The probes 50 are in effect a specially designed balloon sensor that adjusts to individual patient anatomy. Additionally, the probes' pneumatic design allows the probe to be used without placing electrical components in the user's body.

A tube-like conduit 66 is attached at one end to the probe 50, and at its other end to a control/display unit 70. The conduit 66 may be interrupted, for example, by a male/female coupling joint 68, so that the probe 50 and unit 70 can be selectively disconnected. The conduit serves an air conveying function described in more detail below.

The control/display unit 70 (FIGS. 1 and 2) attached to one end of conduit 66 includes a housing, having a top face 72, a pump bladder 74 operatively connected to conduit 66 for inflating probes 52, 54, and a user- visible display 76 for providing biofeedback to the user. Preferably, bladder 74 is made of any suitable shape-retentive elastomeric material which is resiliency reboundable, and display 76 is electronically controllable by electronic componentry located inside unit 70 and described in more detail below. Display 76 can include multiple, light- emitting diodes (LEDs) 78 forming a substantially linear array, generally in the form of a bar- graph type display. An on/off switch 80 controls the electronic componentry described above and is movable between three different settings or power ranges which include an easy, medium, and advanced setting for allowing the user to define and vary the strenuousness of the exercises.

As shown in FIGS. 2 and 3, bladder 74 may be mounted on a manifold 82 by a circular clamping member 84, and the manifold in turn is fixed on a board 86 inside unit 70. The bladder is generally hemispherically shaped and includes a central aperture 74a. When housing face 72 is in place, bladder 74 extends through an aperture 72a in housing face 72 so as to be accessible by the user. It will be appreciated that the reboundable characteristics of bladder 74 are due to its elastomeric construction, which also makes it yieldable in response to digital pressure applied by a user, as described in more detail below.

Alternatively, not shown, the bladder 74 can be an automatic air pump controlled by the electronic componentry described below. In this automated system, the air pump inflates the inflatable probes to a pre-set pressure.

FIG. 3 shows manifold 82 mounted on board 86 with screws 88, 90. Manifold 82 includes a cylindrical wall portion 92 having a flat bottom face abutting wall portion 92, and a top flat face 94. Apertures 96 pass through flat face 94 to enable check valves 98 (FIG. 2) and 100 (FIG. 3) to pass therethrough, for a purpose described in more detail below. A standard T- joint connector 102 is connected between manifold 82 and conduits 66, 104.

A pressure- sensing transducer 110 (FIG. 3), also called a sensor, is mounted within a cavity 112, within manifold 82, and includes electrical contact structure 114 which couples the transducer between probe 50 and display 76. An O-ring 116 provides an air-tight seal for accurate transducer operation.

A simplified diagram of the electrical system of the current invention is shown in FIG. 4. The pressure sensor 110, which senses and determines pressure input generated by compression of the central compressible portions of the probe 50, converts the sensed pressure into a representative signal which is conveyed to display/driver module 130 after suitable amplification by amplifier 120. The display/driver module 130 includes the LED-formed array 78. The specific components to implement the electrical system just described will be understood by those of skill in the art.

Another embodiment of the training unit is shown in FIGS. 7-13. The probe 50 can be essentially the same as shown in FIGS. 1-6, but the training unit that receives pressure signals and provides feedback to the user is different. As particularly shown in FIG. 13, a training unit 130 includes an outer case 132 for housing a printed circuit board 134. As shown in the side view FIG. 13B, a lid 136 is rotatably mounted to the outer case 132 by a hinge 138. The top view of FIG. 13A shows the lid 136 in the closed position wherein the lid 136 protects the user interface components, including a display 140, user input buttons 142 and a pump bladder 144. The display 140 is a liquid crystal display (LCD) having a pressure indicator portion 146, a strength or scale portion 148, and a timing portion 150, each of which will be described more fully below. The training unit 130 guides a user through an exercise routine that includes alternating cycles wherein the user flexes and then relaxes their pelvic floor muscles.

The user input buttons 142can include a power on/off button 152, a strength button 154, a solo button 156 and/or a time button 158. The power on/off button 152 turns the training unit on and off. The strength button 154 changes a scale setting of the pressure indicator portion 146 of the display 140. The solo button 156 places the training unit 130 in solo or probe mode wherein the probe 50 can be disabled or enabled, respectively. The time button 158 changes the duration of the flexing and relaxation cycles. The pump bladder 144 is similar to that shown and described in FIG. 3.

