Note: Descriptions are shown in the official language in which they were submitted.
CA 02563723 2006-10-13
1 CHEST VIBRATING DEVICE
2
3
4
FIELD OF THE INVENTION
6 The present invention generally relates to a therapeutic device for use by
people with
7 cystic fibrosis or other conditions which obstruct the air ways and/or the
lungs. Additionally, the
8 present invention relates to a method to assist in loosening obstructions in
the air ways and/or
9 lungs of human users.
BACKGROUND OF THE INVENTION
11 In healthy individuals, clearance of mucus from the respiratory tract is
accomplished
12 primarily by the body's normal mucociliary action, coupled with coughing.
Under normal
13 conditions these mechanisms are very efficient; the mucociliary transport
system continually
14 transports a layer of mucus secreted in the lungs up the trachea and out of
the respiratory system
to be swallowed, while coughing displaces larger blockages. The mucociliary
transport system
16 depends upon cilia, small cytoplasmic extensions of cells lining the inside
of the respiratory
17 system. Cilia rhythmically move side to side, progressively shifting the
layer of mucus to the
18 trachea. Ciliary movement has a predictable rate (the Cilia Beat Frequency
(CBF)), which in
19 healthy individuals has a frequency of about 10-30 beats per second.
Impairment of the normal
mucociliary transport system (slowing the CBF below 10 beats per second) or
hypersecretion of
21 respiratory mucus results in an accumulation of mucus and debris in the
lungs which may lead to
22 severe medical conditions such as hypoxemia, hypercapnia, chronic
bronchitis, and pneumonia.
23 These conditions diminish quality of life, and may even prove fatal. Many
medical conditions
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CA 02563723 2006-10-13
1 can produce abnormal respiratory mucus clearance, including pertussis,
cystic fibrosis,
2 atelectasis, bronchiectasis, cavitating lung disease, vitamin A deficiency,
chronic obstructive
3 pulmonary disease, asthma, and immotile cilia syndrome. Exposure to
cigarette smoke, air
4 pollutants, and viral infections also inhibits mucociliary function. Post
surgical patients,
paralysed persons, and newborns with respiratory distress syndrome also
exhibit reduced
6 mucociliary transport. Respiratory system blockages also occur in patients
suffering from
7 emphysema, tuberculosis, and disorders caused by many other pathogens which
affect the
8 respiratory system.
9 Chest physiotherapy (CPT) is used to enhance respiratory mucus transport.
CPT may
include mechanical manipulation of the chest, postural drainage with
vibration, directed cough,
11 active cycle of breathing, and autogenic drainage. External manipulation of
the chest and
12 respiratory behavioural training are accepted practices according to the
American Association for
13 Respiratory Care Guidelines, 1991. CPT involves a caregiver "clapping" or
pounding on the
14 chest and back over each lobe of the lungs, coupled with inhalation
therapy. A typical CPT
session requires half to three-quarters of an hour. While the mechanism by
which CPT clears
16 mucus is not entirely clear, the pounding dislodges air way secretions
which drain towards the
17 mouth and are removed by active coughing. Various kinds of CPT are often
combined by
18 physicians when designing regimes to enhance mucus clearance.
19 Cystic fibrosis (CF) is one important disorder in which CPT is used to help
clear air ways
or lungs. Cystic fibrosis (CF) is an inherited life-threatening genetic
disease among Caucasians,
21 afflicting about 1 in 600 children. One in twenty five persons of European
descent carry the
22 mutation which causes CF. This genetic defect disrupts cellular chloride
ion transfer, causing
23 mucus from the exocrine glands to become abnoimally thick and sticky,
eventually blocking
24 passages within the pancreas, lungs, reproductive organs, and liver.
Disruption of the pancreas
inhibits enzyme secretion, sometimes resulting in osteoporosis. Thick mucus
may block
26 reproductive tracts, in particular lowering male fertility. Crucially, the
thick mucus accumulates
27 in the lung's respiratory tracts, causing chronic infections, scarring, and
decreased vital capacity.
28 Normal coughing is not sufficient to dislodge these mucus deposits. CF
symptoms usually
29 appear during the first 10 years of life, typically in infancy, and
significantly reduce life
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1 expectancy. However, with advances in digestive enzyme supplementation, anti-
inflammatory
2 therapy, chest physical therapy, and antibiotics, the median life expectancy
currently exceeds 30
3 years, and some patients live into their 50's and beyond. While some patient
mortality results
4 from severe gastrointestinal disruptions, the majority of CF patients (90
percent) ultimately
succumb to respiratory system failure.
6 Most CF patients use CPT once to four times a day as part of their standard
preventative
7 care program to maintain vital capacity and inhibit infection. CPT requires
the assistance of a
8 second individual, ideally a nurse or respiratory therapist, but more
typically a family member.
9 Effective CPT requires precise pounding, and CPT is exhausting for the CF
patient and
caregiver. A tired or inaccurate caregiver often only provides incomplete
relief. CF patient
11 dependence upon a second individual to perform CPT severely limits the
independence of the CF
12 patient. Additionally, pounding involves sharp blows, which can bruise
patients, and may even
13 break bones, particularly in small children and CF patients who suffer from
osteoporosis.
14 Over the past several decades, a diverse assortment of devices have
attempted to provide
an alternative to caregiver delivered CPT for persons suffering from disorders
which obstruct
16 lungs or air ways, including CF. CPT replacement devices typically mobilize
and clear mucus by
17 creating chest wall oscillations analogous to those experienced by a
patient undergoing manual
18 CPT. These devices differ in the kind of force applied and any resulting
motion experienced by
19 the subject, and by whether the force is administered locally, over a large
area, to the entire chest,
or the entire body. Inventions apply force by repeated chest constriction,
chest vibration, and
21 impact or blow-like forces (percussion) to the entire patient, or specific
locations.
22 Most marketed devices address lung congestion by pneumatically generated
vibrations.
23 These devices are usually large and restrict user mobility, and fail to
target the lower lobes of the
24 lungs, the typical infection start point.
Percussion based devices have been described in the literature. Strom et al.,
in U.S.
26 Patent No. 4,508,107, discloses a hand-held pneumatic impact system, and
Mulligan et al., in
27 U.S. Patent No. 5,261,394 describe a chest pack containing two
reciprocating arms which
28 simultaneously strike the user's chest on either side of the sternum.
Percussion based devices
29 possess many of the drawbacks associated with manual CPT therapy, the shaip
impacts can
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1 injure young or frail patients, and therefore these devices are not suitable
in all cases.
2 Furthermore, the strength of the impacts and associated recoil makes
manipulation and control of
3 these devices inherently difficult.
