Note: Descriptions are shown in the official language in which they were submitted.
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DEVICES AND ~.O~S FOR ~S~fi~ENT AND ~ENT OF
~RT~A~Y AND FECAL INCONTINENCE
Field of the Invention
The present invention relates generally to medical
devices and methods, and more particularly to devices and
methods for evaluating and treating urinary as well as
fecal incontinence by using proprioceptive neuromuscular
facilitation.
Backaround of the Invention
Urinary incontinence is believed to affect 15% to
30% of noninstitutionalized persons over the age of 60,
and more then 50% of elderly persons (over the age of 60)
who reside in nursing homes.
The presently available modes of treatment for
urinary incontinence fall into four general categories,
namely: i) management apparatus, ii) behavioral, iii)
pharma-cologic, and iv) surgical.
i. Manaqement Apparatus For Inconti~en~
The management apparatus modes of treatment
generally comprise absorbent and/or catheter structures
worn by a user to retain any urinary and/or fecal
incontinence. In their simplest forms, such devices
comprise diaper-like structures which must be
periodically changed by the user. Although such
management apparatus has proven generally effective in
masking the results of incontinence, they are
uncomfortable to wear, difficult to change, and
oftentimes fail during use thereby embarrassing the user.
ii. ~ehavioral Treatment For Inconti~en~e
The use of behavioral training as a treatment for
urinary and/or fecal incontinence can involve numerous
behavioral techniques including; bladder re-training
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(e.g., voiding on a timed schedule), and/or the
performance of exercises (e.g., Kegel exercises) to
strengthen and retrain a group of muscles collectively
known as the "pelvic floor muscles". As an adjunct to
these behavioral training techniques, various
intravaginal and/or intra-anal devices may be utilized to
facilitate the performance of such pelvic muscle training
exercises. Such intravaginal and/or intra-anal devices
have included simple pressure-exerting or weighted
apparatus such as pessaries or intravaginal cones.
Exemplary of such prior art pessaries are the pessaries
manufactured by Milex Wester Company, 639 North Fairfax,
Los Angeles, California 90036; while an example of such
weighted cone device is the "FEMINA" cone manufactured by
Dacomed Corporation, 1701 East 79th Street, Minneapolis,
Minnesota, 55425. Other types of prior art devices
include electromyographic (EMG) transducers or sensors
which are insertable into or placed just outside o~ the
vagina and/or anus to obtain EM~ data indicative of
baseline pelvic floor muscle tone and/or contraction(s)
of the pelvic floor muscles during the performance of
specific muscle contraction exercises. Such EMG data may
be usable for diagnostic purposes as well as for
monitoring the performance and/or effect of muscle
training exercises. Some EMG devices have included means
for providing visual or auditory ~eedback to assist the
patient in the performance of pelvic floor muscle
exercises (e.g., Myoexorciser III, available from Verimed
1401 East Broward Boulevard, Suite 200, Fort Lauderdale,
Florida 33301 and the PRS 8900 Office System made by
Incare Medical Products, Libertyville, Illinois 60048.
Additionally, the prior art has included at least
one transvaginal electrical stimulation device which is
operative to deliver periodic or timed electrical
stimulation to the pe~vic floor muscles and nerves. Such
electrical stimulation causes involuntary contraction of
the pelvic ~loor muscles and may serve as an adjunct to
-
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the performance of volitional exercise and/or other
behavioral training techniques (e.g., Microgyn II
Stimulation Device, InCare Medical Products, Division of
Hollister Incorporated, 2000 Hollister Drive,
LibertyVille, Illinois, 60048 and also the Innova
F~m;nine Incontinence Treatment System available from
EMPI, Inc., 1275 Grey ~ox Road, St. Paul, Minnesota
55112).
Although some of or all of the above-described
devices and systems for exercise and/or training of the
pelvic floor muscles may be effective in the treatment of
urinary incontinence, there r~ ~i n~ a need for the
development of improved devices and systems which are
capable of strengthening and training the pelvic floor
muscles in ~;n; ~l time, with i n; ~1 assistance from
physicians or other health care professionals as well as
a system which serves to remind a user to perform muscle
exercises and to provide proprioceptive input to assist
the user in exercising and strengthening desired muscles.
