U.S. patent application number 14/534857 was filed with the patent office on 2016-07-21 for device for supporting a user's body.
This patent application is currently assigned to Thera Torr Medical, Inc.. The applicant listed for this patent is Thera Torr Medical, Inc.. Invention is credited to Timothy E. Moutafis.
Application Number | 20160206114 14/534857 |
Document ID | / |
Family ID | 39512035 |
Filed Date | 2016-07-21 |
United States Patent
Application |
20160206114 |
Kind Code |
A1 |
Moutafis; Timothy E. |
July 21, 2016 |
DEVICE FOR SUPPORTING A USER'S BODY
Abstract
The invention provides a variety of devices for supporting at
least a portion of a user's body. In some embodiments, the
invention provides a support device which includes a bladder
capable of containing a fluid and a post adjacent the bladder. The
bladder may form a rolling diaphragm portion with the post such
that when a force is applied to the bladder, the rolling diaphragm
portion of the bladder rolls along the post decreasing the volume
of the bladder. In some embodiments, the invention provides a post
which includes a reduced cross-sectional area in comparison to an
adjacent region of the post such that the resistance of the rolling
diaphragm portion of the bladder to rolling movement along the post
due to the applies force decreases as the bladder rolls along the
reduced cross-sectional area region. In some embodiments, the
support device includes a plurality of bladders and/or a plurality
of posts.
Inventors: |
Moutafis; Timothy E.;
(Gloucester, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Thera Torr Medical, Inc. |
Beverly |
MA |
US |
|
|
Assignee: |
Thera Torr Medical, Inc.
Beverly
MA
|
Family ID: |
39512035 |
Appl. No.: |
14/534857 |
Filed: |
November 6, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14012606 |
Aug 28, 2013 |
|
|
|
14534857 |
|
|
|
|
12448027 |
Feb 22, 2010 |
8572783 |
|
|
PCT/US2007/025132 |
Dec 7, 2007 |
|
|
|
14012606 |
|
|
|
|
60909655 |
Apr 2, 2007 |
|
|
|
60873742 |
Dec 9, 2006 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61G 7/05769 20130101;
A61G 7/05776 20130101; A61G 5/1043 20130101; A47C 27/10 20130101;
A47C 27/081 20130101 |
International
Class: |
A47C 27/08 20060101
A47C027/08; A47C 27/10 20060101 A47C027/10 |
Claims
1. A device for supporting at least a portion of a user's body, the
device comprising: a plurality of bladders capable of containing a
fluid, the plurality of bladders including at least a first bladder
and a second bladder; and a plurality of posts adjacent to and
supporting the plurality of bladders, such that at least one post
is positioned adjacent to and supports each of the plurality of
bladders, the plurality of posts including at least a first post
and a second post, with the first post positioned adjacent to and
supporting the first bladder and the second post positioned
adjacent to and supporting the second bladder, wherein the first
and second bladders each forms a rolling diaphragm portion with the
first and second posts, respectively, such that when a force is
applied to the first bladder, the rolling diaphragm portion of the
first bladder rolls along the first post decreasing the volume of
the first bladder, and when a force is applied to the second
bladder, the rolling diaphragm portion of the second bladder rolls
along the second post decreasing the volume of the second
bladder.
2.-15. (canceled)
16. A device for supporting at least a portion of a user's body,
the device comprising: at least one bladder capable of containing a
fluid; and a plurality of posts adjacent the at least one bladder,
the plurality of posts including at least a first post and a second
post, wherein at least a portion of the at least one bladder forms
a first and second rolling diaphragm portion with the first and
second posts, respectively, such that when a force is applied to
the at least one bladder at a location adjacent the first post, the
first rolling diaphragm portion of the at least one bladder rolls
along the first post decreasing the volume of the at least one
bladder, and when a force is applied to the at least one bladder at
a location adjacent the second post, the second rolling diaphragm
of the at least one bladder rolls along the second post decreasing
the volume of the at least one bladder.
17.-27. (canceled)
28. A device for supporting at least a portion of a user's body,
the device comprising: a bladder capable of containing a fluid; a
post adjacent the bladder, wherein the bladder forms a rolling
diaphragm portion with the post such that when a force is applied
to the bladder, the rolling diaphragm portion of the bladder rolls
along the post decreasing the volume of the bladder; and wherein
the post includes at least one region having a reduced
cross-sectional area in comparison to an adjacent region of the
post such that the resistance of the rolling diaphragm portion of
the bladder to rolling movement along the post due to the applied
force decreases as the bladder rolls along the at least one region
having the reduced cross-sectional area.
29.-34. (canceled)
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 14/012,606, filed Aug. 28, 2013, which is a continuation of
U.S. application Ser. No. 12/448,027, filed Feb. 22, 2010, and
issued as U.S. Pat. No. 8,572,783 on Nov. 5, 2013, which is a
national stage of International Application Serial No.
PCT/US2007/025132, filed Dec. 7, 2007, which is hereby incorporated
by reference in its entirety. International Application Serial No.
PCT/US2007/025132 claims the benefit under 35 U.S.C. .sctn.119(e)
of U.S. Provisional Application Ser. No. 60/873,742, filed Dec. 9,
2006 and U.S. Provisional Application Ser. No. 60/909,655, filed
Apr. 2, 2007.
FIELD OF THE INVENTION
[0002] The present invention relates generally to devices for
providing support to at least a portion of a user's body, and in
particular to a device which may adjust the pressure on certain
portions of the user's body.
BACKGROUND OF THE INVENTION
[0003] Various types of support devices, such as mattresses,
cushions, chairs, are known to support a user's body. A
conventional mattress may include an array of spring elements to
support a body. When a user lays on a conventional mattress, the
springs compress. As the level of compression increases, the
resistive force in the springs increase as a result of user's
weight on the mattress. This increased resistance tends to focus on
protruding regions of patient anatomy which may cause lesions such
as pressure ulcers, or other local circulatory problems, especially
in bedridden patients. Protuberant regions of the anatomy are more
prone to develop pressure sores because they tend to penetrate more
deeply into mattresses, encountering greater forces than nearby
regions and thus are more likely to have diminished local blood
circulation.
[0004] Areas of a patient's body exposed to higher pressures when
positioned on a support device, i.e., pressure points, are
undesirable. Current methods to reduce pressure points on bedridden
patients involve frequently moving or rotating the position of the
patient on the support device so that a pressure point does not
lead to the above-mentioned lesions. While this approach may be
helpful, it requires someone, such as a nurse, to physically move
the patient. This is time consuming and may also lead to injuring
the nurse and/or the patient.
