Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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PCT/US2013/022021
PATIENT POSITIONING DEVICE
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BACKGROUND OF THE INVENTION
[001] The transfer of a patient from one support platform to another is a
difficult procedure for
hospital staff In a hospital setting, patients are constantly being moved. For
example, a patient
entering the hospital via ambulance is moved from the medical stretcher or
ambulance gurney to
a hospital gurney, a fixed hospital bed, an examination table, or an operating
table. Also,
patients already in a hospital need to be moved as well. For instance, a
patient having surgery
may be moved from a fixed hospital bed to a hospital gurney then to an
operating table and
finally back to a fixed hospital bed. Each time a patient is moved a sliding
or lateral movement
of the patient from one support surface to another is required.
[002] Difficulties for patients and hospital staff may arise from this lateral
transferring of
patients. Typically, the hospital staff acting in concert is responsible to
position and move the
patient to the new support surface by means of lifting, sliding or dragging.
This action may
cause injury to the patient if the patient accidently slides off of the
support surface or if the
patient is dropped. Also the hospital staff may be injured from the act of
lifting, sliding or
dragging a heavy patient.
[003] The prior art teaches various systems designed to move patients without
actually lifting.
These systems employ air rollers, pull straps and inflation as a means to drag
patients to and
from support surfaces. Many of these systems are intended for single-
patient/single-use
application, such that the devices stay with the patient from the hospital bed
to the operating
room table.
[004] Hypothermia is a recognized and common occurrence for patients during
surgery.
Patients who develop hypothermia are at a greater risk for complications,
including a greater
chance of heart problems, higher rates of infection, increased blood loss and
prolonged recovery.
To counter this, medical personnel may cover the patient with blankets.
Blankets are typically
bulky, frequently unravel, and may fall off the patient during pre-surgery,
surgery, post-surgery
or transport.
[005] The use of surgical drapes or surgical leggings is known in the art.
These are typically
sterile, disposable, thin panels of fabric that are used during surgeries when
the patient is in a
lithotomy position involving the pelvis and lower abdomen such as during colon
or genitourinary
surgery. The main purpose of drapes or leggings is to isolate the surgical
area and maintain a
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sterile environment thus helping to prevent infection. Also, some drapes or
leggings control and
contain fluid. These drape and leggings must be impervious to liquid
strikethrough.
[006] A design for positioning a patient is provided in "Patient Positioning
Device," US patent
application serial number 13/153,432, filed June 5, 2011, referred to as "Giap
patent
application," which is hereby incorporated by reference in its entirety for
all purposes.
BRIEF SUMMARY OF THE INVENTION
[007] A positioning device is described. This device includes a planar sheet
having first and
second side edges and a top surface. A patient is positioned on the top
surface where the first
and second side edges are adjacent to the patient's legs. A first flexible
substrate and a second
flexible substrate are coupled to the respective first and second side edge of
the sheet and are
capable of wrapping around an adjacent leg of the patient creating a wrapped
engagement. This
wrapped engagement of the patient's legs prevents heat loss during pre-
surgery, surgery, post-
surgery or transport of the patient. Handles coupled to the sheet may be
utilized for lifting or
moving the sheet when the patient is supported by the sheet.
[008] The present invention is better understood upon consideration of the
detailed description
below in conjunction with the accompanying drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[009] Figure 1 is a flowchart of an embodiment of surgical events.
[010] Figure 2 shows an embodiment of the patient positioning device.
[011] Figure 3A depicts an embodiment of the patient positioning device.
[012] Figure 3B is an embodiment of the patient positioning device with
continuous attachment
points.
[013] Figure 3C is an embodiment of the patient positioning device with non-
continuous
attachment points.
[014] Figure 4 shows a patient in a lithotomy position.
[015] Figure 5 depicts an embodiment of the patent positioning device with
perforated and
disposable leggings.
