Note: Descriptions are shown in the official language in which they were submitted.
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APPARATUS FOR SECURING A PATIENT ON AN ORTHOPEDIC SURGICAL
TABLE PLATFORM
TECHNICAL FIELD
[00011 The present invention relates generally to the field of medical devices
for use in the
surgical theater, and more particularly to an apparatus for securing a patient
on an orthopedic
surgical table platform and a method of using such an apparatus to move
patients more
ergonomically to facilitate a surgical procedure.
BACKGROUND ART
100021 Current pad systems such as the "Pigazzi Pad" disclosed in U.S. Patent
No. 8,464,720
B I; the Ocean Breeze Pad by Prime Medical; and many other similar pads
offered in the
surgical market space; rely on either securing a viscoelastic pad via the bed
rail system by
means of hook and loop fastener based systems, or using the pad's viscoelastic
surface along
with the patient's weight to keep the pad from sliding. These systems are
designed to keep the
pad and the patient from sliding during surgical bed positioning changes, most
commonly the
Trendelenburg (head down) surgical position. This angled Trendelenburg
position may range
from 0 to 40 degrees. As with current viscoelastic pad systems, standard draw
sheets (both
woven and nonwoven materials) are then placed under the patient to either move
the patient or
to keep the patient's arms in place at the patient's side. It is important to
note that these draw
sheets can minimize full contact surface between the patient's back (skin) and
the pad or gel
surface increasing the risk or possibility for patient slippage or drifting in
gravity dependent
positions. This result is due to a reduction in contact between the
viscoelastic pad and the
patient's skin resulting in less friction or impression/residual compression
needed to keep the
patient in a static position. These risks are compounded with each increase in
the angle of the
Trendelenburg position.
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[0003j One problem with existing pad or gel based systems is that once they
are secured to
bed rails, the existing systems are not easily moveable, especially when under
the weight of the
patient. They are fixed in their location once secured. This limits ease of
movement of the
patient to an optimal surgical position once the patient is settled into the
pad system and
secured. Due to the lack of easy and ergonomic movement of patients placed
upon these fixed
surfaces, providers are routinely forced to place the patient in a less than
optimal position for
anesthesia airway access needed for direct laryngoscopy, a necessary
requirement for general
anesthesia. Providers either place short patients more proximal to them for
optimal airway
access, or place patients farther down the table away from them, to minimize
the repetitive
lifting of patients under general anesthesia.
100041 Because most pads are fixed and secured via hook and loop fastener
straps, providers
must physically and bodily lift the patient off of the semi adhesive pad/gel
systems in order to
move the patient into the correct bed position required for surgery. In the
disclosure of the
Pigazzi patent (U.S. Patent No. 8,464,720 B 0this is performed via the "cloth-
like" draw sheet,
which is also used to facilitate arm adduction. The draw sheet included in
many viscoelastic
foam packs is made of a paper/cloth like material and often lacks full
strength to facilitate
movement of the patient by providers when positioning changes are required.
The providers
must routinely grab bodily portions of the patient's torso in contact with the
pad in order to
move the patient down. It is fairly common in practice to see the pad move or
bundle under the
patient as larger patients cannot be fully elevated off of the pad thereby
dragging the pad with
the patient. This foam or gel bundling can lead to pressure points that may
lead to injury (e.g.,
pressure-related skin injuries).
100051 Another issue with viscoelastic or memory foam is that the temperature
at which a
memory foam retains its properties is limited. If it is too cold, the memory
foam will harden.
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If it is too hot, the memory foam will act like conventional foams, easily
springing back to its
original shape.
11:10061 Routine movement and methodologies for moving patients on these
pad/gel based
systems begin to fail, especially during the care of moderate to morbidly
obese patients. Rising
obesity rates in the United States also place significant ergonomic safety and
injury risks to
health care providers as they must routinely physically lift and move these
patients in order to
facilitate certain surgical procedures. The healthcare industry faces a
problem with a lack of
products focused on improving methodologies and practices that facilitate less
variance and
safe care strategies, i.e., process improvements required for surgical
positioning. The industry
also lacks products designed to provide safer and more ergonomic processes for
moving
patients, which can be a key contributor to musculoskeletal disorders (MSD)
and injuries
(especially involving the back) suffered by providers.
100071 Orthopedic surgical technologies are rapidly evolving in their pursuit
to improve
outcomes, while reducing time for convalescence and rehabilitation -through
the use of less
invasive surgical implant techniques. Over the last decade there has been a
huge shift from
traditional lateral hip implant insertions to anterior hip insertion of
implants.