Alternatively, not shown and as previously described, the bladder 144 can be an automatic air pump controlled by the electronic componentry described below, hi this automated system, the air pump inflates the inflatable probes to a pre- set pressure. FIG. 13C shows a cross-sectional view of the training unit 130. In this embodiment, the display 140 is mounted to the outer case 132 and is spaced apart from the printed circuit board (PCB) 134. Switching supplies 160 are mounted to the PCB 134 and provide backlighting to the display 140. Batteries 162 supply power to the training unit 130. FIG. 13D shows another embodiment of the present invention with the PCB 134 mounted directly to and supported by the display 140. In this embodiment, the display is not backlit so switching supplies are not needed. Although FIGS. 13C and 13D show several different alternatives to packaging for the training unit 130, the packaging is not critical to the invention and alternative designs may be used; FIG. 7 illustrates components mounted to the PCB 134; including pressure transducer

110, amplifier 120, display 140, user input 142, and controller 168. The sensor or pressure transducer 110 is similar to the transducer shown in relation to FIGS. 3 and 4. The amplifier 120 is also similar to that already described in connection with FIG. 4. User input 142 can include the user input buttons, such as the power on/off button 152, the strength button 154, the solo button 156, and/or the time button 158. Other user input devices may be used in place of the buttons. The user input 142 is coupled to input ports on the controller and can be latched, polled, or detected through interrupt control. Those skilled in the art will readily appreciate other techniques can be used for receiving input data from a user input. Regardless of the technique used, the controller 168 recognizes when a user is activating one of the user input button(s). The display 140 is coupled to the controller 168 allowing the controller to guide the user through an exercise routine using information displayed on display 140. The displayed information is based on user input received from the user input buttons. FIG. 8 shows the functionality of the electronic training unit 130 after the power on/off button 152 is activated. Even when the training unit 130 is switched off, power is supplied to the controller 168 by batteries 162 (FIG. 13C). When off, the controller 168 is in a low-power or sleep mode that allows previous operating parameters, such as strength and time settings, to be stored for later retrieval. During this sleep mode, the controller 168 deactivates its own clock to conserve energy. Upon activation by the user of the power on/off button 152 (step 174), the controller 168 exits the sleep mode, resets other components on the PCB, provides excitation voltage to the transducer 110 and begins executing internally- stored instructions (step 176). Additionally, excitation voltage is applied to the transducer. When the power-on sequence is completed, the controller 168 automatically switches the training unit 130 to a set-up mode (step 178). In the setup mode, the strength and time operating parameters may be adjusted by the user by using the strength button 154 and time button 158.

Turning briefly to FIG. 12E, the strength and time buttons are described more thoroughly with reference to the display 140. The pressure indicator portion 146 of the display 140 shows multiple, semicircular or concentric arcuate pressure-indicator segments that indicate probe pressure induced by the contraction of the user's pelvic floor muscles. The stronger the contraction of the pelvic floor muscles, the greater the number of semicircular segments are displayed. A maximum pressure under the current pressure scale is indicated with a solid circle located at the center of the semicircular segments. The strength button 154 allows the user to change the pressure scale (i.e., change the maximum pressure) of the pressure indicator portion 146. Thus, the training unit 130 is adaptable to users having pelvic floor muscles of varying strengths. FIG. 12E shows the strength setting set to 1 in the strength portion 148 of the display. To change the strength setting, the user presses the strength button 154 until the desired setting is displayed. The time buttons are used to adjust the exercise routine by changing the length of flex or relaxation cycles.

Returning to FIG. 8, steps 180 and 182 show a pump mode wherein the. subject uses the pump bladder 144 (FIG. 13.) to inflate the probe 50. During these steps, the user is directed to inflate the probe 50 through a "pump" indication on the display 140. As the probe is inflated, the controller 168 monitors the probe pressure to determine if it is at a sufficient pressure for exercising. If the probe is below the desired pressure, step 182 is answered in the negative and the controller 168 continues to direct the user to pump the bladder 144. When the probe is sufficiently inflated, step 182 is satisfied and the controller automatically enters a ready period (184). Thus, the controller 168 automatically detects when sufficient pressure is in the probe 50 and begins the ready period in response thereto. Additionally, the controller stores the value of the pressure during the ready period. This pressure is called the at-rest pressure because the user has not started muscle contractions.