SUMMARY OF INVENTION
[0005] Aspects of the present invention are directed to a support
device which helps to minimize pressure points on a user's body
when the user is supported by the device. By minimizing the
pressure points on a user's body, aspects of the present invention
are directed to reducing the incidence of pressure ulcers and local
circulatory problems.
[0006] Certain embodiments of the present invention are directed to
providing a support to device with a low interface pressure. By
providing a low interface pressure, the certain embodiments of the
present invention may reduce the need to move and/or rotate a
bedridden patient as frequently.
[0007] In one embodiment, a device is provided for supporting at
least a portion of a user's body. The device includes a bladder
capable of containing a fluid, and a post adjacent the bladder. The
bladder forms a rolling diaphragm portion with the post such that
when a force is applied to the bladder, the rolling diaphragm
portion of the bladder rolls along the post, decreasing the volume
of the bladder.
[0008] In certain embodiments, the invention provides a support
device with the above described bladder and post where the
cross-sectional area of the post varies along its length. As set
forth in greater detail below, altering the cross-sectional area of
the post can alter the amount of resistance of the bladder to the
rolling movement along the post. In one embodiment, the post
includes at least one region having a reduced cross-sectional area
in comparison to an adjacent region of the post such that the
resistance of the rolling diaphragm portion of the bladder to
rolling movement along the post due to the applied force decreases
as the bladder rolls along the at least one region having the
reduced cross-sectional area.
[0009] In certain embodiments, the invention provides support
device for supporting at least a portion of a user's body. The
support device includes a plurality of bladders capable of
containing a fluid, where the plurality of bladders includes at
least a first bladder and a second bladder. The support device
further includes a plurality of posts adjacent to and supporting
the plurality of bladders, such that at least one post is
positioned adjacent to and supports each of the plurality of
bladders. The plurality of posts include at least a first post and
a second post, with the first post positioned adjacent to and
supporting the first bladder and the second post positioned
adjacent to and supporting the second bladder. The first and second
bladders each forms a rolling diaphragm portion with the first and
second posts, respectively, such that when a force is applied to
the first bladder, the rolling diaphragm portion of the first
bladder rolls along the first post decreasing the volume of the
first bladder, and when a force is applied to the second bladder,
the rolling diaphragm portion of the second bladder rolls along the
second post decreasing the volume of the second bladder.
[0010] In certain embodiments, the invention provides a device for
supporting at least a to portion of a user's body. The device
includes at least one bladder capable of containing a fluid, and a
plurality of posts adjacent the at least one bladder. The plurality
of posts includes at least a first post and a second post. At least
a portion of the at least one bladder forms a first and second
rolling diaphragm portion with the first and second posts,
respectively, such that when a force is applied to the at least one
bladder at a location adjacent the first post, the first rolling
diaphragm portion of the at least one bladder rolls along the first
post decreasing the volume of the at least one bladder, and when a
force is applied to the at least one bladder at a location adjacent
the second post, the second rolling diaphragm of the at least one
bladder rolls along the second post decreasing the volume of the at
least one bladder.
BRIEF DESCRIPTION OF DRAWINGS
[0011] The accompanying drawings are schematic and are not intended
to be drawn to scale. In the figures, each identical, or
substantially similar component that is illustrated in various
figures is typically represented by a single numeral or notation.
For purposes of clarity, not every component is labeled in every
figure, nor is every component of each embodiment of the invention
shown where illustration is not necessary to allow those of
ordinary skill in the art to understand the invention. In the
drawings:
[0012] FIGS. 1A-1C are schematic cross-sectional illustrations of a
support device according to one embodiment;
[0013] FIGS. 2A-2B are schematic cross-sectional illustrations of
two posts having different cross-sectional areas.
[0014] FIGS. 3A-3B are schematic cross-sectional illustrations of a
support device in a first position and a second position according
to another embodiment;
[0015] FIGS. 4A-4C are schematic illustrations of three differently
shaped posts along the stroke axis illustrating the different
pressure and reaction force characteristics associated with the
different posts;
[0016] FIGS. 5A-5C are schematic illustrations of a support device
including a blower for air pressure delivery and a pressure
controller;
[0017] FIGS. 6A-6B are schematic illustrations of a support device
including a plurality of zones according to another embodiment;
[0018] FIGS. 7A-7C are schematic illustrations of a support device
including a plurality of zones according to another embodiment for
use in a hospital bed with a Personal Digital Assistant;
[0019] FIGS. 8A-8B are schematic illustrations of a support device
including perforations for ventilation according to another
embodiment;
[0020] FIGS. 9a-9h are schematic illustrations of a bladder being
coupled to a post according to other embodiments;
[0021] FIGS. 10A-10B are schematic illustrations of a disposable
patient contacting surface for the support device according to
another embodiment;
[0022] FIG. 11 is a schematic illustration of a support device
according to another embodiment;
[0023] FIG. 12 is a schematic illustration of a support device
according to yet another embodiment;
[0024] FIG. 13A is a graph of load vs. deflection for a support
device at various pressures according to another embodiment;
[0025] FIGS. 13B-13C are schematic illustrations of a support
device used to generate the data in FIG. 13A;
[0026] FIG. 13D is a graph of Contact Pressure vs. Compression
Distance for a support device at various pressures according to yet
another embodiment; and
[0027] FIG. 14 is a graph of load vs. deflection for a support
device according to one embodiment compared to data for a foam
mattress and a water bed.
DETAILED DESCRIPTION
[0028] The present invention provides a device for supporting a
portion of a user's body. It should be appreciated that in some
embodiments, the device may be part of and/or may form a mattress.
In other embodiments, the device may be part of and/or may form a
chair, and in yet other embodiments, the device may be part of
and/or may form a cushion or pillow or other support surface/device
or portion thereof.
[0029] Certain embodiments of the support device include bladders
with portions which act as a rolling diaphragm. In particular, the
support device may include at least one bladder and a post
positioned adjacent to and supporting the bladder. The bladder may
to include a rolling diaphragm portion capable of rolling along the
post. The rolling diaphragm portion of the bladder may roll along
the post in response to a force applied to the bladder. The
position of the bladder with respect to the post can affect the
volume within the bladder. In one embodiment, the volume of the
bladder decreases and increases as the bladder rolls along the post
in a first and second direction of travel, respectively.