~ii. Pharmacologic Treatment For Incont;n~nce
The prior art pharmacologic treatment of urinary
incontinence typically involves the long term
administration of drugs. Such pharmacologic treatment may
result in drug-related side effects. Also, the efficacy
of such pharmacologic treatment is frequently limited and
largely dependant upon the patient~s ability or
willingness to comply with the prescribed drug dosage
schedule.~0
iv. Surgical Treatment For Inconti~e~
The prior art surgical modes of treatment of urinary
incontinence typically involve the performance of one or
more major surgeries procedures under anesthesia. These
major surgical procedures can be associated with
significant risks and may sometime result in post-
surgical failure, infections, or other complications.
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Also, these surgical procedures typically result in
significant expense to the patient and/or the patient's
third party insurer.
As such, there exists a substantial need in the art
for an incontinence treatment system and methodology
which reduces or el; ;nAtes the need for prior art
management apparatus and/or surgical treatments, reduces
the use of long-term drug administration, accentuates
muscle strengthening and training while rA ; n~; ng a
patient to conduct muscle strengthening exercise, as well
as provide a proprioceptive input to assist the patient
in contracting the appropriate muscles and/or muscle
groups necessary for the effective treatment of
incontinence.
S~ ry of the I~vention
In accordance with the present invention, there is
provided a device which is insertable into a pelvic
anatomical passageway of a patient (e.g., the vagina or
anus) to facilitate the performance of pelvic muscle
exercises. The device generally comprises a device body
which is a~ternately transitionable between i) a rest
mode con~iguration wherein said device body exerts no
more than a base line amount of pressure against a
predetermined region of the anatomical passageway within
which the device body is located and, ii) an exercise
mode con~iguration wherein the device body exerts more
than the base line amount of pressure against the
predetermined region o~ the anatomical passageway within
which the device body is inserted. A small battery and
battery-powered motor may be mounted on or within the
device to drive the transformation of the device between
the rest mode configuration and the exercise mode
configuration. Additionally, a timer apparatus may be
mounted on or within the device to trigger and control
the timing, duration, repetitions, and frequency of
transformation of the device between the rest mode
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configuration and the exercise mode configuration, on a
predetermined time schedule.
Further in accordance with the invention, a vibrator
apparatus may be mounted on or within the device to cause
at least a portion of the device to vibrate in an
exercise mode configuration.
Still further in accordance with the invention, a
remote controlled triggering device may be used in
addition to, or in place of, a timer or other control
apparatus mounted on or within the device. Such remote
control apparatus may be utilized to trigger, control
and/or schedule all operational parameters of
transformation of the device, back and forth, between its
rest mode configuration and exercise mode configuration,
from a remote location.
Still further in accordance with the invention,
there is provided a method of treating urinary and/or
fecal incontinence in a patient. In general, the method
comprises the steps of inserting a device of the forgoing
character into either the vagina or anus, and utilizing
the device to intermittently deliver increased
stretch/resistance/vibration/pressure or heat stimuli
against the wall and/or adjacent muscles o~ the vagina or
anus to facilitate the performance of pelvic muscle
strengthening exercises by the patient in whom the device
is inserted.
Brie~ Description of the Drawings
Figure 1 is a perspective view o~ a first embodiment
of an indwelling urinary and/or fecal incontinence
treatment device of the present invention.
Figures 2 is a cross sectional view of the device of
Figure 1 disposed in a resting mode and operatively
inserted in to the vagina.
Figure 3 is a cross sectional view of the device of
Figure 1 disposed in exercise mode and operatively
inserted into the vagina.
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Figure 4 is a perspective view of an alternative
second embodiment of the indwelling urinary and/or fecal
incontinence treatment device of the present invention.
Figure 4a is a perspective view of an alternative
s embodiment of the incontinence treatment device of Figure
4.
Figure 5 is a cross sectional view of the device of
Figure 4 disposed in a resting mode and operatively
inserted into the vagina.
Figure 6 is a cross sectional view of the device of
Figure 4 disposed in an exercise mode and operatively
inserted into the vagina.
Figure 7 is a cross sectional view of an alternative
third embodiment of the indwelling incontinence treatment
device of the present invention.
Figure 8 is a cross sectional view of the device of
Figure 7 further equipped with an optional vibrator
and/or heater apparatus.