[016] Figure 6 illustrates an embodiment of the patent positioning device with
a patient
supported thereon.
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[017] Figure 7 illustrates an embodiment of the patient positioning device
with the legging
wrapped engagements.
[018] Figure 8 depicts an embodiment for fasteners for the patient positioning
device.
[019] Figure 9 shows an embodiment for the patient positioning device with
windows.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[020] Described herein is a patient positioning device used to position,
protect, secure and
prevent heat loss of a patient while on a support surface, during transfer to
another support
surface, and/or during pre-surgery, surgery or post-surgery. The positioning
device may be used
during any surgery regardless of the position of the patient. In fact, when
the patient is in a
lithotomy position, one embodiment of the patient positioning device is a
surgical leggings
feature. These surgical leggings, also referred to as support substrates, of
the present invention
are used to protect the patient as well as prevent heat loss.
[021] The following description is presented to enable a person of ordinary
skill in the art to
make and use the invention. Descriptions of specific materials, techniques,
and applications are
provided only as examples. Various modifications to the examples described
herein will be
readily apparent to those of ordinary skill in the art, and the general
principles defined herein
may be applied to other examples and applications without departing from the
spirit and scope of
the invention. Thus, the present invention is not intended to be limited to
the examples described
and shown, but is to be accorded the scope consistent with the appended
claims. Reference now
will be made in detail to embodiments of the disclosed invention, one or more
examples of
which are illustrated in the accompanying drawings.
[022] A patient experiences a multitude of stages when undergoing surgery.
Figure 1 is a
flowchart of possible surgical events 100. The process starts in a pre-
operative area. At step
102, the patient waits here before entering the operating room for surgery.
Next, the patient is
transferred into the operating room and at step 104, the pre-induction phase
begins. The patient
is placed on any necessary monitors such as blood pressure cuffs,
Electrocardiography (EKG)
electrodes, pulse oximeter, intravenous therapy (IV), or the like. At step
106, or induction, the
patient is administered anesthesia for surgery.
[023] At step 108, the patient is positioned for surgery. Depending on the
type of surgery, the
patient may be positioned in a prone, supine, lithotomy or lateral decubitus
position. During this
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time the patient's body parts are often exposed to cold, ambient air normal in
an operating room.
Loss of body heat is a concern during the surgical process and the patient's
body may become
hypothermic.
[024] Hypothermia may occur during the surgical process. Under anesthesia
there may be a
loss of the behavioral response to cold and impairment of thermoregulatory
heat-preserving
mechanisms through the hypothalamus and autonomic nervous system. Anesthetics
also cause
peripheral vasodilation, causing redistribution of the blood volume with
associated heat loss,
leading to significant reduction of core temperature. In addition to this,
patients may be exposed
during their surgery, further accelerating heat loss, and may already have
become cold during the
inactive period waiting for surgery. With fluid deprivation, conventionally
practiced for up to 6-
8 hours before general anesthesia, the patient may also become relatively dry
and poorly
perfused so that heat distribution by their circulation is further impaired.
Finally, although steps
may be taken to avoid it, un-warmed anesthetic gases and intravenous infusions
may also add to
the reduction of core temperature.
[025] At step 110, the patient is prepared for surgery: This involves
preparing the patient's skin
area for surgical incision by using an antiseptic solution to help reduce
infection. Further heat
loss from the patient's body may occur. Next, draping the patient occurs at
step 112. During
this stage, the patient's incision area is isolated and exposed for surgery,
while the remainder of
the body is typically covered with sterile drapes. These sterile drapes are
normally made of thin
polypropylene material providing minimal heat loss prevention while the
primary purpose is to
provide a sterile environment to reduce infection during the surgery.
[026] At step 114, surgery starts. Depending on the procedure, surgery may be
short or last
several hours. Again, additional heat loss from the patient's body may occur.
At step 116,
surgery ends.