4 A number of commercially available lung clearing devices use constriction, a
repeated
squeezing and release of the entire chest region. Constriction may be provided
by a variety of
6 means. Certain apparatus, such as the commercially available Vest Airway
Clearance System
7 ("The VestTM") distributed by Hill Rom, a subsidiary of Hillenbrand
Industries, Inc. (described in
8 Van Brunt et al., U.S. Pat. No. 5,769,797 and numerous other patents) apply
pressure to the
9 patient's chest pneumatically. The Vest contains air bladders which are
periodically pressurized
and depressurized by an external air pressure system, repeatedly squeezing the
chest at a
11 frequency of 5-20 Hz. Another vest apparatus with a distinct pneumatic
pressure source,
12 operating at 5-25 Hz, is described by Hansen, see for example U.S. Pat. No.
6,547,749. The
13 device described in Van Brunt, U.S. Pat. No. 6,736,785 creates analogous
patient body motions
14 via a mechanism cyclically squeezing the subject's chest with an inflexible
circumferential chest
band. Arbisi et al., in U.S. Patent No. 5,235,967 describe forces being
applied to a subject by
16 repulsion between numerous electromagnets mounted within a flexible vest or
shirt like garment,
17 the magnetic repulsion pressing a layer of electromagnets onto the subject.
All these apparatus
18 apply force over the entire chest, typically by surrounding the chest in a
garment, and then
19 repeatedly squeezing inward. These inventions are often bulky, for example,
the pneumatic vests
require a large external pressure source. Patients undergoing constriction
based therapy often
21 have difficulty breathing due to the way these devices compress the chest.
22 A wide variety of hand-held vibrators have been described for treating CF
patients and
23 other respiratory ailment sufferers. These devices may rhythmically pound
the chest at high rates
24 (ex. Denton et al. U.S. Patent No. 4,079,733, preferably impacting the
chest at 115 Hz), move
parallel to the surface of the subject (ex. Muchinsky et al., U.S. Patent No.
4,098,266), or both at
26 once (ex. Muchinsky et al., U.S. Patent No. 4,102,334). Many of these hand-
held units are not
27 particularly portable, and have a large external mechanical power source.
Additionally, these
28 hand-held vibrators require an attendant to maintain the device in contact
with the patient, and
29 press the vibrator against the patient. Since these devices inherently move
and vibrate, the
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1 person holding the vibrator must overcome these motions to keep the hand-
held vibrator in place,
2 an effort that can be tiring and inconvenient. Larouche et al., in U.S.
Patent No. 5,167,226,
3 discloses a combined clapping and vibrating device where a nominally hand-
held device is only
4 practical once mounted on a bed by a supporting arm, presumably to address
this problem. With
hand-held vibrations, treatment is local and the user must reposition the
vibrator from chest area
6 to chest area, resulting in lengthy and potentially incomplete treatment
sessions.
7 Other devices which assist clearing lungs and air ways vibrate the entire
subject, or the
8 subject's chest. One strategy involves submerging the subject in a bath,
then transmitting
9 vibrations from a source such as a audio speaker to the subject via the
fluid (see for example
Nedwell, U.S. Patent No. 6,190,337, Rogers et al., U.S Patent Application No.
2002/0014235,
11 published Feb. 7, 2002). Obviously, these vibrators are large and
essentially immobile, and
12 impractical for daily home use. Vibrating beds such as the pneumatic design
described in Hand
13 et al. (U.S. Patent Application No. 2002/0195144, published Dec. 26, 2002)
have similar
14 limitations.
Another approach is to vibrate the air within the patient, rather than the
patient's body
16 (see for example Gibson, UK Patent No. 2,196,585, Jam, U.S. Patent
Application No.
17 2004/0069304, published April 15, 2004, Benarrouch, et al., U.S. Patent No.
6,176,235, Fowler-
18 Hawkins, U.S. Patent No. 6,702,769). One variant of this approach has been
marketed by
19 Scandipharm as "The Flutter"". The Flutter uses the patient's breath to
oscillate a ball bearing,
creating vibrations which are then transmitted down the patient's air ways.
This technique is
21 limited by the strength at which the patient's breath can oscillate the
ball bearing, a potentially
22 serious limitation when treating patients suffering from chronic
respiratory illness. Furthermore,
23 these techniques transmit vibrations by air, a much less mechanically
efficient vibration
24 transmission method than vibration transmission through solids.
There remains a need for a device which adequately provides a replacement for
manual
26 CPT, allows patient independence, and provides rapid, efficient, and
consistent treatment.
27 SUMMARY OF THE INVENTION
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1 In one embodiment, the invention broadly provides a chest vibrating device
including a
2 frame (i.e. rigid frame), shoulder pads, chest pad (i.e. front pad) and back
pad. The frame is
3 configured to fit around an upper body of a user. The shoulder pads extend
from the frame to
4 rest the frame on shoulders of the user. The chest pad extends from a front
inside of the frame
towards the chest of the user. The back pad extends from the rear inside of
the frame towards the
6 back of the user. A vibrating unit is attached to the frame and produces a
vibration that travels
7 from the vibrating unit, through the frame onto the chest pad and at least
one back pad.
8 In a second embodiment, broadly stated, the invention provides a vibrating
device for
9 assisting in loosening of obstructions in the lungs or air way of a human
user. The vibrating
device includes: a rigid frame for positioning and clamping around the user's
chest; a plurality of
11 pads connect to, and extending inwardly from, the rigid frame to contact
the chest from opposite
12 sides of the chest when the frame is clamped around the user's chest; and a
vibrator connected to
13 the rigid frame, the vibrator generating and imparting vibrations
sufficient to transfer through the
14 rigid frame and pads to the user's chest to assist loosening of
obstructions in the lungs or air way
of the user.
16 Through testing of the device of the present invention with CF patients, it
was
17 surprisingly discovered that the device was effective when the vibrations
imparted to the rigid
18 frame had a frequency sufficient to stimulate the user's cilia beat
frequency (CBF) to assist in
19 loosening of obstructions in the lungs or air way. Preferably, this
frequency is greater than 10
Hz, more preferably at 11 to 20 Hz, and most preferably in a range of 13 to 16
Hz. Also
21 discovered during testing of the device was that the amplitude of the
vibrations to be effective in
22 transferring vibrations through to the chest is preferably in the range of
about 0.1 to 2 mm.
23 Preferably, one or more of the plurality of pads are connected to the rigid
frame in an
24 adjustable manner to adjust their position andlor orientation to
accommodate users of differing
size and gender. In one embodiment, the one or more of the adjustable pads may
be adjusted in a
26 lateral to medial direction, and/or the one or more of the adjustable pads
are connected to the
27 rigid frame through a pivoting or a ball and socket connection to adjust
orientation.