Detailed Description of the Preferred '~; ts
The following detailed description and the
accompanying drawings are provided for the purpose of
describing certain presently preferred embodiments of the
invention only, and are not intended to limit the scope
of the claimed invention in any way.
Some of the accompanying drawings include showings
of the device of the present invention operatively
positioned within the human body. The anatomical
structures shown on such drawings are labeled in
accordance with the following legend:
Urethra . . . . . . . . U
Vagina. . . . . . . . . V
Anus. . . . . . . . . . A~5
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i. First Emho~i ~nt
Figure 1 shows a ~irst embodiment of a intra-vaginal
or intra-anal device 10 of the present invention which
may be utilized for the effective treatment of both
urinary and fecal incontinence in female as well as male
users or patients. The device 10 is operative to provide
timed or periodic changes in stimuli such as pressure or
resistance against the pelvic floor muscles. The changes
in pressure, stretch, or resistance created by the
indwelling device 10 will promote proprioceptive
neuromuscular facilitation and serve as a reminder to
perform, and/or will facilitate the performance of,
muscle-strengthening exercises (e.g., Kegal exercises) by
the patient in whom the device 10 is indwelling. A more
detailed description of proprioceptive neuromuscular
facilitation is found in Sullivan, P. E., et al.: "An
Integrated Approach To Therapeutic Exercise", published
by ~eston Publishing Co., Reston, Virginia, pages 161-
183, the disclosure of which is expressly incorporated
herein by reference.
With reference to Figures 1-3, the first embodiment
of the device 10 comprises a generally elongate body 12
having a first end wall 14, a second end wall 16 and a
pliable side wall 18. The first end wall 14 has a
diameter D1 which permits the device 10 to be easily
inserted into the intended pelvic anatomical passageway
(e.g, vagina, anus) but be large enough to capture, i.e.,
maintain, the device 10 at a desired position within the
anatomical passageway. When inserted, the device 10 is
in a rest mode (Figure 2) wherein the pliable side wall
18 may have an inwardly curved configuration of a second
diameter D2 at it narrowest point. Such inwardly curved
configuration of the side wall 18 may, for example, cause
the device body 12 to have a hyperboloid or venturi-like
configuration while in its rest mode.
An optional tube 20 extends longitll~; n~l ly through
the body 12 of the device lo and forms a channel through
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which vaginal secretions may flow. A hollow, annular
internal cavity 24 is de~ined within the device body 12,
inboard of the pliable sidewall 18 and surrounding the
tubular passageway 20.
s A ~rusto-conical pressure-exerting member 22 is
disposed within the generally annular internal cavity 24
formed within the body 12 of the device 10. A hollow
central bore 26 extends longitll~; n~l ly through the
~rusto-conical pressure-exerting member 22. As shown,
the frusto-conical pressure-exerting member 22 is
initially located in a rest mode position within the
internal cavity 24, adjacent the first end wall 14 of the
device body 12. The tube 20 passes through the central
bore 26 ~ormed in the pressure-exerting member 22. The
pressure-exerting member 22 is slidably moveable in a
downward direction, to an "exercise mode" position (Fig.
3) where at upper end (i.e., the larger diameter base) o~
the frusto-conical pressure exerting member 22 will exert
radially outward pressure against the pliable side wall
18, thereby causing the inwardly curved region of the
sidewall 18 to de~orm outwardly and to exert pressure
against an adjacent region o~ the anatomical passageway
(e.g., vagina or anus), as shown.
A motor housing 28 is mounted on the outer surface
of the first end wall 14 of the body 12 and serves as an
enclosure or housing for a small electric motor 30 along
with a battery or power source 32 for powering the motor.
An externally screw-threaded rotatable drive member 34 is
connected to, and is driven by, the electric motor 30.
Such screw-threaded rotatable drive member 34 extends
through the ~irst end wall 14 of the device body 12 and
into an internally threaded first longitudinal bore 36
~ormed in the ~rusto-conical pressure-exerting member 22,
as shown. A positioning dowel 38 is anchored to the
underside of the motor housing 32 at a location opposite
or spaced away ~rom that of the rotatable threaded drive
member 34. Such positioning dowel 38 extends through the
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first end wall 14 of the device body 12 and into a second
longitudinal bore 40 which extends into the frusto-
conical pressure-exerting member 22, as shown. In this
regard, the motor 30 is initially operated in a first
direction to cause the threaded rotatable drive member 34
to rotate in a first (e.g, counterclockwise) direction.
