APPARATUS, SYSTEM, AND METHOD FOR TESTING AND EXERCISING THE PELVIC FLOOR MUSCULATURE

Abstract

An apparatus for testing and exercising pelvic floor musculature, the apparatus comprising an elongate housing adapted for a pelvic floor aperture. The housing accommodates an oscillator and an accelerometer connected to a signal processor configured for communicating signals representative of values read from the accelerometer. A result is calculated from an applied oscillation and a response measured, and used for characterizing the musculature. In one embodiment the frequency resulting in the greatest response from the musculature is measured, and this frequency is applied during exercise.

Claims

1. An apparatus for strengthening vaginal tissue, the apparatus being removably insertable into a pelvic opening, the apparatus comprising: a probe configured to be removably insertable into the pelvic opening, the probe having an interior; an oscillator disposed in the interior of the probe, the oscillator capable of oscillating in a plurality of axes; an accelerometer disposed in the interior of the probe, the accelerometer capable of detecting a plurality of oscillations along a plurality of axes; and a signal processor in operative communication the oscillator and the accelerometer, wherein the signal processor calculates a change in oscillations between the oscillator and the accelerometer; a display in communication with the signal processor, the display being configured to show the change to a user.

2. The apparatus of claim 1, wherein the change in oscillations is a change in an amplitude or frequency between the oscillator and the accelerometer.

3. The apparatus of claim 1, wherein an x-axis of oscillator and an x-axis of the accelerometer are generally parallel.

4. The apparatus of claim 1, wherein the change correlates to a visco-elastic property of the pelvic tissue.

5. The apparatus of claim 1, wherein the change correlates to a cell volume of the pelvic tissue.

6. The apparatus of claim 1, wherein the change correlates to a rigidity of a cell's o the pelvic tissue.

7. The apparatus of claim 3, wherein the x-axis of the oscillator and accelerometer are perpendicular to a long axis of the probe.

8. The apparatus of claim 1, further comprising a signal processor housing containing the signal processor and display.

9. The apparatus of claim 8, further comprising a plurality of spaced display segments extending at least partially about the signal processor housing.

10. The apparatus of claim 8, wherein the signal processor housing is generally disc shaped.

11. The apparatus of claim 9, wherein the plurality of segments correspond to a strength of pelvic tissue, a cell volume of pelvic tissue, or a cell rigidity of pelvic tissue, determined from the change.

12. The apparatus of claim 3, wherein the oscillator and the accelerometer are generally offset along a long axis of the housing.

13. The apparatus of claim 1, wherein an x-axis, y-axis, and z-axis of the oscillator and an x-axis, y-axis, and z-axis of the accelerometer are generally parallel.

14. The apparatus of claim 13, wherein a frequency of oscillations along the x-axis, y-axis of the oscillator and the accelerometer are generally different.

15. The apparatus of claim 14, wherein the different frequencies are in a range of approximately 15 Hz and 120 Hz.

16. The apparatus of claim 1 further comprising an amplifier configured to amplify a signal from the accelerometer.

17. The apparatus of claim 1 further comprising a sensor configured to sense a muscle acting upon the probe.

18. The apparatus of claim 1, further comprising a gyro sensor operatively positioned in the interior of the housing, the gyro sensor being capable of detecting an orientation of the housing.

19. The apparatus of claim 1, wherein the display is in wireless communication with the apparatus.

20. The apparatus of claim 1, further comprising a control module in operative communication of the apparatus, the control module being configured to control a frequency and an amplitude parameter of the oscillator.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The invention will be described in more detail in the detailed description below with reference to the appended drawings, in which:

[0025] FIG. 1 is a longitudinal schematic section of an apparatus;

[0026] FIG. 2 illustrates alignment of a triaxial accelerometer in the apparatus of FIG. 1;

[0027] FIG. 3 (prior art) shows the principle of an oscillator;

[0028] FIG. 4 (prior art) shows the principle of an accelerometer;

[0029] FIG. 5 is a schematic illustration of a system according to the invention;

[0030] FIG. 6 is a schematic depiction of the functions of the system;

[0031] FIG. 7 is a flow diagram illustrating a method according to the invention; and

[0032] FIGS. 8A-8D illustrate a more detailed embodiment of the signal processor according to the invention.

