U.S. patent application number 15/234963 was filed with the patent office on 2016-12-01 for compressive patient warming device.
The applicant listed for this patent is CareFusion 2200, Inc.. Invention is credited to James Chan, Thomas Dillingham, Michael McMahon, Noah Meade, Jennifer Raeder-Devens, Todd Schmaltz, Christopher M. VARGA.
Application Number | 20160346161 15/234963 |
Document ID | / |
Family ID | 51530594 |
Filed Date | 2016-12-01 |
United States Patent
Application |
20160346161 |
Kind Code |
A1 |
VARGA; Christopher M. ; et
al. |
December 1, 2016 |
COMPRESSIVE PATIENT WARMING DEVICE
Abstract
A compressive patient warming device is provided. The device
includes an elastic inner layer that conforms snugly to a shape of
an appendage of a patient so that the inner layer wraps around and
substantially contacts most of an underlying surface area of the
appendage. An outer layer is attached to and covers the inner layer
to form a space that holds a heat transfer medium between the inner
layer and the outer layer while the inner layer is wrapped around
the appendage. The outer layer may be a rigid layer, and a
predetermined compressive load may be applied to the outer layer to
encourage blood flow in the appendage. A source of heat may be
applied to the device to maintain normothermia and/or treat
hypothermia.
Inventors: |
VARGA; Christopher M.;
(Laguna Hills, CA) ; McMahon; Michael; (Yorba
Linda, CA) ; Dillingham; Thomas; (Aliso Viejo,
CA) ; Chan; James; (San Marino, CA) ;
Schmaltz; Todd; (San Diego, CA) ; Meade; Noah;
(Grayslake, IL) ; Raeder-Devens; Jennifer; (Saint
Paul, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CareFusion 2200, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
51530594 |
Appl. No.: |
15/234963 |
Filed: |
August 11, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13801270 |
Mar 13, 2013 |
9433527 |
|
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15234963 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 7/02 20130101; A61F
2007/0054 20130101; A61F 2007/0045 20130101; A61H 2205/06 20130101;
A61H 2201/10 20130101; A61F 2007/0268 20130101; A61H 2205/065
20130101; A61H 2201/0242 20130101; A61H 2201/0207 20130101; A61F
2007/0091 20130101; A61H 9/0078 20130101; A61H 2205/106 20130101;
A61F 2007/0036 20130101; A61H 2209/00 20130101; A61F 2007/0231
20130101 |
International
Class: |
A61H 9/00 20060101
A61H009/00 |
Claims
1-20. (canceled)
21. A compressive patient warming device comprising: an elastic
inner layer that conforms snugly to a shape of an appendage of a
patient so that the elastic inner layer wraps around and
substantially contacts most of an underlying surface area of the
appendage; and an outer layer attached to and covering the elastic
inner layer to form a space to hold a heat transfer medium between
the elastic inner layer and the outer layer while the elastic inner
layer is wrapped around the appendage, wherein the outer layer is a
substantially rigid material that surrounds the elastic inner layer
when the device is worn on the appendage.
22. The device of claim 21, wherein the elastic inner layer
comprises a compressive sleeve that is sufficiently strong to
compress surface veins, arteries, and muscles of the appendage.
23. The device of claim 21, wherein at least a portion of the
elastic inner layer is concentric with the outer layer.
24. The device of claim 21, further comprising a connection at
which a portion of the outer layer is attached to a portion of the
elastic inner layer.
25. The device of claim 21, further comprising a tab for fastening
the outer layer around the appendage.
26. The device of claim 25, wherein the tab is configured to attach
to an external surface of the outer layer.
27. The device of claim 26, wherein the tab is configured to attach
to the external surface of the outer layer by a hook and loop
fastener, adhesive tabs, buttons, snaps, or press and seal
fasteners.
28. The device of claim 21, wherein the heat transfer medium
comprises one or more of a visco-elastic foam, a viscous gel, sand,
heat transferring beads, or any combination thereof.
29. A method for warming and applying compressive force on an
appendage of a patient, the method comprising: inserting an
appendage of the patient into an elastic inner layer of a
compressive patient warming device, the elastic inner layer
conforming snugly to an irregular shape of the appendage so that
the elastic inner layer wraps around and substantially contacts
most of a surface area of the appendage; applying a predetermined
compressive load on a rigid outer layer to encourage blood flow in
the appendage, wherein the rigid outer layer adjoins the elastic
inner layer forming a space therebetween to hold a heat transfer
medium and the predetermined compressive load applies pressure to
the appendage through the heat transfer medium and the elastic
inner layer; and applying a source of heat to the compressive
patient warming device.
30. The method of claim 29, further comprising applying a localized
heat source at a section of the elastic inner layer that covers an
area of high venous density on the appendage.
31. The method of claim 29, further comprising filling the space
between the elastic inner layer and the rigid outer layer with the
heat transfer medium.
32. The method of claim 31, wherein the heat transfer medium is a
visco-elastic foam, a viscous gel, sand, or heat transferring
beads.
33. The method of claim 29, wherein the heat transfer medium is a
liquid.
34. The method of claim 33, wherein applying the predetermined
compressive load comprises connecting a fluid inlet to a fluid
control pump, and controlling a liquid flow through the fluid inlet
so as to inflate the space and exert pressure across a portion of
the elastic inner layer that is in contact with an underlying
surface area of the appendage.
35. The method of claim 34, wherein applying the source of heat
comprises heating the liquid to a temperature that is about
20.degree. C. to about 41.degree. C.
36. The method of claim 34, further comprising directing the liquid
from the space to a fluid outlet.
37. The method of claim 29, further comprising adjusting the rigid
outer layer around the appendage using a tab attached to the rigid
outer layer.
38. The method of claim 29, wherein the elastic inner layer
comprises a non-permeable material.
39. The method of claim 29, further comprising inflating the space
so that at least about 90% of the elastic inner layer is in contact
with an underlying surface of the appendage.
40. The method of claim 29, wherein inserting the appendage into
the elastic inner layer comprises inserting at least one or more of
a hand, forearm, upper arm, calf, shin, and thigh of the patient,
or any combination thereof, into the elastic inner layer.
Description
TECHNICAL FIELD
[0001] Embodiments disclosed In the present application relate
generally to patient warming devices embodied as wraps for
maintaining normothermia and/or treating hypothermia.
[0002] During surgical procedures, patients may be placed under
anesthesia. As a result the body's natural thermoregulatory
mechanisms maybe affected and systemic vasodilation may occur.
Systemic dilation counteracts the body's natural heat retention
mechanism and allows body heat to flow down a concentration
gradient to the extremities, where heat is lost to the environment.
As a result, the patient is at risk of perioperative hypothermia.
Medical complications may result from perioperative hypothermia and
may include peri-operative and post-operative complications,
including for example, increased wound infection rates, metabolic
acidosis, respiratory distress, cardiovascular effects, surgical
bleeding, and increased risk of mortality. Therefore, a need exists
for patient warming devices that actively warm the patient to
maintain normothermia and prevent perioperative hypothermia.
[0003] Forced air convective warming blankets, large wraps, or pads
are commonly used to cover various parts of the body. These warming
devices generally cover a large portion of the body, restricting
access to the patient In covered areas. A surgeon, or other medical
staff, requiring access to the covered portions of the body in
order to introduce surgical elements, such as intravenous feed
lines, pulse oximetry probes, needles, vitals monitoring
instruments, and other medical instruments, may need to reposition
or remove the warming device. Removal and repositioning of the
device not only increases the time required for the surgical
procedure, but may also significantly reduce heat transfer to the
patient during that time. Moreover, control systems for forced air
convective devices tend to generate loud noise that may distract or
interfere with communication between surgeons and medical personnel
in an operating room.
[0004] Active warming devices also tend to cause stippling on
patients'skin. Stippling may cause pain in elderly patients, very
young patients, or patients with sensitive skin. Stippling is also
unsightly, and may evoke unnecessary concern from a patient and
from friends and family members who observe the stippling on the
patient's skin.
[0005] Deep vein thrombosis (DVT) is another common concern during
surgical operations. Compression devices are commonly used to
prevent deep vein thrombosis by applying intermittent pneumatic
compression to a patient's lower extremities, such as the legs and
feet of a patient. The intermittent pressure promotes venous blood
flow so as to prevent deep vein thrombosis. DVT prevention devices
may use negative pressure, or vacuum pressure, to apply
compression, which requires a seal around the patient's extremity
and does not allow for access to the underlying surface of the
patient. Applying negative pressure, or vacuum pressure, for DVT
prevention also tends to increase stippling.
[0006] During surgical procedures, it is common to use a device for
preventing deep vein thrombosis and a separate device for active
patient warming on different body portions of the patient. For
example, a device for preventing deep vein thrombosis may be
attached to the patient's leg, while a device for active patient
warming may be attached to another part of the patient's body.
Therefore, there is a need and/or desire in the art to provide
devices and methods for patient care that will promote and maintain
normothermia and/or treat hypothermia while providing access to
portions of the patient's body underlying the device, preventing
deep vein thrombosis, and avoiding or minimizing stippling,
impressed wrinkles, or the like on a patient's skin.
BRIEF SUMMARY
[0007] In one aspect, a compressive patient warming device is
provided to maintain normothermia and/or treat hypothermia. The
device includes an elastic inner layer that conforms snugly to a
shape of an appendage of a patient so that the inner layer wraps
around and substantially contacts most of an underlying surface
area of the appendage. An outer layer is attached to and covers the
inner layer to form a space that holds a heat transfer medium
between the inner layer and the outer layer while the inner layer
is wrapped around the appendage.
