Note: Descriptions are shown in the official language in which they were submitted.
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SURGICAL FIXATION AND RETRACTION SYSTEM
Backgraund
1. Field of the Invention
This invention relates to systems and methods for fixation or immobilization
and
retraction of various anatomical and other structures dwring surgery,
including, for example,
surgical fixation and retraction of flesh, bone, feet, legs, arms, hands,
digits, surgical drapes,
and other surgical equipment.
2. Prior Art
Although elements of many new technologies have been transferred to medicine
from their original f elds, this has generally not happened in the area of
basic surgical
instruments, even though surgery still largely depends on the skill of an
individual
surgeon using these tools. Recent research and development activity in medical
equipment has been more focused on expensive procedure sets, diagnostic tools,
and life
support systems. As a result, conventional surgical fixation and retraction
devices have
changed slowly and suffer from a number of shortcomiings.
(a) Retraction
Surgical retractors are used to provide medical personnel with the ability to
hold open
an incision area. Typically, retractors are hand held or mount on a fixed
support assembly.
Restraining limbs and digits provides a particular chal:(enge for medical
personnel. Hand
surgery requires a retraction system that provides a surgeon with flexibility
and stability. For
example, a surgeon may wish to stabilize a wrist or forez~rm while adjusting
retractors around
an incision area of a hand or finger. Often critical decisions are made during
the course of the
surgical procedure that require alteration to the fixation apparatus.
Traditional retraction systems typically utilize mechanical fasteners to
provide a rigid
connection among components. Re-positioning the. retractor may require
additional
equipment to change retractive or stabilizing forces. Ad<iitional tools may
also be required to
assemble or to disassemble equipment. This presents problems because it is
difficult to add
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ar change equipment in an operating room without compromising the sterile
environment.
As a result, surgical procedures can be delayed while additional sterile
equipment is
introduced to the operating facility.
~b1 Fixation
S A variety of needs also arise in connection with surgery to fix the position
of
structures, such as surgical instruments, drapes, or a portion of a patient's
anatomy, some of
which structures "resist" repositioning or maintenance ~~f a selected
position. These needs are
conventionally addressed with adhesive, such as by use of adhesive tape, and
by use of
devices that mechanically connect or attach, such as claanps and retractors.
Another problematic shortcoming of existing fixation systems is their reliance
on
threaded or incremental adjusters. Threaded adjusters are frequently too slow
for mid-
procedure adjustment. Incremental adjusters are faste~° but often exert
too little or too much
retraction in detent positions.
Advances in surgical techniques have created the need for a fixation and
retraction
1 S system that can be manipulated by the surgeon in the course of the
procedure. This is often
necessary to provide clear and varied views (visuali~:ation) of the incision
site during the
procedure. Traditional systems and practices require; the presence of an
assistant for the
duration of the procedure to provide and adjust retraction. As a result,
procedure errors can
occur because of misunderstood verbal communication between the surgeon and
the assistant.
Thus, it is desirable for the surgeon to be able to manipulate the apparatus
and is preferable
that it be possible to do so with one hand.
(c~ Drapes
Surgical drapes cover patients during surgery to maintain a sterile
environment around
the operative site. Traditional drapes consisted of cotton polyester blend
textile similar to
2S bedsheets. Users of this traditional fabric encounter problems of poor
fluid transmission
control and virtually no containment of fluids.
In a traditional drape fixation system, pincer sstyle towel clips grasp a
surgical drape
and are secured to a patient or operating room structure with adhesive tape.
To cover a
patient with a surgical drape during a surgical procedure using the
traditional fixation system,
a user must lay a drape over the patient. Once in position, the user clasps a
portion of the
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drape with the pincers of a towel clip. Pincers have pointed tips requiring
care by users to
avoid puncturing the drape. After grasping the drape, the user must secure the
towel clip to a
surface, such as an operating room table. Typically, adhesive tape is placed
through a towel
clip loop and affixed to a surface. In some situations, drapes must be clipped
or sutured to the
patient to provide fail-safe protection.
New drape fabrics have been developed, including one introduced by W. L. Gore
using GoretexTM fabric. Use of the GoretexTM drape during a surgical procedure
offers
advaintages found in outdoor clothing such as protection against wetness.
However, new
problems are associated with use of the GoretexTM drape. Holes in the drape
resulting from
IO the pincer style towel clips destroy the desirable properties of the
membrane. It is also
undesirable to puncture such drape material with suturea.
In response to these problems, a new generation of drape clips have locking
hemostats
with large blunt surfaces to support the drape material. In addition, double
faced tapes are
available for securing drapes. However, double faced adhesive tapes lack the
ability to
adhere to the drapes effectively, particularly when attaching drapes to skin.