[0008] One significant change in the industry has been through the advent of
advanced
orthopedic surgical table platforms designed specifically for anterior hip
surgical access. This
includes total hip arthroplasties, hip arthroscopies, and other open reduction
internal fixation
techniques. This also includes platforms designed to improve pelvic orthopedic
traumas. There
are many manufactures of these highly specialized surgical tables, but one of
the most prevalent
in the United States is the HANA table available from Mizuho OS1 of Union
City, California.
100091 Most hip tables require the use of a center post. This post is designed
to secure and
stabilize the patient's pelvis and to serve as a fulcrum when the legs are
pulled (and/or slightly
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rotated) in order to disarticulate the joint space needed. This fulcrum
distraction force is
measured in either pounds or Newtons. This often foam or gel padded post also
serves as a
lateral stabilizing force, especially on narrow angles surgical table
platforms like the Mizuho
OSIQO HANA* table, as well as other distal angled manufactured tables.
100101 There has recently begun a trend toward not using this post as a
primary pelvic traction
anchor due to the high potential for perineal or genital tissue pressure
injuries, as well as
injuries to surrounding tendons, muscles, and nerves, especially the pudendal
nerve.
(00111 As the legs are pulled, the patient's weight is centered on the round
post, increasing the
risk for pressure injury. This creates a "straddle" type pressure model of
force, despite the
extra padding placed. Despite the use of padding, human tissue pressure
greater than 30 mmHg
(or .6 lbs of force) can decrease capillary blood, thus increasing the risk of
tissue, nerve, and
vascular ischem ia.
100121 Having a post may be desirable from a patient safety perspective, as
the table is narrow
and angled distally to allow for surgical access needed for joint insertion
and fluoroscopy (X-
ray) needed to guide implant selection and placement. Accordingly, there is a
need for an
improved system to be used with a post.
[00131 Most existing foam technologies currently used for gravity dependent
stability or force
pulled distraction are made up of 1-3 inches of foam with straps sewn or glued
into the foam
substrate. This creates laxity within the material when under the sheer stress
of gravity or
during extremity distraction. This can impact stability on the table, and
perioperative
fluoroscopy (X-ray) as the patient's movement from tearing or elongation, of
even just a few
inches, impact time and efficacy of fluoroscopy (X-ray). What is needed is a
pad assembly that
will provide the friction needed to stabilize patient's during joint
distraction, with or without
the post (at low distraction force pound or Newtons), while maintaining the
utility of movement
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needed to facilitate both general and regional anesthesia techniques for
anesthesia and surgical
staff.
BRIEF SUMMARY OF THE INVENTION
100141 The present invention meets the above described need by providing a
device that
allows the post to be placed during loading, surgical preparation, and
surgical de-draping prior
to movement to post-operative stretcher or bed_ It may also be used on certain
patient
populations if the patient were extremely thin or large. The design of the
foam overlay on the
post is designed to achieve the level of stability needed, while reducing the
"straddle" pressure
needed to minimize inertia of force against the round post during distraction.
100151 With parenthetical reference to the corresponding parts, portions or
surfaces of the
disclosed embodiment, merely for the purposes of illustration and not by way
of limitation, the
present invention provides an apparatus for positioning a patient on a
surgical table. The
apparatus includes a base (203) having a top surface (500). The base (203) has
a plurality of
handles (206a-c; 207a-c) attached thereto. A foam top (72) is fixedly mounted
to the top
surface (500) of the base (203) to form a pad assembly (69). The foam top (72)
has an upper
surface (75) and a lower surface. The lower surface is disposed on the base
(203).
[00161 At least one strap (306, 309) is attached to the pad assembly (69).
100171 The pad assembly (69) is configured to prevent bunching when lifting or
repositioning
the patient during surgical table positioning changes required during surgery.
The reinforced
pad assembly (69) is configured for movement in multiple directions during
surgery.
100181 In another aspect, the foam top (72) comprises a pneumatic foam. The
foam top (72)
may also comprise a polyurethane foam.
[0019] In another aspect of the invention, the base (203) may comprise a
plurality of layers of
a nonwoven material.
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[00201 In yet another aspect of the invention, the pad assembly (69) may
further comprise a
reinforcing sheet (200) disposed between two of the layers of the base (203).
100211 The reinforcing sheet (200) may comprise a condensed foam or a
biodegradable
cardboard.
[00221 In another aspect, the apparatus may also comprise a post overlay (106)
disposed on the
upper surface (75) of the foam top (72). The post overlay (106) may have at
least one concave
side wall (115, 118).
100231 In another aspect of the invention, the front wall (109) of the post
overlay (106) is
concave.
1002.41 The bottom edge (127) of the side wall (118) may be longer than the
top edge (130) of
the side wall (118).
100251 The front of the side wall (115, 118) may curve upward from the bottom
end to the top
end.
[0026] In yet another aspect of the invention, the post overlay (106) has a
front wall (109)
that is concave and has a reduced width in the middle due to concave side
walls (115, 118).