[027] Clean up starts at step 118. The patient, sheets, coverings and
instruments are cleaned
and removed from soiling due to body fluids. At step 120, the patient begins
to emerge from
anesthesia and may be awaken by medical personnel. The patient is then moved
to a
transporting gurney at step 122 and transferred to a recovery room entering
the post-operative
area. At step 124, the patient further recovers from anesthesia.
[028] Figure 2 depicts an embodiment of the patient positioning device 10.
This device is
partially described in the "Giap patent application," which has already been
incorporated by
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reference. A top surface 24 is positioned opposite a bottom surface 26. Top
surface 24 and
bottom surface 26 are formed of a flexible fabric sheet. A center section is
of a rectangular
geometry and adapted in length and width to accommodate the size and shape of
a human being.
[029] A plurality of handles 14 are coupled to the outer edge of the sheet
which allow for a safe
grip on the device when used for lifting, pulling or moving the device while
the patient is being
supported by top surface and secured. The quantity and orientation of handles
14 is not limited
by the figure as shown but is merely simplified for illustrative purposes.
Bottom surface 26
which is exposed, may be formed of any low friction material as would occur to
those skilled in
the art including but not limited to one or a combination of materials from a
group including
PTFE impregnated or coated fabric, spunbond or other fabric when woven or
formed has a
slippery surface, or fabrics such as rip-stop or micro fiber-based materials
woven or knitted from
woven nylon, or polyester. The slippery bottom surface 26 may be sewn or
laminated or coated
to device 10 or on the opposite side of the material forming top surface 24.
[030] Figure 2 also shows two disengaged padded substrates 16 which have a
layer of padding
imbedded or engaged such that when engaged around the arm of a patient, a
means to pad the
arm is provided. This protects the patient's arm from any pressure forces
imparted by the table
or by a surgeon. Padded substrates 16 also are configured to engage around the
arms of the
patient, and hold them against their body and slightly elevated from the
underlying table or
support surface. This helps eliminate injury to the patient's arm when it is
supported on a hard
table surface for a long duration by placing a gap between the table and arm.
[031] The back surfaces of padded substrates 16 have strips of hook and loop
fasteners for
securing. Straps 40 have hook and loop fasteners for securing to padded
substrates 16 when
padded substrates 16 are wrapped around a patient's arm. In an example
embodiment of the
invention, an overlap system may be employed to further secure and elevate the
patient's arms.
The overlap system employs a flexible, rectangular overlap substrate 18
oriented lengthwise
across the width of top surface 24 and attached to top surface 24. The bottom
surface of overlap
substrate 18 has strips of hook and loop fasteners which fasten to the hook
and loop fasteners on
the padded substrates 16 when engaged. Overlap substrate 18 provides a
secondary means to
secure the patient's arms. Furthermore, a first and second flexible substrate
forming legging 52
and legging 54 are shown.
[032] Figure 3A depicts another embodiment of the patient positioning device.
This
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embodiment is simpler than the embodiment of Figure 2 and focuses on the leg
support. A
planar sheet has a first and second side edge and a top surface 24. This sheet
is configured for
positioning a patient thereon where the patient is supported by top surface 24
with the first and
second side edges adjacent to the legs of the patient. A first and second
flexible substrate
capable of wrapping around an adjacent leg of a patient, thus creating a
wrapped engagement,
are detailed as legging 52 and legging 54. These wrapped engagements of the
legs prevent heat
loss during pre-surgery, surgery, post-surgery or transport and protect
against pressure injury.
[033] Legging 52 is mostly covered by legging 54 until it is engaged with the
patient's leg. For
example, more than 50%, 60%, 70%, 75%, 80%, 90% or 95% of legging 52 may be
covered by
legging 54. Referring to figures 2 and 3A, to use the patient positioning
device in one
embodiment, the patient is positioned on top surface 24. Optional padded
substrates 16 are
configured to engage around the arms of the patient, and hold them against
their body and
slightly elevated from the underlying table or support surface. This helps
eliminate injury to the
patient's arm when it is supported on a hard table surface for a long duration
by placing a gap
between the table and arm. Padded substrates 16 are wrapped around a patient's
arms and
secured with strips of hook and loop fasteners and straps (described in more
detail in "Giap
patent application").