28 In the preferred embodiment of this invention, the vibrator is an off-set
weight mounted
29 for rotation by a motor. Preferably, the motor and the off-set weight are
oriented to rotate the
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1 off-set mass around an axis parallel to a medial to lateral axis of the
user's chest.
2 Preferably, the vibrating device has a plurality of pads which include: one
or more pairs
3 of back pads positioned to contact the back of the user on either side of
the spine; and a plurality
4 of front pads including an upper front pad positioned to contact the front
of the user over the
sternum, and one or more pairs of lower front pads positioned to contact the
front and/or sides of
6 the user's chest near the lower lobes of the lungs. As well the device
further comprises shoulder
7 pads connected to, and extending radially inwardly from, the rigid frame,
and positioned to
8 contact the user's shoulder to support the vibrating device when the user is
sitting or standing
9 upri ght.
Another broad aspect of the invention provides a method to assist in loosening
of
11 obstructions in the lungs or air way of a human user. The method includes:
positioning and
12 clamping a rigid frame around the user's chest such that the chest is
clamped within the rigid
13 frame from opposite sides of the user's chest; generating vibrations; and
imparting the vibrations
14 through the rigid frame to the user's chest to assist in loosening
obstructions within the lungs or
air way of the user.
16 This invention has significant advantages over both mechanical and care-
giver
17 administered CPT techniques. As a second party (a caregiver) need not be
involved when using
18 this vibrating device, the respiratory ailment patient has considerably
greater independence and
19 can schedule treatments with greater flexibility. In the preferred
embodiment of this invention,
the vibrating device is sufficiently light and small that the vibrating device
may be worn by a
21 standing or sitting user, and does not require a second person to enter,
exit, or operate the device.
22 Furthermore, this invention provides consistent, uniform treatment not
dependent upon
23 personnel who may have limited familiarity with CPT techniques, or upon a
caregiver who
24 becomes fatigued during lengthy CPT sessions. Since the patients themselves
control the
rotation of the off-set weight and the resulting vibration frequency, the user
may fine-tune their
26 treatment to match their particular needs and physical characteristics.
27 Unlike the localized application of force applied during manual CPT
procedures and by
28 many percussion devices, this invention transmits vibrations to the entire
chest through an array
29 of pads which cover broad areas of the user's chest, thereby avoiding
impact injuries such as
7
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1 bruising, or broken bones. As a result, patients too young or ill to receive
impact-based CPT may
2 safely use this invention. Unlike hand-held devices in which each area of
the chest and
3 respiratory system are individually vibrated, this invention vibrates the
entire chest and therefore
4 leads to treatment sessions of shorter duration.
Since this invention may be embodied in a single, self-contained unit worn by
a user, the
6 vibrating device is considerably more convenient than many alternative lung
clearing vibration
7 devices. For example, the The VestTM requires a bulky external pneumatic
pressure source, and
8 liquid filled vibration tanks are, by necessity, large fixed instillations.
Similarly, other vibrating
9 devices are essentially beds. The vibrating device of this invention may be
embodied in a form
which is sufficiently small and light that the user may walk about and engage
in other activities
11 while undergoing treatment.
12 An additional advantage of this invention is that the user need not hold
and manipulate
13 the vibrating apparatus while in use, thereby avoiding operator fatigue.
The vibrating device
14 does not require any user effort to maintain vibrator to chest contact, as
the frame clamps the
various pads against the user.
16 Through testing of the device of the present invention with CF patients, it
was discovered
17 that while using this invention, users may breath freely and deeply,
without the device
18 significantly impairing their lung vital capacity. The constrictive forces
associated with chest
19 compression devices such as The Vest may restrict users from engaging in
the full range of chest
motions required for deep breathing up to the user's vital capacity.
Additionally, when wearing
21 the device of the present invention, the user may continue to vibrate their
chest while coughing to
22 remove certain smaller lung and air way obstructions. To remove larger
obstructions, the user
23 only needs to temporarily stop the device's vibrations, then cough without
ever having to remove
24 the device from the chest. In contrast, a treatment session with a chest
compression device may
require the user remove the device on one or more occasion, breath deeply and
cough to mobilize
26 and remove lung and air way obstructions, then replace the device and
resume treatment.
27 Treatment using the present invention may result in shorter treatment
sessions.
28 The term "chest" as used herein and in the claims refers to the part of the
human skeleton
29 and musculature, including the diaphragm, which surrounds the pleural
cavity and encloses the
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1 lungs.
2 The term "medial to lateral" as used herein and in the claims refers to
either a direction of
3 movement or an axis relative to the chest or body of the user where the
referenced movement is
4 parallel to the axis through the shoulders of a human user, and where the
referenced axis is
parallel to the axis through the shoulders of a human user.
6 The phrase "opposite sides of the chest" as used herein and in the claims
refers to
7 locations on the chest which are generally on opposite sides of the human
chest skeleton and
8 musculature, for example the front and back, or the two sides, and is not
limited to locations on
9 the human chest which are diametrically opposed.
As used herein and in the claims, the terms "vertical" and "horizontal",
"upper" and
11 "lower", "right" and "left", "front", "side" and "back", "top" and "bottom"
and other like terms
12 refer either to the terms conventional meaning with reference to the user's
chest or body when
13 the user is standing upright, or refer to an apparatus positioned around a
user's chest, the term's
14 meaning defined by the terms conventional meaning with reference to the
user's chest or body
when the user is standing upright.
16 As used herein and in the claims, the word "comprising" is used in its non-
limiting sense
17 to mean that items following the word in the sentence are included and that
items not specifically
18 mentioned are not excluded. The use of the indefinite article "a" in the
claims before an element
19 means that one of the elements is specified, but does not specifically
exclude others of the
elements being present, unless the context clearly requires that there be one
and only one of the
21 elements.
22 BRIEF DESCRIPTION OF THE DRAWINGS
23 FIG. 1 is a perspective view of a chest vibrating device according to the
present
24 invention;
FIG. 2 is a front view of a chest vibrating device according to the present
invention;
26 FIG. 3 is a partial rear exploded view of a chest vibrating device
according to the present
27 invention;
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1 FIG. 4 is a partial cutaway perspective view of a hinge and shoulder pad
according to the
2 present invention;
3 FIG. 5 is a partial perspective view of a clamping unit according to the
present invention;
4 FIG. 6 is a partial perspective view of a female version chest pad according
to the present
invention;
6 FIG. 7 is an exploded view of a vibrating unit according to the present
invention;
7 FIG. 8 is a front perspective view of a further embodiment of a chest
vibrating device of
8 the present invention;
9 FIG. 9 is a partially exploded rear perspective view of the embodiment of
FIG. 8,
showing the vibrator housing cover removed to show the motor and off-set
weight;
11 FIG. 10 is a front view of the embodiment of FIG. 8, showing details of the
multiple
12 adjustable front pads, the front pad support bar, and the arcuate support
bars;
13 FIG. 11 is a side perspective view of the embodiment of FIG. 8, with the
frame opened to
14 allow a user to enter the frame, showing details of the multiple adjustable
front and back pads,
the rocker arms, and pad ball and socket and hinge connections; and
16 FIG. 12 is an end view of the off-set weight and shaft of the embodiment of
FIG. 8,
17 showing the preferred off-set weight shape, and the shaft position.