[0008] In another aspect, a method for warming and applying
compressive force on an appendage is provided. The method includes
inserting an appendage of the patient into an elastic inner layer
of a compressive patient warming device. The inner layer conforms
snugly to an irregular shape of the appendage so that the inner
layer wraps around and substantially contacts most of a surface
area of the appendage. A predetermined compressive load is applied
on a rigid outer layer to encourage blood flow in the appendage.
The rigid outer layer adjoins the inner layer so as to form a space
between the two layers to hold a heat transfer medium. The
predetermined compressive load applies pressure to the appendage
through the heat transfer medium and the inner layer. The method
further includes applying a source of heat to the compressive
patient warming device.
[0009] In another aspect, a method for warming and applying
compressive force on an appendage of a patient is provided. The
method includes inserting an appendage of the patient into an
elastic inner layer of a compressive patient warming device. The
inner layer conforms snugly to an irregular shape of the appendage
so that the inner layer wraps around and substantially contacts
most of a surface area of the appendage. A predetermined
compressive load is applied on a rigid outer layer to encourage
blood flow in the appendage. The rigid outer layer adjoins the
inner layer so as to form a space between the two layers to hold a
heat transfer medium. The predetermined compressive load applies
pressure to the appendage through the heat transfer medium and the
inner layer. The method further includes applying a source of heat
to the compressive patient warming device.
[0010] Other systems, methods, features, and advantages of the
disclosure will be, or will become, apparent to one with skill in
the art upon examination of the following figures and detailed
description. It is intended that all such additional systems,
methods, features and advantages be included within this
description, be within the scope of the invention, and be protected
by the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a cross sectional view of an exemplary patient
warming device with patient access;
[0012] FIG. 2 is a view of an exemplary patient warming device with
patient access aligned with a hand and a lower arm;
[0013] FIG. 3 is a first view of an exemplary patient warming
device with patient access;
[0014] FIG. 4 is a view of an exemplary patient warming device with
patient access with a fluid flow path;
[0015] FIG. 4A is another view of an exemplary patient warming
device with patient access;
[0016] FIG. 5 is a view of an exemplary patient warming device with
patient access with fasteners;
[0017] FIG. 6 is a view of art exemplary patient warming device
with patient access with a fluid flow path;
[0018] FIG. 7 is a view of an exemplary patient warming device with
patient access aligned with a foot and a lower leg;
[0019] FIG. 8 is a diagrammatic view of a cross-section of an
exemplary compressive patient warming device;
[0020] FIG. 9 is a diagrammatic view of a cross-section of an
exemplary compressive patient warming device;
[0021] FIG. 10 is a diagrammatic view of a cross-section of an
exemplary compressive patient warming device;
[0022] FIG. 11 is a view of an exemplary compressive patient
warming device;
[0023] FIG. 12 is a system diagram of an exemplary patient warming
and DVT prevention system;
[0024] FIG. 13 is a view of an exemplary patient warming device in
a patient warming and DVT prevention system;
[0025] FIG. 14 is a view of a fluid flow path in an exemplary
patient warming device in a patient warming and DVT prevention
system;
[0026] FIG. 15 is a view of an exemplary patient warming device
with fluid control mechanisms in a patient warming and DVT
prevention system;
[0027] FIG. 16 is a view of a diagrammatic view of a cross-section
of an exemplary patient warming device in a patient warming and DVT
prevention system.
DETAILED DESCRIPTION
[0028] Commonly owned U.S. applications Ser. Nos. 13/___,___ and
13/___,___, entitled, respectively, "Patient Warming Device with
Patient Access" and "Patient Warming and Deep Vein Thrombosis
Prevention System," are being filed concurrently herewith, and each
is incorporated herein by reference in its entirety. Various
embodiments are described below with reference to the drawings in
which like elements generally are referred to by like numerals. The
relationship and functioning of the various elements of the
embodiments may better be understood by reference to the following
detailed description. However, embodiments are not limited to those
illustrated in the drawings. It should be understood that the
drawings are not necessarily to scale, and In certain instances
details may have been omitted that are not necessary for an
understanding of embodiments disclosed herein, such as--for
example--conventional fabrication and assembly. The Invention is
defined by the claims, may be embodied in many different forms, and
should not be construed as limited to the embodiments set forth
herein; rather, these embodiments are provided so that this
disclosure will be thorough and complete., and will fully convey
enabling disclosure to those skilled in the art. As used in this
specification and the claims, the singular forms "a," "an" and
"the" include plural referents unless the context clearly dictates
otherwise.
[0029] A patient warming device with patient access and a patient
warming method are provided in some embodiments. The patient
warming device includes a first compliant layer and a second
compliant layer that are sealed together around an outer border to
contain a liquid between the two layers. The layers form a wrap
that surrounds and conforms to a body portion, appendage, or
extremity of a patient so as to maintain normothermia of the
patient or to treat hypothermia. As used herein, normothermia is
defined as a range of body core temperature between about
36.5.degree. C. to 37.5.degree. C..+-.0.5.degree. C. (about
97.7.degree. F. to 99.5.degree. F..+-.0.9.degree.). Hypothermia is
defined as a core temperature less than about 36.degree. C. (about
96.8.degree. F.). Mild hypothermia is defined as ranging from about
1.degree. C. to 2.degree. C. (about 1.8.degree. F. to 3.6.degree.
F.) below body core temperature, while moderate hypothermia
constitutes a body core temperature of about 35.degree. C. (about
95.degree. F.), and severe hypothermia is a body core temperature
below 35.degree. C.
[0030] The wrap may include a generally longitudinal central
portion that is sized to cover a surface of the body portion, or
appendage, of the patient. A plurality of flaps may extend from one
or more sides of the central portion and fasten to each other to
surround the body portion, or appendage, of the patient. A
continuous fluid flow path may extend between the first and second
compliant layers. The fluid flow path may be defined by the outer
border and a plurality of internal sealed connections between the
first and second compliant layers. The fluid flow path may guide a
liquid, such as a warm or heated liquid (e.g., water or other
aqueous liquids, a viscous gel, a hydrogel, an organic liquid
(e.g., oil or oil-based liquid, or any other organic liquid or
flowable material with a heat capacity suitable for effective use
in keeping with the principles of the present disclosure), a
synthetic oil, a foam, or any combination thereof), through the
flaps and central portion of the wrap so as to substantially fill
the wrap.
[0031] In some embodiments, a patient warming method includes
wrapping a body portion, appendage, or extremity of a patient in a
patient warming device that includes a first compliant layer and
second compliant layer sealed together around an outer border to
contain a liquid between the two layers. A generally longitudinal
central portion of the patient warming device is aligned along an
underside of the appendage. A first set of flaps extending from a
first side of the central portion is folded around the topside of
the appendage. A second set of flaps extending from a second side
opposite the first side of the central portion is folded around the
topside of the appendage. The first and second sets of flaps are
fastened to each other such that the first compliant layer makes
skin contact with the appendage. The liquid is directed, via a
fluid inlet, of the patient warming device, into a continuous fluid
flow path extending between the first compliant layer and the
second compliant layer, The fluid flow path guides the liquid
through the central portion, the first set of flaps, and the second
set of flaps.
[0032] As used herein, the term "underside" means any surface area
of the patient's skin that is in contact with the central portion
of the patient warming device, and does not limit the use of the
patient warming device to any particular orientation. For example,
the "underside" of a hand may mean the palm of the hand or the hack
of the hand, whichever is in contact with the central portion of
the patient warming device. As used herein, the term "topside"
means any surface area of the patient's skin that is in contact
with flaps of the patient warming device, and does not limit the
use of the patient warming device to any particular orientation.
For example, the "topside" of a lower leg may mean a calf or a
shin, whichever is in contact with flaps of the patient warming
device. As another example, the palm and inner forearm are referred
to as the "underside" when the patient warming device is aligned on
a patient so that the palm and inner forearm of the patient lies
on, or is in contact with, the central portion of the patient
warming device. In this example, the back of the hand and outer
forearm are referred to as the "topside."
[0033] The disclosed patient warming device may be prepackaged as a
disposable or reusable unit for use in surgical environments.
Prepackaging may include any necessary sanitation of all components
of the device. Prepackaging may also Include "seeding" the device
with a disinfectant agent, for example, at the fluid inlet so that
the liquid carries the agent through the device and an attached
pump system. Materials used may include medical grade materials
that are antimicrobial, anti-infective, anti-biofilm, disinfecting,
decontaminating and/or are embedded with antimicrobial,
anti-infective, anti-biofilm, disinfecting or decontaminating
materials.
[0034] The disclosed patient warming device and method may maintain
normothermia or treat hypothermia in a patient whose
thermoregulatory mechanisms are affected by a health condition,
anesthesia, or other causes, by surrounding about 5% to about 10%
of a patient's external surface area with a wrap that is
substantially filled with a heat transferring liquid. Liquid, such
as water, is a preferred heat transferring medium because it is
readily available, has superior heat transfer properties relative
to gas or air, and because operation of fluid control pumps for
liquids creates less noise than for forced air systems. One of
skill in the art would recognize, however, that the patient warming
devices and methods disclosed herein may also be used with any
suitable fluid, including, for example, forced air.