100271 The post overlay (106) may comprise a polyurethane foam. The foam may
comprise a
polyurethane foam having 1.8-6 PG density with a 24-45 ILD (indentation load
deflection).
[00281 The post overlay (106) has a bore (124) defined therein. The bore (124)
may be
configured to receive a post (45) mounted on an orthopedic table.
100291 The strap (306, 309) may further comprise hook and loop fasteners
(311).
100301 The strap (306, 309) may be configured to wrap around a bed rail.
[00311 A strap (318) may be configured to extend across a narrow end of an
anterior hip table.
[0032] ln another aspect of the invention, a post overlay (106) may be
configured to mount
over a post (45) on a surgical table platform (30). The post overlay (106) may
comprise a body
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(121) bordered at least in part by a front wall (109) and a pair of side walls
(115, 118). The
body has a bore (124) defined therein configured to receive the post (45).
[00331 The side walls (115, 118) have a concave surface. The front wall (109)
also has a
concave surface.
100341 In yet another aspect of the invention, the present invention provides
an apparatus for
positioning a patient on a surgical table. The apparatus comprises a base
(203) having a top
surface (500). The base (203) has a plurality of handles (206a-c; 207a-c)
attached thereto.
[0035] A foam top (72) is fixedly mounted to the top surface (500) of the base
(203) to form a
pad assembly (69). The foam top (72) has an upper surface (75) and a lower
surface. The
lower surface is disposed on the base (203).
100361 At least one strap (306,309) is attached to the pad assembly (69).
[0037] A post overlay (106) is operatively associated with the upper surface
(75) of the foam
top (72). The post overlay (106) has concave side walls (115, 118) and a
concave front wall
(109) facing the genital area of a patient.
[0038] The pad assembly (69) of the present invention is configured to prevent
bunching when
lifting or repositioning the patient during surgical table positioning changes
required during
surgery, and the reinforced pad assembly (69) is configured for movement in
multiple
directions during surgery.
[0039] The foam top (72) comprises a pneumatic foam.
[0040] The apparatus of the present invention improves and optimizes clinical
efficacy, time,
staff utilization, and safety for both patients and staff. The pad system
facilitates
standardization of care by creating less variance during use, while serving to
improve safety
for providers during ergonomic weight bearing physical movements routinely
required during
surgical positioning.
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[0041] The apparatus of the present invention provides a standard approach to
moving
patients during routine and well known surgical procedures requiring
positioning changes
while securing the patient by means of a unique material reinforced foam pad
using a non-
residue pressure sensitive adhesive ('NA') system.
[0842] The apparatus of the present invention reduces or eliminates the need
to pick the
patient off of a viseoelastidgel-based pad via either the "draw sheeC' or
awkward manual
bodily lifting methodologies conducted by the staff.
[0043] Instead, the apparatus of the present invention provides a fully
moveable system that
moves both pad and patient and even helps transfer the patient to a post-
operative stretcher,
which also aids ergonomic processes inherent in surgical care.
[0044] The present invention incorporates a handled lift and slide utility to
serve as an extended
utility to this platform. The antiskid (or friction) Pneumatic (PNEUMAFOMM)
foam top
provides the necessary resistance and friction required when pulling to
dislocate the hip joint.
The foam top also provides traction and stability when moderate tifting of the
table or
Trendelenburg (head down) is used to improve distraction.
[0045] It is always a necessary requirement to lift and move anesthetized
(spinal, epidural, or
general anesthesia) patients from the patient stretcher after insertion of
regional anesthesia, or
after the induction of general anesthesia, to the orthopedic table. It is also
required to move the
patient, if applicable based on the surgical table's design, up to 1-2 feet to
the distal end of the
table to facilitate the procedure. This movement is usually performed by staff
lifting a patient
by hand and sheet. This procedure is why the ability to move both patient and
friction pad are
important. It serves to improve staff ergonomics, facilitate anesthesia
technique (general,
regional, or combined), and to stabilize the hip or fracture, as it reduces
the traditional patient
handling methodologies require to roll and turn patients in order to move
them.
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[0046J While there may be hover assist devices to move patients from lateral
to lateral surfaces,
they were not designed to withstand gravity dependent forces, as the
structural fabric against
the mattress top is a low friction surface. They are also oversized and most
of these tables are
consolidated in their design to facilitate exposure to the hip. None of them
are meant to be kept
under patients undergoing gravity dependent rotations of the surgical table,
or during forced
distraction of the hip by pulling one portion of the lower body, while the
main part of the
patient's body (torso) is secured via friction or a perinea! post. This
reality increases the risk
of sliding in gravity dependent bed changes or when the body is pulled a
contralateral direction.
