U.S. patent application number 14/421216 was filed with the patent office on 2015-08-20 for pulmonary system resistance training apparatus and methods.
The applicant listed for this patent is Christopher I. Halliday. Invention is credited to Christopher I. Halliday.
Application Number | 20150231443 14/421216 |
Document ID | / |
Family ID | 50101582 |
Filed Date | 2015-08-20 |
United States Patent
Application |
20150231443 |
Kind Code |
A1 |
Halliday; Christopher I. |
August 20, 2015 |
PULMONARY SYSTEM RESISTANCE TRAINING APPARATUS AND METHODS
Abstract
A respiratory exerciser having a hollow body, where the hollow
portion is in communication with a porous or non-porous material
and with an opening that provides access for a user to breathe
through the device.
Inventors: |
Halliday; Christopher I.;
(Phoenixville, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Halliday; Christopher I. |
Phoenixville |
PA |
US |
|
|
Family ID: |
50101582 |
Appl. No.: |
14/421216 |
Filed: |
August 12, 2013 |
PCT Filed: |
August 12, 2013 |
PCT NO: |
PCT/US2013/054494 |
371 Date: |
February 12, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61682429 |
Aug 13, 2012 |
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61721186 |
Nov 1, 2012 |
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Current U.S.
Class: |
482/13 |
Current CPC
Class: |
A63B 21/00196 20130101;
A63B 23/18 20130101; A61M 16/0866 20140204; A61M 16/208 20130101;
A63B 21/0088 20130101; A63B 2213/005 20130101 |
International
Class: |
A63B 23/18 20060101
A63B023/18 |
Claims
1-20. (canceled)
21. A pulmonary exercise device comprising: a rigid body formed at
least partially from porous material and having an interior space;
and, a mouthpiece communicating with said interior space, wherein
ambient air external to the rigid body can pass through the porous
material into the interior space and then communicate with the
mouthpiece during an inhalation event without flowing through a
valve.
22. The device of claim 21, wherein the porous material comprises
porous plastic having a porosity of between about 5 microns and
about 500 microns.
23. The device of claim 22, wherein at least a portion of the
porous plastic has a thickness of between 0.1 to 1.0 inches.
24. The device of claim 21, wherein the rigid body is removably
connected to a second rigid body.
25. The device of claim 21, further comprising a one way valve in
communication with said interior space.
26. The device of claim 23, wherein the porosity and wall thickness
are sufficient to create a resistance of 10 to 25 inches of water
during a user's inhalation at a rate of 1 liter of air per
second.
27. The device of claim 23, wherein the porosity and wall thickness
are sufficient to create a resistance of greater than 26 inches of
water during a user's inhalation at a rate of 1 liter of air per
second.
28. A method of increasing pulmonary strength comprising; obtaining
a porous plastic pulmonary exerciser comprising (a) a rigid body
having an interior passageway, (b) a mouthpiece communicating with
the interior passageway, and (c) at least one porous plastic
portion; inhaling through the mouthpiece such that the inhalation
urges a portion of air through the porous plastic portion, thereby
increasing inhalation effort, wherein ambient air and the
mouthpiece are in communication through the porous plastic
member.
29. The method of claim 28, wherein at least a portion of the
porous plastic has a porosity of between about 5 microns and about
500 microns.
30. The method of claim 28, wherein at least a portion of the
porous plastic has a thickness of between about 0.1 to 1.0
inches.
31. The method of claim 28, wherein the exerciser further comprises
a one way valve cooperative with the rigid body such that upon
exhalation at least a portion of the exhaled air bypasses the
porous plastic portion and exits the exerciser through the valve to
thereby minimize an increase in exhalation effort.
32. The method of claim 28, wherein the user traverses at least 100
yards while using the device hands free.
33. A pulmonary exercise device comprising: a rigid body formed at
least partially from porous plastic and having an interior space;
and, a mouthpiece communicating with said interior space, wherein
air inhaled by a user during an inhalation event can communicate
with ambient air external to the rigid body by traversing through
the porous plastic and without communicating through a valve,
wherein the user experiences a resistance during the inhalation
event.
34. The device of claim 33, further comprising a one way valve
cooperative with the rigid body wherein upon exhalation, at least a
portion of the exhaled air bypasses the porous plastic portion and
exits the pulmonary exercise device through the valve to thereby
minimize an increase in exhalation effort.
35. The device of claim 33, wherein the rigid body has a weight of
less than 5 ounces.
36. The device of claim 33, further comprising a cassette having a
weight between 0.1 and 1 ounce.
37. The device of claim 33, wherein the center of gravity of the
device is located proximal to a user's teeth.
38. The device of claim 33, further comprising a dead space
introducing member.
39. The device of claim 33, further comprising a cassette in fluid
communication with the rigid body and a one way valve in fluid
communication with the rigid body wherein upon exhalation, at least
a portion of the exhaled exits the exerciser through the valve to
thereby minimize an increase in exhalation effort.
40. The device of claim 33, further comprising an adjustable
one-way valve having a cracking pressure of less than 0.3 psi in
fluid communication with the rigid body.
41. A pulmonary exercise device comprising: a device body and a
rigid cassette formed at least partially from porous plastic having
a porosity between 5 microns and 250 microns and a wall thickness
of between 0.05 inches and 0.5 inches, wherein the rigid device
body is adapted to removably receive: (a) a mouthpiece; and, (b) at
least one other component selected from: (1) a valve having a
cracking pressure of less than 1 psi, (2) a cassette having an
aperture, (3) a cassette having a valve with an adjustable cracking
pressure, and (4) a dead space introducing member.
Description
BACKGROUND OF THE INVENTION
[0001] Respiratory exercisers, in general, are designed for
purposes including the assistance of patients with lung problems
due to chronic obstructive pulmonary disease (COPD) or
postoperative loss of spontaneous deep breaths. The types of
devices vary-one type may provide inhalation resistance while a
second type may provide exhalation resistance. The devices are
designed so that resistance can be varied to adjust for the
changing strength or weakness of the user.
[0002] Other respiratory exercise devices include large and/or
complex multi-component assemblies of springs, valves, diaphragms
notches and/or apertures, such as the devices shown in U.S. Pat.
Nos. 6,726,598, 5,899,832 and 4,739,987, the contents of which are
incorporated by reference in their entirety.