DETAILED DESCRIPTION

[0033] FIG. 1 is a longitudinal schematic section of an apparatus 100 according to the invention. The apparatus is comprised of an elongate, cylindrical housing 101, which can be made of a relatively rigid plastic material. Advantageously, an outer casing 102 made of medical silicone can be provided on the outside of housing 101. The size of the housing is adapted for an opening in the pelvic floor.

[0034] Housing 101 includes an oscillator 120 able to oscillate along one, two, or three axes, and an accelerometer 130 able to measure the acceleration along one, two, or three axes. Preferably, the accelerometer axis or axes is/are aligned with the oscillator axis or axes, for the following reason:

[0035] Assume that oscillator 120 effects an oscillation of the apparatus along an axis x, and that the response is measured along an axis x′ forming an angle a with the x-axis. If a response along the x-axis is B, then the response along the x′-axis B′=B.Math.cos α. B′ has a maximum for cos α=1, i.e. with α=0 and the x′-axis parallel with the x-axis. Correspondingly, B′=0 when the accelerometer axis is perpendicular to the oscillation (cos 90°=0). Thus, by arranging the x-axis of accelerometer 130 in parallel with the x-axis of oscillator 120 we expect the largest possible signal and hence the greatest sensitivity possible. The same is true along the y- and/or z-axes when apparatus 100 has more than one axis. Also, the level of crosstalk between the measured signals is minimized when the axes are perpendicular to each other, e.g. as shown with the x, y, z coordinate system of FIG. 1.

[0036] From FIG. 1 is can also be seen that oscillator 120 and accelerometer 130 are offset relative to each other along the longitudinal axis of the apparatus, i.e. the z- axis. Strictly speaking, therefore, they have separate axes in the x direction, e.g. x and x′. However, this has no significance as long as the axes are parallel to each other, cf. the previous section. Hence, for convenience, the x-axes of the oscillator, accelerometer and apparatus are referred to as one axis, “the x-axis”. The same applies for the y- and z-axes.

[0037] FIG. 2 illustrates a triaxial accelerometer 130, having its axes x, y, and z parallel with the axes x, y, and z of the apparatus shown in FIG. 1. In a preferred embodiment, the frequencies of the oscillations, and optionally also the amplitudes, can be controlled independently of each other along said x, y, and z axes. This makes it possible to measure the strength of a muscle or muscle group running in parallel with the main axis of the apparatus, the z-axis, independently of muscles or muscle groups acting radially on the apparatus along a combination of the x- and y-axes of FIG. 1.

[0038] In the following, parameters of one, two, or three dimensions are denoted with boldfaced characters, and the component of a parameter along the x, y, and/or z axis is indexed with x, y, and z, respectively. For example, the frequency ω=(ω.sub.x, ω.sub.y, ω.sub.z). In some embodiments, the three frequency components may have different values, and one or two of the components can be zero, i.e. one or two oscillators could be eliminated. The same applies for a response or out signal a from accelerometer 130, calculated results ΔA, φ.A, and so on. Components along the x, y, and z axes are measured and calculated independently of each other, e.g. as indicated in eqs. (1) to (4).

[0039] The oscillator 120 can be controlled to vibrate with a specific frequency, preferably within the range of 15-120 Hz, by a power supply 110. Alternatively, the oscillator 120 can be driven by a battery 111a, shown with broken lines in FIG. 1.

[0040] The output signal from accelerometer 130 can be passed to a signal processor 140 and thence to a computer 200 (see FIGS. 5 and 6). Alternatively, the entire or parts of the signal and data processing can be performed by a unit 200a inside the housing 101.

[0041] Oscillator 120, accelerometer 130, and signal processor 140 are commercially available products, and it is within the ability of a person skilled in the art to select models suited for the particular purpose. It is understood that FIG. 1 is a principle drawing, and that the connections between the components may include several channels, e.g. one input channel per oscillator axis and one output channel per accelerometer axis. In some applications, accelerometer 130 and/or signal processor 140 may be driven by electric power supplied through a USB connection, for example. In other applications, it may be necessary or convenient to have a separate grid-connected transformer 111 in the power supply 110, as shown in FIG. 6.