These tables are usually very narrow, and any oversized movement assist device
would get in
the way of various accessories required for surgical access and manipulation.
10047] Thehandled lift pad utility of the present invention helps improve the
ergonomic patient
handling and positioning of patients over the standard and historic use of
moving patients by
hand and lift sheet, especially when caring for obese patients, or those
patients with hip
fractures. The current embodiment can be placed under the patient when
regional anesthesia
(spinal, epidural, and combined) is used on the patient stretcher, thus
allowing safer ergonomic
transfer of patients to the table after regional, sedation, or general
anesthesia is performed, as
patients cannot be placed on these narrow tables before these anesthesia
processes due to the
table size, or when the tables accessories are not utilized correctly.
10048] The supportive non-woven structure of the pad assembly of the present
invention allows
for the device to be anchored onto the table via two methods, a set of
bilateral straps at the
upper end of the pad are secured to the surgical bedrail and either the distal
end of the table's
rail structure, or around the narrow angle of specialty tables. The lower end
of the pad may also
be anchored via an optional post insertion placed proximal the structure of
the foam pad lift
system distal end. A tear away foam structure may accommodate this post
insertion.
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structure provides a
stronger and more reinforced fixed anchor to the table, than a foam pad alone.
This allows
greater degrees of force stabilization needed for disarticulation and gravity
dependent forces
that would normally stretch/elongate, or tear the pad.
100501 The accessory post design of the present invention also has a unique
foam design utility,
one that provides greater resistance, when combined to the opposing friction
force of the
PNEUMAFOMS top, during distraction when forces of greater than 1501bs of force
are used.
This provides additional resistance and sheer needed to maintain traction
against the perineal
post that serves to minimize tissue injury secondary to sheering and sliding
against the fixed
post imbedded into foam material overlay. The unique non rounded radius of the
post overlay
accommodates male and female genitals to reduce pressure into a normally
rounded surface
area (straddling).
100511 The foam pad is made of polyurethane or other types of fast recovery or
compressible
foam needed to provide some degree of traction and support. The most
predominant of these is
non "memory foam" or "viscoelastic" in origin or ingredients. The density is
set to provide
adequate cushioning needed to reduce pressure injuries, as most current
viscoelastic foams
"bottom out" when subjected to heavy patient and bony skeletal structures such
as the scapula
and sacrum, as they are only 1-3 inches on average. The foam is temperature
stable and not
subject to the "glass transition" or hardening viscosity clue to cold
operating room
environments. It does not impede grounding during cautery and is readily
radiolueent.
100521 The post overlay design fits over the standard perineal post on any
anterior hip table in
the industry. It may be made for posts with an external diameter of 2-6
inches. The design is
unique to the procedure use and utility of the post.
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[0053] The foam overlay fits over and secures the distal end of the pad and
table to stabilize
the patient. The post also provides a fulcrum of stability and resistance
during hip joint
distractions of 80-300 lbs. of force, as the legs are manually or mechanically
pulled via the
table's leg accessory traction devices. These posts are typically round.
[0054] When the legs are pulled, two forces happen. Once force moves the
patient into the
post. This is where post stability provides a mechanical fulcrum needed to
distract the hip joint.
Then the leg is pulled, the other leg is usually fixed it to place, but in
some systems this may
not provide enough retraction to overcome the contralateral shifting of weight
or the patient to
towards the side being pulled. This can impact X-ray and fluoroscopy needed to
identify the
distraction. In essence, instability creates a moving target of a few inches.
This can force
movement of X-ray repetitively during the procedure.
The underlying pneumatic (PNEUIVIAFONM) friction pad will also greatly reduce
the
amount of overall force and inertia into the underlying post.
[0055] The lower edge of the post overlay is elongated to restrict the
patient's movement at the
surface of the pad. As it rises, it further restricts forward movement into
the post. The concave
cuts are designed to accommodate and restrict the amount of force against the
patient's perineal
and genital tissue. Typical round post foam pads do not make space for the
genitals.
BRIEF DESCRIPTION OF THE DRAWINGS
[0056] FM. I is a perspective view of an orthopedic surgical table platform
designed
specifically for anterior hip surgical access.
[0057] FIG. 2 is a perspective view of a pad assembly disposed on the upper
surface of an
orthopedic surgical table platform.
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[00581 FIG. 3 is a perspective view of a pad assembly and a post overlay on a
standard
surgical table.
[00591 FIG. 4 is a top perspective view of a post overlay of the present
invention.
[0060] FIG. 5 is a perspective view of the post overlay
of FIG. 4.
100611 FIG. 6 is a top perspective view of the post
overlay of FIG. 4.
100621 FIG. 7 is a side elevational view of the post
overlay of FIG. 4.