[0003] Other devices show exhalation through a porous component, as
shown in U.S. Pat. No. 7,921,964 and WO 2009/106062, the entire
contents of which are hereby incorporated by reference in their
entirety. However, in these other devices, exhalation effort and
pressure is sought to be minimized, and inhalation through the
porous plastic is not possible due to valve restrictions to avoid
drowning.
SUMMARY OF THE INVENTION
[0004] A pulmonary exercise device including a rigid body which can
be formed from a non-porous material or at least partially from a
porous material (e.g., porous plastic), having an interior space
and a mouthpiece communicating with the interior space. In some
embodiments, ambient air external to the rigid body can pass
through the porous material into the interior space and then
communicate with the mouthpiece during an inhalation event. In some
embodiments, such inhaled gas communication can occur without one
or both of: (1) communication through a non-adjustable one way
valve or (2) by virtue of an external high pressure air or oxygen
source urging gas flow into a user's lungs.
[0005] In another embodiment, a method of increasing pulmonary
strength of a user includes the steps of obtaining a porous plastic
pulmonary exerciser composed up at least (a) a rigid body having an
interior passageway, (b) a mouthpiece communicating with the
interior passageway, and (c) at least one porous plastic portion;
and inhaling through the mouthpiece such that the inhalation urges
a portion of air through the porous plastic portion, thereby
increasing inhalation effort, wherein ambient air and the
mouthpiece are in communication through the porous plastic
member.
[0006] In another embodiment, a pulmonary exercise device includes
a rigid body formed at least partially from porous plastic and
having an interior space; and a mouthpiece communicating with the
interior space, wherein air inhaled from a user during an
exhalation event can communicate with ambient air external to the
rigid body without communicating with a valve, wherein the user
experiences a resistance of greater than 26 inches of water at an
inhalation rate of 1 liter per second.
[0007] In one embodiment, the present invention includes a device
body adapted to removably receive: (a) a one-direction valve having
a cracking pressure of less than 1 psi; (b) a mouthpiece; and, (c)
at least one other component selected from a cassette, a valve and
a dead space introducing member.
[0008] A pulmonary exercise device comprising: a rigid device body
formed at least partially from porous plastic having a porosity
between 5 microns and 250 microns and a wall thickness of between
0.05 inches and 0.5 inches, wherein the rigid device body is
adapted to removably receive: (a) a mouthpiece; and, (b) at least
one other component selected from: (1) a cassette having a porosity
between 5 microns and 250 microns and a wall thickness of between
0.05 inches and 1 inch, wherein the porosity or wall thickness of
the cassette is different than the porosity or wall thickness of
the device body, (2) a valve having a cracking pressure of less
than 1 psi, and (3) a dead space introducing member.
[0009] Additional methods of use and other embodiments are also
disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Further details are explained below with the help of the
examples illustrated in the accompanying drawings in which:
[0011] FIG. 1 shows various perspective view of embodiments of the
present invention;
[0012] FIG. 2 shows a cutaway view along line A-A of FIG. 1(c);
[0013] FIG. 3 shows an alternative embodiment using reference line
A-A of FIG. 1(c);
[0014] FIG. 4 shows a cutaway view of an embodiment of the present
invention;
[0015] FIG. 5 shows an adjustable embodiment of the present
invention; and
[0016] FIG. 6 shows an ergonomic embodiment of the present.
DETAILED DESCRIPTION OF THE INVENTION
[0017] The present invention relates to respiratory exercise
devices and, more particularly, to breathing exercise devices which
promote proper or stronger inhalation and exhalation by the
user.
[0018] As with other resistance training, inhalation and exhalation
resistance training can increase athletic performance. In certain
instances, performance can be increased between 1 and 10 percent,
most typically between about 2 and about 7 percent with about 5
percent not being an uncommon increase in physiologic/athletic
performance. In certain embodiments, the present invention can be
configured to provide one or more of flow resistance loading,
pressure threshold loading or isocapnic hyperpnea. In certain
embodiments, the present invention can be configured to provide one
of flow resistance loading, pressure threshold loading or isocapnic
hyperpnea and optionally provide an additional mode of operation
(e.g., flow resistance and optionally pressure threshold and/or
isocapnic hyperpnea). In one embodiment, the present invention can
be configured to provide two or more of: flow resistance loading,
pressure threshold loading or isocapnic hyperpnea.
[0019] In certain embodiments, the present invention includes a
device body. The device body can be non-porous or include a porous
portion, as a whole or as part of a device body. The present
invention, in certain other embodiments optionally includes one or
more of an optional cassette, an optional valve and an optional
dead space introducing member.
[0020] In certain embodiments, a respiratory exercise device of the
present invention includes a rigid or semi-rigid body, where the
body defines an interior space or hollow portion, and a mouthpiece
in gaseous communication with the interior space, where ambient air
external to the body can pass through a porous material into the
interior space and then communicate with the mouthpiece during an
inhalation event. Alternatively exhaled air can pass from a user
into the interior space and then communicate with ambient air
external to the present invention after passing through a porous
portion of material. In certain embodiments, during an inhalation
event some or a portion of ambient air can communicate with a
mouthpiece without first opening or passing through a one way
valve. In other embodiments, some or a portion of exhaled air can
communicate with ambient air without first opening or passing
through a one way valve.
[0021] As used herein, the general term "device of the present
invention" or "present invention" is understood to include each of
the device body, cassette, valve, or dead space introducing member
alone or in any combination, as dictated by context and
description.
[0022] In another embodiment, the present invention includes a
pulmonary exercise device including a device body shaped to define
an interior space, a mouthpiece boss, a one way valve cooperative
with the rigid body and communicating with the interior space,
permitting communication in a direction from the interior space to
ambient air outside the rigid body, an aperture in communication
with the interior space that freely permits a flow of air into the
interior space from ambient air and also from the interior space to
ambient air, a selector that is adapted to close at least either
the one way valve or aperture, a porous plastic member cooperative
with the rigid body and permitting communication between the
interior space and ambient air, a mouthpiece connected to the
mouthpiece boss and communicating with said interior space, wherein
ambient air and the mouthpiece are in communication through the
porous plastic member without communicating through a valve.