Such rotation in the first direction will cause the
threaded rotatable drive member 34 will rotatably
withdraw from the threaded first longitll~; n~l bore 36.
Such retraction of the drive member 34 from the threaded
first bore 36 will cause the frusto-conical pressure-
exerting member 22 to move downwardly within the annular
internal cavity 24 of the device body 12 from its initial
rest mode position (Figure 2) to its exercise mode
position (Figure 3). Concurrently with this downward
travel of the frusto-conical resistance member, the
positioning dowel 38 will slide partially out of the
second bore 40, but will remain partially inserted into
second bore 40 so as to hold the frusto-conical pressure-
exerting member 22 firmly in the orientation shown inFigures 2 and 3.
When the frusto-conical pressure-exerting member 22
has descended to its exercise mode position, the patient
will sense the exertion of pressure stretch or resistance
against the vaginal or anal wall and/or adjacent muscles
created by such operative positioning of the frusto-
conical pressure-exerting member 22. The patient will be
thereby reminded and compelled to volitionally perform
the prescribed pelvic wall muscle exercises. Also, the
pressure, stretch and/or resistance created by the
operatively positioned pressure-exerting member 22 will
improve the muscle-strengthening efficacy of such
exercises by proprioceptive neuromuscular facilitation.
; After a predetermined time (e.g., sufficient time
for the patient to perform the prescribed muscle
exercise) has expired, or upon delivery of other
triggering input (e.g., a remote control signal), the
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electric motor 30 will drive the rotatable drive member
34 in a second direction (e.g., clockwise) such that the
threaded drive member 34 will rotatably advance into the
first threaded bore 36 of the frusto-conical pressure-
exerting member 22, thereby causing the frusto-conical
pressure-exerting member 22 to move from its "operative"
position (Fig. 3) back to its "non-operative" position
(Fig. 2). Again, the positioning dowel 38 will slide
downwardly into the second longitudinal bore 40 of the
frusto-conical pressure-exerting member 22 thereby
maintA;ning the desired positioning of the ~rusto-conical
pressure-exerting member 22 within the annular internal
cavity 24 of the device body 12.
After the frusto-conical pressure-exerting member 22
has returned to its "non-operative" position (Fig. 2) the
device 10 may remain in its rest mode and indwelling
within the vagina V or anus A. Upon expiration of a
predetermined time period or upon receipt of a triggering
input signal, the motor 30 will again drive the rotatable
threaded drive member 34 in the first direction so as to
cause the frusto-conical pressure-exerting member 22 to
once again descend to its "operative" position (Fig. 3),
thus returning the device 10 to its exercise mode for an
additional period of time.
The above-described sequence of events may be
repeated on any prescribed schedule, or at any prescribed
~requency or variable extension, so long as the device 10
L~ ~i n~ indwelling within the vagina V or anus A. A
small triggering and control apparatus, such as a timer,
53 may be mounted within the motor housing 58 and
connected to the motor 60 to cause the motor to move the
pressure-exerting member 22, up and down, on a
predetermined time schedule. Alternatively, a remote
control or telemetric switch or signal receiver may be
utilized to receive remote control signals and to
schedule the operation of the device by actuating or
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deactuate the movement of the pressure exerting member
22, as desired.
ii. ~~~onA r hl~A; nt
By way of example, a second alternative embodiment
of the device lOa is shown in Figures 4-6 which utilizes
a different articulation mech~n; ~m to function in an
analogous manner to that described in relation to Figures
1-3. In this second alternative embodiment, the device
lOa comprises a device body 50 having first and second
end walls 52, 54 and a pliable side wall 56. The pliable
side wall 56 is bendable or otherwise alternately
configureable in a first rest mode configuration (Fig. 5)
wherein the sidewall 56 is inwardly curved (e.g., a
hyperbolic or venturi-like shape) to a ~i n; -1 diameter
at its mid-region and a second exercise mode
configuration (Fig. 6) wherein the side wall 56 is
outwardly deformed or outwardly curved to an expanded
diameter at its mid-region (Fig. 6).