100631 FIG. 8 is a rear elevational view of the post
overlay of Fla 4.
100641 FIG. 9 is an exploded perspective view of the pad assembly of the
present invention.
100651 FIG. 10 is a top perspective view of a first embodiment of the pad
assembly.
100661 FIG. 11 is a bottom perspective view of the embodiment shown in FIG.
10.
100671 FIG. 12 is a top plan view of the base prior to mounting the foam top.
100681 FIG. 13 is a bottom plan view of an alternate embodiment of the base.
100691 FIG. 14 is a top plan view of an alternate embodiment of the base prior
to mounting
the foam top.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
100701 At the outset, it should be clearly understood that like reference
numerals are intended
to identify the same structural elements, portions or surfaces consistently
throughout the several
drawing figures, as such elements, portions or surfaces may be fiirther
described or explained
by the entire written specification, of which this detailed description is an
integral part. Unless
otherwise indicated, the drawings are intended to be read (e.g., cross-
hatching, arrangement of
pails, proportion, debris, etc.) together with the specification, and are to
be considered a portion
of the entire written description of this invention. As used in the following
description, the
terms "horizontal", "vertical", "left", "right", "up" and "down", as well as
adjectival and
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adverbial derivatives thereof, (e.g., "horizontally", "rightwardly",
"upwardly", etc.), simply
refer to the orientation of the illustrated structure as the particular
drawing figure faces the
reader. Similarly, the terms "inwardly" and "outwardly" generally refer to the
orientation of a
surface relative to its axis of elongation, or of rotation, as appropriate.
100711 Referring to FIGS. 1-18 generally, and initially to FIG. 1, an
orthopedic surgical table
platform 30 such as the RANA brand table available from Mizattho Os! of Union
City,
California, has a first end 33 and a second end 36 disposed opposite from the
first end 33. The
platform 30 is wider at the first end 31 and gradually narrows inward from
opposed sides 39,
42 until it reaches the second end 36. A cylindrical post 45 may be disposed
in spaced apart
relation from the second end 36. The post 45 may extend for a relatively short
distance above
a top surface 48 of the surgical table platform. The top surface 48 may be
planar as shown. In
use, a patient may be supported on the top surface 48 such that the torso
extends downward
and each leg of the patient may be disposed on opposite sides of the post 45.
The legs of the
patient may extend to foot support 51 that may be supported by elongate
members 57 and 60
extending from the base 63. A foot support 51 may be adjustably mounted on
both elongate
members 57, 60 as shown in connection with member 60 in the drawing. The base
63 supports
the elongate members 57 and 60 and provides for adjustment of the elongate
members 57, 60
in multiple planes. The base 63 also supports the platform 30 and top surface
48. The base 63
may also be provided with casters 66.
100721 Turning to FIG. 2, a pad assembly 69 of the present invention may be
supported on
the top surface 48. The pad assembly 69 has a foam top 72 with a planar
surface 75 that
supports a patient undergoing a procedure on the platform 30. As shown the
foam top 72 has
a shape that conforms to the shape of the top surface 48 with a bottom portion
78, opposed side
portions 81, 84, and a top portion 87. The top portion 87 is formed by two
inward angled
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sections 90 and 93 that provide for a truncated top portion 87 that provides
room for the post
45 (FIG. 1). The pad assembly 69 is described in greater detail herein.
100731 In FIG. 3, an alternate embodiment of the pad assembly 69 is shown. Pad
assembly
100 may be mounted on a standard rectangular shaped surgical table 103. A
standard bed rail
106 extends from the side of the table 103. A post 45 and post overlay 106 are
shown at one
end of the table 103. The components of the pad assembly 100 and post overlay
106 are
described in greater detail herein.
100741 Turning to FIG. 4, the post overlay 106 may be constructed of a
resilient, flexible
material that provides cushioning to prevent injuries when the body of the
patient contacts the
post 45 during a medical procedure. The foam may comprise a polyurethane foam
having 1.8-
6 lb density with a 24-45 ILD (indentation load deflection) range. Other
flexible foam materials
may also be suitable. The post overlay 106 has a front wall 109, a rear wall
112, and opposed
side walls 115, 118. The post overlay 106 has a central body portion 121 with
an opening 124
defined therein. The opening 124 has an inside diameter sized to mate with the
outside
diameter of the post 45. Other shapes for the opening 124 and the post 45 may
also be suitable
as will be evident to those of ordinary skill in the art based on this
disclosure.
(0075] In FIG. 5, the side wall 118 is concave. The side wall 115 on the side
opposite from
side wall 118 is also concave. The front wall 109 is also concave. The front
wall 109 is widest
as the top 140 and the bottom 143 and is narrower in a mid-portion 146.
Accordingly, the front
wall 109 has an "hourglass" shape with inward curves at the top and bottom and
in the middle.