[0035] In addition to actively warming the patient by delivering
heat through a wrap in contact with the patient's skin, some
embodiments of the patient warming device may apply a predetermined
compressive load, or pressure, to the surrounded body portion, or
appendage, so as to facilitate increased local blood flow. The
compressive load, or pressure, may be applied statically or In
pulses. When the compressive load is applied in pulses, the
pressure may alternate between a higher pressure and a lower
pressure, between a high pressure zero pressure, or between a
positive pressure and a negative/vacuum pressure. The compressive
load may be applied evenly over the surface of the surrounded body
portion or concentrated at predetermined locations along the
surrounded body portion. Applying a compressive load in combination
with heat delivery may increase blood flow and decrease the amount
of time required to warm the patient.
[0036] A compressive patient warming device may include an inner
layer and an outer layer. The inner garment may be an elastic inner
layer that conforms snugly to the shape of an appendage, or body
portion, of the patient so that the inner layer wraps around and
substantially contacts most of an underlying surface area of the
appendage. The outer layer is attached to and covers the inner
layer to form a space that holds a heat transfer medium between the
inner and outer layers while the inner layer is wrapped around the
appendage. The compressive patient warming device may
simultaneously deliver heat and apply a predetermined compressive
load to the surrounded appendage so as to maintain normothermia
and/or treat hypothermia so the patient.
[0037] In some embodiments, a method for warming and applying
compressive force on the appendage includes inserting the appendage
into an elastic inner layer of a compressive patient warming
device. The inner layer conforms snugly to the irregular shape of
the appendage so that the inner layer wraps around and
substantially contacts most of an underlying surface area of the
appendage. A predetermined compressive load is applied to an outer
layer that adjoins the inner layer. A space is formed between the
inner and outer layers to hold a heat transfer medium. The
predetermined compressive load applies pressure to the appendage
through the heat transfer medium and the inner layer.
[0038] Prevention of deep vein thrombosis (DVT) may be achieved
using the disclosed patient warming device by applying intermittent
pressure to the liquid in the fluid flow path and using a valve
system and/or a single-channel or multi-channel fluid pump system.
Alternatively, the patient warming device may be configured with an
inflatable layer that is in communication with an air pump. The
inflatable layer is partially or fully concentric with the first
and second compliant layers of the patient warming device when the
wrap surrounds a body portion of the patient. The air in the
inflatable layer remains separate from the liquid between the first
and second compliant layers.
[0039] to some embodiments, a patient warming and deep vein
thrombosis prevention system includes a first compliant layer and a
second compliant layer sealed together around an outer border to
contain a warm liquid between the two layers. As used herein, a
"warm liquid" means a liquid provided at a temperature of at least
about ambient temperature, or 20.degree. C. (68.degree. F.), to
about 41.degree. C. (105.8.degree. F.). Ambient temperature may be
the temperature of the environment surrounding the patient, and
therefore, may vary with the surrounding environment. The layers
form a wrap that surrounds and conforms to a body portion of a
patient. The wrap includes a generally longitudinal central portion
sized to cover a surface of the body portion. A plurality of flaps
extends from opposite sides of the central portion. One or more
flaps from the opposite sides fasten to each other to surround the
body portion and the flaps are openable during functional use to
provide access to an underlying patient body surface. A continuous
fluid flow path extends between the first compliant layer and the
second compliant layer between a fluid inlet and a fluid outlet.
The fluid flow path is defined by the outer border and a plurality
of internal sealed connections between the first and second
compliant layers. A fluid control pump is connected to the wrap to
direct the liquid through the fluid flow path so as simultaneously
to inflate the wrap and apply pressure and heat to the body portion
being surrounded by the wrap.
[0040] In some embodiments, a method for patient warming and
prevention of deep vein thrombosis using the patient warming and
deep vein thrombosis system may be provided. The method includes
fastening a first pair of flaps of the plurality of flaps to
surround an upper portion of the shin. A second pair of flaps of
the plurality of flaps is fastened to surround a lower portion of
the shin. A third pair of flaps of the plurality of flaps is
fastened to surround the foot of the patient. The pump is activated
to fill the fluid flow path with warm liquid sufficiently to exert
surface pressure on the patient. The pressure is provided at a
level generally effective to prevent deep vein thrombosis.
[0041] In some embodiments, a method for patient warming and
prevention of deep vein thrombosis may be provided. The method
includes wrapping an appendage of a patient in a wrap comprising a
first compliant layer and a second compliant layer sealed together
around an outer border to contain a liquid between the two layers.
The appendage is positioned on a generally longitudinal central
portion of the wrap so that substantially most, or substantially
all (e.g., about 90% to 95%), of the central portion is in contact
with a surface of the appendage. The appendage is enclosed in the
wrap by fastening a plurality of flaps around the appendage. The
plurality of flaps extends from the central portion of the wrap and
is defined by the outer border of the wrap. The wrap is filled, via
a fluid inlet that is at a distal end of the central portion of the
wrap, with a warm liquid sufficiently to exert a surface pressure
on the patient. The surface pressure is provided at a level
generally effective to prevent deep vein thrombosis and the warm
liquid is provided at a temperature that is generally effective to
maintain normothermia or treat hypothermia.
[0042] With reference to FIGS. 1-5, some embodiments of the patient
warming device with patient access 100 may include a wrap 102
formed from a first compliant layer 104 and a second compliant
layer 106 sealed together around an outer border 108, or outer
edges, to contain a liquid 110 between the layers 104, 106. The
first and second compliant layers 104, 106 may be, for example,
PVC, urethane, polyurethane, polyethylene (PE), ethylene-vinyl
acetate (EVA), EVA/PE blends or copolymers, styrenic block
copolymers (SBC), medical elastomers, olefin-based compounds,
acrylonitrile butadiene styrene (ABS), or any other material that
is sufficiently non-permeable, flexible, and thin so as to be
suitable for containing liquid and conforming to a body portion or
appendage of a patient. The first and second layers 104, 106 may be
sealed around the border 108, for example, by radio frequency (RF)
welding, so as to contain the liquid. Other plastic welding
techniques, such as hot gas welding, head sealers, speed tip
welding, contact welding, hot plate welding, ultrasonic welding,
friction welding, laser welding, or any other known techniques may
be used to seal the first and second layers 104, 106 together. The
first and second layers 104, 106 may alternatively be adhesively
bonded. Alternatively, the first and second layers 104, 106 may be
partially sealed together, by RF welding or other plastic welding
techniques, to allow for a heat transfer media (e.g., memory foam,
heat transfer liquid or gel, sand, or heat transferring beads) to
be inserted between the layers. The first and second layers 104,
106 may be made from the -same-material, or different material, or
a combination of different materials. The liquid may be water or
other aqueous liquids, a viscous gel, an organic liquid (e.g., oil
or oil-based liquid, or any other organic liquid or flowable
material with a heat capacity suitable for effective use in keeping
with the principles of the present disclosure), a synthetic oil, a
foam, or any combination thereof, or any other liquid that has
appropriate heat transfer qualities, e.g. high heat capacity and
high thermal conductivity, to deliver heat quickly and efficiently
to the patient.
[0043] The first compliant layer 104 may be configured to contact
the skin of the patient, and the second compliant layer 108 may
face away from the skin, or be exposed to the surrounding
environment. Because first compliant layer 104 is in contact with
the skin of the patient, it may be desirable for the first
compliant layer 104 to be thinner and/or more skin-conformingly
compliant than the second compliant layer 106 so as to provide more
efficient heat transfer to the patient. Because second compliant
layer 106 is exposed to the surrounding environment, it may have a
greater thickness and/or insulating properties so as to reduce heat
loss to the surrounding environment.
[0044] With reference to FIG. 1, for example, the first compliant
layer 104 may have a thickness T1 that is approximately 50% or less
of the thickness 12 of the second compliant layer 108.
Alternatively, the first compliant layer 104 may have any thickness
that is less than the thickness, the same thickness, or a greater
thickness than the thickness T2 of second compliant layer 108,
[0045] In some embodiments, the first compliant layer 104 has a
thickness T1 of about 0.004 inch (about 0.10 mm) to about 0.008
inch (about 0.15 mm) and the second compliant layer 108 has a
thickness T2 of about 0.009 inch (0.22 mm) to about 0.011 inch
(0.28 mm). In other embodiments, the thicknesses T1, T2 may be the
same. For example, the thicknesses T1, T2 may each be 0.009 inch
(0.22 mm) to 0.011 inch (0.28 mm). The thicknesses T1, T2 of the
first and second compliant layers 104, 106 may vary depending on
the material of the layers and intended functional use of the
patient warming device.
[0046] As used herein, the term "functional use" means during
operation of the device where a fluid is being moved therethrough
to treat a patient. Functional use of the patient warming device
may include, for example, wrapping a body portion, or appendage of
the patient, in the device during an operative procedure so as to
maintain normothermia or treat hypothermia in the patient while the
patient is under anesthesia and undergoing a surgical procedure.
For example, for use with patients who have greater heat
sensitivity (e.g., elderly or very young patients) the first
compliant layer 104 may be configured to have a greater thickness
than for use with patients who have less heat sensitivity. As
another example, a patient warming device configured for use on a
patient's foot and leg may have a first compliant layer 104 with a
greater thickness than for a patient warming device configured for
use with areas that are generally more heat sensitive, such as a
patient's hand, arm, or abdominal area. Other functional uses of
the patient warming device are contemplated, such as patient
comfort heating, general heat therapy and/or joint therapy.