A hollow interior cavity 57 is defined within the
device body 50. A motor housing 58 is mounted on the
first end wall 52 of the device body 50. The motor
housing 52 serves as an enclosure or housing for a small
electric motor 60 and battery 62. The battery 62 is
connected to the electric motor 60 for the purpose of
driving the electric motor 60.
A pressure-exerting assembly 64 is connected to the
underside of the motor housing 58, and is disposed within
the hollow interior cavity 57 of the device body 50. The
pressure-exerting assembly 64 is operative to alternately
move the side wall 56 of device body 50 between its rest
- mode configuration (Fig. 5) and its exercise mode
configuration (Fig. 6). The preferred pressure-exerting
assembly 64 generally comprises a central telescoping
portion 66 and a plurality of hinged strut members 68
disposed about the central telescoping portion 66.
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In particular, the central telescoping portion 66 ofthe pressure-exerting assembly 64 comprises a first
rotatable shaft member 70 which is rotatably connected to
the electric motor 60, and which is alternately rotatable
inopposite directions (e.g., clockwise/counterclockwise)
in accordance with forward or reverse rotation of the
motor 60. The first shaft member 70 has an internally
threaded longitudinal hollow bore extending through at
least a portion thereof. A second solid shaft member 72,
having an externally threaded outer surface is received
within internally threaded hollow bore of the first shaft
member 70 such that, when the first shaft member 70 iS
rotated in a first direction, the second shaft member 72
will advance longitudinally out of the end of the first
shaft member 70 and when the first shaft member 70 iS
rotated in an opposite second direction, the second shaft
member 72 will retract into the hollow bore of the first
shaft member 70. In this regard, the central telescoping
member 66 may alternate between a first rest mode length
Ll (Fig. 5) and a second exercise mode length L2 (Fig. 6).
The bendable strut members 68 are disposed about the
central telescoping member 66 such that, when the central
telescoping member 66 shortens from its first length L
to its second length L2, the bendable strut members ~8
will bend and diverge at their hinged mid points 76,
thereby exerting radially outward pressure against the
side wall 56 to move from its rest mode configuration
(Fig. 5) to its exercise mode configuration (Fig. 6).
The hinged strut members 68 are hingeably or
bendably connected to non-rotating anchoring flanges 74,
75. The lower anchoring flange 74 is affixed to the end
of the non-rotating second sha~t member 72, as shown.
The upper Eirst flange member 75 is aEfixed to the
underside of the motor housing 58 and is provided with a
central aperture slightly larger in diameter than the
outer diameter of the first shaft member 70 such that the
first shaft member 70 extends through such aperture and
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r~;n~ freely rotatable while the first flange member 75
remains non-rotatably anchored to the motor housing 58.
In this regard, when it is desired to cause the
device lOa to transition from its rest mode configuration
(Fig. 5) to its exercise mode configuration (Fig. 6), the
motor 60 will rotate the first shaft member 70 in a first
direction (e.g., counter clockwise) such that the second
shaft member 72 will telescopically retract into the bore
of the first shaft member 70, thereby causing the central
telescoping member 66 to shorten from its initial rest
mode length L1 to its exercise mode length L2.
Concurrently with such shortening of the central
telescoping member 66, the hinged strut members 68 will
bend at their central hinges 76 and will splay or diverge
outwardly to exert radially outward pressure against the
pliable side wall 56 of the device lOa, thereby forcing
the side wall 56 from its inwardly curved configuration
(Fig. 5a) to its outwardly curved or outwardly deformed
configuration (Fig. 6).
Thereafter, when it is desired to return the device
lOa to its rest mode configuration, the motor 60 will
drive the first shaft member 70 in a second direction
(e.g., clockwise) such that the second shaft member 72
will advance out of and longitudinally extend from the
bore of the first shaft member 70, thereby causing the
central telescoping member 66 to lengthen from its
exercise mode length L2 to its rest mode length L1.
Concurrently therewith, the hinged strut members 68 will
move toward a straight, non-bent configuration such that
the central hinge members 76 thereof will move radially
inwardly so as to allow the pliable side wall 56 of the
device to return from its outwardly curved exercise mode
configuration (Fig. 6) to its inwardly curved rest mode
configuration (Fig. 5).