100761 Turning to FIG. 6, the rear wall 112 may be substantially flat and is
straight at the top
edge 150 and bottom edge 153. The sides 156, 159 of the rear wall 112 are
curved inward.
The opening 124 for the post 45 extends from the top surface through the
entire height of the
post overlay 106. The front wall 109 is concave.
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100771 In FIG. 7, the side wall 118 is shown in greater detail. At the bottom
edge 127, the
side wall 118 has a length Li that is greater than the length L2 of the top
edge 130. The rear
133 of the side wall 118 is substantially vertical and is oriented at
approximately ninety degrees
with respect to the top and bottom edges 130, 127 of the side wall 118. The
front of the side
wall 118 curves from the bottom edge 127 to the top edge 130.
[0078] In FIG. 8, the rear wall 112 is best shown. The side walls 115, 118
curve inward from
the top edges to the bottom edges along an arc.
[0079] The design of the post overlay 106 provides space to accommodate the
genital area
thereby reducing the overall pressure into the post 45 as it relates to
genital tissue. The lateral
concave surfaces of the side watts 115, 118 accommodate the legs when
adducted, or during
any crossover movements required to help with joint distraction. The ILD and
makeup of the
foam pad 72 provides the necessary force deflection to minimize tissue
pressure while
absorbing inertial forces into foam instead of the post 45 in contrast to
typical round overlays.
When combined with the underlying movable friction foam pad option, the
overall inertia into
the post 45 is greatly reduced over standard reliance on either post overlay
or foam pad alone.
[0080] Referring to FIG. 9, the pad assembly 69 of the present invention is
shown in an
exploded view. The pad assembly 69 may comprise three main components
including the foam
top 72, a reinforcing substrate sheet 200, and a base 203.
100811 The foam top 72 provides a support surface for the patient. The foam
top 72 may be
constructed of a polyurethane foam referred to as a pneumatic foam. A fast
recovery,
compressible and resilient foam is used to provide a high degree of traction
and support at
distraction pressures of 5-300 tbs of force pulled via manual or mechanical
pulling of the lower
extremities. Pneumatic foam having an optimized ILD (indentation load
deflection) to restrict
"bottoming out" provides resilient rebound needed to protect skin and tissue
integrity in cold
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operating room environments is provided. Most viscoelastic memory foams
collapse greater
than or equal to 70-98% due to their ILD when patient weight is added, and
provide slow
rebound due to changes in foam viscosity in cold operating room environments.
The foam top
72 of the present invention may comprise a pneumatic foam that is a foam that
remains flexible
at low temperatures in contrast to memory foam.
The foam remains flexible at low
temperatures because of its conventional foam chemistry (non-viscoelas-tic).
The foam
improves pressure reduction in cooler environments like the operating room and
can function
without efficacy loss across a temperature gradient of 0 to 100 degrees F. The
foam may
comprise a polyurethane foam with the following ingredients: polyether, polyol
MIDI, water,
silicone, surfactant, amine, catalyst blue and pigment. The pneumatic foam is
a polyurethane
foam available by product number HRIZ122508UM from Rogers Foam Corporation in
Somerville, MA. The foam may have a density of 2.35-2.65 pounds per cubic foot
(PCF). The
foam has 25% IFD (15x15x9) of 1217. Additional properties include: Tensile
ps1=6 (mm.);
Elongation %=120 (min); Tear, ppi=0.5 (min); Comfort factor =1.6 (min);
Hysteresis %=25
(max); and ball rebound 20-25%.
[0082] The base 203 may be made of a sturdy, flexible material. The material
may be a
nonwoven layered material such as SMS (spun-melt-spun), similar celluloid
material, or the
like. The base 203 is also provided with a plurality of handles 206a, 206b,
206c, and 207a,
207b, and 207e extending outward from the sides 209,212 of the base 203. The
handles 206a-
c and 207a-c may be formed by loops of material attached to the sides 209, 212
of the base
203. The handles 206a-c and 207a-c are sized to receive the hand of a provider
such that a
provider on each side of the device can grasp the handles 206a-c or the
handles 207a-e with
their hands in order to move the base 203 along the length of the surgical
table to position and
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re-position the patient as necessary during a surgical procedure.
Alternatively, two providers
on each side can each grab a handle 206a-c or 207a-e to move heavier patients.
100831 The reinforcing substrate sheet 200 provides additional structural
support for the pad
assembly 69. The reinforcing substrate sheet 200 may be constructed of a
condensed foam or
biodegradable cardboard piece that may be inserted between layers of the
nonwoven material
that comprise the base 203.