[0030] The inventive support device will now be described in more
complete detail in the context of several specific embodiments
illustrated in the appended figures. It is to be understood that
the embodiments described are for illustrative purposes only and
that the inventive features of the invention, as described in the
appended claims, can be practiced in other ways or utilized for
instruments having other configurations, as apparent to those of
ordinary skill in the art.
[0031] Certain embodiments of the present invention are directed to
a support device which may include one or more bladders 10 capable
of containing a fluid. The embodiment illustrated in FIG. 1 depicts
a pair of support devices 5, each including a fluid-filled bladder
10 with an adjacent post 14. The dashed region in FIGS. 1B-1C
illustrates the fluid within the bladders 10.
[0032] It should be appreciated that the bladder 10 and posts 14
may be made of a variety of materials as the invention is not so
limited. For example, the bladder 10 may be made from materials
such as, but not limited to various flexible and substantially
fluid impermeable material like rubber and various plastic
materials, and the post may be made from materials such as plastic
materials, metals, wood, etc. without limitation.
[0033] In one embodiment, the bladder is constructed of a fabric
coated with or molded to an elastomer. The elastomer may be a
natural rubber or a synthetic compound, and may, for example be
between approximately 30-90 shore D durometer. In one embodiment,
the fabric may be a cotton, polyester, polyester, such as
polyethylene, or KEVLAR.RTM., obtained from DuPont. In one
embodiment, the thickness of the bladder is between approximately
0.01-0.04 inches. In one particular embodiment, the bladder is made
from a non-latex elastomer, such as neoprene, with a cotton
embedded fabric. The thickness of the bladder material may be
approximately 0.03 inches and the expanded bladder diameter may be
approximately 2 inches.
[0034] In one embodiment, the post 14 may be made from ABS
(Acrylonitrile butadiene styrene), polycarbonate, PVC (Polyvinyl
chloride), or styrene. As discussed in greater detail below, in
some embodiments, the post 14 is a rigid structure, whereas in
other embodiment, the post 14 is a resilient structure, and may for
example be inflatable.
[0035] Some of the below-mentioned embodiments utilize air as the
fluid within the bladder. It is also contemplated that other
fluids, including other gases as well as liquids, such as water,
may also be employed. It should also be recognized that the fluid
may be temperature controlled.
[0036] FIG. 1A is a top view of one bladder 10, illustrating one
embodiment with an approximately square upper surface 12. In
another embodiment, the bladders 10 may be shaped differently as
the present invention is not limited in this respect. For example,
in one embodiment, the bladder 10 may be approximately hexagonal
and/or approximately round in shape rather than square.
[0037] In one embodiment, the upper surface 12, and/or the upper
portion of the walls 16 of the bladder 10, may include a
patient-contacting finish or layer, which may include various types
of foam, gel, and/or padding.
[0038] FIG. 1B illustrates a cross-section of a bladder 10 and a
post 14 on which it may be coupled. In this particular embodiment,
the side wall 16 of the bladder 10 is coupled at region 18 to the
post 14 by adhesive or other coupling. In this particular
embodiment, the side wall 16 of the bladder 10 passes downward
initially, then curves upward in region 34 and runs upward to top
surface 12 of the bladder. In one embodiment, the post 14 includes
a channel or passage 22 which fluidly connects a fluid duct 24
running through the base region 26 of post 14 with the inside of
the bladder 10. The base region 26 may be connected to a supporting
frame 28. Fluid ducts 24 may be connected by connectors 30 to each
other, or to tubing (not illustrated) to form a support device
including a fluidly connected array of bladders 10 and posts
14.
[0039] The support device 5 is typically at a given pressure P (not
labeled), which in one embodiment, is the same for all bladders 10
within a device, or within one or more specific regions or zones of
a device 5. As discussed in greater detail below, the posts 14 may
be disposed in one or more separately pressure regulated regions or
zones, and may also be connected to a fluid pressurizing system to
fill the bladder with fluid, such as, but not limited to, an air
compressor, a fan, a pump for liquid or air, or a liquid reservoir
raised to an appropriate height above the connectors 30 (not
illustrated).
[0040] The fluid ducts 24 may be coupled via connectors 30 which
are able to withstand the anticipated pressures in the device. In
one embodiment, the pressure within the device is between
approximately 0.1-1 psig. In another embodiment, the pressure
within the device may be as much as approximately 1-10 psig or
more. It should be appreciated that a larger pressure may be useful
to elevate or move patients. The pressure may be regulated by a
pressure regulator of any type, and/or a centrifugal pump, and the
system pressure may be variable with time, or zoned, or both, as
described below. Local controls may regulate particular zones of
the device, using conventional electric and fluidic control
devices. In another embodiment, posts 14 may be mounted directly
into a manifold, and the manifold is fluidically connected to the
rest of the device, for example through valves or regulators.
[0041] FIG. 1C illustrates an embodiment similar to the that shown
in FIG. 1B, except the bladder 10 has been pushed in a downward
direction by an applied force. In this configuration, the bladder
10 forms a rolling diaphragm as the bladder wall 16 has rolled down
the post 14 until curved region 34 has contacted the base 26 of the
post 14. As shown, the interior volume 32 of the bladder shown in
FIG. 1C is smaller than the interior volume 32 of the bladder shown
in the configuration shown in FIG. 1B. In this particular
embodiment, the fluid lost in pressing down the top surface 12 of
the support device 5 in FIG. 1C exits through the fluid passages
22, fluid ducts 24, and connectors 30. In one embodiment, the fluid
passage 22 is approximately 0.06 inches in diameter and is
approximately 1 inch in length. In one particular embodiment, the
fluid passage 22 is formed with a hole axially extending through a
fastener, such as a screw.
[0042] In one embodiment, the distance the bladder wall 16 is
capable of rolling down the post 14 from its fully extended
position (such as FIG. 1B), before encountering any region of
increased post diameter (e.g. base 26, such as in FIG. 1C), may be
at least approximately 50% or more of the length of the post. In
another embodiment, the bladder wall 16 is capable of traveling
along at least approximately 70% or more of the length of the post,
and in yet another embodiment, the bladder wall 16 is capable of
traveling at least approximately 80% or more of the length of the
post.
[0043] As illustrated in FIGS. 1B-1C, in one embodiment, a
plurality of bladders 10 may be fluidically interconnected so that
the pressure within a first bladder is capable of reaching an
equilibrium with the fluid pressure within a second bladder. In one
illustrative embodiment, the fluid duct 24 and fluid passage 22
extending through the posts 14 fluidly connects the first and
second bladders 10. It should be appreciated that in other
embodiments, the fluid pressure within the first bladder may be
capable of reaching an equilibrium with the fluid pressure within a
second bladder 10 through various types of conventional sensors as
the invention is not so limited.