[034] Legging 52 and legging 54 are configured to engage around the legs of
the patient to
protect the patient as well as prevent heat loss. Once the patient is
positioned on top surface 24,
the user would grasp and lift free edge 64 (see figure 3A) of legging 54
wrapping this flexible
substrate around, e.g., over and then under, the adjacent leg, creating a
wrapped engagement (see
figure 6). Fasteners such as hooks of a hook and loop (e.g., Velcro ) may be
located on the
underside of legging 52 and legging 54 at respective free edges 62 and 64 (see
figure 3A) while
loops from a hook and loop fastener (e.g., Velcro ) may be located on the
topside of legging 52
and legging 54 at respective attached outer edges 58 and 60 (see figure 3A).
[035] The use of these leggings is practical when the patient is in a
lithotomy position (i.e.
when the legs are placed in stirrups, see figure 4) thus involving the pelvis
and lower abdomen
such as during colon or genitourinary surgery. In one embodiment, legging 52
and legging 54
may be padded for protection from pressure injury that may occur due to the
medical devices
such as stirrups. Some studies have found a significant relationship between
prolonged surgical
procedures with the patient in the lithotomy position and a circulatory
complication. This
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condition occurs when increased tissue pressure within a limited tissue space
compromises the
circulation and function of the contents of the space. Nerve injury to the
femoral or peroneal
nerve is also possible. Padding may be imbedded or engaged in the entire
legging 52 and
legging 54 or only in certain areas, such as in the area of contact to the
knee joint, calf and/or
ankle.
[036] Referring to figure 3A, the lower portion of top surface 24 is the area
of attachment for
legging 52 and legging 54. These are substantially planar and integral with
the sheet and
attached at a top edge 66 of legging 52 and legging 54 to top surface 24.
Legging 52 is also
attached at an outer edge 58 of top surface 24 while legging 54 is attached at
an outer edge 60 of
top surface 24. These attachment areas 68 may be continuous along the entire
outer edge as
shown in figure 3B or may be non-continuous as shown in figure 3C. Also, the
attachments may
be permanently attached such as by sewing, or temporarily attached such as by
hook and loop
fastener (e.g. Velcro ) allowing adjustability. In one embodiment, legging 52
and legging 54
may be constructed from a material that is perforated 70 and disposable. In
this way, the
leggings may be easily, conveniently and completely removed from top surface
24 and thrown
away. Figure 5 illustrates this embodiment.
[037] Figure 6 illustrates an embodiment of the present invention with a
patient supported
thereon. The patient positioning device 10 is utilized to position, protect
and secure a patient on
a support surface for transfer to another support surface or for preparation
for surgery. In
different embodiments, it may function as a regular bed sheet, a surgical bed
sheet, leggings or
any combination. To utilize the legging feature, after the patient is
positioned and secured on the
sheet, legging 52 and legging 54 may be engaged. To do this, an unattached
edge, or free edge
64 of legging 54 is lifted and wrapped around, i.e., over and then under, the
adjacent leg, and
then fastened. Legging 52 is constructed in the same manner but using free
edge 62 of legging
52.
[038] Figure 7 illustrates another embodiment of the patient positioning
device with the legging
wrapped engagements. In this embodiment, legging 52 and legging 54 are loosely
fitted on the
legs of the patient. In this manner, any necessary medical devices such as leg
compression
devices, could be used when legging 52 and legging 54 are engaged.
[039] To fasten legging 52 and legging 54, fasteners 56 such as hooks from a
hook and loop
fastener large or small (e.g., Velcro ) are located on the underside of
legging 52 and legging 54
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at respective free edges 62 and 64 while loops from a hook and loop fastener
(e.g., Velcro ) are
located on the topside of legging 52 and legging 54 at respective attached
outer edges 58 and 60.