[0047] The wrap 102 may include a generally longitudinal central
portion 112 that is sized to cover a surface or skin of the body
portion of a patient. As shown in FIG. 2, for example, the central
portion 112 may have a length L and width W that is anatomically
proportionate to the length and width of a hand 114 and forearm 118
of an average human male or female adult or child. The central
portion may be aligned to contact an underside of a body portion,
such as the palm of the hand 114 and inside of forearm 118.
Alternatively, the central portion 112 may be sized to fit an upper
arm (such as around biceps and/or triceps), a hand, a lower leg
(such as a calf and/or shin), an upper leg (such as a thigh) of a
patient, a torso, a chest, an abdominal area, or any portion
thereof, any other body portion of the patient or any combination
thereof.
[0048] A plurality of flaps may extend from a first side 118 or a
second side 120 of the central portion, or from a proximal end 122
or a distal end 124 of the central portion. For example, flaps 126,
128, 130, 132 may extend from the first side 118 of the central
portion 112, and flaps 134, 136, 138, 140 may extend from the
second side 120 of the central portion 112. Flaps on opposite sides
of the central portion 112 may correspond in size, shape and
position along the central portion 112. Alternatively, flaps
extending from one side of the central portion, or the first side
118, may differ in size, shape, and/or position along the central
portion than flaps extending from an opposite side of the central
portion, or the second side 120. In other embodiments, flaps may
extend only from one side or one end of the central portion, or
from one side and one end of the central portion 112, or any
combination of sides and ends of the central portion 112.
[0049] Flaps extending from opposite sides of the central portion
112 may fasten to each other to surround a body portion of the
patient. Alternatively, flaps may extend from one side of the
central portion 112 and fasten to another side of the central
portion 112. The flaps may be fastened by any suitable fastener,
including, for example, hook and loop fasteners, adhesive tabs,
buttons, snaps, or press and seal fasteners.
[0050] In some embodiments, when the wrap 102 is used to cover a
hand 114 and forearm 116, the flaps 126, 134 located at or near the
distal end 124 may extend a shorter distance from the central
portion than flaps 132, 140 located at or near the proximal end 122
of the central portion. Flaps 126, 134 may be configured (e.g.,
sized, shaped, tapered, and/or contoured) to fold over and cover
the fingers of hand 114, flaps 128, 136 configured to fold over and
cover the back of the hand 114, flaps 130, 138 configured to fold
over and cover a lower portion of the topside of forearm 116, and
flaps 132, 140 configured to fold over and cover an upper portion
of the topside of forearm 118. Flaps 128, 128, 130, 132 may extend
a predetermined distance from the central portion so as to
completely overlap or partially overlap with flaps 134, 136, 138,
140. Alternatively, flaps 128, 128, 130, 132 and 134, 136, 138, 140
may fold over to cover a body portion without overlapping another
flap. As used herein, the term "fold over" or "fold around" means
to bend and conform around a body portion to be surrounded by the
wrap, and does not limit use of the patient warming device to any
particular orientation. For example, from a perspective looking
down at the patient the central portion 112 may be held on the
topside of any body portion or appendage of the patient while the
flaps may be folded to cover the underside, or the central portion
112 may be held on the side of any part of the patient and the
flaps may be folded to cover the other side of that body portion or
appendage.
[0051] The patient warming device 100 provides patient access to a
target area of the underlying patient body surface being surrounded
by the wrap 102. For example, during an operative procedure, a
surgeon or other medical personnel may access a portion of the hand
114 or arm 116, such as the topside or underside, without exposing
the other body portions of the patient. In some embodiments, an
intravenous line may be inserted to the topside or back of hand 114
or accessed on the back of the hand 114 by unfastening, opening, or
unfolding a pair of flaps 128, 136, while the other flaps remain
covering the fingers, and lower and upper forearm of the patient.
Alternatively, access to the back of the hand may be provided by
unfolding only one of flap 128 and/or flap 136 while the other
flaps remain in contact with the patient's skin. In a similar way,
access to the fingers may be provided by unfastening, opening, or
unfolding, one or both of flaps 126, 134, access to the lower
forearm may be provided by unfastening one or both of flaps 130,
138, and access to the upper forearm may be provided by unfastening
one or both of flaps 132, 140. In some embodiments, intravenous
lines and/or pulse oximeter probes may be accessed on either the
hand 114 or arm 116 by unfastening, opening, or unfolding one or
more of flaps 126, 134, 128, 136, 130, 138, 132, or 140 while the
remaining flaps remain fastened and covering the hand 114 and the
arm 116.
[0052] Providing access to a target area of the underlying patient
body surface while maintaining contact with other pads of the
surrounding areas increases the ability of the patient warming
device 100 to maintain normothermia or treat hypothermia in the
patient by maintaining heat transfer to body portions that remain
covered. Also, by providing access to the target area while the
wrap 102 remains in place, there is no need reposition or remove
the patient warming device in order to introduce surgical elements,
such as intravenous feed lines, needles, and vitals monitoring
instruments. As such, it may be preferable for the flaps to be
sized, shaped, and positioned so as to provide access during
functional use. As described elsewhere herein, the desired access
provided by the flaps will preferably be to patient surface areas
used for treatment (e.g., IV sites) and/or diagnosis/monitoring
(e.g., pulse oximetry monitoring).
[0053] Flaps extending from one side of the central portion 112 may
correspond to flaps extending from the opposite side of the central
portion 112 in size, shape, and/or location. Alternatively, flaps
extending from one side of the central portion 112 do not
correspond with flaps extending from the opposite side in size,
shape, and/or location. For example, flaps 134, 136, 138, and 140
may each extend a distance corresponding to the distances of flaps
128, 126, 128, 130 and 132, respectively. Flaps 134, 136, 133, and
140 may each have a height corresponding to the heights of flaps
126, 128, 128, 130 and 132, respectively. Alternatively,
corresponding flaps on opposite sides may extend different
distances and have different heights. Additional, fewer, or
different flaps may be included in the patient warming device
100.
[0054] For example, as illustrated with reference to FIG. 3, flaps
126, 128, 130 and 132 may each extend a distance D1, D2, D3, and
D4, respectively from the first side of the central portion 112.
Flaps 134, 136, 138, and 140 may each extend a distance equal to
the distance of corresponding flaps 126, 128, 128, 130 and 132,
respectively. Distances D1, D2, D3, and D4, of the flaps when added
to the width W of the corresponding portion of central portion 112,
may be configured to fit the circumference of a predetermined body
portion, or appendage, to be surrounded or covered, such as a
patient's fingers, hand, lower forearm, and upper forearm, or any
other part of the patient's body. In some embodiments, distance D1
may be approximately 3.0 to 4.0 inches (7.5 to 10.2 cm), distance
D2 may be approximately 3.4 to 4.8 inches (8.6 to 11.7 cm),
distance D3 may be approximately 4.25 to 5.75 inches (10.7 to 14.6
cm), and distance D4 may be approximately 4.4 to 6 inches (11.3 to
15.3 cm). Alternatively, flaps may extend equal distances from each
side of the central portion 112. The size of the flaps may be
configured to fit patients of various sizes and stature.
[0055] The flaps may be arranged contiguously along each side of
the central portion 112, or the flaps may be spaced apart from each
other. As shown in FIG. 3, for example, flaps 126, 128, 130 and 132
may each have a height H1, H2, H3, and H4, respectively. Heights
H1, H2, H3, and H4 may correspond to the length of a predetermined
body portion, or appendage, to be surrounded or covered, such as a
patient's fingers, hand, lower forearm, and upper forearm, or any
other part of the patient's body. In some embodiments, height H1
may be approximately 4.5 to 6.3 inches (11.8 to 16.1 cm), height H2
may be approximately 3.5 to 4.9 inches (9.0 to 12.5 cm), height H3
may be approximately 4.25 to 5.75 inches (10.7 to 14.7 cm), and
height H4 may be approximately 4.25 to 5.75 inches (9.1 to 12.4
cm). The total height of the flaps may equal the overall length L
of the central portion 112, or may be less than or greater than the
overall length L of the central portion 112. The size of the flaps
may be configured to fit patients of various sizes and stature.
[0056] In some embodiments, liquid 110 may enter the wrap 102
through fluid inlet 142 and exit through fluid outlet 144. At
the-fluid inlet 142, the liquid 110 may be a warm or heated liquid
that is at a temperature between about ambient temperature, or
about 20.degree. C. (68.degree. F.), to about 41.degree. C.
(105.8.degree. F.). As the fluid travels from the fluid inlet 142
to the fluid outlet 144, the temperature of the fluid may gradually
decrease, such that the temperature of fluid at the fluid outlet
144 is less than the temperature of the fluid at the fluid inlet
142. For example, the temperature of the liquid at fluid inlet 142
may be approximately 0.2.degree. C. (32.degree. F.) to 1.0.degree.
C. (34.degree. F.) warmer than the temperature of the liquid at the
fluid outlet 144. Fluid inlet 142 and outlet 144 may include
flexible or rigid tubes, such as PVC, urethane, polyurethane, PE,
EVA, EVA/PE blends or copolymers, SBC, medical elastomers,
olefin-based compounds, ABS, polycarbonate. A fluid control pump
may be connected to fluid inlet 142 to heat and pump the liquid 110
through a continuous fluid flow path 146. The fluid inlet 142 and
fluid outlet 144 maybe located on the same or separate sides or
ends of the wrap 102. In some embodiments, fluid inlet 142 and/or
fluid outlet 144 may include a control valve to control the flow of
liquid 110 in and out of the wrap 102, or fluid flow path 146.