[0044] Turning now to the schematic illustrations shown in FIGS. 2A
and 2B, the mechanistic basis for one embodiment of the support
device according to the present invention is more fully described.
To better enable the understanding of the support devices, a simple
mechanical analogy is shown in cross section in FIGS. 2A-2B. In
FIG. 2A, a piston 110, having a diameter D 1 and a top surface 112,
passes through a sealing ring 114 into a cylinder 116 having a side
wall 118, a top surface 120 and an air outlet 122.
[0045] If the cylinder 116 is supplied with air at pressure P, then
to prevent the piston from moving, a certain force, F1, will be
required to prevent the piston 110 from being forced out of the
cylinder by pressure P. The required force will be proportional to
the cross-sectional area of the piston 110 where the piston passes
through the sealing ring 114. If the piston is cylindrical in
shape, the required force will be proportional to the square of the
diameter D1 of the piston 110 where it passes through the sealing
ring 114 into the cylinder 116. If the actual force applied is
greater than F1, the piston will enter the cylinder, and unless
pressure P is increased, the piston will eventually reach the top
120 of the cylinder 116.
[0046] FIG. 2B is similar to FIG. 2A except that piston 111 has a
smaller diameter, D2, with an upper end 113, and going through a
smaller sealing ring 115. A smaller force, F2, proportional to the
square of the diameter D2 of the portion of the piston passing
through the seal 113, will be required to maintain the piston 111
in place, or to force it into the cylinder 118. Note that the
appropriate place to measure the diameter to determine the force to
prevent motion is at the seal, and not at the inward ends 112, 113.
For example, one could place a thin plate on end 113 of FIG. 2B
that was as big as that of end 112 of FIG. 2A, and as long as the
plate did not make sealing contact with the walls of the cylinders
118, it would make no difference to the force required to balance
the respective pistons 110, 111 against pressure P.
[0047] FIGS. 2A-2B are similar to FIGS. 1B-1C, with the cylinder
118 analogous to bladder 10 and pistons 110 or 111 analogous to
post 14. In one embodiment, instead of a sliding seal 114 or 115
and motion of a piston through it, the curved region 34 of the
bladder 10 acts as a rolling diaphragm moves up and down with
respect to the top surface 20 of the post 14. The diameter and
geometry of post 14 may be selected to control the critical
intra-bladder pressure Pc, below which critical pressure a given
weight will start to depress the upper surface of a bladder 10.
[0048] In one embodiment, the resistance of the bladder 10 to the
rolling movement along the post 14 due to an applied force may
decrease as the bladder 10 moves along certain regions of the post.
As shown in FIGS. 3a and 3b, in one embodiment, a support device is
provided where the resistance of the bladder to losing volume
decreases as the top surface 146 of the bladder is pressed
downwards. In other words, as a person sinks part of their anatomy
into the support device, such as a mattress, and pushes below the
surface, the reaction force or upward pressure is reduced as
deflection is increased. This is in sharp contrast to typical
support devices, such as s spring mattress, where as the deflection
is increased, the force of resistance of the spring would increase.
This decreasing resistance behavior can be measured with exemplary
data being provided below.
[0049] In one embodiment, this is accomplished by including a post
162 with a reduced cross-sectional area in comparison to an
adjacent region of the post 162. In the embodiment illustrated in
FIGS. 3A-3B, the post's outer diameter tapers, either smoothly or
abruptly at a defined depth of travel from the top surface. In FIG.
3A, the post 162 has an upper region 160 with a larger diameter and
a lower region 166 of reduced outer diameter, with a transition
region 168 having a varying diameter in between. The bladder 142
has top surface 146, a seal 144, and may be generally similar to
the bladders of previous embodiments. The post 162, includes a
fluid flow lumen 150 in fluid communication with a connector 152
With no weight or force applied, and when inflated by a positive
system pressure, the bladder 142 will have a chamber 148 inflated
to its maximum volume.
[0050] FIG. 3B illustrates the effects of applying weight above the
critical pressure to the support of FIG. 3A. As such a weight is
applied to top surface 146, the bladder 142 is compressed and the
volume of chamber 148 decreases, and the rolling diaphragm portion
or dependent region 164 increases in depth (i.e. moves towards base
170 of post 162). The balloon-like bladder's folded under outer
surface 172 may be maintained in contact with the post 162 by the
pressure in the bladder. As shown in FIG. 3B, the bladder 142 may
eventually contact the reduced diameter section found in region 166
of post 162. As noted above, the effective area of the "piston"
here resisting further displacement forces (the post 162 in FIGS.
3A-3B) is less when the curved region 164 of the bladder is
positioned opposite a smaller diameter post region 166 (FIG. 3B)
than when it is positioned opposite a larger diameter post region
160 (FIG. 3A). In the illustrated embodiment, once the curved
region 164 of the bladder reaches the narrower post beginning at
region 168, it takes less force to push the bladder further down
onto the post, because the pressure in the device is available over
a smaller area. Thus, as the bladder is pushed downward onto a
tapered post, the resistance to movement further decreases. As
shown, the rolling diaphragm portion 164 may be approximately
annular in shape as it rolls along the post 162. As the
cross-sectional area of the post 162 decreases, the inside diameter
of the annular shaped rolling diaphragm portion 164 may also
decrease as it may be pulled inwardly to follow the contour of the
post 162.
[0051] This is in contrast to a conventional spring mattress or
sealed fluid bladder mattress where the resistance to movement
would increase as the springs or sealed bladder is compressed. It
should be appreciated that the decrease or reduction in slope of
the force versus displacement curve and the effective range of such
a decrease is dependent on the exact geometry of the posts with
respect to height, taper and/or rate of change of the
cross-sectional area of the taper.
[0052] In the embodiment illustrated in FIGS. 3A-3B, the
substantially straight or linear constant-force region 160 at the
top of the post 162 is relatively short, proportionally, in the
vertical dimension in comparison to the remaining lower portion 166
of the post. In one embodiment, for example, when the support
device is a cushion for sitting, a short region of constant force
may be appropriate. In another embodiment, such as when the support
device is a mattress, a longer distance of travel, i.e. a larger
straight or linear constant-force region at the top of the post
before the resistance begins to decrease, may be more appropriate.
In this particular embodiment, the taper in region 168 is of an "S"
type, going through a curved surface from a first constant diameter
to a second constant diameter. It should be appreciated that other
patterns are also contemplated, such as, but not limited to a
gradual taper, an abrupt taper or step change after a constant
diameter section, or any number of other configurations.