FIGS. 11A-E show the display 140 as the controller 168 executes steps 180 and 182. On the pressure indicator portion 146 of the display 140, the word "pump" is displayed to direct the user to continue pressing the pump bladder 144. In FIG. 11 A, when the probe 50 is at a low pressure, a single vertical line is displayed to indicate the at-rest pressure in the probe 50. As the user continues to press the pump bladder 144, the pressure indicator portion 146 of the display continuously displays a corresponding increase in probe pressure by adding additional vertical lines and other graphics, as shown in FIG. 1 IB through FIG. 1 IE. The display signals that the maximum pressure has been reached when the solid circle appears at the center of the display. Subsequently, as shown in FIG. 11 F, when the controller has detected sufficient pressure in probe 50 to begin the exercise routine, the word "ready" appears indicating the controller has switched to the ready period (FIG. 8, step 184).

During the ready period (step 184), the controller waits a predetermined period of time to allow the user to prepare for the exercise routine. The controller decrements a count on the timing portion 150 of the display 140 so the user knows exactly when the exercise routine is to begin. FIGS. 12A-C show the display 140 during the ready period. A timing element 186 on the timing portion 150 sequentially counts from a predetermined number, such as five seconds (as shown in the bottom margin of display 140 in FIG. 12 A), to one second, as shown in the bottom margin of the display 140 in FIG. 12C. FIG. 12B also shows an intermediate screen with three seconds left in the timing period.

Returning to FIG. 8, in step 188 the controller 168 automatically checks to ensure that the inflation pressure in the probe 50 does not exceed a predetermined threshold. If the probe exceeds a recommended pressure, a warning is given to the user (step 190). The controller 168 then automatically returns the to the set-up mode initialization screen executed at step 178. If at step 188 the probe pressure is at an acceptable pressure, the controller automatically enters the training unit 130 into a workout phase, shown in FIG. 9.

FIG. 9 shows that the training unit 130 has four workout modes 192, 194, 196 and 198. Two of the modes, 192 and 194, utilize the probe 50 (called probe mode). Two of the modes 196 and 198 do not utilize the probe (called solo mode). When the probe is not utilized, the user is directed by the training unit 130 when to flex and relax muscles so as to guide the user through a prescribed exercise routine. The solo mode allows the user to exercise their pelvic floor muscles in a public area. In step 199, the controller determines whether the training unit is in solo mode. If the training unit is in probe mode, the controller 168 determines which of two probe modes the user selected. For purposes of this application, the two probe modes 192, 194 are called probe wink mode and probe work mode, respectively.

In step 200, the controller 168 determines whether probe wink mode 192 is selected. In probe wink mode, the user flexes the pelvic floor muscles (after insertion and inflation of the probe) while the pressure indicator portion 146 of the display 140 displays the associated pressure increase due to the contraction of the user's pelvic floor muscles. In step 202, the controller 168 executes wink mode which is described further below in relation to FIG. 10. A predetermined timer is also set and continuously checked (step 204). If the timer has not expired, the controller 168 continues to execute the wink mode (step 202). However, after the

predetermined time period has expired, the controller 168 returns to step 176 (FIG. 8) and enters a sleep mode. Thus, for example, the probe wink mode 192 helps the user to flex the pelvic floor muscles by indicating when they are contracting them, and then subsequently relaxing them, for a pre-set time period (for example two to five minutes) before returning to a sleep mode. In an alternative embodiment of the probe wink mode, the training unit 130 alternates between contraction and relaxation cycles in very quick intervals, such as every 2 seconds.

If in step 200 the controller _^determines the wink mode 192 is not selected, then the controller enters a probe work mode 194. The probe work mode 194 requires the user to choose different time settings by depressing the time button 158 during the setup mode initialization 178. For example, a time setting of five or ten seconds maybe used. The time settiiig controls the time between alternating flex cycles (where a flex cycle is a contraction). In step 206, the probe work mode is executed, as is further described in relation to FIG. 10. A predetermined timer is also set and continuously checked (step 208). If the timer has not expired, then the controller continues to execute the probe work mode (step 206). However, after the predetermined time period has expired, the controller 168 returns to step 176 (FIG. 8) and enters a sleep mode.

One skilled in the art will recognize that the function of solo modes 196 and 198 are similar to the probe modes 192 and 194, as described above. The differences between solo and probe modes is more clearly understood in relation to FIG. 10.