[0042] FIG. 3 illustrates the principle of a possible oscillator 120. The oscillator shown includes a permanent magnet 126 arranged in a coil 125. When an AC voltage Vx is applied to the poles and a current is driven through the coil, a variable magnetic field is induced which drives the permanent magnet 126 back and forth in a reciprocating motion. The permanent magnet 126 is attached to a weight 122 which hence also moves back and forth. When the oscillator is attached to housing 101, the apparatus 100 will oscillate along the x-axis.

[0043] FIG. 4 illustrates the principle of a typical accelerometer. A piezoelectric disc or bar 133 is fixedly clamped within a housing 131. The disc 133 retains a seismic mass 132. When the housing is moved back and forth along the x-axis, the disc will be acted on by the mass 132 and an electric charge is produced, typically a few pC/g, on the disc 133 by the piezoelectric effect. For frequencies below about one third of the resonance frequency of the accelerometer housing, this charge will be proportional with the acceleration. The output signal is illustrated schematically as a.sub.x in FIG. 4. Commercial vibrational testing accelerometers of this type typically have a frequency range from approx. 0.1 to above 4 kHz, i.e. far outside the range of 15-120 Hz preferred in the present invention.

[0044] The present invention does not rely on any specific types of oscillators or accelerometers. For example, eccentric weight oscillators may be used instead of the type shown schematically in FIG. 3. A design of the type shown in FIG. 3 can also be used as an accelerometer: In such a case, weight 122 is moved in dependency of the applied forces. This induces a movement of permanent magnet 126 inside coil 125, and a current is induced that can be read at the poles at Vx.

[0045] FIG. 5 illustrates a system in which a computer 200 controls an oscillator of apparatus 100 through a power supply 110. The computer 200 can be of any design. Suitable computers have a programmable processor, and include personal computers, portable units (PDAs), etc. Computer 200 can be connected to a display, printer, and/or data storage in a known manner for displaying and/or logging measurement results.

[0046] Signals from an accelerometer (130, FIG. 1) of apparatus 100 are amplified and/or processed in a signal processor 140, and transferred to computer 200 for analysis and/or logging. The connection between apparatus 100 and the box 110, 140 may include several channels for controlling oscillators along several axes independently of each other as well as for measuring responses of a uniaxial or multiaxial accelerometer. The same applies for the connection between box 110, 140 and computer 200. This connection may be a US8 (2.0 or the like) connection, and, in some applications, electric power may be supplied from the computer through the US8 connection.

[0047] In some embodiments, signals may be transferred wirelessly (not shown), e.g. by way of radio signals, infrared light, or ultrasonic signals.

[0048] FIGS. 8A-8D show another embodiment of the system, and in particular a more detailed embodiment of signal processor 110, 140, according to the present invention, in which the power supply 110 and signal processor 140 can be embedded into a separate unit or box 110, 140 accommodating at least one rechargeable or replaceable battery or battery package 113 (FIG. 8D).

[0049] Signal processor 140 may also include: a CPU including the appropriate software; electronic circuitry programmed with suitable algorithms for managing and controlling the oscillation frequency and optionally the oscillation amplitude; input(s) for at least one EMG sensor (EMG=Electromyography); and input(s) for at least one force sensor.

[0050] The stand-alone unit or box 110, 140 can include a charge input. Additionally to the charge input, or in an alternative embodiment, in which the battery or batteries or the battery package 113 is to be replaced or charged at another location, the stand-alone unit or box 110, 140 may include a cover 114 which can be opened and closed, or the casing (housing) of the unit or one half of the unit or box 110 may be arranged so as to be easily opened and closed (i.e. without the need for using a tool).

[0051] The wire 115 from apparatus 100 may be permanently connected 115A to the box 110 of signal processor 140, or, alternatively, may be arranged so as to be pluggable 1158 (by means of a plug 1158) into the input port or connector 116 of the unit 110, 140.