18 DESCRIPTION OF THE PREFERRED EMBODIMENTS
19 A first embodiment of the present invention is shown in FIGS. 1-7 to
include a chest
vibrating device 10, to be attached to the user. The chest vibrating device 10
includes a frame
21 12, chest pad (i.e. front pad) 16, back pads 18, shoulder pads 20, clamping
unit 22 and vibrating
22 unit 24. The chest vibrating device 10 vibrates, and by virtue of the rigid
frame, pad placement,
23 and clamping, transfers the vibrations through the frame and the pads to
the lungs of the user.
24 This clears the lungs by loosening obstructions in the air ways. The chest
vibrating device 10 is
fully adjustable to fit all sizes and can be fitted for both male or female
users. While the chest
26 vibrating device 10 can be used particularly for people with cystic
fibrosis, it has broad
27 application for users with other lung conditions and/or obstructed air
ways.
CA 02563723 2006-10-13
1 The frame (i.e. rigid frame) 12 includes a left arm, right arm, cross-member
30 and clamp
2 support 32. The left and right arms 26, 28 each include back pad rails 34
and housing rail
3 receivers 36. As shown in FIG. 3, each back pad rail 34 extends from an
inside surface of the left
4 and right arms 26, 28 at the rear half 38 of the frame 12 to connect to the
back pads. Each back
pad rail 34 includes a plurality of holes 40 along the back pad rail 34. Each
housing rail receiver
6 36 is a pair of rails 42 extending outward from the left and right arms 26,
28 at the rear half 38 of
7 the frame 12 and includes a plurality of aligned holes 44. The left and
right arms 26, 28 each
8 include a hinge 46 along their length at about the half way point, as shown
in FIGS. 1-2 and 4.
9 The hinges 46 allow the opening and closing of the frame 12 for entrance by
the user. FIG. 4
shows the employment of a ball hinge 48 and a flexible hinge cover 50. The
hinge cover 50 is
11 used to reduce wear, for aesthetic reasons, and for safety of the user. The
cross-member 30 is
12 attached to the front half 52 of the left and right arms 26, 28. As shown
in FIG. 1, the
13 cross-member 30 includes holes 54 to allow the adjustment of positioning of
the left and right
14 arms 26, 28. Fasteners 56 are used to attach the cross-member 30 to the
left and right arms 26,
28. The left and right arms 26, 28 also include clamp supports 32 attached to
the rear half 38 of
16 the left and right arms 26, 28. The clamp supports 32 extend from the rear
and towards the front
17 of the frame 12. A clamping unit 22 is attached to the cross-member 30 and
the clamp support
18 32 on each side of the frame 12. The clamping unit 22 is fully adjustable
to various size users.
19 The clamping unit 22 shown in FIGS. 1-2 and 5-6 is similar to belt-buckle
combinations used in
ski boots and in-line skates.
21 FIGS. 1-2 show a male version of the chest pad 16 and FIG. 6 shows a female
version of
22 the chest pad 60. The male chest pad 16 is mounted to the inside front half
52 of the left and
23 right arms 26, 28 using fasteners 62 and rubber mounts 64. The male chest
pad 16 is sized such
24 that the chest pad 16 extends down to vibrate the lower lobes of the lungs.
The female chest pad
60 includes an upper pad (i.e. upper front pad) 66, lower pad (i.e. lower
front pad) 68 and pad bar
26 (i.e. pad support bar) 70. The upper pad 66 is connected to the top of the
pad bar 70. The lower
27 pad 68 is connected to the bottom of the pad bar 70. The pad bar 70
includes adjustment holes
28 72 and is connected to the cross-member 30 using fasteners 74 and rubber
mount 76. The upper
29 pad 66 is sized to produce vibrations in the top of the lungs. The lower
pad 68 is sized to
11
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1 produce vibrations that reach not only the front of the lower lungs, but
also the sides of the
2 middle and lower lobes. The pad bar 70 is curved to wrap around the chest of
a female.
3 The back pads 18 are sized to reach from the upper to the lower lobes of the
lung. The
4 back pads 18 include back pad rail receivers 78, as shown in FIG. 3. Each
back pad rail receiver
78 is a pair of rails 80 extending outward from the rear of the back pads 18
and includes a
6 plurality of aligned holes 82. The back pads 18 are mounted to the left and
right arms 26, 28 by
7 sliding the back pad rails 34 between the rails 80 of the back pad rail
receiver 78. Then, one of
8 the holes 40 of the back pad rail 34 is aligned with a set of aligned holes
82 of the back pad rail
9 receiver 78 and a fastener 84 is inserted to secure the back pads 18 to the
left and right arms 26,
28. The shoulder pads 20 are curve shaped to fit over the shoulders of the
user and include
11 shoulder pad supports 86, as shown in FIGS. 1 and 4. The shoulder pad 20
are designed to
12 transfer the weight of the invention to the shoulders of the user. The
shoulder pads 20 should be
13 padded for comfort of the user. FIG. 1 shows the shoulder pad supports 86
attached permanently
14 using a technique such as welding, while FIG. 4 shows the shoulder pad
supports 86 mounted
between two plates 88 extending from the left and right arms 26, 28. The
mounting as shown in
16 FIG. 4 includes holes 90 through the two plates 88 and the shoulder pad
support 86 and fasteners
17 92 are used to connect the two plates 88 and the shoulder pad support 86.
The chest pad 16, back
18 pads 18 and shoulder pads 20 can include a coating that moulds to the shape
of the user for
19 comfort.
The vibrating unit 24 is shown in FIGS. 1-3 and 7. The vibrating unit 24
includes a
21 housing 94, housing rails 96 and vibrator 98. The vibrator 98 is shown as a
motor 100 which
22 rotates an off-set weight 102 to cause vibrations. The motor 100 is usually
of the type that runs
23 on 12 Volt DC or 120 Volt AC. The motor 100 is mounted to the inside back
104 of the housing
24 94. The housing 94 includes a housing cover 106 for safety. The housing
rails 96 extend
outward and along the outside back 108 of the housing 94. The vibrating unit
24 is mounted to
26 the frame 12 by inserting housing rails 96 between the rails 42 of the
housing rail receivers 36 of
27 the left and right arms 26, 28, and fastening using fasteners 110 through
holes 97. The vibrations
28 generated by the vibrator 98 are transferred through the housing 94 and the
housing rails 96 onto
29 the frame 12 and then to the chest and back pads 16, 18.