[0023] In certain embodiments, the present invention includes a
generally linear device body or in certain embodiments a W-shaped,
U-shaped, T-shaped or L-shaped body, in connection with a
mouthpiece. None, all, or a portion of the overall device body may
be composed of a porous material, e.g., porous ceramic, porous
metal or porous plastic material. In certain embodiments, the
weight of the present invention is sufficiently low so as to permit
a user of the present invention to hold the present invention in
the user's mouth solely by use of a mouthpiece. In such
embodiments, the weight of the present invention can minimize jaw
fatigue while the user is biting down on the mouthpiece and using
the present invention, and also permits hands free use, e.g.,
during running, cycling, stair climbs, or other exercises involving
cardiovascular or muscle training
[0024] Porous portions of the present invention (e.g., all or
portions of the device body and/or cassette, and/or valve and/or a
dead space introducing member) include pores or interconnected
cavities permitting gaseous or fluidic communication throughout the
solid porous portions. These pores allow ambient air to be in
communication with the interior space of the present invention and
thusly ambient air is in communication with a mouthpiece and by
virtue of the mouthpiece, the lungs of a user. Unlike apertures,
the porous portions create numerous (e.g., thousands of) indirect
paths for air to travel through the material. By controlling the
porosity and wall thickness of portions of the present invention a
smaller, lighter, easier to clean, ergonomically shaped, and
overall more simplified breathing resistance device can be created
for use.
[0025] If the device body is non-porous or has a portion of porous
material, then in such embodiments one or more additional porous
cassettes can be connected to the device body to create an
additional porous barrier between ambient air and a user. If all or
a substantial portion of the device body is porous, the cassettes
can also still be used and connected to the device body.
[0026] With respect to a porous portion, the porosity and wall
thickness affect the resistance experienced by a user. Each is
hereafter described.
[0027] Porosity
[0028] As described herein, portions of the present invention
(e.g., the device body or cassette) can have varying porosity. The
porosity of a portion of present invention, as defined by a
standard porossimeter test, can be between 5 and 200 microns. In
certain embodiments, the porosity can be between 5 and 100 microns.
In certain embodiments, the porosity can be between 5 and 80
microns. In certain embodiments, the porosity can be between 5 and
50 microns. In certain embodiments, the porosity can be between 5
and 25 microns. In certain embodiments, the porosity can be between
10 and 50 microns. In certain embodiments, the porosity can be
between 25 and 100 microns. In certain embodiments, the porosity
can be between 25 and 200 microns. In certain embodiments, the
porosity can be between 50 and 150 microns. In certain embodiments,
the porosity is between 25 and 250 microns
[0029] In certain embodiments, the porosity of a porous portion, if
any, of a device body or cassette or valve (e.g., a pressure
threshold member) or dead space introducing member is selected
from: about 5 microns, about 10 microns, about 20 microns, about 30
microns, about 40 microns, about 50 microns, about 60 microns,
about 70 microns, about 80 microns, about 90 microns, about 100
microns, about 110 microns, about 120 microns, about 130 microns,
about 140 microns, about 150 microns, about 160 microns about 170
microns, about 180 microns, about 190 microns, about 200 microns,
about 210 microns, about 220 microns, about 230 microns, about 240
microns, about 250 microns, about 260 microns, about 270 microns,
about 280 microns, about 290 microns, about 300 microns.
[0030] In certain embodiments, the porosity is less than 300
microns.
[0031] In certain embodiments, the porosity is less than 200
microns.
[0032] In certain embodiments, the porosity is less than 100
microns.
[0033] In certain embodiments the porosity is less than 75
microns.
[0034] In certain embodiments, the porosity is between 5 microns
and 75 microns.
[0035] In certain embodiments, the porosity is between 5 microns
and 250 microns.
[0036] Material Thickness
[0037] In certain embodiments, the thickness of the material that
defines a portion of the device (e.g., the device body or cassette)
can be between about 0.1 inches and about 2.0 inches. In porous
embodiments, the thickness of the porous material is between about
0.1 inches and about 1.0 inches. In certain embodiments, the wall
thickness is between about 0.05 and about 0.15 inches. In certain
embodiments, the thickness of the porous material is about 0.1
inches. In certain embodiments, the thickness of the porous
material is about 0.2 inches. In certain embodiments, the thickness
of the porous material is about 0.3 inches. In certain embodiments,
the thickness of the porous material is about 0.4 inches. In
certain embodiments, the thickness of the porous material is about
0.5 inches. In certain embodiments, the thickness of the porous
material is about 0.6 inches. In certain embodiments, the thickness
is between 0.1 and 0.6 inches. In certain embodiments, the
thickness is between about 0.1 and about 0.15 inches. In certain
embodiments, the thickness is between about 0.05 and 0.2 inches. In
certain embodiments, the thickness is between about 0.05 and 0.5
inches. In certain embodiments, the thickness is between about 0.05
and 1 inch.
[0038] The porous material used in the present invention restricts
airflow to provide inhalation resistance, exhalation resistance, or
both.
[0039] In certain light weight and/or easy to clean embodiments,
all or a portion of the present invention can be made from porous
plastic. In certain embodiments, polyethylene (PE) ultra-high
molecular weight polyethylene (UHMWPE), high-density polyethylene
(HDPE), polypropylene (PP), polytetrafluoroethylene (PTFE), and
polyvinylidene fluoride (PVDF) are suitable. Ethylene vinyl acetate
(EVA), polyethersulfone (PES), polyurethane (PU) and PE/PP
co-polymer are also suitable. The material, or a portion thereof,
can hydrophobic or hydrophilic. Porous plastic material can be
readily obtained from Genpore, 136 Morgantown Rd., Reading, Pa.
19607.
[0040] Inhalation and Exhalation Effort
[0041] In certain embodiments, the porosity and wall thickness of
the present invention can be varied to provide the following loads
experienced by a user during inhalation, exhalation or both. The
inhalation effort, exhalation effort, or both, applies to use of
the device body alone as well as use of a device body combined with
one or more cassettes and/or pressure threshold members (e.g., a
fixed or adjustable one way valve).
[0042] Respiratory loads can be classified as light, medium and
heavy resistance and apply to both flow resistance loading and
pressure threshold loading. To the extent there is overlap in
ranges, such overlap in characterization may relate to the
perceptions of the individual user.