[0057] As shown in FIG. 4, for example, fluid inlet 142 and outlet
144 may be located at a portion near or at the distal end 122 or
near or at the proximal end 124 of the central portion 112. For
example, fluid inlet 142 may be located on a first side 118, or
half, of the central portion 112, and the fluid outlet 144 may be
located on a second side 120, or half, of the central portion 112.
Alternatively, the fluid inlet 142 and outlet 144 may be located at
opposite ends. In other embodiments, the fluid inlet 142 and outlet
144 may be located adjacent or separately at any location along an
outer edge, flap, or middle of the wrap 102.
[0058] The continuous fluid flow path 146 may guide the liquid 110
through the wrap 102 and substantially fill the space between the
first and second compliant layers 104, 106. The fluid flow path 146
may be defined by the outer border 108 and a plurality of internal
sealed connections 150 between the first and second compliant
layers 104, 106. The liquid 110 may enter the fluid flow path 146
at a rate of at least about 500 mL/min (30.5 in.sup.3/min) to about
800 mL/min (48.8 in.sup.3/min) to deliver sufficient heat to
maintain normothermia or treat hypothermia of the patient during
functional use of the patient warming device. To increase heat
delivery to the patient, the liquid flow rate may be increased to
about 2 L/min (0.07 ft.sup.3/min) or more. The desired flow rate
may be adjusted by using a fluid control pump.
[0059] In some embodiments, the fluid flow path 146 may guide the
liquid 110 to fill, sequentially., flaps 134, 136, 138, and 140
extending from the second side 120 of the central portion 112 and
then to fill, sequentially, flaps 132, 130, 128, and 126 extending
from the first side 118 of the central portion 112. As the liquid
110 travels through the wrap 102 along fluid flow path 146, the
liquid 110 delivers heat to the patient through the first compliant
layer 104 that is in contact with the patient's skin. Therefore, as
the liquid 110 flows along the fluid flow path 146, the liquid 110
loses heat, or becomes cooler (i.e., liquid flowing through flaps
134, 136, 138, 140 is warmer than liquid flowing through flap 126,
128, 130, 132). For example, temperature of the liquid 110 at the
fluid inlet 142 may decrease approximately 0.2.degree. C.
(32.degree. F.) to 1.0.degree. C. (34.degree. F.) by the time it
reaches the fluid outlet 144. The difference in temperature between
liquid at the fluid inlet 142 and fluid outlet 144 may vary
depending on the body temperature of the patient, which creates a
gradient that drives heat transfer from the liquid 110 to the
surface of the patient as the liquid 110 flows along the fluid flow
path 146. To maximize heat delivery to the patient, flaps 134, 136,
138, 140 may fold over to directly contact the patient's skin, and
flaps 126, 128, 130, 132 may fold over the flaps 134, 136, 138,
140, respectively.
[0060] The plurality of internal sealed connections 150 may be
formed by RF welding, or another plastic welding technique. The
sealed connections 150 may be formed as lines 152, circular dots
154, or any other shape. The sealed connections 150 may also form
patterns. The liquid 110 substantially fills the space 148 and
flows around the internal sealed connections 150 as it circulates
along the fluid flow path 146. The internal sealed connections 150
may distribute the liquid 110 more evenly throughout the wrap 102
so as to provide a low profile patient warming device. Those of
skill in the art will appreciate, in view of the present
disclosure, that the flow path may take different configurations
(e.g., the flow path may go first through the central portion 112,
then return to the outlet 144 via paths through the laps).
[0061] The shape, location, and/or pattern of the sealed
connections 150 and the distance between the sealed connections 150
may be configured to reduce stippling and facilitate even
distribution of the liquid 110 without inhibiting or overly
reducing the fluid flow rate. In other words, the shapes and
spacing of the sealed connections may be configured to minimize
flow resistance while facilitating distribution of the liquid 110
and also reduce stippling to the patient's skin. Moreover, the
sealed connections 150 may be formed in any shape and any pattern.
For example, internal sealed connections 150 may be formed or
patterned as circles, ovals, squares, heart shapes, star shapes,
animal shapes, company or sports team logos, or any other indicia.
The shape and/or pattern of the sealed connections may be chosen to
appeal to the target patient, purchaser, distributor, or user.
[0062] in some embodiments, the sealed connections 150 may include
circular dots 154 that are spaced at least about 3/16 inch (4.0 mm)
apart, and located throughout the flaps and central portion 112 of
the wrap. As shown in FIG. 4, for example, the sealed connections
150 may also include a longitudinal line 152 along a longitudinal
axis of the central portion 112, and a plurality of flow directing
lines 156, 158, 160 extending from the longitudinal line into the
plurality of flaps. In some embodiments, the sealed connections 150
may include a line 152 that runs along a longitudinal axis of the
central portion 112, and flow directing bars or lines 156, 158,
160, and 162 that intersect the line 152 and extend from the a
central area of a flap on, or extending from, the first side 118 of
the central portion 112 to a central area of a flap on, or
extending from, the second side 120 of the central portion 112. The
fluid flow path 146 may guide the liquid 110 through the fluid
inlet 142, around line 156 in flap 134 and into flap 136 around
line 158 and continue through the fluid flow path 146, as indicated
by the arrows and winding dotted lines of FIG. 4. In this way, flow
directing bars or lines 156, 158, 160, and 162 may guide or
disperse the liquid 110 more evenly through each flap. Other
embodiments may include additional, fewer, or different flow
directing lines,
[0063] For example, as shown in FIG. 4A, flow directing bar or line
156 is removed from laps 126, 134. Reducing the number of flow
directing lines or bars, or other sealed connections, in a
particular portion of the wrap 102 may decrease flow resistance in
that portion of the wrap 102. For example, in some embodiments,
decreased How resistance in the flaps 126, 134 covering the
patient's hand, or other body portion or appendage, may increase or
speed up heat transfer to the hands, or other body portion or
appendage. Flow directing lines or bars and/or other sealed
connections may be arranged in any configuration or in any quantity
to control, direct, or achieve desired flow conditions.
[0064] Lines 152, 156, 158, 160, and 162 may end in sealed
connections shaped as circular dots 154 so as to decrease flow
resistance. The corners of the flaps and intersections of lines
152, 156, 158, 160, and 162 may also be rounded so as to facilitate
even distribution of the liquid 110 into the corners and to
decrease flow resistance. Rounded comers may also improve comfort
and feel of the patient warming device when worn by the patient.
Those of skill in the art, when informed by the present disclosure,
will appreciate that different flow paths (differing with respect
to directionality, liquid volume and flow rate, etc.) may be
provided by modifying the position, number, and/or distribution,
frequency, or density of internal sealed connections.
[0065] In some embodiments, hook and loop fasteners may be used to
prompt a user as to the appropriate placement of the flaps so as to
maximize heat delivery. For example, as illustrated with reference
to FIG. 5, the hooks or loops 134a, 136a, 138a, 140a may be
arranged on the second compliant layer 106 of flaps 134, 136, 138,
140; and the corresponding hooks or loops 126a, 128a, 130a, 132a
may be arranged on the first compliant layer 104 of flaps 126, 128,
130, 132 so that when the flaps are fastened, flaps 126, 128, 130,
132 overlap flaps 134, 136, 138, 140, which are in contact with the
patient's skin. Alternatively, the hooks or loops 134a, 136a, 138a,
140a may be arrange on either or both of the first and second
compliant layers 104, 106 of flaps 134, 136, 138, 140, in any
order, such that the one or more of flaps 134, 136, 138, 140 may
contact the patient's skin, and one or more of flaps 126, 128, 130,
132 may contact the patients skin. Alternatively, straps or bands
that are not integral to the wrap may be positioned around the wrap
to secure the flaps and/or to provide insulation.
[0066] Some embodiments of a patient warming device with patient
access 200 are illustrated with reference to FIG. 6. The device 200
may include a wrap 202 formed from a first compliant layer 204 and
a second compliant layer 206 sealed together around an outer border
208, or outer edges, to contain a liquid 110 between the layers
204, 206. The wrap 202 may include a generally longitudinal central
portion 212 that is sized to cover a surface or skin of the body
portion of a patient, such as a foot 214 and/or a lower leg 216, as
shown in FIG. 7, discussed below.
[0067] A plurality of flaps may extend from a first side 218 or a
second side 220 of the central portion 212, or from a proximal end
222 or a distal end 224 of the central portion 212. For example,
flaps 226, 228, 230 may extend from the first side 218 of the
central portion 212, and flaps 234, 236, 238 may extend from the
second side 220 of the central portion 212. Flaps on opposite sides
of the central portion 212 may correspond in size, shape and
position along the central portion 212, Alternatively, flaps
extending from one side of the central portion 212, or the first
side 218, may differ in size, shape, and/or position along the
central portion 212 than flaps extending from an opposite side of
the central portion 212, or the second side 220. In other
embodiments, flaps may extend only from one side or one end of the
central portion 212, or from one side and one end of the central
portion 212, or any combination of sides and ends of the central
portion 212. Additional, fewer, or different flaps may be included
in the patient warming device 200.
[0068] Flaps extending from opposite sides of the central portion
212 may fasten to each other to surround a body portion of the
patient. Alternatively, flaps may extend from one side of the
central portion 212 and fasten to another side of the central
portion 212. The flaps may be fastened by any suitable fastener,
such as, for example, hook and loop fasteners, adhesive tabs,
buttons, snaps, or press and seal fasteners.