Fasteners 56 are accessible when respective legging 52 and legging 54 are in
the wrapped
engagement with a respective leg.
[040] Figure 8 depicts an embodiment for fasteners for the patient positioning
device showing a
plurality of fasteners. The quantity and orientation of fasteners 56 is not
limited by the figure as
shown but is merely simplified for illustrative purposes. In one embodiment,
fasteners 56 are
non-continuous. This allows access to the leg of the patient for medical
equipment such as
cables and tubes or for monitoring.
[041] Forced warm-air technology is active patient warming and is associated
with normalizing
the patient's body temperature. This helps to maintain body temperature and
prevent
hypothermia. A forced air warming system is a medical electrical device used
to help keep
patients warm during anesthesia and surgery. The device typically comprises a
reusable
controller and disposable, single-use blankets. Using forced-air warming may
reduce time in
recovery and reduce patient shivering thus improving patient comfort and
satisfaction.
[042] The blanket used in a typical forced air-warming system is double
layered and inflates in
operation. The patient contact surface is permeable to air and the warm air
exits the blanket and
moves over the patient's skin and transfers heat to the patient by convection.
The blankets are
bulky and require storage space. Other methods for keeping the patient warm
may be used as
well.
[043] Forced warm-air technology may be utilized with the present invention
when the lower
portion of the patient positioning device is configured with legging 52 and
legging 54. In
different embodiments, small openings, holes or channels may be placed in
legging 52 and
legging 54 to allow forced warm-air to penetrate through the openings and onto
the patient's
skin. In this manner, using forced warm-air may warm the patient or may help
maintain body
temperature thus preventing hypothermia. Also, a blanket may no longer be
required when using
the device because legging 52 and legging 54 may provide the warming function.
[044] Figure 9 shows optional windows 72 on padded substrates 16. Windows 72
in the
padded substrates 16, which wrap around a patient's arms, are created for the
purpose of passing
through medical lines such as blood pressure cuff tubing, pulse-oximeter
cables, and/or
intravenous lines. These windows are also used for viewing the patient's arm
without having to
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unwrap padded substrates 16 from the patient's arms. In one embodiment, window
72 are
openings in padded substrates 16. In another embodiment, window 72 consists of
a flap of
material attached permantently on one side. In yet a further embodiment,
window 72 consists of
a flap of material temporarily attached on one or more sides such as with
hook/loop Velcro .
The amount of windows may vary and the number shown in figure 9 is for
illustration purposes.
[045] The initial position of legging 52 and legging 54 before the wrapped
engagement is flat to
top surface 24 as shown in figure 2. Referring to figure 2, the position of
padded substrates 16
for the patient's arms, along with legging 52 and legging 54 for the patient's
legs, may be
adjustable by using attachment areas 68, for example, hook/loop Velcro
placement on top
surface 24. This allows the device to accommodate a wide range of different
patient sizes. Also,
padded substrates 16 for the patient's arms may be perforated 74. In this way,
the padded
substrates 16 may be easily, conveniently and completely removed from top
surface 24 for
disposal.
[046] While the specification has been described in detail with respect to
specific embodiments
of the invention, it will be appreciated that those skilled in the art, upon
attaining an
understanding of the foregoing, may readily conceive of alterations to,
variations of, and
equivalents to these embodiments. These and other modifications and variations
to the present
invention may be practiced by those of ordinary skill in the art, without
departing from the spirit
and scope of the present invention, which is more particularly set forth in
the appended claims.
Furthermore, those of ordinary skill in the art will appreciate that the
foregoing description is by
way of example only, and is not intended to limit the invention. Thus, it is
intended that the
present subject matter covers such modifications and variations as come within
the scope of the
appended claims and their equivalents.