[0043] In certain embodiments, the resistance is between 26 and 300
cm. water at a rate (inhalation or exhalation) of 1 liter per
second. In certain embodiments the resistance is greater than or
equal to 26 cm. water at 1 liter per second. However, in certain
embodiments, inhalation resistance can be less, and in some
embodiments, inhalation or exhalation resistance is from 10 to 25
cm. water at 1 liter per second.
[0044] Light resistance can be between 26 and 110 cm. water at 1
liter per second. In certain embodiments the resistance is about 35
cm. water at 1 liter per second. In certain embodiments the
resistance is about 45 cm. water at 1 liter per second. In certain
embodiments the resistance is about 56 cm. water at 1 liter per
second. In certain embodiments the resistance is about 65 cm. water
at 1 liter per second. In certain embodiments the resistance is
about 75 cm. water at 1 liter per second. In certain embodiments
the resistance is about 90 cm. water at 1 liter per second.
[0045] Medium resistance can be between 26 and 190 cm. water at 1
liter per second. In certain embodiments, resistance can be between
56 and 180 cm. water at 1 liter per second. In certain embodiments
the resistance is greater than or equal to about 56 cm. water at 1
liter per second. In certain embodiments the resistance is about 70
cm. water at 1 liter per second. In certain embodiments the
resistance is about 100 cm. water at 1 liter per second. In certain
embodiments the resistance is about 140 cm. water at 1 liter per
second. In certain embodiments the resistance is about 160 cm.
water at 1 liter per second. In certain embodiments the resistance
is about 170 cm. water at 1 liter per second. In certain
embodiments the resistance is about 180 cm. water at 1 liter per
second.
[0046] Heavy resistance can be between 30 and 300 cm. water at 1
liter per second. In certain embodiments, heavy resistance can be
between 150 and 270 cm. water at 1 liter per second. In certain
embodiments the resistance is about 150 cm. water at 1 liter per
second. In certain embodiments the resistance is about 200 cm.
water at 1 liter per second. In certain embodiments the resistance
is about 230 cm. water at 1 liter per second. In certain
embodiments the resistance is about 250 cm. water at 1 liter per
second. In certain embodiments the resistance is about 270 cm.
water at 1 liter per second.
[0047] In some embodiments, the resistance is greater than 56 cm.
water at 1 liter per second. In some embodiments, the resistance is
between 56 cm. water and 300 cm water at 1 liter per second.
[0048] In some embodiments, one or more of the device body,
cassette or valve can impart a vibration or oscillatory effect on
inhalation, exhalation or both. In some embodiments, the vibration
is between 6 to 12 Hz. In some embodiments, the vibration is
between 20 and 40 Hz. In other embodiments the vibration is greater
than 20 Hz. In some embodiments, the vibration is about 5, 6, 7, 9,
10, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 25, 30, 35 Hz.
[0049] Each of the device body, cassette, valve and dead space
introducing member for isocapnic hyperpnea is hereafter
described.
[0050] Device Body
[0051] The device body of the overall device of the present
invention typically defines an interior (e.g., hollow) space
through which exhaled and inhaled air can pass from external
ambient air to a user, typically through a mouthpiece.
[0052] In certain embodiments, the body of the device that defines
an interior space can be made from any material, such as plastic or
metal. In some embodiments, the entirety of the body can be solid,
non porous material (e.g., plastic).
[0053] However, in other embodiments, at least a portion of the
device body is made from porous material, such as ceramic or porous
plastic. In certain porous embodiments, an interior space is not
required for the present invention to function. In certain porous
embodiments, the entirety of the device body can be porous material
with no clearly defined interior hollow space.
[0054] In certain embodiments, at least 10% of the overall weight
of the device body, exclusive of any valves, mouthpieces,
mouthpiece bosses, fittings, plugs or cassettes, is derived from
porous material. In other embodiments, at least 20% by weight is
porous material. In other embodiments, at least 30% by weight is
porous material. In other embodiments, at least 40% by weight is
porous material. In other embodiments, at least 50% by weight is
porous material. In other embodiments, at least 60% by weight is
porous material. In other embodiments, at least 70% by weight is
porous material. In other embodiments, at least 80% by weight is
porous material. In other embodiments, at least 90% by weight is
porous material. In other embodiments, at least 95% by weight is
porous material. In other embodiments, the device body, is entirely
porous.
[0055] In certain embodiments, the device body (e.g., free of any
cassettes, dead space introducing members, mouthpiece, etc) is
light weight and weighs less than 5 ounces. In certain embodiments,
the device body weighs less than 4.5 ounces. In certain
embodiments, the device body weighs less than 4.0 ounces. In
certain embodiments, the device body weighs less than 3.5 ounces.
In certain embodiments, the device body weighs less than 3.0
ounces. In certain embodiments, the device body weighs between 1.0
and 4.0 ounces. In certain embodiments, the device body weighs
between 1.0 and 3.0 ounces.
[0056] In certain embodiments, when in use the center of gravity of
the device (as determined when a device body is free of any
cassettes or other components, or as determined inclusive of one or
more of a valve, cassette, mouthpiece, dead space introducing
member, etc), is located proximal to the lips of a user. In certain
embodiments, the center of gravity is less than 1 cm. from the
external surface of a user's lips. In certain embodiments the
center of gravity is less than 1.5 cm away from a user's lip. In
certain embodiments, the center of gravity is less than 2 cm away
from a user's lips. In certain embodiments the center of gravity is
less than 3 cm away from a user's lips. In certain configurations,
the center of gravity is located in front of a user's lips. It is
contemplated that in certain configurations the center of gravity
of the device of the present invention can be located such that it
is inside a user's mouth, proximal to the teeth (e.g., inside the
oral cavity). In certain embodiments, it is contemplated that the
center of gravity of the device of the present invention is
proximal to, or in relative contact with, the lips or mouth of a
user.
[0057] In certain embodiments, the present invention can be
modular. In certain embodiments, the present invention includes a
device body that is adapted to removably receive a breathing
related component, e.g., a cassette, a valve (non-adjustable or
adjustable) or a dead space introducing member. In certain
embodiments, the present invention includes a device body that is
adapted to removably receive at least two breathing components
selected from: cassette, a valve (non-adjustable or adjustable) or
a dead space introducing member. In certain embodiments where two
or more breathing components are used in the present invention, the
breathing components can be of the same type (e.g., two cassettes)
or different types (e.g., a valve and a cassette).