This problem has
led to somewhat extreme procedures such as scrubbing the patent to improve
adhesion. Thus,
current fastening methods are inefficient and unreliable, and a need exists
for a method and
system for securing a surgical drape to a skin surface without puncturing the
surgical drape.
The above-described needs and problems, which are merely exemplary,
demonstrate
that a need exists far a surgical fixation and retraction system that provides
stability while
allowing efficient, sterile, relatively effortless adjustment of the system
prior to or during a
surgical procedure.
Summary of the Inv~antion
This system utilizes table-like ferromagnetic, typically metal, base
components to
which shielded magnet components attach in order to locate movable fixation
and retraction
components or other operating theater devices, such a surgical drapes.
Ferromagnetic
material conducts magnetic flux lines and is therefore i;s attracted to, and
attracts, magnets.
Use of small, powerful rare earth magnets permits systE;m components to be
attached quickly,
easily and securely in an almost infinite number of configurations. Several
different
configurations of magnet-containing components are designed for direct contact
with
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anatomical and other structures and for attachment to elastic and metal
fixation and retraction
components. Many of the magnet-containing components resemble chess pieces and
are
symmetrical. about a longitudinal axis normal to the face of the magnet that
attaches the
component to a metal plate that serves as the base component. As a result,
only location on
the base plate matters, while rotational position relative to the base plate
and other
components does not matter. This simplifies assembly and adjustment of the
components
during use since rotational position generally does not need to be controlled.
Fixation
components in the form of such bodies of rotation are rE;adily manufactured
and are also well
adapted for use with readily available disc-shaped rare c;arth magnets. These
shapes also
facilitate magnetic flux management, which is critical in the operating
theater environment
where numerous ferromagnetic components and sensitive instrumentation may be
present.
As is demonstrated in the detailed description of illustrative embodiments of
the
invention and some of the accompanying figures, this invention is readily
usable for human
hand surgery. It may also be used in a variety of other lxuman and veterinary
surgical
Z 5 procedures with appropriate adjustment of the scale of the components to
match the
requirements of the human or animal anatomy involved.
The system is also usable for fixation of a surgical drape. One surgical drape
fixation
embodiment uses a metal cup and fixation tape to secure a surgical drape to a
skin surface by
attaching one magnet-containing structure to a skin surfvace with adhesive
tape and trapping
the drape between the magnet-containing structure and .a second magnet or
other component
attracted by the magnet-containing structure. The metal cup includes a rim for
coupling to
the fixation tape, and the second side has a recess that receives one of the
magnets. Two-
sided adhesive tape bonds the cup to a skin surface or other surface. This
embodiment gives
medical personnel the ability to secure a surgical drape to the sterilized
components of the
fixation and retraction system while providing flexibility to adjust the
position of the drape as
needed. Securing a surgical drape with this invention protects a patient from
fluid or other
contaminants during a surgical procedure.
The fixation and retraction system of this invention reduces preparation and
setup
time, providing superior control and visualization arnd resulting in
significantly reduced
procedure times. The system provides a new level of direct control minimizing
error
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from miscommunication between surgeon and assistant using powerful permanent
rare-
earth magnets. Force can be exerted and objects may 3~e adjustably positioned
during surgery
using magnetic components, permitting a broad range of applications and
component
interoperability.
Use of rare-earth magnets in medical appli~;ations is challenging. The magnets
must able to withstand autoclave temperatures and vigorous cleaning systems
without
power loss. Rare earth magnets contain iron, which requires corrosion
protection.
Normal magnet plating will not withstand repeated cleaning cycles, and
encapsulation
degrades magnetic performance. At the same tune, the magnetic strength has to
be
harnessed in a manner that captures the bipolar power while controlling the
magnetic flux
field. The temperature, cleaning, corrosion and flux management problems can
be solved
by utilizing a magnetic alloy that is unaffected by temperatures up to
300° Fahrenheit
( 150° Celsius), and by creating thin wall stainless :steel containers
that hermetically seal
the magnet and by fully shielding the magnets. A.t the same time, the system
fixation
I S components are designed to focus their magnetic strength on a single face,
harnessing the
maximum power of the magnets while simultaneously controlling the flux fields.
Unshielded magnets display a natural magnetic field consisting of a series of
polar
radiating loops of flux lines. In an unshielded state, magnets attract equally
at their north and
south poles. Once established on a metal plane, such an unshielded magnet
provides both
fixative force to the plate as well as radiating attractive force from the
unobstructed pole,
which is amplified from the natural state due to decrease in flux path losses.