12
CA 02563723 2006-10-13
1 The operation of the chest vibrating device 10 is as follows. The user
adjusts the position
2 of the left and right arms 26, 28 along the housing rails 96 and cross-
member 30 for proper
3 sizing. The user lifts the front half 52 of the left and right arms 26, 28
upward along the hinges
4 46 to enter the frame 12. Then, the user slips into the frame 12 and closes
the front half 52 of the
left and right arms 26, 28 along the hinges 46. Finally, the user uses the
clamping unit 22 to
6 secure the frame 12 about the user, such that the chest pad 16 and back pads
18 are pressured
7 against the user. The chest vibrating device 10 can then be turned on to
create vibrations. The
8 vibrations transferred to the chest and back pads 16, 18 are passed onto the
lungs through the
9 chest and back of the user. As shown in FIG. 1, the chest vibrating device
10 can include a
controller 112 to vary the intensity of the vibrations (i.e. the rate of
rotation of the motor) to
11 create different strengths (i.e. frequencies) of vibrations to clear
secreted mucus from the lungs.
12 A second embodiment of present invention shown in FIGS. 8-12 and includes a
chest
13 vibrating device 120 to be attached to a user, to assisting loosening of
obstructions in the lungs or
14 air way of a human user. The chest vibrating device 120 can be used with
humans with lung or
air way conditions which involve obstructed air ways or a reduced CBF that
results in inadequate
16 mucus transport, including CF. The chest vibrating device 120 includes a
rigid frame 122, an
17 upper front pad 124, side lower front pads 126, lower front pads 127, back
pads 128, shoulder
18 pads 130, clamping units 132, and a vibrator 182. The frame 122 is shaped
to be positioned and
19 clamped around the user's chest. The pads 124, 126, 127, 128 are connected
to the frame 122 so
as to extend radially inwardly from the frame such that the pads are
positioned to contact the
21 user's chest from the opposite sides of the chest, when the frame 122 is
clamped around the
22 user's chest. The vibrator 182 is connected to the frame 122, and is
operative to generate
23 vibrations sufficient to transfer through the frame 122 and pads 124, 126,
127, 128, impart the
24 vibrations to the user's chest, and thereby assist in loosening
obstructions in the lungs or air ways
of the user. The pads 124, 126, 127, 128, 130, and rigid frame 122 are
manufactured from a
26 material such as metal which is sufficiently rigid to efficiently transfer
vibrations to the user's
27 chest. The chest vibrating device 120 is adjustable to persons of varying
body size and can be
28 fitted to both male or female users. In the preferred embodiment of this
invention, the vibrating
29 device 120 is sufficiently light and small so as to be comfortably worn by
a standing or sitting
13
CA 02563723 2006-10-13
1 user, and without requiring a second person to assist entering, exiting, or
operating the device.
2 Other embodiments of this invention may be used, for example, a stationary
device for use in
3 hospital, clinic, or other institutional settings, and may surround and
clamp the user's chest while
4 the user in other positions, for example while prone, reclined or recumbent.
In such
embodiments, a frame is clamped around the chest such that pressure may be
applied by the pads
6 to press and hold the appropriate rigid chest bone and muscle structures for
effective transfer of
7 the vibrations to the chest with the pads biased against the chest's bone
and musculature.
8 The rigid frame 122 preferably includes a left arm 136, a right arm 138, a
cross-member
9 140, front clamp supports 142, back clamp supports 144, and a vibrator
housing 180. The frame
122 may be lightened to improve user comfort by cutting holes 123 in the frame
122 in a manner
11 which retains the rigid frame mechanical strength. The left and right arms
136, 138 each include
12 a hinge 156 along their length at about the half way point. The hinges 156
allow the opening and
13 closing of the frame 122 for entrance and exit by the user. The cross-
member 140 connects to
14 the front half 162 of the left and right arms 136, 138. A pair of front
clamp supports 142 connect
to the cross-member 140 and extend towards the rear of the rigid frame 122,
and a pair of back
16 clamp supports 144 attach to the vibrator housing 180 and extend towards
the front of the rigid
17 frame 122. In FIGS. 8-11, the cross-member 140, the front half 162 of the
left and right arms
18 136, 138, and the front clamp supports 142 are a single integral unit
within the frame 120, so as
19 to more properly be described as a cross-member section, left and right
front half arm sections,
and front clamp support sections of the frame 122. It will be apparent to
those of ordinary skill
21 in the art that alternative frame structures 122 other than those
specifically detailed herein can be
22 employed or readily adapted for positioning and clamping around a usei-'s
chest, connecting to a
23 plurality of pads which extend radially inwardly to contact the user's
chest from opposite sides of
24 the chest when the frame is clamped around the user's chest, and in
transmitting vibrations from
a vibrator 182 through pads to the user's chest to assist in loosening of
obstructions in the lungs
26 or air way of a user.
27 Clamping units 132 are attached to the clamp supports 140 on each side of
the frame 122.
28 In the preferred embodiment, the clamping units 132 are similar to belt and
buckle combinations
29 used in ski boots and inline skates, and each clamping unit comprises a
clamp buckle 133
14
CA 02563723 2006-10-13
1 attached to a front clamp support 142, and a clamp tongue 134 attached to a
rear clamp support
2 144. Other embodiments of the clamp units are possible. For example, the
attachment of the
3 clamp buckle 133 and the clamp tongue 134 to the front and rear clamp
supports 142, 144 may
4 be reversed, and it will be apparent to those of ordinary skill in the art
that alternative kinds of
clamping unit types and alternative clamping unit and clamp support
arrangements may be
6 employed or readily adapted to practice this invention. By varying the
position at which the
7 clamp buckle 133 is attached to the clamp tongue 134, the clamping units 132
are adjustable to
8 accommodate users of varying size and gender.
9 Transmission of vibrations from the rigid frame 122 to the user's chest is
accomplished
by positioning the pads 124, 126, 127, 128 so that the rigid frame 122 clamps
the pads onto chest
11 locations such that vibrations are effectively transferred from the frame
122 to the chest. For
12 comfort and effective vibration transfer, the pad surfaces are generally
parallel to the user's chest
13 surface. The chest vibrating device is shown to include adjustable features
to accommodate the
14 wide variation in human body form and size between and within the genders.
In FIGS. 8-11, the
position and orientation of the pads 124, 126, 127, and 128 are adjustable.
16 The invention clamps the user's chest with pads which contact the chest
from opposite
17 sides of the chest when the frame 122 is clamped around the user's chest.