[0058] Cassettes
[0059] In certain embodiments, the cassettes can alter, increase or
reduce the inhalation or exhalation effort of a user of a device of
the present invention while using a device of the present
invention.
[0060] In certain embodiments, one, two or three or more cassettes
having any regular or irregular shape can be used with the device
body. In certain embodiments, a cassette can be generally
cylindrical or tubular. In certain embodiments, a cassette can
further define an interior (e.g., hollow) space such that the
interior space of a cassette is in direct communication with an
interior space of a device body.
[0061] A cassette (or other component for use in the present
invention) can be placed in fluid (where fluid is understood to
encompass gases or liquids) communication with the interior space
of a device body by removable or permanent means such as threaded
couplings, snap fittings, adhesives, heat application and the like.
Such attachment methods may be integral, or of one piece
construction, with the material or may be adhered to the material
though the use of adhesive or sonic welding and the like.
[0062] As noted above, a cassette for use in the present invention
can have the same or different porosity, wall thickness, or
material composition as the device body. The differences in these
factors as between the device body and cassettes allows for
customization of the inhalation and exhalation effort to suit the
needs of a particular user without the need for springs, diaphragms
or valves.
[0063] In some embodiments where the device body includes a porous
portion, the porosity of the cassette, wall thickness of the
cassette, or both, can be different than the device body. In
certain embodiments, the resistance to airflow through the device
body is relatively high (e.g. about 270 cm. water or more) as
compared to the resistance of a cassette. In such embodiments, use
of cassettes can reduce the overall resistance to inhalation or
exhalation airflow by providing paths of less resistance in
communication with the mouthpiece and ambient air. Thus, inhalation
effort and/or exhalation effort of a device of the present
invention can be adjusted by varying the porosity and/or wall
thickness of cassettes that are in communication with a device body
and/or in communication with an interior space of a device
body.
[0064] Any of the resistances described above can apply to a
cassette. In addition, in certain embodiments where the device body
includes a porous portion, the resistance to airflow in a cassette
is 5% less than the device body when a device body is properly used
alone. In other embodiments, the resistance is about 10% less than
the device body. In other embodiments, the resistance is about 20%
less than the device body. In other embodiments, the resistance is
about 30% less than the device body. In other embodiments, the
resistance is 40% less than the device body. In other embodiments,
the resistance is about 50% less than the device body. In other
embodiments, the resistance is 60% less than the device body. In
other embodiments, the resistance is about 70% less than the device
body. In other embodiments, the resistance is about 80% less than
the device body resistance.
[0065] In other embodiments, the resistance of a cassette is 5% to
30% less than the device body. In other embodiments, the resistance
is 5% to 80% less than the device body. In other embodiments, the
resistance is 10% to 50% less than the device body.
[0066] In certain embodiments, a cassette of the present invention
can include a one way valve (e.g., an adjustable one way valve, as
described herein) and may optionally be free or substantially free
of porous material.
[0067] In certain embodiments, a cassette can be used to create a
modular device. In certain such embodiments, one or more cassettes
can be stacked, coupled together or arranged in series (e.g.,
linearly), or in certain designs of a device body (e.g., a T-shaped
design) one or more cassettes can alternatively be arranged in a
parallel fashion relative to the device body. In other embodiments,
one or more cassettes can simultaneously be arranged in both series
and also in parallel.
[0068] Relative to a user, during inhalation a first porous
cassette may be located in series (e.g., upstream) with a second
porous cassette having the same or different inhalation resistance.
Alternatively, a one way valve cassette (e.g., an adjustable one
way valve) may be placed upstream or downstream (e.g., proximally
or distally) relative to another cassette of any type.
[0069] In certain embodiments, a cassette for use in the present
invention has a weight between 0.1 and 1 ounce. In certain
embodiments, a cassette weighs less than 0.9 ounces. In certain
embodiments, a cassette weighs less than 0.8 ounces. In certain
embodiments, a cassette weighs less than 0.7 ounces. In certain
embodiments, a cassette weighs less than 0.6 ounces. In certain
embodiments, a cassette weighs less than 0.5 ounces. In certain
embodiments, a cassette weighs less than 0.4 ounces. In certain
embodiments, a cassette weighs less than 0.3 ounces. In certain
embodiments, a cassette weighs less than 0.2 ounces.
[0070] In certain embodiments of the present invention, a cassette
can have an opening on the distal end that can be optionally opened
or closed by a user. The opening can be adapted to receive
additional components (e.g., a one way valve) to be placed in
series with the cassette (e.g., by virtue of a threaded or
unplug-able opening).
[0071] The resistance to exhalation can also be increased or
decreased by altering the exposure of the total amount of pores to
ambient air, porosity, wall thickness, etc. In certain embodiments,
an adjustable cap or other covering can be used to reduce or
increase the amount of porous material that is exposed.
[0072] Alternatively, in some embodiments a device of the present
invention can include one or more apertures in the device body or
cassettes which can be covered or uncovered to increase or decrease
resistance, respectively.
[0073] Valve
[0074] In certain embodiments, one, two or three or more one way
valves can be used to affect the functionality of a device of the
present invention by altering, facilitating or easing inhalation
effort, exhalation effort or both. In another embodiment, a valve,
such as a one way valve (e.g., adjustable or non-adjustable reed or
flap type one way valve), a hole or aperture can be included to
affect the functionality of the device such that a user can
effectively turn off or significantly reduce (by at least 50 to
100%) or substantially eliminate the inhalation or exhalation
resistance caused by the device. A one way valve can be integral
with the device body or may be connected using connection types
apparent to one of skill in the art upon reading this disclosure
(e.g., a threaded fit, bayonet fit or adhesive fit). In one
embodiment, a one way valve (e.g., an adjustable one way valve) can
be removably coupled to a device body and/or substituted for, or
used in series or in parallel with, a porous material cassette of
the present invention.
[0075] One way valves can be used to select whether inhalation or
exhalation of a user undergoes any appreciable resistance,
depending upon the orientation of the valve relative to flow of
fluid (e.g., air) through the valve. When oriented in a first
position, the valve permits inhalation but prevents or
substantially impedes exhalation flow through the valve. In a
reverse of the first position, when oriented in a second position,
the valve permits exhalation but prevents or substantially impedes
inhalation flow through the valve. One way valves can also be used
to impart threshold resistance loading, in that a threshold load
must be exceeded before the valve will open, and the threshold must
be maintained in order for the valve to remain open. One way valves
can be used alone or in combination with a porous material.