In a surgical
environment, radiating magnet flux attracts all fei~rornagnetic materials,
which can be
undesirable. Flux management therefore can be an important feature of the
system. Since a
variety of ferromagnetic components are used during many surgical procedures,
it is
important that there are very high attractive forces between the components
and the base plate
and that the attractive force upward is minimized.
Shielded magnets allow for optimal utilization of the magnetic attractive
forces and
minimize the undesirable radiation of magnetic flux. For example, disk magnets
have equal
fields on each side of the disk. When a disk magnet is. placed in a
ferromagnetic cup, the cup
magnifies the fixative force at the mouth of the cup by eliminating the air
gap (air is a poor
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conductor of magnetic fields) and brings both poles of the magnet to grip on
the plate surface.
A secondary effect is substantial reduction of radiated magnetic flux. A
magnet held in a
ferromagnetic fixture provides an increase in fixation strength through field
focus over a bare
magnet while magnetic shielding is provided through a closed magnetic Loop.
Autoclavable magnets include rare earth mal;nets such as the Somarium Cobalt
(SmCo) types or formulations including neodymium, iron, and boron for
coercivity retention
at high temperatures like those in an autoclave. Other magnets that provide
magnetic
properties adequate for the application and that can be sterilized are also
usable.
Additionally, computer controlled laser v~relding permits the creation of thin
wall stainless
steel containers that hermetically seal the magnet, preventing corrosion
without materially
degrading the magnetic circuit performance.
One advantage of this surgical system is unrestricted motion, providing ease
in
positioning components. The magnetic fixators can be anchored anywhere on the
surgical
table, yet only two fingers are required for repositioning or fine tension
control. The
forces of magnetic attraction and tabletop friction acre balanced to create an
intuitively
tactile holding system.
Surgeons often rely on the steady hand of a skilled assistant to follow their
every
move or command throughout a surgical procedure. This system reduces the
surgeon's
dependency on a helping hand by providing control of fixation and retraction.
The
components often can be set, released, and manipulated with one or two f
ngers. An
advantage to this system is that in many cases the :>urgeon can conduct the
procedures
without assistance, permitting some procedures to be carried out in a clinical
setting under
local anesthetic, rather than in a standard operating room.
Retraction applied by the surgeon is precisely :rriaintained by the system. In
a hand
surgery embodiment, the system provides either static or dynamic forces up to
about 800
grams. The 360° radial retraction and slim retractor profiles improve
visualization at the
operative site. All of the components snap or slide together, allowing the
surgeon to
create and evolve fixation and retraction solutions as required throughout a
procedure.
The use of magnets provides properties not available with purely mechanical
devices.
The ability to move and Leave a component under tension using a contained but
powerful
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built-in magnetic field avoids the use of locking or latching mechanisms
common to
purely mechanical systems. The system is not only faster, but also provides a
far more
sensitive adjustment range. The system uses strong rare-earth magnets built
into
component bases with a design that maximized i:ixative properties while
effectively
containing magnetic flux fields.
This fixation and retraction system stabilizes staructures during surgery
while allowing
efficient, sterile adjustment of the system prior to or during a surgical
procedure. The system
may be used during various types of surgical procedures, including, but not
limited to, hand,
limb, digits, crania-facial, and veterinary surgery.
In one embodiment, this invention is a system f:or using a magnet in surgical
fixation.
In one form of this embodiment, the magnet forms pan of a fixation component,
which may
also include a non-magnetic housing and a ferromagnetic cup. Another form of
this
embodiment includes a fixation component containing the magnet, and a
ferromagnetic base
plate to which the magnet attaches. In yet another form, the fixation
component includes the
magnet, a housing for the magnet, and a cleat attached to the housing.
Another embodiment of the invention is a device for repositionahly securing a
structure in a desired position during surgery, which device contains a
magnet. One form of
this embodiment can include a fixation component, a coupling component, a
silicone rubber
tube and a ferromagnetic base plate.
Yet another embodiment of this invention is a method for stabilizing or
retracting an
anatomical member during surgery that involves coupling a magnet to the
anatomical
member and attaching the magnet to a ferromagnetic base plate.
Accordingly, one feature of this invention is a surgical fixation and
retraction system
using magnetic components.
A further feature of this invention is a fixation and retraction system that
allows good
visibility of the operative site.
Another feature of this invention is a fixation and retraction system that
provides a
rigid connection and that has components that are pant of a system and that
are compatible
with all other system elements.
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An additional feature of this invention is that the components of the system
disassemble for easy sterilization or disposal. Furthex, components do not
degrade during
aggressive stexilization methods.
Another feature of this invention is support on multiple planes. The system of
this
invention provides a broad range of retractive or stabilizing forces.
Another feature of this invention is very precise stabilization without
backlash.
Multiple components combine in series to increase range or in parallel to
increase strength.