FIG. 10 shows the four workout modes 192, 194, 196 and 198 in greater detail. First turning to modes 194 and 198 shown in FIG. 10A, the controller 168 enters a flex cycle (step 220). During the flex cycle, the display 140 displays the word "flex" on the pressure indicator portion 146 of the display. Additionally, the pressure indicator portion 146 shows concentric semicircles that indicate the pressure increase over the at-rest pressure. This pressure increase is due to squeezing of the probe 50 when the user contracts the pelvic floor muscles. Unlike previous prior art displays that show the total pressure in the probe 50, the pressure indicator portion 146 of the present invention only shows an increase in pressure due to contraction of the pelvic floor muscles. To display only the contraction pressure, the controller stores the at-rest pressure obtained during the ready period prior to contraction by the user. The controller then obtains the total pressure during exercising. The at-rest pressure is subtracted from the total pressure to obtain the contraction pressure resulting from the subject's contraction of the pelvic floor muscles. As indicated in FIG. 12E, the more pressure the user places on the probe 50 due to the muscle contractions, the more concentric semicircles are displayed. If the user squeezes sufficiently to register a maximum pressure in the probe 50, the display shows multiple concentric semicircles and a solid-filled circle at the center (FIG. 12F). Each semicircle in the pressure indicator portion 146 of the display 140 represents a pressure threshold that has been exceeded.

The display shown in FIG. 12 is particularly advantageous for the biofeedback device of the present invention, where contraction of the pelvic floor muscles around the probe 50 constitutes a tightening of the muscles around the probe. As muscles tighten, they reduce in size. The series of nested semi-circles on the display in FIG. 12 therefore have an mtuitive

physiological correspondence to the anatomic act being performed. As the muscles tighten to a smaller area, the semi-circles correspondingly have smaller diameters. The solid dot at the center of the display also corresponds to the probe 50 around which the muscles are tightening. This intuitive display helps many users overcome the inherent difficulty of coordinating contraction of an unfamiliar muscle group around the probe.

The display can take many other forms while still conveying this mtuitive physiological correspondence to the tightening of the pelvic floor muscles. For example, any nested series of regular patterns converging to a common center would achieve a similar effect. Nested half- rectangles or arcuate concentric or parallel curves are examples of alternative patterns that would be suitable. A series of concentric circles or ovals can also be used instead of the half circles shown in the embodiment of FIG. 12. The converging nested patterns could also be used without the central solid circle.

Returning to FIG. 10, the pressure response is displayed to the user during the workout modes 194 and 198 (step 222). In the probe workout mode, the displayed pressure response is associated with the actual pressure on the probe 50. In the solo workout mode 198, the pressure response shown is a fictitious response generated by the controller 168 to indicate an ideal pressure response. In step 224, a countdown is displayed on the timing portion 150 of the display 140 to indicate the amount of time remaining in the flex cycle (see FIGS. 12D and 12E). In step 226, the controller 168 determines whether the flex cycle is over. If the cycle is not over, steps 222 and 224 are executed again. If, however, the flex cycle is over based upon reaching a predetermined time limit, the controller automatically enters a relaxation cycle (step 228). The controller displays the word "relax" on the pressure indicator portion 146 of the display to direct the user to relax the pelvic floor muscles. A count on the timing portion 150 of the display is incremented or decremented to indicate to the user the amount of time remaining in the relax cycle (step 230). In step 232, the controller 168 determines whether the relaxation cycle is over. If it is not, the controller continues to increment or decrement the count on the timing portion of the display. When the relaxation cycle is over, the controller 168 automatically checks to determine if the pressure in the probe 50 is below a predetermined threshold (step 234). If the pressure is low, the controller automatically enters the setup mode (178— FIG. 8) to allow the user to increase pressure in the probe by using bladder 144. If the probe pressure is acceptable in step 234, then the controller again enters the flex cycle 220. The flex and relaxation cycles thereby alternate for predetermined periods of time.

The probe and solo wink modes 192 and 196 help the user to flex for a predetermined period of time. During this period, the actual pressure response is displayed in probe wink mode (step 236) and a simulated pressure response is displayed in solo wink mode. In step 238, the controller 168 determines whether the flex cycle is over. During the probe wink mode, a relax cycle is not entered. However in the solo wink mode a relax cycle is entered. The controller 168 then returns to the sleep mode (step 176 -FIG. 8). Alternatively, the controller can alternate between flex and relaxation cycles during the wink modes. The training unit 130 can also be provided with a data port for connecting the device to an external conventional personal computer. A serial data communications port can utilize an infrared optical coupling to implement an asynchronous serial data communication port. This transmit only port allows external monitoring and verification of sensor transducer pressure. It can also be used to monitor compliance with a prescribed exercise regimen, and can even be downloaded to a remote site for evaluation by a health care provider. To maximize battery life, the port will transmit transducer pressure at one minute intervals only if the solo button is held in the depressed condition while the unit is switched on. When the unit is turned off, data transmission is disabled. In operation, either of probes 52, 54 are inserted into the orifice of a user and inflated to a user-determined level. Thereafter, the user may, by successively flexing and relaxing the pelvic floor muscles adjacent and surrounding the probe, observe over display 76 or display 140, representations of the pressures exerted on the probe and detected by transducer 110.