[0076] For example a one way valve (adjustable or non-adjustable)
can be used and oriented to allow for the rapid release of exhaled
air from a user through a valve in the device body and into ambient
air. However, upon inhalation the one way valve closes, thus
forcing inhalation effort to increase as the inhaled air passes
through a cassette, porous portion or other component of the
device. In some embodiments, cracking pressures for valves,
including non-adjustable valves can be less than: 1.0 psi, 0.3 psi,
0.2 psi, 0.15 psi, or 0.09 psi. In certain embodiments, the
cracking pressure is less than 0.17 psi. In certain embodiments,
the cracking pressure can be the initial cracking pressure
necessary for an adjustable one way valve.
[0077] In other embodiments, the one way valve can be adjusted so
that the valve itself, in addition to a porous portion of the
device (e.g., the device body or cassette), provides for
variability in resistance by virtue of compression springs,
membranes, and the like. Such embodiments provide a resistance
(i.e., a respiratory load) and any of the resistances described
above with respect to the device body can be used with a valve of
the present invention. In certain embodiments, the device body has
a resistance to flow that is greater than the resistance to flow of
the valve.
[0078] Examples of one way valves, adjustable one way valves, or
membranes and the arrangement thereof can be found at U.S. Pat. No.
6,726,598 and U.S. Pat. No. 4,739,987, the entire contents of which
are hereby incorporated by reference.
[0079] In certain embodiments, the housing of a one way valve can
be constructed from a porous material as described herein.
[0080] In certain embodiments, a valve for use in the present
invention has a weight between 0.1 and 1 ounce. In certain
embodiments, a valve weighs less than 0.9 ounces. In certain
embodiments, a valve weighs less than 0.8 ounces. In certain
embodiments, a valve weighs less than 0.7 ounces. In certain
embodiments, a valve weighs less than 0.6 ounces. In certain
embodiments, a valve weighs less than 0.5 ounces. In certain
embodiments, a valve weighs less than 0.4 ounces. In certain
embodiments, a valve weighs less than 0.3 ounces. In certain
embodiments, a valve weighs less than 0.2 ounces.
[0081] In certain embodiments, a valve can have an opening on the
distal end that can be optionally opened or closed by a user (e.g.,
by using a threaded plug or the like). The opening can be adapted
to receive additional components (e.g., a cassette) to be placed in
series with the valve (e.g., by virtue of a threaded or unplug-able
opening).
[0082] Dead Space Introducing Member for Isocapnic Hyperpnea
[0083] The average total lung capacity of an adult human male is
about 6 liters and females it is about 4.2 liters. Functional
residual capacity is the amount of air left in the lungs after
normal exhalation. Men leave about 2400 ml on average while women
retain around 1800 ml. Thus, men typically exhale 3.6 liters and
women typically exhale 2.4 liters. Residual volume is the amount of
air left in the lungs after a forced exhalation. The average
residual volume in men is 1200 ml and for women is 1100 ml. Vital
capacity is the maximum amount of air that can be exhaled after a
maximum inhalation, where men tend to average 4800 ml and women
3100 ml.
[0084] In certain embodiments, the present invention the device
body, alone or in combination with one or more of a cassette or
adjustable or non-adjustable valve member, provides or is
sufficient to provide a dead space volume. In certain embodiments,
in the absence of a dead space introducing member, the volume of
the device, alone or in combination with one or more of a cassette
or valve member, is insufficient to provide substantial
retention/accumulation of carbon dioxide.
[0085] In certain other embodiments, in the absence of a dead space
introducing member, the volume of the device, alone or in
combination with one or more of a cassette or valve member, is
sufficient to provide substantial retention/accumulation of carbon
dioxide. Thus, in such embodiments, the device body and/or cassette
and/or adjustable or non-adjustable valve member function as a dead
space forming member.
[0086] In other embodiments, the present invention includes a
member that introduces a dead space volume, where the dead space
introducing member can, in some embodiments, be removably coupled
to the device body (e.g. it is a modular component), or the member
can be permanently affixed to the device body and/or arranged in
parallel or in series with one or more of a cassette or valve as
disclosed herein. The dead space introducing member can be any
regular or irregular shape, and in certain embodiments it can be
tubular. In certain embodiments, the dead space retaining member
can be an expandable or elastomeric bag.
[0087] The dead space introducing member can be of any material
having any parameters as described herein, (e.g., porous or
non-porous). The purpose of the dead space volume and/or dead space
introducing member is to retain a certain percentage of exhaled gas
in the overall internal volume of the device, thereby maintaining
an elevated level of carbon dioxide in the device of the present
invention with each subsequent inhalation and/or exhalation. Such
retention of carbon dioxide can reduce the incidence of
hyperventilation.
[0088] In certain embodiments, excluding the amount of exhaled gas
that may be present in the porous walls of the device, alone or in
combination with one or more of a cassette or adjustable valve
member, or dead space introducing member if a porous material is
used in the manufacture of the dead space introducing member, the
overall dead space is about 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%,
40%, 45%, 50%, 55% of a typical exhalation volume of a user. In
another embodiment, a dead space introducing member alone is
sufficient to retain (or increases the overall volume of the total
device) about 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%,
55% of a typical exhalation volume of a user. Thus, in certain
embodiments, the dead space introducing member is about 1.08 liters
(i.e., 3.6 liters.times.30%) in volume.
[0089] Additional information concerning CO2 measurement can be
found in U.S. Pat. No. 4,601,465 and WO2007/089465, the contents of
which are incorporated herein by reference in their entirety.
[0090] Methods of Use and Treatment
[0091] The present invention can be used to treat or assist
patients with breathing disorders, including patients having COPD,
neuromuscular disease, quadriplegia, post operative complications
resulting in altered lung function, dyspnea, chronic congestive
heart failure and other related conditions.