An additional feature of this invention is that no tools are required to set
up ox
disassemble the surgical fixation and retraction system.
Another feature of this invention is to provide are invention that adapts to
include non-
system components.
Another feature of this invention is managemc;nt of the collective magnetic
forces
generated by the system so as not to create undesirable magnetic attraction.
A feature of this invention is a surgical fixation and retraction system using
magnets
1 S to hold through drape material without puncturing the membrane of the
material.
An additional feature of this invention is a surgical fixation and retraction
system with
system components that operate through sterile drapes or plastic film without
damage and
provide isolation from other medical apparatus while m~untaining
stabilization.
Another feature of this invention is a method and system for attaching a
surgical drape
to a skin surface.
These and other features of this-invention will be readily understood by those
skilled
in the art by reference to the following descriptions of the invention and the
accompanying
drawings.
Brief Description of the Drawings
Fig. 1 is a perspective view of various components of the fixation and
retraction
system of this invention.
Fig. 2 is an exploded perspective view of variious components of the fixation
and
retraction system.
Fig. 3 is a perspective view of various components of the fixation and
retraction
system of this invention used during hand surgery.
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Fig. 4 is a top plan view of the plate of the fixation and retraction system
of this
invention.
Fig. S is a top plan view of the wrist bridge oe the fixation and retraction
system of
this invention.
Fig. 6 is a top plan view of the fabric plate cover of this invention.
Fig. 7 is an exploded perspective view of thc; components of the magnetic
circuit
design of this invention.
Fig. 8 is a side elevation view of the pawn of this invention.
Fig. 9 is a side elevation view of the queen of this invention.
Fig. 10 is an exploded side elevation view of thf; rook of this invention.
Fig. 11 is a cross sectional view through the veutical center of the cam
locking base of
this invention.
Fig. 12 is a side elevation view of the lance of this invention.
Fig. 13 is a side elevation view of the knight of this invention.
Fig. 14 is a top plan view of a flat blank of a four prong, blunt retraction
component of
this invention.
Fig. 15 is a perspective view of a four prong, blunt retraction component of
this
invention.
Fig. 16 is a side elevation view of the retraction component of Fig. 15.
Fig. 17 is a perspective view of a fang of this invention.
Fig. 18 is a perspective view of the extension retraction component of this
invention
joined with another retraction component of this inventiion.
Fig. 19 is a perspective view of a retractor extension end of this invention.
Fig. 20 is a perspective view of a specialty retractive component of this
invention.
Fig. 21 a perspective view of a scalpel holder of this invention.
Fig. 22 is a top plan view of a sterilization tray of this invention.
Fig. 23 is an exploded perspective view of stacked sterilization trays of this
invention.
Fig. 24 is a perspective view of a method of fi:~cation using this invention
to trap and
stabilize digits.
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Fig. 25 is a perspective view of a method of fixation using this invention to
bind
digits.
Fig. 26 is a perspective view of a method of fi,tation using this invention to
stabilize a
gloved finger.
S Fig. 27 is an exploded perspective view of a method and system for active
fixation
of a magnet fixation system.
Fig. 28 is a perspective view of a fixation tape system.
Fig. 29 is a perspective view of a method anf~ system for passve fixation of
the
magnetic fixation system of this invention.
Detailed Description of Specific Embodiments
Overview
This fixation and retraction system 10 may be utilized during a surgical
procedure to
stabilize, immobilize, or retract structures such as, but not limited to,
flesh, bone, feet, legs,
arms, hands, digits, surgical drapes, and other surgical equipment. The system
10 generally
includes table components, fixation components, retraction components, and
dynamic
components. Various components are used for coupling a magnet to anatomical
members or
other surgical theater devices such as surgical drapes. Fig. 1 illustrates
possible combinations
of the components of the system to form a variety o~f magnetic and mechanical
structures.
Fig. 2 shows discreet components as an exploded perspective view. Fig. 3 shows
various
components of the system, as used during a surgic<il procedure of the hand.
Figs. 4-23
illustrate individual components of the system in amore detail, while Figs. 24-
26 show
additional combinations. Figs. 27-30 show alternative; embodiments of the
system for use in
securing surgical drapes during surgery.
Table Components
The foundation of the table components its stainless-steel plate 50, which is
essentially the surgical operating table or base, as shown in Fig. 1. Plate 50
may be
formed from 0.065 inch thick stainless steel. As shown in Figs. 1, 2, and 4,
plate 50 has
four edges 52 and stainless steel surface 54. In one embodiment, plate 50 has
four feet
53, shown in Figs. 1 and 2. One or both faces of plate 50 may be laser etched
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otherwise permancrniy marked with text or diagrams 55 so that it is a complete
inistructional tablet. This is advantageous because traditional papEr
instructions tend to be
lost, so that advanced functionality is forgotten and tberefore effcxtively
lost over time.