Preferably, the pads
18 are connected to the frame 122 as follows in order to effectively clamp the
device against the
19 bone structure of the user's chest such that pressure can be applied in the
clamping, and such that
the vibrations can most effectively be transferred to the user's lungs:
21 = the back pads 128 arranged as pairs on either side of the user's spine to
overlie the
22 scapulae and ribs of the user, preferably with two pairs of back pads 128
positioned over
23 the upper and lower lobes of the lungs;
24 = the upper front pad 124 is arranged to overlie the user's sternum,
preferably over the
manubrium or upper gladiolus; and
26 = the lower front pads 126, 127 are arranged as a pair of side lower front
pads 126 to
27 overlie the lower side of the rib cage near the diaphragm, and preferably
positioned near
28 the sides of the lower lobes of the lungs, and a pair of lower front pads
127 to overlie the
29 lower front of the rib cage near the diaphragm, and preferably positioned
near the front of
CA 02563723 2006-10-13
1 the lower lobes of the lungs.
2 The weight of the vibrating device 120 is supported on the user by a pair of
shoulder pads
3 130 connected to, and positioned to extend radially inwardly from the frame
122 to the shoulders
4 of standing or sitting users. It will be apparent to those of ordinary skill
in the art that alternative
pad positions and combinations other than those specifically detailed herein
can be employed or
6 readily adapted to allow effective clamping from at least two opposite sides
of the user's chest
7 within a frame 122, and to support the vibrating device 120 on the user.
8 Preferably, the vibrating device 120 has features to accommodate users of
differing size
9 and gender. Consequentially, the pads 124, 126, 127, 128 are connected to
the frame in an
adjustable manner to adjust their position and/or orientation to accommodate
users of differing
11 size and gender. The lower front pads 126 and 127 may be adjusted in a
lateral to medial
12 direction, and upper front pad 124 may connect to the frame 122 by a pivot
152, and lower front
13 pads 126 and 127, and back pads 128 may connect to the frame by a ball and
socket connection
14 151. In the specific embodiment shown in FIGS. 8-11, each pad 126, 127, 128
connects to the
frame by a ball and socket connection 151 in which the ball rotates within a
socket which is
16 connected to the back of the pads 126, 127, 128. Other embodiments of the
adjustable
17 connections between the pads 124, 126, 127, 128 and frame 122 are possible.
For example, each
18 ball and socket connection 151 may instead have the ball connected to the
pads, the ball rotating
19 within a socket attached to the frame 122. It will be apparent to those of
ordinary skill in the art
that alternative kinds of adjustable pad connections may be employed or
readily adapted to
21 practice this invention.
22 In this specific embodiment of FIGS. 8-12, accommodation of users of
varying size and
23 gender is achieved as follows. A generally inverse T-shaped front pad
support bar 170 is
24 connected on the inside to the cross-member 140 of frame 122. A pair of
generally arcuate
support bars 158, 159 are connected to the front pad support bar 170 by
fasteners 160, the left
26 arcuate support bar 158 being mounted generally horizontally to the left
portion 171 of the T-
27 shaped section of the front pad support bar 170, and the right arcuate
support bar 159 being
28 mounted generally horizontally to a right portion 172 of the inverse T-
shaped section of the front
29 pad support bar 170. One of each of the pair of side lower front pads 126,
and one of each of the
16
CA 02563723 2006-10-13
1 pair of lower front pads 127 connect to the left arcuate support bar 158 by
ball and socket
2 connections 151, and the other side lower front pad 126, and the other lower
front pad 127
3 connect to the right arcuate support bar 159 by ball and socket connections
151, the ball and
4 socket connections 151 allowing for adjustment of the side lower front pads
126, and lower front
pads 127 orientation to facilitate contact to the lower side of the user's
chest, and the lower front
6 of the user's chest, respectively, near a lower lobe of the user's lungs.
The upper front pad 124 is
7 connected to the top portion 173 of the T-shaped front pad support bar 170
through a pivot 152
8 allowing for movement around a lateral to medial axis to facilitate chest
contact over the
9 sternum. As shown in FIG. 10, the fasteners 160 connecting the left and
right arcuate support
bars 158, 159 to the left and right portions of the T-shaped section 171, 172
of the front pad
11 support bar 170 are positioned in pairs of generally horizontal slots 174
in the left and right
12 portions 171, 172 of the front pad support bar 170. Loosening the fasteners
160 allows the left
13 and right arcuate support bars 158, 159 to slide in a medial to lateral
direction to position the side
14 lower front pads 126 and the lower front pads 127 over users of differing
size and gender, at
which point the fasteners 160 are tightened to hold the arcuate support bars
158, 159 in place. As
16 will be apparent to those of ordinary skill in the art, other embodiments
are possible, for
17 example, different numbers of slots 174 and fasteners 160 per arcuate
support bar 158, 159 to
18 front pad support bar 170 connection. Alternatives to the arcuate support
bars and their
19 connections may be employed or readily adapted to provide lateral to medial
adjustability of the
pads 126, 127.
21 To connect the back pads 128 for adjustability, in the specific embodiment
shown in
22 FIGS. 9, 11, a pair of vertical rocker arms 143 attach to the vibrator
housing 180 by pivots 145
23 proximate to their midpoint, and position two pairs of back pads 128 over
the back of the user on
24 either side of the spine. The two pairs of back pads 128 connect to the
rocker arms 143, one back
pad connecting to each end of each rocker arm 143 by ball and socket
connections 151 to allow
26 adjustment of back pad 128 orientation to facilitate contact on the user's
back on either side of
27 the spine. The pivots 145 allow each rocker arm 143 to rotate around a
lateral to medial axis to
28 facilitate back pad 128 to chest contact.
29 As shown in FIG. 11, the shoulder pads 130 are curved shaped to fit over
the shoulders of
17
CA 02563723 2006-10-13
1 the user and include shoulder pad supports 176. The shoulder pads 130 are
designed to transfer
2 the weight of the invention to the shoulders of the user when the user is
sitting or standing
3 upright. The shoulder pads 130 are padded with soft shoulder pad cushions
177 to increase the
4 comfort of the user. In the preferred embodiment, a deformable pad cover 178
is attached to
each of the upper front pad 124, the side lower front pads 126, the lower
front pads 127, and back
6 pads 128, in which the pad covers are a layer of deformable material such as
neoprene that covers
7 the surface of the pad which contacts the users. When the vibrating device
120 is clamped to the
8 user's chest, the pad cover deforms and moulds to the shape of the user for
comfort, to facilitate
9 pad to chest contact, and to enhance vibration transmission.