As will be recognized, this second embodiment of the
present invention additionally includes a timer or
controller which functions to selectively cause the
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device 10 to go from a rest configuration to an operative
configuration as desired. Additionally, in lieu of the
plural articulating strut members 68 shown in Figure 4,
the plural spring members 68a may be utilized as depicted
in Figure 4a to provide an analogous expansion and
contraction of the device 10. The spring members 68a may
be formed of a metal or polymer material as desired.
iii. Third r h~ nt
By way of ~urther example, an alternative third
embodiment of the invention is shown in Figures 7 and 8.
With reference to ~igure 7, the third embodiment of
the device lOb comprises a device body 100 having a first
end wall 102, a second end wall 104, and a side wall 106
having an inwardly curved (e.g., hyperboloid or venturi-
like) configuration. A hollow interior space 114 i5
defined within the rigid side wall 106 and end walls 102,
104 of the device body 100. A pliable cylindrical
membrane or balloon member 108 is mounted about the outer
surface of the side wall 106 such that a fluid-tight
inflation space 110 is formed between the inner surface
of the pliable membrane or balloon member 108 and the
outer surface of the rigid side wall 106.
A small battery-operated pump 112, including a
battery therefore, is mounted within the interior space
114 of the device body in communication with an inflation
inlet/outlet aperture 120 formed in the rigid sidewall
106 to permit passage of air or other inflation fluid
into and out of the inflation space 110.
An inlet aperture 103 is formed in the top end wall
102 of the device body 100 to permit body secretions to
flow through the device 10. An outlet aperture 105 is
formed in the bottom end wall 104 to permit such
secretions to flow out of the device 10.
When inserted in the vagina or anus, the body 100 of
the device lOc will remain in its rest mode configuration
such that the balloon or membrane 108 is inwardly curved
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to a diameter D2 at it narrowest point, as shown in
Figure 7. Thereafter, when it is desired to cause the
device 10c to exert radially outward pressure, stretch or
resistance against the vaginal or anal wall and/or
adjcent muscles, the pump 112 will be energized so as to
pump air or other inflation fluid into the inflation
space 110, thereby causing the balloon or membrane 108 to
bulge outwardly to its configuration having a diameter D3
at is widest point.
Thereafter, when it is desired to return the device
10c to its rest mode configuration, the pump 112 will be
utilized to pump or vent inflation fluid from the
inflation space 110 out of inflation inlet/outlet
aperture 120, thereby allowing the balloon or membrane
108 to deflate, and to return to its original venturi-
like rest mode configuration.
iv. Optional Vibrator and/or Heater Apparatus
In any embodiment of the invention, a vibrator
apparatus or heater apparatus may optionally be mounted
on or within the device to provide vibratory stimulation
to the vaginal or anal wall and/or adjacent muscles to
facilitate strengthening of the pelvic wall muscles
and/or to serve as a sensory reminder to the patient to
volitionally perform prescribe muscle-strengthening
exercises. By way of example, Figure 8 shows the device
10c of Figure 7 having first and second optional vibrator
and/or heater apparatus 122 mounted on the inner surface
of the balloon or membrane 108. Such vibrator and/or
heater apparatus may incorporate a small electrical motor
or other vibrating device or conventional electric heater
coupled to a small battery (not shown). The vibrator
and/or heater apparatus 122 may be operated on a timed
cycle, or may receive other triggering input which will
cause the vibrator apparatus 122 to vibrate and/or heat
when the device 10c is in its exercise mode
configuration, but will allow the vibrator and/or heater
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apparatus 122 to remain non-vibrating and quiescent when
the device lOc is in its rest mode configuration.
Further, it will be recognized that the vibrator
apparatus 122 may be used in lieu of the articulating
motor drive mech~ni~ ~ when desired.
It is to be understood that the individual elements
and components of each above-described embodiment may be
interchanged among and/or incorporated into any and all
embodiments of the invention, even though certain
elements or components may have been mentioned or
described herein with respect certain embodiment(s) of
the invention only.
It is to be further understood that various
additions, deletions, modifications and alterations may
be made to the above-described embodiments w~thout
departing from the intended spirit and scope of the
present invention. Accordingly, it is intended that all
such additions, deletions, modifications and alterations
be included within the scope of the following claims.