Hridse 56, shown in Figs. 1, Z, and S, is a crescent shaped plate which, as
its name
implies, bridges a body part, such as the wrist, and serves as an auxiliary
bast. Bridge SG
may be held in piece by flxat'ton componerns caU~ed "cam locking bases,"
discussed
below. Bridge 56 has legs 58, farmed, as can be sam in Fig. 2 by bending each
end of
stainless steel bridge plate 56 at a 90° angle to the; rest of the
bridge SG. Bridge 56
provides an anchor for retraction components at an ellevated height in the
area, where part
of the body, such as the wrist and forearm, court base plate 50. Bridge 56 may
be custom
made in any size or shape. ~Ldding bridge 56 allows the system to provide
retraction at any
vector above the base plate 50, permitting rctracttoii toward any point in a
hemisphere
covering the surgical field. This is ideal for palm or wrist procedures
requiring proximal
retraction. t3ridge S6 has the same ferromagnetic pcopertics as plate 50, and
at! of the
1 S f ration components can be used with it. Bridges :56 can be combined to
build semi-
Wccular or circular structures.
As shown in Figs. 1 and 2, plate 50 may be covered with micro$ber textile
surgical fabric 62 or used bare. In one embodimErny fabric 62 has an octagonal
shape,
formed by removing confer portions of a rectangle; shown in Fig. 6. Fabric b2
aids in
movement of the fixation components on plate 50 by decreasing the coefficient
of friction.
Thus, through their functional range, stationary to f~ll motion, the fixation
components
provide near linear resistance. This ~rtaits the surgeon to make fine
adjustments using one
Emger to slide the fixation cornponGnts along the operaiing suif~tcc with a
Iincar and
predictable force. At rest, a fixation ca~tnponont indEnt;; fabric 62 slightly
so that fabric 62 it
slightly dcptnssed and does not detract from the fixati~an component's
vertical attraction for
plate 50. Fabric 62 may be made from a microfibar that has substantially
reduced blood
tsansmissioa characteristics over normal 5bcrs and is~ washable a large number
of times.
Fabric 62 may be obtained from Burlington Cloppman and is generically erred.
to as a
micmfiber fabric. An example of a suitable microfibeav is one that is 99%
polyester and 1%
carbon fiber. rubric 62 is attached to plate SO by a crack and peel tape
sysicrn or by battens
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and fixation components. In an alternative embodiment, plate 50 may be coated
or treated to
achieve the functional benefits of the described fabric. Bridge 56 optionally
may be coated
with the same textile component or covering.
Fixation Components
The fixation and retraction system 10 also includes fixation components. All
of
the f xation components contain rare-earth magnets and attach to plate 50 or
bridge 56 or
to other fixation components. System fixation components work on both bare and
draped
plates 50 and 56. In designing the fixation components, larger magnets are
used for larger
elements that, as a consequence of their greater height, have a larger moment
arm when a
retraction component is attached. Generally, in hand surgery applications,
components
with more elevated retractor points have correspondingly larger base magnets
to ensure
all components have a minimum of about 800 gram: of retraction from any point
in the
system. As shown in Figs. 1-3, illustrative fixation components include pawn
64, queen
66, rook 68, lance 72, knight 74 (shown only in Fig. 13), and cam locking base
76.
~aL Magnetic Circuit Desi~
The fixation components may all have a magnetic circuit design utilizing the
components shown in Fig. 7, consisting of external housing 80, ferromagnetic
cup 82,
rare earth magnet 84, and base cap 86. Rare earth magnet 84 (typically a disk
or
cylindrical section) is housed in ferromagnetic cup 82 (typically, for
instance, 12L14
steel), in turn housed in external housing 80, which external housing is a
stainless steel
(e.g., non-magnetic 304 stainless steel). Base cap 86 (for example, a thin
plate of 304
stainless steel) fits over magnet 84 and hermetically seals the magnet 84 and
cup 82
within the external housing 80. Housing magnet 84 within ferromagnetic cup $2
focuses
the magnetic field so that the magnetic force downwaard is maximized, while
the magnetic
force radiated upward is minimized. The narrow waist of queen 66 and rook 68,
shown in
Figs. 1 and 2 and further described below, and the cleats, described below,
also serve to
maximize magnetic force downward and minimize magnetic force radiated upward.