The vibrator 182 is best shown in FIG. 9. The vibrator 182 is contained in a
vibrator
11 housing 180. The vibrator 182 generates and imparts vibrations sufficient
to transfer through the
12 rigid frame 122 and the pads 124,126,127, 128 to the user's chest to assist
in loosening of
13 obstructions in the lungs or air way of the user. Vibrators 182 may involve
motions generated by
14 mechanical, electromagnetic, pneumatic, and hydralic mechanisms which
rotate or oscillate
vibrator components. In the preferred embodiment of this invention, the
vibrator 182 includes a
16 motor 184 which rotates an off-set weight 186 to cause vibrations. The
rotating off-set weight
17 (or rotating imbalance) 186 is mounted for rotation by two off-set weight
bearings 188 attached
18 to the vibrator housing 180. The motor 184 may typically be a 12 V DC or
120 V AC motor and
19 is mounted to the vibrator housing 180. As is best illustrated in FIG. 9,
the vibrator housing 180
includes a housing back bracket 190, two end plates 194, and a removable
housing cover 192
21 allowing access to the vibrator for repair (FIG. 9 shows detached to view
the motor 184 and off-
22 set weight 186). The vibrator housing 180 connects to the frame 122 by the
housing back bracket
23 190, which attaches to the left and right arms 136, 138, preferably at the
back of the frame 122.
24 In this embodiment, the off-set weight includes a rigidly mounted off-set
weight shaft 187 (not
shown), positioned through a hole in the off-set weight such that the shaft
protrudes as stub
26 shafts 189 (FIG. 12) on either side of the weight 186. The stub shafts 189
are supported by the
27 bearings 188 and the off-set weight shaft 187 is connected to the motor 184
for direct rotation of
28 the off-set weight 186. The motor 184 and the bearings 188 are connected to
the back bracket
29 190 of the vibrator housing 180.
18
CA 02563723 2006-10-13
1 The amplitude of the vibrations generated by rotating the off-set weight 186
increases
2 with the mass and off-set (the distance from the center of gravity to the
center of rotation) of the
3 rotating weight. The off-set weight of this specific embodiment of the
invention is shown in
4 FIGS. 9, 12. One example of an off-set weight 186 found to be effective was
formed from a
composite of a steel cylinder (3.8 cm in diameter, and 6.5 cm in length) with
an off-center 1.3 cm
6 sized hole drilled parallel to the long axis of the cylinder, located with
the center of the hole 1 cm
7 from the center of the steel cylinder, and by adding an additional mass of
solder or other weight
8 to the surface of the cylinder furthest from the offset hole. This resulting
off-set weight had an
9 approximately egg-shaped cross section of approximately 4.5 cm by 3.8 cm, as
best shown in
FIG. 12. This off-set weight 186 was rigidly connected to a 11.5 cm long, 1.3
cm diameter
11 cylindrical steel off-set weight shaft 187. This off-set weight 186 had a
total weight of 650
12 grams, including an off-set weight shaft 187 weighing 150 grams.
Alternatives to this off-set
13 weight or rotating imbalance will be evident to those skilled in the art,
for instance with differing
14 size, composition, weight, and off-set.
During operation, the motor 184 rotates the off-set weight 186 at a rate which
transfers
16 vibrations to the rigid frame 122 such that the vibration frequency is
effective at loosening
17 obstructioris in the lungs or airways of the user. As discovered
specifically during CF patient
18 usage, preferred frequencies are greater than 10 Hz, more preferably at 11
to 20 Hz, and most
19 preferably in a range of 13 to 16 Hz. Without limiting the scope of this
invention, it is believed
that these vibration frequency ranges are sufficient to stimulate the lung CBF
to that normally
21 observed in persons with unimpaired mucus clearance. The mass and degree of
off-set of the off-
22 set weight 186 are sufficient to generate vibrations with an amplitude
which effectively transfers
23 the vibrations through the rigid frame 122 and pads 124, 126, 127, 128 to
the user's chest to
24 assist in loosening of obstructions in the lungs and air way. When
operating the vibrating device
120 with CF patients, it has been experimentally deter-mined that vibration
amplitudes of about
26 0.1 to 2 mm effectively transfer vibrations of the above frequency through
the rigid frame 122
27 and pads 124, 126, 127, 128 to the user's chest. Preferably, the off-set
weight 186 is mounted to
28 rotate around an axis parallel to the medial to lateral axis of the user's
chest, as is illustrated in
29 FIG. 9 by the lateral to medial axis A. The chest vibrating device 120 can
include a controller
19
CA 02563723 2006-10-13
1 198 (not shown) such as a dial to allow the user to vary the rate of
rotation of the off-set weight,
2 as will be apparent to those of ordinary skill in the art, to assist in
loosening obstructions within
3 the lungs or air way of the user.
4 Through testing of the vibrating device 120 with CF patients, it was
discovered that when
users may breath freely and deeply, without the device significantly impairing
their lung vital
6 capacity. Additionally, when wearing the device of the present invention,
the user may continue
7 to vibrate their chest while coughing to remove smaller lung and air way
obstructions. To
8 remove larger obstructions, the user only needs to temporarily stop the
device's vibrations, then
9 cough without ever having to remove the device form the chest.
With reference to FIGS. 8-11, the operation of the chest vibrating device 120
will be
11 described as follows. The user lifts the front half 162 of the left and
right arms 136, 138 upward
12 along the hinges 156 to enter the rigid frame 122. Then, the user slips
into the rigid frame 122,
13 rests the shoulder pads 130 on the user's shoulders, and closes the front
half 162 of the left and
14 right arms 136, 138 along the hinges 156. The rocker arms 143 rotate to
place the back pads 128
against the user's back on either side of the spine to overlie the scapulae
and ribs of the user, and
16 the back pads 128 rotate on ball and socket connections 151 to contact the
user's back, preferably
17 over the upper and lower lobes of the lungs. The left and right arcuate
support bars 158, 159 are
18 adjusted in a lateral to medial direction, and position the side lower
front pads 126 and the lower
19 front pads 127 over the lower side and front of the rib cage near the
diaphragm, respectively, of
the user's chest near a lower lobe of the lungs. The side lower front pads 126
and the lower front
21 pads 127 rotate on ball and socket connections 151 to contact the front and
sides, respectively, of
22 the user's chest, preferably near a lower lobe of the lungs. The upper
front pad 124 rotates to
23 contact the pad against the user's chest over the sternum, preferably over
the manubrium or upper
24 gladiolus. Finally, the user uses the clamping units 132 to clamp and
secure the rigid frame 122
about the user, such that the upper front pad 124, the side lower front pads
126, the lower front
26 pads 127, and back pads 128 are securely clamped, or pressured, against the
user's chest. The
27 chest vibrating device 120 can then be activated to create vibrations. The
motor 184 rotates the
28 off-set weight 186, generating vibrations which are transferred from the
vibrator 182 through the
29 rigid frame 122 to the front pads 124, 126, 127 and back pads 128. These
vibrations are
CA 02563723 2006-10-13
1 transferred to the chest and lungs of the user via the pad to chest contact,
and assist in removing
2 obstructions from the lungs and air way of the user. The user may then
control the frequency of
3 vibrations by varying the rate of rotation of the off-set weight 186 via the
controller 198, for a
4 frequency which proves individually effective. As necessary, the user may
start and stop the
vibrator 182 to allow coughing to clear obstructions in the lungs and air way
of the user without
6 removing the vibrating device 120.