[0052] Signal processor 140 may further include a loudspeaker and/or display 118 for the instantaneous or immediate biofeedback on muscle activation as observed through the dampening of oscillations and/or force read from the apparatus 100 and/or EMG activity in the muscle acting on apparatus 100. Display 118 may have a suitable shape adapted for the requirements of functionality and placement. An octagonal (eight-sided) 118B, six-sided or round 118A LCD or LED display 118, having about 40 segments 119, for example, could be used. The unit 110, 140 may also include an on/off button 117. In addition, or alternatively, the electronic circuitry of signal processor 140 may be configured so as to switch off after a predetermined time interval of inactivity, e.g. from one to a few minutes of no active use.

[0053] Additionally, the stand-alone unit or box 110, 140 may include a CPU device and/or calibration means including at least one of a CPU device and various sensor means to allow, among other things, the calibration of a new apparatus 100 in the system. Unit 110, 140 may also transfer, e.g. wirelessly, real-time data to computer 200 of various reasons.

[0054] Apparatus 100 may include an integrated triaxial gyro sensor which, together with the triaxial accelerometer 130, allows the data or signal processor 140 or computer 200 to calculate the 3D orientation of the apparatus 100.

[0055] FIG. 6 is a schematic depiction of components of the system illustrated in FIG. 5.

[0056] A control module 230, e.g. hardware and software in the computer 200, determines an oscillator parameter, i.e. frequency and/or amplitude, for oscillator 120. When the apparatus is being used for the first time, the control module 230 could set the frequency ω to a fixed initial value and then increase the frequency in predetermined increments Δω. On subsequent use, control module 230 can use previous results for selecting other initial values and/or frequency intervals. This is described in more detail below. The same applies for the amplitude settings. Alternatively, oscillator parameters could be determined in a binary search which is ended when the values of two consecutively calculated values are closer than a predetermined resolution, e.g. Δω.sub.x=5 Hz.

[0057] Both frequency and amplitude may be adjusted along the x, y, and z axes independently of each other by means of controller 112. In FIG. 6, controller 112 is connected to a power source in the form of a transformer 111 connected to the grid voltage V.sub.1, delivering a power P with the desired current and voltage. As shown in FIG. 1, in the alternative, the power source could be a battery 111a located inside the housing 101 of the apparatus. For example, the controller 112 may control the amplitude A.sub.x and frequency ω.sub.x of the oscillator by controlling the current, voltage, and frequency of the signal supplied at the poles Vx of FIG. 3, and in a similar manner for oscillators oscillating along the y and/or z axes.

[0058] The oscillation is imposed on tissue surrounding apparatus 100, and the response is measured by accelerometer 130.

[0059] Signals from accelerometer 130 of apparatus 100 are passed to a signal processor 140, which is provided as a separate box including an array of accelerometers. Accelerometer 130 may include a preamplifier, and unit 140 may include a pre-amplifier. Other configurations are possible as well. The output signal from signal processor 140 is shown as a, and may represent, for example, acceleration along the x, y, and/or z axes at a measurement point at which the imposed oscillation was ω.sub.i.

[0060] A data capturing module 210 process the signal further, and may, for example, integrate an acceleration to obtain a velocity and once more to obtain a displacement, measure a phase difference, etc. Said integration of acceleration, measurement of phase difference, etc. may be carried out at several locations in the signal path using feedback operational amplifiers, firmware, and/or software, for example, in a known manner. Note that the signal path of FIG. 6 is exemplary only.

[0061] Output data from the data capturing module 210 are shown schematically as a measurement point ω, R, at which a result R is measured or calculated at an applied frequency ω. The result R may represent one or more of: acceleration a, velocity, displacement, relative amplitude attenuation ΔA, phase shift, stress, strain, and/or dynamic modulus as discussed above. In some applications, the oscillator amplitude may also be varied. Advantageously, the data capturing module can store a measurement sequence including a series of measurement points each representative of an oscillator parameter ω or A and a measured or calculated result R. As used herein and in the claims, the term “data values” is understood to mean any parameter value and/or the components thereof along the x, y, and/or z axes.