[0084i The foam top 72 may be attached to the base 203 by pressure sensitive
adhesive or
spray adhesives or any other attachment method as will be evident to those of
ordinary skill in
the art based on this disclosure. A high friction polyurethane or pneumatic
foam top 72 is
joined to the nonwoven base via spray adhesive or pressure sensitive adhesive.
All of the
adhesives are FDA approved.
[00851 The pad assembly 69 with a pneumatic foam top 72 is preferable to foam
by itself
because the extra support provided by the combination of the base 203 and the
foam top 72
prevents the foam from bunching up under the patient when lifting and/or
repositioning the
patient. It also allows the provider to pull back in case the patient was not
positioned correctly.
The pad assembly 69 provides structure so that the foam does not elongate,
tear, or create laxity
during distraction forces required to expose the joint.
[0086] The pad assembly 69 may be assembled and mounted by means of PSA strips
503a-
503e and 403a- 403e as described in greater detail herein.
100871 Turning to FIG, 10, pad assembly 69 has a foam top 72 that has a front
section with a
frangible portion 300 that can be removed to accommodate a post 45. The pad
assembly 69
may also be used on a table without a post 45. A pair of straps 306 and 309
extend in opposite
directions from the rear of the assembly 69. The straps 306 and 309 may be
provided with
mating hook and loop fastening surfaces 311 such that the distal end 312, 315
of the straps
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306, 309 can be inserted through a bed rail and then secured to the mating
hook and loop
fastening surface 311. For a narrow table design specific to hip procedures,
the front of the
pad assembly 69 may be provided with a strap 318 extending from one side and a
buckle 321
extending from the opposite side. At the narrower portion of the table the
strap 318 can extend
across the underside of the table and engage with the buckle 321 to secure the
pad assembly 69
to the platform 30.
100881 Turning to FIG. 11, a bottom surface 400 of the pad assembly 69 may be
provided
with a plurality of strips of pressure sensitive adhesive ("PSA") 403a, 403b,
and 403c. The
PSA strips 403a-c are configured to engage with the top surface 48 (FIG. 1) of
the platform 30,
The PSA is FDA approved, and provides for temporarily securing the pad
assembly 69 at
different locations on the top surface 48 of the platform 30.
100891 In FIG. 12, the base 203 is shown in greater detail. A top surface 500
of the base 203
provides a mating surface for mounting the foam top 72. As shown, the foam top
72 may be
attached, secured or fused to the base 203 by means of pressure sensitive
strips 503a, 503b,
503e, 503d and 503e. Other means for attaching the foam top 72 to the base 203
such as by
sewing, fusing, adhesives or the like may also be used as will be evident to
those of ordinary
skill in the art based on this disclosure.
100901 Turning to FM. 13, a bottom surface 600 of the pad assembly 69 may be
provided
with a plurality of areas of spray adhesive 603a, 603b, and 603c. The areas of
spray adhesive
603a-e are configured to engage with the top surface 48 (FIG. I) of the
platform 30_ The spray
adhesive is FDA approved, and provides for temporarily securing the pad
assembly 69 at
different locations on the top surface 48 of the platform 30.
[0091] In FIG. 14, another process for attaching the foam top 72 to the base
203 may include
use of a spray adhesive. The spray adhesive 550 may be applied across the
entire area of the
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top surface 500. After the spray adhesive is applied, the foam top 72 may be
secured to the
base 203 on the top surface 500 by means of the adhesive.
100921 The present invention provides many advantages. The present invention
provides
surgical providers with a pad assembly 69 to be placed under a patient (before
or after)
performing routine processes such as regional anesthesia (spinal, epidural, or
combined/CSE),
in either a sitting or lateral position, or (before or after) general
anesthesia induction and
intubation processes while on the patient's bed or stretcher. The movable
friction pad assembly
69 allows staff to safely move a patient onto a narrow anterior hip table with
better ergonomics
over traditional sheet and hand lifting. The foam pad also allows staff to
move both patient
and pad distal to the apex of the table for surgery. Next, they strap and
secure the patient.,
placing an optional post pad overlay and post between the patient's legs to
lock the system
down for security and stability for both lateral and distraction stability.
100931 The present invention provides a modular friction pad assembly made of
pneumatic
foam that is resilient and provides rebound support required for optimized
tissue management.
Pneumatic foam is not a "memory foam" and does rely on the indention of
patient weight to
hold and secure the patient during distraction. It relies on its high friction
coefficient to maintain
traction and support needed for stability. The foam is not affected to
temperature via the "glass
transition" typical of memory foams. It does not require the patient's warmth
or direct contact
to provide pressure support or relief, especially in colder operating room
environments.
Pneumatic foam does not change viscosity based on temperatures in ranges from
0 degrees
Fahrenheit to 100 degrees Fahrenheit. The foam maybe designed to overlay
distal handles
located bilaterally at the hip needed to assist safe ergonomic movement of
patients during hip
surgeries on narrow surgical tables, while protecting the integrity of the hip
during movements
to reduce tissue injury of lacerations that could potentially impact tissue
integrity and infection.