[0069] The patient warming device 200 provides patient access to a
target area of the underlying patient body surface being surrounded
by the wrap 202. For example, during an operative procedure, a
surgeon or other medical personnel may access a portion of the foot
214 or lower leg 216 without exposing the other portions of the
underlying patient body surface, in some embodiments, the foot 214
may be accessed by unfastening, opening, or unfolding a pair of
flaps 226, 234, while the other flaps remain covering the upper and
lower portions of the calf and/or shin of lower leg 216 patient.
Alternatively, access to the foot 214 may be provided by unfolding
only one of flap 226 and/or flap 234 while the other flaps remain
in contact with the patients skin. In a similar way, access to the
lower portion of the calf and/or shin may be provided by
unfastening, opening, or unfolding, one or both of flaps 229, 236,
access to the upper portion of the calf and/or shin may be provided
by unfastening one or both of flaps 230, 238.
[0070] Providing access to a target area of the underlying patient
body surface while maintaining contact with other parts of the
surrounding areas increases the ability of the patient warming
device 200 to maintain normothermia and/or treat hypothermia in the
patient by maintaining heat transfer to body portions that remain
covered. Also, by providing access to the target area while the
wrap 202 remains in place, there is no need reposition or remove
the patient warming device in order to introduce surgical elements,
such as intravenous feed lines, pulse oximetry probes, needles,
vitals monitoring instruments, or other surgical or medical
instruments.
[0071] In some embodiments, liquid 110 may enter the wrap 202
through fluid inlet 242 and exit through fluid outlet 244. The
liquid 110 may be a warm or heated liquid that is at a temperature
between about ambient temperature, or about 20.degree. C.
(68.degree. F.), to about 41.degree. C. (105.8.degree. F.). Fluid
inlet 242 and outlet 244 may include flexible or rigid tubes, such
as PVC, urethane, polyurethane, RE, EVA, EVA/PE blends or
copolymers, SBC, medical elastomers, olefin-based compounds, ABB,
polycarbonate. A fluid control pump may be connected to fluid inlet
242 to pump the liquid 110 through a continuous fluid flow path
246. The fluid inlet 242 and fluid outlet 244 maybe located on the
same or separate sides or ends of the wrap 202.
[0072] For example, fluid inlet 242 and outlet 244 may be located
at a portion near or at the distal end 222 or near or at the
proximal end 224 of the central portion 212. For example, fluid
inlet 242 may be located on a first side 218, or half, of the
central portion 212, and the fluid outlet 244 may be located on a
second side 220, or half, of the central portion 212.
Alternatively, the fluid inlet 242 and outlet 244 may be located at
opposite ends. In other embodiments, the fluid inlet 242 and outlet
244 may be located adjacent or separately at any location along an
outer edge, flap, or middle of the wrap 202.
[0073] he continuous fluid flow path 246 may guide the liquid 110
through the wrap 202 and substantially fl the space between the
first and second compliant layers 204, 206. The fluid flow path 246
may be defined by the outer border 208 and a plurality of internal
sealed connections 250 between the first and second compliant
layers 204, 206. The liquid 110 may enter the fluid flow path 246
at a rate of at least about 500 mL/min (30.5 in.sup.3/min) to about
800 ml/min (48.8 in.sup.3/min) to deliver sufficient heat to
maintain normothermia and/or treat hypothermia in the patient
during functional use of the patient warming device. To increase
heat delivery to the patient, the liquid flow rate may be increased
to about 2 L/min (0.07 ft.sup.3/min) or more. The desired flow rate
may be adjusted by using a fluid control pump.
[0074] The patient warming device 200 may include fastener tabs
234a, 236a, 238a extending from flaps 234, 236, 238, respectively.
The fastener tabs may be, for example, adhesive tabs, hook and loop
fasteners, or other fastener that removably attaches to the second
compliant layer 206 of flaps 226, 228, 230. The fastener tabs 234a,
236a, 238a and corresponding flaps 234, 236, 238 may correspond
with flaps 226, 228, 230 in size, shape, and/or location along the
central portion 212, Alternatively, the 234a, 236a, 238a and
corresponding flaps 234, 236, 238 may vary in size, shape, and/or
location along the central portion 212 without corresponding with
flaps 226, 228, 230 in size, shape, and/or location along the
central portion 212,
[0075] In other embodiments, the patient warming device with
patient access may include any number of flaps and fasteners. The
fasteners may include any suitable fasteners, including, for
example, hook and loop fasteners, adhesive tabs, buttons, snaps, or
press and seal fasteners, or any combination thereof. The fasteners
may be located anywhere on the flaps, such as on the first
compliant layer or the second compliant layer, or on the central
portion of the wrap. Fasteners may be located on one or more, or
all, of the flaps.
[0076] In some embodiments, as illustrated with reference to FIG.
7, the wrap 202 is used to cover a foot 214 and lower leg 216, the
flaps 226, 234 located at or near the distal end 224 may extend a
shorter distance from the central portion 212 than flaps 230, 238
located at or near the proximal end 222 of the central portion 212.
Flaps 226, 234 may be configured (e.g., sized, shaped, tapered,
and/or contoured) to fold over and cover the foot 214, flaps 228,
236 configured to fold over and cover a portion of the calf and
shin of lower leg 216 nearest the foot, and flaps 230, 238
configured to fold over and cover an upper portion of the calf and
shin of lower leg 216 nearest the knee. Flaps 226, 228, 230 may
extend a predetermined distance from the central portion 212 so as
to completely overlap or partially overlap with flaps 234, 236,
238. Alternatively, flaps 226, 228, 230 and flaps 234, 236, 238 may
fold over to cover a body portion without overlapping another flap.
Although the patient warming device 200 is described here for use
with a foot 214 and lower leg 216, the device 200 may be configured
(e.g., sized, shaped, tapered, and/or contoured) to surround any
other body portion or appendage of a patient.
[0077] The patient warming device 200 may include a sealed border
defining an opening 260 that is configured to fit a heel of the
foot 214. For example, the opening 260 may be sized and located on
the central portion 212 so that the heel may rest in the opening
260, thereby exposing and relieving pressure to the heel of the
foot 214. The patient warming device 200 may include additional,
different, or fewer openings configured to fit any body portion or
appendage of the patient.
[0078] In some embodiments, as illustrated diagrammatically with
reference to FIG. 8, a compressive patient warming device 300
simultaneously delivers heat: and applies a compressive load to an
appendage 302, or body portion, of a patient by surrounding the
appendage, or body portion, with an elastic inner layer 304 and an
outer layer 306 that is attached to and covers the inner layer. The
outer layer 306 may be an insulating material such as a foam, gel,
or insulative fabric. The elastic inner layer 304 conforms snugly
to the shape of the appendage.
[0079] The elastic inner layer 304 may be a tight fitting wrap,
sleeve, or garment that wraps around, or surrounds, and contacts
substantially most, or substantially all, of an underlying surface
area of the appendage 302 to maximize heat transfer to the patient.
For example, at least about 90% to about 95% of the surface area of
the elastic inner layer 304 contacts the patient's skin. The
elastic inner layer 304 may be an elastic material that is
sufficiently strong to apply a compressive force on the surrounded
appendage, or body potion, so as to compress surface veins,
arteries, and muscles, increasing venous blood flow velocity and
valve effectiveness. The outer layer 306 may be an elastic material
or a rigid material. When the device is wrapped around the patient
appendage 302, or body portion, the inner layer 304 is
substantially entirely, or at least partially, concentric with the
outer layer 306.
[0080] A space 308 between the inner and outer layers 304, 306
holds a heat transfer medium, or liquid, 110 that delivers heat to
the patient through the inner layer 304, while the compressive
patient warming device 300 is wrapped around the appendage 302. The
heat transfer medium, or liquid, 110 may fill substantially all,
e.g., about 90% to 95% or more, of the space between the inner
layer 304 and the outer layer 306 and distribute heat generally
across the surface of the underlying surface area of the patient's
skin. Alternatively, the heat transfer medium 304 may partially
fill the space between the inner layer 304 and outer layer 306 so
as to deliver heat to a localized area of the underlying surface
area. In other embodiments, heat may be applied to a localized beat
source may be applied at a section of the inner layer that covers
an area of high venous density, or any other desired area.
[0081] In some embodiments, as illustrated with reference to FIG.
9, a compressive patient warming device 400 simultaneously delivers
heat and applies a compressive load to an appendage, or body
portion, of a patient by surrounding the appendage, or body
portion, with an elastic inner layer 402 and an outer layer 404
that is attached at a connection 406 to the inner layer 402. The
patient warming device 400 includes a space 408 between the inner
and outer layers 402, 404 that is substantially filled with a heat
transfer medium 110. The patient warming device 400 may include
additional connections between the inner and outer layers 402, 404,
The outer layer 404 may include a tab 412 for fastening, tightening
or adjusting the outer layer 404 around the appendage, or body
portion. The tab 412 may attach to an external surface 414 of the
outer layer 404, such as by using a fastener, including for
example, a hook and loop fastener, adhesive tabs, buttons, snaps,
or press and seal fasteners.
[0082] When the outer layer 306, 404 of compressive warming device
300, 400 is a rigid material or an elastic material, a compressive
load or pressure may be applied to the appendage by controlling the
flow of the heat transfer medium 110 using a fluid control pump, or
other controller. When the outer layer 306, 404 is an elastic
material, a compressive load may be applied, additionally or
alternatively, on an external surface of the outer layer 306,
404.