[0062] A data bus 205 carries data values between various components and modules of computer 200. For example, a measurement series with a sequence of measurement points (ω.sub.i, R;) can be temporarily be stored in a data storage 201 before the measurement series is further processed in an analysis module 220. In another embodiment, the measurement points (ω.sub.i, R;) could be passed to analysis module 220 at a later point, and the processing results, represented by (ω.sub.r, S), could be stored in data storage 201 and/or displayed on a display means 202.

[0063] Analysis module 220 is a module processing one or more measurement series to characterize the musculature and the development thereof using one or more parameters deemed suitable.

[0064] In a preferred embodiment, a maximum response frequency ω.sub.r is obtained for each measurement series. The maximum response frequency ω.sub.r is the value of the imposed frequency for which the measurement parameter selected indicated a maximum response from the tissue surrounding the apparatus, such as the maximum amplitude attenuation, minimum amplitude measured, largest dynamic modulus, etc. This is discussed in more detail below.

[0065] In principle, analysis module 220 may calculate any desired group value and/or carry out statistical analysis of the acquired data, such as statistical distributions, mean or expected value, variance, maximum values, and trends in the development of the measured and calculated results described above, for example.

[0066] In one embodiment, for example, the group value S may represent a subinterval of the range of 15-120 Hz within which the maximum response frequency ω.sub.r is located with a given probability. This interval may be calculated as a confidence interval from earlier measurement series using known statistical methods, and is expected to become smaller as the number of measurement series increases and the variance hence reduces. The purpose of calculating such a subinterval is to avoid superfluous measurements.

[0067] An exemplary trend analysis is the development of the maximum response frequency ω.sub.r over a few days or weeks, which may provide information on training effect.

[0068] FIG. 7 illustrates a method according to the invention.

[0069] In block 710, the musculature is imposed a first oscillation represented by ω.sub.r. In practice, this can be accomplished by introducing an apparatus as described above into a pelvic floor aperture and supply the oscillator 120 with electric power. The oscillation may be imposed along one or more mutually orthogonal axes (x, y, z). At the first use, the initial value could be about 15 Hz, for example, along each axis. After the apparatus has been used one or more times the initial values may be based on previous results and analyses.

[0070] In block 720, the response a.sub.i, from the musculature is measured by means of an accelerometer 130 having axes oriented in parallel with the oscillator axes x, y, and/or z.

[0071] Block 730 illustrates that a result R.sub.i is found from an imposed oscillation ω.sub.i and its response a; as measured in a predetermined time interval. The measurement point (ω.sub.i, R.sub.i) may be part of a measurement series in which i=1, 2, . . . n, and each index i represents a separate time interval. Both the imposed frequency and the measured or calculated result have distinct values along the oscillator axes. Results suitable for characterizing the musculature may be the relative amplitude attenuation ΔA, dynamic modulus λ, and/or phase shift ϕ between the applied and measured signals. The values may be measured and/or calculated as set out above in connection with eqs. (1) to (4), and independently of each other along the axis or axes x, y, and/or z. The measurement point (ω.sub.i, R.sub.i) can be stored or logged as part of this step.

[0072] In block 740 an oscillation frequency for the next measurement point is calculated, and in determination block 750 a determination is made whether the measurement series has been completed.

[0073] In a first embodiment of the method, the imposed frequency is incrementally increased in block 740, for example according to ω.sub.i,=ω0+i.Math.Δω, where Δω denotes a desired resolution for the measurement series, such as 1 Hz or 5 Hz. In this case, the loop ends indetermination block 750 when the new frequency Δω.sub.i+1 exceeds a predetermined threshold, e.g. 120 Hz, along the axis or axes.