[0092] The present invention can also be used to assist breath
training in an athletic context to increase the strength and
efficiency of breathing. In some embodiments, the resistance to
inhalation, exhalation, or both, can be set such that a user can
use an embodiment of the present invention for between 3 to 300
minutes per day. In some embodiments, a user can use the present
invention periodically or continuously throughout an entire day. In
some embodiments, a user can use the present invention for 10 to 20
minutes per day. In some embodiments, a user can use the present
invention for more than 5 minutes per day. In some embodiments, a
user can use the present invention for more than 20 minutes per
day.
[0093] In some embodiments, the present invention can be used in a
manner consistent with resistance training. In some embodiments,
such resistance training includes a time period of exhalation
and/or inhalation resistance or a predetermined number of breaths
through a device of the present invention followed by a period of
rest wherein the device of the present invention is not used. In
some embodiments, the time period of breathing with resistance is
selected from about 10 seconds, about 15 seconds, about 20 seconds,
about 25 seconds, about 30 seconds, about 45 seconds, about 60
seconds, 90 seconds, 120 seconds, about 10 seconds to 40 seconds,
about 10 seconds to about 60 seconds, about 10 seconds to 90
seconds, about 10 seconds to 120 seconds.
[0094] In certain other embodiments, the predetermined number of
breaths of a training set include at least 5, at least 10, at least
12, at least 15, at least 20, at least 25 at least 30, at least 40,
between 5 and 15, between 10 and 20 breaths, between 20 and 40
breaths.
[0095] In other embodiments, the rest period is selected from about
10 seconds, about 15 seconds, about 20 seconds, about 25 seconds,
about 30 seconds, about 45 seconds, about 60 seconds, 90 seconds,
120 seconds, about 10 seconds to 40 seconds, about 10 seconds to
about 60 seconds, about 10 seconds to 90 seconds, about 10 seconds
to 120 seconds, about 6 hours, about 8 hours about 12, and between
8 and 12 hours. When used in a manner consistent with resistance
training a user is typically not physically active (e.g., not
running, biking, playing a sport or otherwise training, or in the
alternative a user is sitting, driving or is generally not engaged
in cardiovascular or muscular training during use of the device)
and the user is focusing primarily on pulmonary exercise. The user
can complete 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 sets with a rest
period between each set. In some embodiments, a user can complete 3
or more sets, with a rest period between each set.
[0096] In certain embodiments, and as described below, the present
invention is ergonomically formed, small enough and/or light enough
that it can be used for or during endurance training or while
exercising, e.g., while running, stair climbs, cycling,
weightlifting, engaging in aerobics, walking, rock climbing, or
swimming with a kickboard or other activity.
[0097] Alternatively, the device of the present invention can be
used for much longer periods, e.g., for endurance training to
impart or provide hill climb or high altitude training intensities.
In such embodiments, the device of the present invention may be
used while a user is relatively inactive (e.g., resistance training
over an extended period) or while the user is actively
covering/traversing a certain distance.
[0098] In one embodiment, a user may employ the present invention
in the course of inhaling, exhaling, or both, for an extended
period of time. In one embodiment, the device of the present
invention may be used for about 3 minutes, about 4 minutes, about 5
minutes, about 10 minutes, about 15 minutes about 20 minutes. In
some embodiments the present invention may be used for between 10
minutes and 60 minutes. In other embodiments a user can use the
present invention for a time period greater than an hour.
[0099] In some endurance related embodiments, a user may actively
traverse a distance while the user is also engaged in
cardiovascular exercise, where the distance is selected from: about
10 yards, about 100 yards, at least a quarter mile, at least a half
mile, at least a mile, at least 3.1 miles, at least 6.2 miles at
least 10 miles, at least 13.1 miles, at least 20 miles, at least
26.2 miles, at least 30 miles, at least 50 miles, from 1 mile to 10
miles, from about 3.1 miles to 13.1 miles from about 1 mile to 20
miles.
[0100] In some other embodiments, a user may actively undertake an
elevation change while using the device. In such embodiments, a
user may ascend at least: about 10 feet, about 20 feet, about 30
feet, about 50 feet, about 100 feet, about 500 feet, about 1000
feet, or about 5000 feet
[0101] In certain embodiments, the device of the present invention
can be configured to provide flow resistive loading for inhalation
and exhalation. In certain embodiments, the device of the present
invention can be configured to provide flow resistive loading for
inhalation only. In certain embodiments, the device of the present
invention can be configured to provide flow resistive loading for
exhalation only. In certain embodiments, the device of the present
invention can be configured to provide pressure threshold loading
for inhalation and exhalation. In certain embodiments, the device
of the present invention can be configured to provide pressure
threshold loading for inhalation only. In certain embodiments, the
device of the present invention can be configured to provide
pressure threshold loading for exhalation only. In certain
embodiments, the device of the present invention can be configured
to provide pressure threshold loading for inhalation and flow
resistive loading for exhalation. In certain embodiments, the
device of the present invention can be configured to provide flow
resistive loading for inhalation and pressure threshold resistance
for exhalation. Isocpanic hyperpnea (e.g., by using a dead space
introducing member if the device of the present invention does not
provide sufficient dead space already), can be used in combination
with any of the forgoing configurations.
[0102] Other Components
[0103] In some embodiments, the present invention can include a
nose clip and or nose clip holder to close the nose of user and
thereby force a user to breathe solely through the user's mouth and
therefore solely through the device of the present invention. The
nose clip can be separate or integrated with the device of the
present invention. Alternatively, the present invention can be used
in combination with a nasal inspiratory resistance trainer such as
that shown in U.S. Publication No. 20130157810, the contents of
which are incorporated by reference.
[0104] In other embodiments, the present invention includes two
raised nubs which function to plug the nose of a user. The raised
nubs can be solid plastic, a soft material or porous plastic, or
any other material suitable for at least partially blocking the
nasal passageway of a user.
[0105] Other embodiments may also include packaging and
instructions for using a device of the present invention, e.g., for
a kit including the device.
[0106] Other embodiments may also include one, two or three or more
clip portions or eyelets which permit the attachment of a necklace
or string to a portion of a device of the present invention to
permit a user to simply spit out the device of the present
invention (or in case the device of the present invention falls out
of a user's mouth during exercise) such that the present invention
can hang around a user's neck, thereby permitting continued hands
free operation and reducing the incidence of inadvertent loss of
the device. Accordingly, in one embodiment, the present invention
includes the method of a user releasing the device of the present
invention (e.g., from the user's mouth) while still retaining
possession of the device. In certain other embodiments, the
necklace or string can include an elastomeric material so as to
facilitate retention of the device of the present invention in a
user's mouth. Specifically, the elastomeric material (e.g., rubber
or elastic) provides tension support around a user's head. However,
in certain embodiments, such support permits the easy removal of
the device of the present invention from a user's mouth by one or
more of spitting, by hand, or merely mouth relaxation (e.g., in the
case of loss of consciousness).