Describing the operation of training unit 130 more specifically, once a probe has been inserted into a desired orifice (such as a vagina, anus or rectum), it may be inflated via pump bladder 74 or bladder 144 by the user's repetitive actuation thereof, which causes air to flow through conduit 66 and into the probe via apertures 62 in tubular structure 60. The elastic skin of the probe expands due to the increase in air pressure, filling the user's orifice and exerting a slight positive pressure on the surrounding muscles. Switch 80 may be set by the user to one of three strength settings for achieving the different exercise levels described above. Alternatively, in the embodiment of FIG. 13, the strength button 154 can be used.

FIGS. 5 and 6 depict probes 52, 54, inserted respectively into the rectum of a male, and a vagina. Sphincter and pelvic floor muscles may thereafter be repetitively exercised by the recipient user, for improved urinary and bowel control. More specifically, as the user flexes the surrounding muscles, the central portion of each probe is compressed (as shown in dashed lines), moving air out of the probe, through the conduit, and into cavity 112 in manifold 82, whereupon transducer 110 detects the differential pressure change, produces a representative signal thereof which is conveyed after amplification to the display/driver described above. By observing the . display on control unit 70 or training unit 130, the user is able to ascertain valuable biofeedback information relative to the flexure and relaxation of the muscles. More specifically, with respect to training unit 130 the pressure response is displayed on display 140. Alternatively, with respect to display 76, the reader will appreciate that biofeedback information relative to the user's muscle flexure and relaxation is provided in the form of plural LEDs 78, which are signal-responsive and have a first direction which is serially-progressing, LED-by-LED, corresponding to successive on- states. During such serial progression (which corresponds to progressive contraction of the user's muscles against the probe), the lighted length of the bar-graph increases in direct proportion to such sensed pressures. Correspondingly, when the user relaxes the muscles adjacent and surrounding the probe, the series of LEDs just described serially digress in a second direction, LED-by-LED, which direction is opposite to the first direction.

If, during a relax period, sensor pressure fails to drop below a predefined threshold level during the first half of the period, the "relax" indicator will alternate between on and off until completion of the relax period. The predefined threshold pressure may be, for example, one-half the selected workout pressure.

Having described and illustrated the principles of our invention with reference to several preferred embodiments, it will be apparent that these embodiments can be modified in arrangement and detail without departing from the principles of the invention. Although the display is shown in the form of LEDs and a LCD, other forms of displays, such as those developed in the future, can easily be substituted. Additionally, although the display is shown with a timing portion, a pressure indicator portion, and a strength portion, the display can have any desired layout. One or more portions of the display may be omitted based on the application.

Referring to Figs. 14-17, there is shown an inflatable probe having a replacement indicator. The replacement indicator communicates to the user that the inflatable probe has reached its usable life.

One approach is to render the inflatable probe inoperable after a specific period of time or number of uses. Referring to FIG. 14, the inflatable probe 250 includes a replacement indicator 252 positioned on its outer wall 254. The replacement indicator 252 includes a water soluble film seal or plug 256 that seals an air pathway 258. The air pathway 258 is in fluid communication with the air pathway 260 used to pressurize the balloon 262 portion of the inflatable probe 250. After a specified number of uses and cleanings, the water soluble seal 256 degrades, opening air pathways 258 and 260. With air pathways 258 and 260 open, the balloon 262 is no longer capable of holding pressure, rendering the inflatable probe 250 inoperable.

Referring to FIG. 15, the inflatable probe 250 includes a replacement indicator 252 positioned on its outer wall 254. The replacement mdicator 252 includes a water soluble film seal or plug 256 positioned over a replacement indicating mark 264. Repeated exposure to fluids and/or wear gradually dissolves the water soluble seal 256, revealing the underlying replacement indicating mark 264, The replacement indicating mark 264 provides a visual indicator to the user that it is time to replace the inflatable probe 250. The replacement indicating mark 264 can be a symbol or color code that is hidden by the water soluble seal 256. Alternatively, the water soluble seal 256 can be color coded, the removal of which indicates that the inflatable probe 250 needs replacement.