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100941 The present invention also provides a modular friction pad assembly
with handles that
allows patients to be moved post operatively onto a stretcher or inpatient
bed, thereby
improving the comfort of patient over moving the patient on a "hard" rolling
board. This creates
a seamless transition and "log-roll" stability needed for post-operative joint
stabilization.
[0095] The present invention also provides a modular pneumatic foam friction
pad with
handles that has a fast recovery of compressible and resilient foam needed to
provide a high
degree of traction and support at distraction pressures of 5-3001bs of force
pulled via manual
or mechanical pulling of the lower extremities. Pneumatic foam has an
optimized ILD
(indentation load deflection) to restrict "bottoming out", thus providing
resilient rebound
needed to protect skin and tissue integrity in cold operating room
environments, as most
viscoelastic memory foams collapse >70-98% due to their ILD when patient
weight is added,
and provide slow rebound due to changes in foam viscosity in cold operating
room
environments.
[0096] The present invention provides a modular reinforced pneumatic foam pad
assembly
with handles that has a high friction coefficient needed to hold patients in
place during hip
distraction for both hip arthroplasties and arthroscopies.
100971 The present invention provides a modular reinforced friction pad
assembly with non-
woven SMS or similar material structure fused to the friction foam pad so the
pad does not
elongate, tear, or create laxity during distraction forces required to expose
the joirtt. tligh
friction polyurethane or pneumatic foam top may be fused to the "handled" non-
woven base
via spray adhesive or high quality pressure sensitive adhesive, each made of
FDA approved
adhesives.
100981 The present invention provides a modular reinforced friction pad
assembly that does
not require a draw or lift sheet to move or transfer a patient, thereby
maximizing pad to skin
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contact needed for maximum traction and stability. Draw sheets create heavy
and poor
ergonomic lifting burdens for surgical stag as they must physically lift
patients off high
friction surfaces in order to move them effectively. This places providers at
risk for ergonomic
MSD injuries. The sheet also reduces effective pad to skin contact needed to
optimize friction
between the patient and the pad.
100991 The present invention provides a modular friction pad assembly that may
be paired with
an optional post overlay designed to restrict movement incrementally from pad
to skin surface
of the lower buttocks, while accommodating genital anatomic structures via a
concave and non-
rounded design that is gradually accentuated from top to bottom. This post
overlay design
reduces the overall force and inertia into the underlying post and accounts
for genital, vascular,
and nerve anatomy, and the special physics involved during hip joint
distraction via manual or
mechanical pulling of the legs.
[00100] The present invention provides an optional post overlay design that is
concave and
slanted from top down towards patient's perineum needed to restrict mechanical
and tissue
force into the genitals, underlying nerves, and surrounding tissue.
[00101] The present invention provides an optional post overlay with lateral
concave design
needed to support the legs during crossover distraction methods, thereby
minimizing force into
the underlying post from a lateral perspective against the thighs. The foam is
a polyurethane
foam of 1.81b-6113 density with 24-45 ILD range. The post overlay may be
paired with a
modular friction pad assembly.
1001021 The present invention provides an optional post overlay that when
combined with a
modular foam friction pad assembly, reduces the overall forces into a perineal
post by more
than either the overlay or pad assembly alone, especially when using
distraction pressures
higher than 150 lbs. of force, or when pulling lower extremities (distraction)
on thin adults that
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may have more contralateral movements during distraction due to their weight
and center of
gravity changes. The combined lateral stability of the pad assembly and
overlay may also
reduce falls in high MAI patients on narrow angled hip tables in comparison to
either product
alone.
1001031 The pad assembly of the present invention provides some friction
resistance needed
to disarticulate the joint and to reduce the amount of "straddling pressure"
into a round post.
If the post is still required to be used, the resistance decreases the amount
of bodily inertia
against the post, as the rest of the body's skin to friction contact on the
underlying material
holds traction and resists distal movement, thus minimizing perineal force
movement into the
post as the feet and legs are pulled.
1001041 The present invention may provide a hybrid approach to include a post.
As it may
be unclear how much force is required for disartieulation, and the fact that
there is no standard
agreed or accepted amount of force in the industry, the post may serve as a
minimal fulcrum
force for distraction, or more importantly lateral stabilization.
1001051 Therefore, while the presently-preferred form of the apparatus for
positioning a
patient on a surgical table has been shown and described, and several
modifications and
alternatives discussed, persons skilled in this art will readily appreciate
that various additional
changes and modifications may be made without departing from the spirit of the
invention, as
defined and differentiated by the following claims.
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