[0074] In an alternative embodiment of the method, the objective is to find a maximum response using the smallest number of measurements possible. This may be carried out efficiently by way of a binary search. For example, assume that the result R from block 730 increases with the response of the musculature to the imposed oscillations, that a first interval is 15 Hz to 120 Hz, and that the desired resolution is 5 Hz along each axis. In this case, the binary search can be performed by bisecting the interval, rounding the frequency down to the nearest integer frequency divisible with the resolution, and compare the results of block 730 for each of the two frequencies in the upper and lower parts of the interval, e.g. R.sub.1 at ω.sub.1=15 Hz and R.sub.2 at ω.sub.2=50 Hz. If R2>R1, ω.sub.3 is selected as the center of the interval 50-120 Hz in block 740, otherwise ω.sub.3 is selected as the center of the interval 15-50 Hz in block 740. Similar bisection of the intervals is repeated in this alternative embodiment until determination block 750 indicates that the next interval is narrower than the desired resolution, e.g. 5 Hz along each axis.

[0075] If the responses along the axes are independent of each other, a binary search in the interval 15-120 Hz with a resolution of 5 Hz along each axis will be able to find an approximate maximum response frequency using at most 6 measurement points, whereas a sequential search in the interval 15-120 Hz with a resolution of 5 Hz would require 21 measurement points.

[0076] If determination block 750 indicates that the measurement series has not been completed, a new iteration is performed in which block 710 imposes an oscillation with a new frequency Δω.sub.i+1, etc. When determination block 750 indicates that the measurement series has been completed, the process proceeds to block 760.

[0077] In block 760 one or more measurement series is analyzed as described for analysis module 220 above. In a preferred embodiment, the maximum response frequency ω.sub.r is calculated for each measurement series. By definition, this is the frequency at which the musculature responds most strongly to the imposed oscillation. In practice, the maximum response frequency can be rounded down to the nearest integer frequency which is divisible with the resolution, i.e.

ω.sub.r=Δω.Math.round(ω.sub.r′lΔω),   (5)

[0078] where

[0079] ω.sub.r is the practical value of the maximum response frequency,

[0080] ω.sub.r′ is the theoretical or ideal value of the maximum response frequency,

[0081] Δω.Math. is the resolution chosen, e.g. 5 Hz as in the above example, and

round( ) is a function which rounds down to the nearest integer.

[0082] Block 770 has been drawn with dashed lines to illustrate that the method may, but does not necessarily, include controlling the oscillator to impose the practical value for the maximum response frequency while a user performs pelvic floor exercises as described in the introductory section. Hence, in a preferred embodiment, the resolution Δω should be selected so that the difference between the practical and actual values is of little or no significance. For example, if it turns out to be a telling difference between training with an imposed oscillation of 62 Hz as compared to 60 Hz, Δω in the above example should be reduced from 5 Hz to 1 Hz.

[0083] The method may further include storing and/or displaying one or more oscillation parameters, measurement values, calculated results, and/or group values. Each data value may be stored in a data storage 201 and displayed on a monitor 202. It is also possible to log parameters by printing them on paper. Hence, a printer (not shown) may optionally be used instead of or in addition to data storage 201 and display 202 (e.g. a monitor) shown in FIG. 6.

[0084] The method described above may further include analyzing the measured and calculated results using known statistical methods. In one embodiment, the development of the maximum response frequency and/or other results over time, for example, may document the training effect. Also, in the present or other applications, a confidence interval for ω.sub.r can be estimated which is smaller than the entire measurement interval, e.g. 15-120 Hz, but still large enough for the probability p that the maximum response frequency is located within said interval to be larger than a predetermined value, such as p>95%.

[0085] This may reduce the number of measurement points in the next measurement series, which may be recorded one or a few days later, for example, and stored in data storage 201 (FIG. 6). Data storage 201 may store several such measurement series recorded during a time period, e.g. one measurement series per day for 1-4 weeks, and/or only the particular frequency ω.sub.r within each measurement series which resulted in, for example, the maximum amplitude attenuation or phase shift.

[0086] Naturally, statistical analysis, trend analysis, etc. may be performed on one or more measured or calculated results, not only on the frequency as described above. The expression “calculating group value”, as used in the patent claims, is intended to include any known types of statistic analysis, trend analysis as well as other forms of analysis performed on one or more measured or calculated results, stored, for example, as measurement series of measurement points (ω.sub.i, R.sub.i;) in data storage 201.