In another aspect, the above features of the replacement indicator 252 may be combined. Referring to FIG. 16, replacement indicator 252 includes a water soluble film seal or plug 256 that simultaneously seals an air pathway 258 and covers a replacement indicating mark 264. In this manner, the water soluble seal 256 will both render the inflatable probe 250 inoperable, as well as providing the user with a visual indication that the inflatable probe 250 needs

replacement. Alternatively, prior to losing the pressure holding ability, the water soluble seal may degrade sufficiently such that the underlying replacement indicating mark 264 is revealed, In this manner, the user is given notice that the mflatable probe 250 will need to be replaced soon.

Referring to FIG. 17, the replacement indicator may be an electronic replacement indicating system. Included in the control system is a tracking program, tracking the usage of the inflatable probe 250. After a predetermined number of uses and/or time, the trainer indicates that it is time to replace the inflatable probe 250. In addition, the control system may be programmed for allow for a predetermined usage of the inflatable probe 250, after which the device will not function until the inflatable probe 250 has been replaced.

The replacement indicator 270 is provided on the display 272 of the control module 274. In addition to indicating that the inflatable probe 250 needs replacement, the replacement indicator 270 can also include an indicator for displaying the reaming usable life of the inflatable probe 250. The inflatable probe 250 can include an imbedded senor/tag 276. The imbedded sensor /tag 270 being in communication with the controller of the control module 274, such that upon replacement of the inflatable probe 250, the control system resets the usage count.

The present disclosure further provides a pressure correction system. In use, the inflatable probe is inserted into the vagina and inflated to a set pressure. This set pressure becomes the reference pressures. When the users flexes the pelvic muscles, the incremental pressure due to the flexing is displayed on the control unit's display. The display can display specific increases in pressure as incremental bands. In an example, if the reference pressure is set to 100 mraHG, and each incremental increase of pressures due to flexing is set to 5 mmHG, the display will display a pressure increase of 15 mmHG and 3 bands.

However, if the inflatable probe has a small leak in the system, dropping the reference pressure from 100 mmHG to 90 mmHG, then a 15 mmHG increase in pressure will be display as only one band. As such, a decrease in the reference pressure will result in a required increase in applied forced in order to display the appropriate number of bands. Referring to FIG. 18, a graph depicting the difference in band displayed between a non- leaking system and a leaking system is provided. As shown, during the exercise session, in a leaking system the reference pressure can continually decrease, resulting in a continuous increase in applied force to achieve the proper display.

In order to allow for decreases in the reference pressure, the reference pressure is continually adjusted over the course of the exercise session. By continually correcting the reference pressure during the exercise session the band representation of the relative strength of the muscle contraction remains constant. Referring to FIG. 19, a continuous reference pressure correction system is provided. Upon initiating and exercise cycle 300 the initial reference pressure is set and the excise contraction period 302 is commenced based on the references pressure 304. During the relaxation period 306 the reference pressure is measured 308. If the measured pressure is less than the minimum pressure necessary for the device to function the exercise session is exited, and the inflatable probe 250 is re-inflated 312. If the measured pressure is greater then the minimum pressure necessary for the device to function, the measured pressure in compared to the reference pressure 314. If the measured pressure is not less than the reference pressure, it is determined if the relaxation cycle has timed out 316. If the measured pressure is less than the reference pressure, the references pressure is set to the measure pressure 318.

It is then determined if the relaxation cycle has timed out 316. If the relaxation cycles has not timed out the steps are continually repeated pressure check step are continually repeated. If the relaxation cycles has timed out the cycles count is checked 320.

If the exercise session cycle count has not been completed, the exercises session enter a muscle contraction period 300, followed by a repeating of the reference/measured pressure check. If the cycle count is completed, the exercise session ends 322.

Referring to FIGS. 20-22, the inflatable probe 350 and training unit 352 can be separable during use, using wireless communication for the transmission of exercise performance and other data between the inflatable probe 350 and the training unit 352. The lack of the physical connection between the inflatable probe 350 and the training unit 352 provides the user with an increased freedom to adjust the exercise position for improved comfort and efficacy.