[0083] The heat transfer medium 110 may be one or more of a liquid,
a visco-elastic foam that conforms to the appendage along with the
inner layer 304, 402, or a viscous gel, sand, heat transferring
beads, or any combination thereof. The inner layer 304, 402 may be
a non-permeable material that holds a liquid between, the inner
layer 304, 402 and the outer layer 306, 404. The non-permeable
material may include, for example, PVG, urethane, polyurethane, RE,
EVA, EVA/PE blends or copolymers, SBC, medical elastomers,
olefin-based compounds, ABS, or any combination thereof.
Alternatively, the inner layer 304, 402 may be any elastic material
that can hold a non-liquid heat transfer medium 110, including, for
example, a viscoelastic foam, or sand. The elastic material may
include, for example, cotton, polyester, nylon, rubber or any combs
nation thereof.
[0084] In some embodiments, as illustrated with reference to FIGS.
10 and 11, a compressive patient warming device 500 may include an
embodiment of a patient warming device with access 100 as described
above and as illustrated with respect to FIGS. 1-5, or an
embodiment of a patient warming device with access 200 as described
above and as illustrated with respect to FIGS. 6-7. An elastic
inner layer 502 may be attached to an intermediate layer 504 at
connection 506. The first compliant layer 104, 204 of a patient
warming device with access 100,200 may form the intermediate layer
504 of the compressive patient warming device 500. The second
compliant layer 106, 206 of the patient warming device with access
100, 200 may form an outer layer 508 of the compressive patient
warming device 500. The elastic inner layer 502 may include, for
example, a compression sleeve, as shown in FIG. 10. The connection
506 may include, for example, hook and loop fasteners, adhesive
tabs, buttons, snaps, or press and seal fasteners.
[0085] As shown in FIG. 11, for example, the elastic inner layer
502a may be attached to the intermediate layer 504a at connection
506a along a longitudinal axis X of the central portion 112, 212 of
the patient warming device 100, 200. The elastic inner layer 502a
may include, for example, a compression sleeve, as shown in FIG.
11. A compressive load may be applied through the compressive
patient warming device 500a by controlling the flow of the liquid
110 through the fluid flow path 146, 246, for example, by using a
fluid control pump. When the wrap 102, 202 is in functional use,
surrounding the body portion, or appendage, the liquid 110 is
directed through the fluid flow path 146, 246, the wrap 102, 202 is
inflated and the liquid 110 exerts a compressive bad through the
first compliant layer 104, 204 on the underlying body portion, or
appendage. The second compliant layer 106, 206 of the patient
warming device with access 100, 200 may form an outer layer 508a of
the compressive patient warming device 500a.
[0086] In some embodiments, as illustrated with reference to FIG.
12, a patient warming and deep vein thrombosis prevention system
includes a patient warming device 600 and a fluid control pump 700.
The fluid control pump 700 circulates a heat transfer medium to the
patient warming device 600, which delivers heat to the patient
across the surface area of the patient warming device 600. The heat
transfer medium may include, for example, a warm liquid, such as
water or other aqueous liquids, a viscous gel, a hydrogel, an
organic liquid (e.g., oil or oil-based liquid, or any other organic
liquid or flowable material with a heat capacity suitable for
effective use in keeping with the principles of the present
disclosure), a synthetic oil, a foam, or forced air, or any
combination thereof. The heat transfer medium is cooled as heat is
delivered to the patient, and pumped out of the patient warming
device 600 by the control pump 700. Alternatively, or additionally,
the cooled fluid may exit the patient warming device 600 through
another mechanism, such as a vacuum, suction, or drain.
[0087] In some embodiments, as illustrated with reference to FIG.
13, patient warming device 600 may include a wrap 602 formed from a
first compliant layer 604 and a second compliant layer 606 sealed
together around an outer border 608, or outer edges, to contain a
liquid 110 between the layers 604, 606. The first and second layers
604, 606 may be sealed around the border 608, for example, by radio
frequency (RF) welding, so as to contain the liquid 110. The first
compliant layer 604 may be configured to contact the skin of the
patient, and the second compliant layer 606 may face away from the
skin, or be exposed to the surrounding environment. The wrap 602
may include a generally longitudinal central portion 612 that is
sized to cover a surface or skin of the body portion of a patient.
The central portion 612 has a first side 618 and a second side 620,
and a proximal end 622 and a distal end 624.
[0088] A plurality of flaps 626, 628, 630, 632, 634, 636, 638, 640
extend from opposite sides of the-central portion 612. One or more
flaps from opposite sides fasten to each other to surround the body
portion. During functional use, the flaps 626, 628, 630, 632, 634,
636, 638, 640 are openable to provide access to an underlying
patient body surface. The liquid 110 enters the wrap at a fluid
inlet 642 and exits at a fluid outlet 644.
[0089] In some embodiments, as illustrated with reference to FIG.
14, a continuous fluid flow path 646 extends between the first
compliant layer 604 and the second compliant layer 606 between the
fluid inlet 642 and the fluid outlet 644. The path 646 is defined
by the outer border 606 and plurality of sealed connections 650
between the first and second compliant layers 604, 606. The sealed
connections 650 may include a vertical line or seam 652 that runs
along a longitudinal axis of the central portion 612, circular or
dot shaped seams 654, and transverse seams, or flow directing lines
or bars, 656, 658, 660, 662 that intersect the vertical seam 652,
Alternatively, or additionally, the sealed connections 650 may
include lines and dots arranged in any other patterns or locations
within the outer borders.
[0090] The fluid control pump 700 is attached to the fluid inlet
642 and pumps liquid 110 into the fluid flow path 646 to fill the
wrap 602. As the wrap 602 is being filled, the liquid 110
simultaneously applies pressure and delivers beat to the body
portion being surrounded by the wrap 602. The fluid control pump
700 controls fluid flow rate to the wrap 602 and fills the wrap 602
sufficiently full to exert surface pressure on the patient. The
pressure provided is generally effective to prevent deep vein
thrombosis. For example, the fluid control pump 700 may alternate
the fluid flow rate between a higher flow rate of about 3 L/min
(0.11 ft.sup.3/min) and a lower flow rate of about 500 ml/min (30.5
in.sup.3/min). The fluid flow rate may exert a pressure, or a
compressive load, on the underlying surface area that is between
about 15 mmHg (2.0 kpa) and 100 mmHg (13.33 kpa). Alternatively the
fluid control pump 700 may vary the flow rate to any appropriate
flow rate effective to maintain normothermia and prevent deep vein
thrombosis. The necessary flow rate may be determined based on
environmental factors, such as ambient temperature (e.g.,
temperature of the surrounding environment), air pressure, patient
body temperature, type of fluid being controlled, size and material
of the wrap, the fluid flow path, the body portion or appendage
being surrounded, and other factors that would be apparent to one
of skill in the art.
[0091] In some embodiments, a patient warming and DVT prevention
system may include sensors to monitor temperature and pressure
applied at the surface of the appendage or body portion. For
example, sensors may be placed on the underlying surface of the
patient body portion or appendage to be surrounded by the patient
warming device 600. The sensors may be coupled to a system
controller, such as the fluid control pump 700. As the liquid 110
fills the wrap 602, the sensors may provide a feedback signal to
the fluid control pump 700, which may be configured to adjust the
temperature of the liquid 110 entering the fluid inlet 642 so as to
maintain the temperature of the underlying surface within a
predetermined range to maintain normothermia. For example, the
temperature of the liquid 110 may be adjusted to maintain a
temperature at the heat transfer surface of between about
36.degree. C. (96.8.degree. F.) and 40.degree. C. (104.degree. F.).
Alternatively, or in addition, the heat may be adjusted using the
feedback system and patient core temperature monitoring.
[0092] in some embodiments, the wrap 602 of a patient warming and
DVT preventions system may be worn around a patient's lower leg and
foot. With reference to FIG. 14, the fluid inlet 642 is located at
or near the distal end 624 of the central portion 612 and the fluid
outlet 644 is locate at or near the proximal end 622 of the central
portion 612. The wrap 602 may be positioned on the patient so that
the fluid inlet 642 is nearer the foot of the patient and the fluid
outlet 644 is nearer the heart of the patient As the liquid 110
enters the wrap 602, the fluid flow path 646 fills the flaps
sequentially beginning with flaps 626, 634 nearest the fluid inlet
642 and ending with flaps 632, 640 nearest the fluid outlet 644.
Sequentially filling the wrap 602 from an end that is further from
the heart to an end that is nearer to the heart may encourage or
promote venous blood flow by applying pressure, such as in an
upward massage motion, to the underlying body portion or appendage
in the same sequence along the underlying body portion and towards
the heart. The wrap 602 may be configured for use with any other
body portion, or appendage, and may be aligned with the body
portion, or appendage, so that the distal end or fluid inlet 642 is
further from the heart than the proximal end or fluid outlet
644.
[0093] In some embodiments, as illustrated with reference to FIG.
15, the wrap may include subsections 664, 666, 668, 670, 672, 674,
676 that are defined by the sealed connections 650 and outer
boundaries. For example, subsection 664 may be defined by the outer
border 608 of flap 626 and a sealed connection 650, such as a
longitudinal line or seam 652 that lies along a longitudinal axis X
of the central portion 612. The subsections 664, 666, 668, 670,
672, 674, 676 may correspond with the flaps 626, 628, 630, 632,
634, 636, 638, 640, or may be defined independently of the flaps.
