U.S. patent application number 13/812185 was filed with the patent office on 2013-05-23 for pelvic muscle trainer.
This patent application is currently assigned to SUNBEAM PRODUCTS, INC.. The applicant listed for this patent is Matthew W. Hoskins, William G. McCoy, Michael S. Wax. Invention is credited to Matthew W. Hoskins, William G. McCoy, Michael S. Wax.
Application Number | 20130130871 13/812185 |
Document ID | / |
Family ID | 45530711 |
Filed Date | 2013-05-23 |
United States Patent
Application |
20130130871 |
Kind Code |
A1 |
McCoy; William G. ; et
al. |
May 23, 2013 |
Pelvic Muscle Trainer
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
Inventors: |
McCoy; William G.; (Spokane,
WA) ; Hoskins; Matthew W.; (Bend, OR) ; Wax;
Michael S.; (Bend, OR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
McCoy; William G.
Hoskins; Matthew W.
Wax; Michael S. |
Spokane
Bend
Bend |
WA
OR
OR |
US
US
US |
|
|
Assignee: |
SUNBEAM PRODUCTS, INC.
Boca Raton
FL
|
Family ID: |
45530711 |
Appl. No.: |
13/812185 |
Filed: |
July 28, 2011 |
PCT Filed: |
July 28, 2011 |
PCT NO: |
PCT/US2011/045667 |
371 Date: |
January 25, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61368421 |
Jul 28, 2010 |
|
|
|
61368431 |
Jul 28, 2010 |
|
|
|
61418913 |
Dec 2, 2010 |
|
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Current U.S.
Class: |
482/113 |
Current CPC
Class: |
A63B 24/0062 20130101;
A63B 2220/56 20130101; A63B 21/0085 20130101; A63B 2220/62
20130101; A63B 23/20 20130101; A63B 24/0075 20130101 |
Class at
Publication: |
482/113 |
International
Class: |
A63B 23/20 20060101
A63B023/20 |
Claims
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 connectable 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.
Description
FIELD OF THE INVENTION
[0001] 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
[0002] 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.
[0003] 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.
[0004] 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.
[0005] 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
[0006] 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.
[0007] 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
[0008] 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.
[0009] 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.
[0010] 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
[0011] 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:
[0012] 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.
[0013] FIG. 2 is an exploded perspective view of the
control/display unit of FIG. 1.
[0014] FIG. 3 is an enlarged view taken along line 3-3 in FIG.
2.
[0015] FIG. 4 is a block diagram schematically illustrating the
electrical components within the control/display unit of FIG.
1.
[0016] FIG. 5 is a schematic cross-sectional view showing the
rectal probe in use in a male subject.
[0017] FIG. 6 is a schematic cross-sectional view showing the
vaginal probe in use in a female subject.
[0018] 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.
[0019] FIG. 8 is a flowchart of steps taken by the training unit of
FIG. 7 prior to entering a workout phase.
[0020] FIG. 9 is a top-level flowchart of steps taken by the
training unit of FIG. 7 after entering a workout phase.
[0021] FIGS. 10A-10B are detailed flowcharts of steps taken by the
training unit of FIG. 7 during a workout phase.
[0022] FIGS. 11A-11F are illustrations of information displayed on
the training unit of FIG. 7 prior to entering a workout phase.
[0023] FIGS. 12A-12F are illustrations of information displayed on
the training unit of FIG. 7 prior to and during a workout
phase.
[0024] FIGS. 13A-13D are top, side and cross-sectional views of the
embodiment of the training unit shown in FIG. 7.
[0025] FIG. 14 depicts an inflatable probe including a disabling
soluble seal.
[0026] FIG. 15 depicts an inflatable probe including a visual
replacement indictor.
[0027] FIG. 16 depicts an inflatable probe including a disabling
soluble seal and a visual replacement indicator.
[0028] FIG. 17 depicts a training unit having a electronic
replacement indicator.
[0029] FIG. 18 depicts a graphical representation of the pressure
difference between a non-leaking and a leaking inflation probe.
[0030] FIG. 19 depicts a flow diagram of a leak correction system
for use in the subject training device.
[0031] FIG. 20 depicts a wireless training unit and inflatable
probe in a joined configuration.
[0032] FIG. 21 depicts a wireless training unit and inflatable
probe in a separated configuration.
[0033] FIG. 22 depicts an exploded view of the inflatable
probe.
[0034] FIG. 23 depicts the training unit in wireless communication
with alternative wireless devices.
[0035] FIG. 24 depicts a block diagram of the sensing unit.
[0036] FIG. 25 depicts a block diagram of the training unit.
DETAILED DESCRIPTION OF THE INVENTION
[0037] 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
incontinence 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] 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 resiliently
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.
[0042] 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.
[0043] 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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 ease 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.
[0048] The user input buttons 142 can 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.
[0049] Alternatively, not shown and as previously described, the
bladder 144 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.
[0050] 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.
[0051] 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.
[0052] 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.
[0053] 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.
[0054] 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.
[0055] 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.
[0056] 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. 11A, 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. 11B through FIG. 11E. 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. 11F, 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).
[0057] 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. 12A),
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.
[0058] 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.
[0059] 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.
[0060] 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.
[0061] 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.
[0062] 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 may be used. The time setting 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.
[0063] 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.
[0064] 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.
[0065] 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 intuitive
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.
[0066] The display can take many other forms while still conveying
this intuitive 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.
[0067] 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.
[0068] 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.
[0069] 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.
[0070] 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.
[0071] 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.
[0072] 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.
[0073] 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.
[0074] 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.
[0075] 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.
[0076] 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.
[0077] 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.
[0078] Referring to FIG. 15, 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 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.
[0079] 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
inflatable probe 250 will need to be replaced soon.
[0080] 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.
[0081] 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.
[0082] The inflatable probe 250 can include an imbedded sensor/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.
[0083] 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 mmHG, 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.
[0084] 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.
[0085] 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.
[0086] 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.
[0087] 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.
[0088] It is then deter pined 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.
[0089] 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.
[0090] 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.
[0091] 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 insertion. 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.
[0092] Referring also to FIG. 24, the sensing unit 356 include a
pressure sensor 360, power source 362, controller 364, transmitter
366, and air release mechanism 368. The pressure sensor 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.
[0093] 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.
[0094] 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 the training unit transmitter 384,
where the controller 380 processes the data for display.
[0095] 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.
[0096] 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.
[0097] 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.
[0098] In operation the inflatable probe 350 and training 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,
[0099] After the balloon portion 354 has been inflated, the
training 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.
[0100] 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,
[0101] 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.
[0102] 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
[0103] 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.
[0104] 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.
[0105] 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.
[0106] All references cited herein are expressly incorporated by
reference in their entirety.
[0107] 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.
* * * * *