The inflatable probe 350 includes a balloon portion 354 that is sized for easy insertion and a sensing unit 356 which acts as a handle to the inflatable probe 354. The balloon portion 354 is releasably mechanically coupled to the sensing unit 356 with an air tight connection 357 that allows air flow to the sensing unit 356. The balloon portion 354 included a balloon stem 358 the provides a column strength to the balloon portion 354 for easy msertion. The balloon potion 354 and sensing unit's 356 connection is configured to be separable, allowing for replacement of the balloon portion 354 as needed.

Referring also to FIG. 24, the sensing unit 356 include a pressure senor 360, power source 362, controller 364, transmitter 366, and air release mechanism 368. The pressure senor 360 is used to sense to the air pressure in the balloon portion 354, where the controller 364 processed the sensed pressure, directing it to the transmitter 366 for transmission to the training unit 352. The transmitter 366 transmits this and other data to the training unit by known wireless transmission means.

The sensing unit 356 can further include a pressure generator 367, such as an automated pump. This allows the sensing unit 356 to automatically pressurize the balloon portion 354 during an exercise session. It is also envisions that the sensing unit 356 can include a manual pump for pressurizing the balloon portion 354.

Referring also to FIG. 25, the training unit 352 includes a housing having a controller 380 operably connected to a visual display 382 and a transmitter/receiver 384. A power source 386 is included in the housing, the power source 386 can be a battery, rechargeable battery, and the like. Data transmitted from the sensing unit 356 is received by me training unit transmitter 384, where the controller 380 processes the data for display.

The training unit 352 can further include a pressure generator 390, such as an automated pump. This allows the training unit 352 to automatically pressurize the balloon portion 354 when the training unit 352 is connected to the sensing unit 356. It is also envisions that the training unit 352 can include a manual pump for pressurizing the balloon portion 354.

The data transmission may be unidirectional, from the sensing unit 356 to the training unit 35t, and can include balloon pressure data, pelvic muscle contraction pressure, sensing unit battery life, and balloon status. Alternatively, the data transmission may be bidirectional, with data being transmitted from the sensing unit 356 to the training unit 352 and the training unit 352 to the sensing unit 356.

Referring to FIG. 24, the training unit 352 may further be configured to communicate with other electronic devices, such a computers, PDA, tablets, and the like, allowing for the tracking and evaluation of the user progress. Such information can be used by clinical experts monitor the user and adjust the treatment as needed. Additionally, the training unit 352 may be configured to communicate with other items or appliances to aid in the tracking of the users overall treatment efforts.

In operation the inflatable probe 350 and trairiing unit 352 are couple together, where the training unit 352 is connected to the sensing unit 356. The training unit 352 and sensing unit 356 can be used as a handle for insertion. Once the insertion is completed, the user activates the training units pressure generator 390 to inflate the balloon portion 354 to a predetermined pressure level,

After the balloon portion 354 has been inflated, the framing unit 352 cues the user that the training unit 352 can be separated from the sensing unit 356, allowing the user to position the training unit 352 as desired. The training unit 352 directed the user to begin the exercise session, controlling the exercise session as previously described. The exercise session ends after the predetermined time period. The user removes the inflatable probe 350, automatically triggering the sensing unit 356 to release the air from the balloon portion 354, depressurizing the probe.

Alternatively, the sensing unit 356 can include pressure generator 367, allowing the sensing unit 356 to inflate the balloon portion 354 without the aid of the training unit 352. In this manner, the inflatable probe 350 and training unit 352 are not connected, where the sensing unit 356 alone acts as a handle for insertion of the inflatable probe 350. Once the insertion is completed, the users activated the training unit 352, which instructs the sensing unit 356 to inflate the balloon portion 356 to a predetermined pressure level,

After the balloon portion 354 has been inflated, the training unit directs the user to begin the exercise session, controlling the exercise session as previously described. The exercise session end after the predetermined time period. The user removes the inflatable probe 350, automatically triggering the sensing unit 356 to release the air from the balloon portion 354, depressurizing the probe.

In another embodiment, the inflatable probe 350 can include biofeedback, enabling the inflatable probe to be utilized without the training unit. The sensing unit 356 can include a feedback mechanism 392, such as a vibration generator, hear or light source

Changes in pressure due to pelvic muscle activity are detected by a pressure sensor 360 in the sensing unit 356. In response the sensing unit 356 actives the feedback mechanism 392 to provide the user with biofeedback on the performance of the exercise. The feedback mechanism 392 can also be used to cue the used as to guide the user through the exercise session. The exercise performance date is stored by the sensing unit 352 for later transfer to the training unit or other device. Also, although particular inflatable probes are shown, any pneumatic or non-pneumatic probe may be used. Other means of inflating the probe, besides the pump bladder, can be used. For example, the pump bladder can be replaced with an electric pump.