The subsections 664, 666, 668, 670, 672, 674, 676 may be in fluid
communication, or may be physically separated by sealed connections
150. The wrap 602 may include one or more fluid control mechanisms
678, 680, 682, 684, 686, 688 positioned between two or more
subsections. Alternatively, or additionally, one or more fluid
control mechanisms may be located in or near the fluid inlet 642
and/or fluid outlet 644.
[0094] For example, the fluid control mechanisms 678, 680, 682,
684, 686, 688 may be positioned to join internal sealed connections
with the outer boundary. Alternatively, or additionally, more or
less fluid control mechanisms may be located at different locations
along the fluid control path 646. The fluid control mechanisms 678,
680, 682, 684, 686, 688 may be check valves that allow fluid to
flow in one direction towards the fluid outlet. Alternatively, or
additionally, other types of fluid control valves may be used such
as duck bill valves, bifurcating valves, or umbrella valves.
[0095] As the liquid 110 enters the wrap 602, the fluid control
mechanisms 678, 684 may allow the subsections 664, 672 nearest the
fluid inlet 642 to be filled sufficiently to exert a surface
pressure onto the patient. Then the next subsections 666, 674, and
the next subsections 668, 676, and subsection 670, may be filled in
sequence until each subsection is sufficiently full to exert a
surface pressure onto the patient. The wrap 602 may be applied to
patient body portion, or appendage, so that the fluid inlet 642
corresponds to a location on the patient that is further from the
heart, and the fluid outlet 644 corresponds to a location on the
patient that is closer to the heart. As such, the sequential
filling of the subsections, from those further from the heart, to
those closer to the heart, may encourage or promote venous blood
flow and effectively prevent DVT.
[0096] As another example, the fluid control mechanisms may be a
plurality of closely spaced seated connections between the first
and second compliant layers. The closely spaced sealed connections
(e.g., less than 3/18 inch (4.0 mm) apart may create localized
areas of increase flow resistance, so as to decrease the fluid flow
rate in those areas. The fluid control mechanisms may be configured
to allow liquid to fill a first section sufficiently full to exert
surface pressure onto the patient before filling a next section,
for example, fluid control mechanisms 678 and 684 may decrease or
stop fluid flow into subsections 666 and 674 until subsections 664
and 672 are sufficiently full to exert surface pressure onto the
patient, in this way, fluid control mechanisms may be configured to
allow the subsections to be sequentially filled from the distal end
624 of the central portion 612 to the proximal end 622 of the
central portion 612. Sequentially filling the subsections provides
for sequential compression of the underlying surface of the patient
so as to promote venous blood flow, and prevent deep vein
thrombosis.
[0097] In some embodiments, as illustrated with respect to FIG. 16,
a patient warming and DVT prevention system 800 includes a wrap
602, having first and second compliant layers 604, 606. FIG. 16
shows a cross-sectional view of the patient warming and DVT
prevention system 800. The system 800 further includes a third
compliant layer 702 that is adjoining, or sealed together around
the outer edge 608 of, the second compliant layer 604 so as to form
an inflatable layer 804 between the two layers. When the wrap 602
is worn around a patient body portion or appendage 806, the third
compliant layer 802 surrounds the second compliant layer 606, and
the first compliant layer 604, so that the inflatable layer 804
applies pressure to the body portion or appendage 806 by
compressing the first and second compliant layers 604, 606 and the
liquid 110 between the first and second layers 604, 606. An air
pump or blower may be coupled with an inlet of the inflatable layer
so as to inflate the layer and apply additional surface pressure on
the body portion, or appendage. The air pump or blower may also be
configured to vary the air flow rate, such as between a higher flow
rate and a lower flow rate, or between a positive flow rate and a
vacuum mode, so as to apply an intermittent pressure on the body
portion.
[0098] In other embodiments, the patient warming and DVT prevention
system may include a patient warming device that includes flaps
extending from one or more sides of the central portion, or from
one or more ends of the central portion. The number of flaps may
vary. Flaps from opposite sides or ends of the central portion may
fasten together to surround the body portion or appendage of the
patient. Alternatively, flaps may extend from one side or end of
the central portion and fasten to another side or end of the
central portion.
[0099] The following variations may apply to any embodiments of the
patient warming device with access, the compressive patient warming
device, the patient warming and DVT prevention system, or
associated methods disclosed herein, Embodiments of the patient
warming device with access, the compressive patient warming device,
the patient warming and DVT prevention system, or associated
methods disclosed herein, may apply to any body portion, appendage,
or extremity of a patient, and may be used during in an operating
or surgical environment, or in other environments.
[0100] In embodiments including flaps that extend from one or more
sides or ends of a generally longitudinal central portion, the
flaps may vary in number, size, shape, or location along the
central portion, depending on the body portion or appendage to be
surrounded, and the intended functional use. The flaps may be
positioned and/or configured to allow access to the underlying
surface of any surrounded patient body portion or appendage, so as
to maintain normothermia and/or treat hypothermia without requiring
removal or repositioning of the device. Any suitable fastening
mechanisms may be used to secure the device around the patient's
body portion or appendage. For example, fasteners may include, for
example, hook and loop fasteners, adhesive tabs, buttons, snaps, or
press and seal fasteners.
[0101] In some embodiments, the first compliant layer makes contact
with the patient's skin, and the second compliant layer is exposed
to the surrounding environment. The first compliant layer may have
a thickness that is less than the thickness of the second compliant
layer, so as to provide more efficient heat transfer to the
patient. The first and second compliant layers may be welded
together using any appropriate technique, including, for example,
plastic welding techniques, such as radio frequency welding, hot
gas welding, head sealers, speed tip welding, contact welding, hot
plate welding, ultrasonic welding, friction welding, and laser
welding, or any combination thereof. The first and second compliant
layers may alternatively be adhesively bonded. The first and second
compliant layers may be the same or different materials, and may
have the same or different thicknesses,
[0102] Materials for the first and second compliant layers may
include, for example, PVC, urethane, polyurethane, polyethylene
(PE), EVA, EVA/PE blends or copolymers, styrenic block copolymers
(SBC), medical elastomers, olefin-based compounds, ABS, or any
combination thereof. Generally, the materials used may vary
depending on the intended functional use, such as for average
patients or patients with specific conditions or requiring special
considerations (e.g., elderly, diabetic, infant, patients with
allergies and/or hypersensitivity).
[0103] The liquid used in the devices and methods may be water or
other aqueous liquids, a viscous gel, a hydrogel, an organic liquid
(e.g., oil or oil-based liquid, or any other organic liquid or
flowable material with a heat capacity suitable for effective use
in keeping with the principles of the present disclosure), a
synthetic oil, a foam, or any combination thereof, or any other
liquid that is suitable for heat transfer. Alternatively, other
heat transfer mediums may be inserted between the first and second
compliant layers, such as visco-elastic foam, sand, heat
transferring beads, and other suitable beat transfer mediums. The
liquids and other beat transfer mediums listed here are provided as
examples, and are not intended as limitations. Other liquids,
fluids, and heat transfer mediums may be used. The liquid, or other
heat transfer medium, may circulate through the device at a
temperature of about ambient temperature, or 20.degree. C.
(68.degree. F.), to about 41.degree. C. (105.8.degree. F.). When
the liquid is water, the flow rate through the continuous fluid
flow path may be about 500 mL/min (30.5 in.sup.3/min) to about 800
mL/min (48.8 in.sup.3/min), or higher.
[0104] The continuous fluid flow path may guide the liquid or other
heat transfer medium between the first and second compliant layers
between the fluid inlet and fluid outlet in any pattern, direction,
or path that allows the liquid, or other heat transfer medium, to
transfer heat efficiently to the underlying surface of the patient.
The fluid inlet and fluid outlet may be located together at or near
the distal end or proximate end, or first or second side, of the
central portion, or at any other location on the device.
Alternatively, the fluid inlet and fluid outlet may be located at
opposite ends or sides of the central portion, or otherwise
separately located at any location on the device.
[0105] Although various embodiments of the invention have been
described, it will be apparent to those of ordinary skill in the ad
that many more embodiments and implementations are possible that
are within the scope of the invention. For instance, steps of a
method as displayed in the figures or reflected in the claims do
not require a specific order of execution by way they are
presented, unless specified. The disclosed steps are listed as
exemplary such that additional or different steps may be executed
or the steps may be executed in a different order. Those of skill
in the art will appreciate that embodiments not expressly
illustrated herein may be practiced within the scope of the claims,
including that features described herein for different embodiments
may be combined with each other and/or with currently-known or
future-developed technologies while remaining within the scope of
the claims.
[0106] Those of skill in the art will appreciate that embodiments
not expressly illustrated herein may be practiced within the scope
of the claims, including that features described herein for
different embodiments may be combined with each other and/or with
currently-known or future-developed technologies while remaining
within the scope of the claims. Although specific terms are
employed herein, they are used in a generic and descriptive sense
only and not for purposes of limitation unless specifically defined
by context, usage, or other explicit designation. It is therefore
intended that the foregoing detailed description be regarded as
illustrative rather than limiting. And, it should be understood
that the following claims, including all equivalents, are intended
to define the spirit and scope of this invention. Furthermore, the
advantages described above are not necessarily the only advantages
of the invention, and it is not necessarily expected that all of
the described advantages will be achieved with every embodiment. In
the event of any inconsistent disclosure or definition from the
present application conflicting with any document incorporated by
reference, the disclosure or definition herein shall be deemed to
prevail.
* * * * *