[0053] Moreover, the contrast in diameter between regions of the
post is depicted in the figures as a large difference to make its
effects easier to visualize. In one embodiment, the post of the
support device may have more subtle tapers. For example, in one
embodiment, the decrease in the cross-sectional area of the post is
in the range of approximately 1% to approximately 50%. In another
embodiment, the decrease in the cross-sectional area of the post is
in the range of approximately 5% to approximately 35%, and in yet
another embodiment, the decrease in cross-sectional area of the
post is in the range of approximately 10% to approximately 30%.
Exact ranges of taper (rate of diameter decrease), or ratio between
largest and smallest diameters or areas of parts of a post, may be
selected based upon a particular application and/or user's medical
condition.
[0054] In the embodiment illustrated in FIGS. 3A-3B, the post
includes a base 170 which, as shown, tapers outwardly. Because the
cross-sectional area of the base 170 is greatly increased in
comparison to other parts of the post, a much larger force would be
required to further move the bladder along the base 170 of the
post. In certain embodiments, an outwardly tapered base 170 may be
provided so that the movement of the bladder 142 stops once the
bladder reaches the base 170. This may help to create a soft
bottoming (i.e. preventing direct contact of the user's body with
the posts, and/or minimize its impact). As mentioned above, in one
embodiment, the posts 162 are inflatable, and may be held at a
pressure greater than system pressure in the bladders. As noted
above, the pressure in the bladders may be less than 1 PSIG
(pressure above atmospheric.) In this respect, any contact between
the user's body and the posts may be cushioned. It is also
contemplated to include a resilient material on the top surfaces
146 of bladders and/or as part of the posts to further provide
cushioning.
[0055] FIG. 4 illustrates three differing geometries for the post
each with a distinct load-deflection curve and overall reduction in
force applied to the portion of patient adjacent the post supported
by the bladder despite increasing load applied from the top. In
each embodiment, the module (i.e. a bladder/post combination)
support force is the combination of the normal (axial) force due to
the changing cross sectional area of the to post and the modulation
effects of the increasing or decreasing annular shape of the
rolling diaphragm portion of the bladder.
[0056] FIGS. 5A-5C illustrates various components of one embodiment
of a support device of the invention 500, where the support device
is a mattress with modules 502 (i.e. bladder/post combination) in
place at the bottom frame 504. In this embodiment, the bottom frame
504 is a thin plenum which fluidly connects a plurality of bladders
together. (FIG. 5A). In one embodiment, the bottom frame 504
supports these modules and the bottom frame 504 may also be
inflatable to provide additional cushioning to a user. It should be
appreciated that the figure is not drawn to scale, but, the basic
configuration of the modules is shown. In this particular
embodiment, the support device includes a cover 506, which is
discussed in greater detail below. As shown in FIG. 5B, the support
device also includes a blower in conjunction with a readily
available pressure pump control (FIG. 5C) interconnected in
operative association with the modules of FIG. 5A in a manner that
would be apparent to those skilled in the art. Together these
components comprise a basic support device unit according to one
embodiment of the present invention. In one embodiment, this basic
unit may operate in a static mode (i.e., no air infusion into the
bladders 508 at constant inflation). In another embodiment, this
unit may operate in an alternating pressure mode (i.e. air
inflow/pressure changing according over time using the simple
blower and the control unit), and in another embodiment, the unit
may operate in a ventilation mode with constant air infusion, for
example by perforating the tops of the bladders as is done for
typical ventilation mattress. Furthermore, the surface of each
module top may include material including foam, gel, padding or
other material or combinations as desired or a patient contacting
surface that is disposable and conforming to the underlying surface
retaining the pressure relieving benefits.
[0057] FIG. 6A illustrates a support device comprising a two
dimensional array of inflated bladders having upper, load-bearing
surfaces 12 which may initially all be inflated to have essentially
the same volume and be pressurized to a first pressure P1. In one
embodiment, the array is surrounded by a side frame (not
illustrated) to maintain the bladders in position. In such
embodiments, the side frame will typically be connected to a bottom
frame such as bottom frame 28 of FIG. 1 or bottom frame 504 of FIG.
5. Such a configuration may serve to create a complete mattress
replacement system.
[0058] If an irregular object, for example, all or a part of a
human body, is applied to the array, and the load per module
exceeds pressure P1 at any point, then protruding sections of the
object may contact surfaces 12 first, and those surfaces may be the
first areas to compress. As more of the object comes in contact
with additional bladder surfaces 12 as the object sinks into the
array, the weight of the object may be distributed over a larger
and larger set of surfaces 12. If the pressure P1 is above a
certain threshold, then at some point, enough surfaces 12 may be
engaged that the weight pressing on each will be below the weight
needed to begin to roll the bladders along the posts, and the
object will stabilize and not sink any further into the array.
[0059] In one embodiment, it may be made easier for a patient to
get into/onto a support device comprising a large array of
bladders, such as a mattress, by raising the internal bladder
pressure to a relatively high pressure so that the mattress will
remain firm while the patient initially sits/lies on it or gets off
it. Once the patient is situated, the pressure may be reduced so
that the patient sinks into the mattress sufficiently to spread his
weight over a larger number of bladders.
[0060] The required supporting pressure may be quite small. For
example, if the area of the patient's torso including buttocks is
about 300 square inches, and the patient weighs about 200 lbs, the
required pressure to support the patient is about 0.67 PSI, when
lying on his back or stomach. In contrast, when a patient "sinks"
into a conventional mattress, the local pressure per unit area may
be considerably higher on protruding areas such as the buttocks,
and especially on the hip bones when lying in the side. Because in
certain embodiments, at least some of the module bladders may be
interconnected in fluid communication such that the pressure in
each fluidically interconnected module will be essentially the same
or, in other embodiments, the pressure in different bladders may be
independently set and/or controlled, protrusions on a patient's
body will not be subject to increased force applied by the support,
but can be subject to essentially the same level of force or even a
lesser level of force than surrounding areas of the patient's body
depending on the particular shape and configuration of the post
geometry of the modules and/or the particular module pressure and
the associated force/displacement response as described
previously.
[0061] Thus, aspects of the present invention are directed to a
support device, such as a mattress, which may reduce the pressure
on any particular area of the body of a patient to (e.g. a
protruding area) with respect to the average pressure exerted on
overall area of contact of the mattress with the patient's body,
dictated by the patient's weight and cross-sectional area of
contact with the support device, in a particular position, compared
to conventional support devices. This effect is not readily
achieved with a conventional mattress or even a conventional air
bed, each of which tends to exert higher forces per unit area on
protruding areas of a patient which leads to pressure points.