In one embodiment of the magnetic circuit design of this invention, external
housing 80 and base cap 86 are both formed from 304. stainless steel, and farm
a hermetic
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sea! so tbat rare earth magnet 84 is completely eneap,sulated within the 304
stainless steel
in order to avoid corrosion that rnay result from steam in the autoclave
envimnmenl. In
this embodiment, ferromagnetic cup 82 may be formed fsorn 12L14 steel. All
stainless
steel components may be surgical stainless steel.
In .some Embodiments of this invention, as indicated above, the housing 80 and
other structures not including the magnetic cup 82 and the magnet 84, are
formed from
non magnetic material. Non-magnetic mataiai iyseludes ma~ecial, such as
copper,
aluminum, some stainless steel and other alloys, and most plastics, to which a
magnet is
not attracted. In a plastic housing 80 embodiment, dbe plastic may be molded
to forth a
shell encasing the magnet.
(b~Pawn
E!s shown in Figs. 1-3 and 8, pawn 64 is a low-.profile f ration component
having a
clear 88 in the form of a deep annular groove between the external housing 80
and a cap
89. Cleat 88 can grip plate edge 52 or be used as a Jam-cleat for an elastic
tube, as
des<xibed below. A boss 90 is positioned on the cap $9 surface arid servrs as
an
attachment point for any of the refraction or dynamic ~compoae~s, discussed
below. Boss
90 has elliptical hob top 92 that capaues a dynamic c~~mponent or that retains
x retraction
component as fint~ described below. Pawn 64 is ~ of~n used at plate edge S2 or
on
bridge Sb. Its low profile makes it idea! for holding fingers in lion, further
described below.
Queen 66, illustrated in Figs. 1-3 and 9, is the ~aost versatile fixation
component of
the system. Queen 6G has a cleat 94, similar in structure to cleat. $8 of pawn
64 and
iikawise enabling duets 66 to grip plate edge 52 or ;3 dynamic component, as
explained
below. Cicat 94 is defined by ~aal housing 80 arui the bottom 95 of queen body
96, a
body of revolution having a concave fact that curves inward in an hourglass
shape, and a
dorac-shaped top 97. Y..ik~e pawn 64, queen G6 is topped with a boss 98 with
an elliptical
hob top 99 that may Engage a rcttaction compon$at or a dynamic component.
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(d~ Rook
As shown in Figs. 1-3 and 10, rook 68 resembles queen 66, except that body
108,
which has a narrow waist 104, is symmetrical and hats a flat top I05. As
shovtm in Fig. 10,
flat head I00 positioned above rook body x08 has .a generally flat underside
I07 spaced
above flat top 1 O5 to define a cleat 106. The flat top surface of head 100
can receive a
pawn 64 or queen 66 and thereby acting as a riser i:or pawn 64 or queen 66,
providing a
higher retraction angle, as shown in Figs. l and 3. Four rooks 68 magnetically
attached
under plate SO can serve as feet, as illustrated in Fig. 1. Rook 68 has cleats
106 at both
top and bottom, allowing it to grip plate edge S:Z or secure fingers with a
dynamic
component. Rook 68 may be made in a two-part design with head 100 press fit
into rook
body 108, as shown in Fig. 10. In one embodiment, head 100 is ferromagnetic
416
stainless steel and body 108 is non-magnetic 304 staunless steel.
Ferromagnetic head 100
allows stable and effective stacking of components, <~s shown in Fig. 3.
(e~, Cam Locking Base
Cam locking base 76, illustrated in Figs. I, 2, and l I, creates the support
for a
second surgical fixation level, such as bridge 56, discussed above, and
provides a base for
lance 72, discussed below. As shown in Fig. 2, bridge legs S8 are formed by
folding each
end of bridge 56 downward at 90° angles. As shovrn in Fig. 2, legs 58
of bridge 56 are
received in a slot I27 in cam locking base 76. Rotating cam shaft 128 with
loop I29
forces cam surface 126 against one face of leg 58, thereby securing it in slot
127 in cam
locking base 76. Numerous other locking mechanisms can also be used, such as a
thumb
screw, a spring clip, and other mechanical locks. Base 76 also has recess 114
for
receiving lance 72, discussed below.
~f1 Lance
Lance 72, shown in Figs. l, 2, and 12, is a rod that fits into recess 114
(shown in
Fig. 11 ) in the top of cam locking base 76 and to which other components may
attach.
Lance 72 has boss I 16 and diameter I 18 of shaft 1f.0 of lance 72 is such as
to allow any
of the retraction components to slide up and down through larger width of
cutout 138,
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WO 001321 I I PCT/1B9910I927
described below, and to engage shaft I20 when shai~t 120 is forced into
smaller width of
cutout 138, described below.