7 This invention is further exemplified by the following non-limiting
examples:
8 Example 1- Use of the vibrating device with a 24 year old male Cystic
Fibrosis subject
9 The vibrating device embodied in FIGS. 8-11 was used to demonstrate the
efficacy of this
device in assisting clearing of the lungs and air ways of mucus in a cystic
fibrosis subject. The
11 subject was a 24 year old male, height 176.5 cm, and weight 76.2 kg.
12 The motor used to power the vibrator was a 120 V rotary motor, with a
maximum speed
13 of 2500 rotations per minute. The motor rotated an off-set weight fashioned
from steel and
14 solder. The weight was constructed with a cylinder of steel 3.8 cm in
diameter, and 6.5 em in
length, with an off-center 1.3 cro sized hole drilled parallel to the long
axis of the cylinder,
16 located with the center of the hole 1 cm from the center of the steel
cylinder. An additional mass
17 of solder was added to the curved surface of the cylinder furthest from the
offset hole, as
18 described below. The weight was mounted and welded on a 11.5 cm long, 1.3
cm diameter
19 cylindrical steel shaft, and was connected to the rotary motor.
The appropriate weight mass and off-set center of mass was determined
experimentally
21 by the subject. Layers of solder was incrementally added to the cylinder to
shift the center of
22 mass increasingly further from the position of the shaft through the steel
cylinder. After each
23 layer of solder was added, the subject tested the vibrating device for
efficacy. Increasing
24 amounts of solder initially led to improvements in device efficacy, however
once efficacy began
to decrease, solder was removed to restore the rotating mass to the optimal
mass and off-set
26 center of gravity.
27 The resulting weight found to be most efficient was 6.5 cm long and had an
21
CA 02563723 2006-10-13
1 approximately egg-shaped cross section of approximately 4.5 cm by 3.8 cm.
The off-set weight
2 and shaft had a total weight of 650 grams, while the shaft itself weighed
150 grams.
3 The subject experimentally determined the preferred speed of rotation for
the rotating
4 mass. While wearing the vibrating device, the subject varied the motor's
speed of rotation,
noting the efficacy at various speeds. The subject observed that optimal lung
and air way
6 clearance occurred at 55% of the maximum motor rotation, but that the
vibrating device
7 produced significant lung clearing effects when rotating between 40% to 70%
of the maximum
8 motor rotation. High efficiency lung and air way clearance was observed by
the user when the
9 motor operated at 50-60% of the maximum motor rotation.
Using the optimized rotating mass, and the preferred speed of rotation,
measurements
11 were conducted of the subject while wearing and operating the vibrating
device. The vibration
12 amplitude and frequency was measured at nine points on the vibrating
device, while the subject
13 wore and operated the vibrating device but otherwise remained motionless.
The subject avoided
14 sneezing, coughing, or other activities which would move the chest. The
resulting observations
are compiled in Table 1, below:
16 Table 1 - Observed vibration characteristics at selected positions on the
vibrating device frame
17 Location Vibration Vibration Vibration
Frequency Amplitude Acceleration (g)
(Hz) (mm)
18 Left Bottom Back Pad 14.75 0.54 0.47
19 Right Bottom Back Pad 15.33 0.15 0.14
Top Left Back Pad 14.25 0.7 0.57
21 Top Right Back Pad 15.5 0.2 0.2
22 Front Left Frame 14.25 0.8 0.66
23 Left Side Lower Front Pad 14.75 0.41 0.36
24 Right Side Lower Front Pad 15.08 0.71 0.65
22
CA 02563723 2006-10-13
1 Upper Front Pad 14.75 0.8 0.7
2 Top Left Frame 14.42 1.59 1.32
3 The data in Table 1 allowed determination of the average rigid frame
vibration frequency
4 (14.8 Hz) observed when operating the vibrating device at the optimal motor
rotation rate, and
the operating rigid frame vibration amplitude (0.1-2 mm). Using the optimal
rigid frame
6 frequency and the range of motor rotation speeds over which the user
observed significant and
7 high efficiency lung clearing effects, the frequency range of effective
rigid frame vibration and
8 preferred rigid frame vibrations was deteimined to be about 11 to 20 Hz, and
13-16 Hz,
9 respectively.
When healthy and engaging in chest vibration therapy for preventative control
of CF
11 pathologies, the subject had used the vibrating device once or twice daily
for 20 minute sessions,
12 and reported the device was efficient in mobilizing mucus from his lungs.
The subject also
13 reported that while wearing and using the vibrating device, he was able to
breath fully and deeply
14 up to the user's vital capacity. When wearing the vibrating device, the
subject reported being
able to continue chest vibrations while coughing to remove certain smaller
lung and air way
16 obstructions. To remove larger obstructions, the subject remained within
the vibrating device,
17 but stopped the motor, coughed, then resumed vibration treatment as
desired. This treatment
18 replaced any daily CPT therapy delivered by a caregiver or other means. The
subject increased
19 the frequency and duration of these treatments as required to address
infections and congestion
beyond that normally experienced by an otherwise healthy CF patient.
21 Example 2 - Use of the vibrating device with a 20 year old female Cystic
Fibrosis subject
22 The vibrating device described in Example 1 was used to demonstrate the
efficacy of this
23 device in assisting clearing of the lungs and air ways of mucus in a cystic
fibrosis subject. The
24 subject was a 20 year old female, height 173 cm, and weight 55.4 kg.
When healthy and engaging in chest vibration therapy for preventative control
of CF
26 pathologies, the subject had used the vibrating device once or twice daily
for 20 minute sessions,
23
CA 02563723 2006-10-13
1 and reported the device was efficient in mobilizing mucus from her lungs.
This treatment
2 replaced any daily CPT therapy delivered by a caregiver or other means. The
subject increased
3 the frequency and duration of these treatments as required to address
infections and congestion
4 beyond that normally experienced by an otherwise healthy CF patient.
All publications mentioned in this specification are indicative of the level
of skill in the
6 art of this invention. All publications are herein incorporated by reference
to the same extent as
7 if each publication was specifically and individually indicated to be
incoiporated by reference.
8 The terms and expressions in this specification are, unless otherwise
specifically defined
9 herein, used as terms of description and not of limitation. There is no
intention, in using such
terms and expressions, of excluding equivalents of the features illustrated
and described, it being
11 recognized that the scope of the invention is defined and limited only by
the claims that follow.
24