In view of the wide variety of embodiments to which the principles of our invention can be applied, it should be apparent that the detailed embodiments are illustrative only and should not be taken as limiting the scope of my invention. Rather, we claim as our invention and all such modifications as may come within the scope of the following claims and equivalence thereto.

All references cited herein are expressly incorporated by reference in their entirety. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention, which is limited only by the following claims.

Claims

What is claimed is:

1. A device for assisting in an exercise routine of pelvic floor muscles of a user, comprising:

an inflatable probe for insertion into an orifice of the user, the inflatable probe having a reference pressure prior to the initiation of the exercise routine; and

a training unit operably connected to the inflatable probe and including,

a controller for determining the reference pressure and pressures applied to the inflatable probe by flexure and relaxation of the pelvic floor muscles by the user,

a display coupled to the controller and having a pressure indicator portion for displaying information associated with the flexure and relaxation of the pelvic floor muscles,

the controller indicating on the display alternating flexing and relaxation cycles for guiding the user through the exercise routine of the pelvic floor muscles, wherein during the flexing cycle an actual pressure applied to the inflatable probe is displayed incrementally, the actual pressure being determined in relation to the reference pressure, and

the controller further including a leak monitor system for detecting changes in the reference pressure in the inflatable probe, wherein the incremental display of the actual pressure is adjusted to compensate for changes in the reference pressure.

2. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 1, wherein the leak monitoring system determines a measured pressure in the inflatable probe when the pelvic floor muscles are in the relaxation cycle.

3. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 2, wherein the measured pressure is compared to the reference pressure, if the measured pressure is less than the reference pressure the measured pressure is saved by the controller as the reference pressure.

4. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 1 , further including a pressure generator connected the inflatable probe.

5. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 4, wherein the pressure generator is positioned in the inflatable probe.

6. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 4, wherein the pressure generator is positioned in the training unit.

7. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 1 , wherein the inflatable probe is connected to the training unit with a conduit.

8. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 1, wherein the inflatable probe is wirelessly connected to the training unit.

9. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 1 , wherein the inflatable probe includes a replacement indicator.

10. A device for assisting in an exercise routine of pelvic floor muscles of a user, comprising:

an inflatable probe for insertion into an orifice of the user, the inflatable probe including a wireless transmitter; and

a training unit including a controller, display, and a wireless transmitter, wherein the training unit is in wireless communication with the inflatable probe.

11. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 10, wherein the wireless communication transmits pressures applied to the inflatable probe by a flexure and relaxation of the pelvic floor muscles by the user.

12. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 11, the display being coupled to the controller and having a pressure indicator portion for displaying information associated with the flexure and relaxation of the pelvic floor muscles; and the controller indicating on the display alternating flexing and relaxation cycles for guiding the user through the exercise routine of the pelvic floor muscles, wherein during the flexing cycle the controller directs the user to flex the pelvic floor muscles and wherein during the relaxation cycle the controller directs the user to relax the pelvic floor muscles.

13. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 12, wherein during the flexing cycle an actual pressure applied to the inflatable probe is displayed incrementally, the actual pressure being determined in relation to a reference pressure.

14. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 13, the controller further including a leak monitor system for detecting changes in the reference pressure in the inflatable probe, wherein the incremental display of the actual pressure is adjusted to compensate for changes in the reference pressure.

15. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 14, wherein the leak monitoring system determines a measured pressure in the inflatable probe when the pelvic floor muscles are relaxation cycle. 15. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 15, wherein the measured pressure is compared to the reference pressure, if the measured pressure is less than the reference pressure the measured pressure is saved by the controller as the reference pressure.

16. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 10, further including a pressure generator positioned in the inflatable probe.

17. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 10, further including a pressure generator is positioned in the training unit.

18. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 10, wherein the inflatable probe is releasably connectabie to the training unit.

19. The device for assisting in an exercise routine of pelvic floor muscles of a user as set forth in claim 10, wherein the inflatable probe includes a replacement indicator.

20. A device for assisting in an exercise routine of pelvic floor muscles of a user, comprising:

an inflatable probe for insertion into an orifice of the user, the inflatable probe including a replacement indicator; and

training unit operable connected to the inflatable probe.