[0062] The present invention is also directed to support devices
and methods of use which may selectively reduce the resistance to
displacement in areas supporting protuberant regions of the user's
body. According to one embodiment, the support device is capable of
selectively reducing the resistance in areas of protuberant regions
of a user's body by reducing the critical pressure of the bladders
in a zone where the protuberant regions are located. In one
embodiment, this may be done by having multiple zones of differing
air pressure and/or multiple zones of modules having posts of
differing geometry. For example, as shown in FIG. 6A, there can be
a small zone R2 with a lower pressure in the middle of a larger
region R1 having higher pressure. As the patient sinks into the
mattress support device, the bladders in zone R2 will yield first,
putting more of the patient's weight on areas of the body lying on
zone R1 with higher pressure. This will likewise reduce the
pressure on the selected area of the patient. The resistance to
further penetration of the mattress support device may be such that
there may be significantly decreased pressure supporting the
protuberant areas.
[0063] In a another embodiment, a region R2 of bladder surfaces 12
may have posts of a smaller cross sectional area than the posts in
a surrounding array region R1. When at least a portion of a user's
body is positioned on the array at R2, it may sink more rapidly
when pressing on modules having posts of smaller area. As the
user's body sinks into the array, it will begin to encounter
surfaces 12 supported by posts of larger area in region R1, and may
encounter greater resistance. When sufficient surfaces are
encountered, the load will be supported at some pressure uniform
pressure P in the bladders in both the R1 and R2 zones (i.e. as
would be the case if the modules were interconnected in fluid
communication with each other; however, in the R2 zone, the modules
with posts of lesser cross-sectional area will not require as much
force applied by the patient areas above and supported by such
modules to create displacement, and so in that region of the body
contacting region R2, the force applied to the body during movement
will be less, essentially according to the ratio of the
cross-sectional areas of the posts in region R2 to those in region
R1. At equilibrium, the pressure will be the same on all of the
body's surface; however, during any subsequent motion, there will
be less pressure applied to the area of the body that is positioned
over region R2.
[0064] One embodiment of the present invention includes a support
device in the form of cushion, mattress or other support containing
an array of bladders supported on an array of posts. A cushion
support device may have at least one region similar to R2 in which
the fluid pressure supplied to the bladders in the region, for
example a region contacting a particular part of the body, is less
than that supplied to bladders in a surrounding area. In
particular, pressure on a region of the body may be lessened during
contact or motion when the body region is in contact with region
R2, while higher pressure may be experienced by the body in a
contiguous region or regions R1. Such a device may be useful in
treating, for example, a broken coccyx, or in curing a pressure
sore on the buttocks, or in relieving pressure on an area that has
been sutured, skin grafted, burned or otherwise is undergoing
healing or treatment.
[0065] In certain embodiments of the invention, a region R2 of a
cushion support device has an array of bladders on posts
characterized in that the posts in the region R2 have a smaller
diameter than posts in a surrounding region R1. This may reduce the
required yield pressure for displacement the bladders in region R2,
so that the weight of the body is borne preferentially by the
bladders in the surrounding region R1.
[0066] In another embodiment, a region R2 has both a lower
pressure, and smaller diameter posts, in comparison to a
surrounding region R1, combining the effects of the previous
embodiments.
[0067] In any embodiment of the above types, valve arrangements or
other pressure/flow control arrangements capable of isolating
individual bladders/post modules or zones of bladders and posts,
for example similar to regions R2 as shown in FIG. 6, may be used
to vary pressure to create a desirable pattern of resilience and
resistance to displacement over the overall area of the support
device and/or to facilitate moving a patient along the surface of a
mattress or other device. Local pressure variation may also be
implemented on a programmed basis to help stimulate healing of a
lesion. For example, selected regions may have their pressures
changed over timescales of seconds, minutes or hours, to improve
local blood flow. In a post and bladder system according to the
present invention, such pulsations may reduce the pressure on the
affected areas when the system pressure is transiently reduced.
Local pressure regulation may also be employed for devices
according to the invention configured for treating regions of a
patient body not on the trunk of the body, such as heels or elbows,
where pressure can be adjusted to be locally lower, e.g. to
simulate a sensation of "weightlessness.". For embodiments in which
the bladders may by directly connected to each other, any such
connection may advantageously provide excess surface/material of
connection to accommodate significant differences in bladder
heights while preventing tension from arising between adjacent
bladders, or within covering materials attached to the top surfaces
of the bladders due to the interconnection. It is also contemplated
that pressure/flow control arrangements may be configured to
inflate and/or deflate certain rows and/or columns of the support
device in various patterns to help reposition or rotate the
patient.
[0068] FIG. 6B illustrates another embodiment in which any of the
above-described support device module characteristics may be
selectively incorporated into any array of existing beds, systems
or other surfaces comprised of all available materials such as
foam, springs, fluid filled bladders, air filled bladders, gel
materials, alternating pressure and ventilation systems. Discrete
zones of actuated and/or programmed modules may be beneficial in
conjunction with some existing systems as illustrated.
[0069] FIGS. 7A-7C illustrate how differing regions of a mattress
support device 700 coupled with an air pressure controller and air
pump (not illustrated), may for example be used as a hospital bed
(FIG. 7C). FIG. 7B illustrates a hand held Personal Digital
Assistant (or in other embodiments a personal computer or other
controller or computing device) which may be configured to
interface with control hardware of the support device and
programmed/configured to monitor, control and/or report the air
flow and pressure and/or other parameters relevant to operation of
the support device, for example as needed to optimize the pressure
reduction therapy for the patient.
[0070] FIGS. 8A and 8B illustrate an exterior view (FIG. 8A) and a
cross sectional view (FIG. 8B) of another embodiment of a bladder
40 of the present invention. In this particular embodiment, the
profile of the top surface 42 of bladder 40 is domed. It should be
appreciated that in other embodiments, the bladder 40 may be
generally square, hexagonal, round or elliptical, as the present
invention is not so limited. It should also be recognized that the
outer shape of the bladder 40 may change depending upon the amount
and pressure of fluid within the bladder. In one embodiment, the
bladders are shaped and arranged to minimize any space between
adjacent bladders. The side wall 46 may have a uniform thickness,
which may, for example, be about 0.03 inch (ca. 0.7 mm) In another
embodiment, the thickness may range from less than 0.01 inch to
over 0.05 inch. The selected thickness may depend on the tensile
properties of the fluid-impermeable material used for the bladders,
on the desired maximum system pressure, and on the anticipated
lifetime of the device, particularly if parts are disposable. In
addition, all or part of the bladder may have flocked, textile, or
other coatings for patient contact, which may be thicker than the
fluid-impermeable material of the bladders. The bladders may also
be reinforced.