[0107] In certain porous embodiments, the porous nature of the
present invention may also permit additional constituents to be
adhered to a porous portion. In such embodiments, detection of
disease, e.g., liver disease, gastrointestinal disease, diabetes or
cancer, can be accomplished by contacting a surface with
appropriate detection agents such that disease biomarkers in saliva
and exhaled air (e.g., nitric oxide, acetone, volatile organic
compounds) can be detected (e.g., by a change in color) upon
contact of the disease biomarker with the detection agents.
[0108] In certain other embodiments, the present invention includes
a porous member alone or in combination with a flexible sheet
(e.g., neoprene), to there by provide resistance. In such an
embodiment one or more of the porous portions described herein can
be integral with such a flexible sheet, such that the sheet forms a
mask to be worn by a user, such that the mask forms at least a
partial seal on a user's face to thereby cause the user to breathe
through the porous member.
[0109] In certain embodiments, the present invention does not
provide a seal for the nose, or is free of nose sealing, where
should such sealing be necessary, such sealing can be provided by a
secondary component, e.g., a nose clip.
[0110] In certain embodiments, the components of the device of the
present invention (e.g., the device body or cassette) can be
constructed free of adhesives. In some embodiments, the portions of
the overall device of the present invention may be welded (e.g.,
sonically welded) together or friction fit together.
EMBODIMENTS
[0111] Referring to FIGS. 1 through 6, there is illustrated various
non-limiting embodiments of the present invention.
[0112] With respect to FIG. 1, FIG. 1(a) shows a top perspective
view a device body 100 of one embodiment of a T-shape design of the
present invention. FIG. 1(b) shows a front view of device 100 with
front portion 160. Front portion 160 can optionally include a
selector 170 to manually choose between an exhale only one way
valve 180, inhale only one way valve 200 and open aperture or valve
190. Selector 170 can be of any design, including sliding or
rotary, which in turn can be seated in rotary track 210.
[0113] In addition, device 100 can also include a mouthpiece mating
boss 120 and optionally removable mouthpiece 110. Ends 140 may be a
porous material, non-porous or an end cap, as detailed further in
FIG. 6. The angle 150 may be from 0 degrees to 90 degrees, with 15
to 25 or 30 to 55 degrees being preferred.
[0114] FIG. 2 shows a cutaway view along line A-A of FIG. 1(c). The
device body 130, which may or may not also be porous, has a wall
thickness 133 (which may be uniform or non-uniform thickness
throughout the device 100) and which defines an interior or hollow
space 220. Plugs 176 and 174 of selector 170 seal the apertures or
valves 200 and 190, to thereby permit the exhale only valve one way
valve 180 to function.
[0115] FIG. 3 shows an alternative embodiment along line A-A of
FIG. 1(c), where the ends 140 have been replaced with coupling
elements 225. In one embodiment, threads 240 threadingly engage
coupling element 225 to couple porous cassette 230 to device 100.
In one embodiment, porous cassette 230 further includes interior
portion 235. When cassette 230 is coupled to device 100, the
interior portion 235 of the cassette is in communication with
interior portion 220 of the device 100 body.
[0116] FIG. 4 shows a cutaway view of a porous device that is free
of any interior or hollow portion. Rather, the entire device 100 is
entirely composed of porous material.
[0117] FIG. 5 shows an adjustable embodiment of then invention.
Caps 550 threadingly engage cassettes 500 via thread portion 510
and screw portion 555 in bore 560. Alternatively, the outer portion
of cassettes 500 can be threaded to allow for a threading
connection of cal 550 to cassette 500.
[0118] By adjusting the distance X that cap covers cassette 500,
the amount of exposed surface area can be increased or decreased,
thereby increasing or decreasing the resistance to inhalation or
exhalation felt by a user. For example, as the amount of exposed
area increase to Y, the inhalation effort experienced by a user
decreases. Exhalation effort is kept at a minimum by virtue of one
way exhaust valve 180 which rotary selector 610 is exposing to
ambient air while covering open aperture 190.
[0119] In addition, apertures 557 may be present on portion of a
device body 130 or cassette 500 or 210. Apertures 210 can be
covered or exposed by a user to alter further the effort of
breathing experienced by the user.
[0120] FIG. 6 shows an alternative embodiment where ends 140 have
been replaced with coupling elements 605. Device 100 also has
angled ends 120. In one embodiment, threads 240 threadingly engage
coupling element 225 to couple porous cassette 230 to device 100.
In one embodiment, other end 605 is coupled to a plug 620 having
threads 625 which substantially match threads 240 of cassette 230.
Plug 620 can be tightened or loosened by any means, however as
shown in FIG. 6, tab 622 can be used to rotate plug clockwise or
counterclockwise to thereby loosen or tighten plug 620.
[0121] As used herein, the term "about" means + or -10% of the
value referenced, inclusive of the value referenced. Thus "about
10" is understood to fully support both "10", as well as the range
of "9 to 11" Moreover, the term "about" is understood to be
optionally applicable to every value set forth herein, whether or
not explicitly stated as such in this disclosure. Thus, for
example, a value of "10%" set forth herein is understood to support
a claim limitation of "10%" as well as a claim limitation of "about
10%."
[0122] It is also understood that individual values provided as
part of a listing of values may be selected individually. For
example, "2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%"
is understood to mean that any particular value may be selected
from the list and used or claimed alone, e.g., 2% or 30%, 55% or
about 55%).
[0123] In this disclosure, there is shown and described various
embodiments of the invention. However, as aforementioned, the
invention is capable of use in various other combinations and
environments and is capable of changes or modifications within the
scope of the inventive concept as expressed herein. Various
embodiments may be altered or combined with other embodiments
without changing or altering the scope of this disclosure.
[0124] Each and every reference set forth in this disclosure is
hereby incorporated by reference in its entirety as if set forth
fully herein.
* * * * *