The combination of base 76 and lance 72, as shown in Fig. I, allows high-angle
retraction using boss 116. The height provided by the combination of base 76
and lance
S 72 allows a hand to be placed on its side for a surgical procedure, for
example, so that the
combination of base 76 and lance 72 acts as an infinitely height-adjustable
retractor
anchor. Boss 116 on top end I2I of lance 72 may attach to a retraction
component, such
as four prong retractor 134, or end 1 S 8, or a dynamic component, such as
elastic tube 160,
discussed below.
As can be seen in Fig. i, shaft I20 of lance 72 fits through the cutout 138 of
retraction component end 158, slightly deforming cutout I38 and creating a
secure fit.
Thus, lance 72 may engage a retraction component, such as four prong retractor
134 or
end 158, anywhere along the height of shaft 120 of lance 72.
g~ Knight
1 S Knight 74, illustrated in Fig. 13, has base 122 that houses a magnet and
cleat 123
that will anchor elastic tubes, discussed below, and that can also grip plate
edge 52.
Knight 74 also has boss 124 on top of shaft 125. Knight 74 functions similar
to the
combination of lance 72 and cam locking base 76. Similar to lance 72, the
diameter of
shaft 12S is such as to allow any of the retraction components to slide up and
down
through larger width of cutout 138, described below, and to lock to shaft 12S
when shaft
12S is forced into smatter width of cutout 138, described below. Knight 74
also allows
high-angle retraction using boss 124. The height provided by knight 74 allows
a hand to
be placed on its side for a surgical procedure, for exaanple. Boss I24 of
knight 74 may
attach to a retraction component, such as four prong retractor I34, or end
158, or a
dynamic component, such as elastic tube 160, discussed below.
Retraction Components
The retraction components of system 10 are light, thin, economical instruments
that perform their coupling function with minimal clutter while providing
superb control
and feel. The retraction components are typically 0.020 inch thick stainless
steel, which is
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and autoclavable to 300°F, although other materials could also be used.
The retractors
have between one and six blunt, flexible hooks or prongs 130. The length of
prong 130
may be increased in proportion to the number of prongs to provide
progressively deeper
reach. Fig. 14 shows flat blank 132, usable to form four prong blunt
retraction component
134, shown in Figs. 1, 3, 15 and 16. Various other retraction components with
one, two,
three, five, and six or more prong blunt ends may also be utilized. As shown
in Fig. 17, a
shazp, single-prong retractor, in the form of fang 136~ may be used for skin
piercing and
wound edge reduction.
Retractors 134, I36, 150, 152, alI share the same system arm design of
repeating
I0 interlocks and key-holes. As shown in Fig. I5, for example, an elongated
arm 144 is a
strip of sheet metal perforated by a series of double-kc;yhole shaped cutouts
138 having at
least two different widths 140 and 142. The "double key-hole" I38 could also
be
described as an oblong opening centered on a round hole having a diameter
larger than the
oblong width but smaller than its length. As shown in Figs. 1 and 3, bass 98
of queen 66
can pass through larger width or diameter 142 of cutout 138, but not through
smaller
width 140. Boss 90 of pawn 64 and boss 116 of lance 72 are the same size as
boss 98 of
queen 66, and those can be received in cutouts 138 and connect with the
retraction
components in the same manner. This allows retractors 134, 136, 150, 152 to
attach to:
(a) bosses 90, 98, 116 of the system 10 fixation components, (b) elastic
tubes, (c) lance
72, or (d) each other. Using 0.020 inch sheet metal for retractors 134, 136,
150, I52,
provides flexibility and a sufficiently constant bend rnodulus to allow them
to be cut or
bent to form specialized instruments. For instance, the end 135 of a
retractor, such as
four-prong retractor 134, rnay be bent so that it attaches directly to edge 52
of plate 50.
As illustrated in Figs. l and 15, the longitudinal outer edges 146 of
retractor 134
arm 144 undulate, alternating wider regions 148 with :narrower regions 149.
Cutouts 138
are long enough to accommodate the wider regions 148 of arms 144, but cutouts
138 are
wide enough at portion 142 to accommodate only the; narrower portion 149 of
arm 144.
This makes it possible to pass an arm 144 through ke;y-hole shaped cutout 138
and then
rotate it 90 degrees to lock the two arms together. Retractors 136, i 50 and
152 generally
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have the same arm 144 configuration as retractor 134. ?n an alicrrLative
embodiment of
arm 144, edge 146 of arm 144 is linear, with single keyhole shaped cutouts_
lrxtendcr coraponent 150, shown in Fig. 18, is; essentially arrn 144 without
prong
I30, and interlocks extender 150 with other retraction components to create
extended
rciraGtion element 152. Extender I50 and anrns 144 of retractors i34, 136,
I50, 152 are
si~cd so that the elastic tube I60 can be slid over a portion of extender i50
and therEby
attached to extender 150, forming a combination elastic tube and retraction
component, as
shown in Fig. I. Extender 150 may also be threaded with elastic tube 160 by
threading
the tubing in and out of successive apertures, creating a self locking
tourniquet
component.