[0071] In one embodiment, the bladder 40 may have a cross-sectional
width 44 of about 2 inches (ca. 50 mm), so that 800 bladders in an
array of 20.times.40 bladders would have a surface about 40 inches
wide and 80 inches long, similar to a conventional mattress. Other
sizes of bladders are also contemplated, and different sizes of
bladders may be placed in the same array. In one mounting system,
the bladder 40 may be formed to taper to a cross section width 48
at its mouth that is smaller than the width 44 of the main portion
of the bladder, and may have a collar 50 with a rim 52 for mounting
to a post. For example, when width 44 is about 2 inches, mouth
width 48 may be about 1.6 inches, and collar 50 might have a
thickness 52 of about 0.1 inches (ca. 2.5 mm).
[0072] FIGS. 9A-9F illustrate two methods of coupling a bladder 60
to a post 70 to obtain a smooth rolling motion of the bladder onto
the post via a curved region 64. A bladder 60 with a neck region 62
is shown in cross section in FIG. 9A. The neck may first be
inverted, as shown in FIG. 9B, creating a curved region 64. A post
70 is provided (FIG. 9C), and the bladder may be slid onto post 70
and sealed with a layer of adhesive 66, as shown in FIG. 9D. The
adhesive may, for example, be applied to post 70 before its
insertion into neck region 62.
[0073] FIG. 9E-9H illustrate installation of a bladder with a
collar, similar to FIGS. 8A and 8B. The bladder 61 has a neck 63
and collar 65 (FIG. 9E), and is inverted (FIG. 9F) forming a curved
region 67. The post 71 has a notch 73 into which collar 65 fits.
When the post 71 is inserted into the neck region 63, the collar 65
snaps into the notch 73. For low pressures (e.g., 1-10 PSI), this
method of sealing may to provide sufficient sealing without the use
of adhesives. However, adhesives may be applied as in FIG. 9D.
[0074] FIGS. 10A-10B illustrate a cross-section of two bladders
having a type of connecting surfaces 180 between adjacent bladders.
The connecting surfaces 180, and the tops 182 of the bladders may
have coatings placed thereon for patient comfort. The entire
connection surface may be made in the form of a sheet which is
adhered to the bladders of an array, and drapes between then. The
arrows shown in FIG. 10A depict possible air flow which may be in
an embodiment with ventilation on top of or on any surface of the
bladder or the patient contacting surface which may help reduce
moisture on the patient contacting surface.
[0075] FIG. 11 illustrates the movement of the connecting surfaces
when there is a large disparity in the degree to which the top
surfaces of adjacent bladders are differentially depressed. A
covering material with a fabric, weave and/or stretch may allow the
translation of the reduced pressure effect. In some embodiments,
the use of a cover may reduce and/or eliminate the reduced pressure
effect. A covering as shown in FIG. 11 that allows for independent
movement of elements or small groups of elements according to the
anatomy may be fashioned from available materials in the specialty
fabric industry.
[0076] Another embodiment of a support device according to the
present invention is illustrated in FIG. 12. Some of the above
described embodiments include individual bladders coupled to posts,
and a top covering layer may be adhered to the bladders. Some of
the above described embodiments also include fluid being supplied
to the bladders through a channel within the posts.
[0077] In the embodiment shown in FIG. 12, the upper surface 211 of
the support device, such as a cushion or bed, may be removable and
disposable, which may simplify sanitation. FIG. 12 illustrates a
cross-sectional view of a support device with a removable surface
280. In particular, the embodiment shown in FIG. 12 includes at
least one bladder 210, and only a single bladder 210 in certain
embodiments, capable of containing a fluid. As shown, the bladder
of this embodiment includes at least one fluid inlet 212 and an
upper surface 214.
[0078] The at least one bladder 210 is positioned over a plurality
of posts 230. Each post may have an upper contacting region 234 or
236 where contact with the bladder is to made. In some embodiments,
the posts may also have a taper 240 or a discrete indentation 242,
or other form of tapering, to give the above-described decrease in
resistance upon travel to discrete areas of the bladder positioned
adjacent to and supported by the posts. As noted above, a post of
the invention may have an outward (increasing) taper or step 246 at
the bottom to provide a gradual stop or foot when depressed too
far. In some embodiments, the posts may be inflatable through an
inflation lumen 250 and connector 254. In another embodiment, the
posts may be solid, and may optionally be made from a resilient
material and/or with resilient material attached to the top surface
234 or 236 of the post. In this embodiment, the posts may be fixed
to a supporting frame 260.
[0079] In this particular embodiment, the at least one bladder 210
includes a plurality of regions 216 and 217 adjacent each post. As
shown, bladder region 217 is depressed in height by a weight 219.
Each inflatable bladder region may include a flexible sidewall 218
and a post-contacting region 220, which may have a preformed shape,
such as the dome shape of contact region 222 of bladder 216 or the
flat contact region 223 of bladder 217.
[0080] Flexible guides 290 may be provided to orient the bladders.
In this particular illustrative embodiment, the guides 290 are
essentially cylindrically shaped and may, for example, be made of
elastic cording or fabric. The guides 290 may encircle each post to
help orient the bladder portions 216, 217, etc to the posts 230. It
should be appreciated that in some embodiments the guides may be
shaped differently, such as, but not limited to, square shaped,
triangular shaped, etc. Connecting region 280 of at least one 210
may act similar to the connector 30 of FIG. 1, providing fluid
communication between bladder regions 216 and 217.
[0081] The upper portion 211 may be disposable and may be installed
row by row, for example, and the upper portion 211 may be coupled
to selected portions of the bladder 210 with a reversible contact
adhesive. In one embodiment, the upper portion 211 may be removably
coupled to the bladder with a fastener such as VELCRO.RTM..
Pressure may be put into the upper portion 211 to partially inflate
the bladder which may assist in locking the bladder in an oriented
state on the posts. After correction of any mismatches and
re-inflation, the support device may be ready to be used. Bladder
region 216 (left) shows the state with no applied weight, and
bladder region 217 (right) shows the effect of weight 219 being
applied. In this embodiment, the bladder region in the
weight-bearing region is still in the linear zone and does not yet
have the low resistance region 242 in operation. The arrows in FIG.
12 depict optional air flow for ventilation on top of or one any
surface of the bladder.
[0082] Supporting Data for the Invention
[0083] According to certain aspects of the present invention, a
profile of pressure reduction as a function of compression is
evident in contrast to similar profiles for foam-based pressure
relieving mattresses. Supporting data for several embodiments are
presented below and compared with data for a foam mattress.
[0084] In particular, FIG. 13A illustrates measurements on a single
module of the invention at four internal pressures wherein a known
load is placed on the top of the module compressing the bladder
down along the length of the post. The internal pressures
represented are: Curve A, 20 mm Hg (diamonds); Curve B, 30 mm Hg
(squares); Curve C, 40 mm Hg (triangles); Curve D, 50 mm Hg
(crosses). The dimensions of the support device module used in this
particular test are illustrated in FIGS. 13B-13C. Five support
device modules with dimensions as in FIGS. 13B-13C were tested in
load-deflection at the nominal inflation pressure of 30 mm-Hg and
were found to have essentially identical results. One of the
modules was load-deflection tested at four pressures (20, 30, 40
and partially 50 mm-Hg). The load measurements were made on a
Chatillon Force Measurement Instrument recently calibrated and
certified. Air was pumped into the module via tubing connections to
outlet 152 (FIG. 3) using a small air pump for home use at 0.03
gal/min, 150 mm-Hg max. 115VAC. A sphygmomanometer gauge 0-200
mm-Hg and a standard forward pressure regulator 0-150 psi were used
to control the internal pressure and to maintain positive pressure.
The rate of change in deflection or displacement was set at 0.4''
per minute to minimize transition effects. Measurements were
recorded of both load and deflection at +/-0.1'' intervals over the
entire stroke of the module. Zero setting was achieved by adjusting
starting position with a load of 0.01'' on the module top. The
surface area of the module top is 4 in sq.
[0085] According to the data in FIG. 13A, the trend for all the
pressures measured show an initial increase in load with deflection
for approximately 0.25'' followed by a reduction in load to
approximately 0.6''. The curves for all pressures remain reduced
relative to the initial peak up to approximately 2'' and end with
increasing load toward the last 0.6'' of the stroke. The higher the
internal pressure the larger the initial peak, as seen in Curve D,
for example, consistent with the mechanism as described earlier.
The first portion of the stroke compresses the air in the diaphragm
which must overcome resistance to rolling over the lip of the base
post accounting for the initial peak and the increasing peak as a
function of internal pressure.
[0086] Subsequently, as the diaphragm rolls over the top of the
post and engages the reduced diameter region of the post, a
reduction in slope of the load is seen. As the post diameter
increases towards the base of the post the load correspondingly
increases till the diaphragm material encounters the actual base
unit and is bottomed out. The behavior as described is consistent
with observation and mechanism as detailed in previous
sections.
[0087] FIG. 13D illustrates the calculated contact pressure based
on the load deflection data presented in FIG. 13A using a
supporting surface area of approximately 2 in.sup.2 representing
the top of the support device module in this case. The calculated
contact pressure for all curves is below 32 mm Hg as shown for
Curve A, 40 mm Hg (upper curve), Curve B, 30 mm Hg (middle curve)
and for Curve C, 20 mm Hg (lower curve).
[0088] The load deflection profiles for some embodiments of the
present invention described herein in comparison to that for a foam
and water mattress is shown in FIG. 14. The data for the foam,
Curve B and water mattress, Curve A, are adapted from Small, C. F.
(1980) Flat Circular Punch Testing of Clinical Support Devices
IMechE 9 (1): 1-15, and measured in a similar fashion with similar
surface area of 5 cm diameter plate which compares with the 4
square inch surface of the support device module tested. According
to the data it can be readily seen from curves A and B that the
foam and water mattress have typical curves reflecting increasing
load with deflection characterized by steeply increasing positive
slopes attaining up to 20 lbs pressure over a compression of about
2''. In comparison with the foam mattress the load-deflection curve
for one embodiment of the present invention, Curve C, is flat and
slightly decreasing in slope in a portion of the stroke. Based on
the comparison of published data and data for the module of the
invention measured directly in the laboratory, certain embodiments
of the present invention described herein may offer reductions in
load and therefore pressure of approximately 38% and 75% at
deflections of 1'' and 2'', respectively, compared to a to typical
high density foam mattress. The reductions in load observed for a
single support device module will also apply to arrays with a
plurality of modules and offer pressure reduction in magnitude and
in a manner not currently available to the pressure reducing
mattress industry or to those suffering from pressure related
ulcers.
[0089] While several embodiments of the invention have been
described and illustrated herein, those of ordinary skill in the
art will readily envision a variety of other means and structures
for performing the functions and/or obtaining the results or
advantages described herein, and each of such variations,
modifications and improvements is deemed to be within the scope of
the present invention. More generally, those skilled in the art
would readily appreciate that all parameters, dimensions,
materials, and configurations described herein are meant to be
exemplary and that actual parameters, dimensions, materials, and
configurations will depend upon specific applications for which the
teachings of the present invention are used. Those skilled in the
art will recognize, or be able to ascertain using no more than
routine experimentation, many equivalents to the specific
embodiments of the invention described herein. It is, therefore, to
be understood that the foregoing embodiments are presented by way
of example only and that, within the scope of the appended claims
and equivalents thereto, the invention may be practiced otherwise
than as specifically described. The present invention is directed
to each individual feature, system, material and/or method
described herein. In addition, any combination of two or more such
features, systems, materials and/or methods, provided that such
features, systems, materials and/or methods are not mutually
inconsistent, is included within the scope of the present
invention. All definitions, as defined and used herein, should be
understood to control over dictionary definitions, definitions or
usage in documents incorporated by reference, and/or ordinary
meanings of the defined terms.
[0090] In the claims (as well as in the specification above), all
transitional phrases or phrases of inclusion, such as "comprising,"
"including," "carrying," "having," "containing," "composed of,"
"made of," "formed of," "involving" and the like shall be
interpreted to be open-ended, i.e. to mean "including but not
limited to" and, therefore, encompassing the items listed
thereafter and equivalents thereof as well as additional items.
Only the transitional phrases or phrases of inclusion "consisting
of" and "consisting essentially of" are to be interpreted as closed
or semi-closed phrases, respectively. The indefinite articles "a"
and " an, " as used herein in the specification and in the claims,
unless clearly indicated to the contrary, should be understood to
mean "at least one."
* * * * *