Figs. 1 Fend 19 show retraction extension end I58, which telescopingiy engages
an
elastic component, described below. End 158 atxaches to any of bosses ~0, 98,
116, or 124.
End I58 is a short section of extender 150.
A special retraction component, "slim j im" 1 Sq~, is shown in Fig. 20, and is
a user
IS farmable retraction component that allows the surgeon to make special
retraction
components or extenders for standard retractors. Slirn~ jim 154 is formed
using 0.020 inch
sheet metal and is narrower than arm 144. Thus, it is useful when a retraction
component
having a narrow arm is required. The setrgeon may form slim jim 154 into a
desired shape
usins standard hemostats.
Fig. 21 shows scalpel handle holder 156, which attaches to a scalpel handle in
place of
a traditional scalpel blade, forming a handle for retractioc~.
As shown in Fig. 3, one or more proflgs 7 30 oc~ the retraction components,
such as
four-prong retractor 134, may hook an area of skin to he refracted. if the
retractor is fang
136, it will penetrate the skin. l:ourprong retractor 134 or fang i36 is then
pulled into
position, so that the wound is opened. Arm 144 of four-prong retractor 134 is
attached to a
fixation component, queen 66, which ma~gneticaJly adhcnrs to plate 50 (not
shown in Fig. 3),
so that the retractive position is secured.
Dynamic Comno~ents
The dynamic components of system 10 include elastic tube 160, shown in T'igs.
1-
3, fhe elastic tube 160 can be made from any suitable elastic material,
including, without
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limitation, latex robber, silicone rubber anti materials of similar
elasticity. In one
embodiment; the elastic tubing has a 0.325 inch intem~~l diameter with a
Poison ratio and
durometer that provide a secure mechanical lock onto a cleat. >rlastie tube
I60 increases
in dianietcr when compressed and decreases in diiameter when stretched.
~lastiic
component I60 caa be dispvsablc and may have an 8:1 stretch modules. These
inherent
qualities makes it easy to slide onta a boss or retractor arm and yet lock
them in position
under tension.
A11 of the f xation components and retraction c:ompanents of system 10 have
the
ability to grip elastic tubes 160. Elastic tube 160 is flexible to allow
linear pull on an
IO incision area even when pulling around objecis. Th.e cleat 88, 94, 106,
712, on all
fixation components makes it easy to aitaeh and adjust the free end of,
elastic tube I60 by
winding a portion of elastic tube 360 into the groove. A half turn mill
secure, and a full
turn will lock, elastic tube 160 in place in cleat it8, 94, 106, I23. Elastic
tube 160 attaches
to cleat 88 of pawn 64 by wrapping amend the shaft of cleat 88, as shown in
Fig. 3. Queen
66, mok 68 and Icuight 74 also have cleats that tether elastic tube 160 in the
same manger.
Any of bosses 90, 98, 116 or 124 may engage elastic tube 160. As shown in Fig.
1, for
example, boss 90 of pawn 64 engages elastic tube t 60, wtuIe second end of
elastic tube 160 is
telescopingly engaged to a retraction eomponer~i.
Sterilisation Trav
A sterilization tray 166, shown in Fig. 22, may 'be made of ferromagnetic
atain3ess
steel or other suitable material, and is generally about onn half the size of
plate S0: Fixation
and retraction components arc loaded onto tray 166 and W en tray 166 and the
components arc
autoclaved. Tray l6ta contains a plurality of raised protru;;ions or kr<obs
167 and holes 168 on
tray plate ! 70. Fixation components, such as pawn 64, ;are held by magnetic
attraction arid
?~ rest on knobs 167, minimizing contact with tray 166 and thereby penni1.dng
good circulation
of steam through holes 168 and around all stnfaces of paw b4 and other system
10
components. Tray 166 is a single sheet with four sides i~69, forming a pan-
shape. 'flee trays
may be stacked during autoclaving or storage, as shown in Fig. 23. Comb-like
polymeric
strips having pegs that arc received in holes 168 can hold retractors during
the autoclaving
cycle. Such comb-like strips are available for use in comnnerciatly available
autoclave trays.
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S~rs~em Utilization
The system components can be used together to create surgical solutions. All
o~
the components of system iU may be used in a varieh~ of combinations and
mechanical
and magnetic an,aagcments t~ achieve the requir;emenls oft a particular
sursical procedure:
)r'or exart~ple, in a hand surgery embodiment, system cornponcnts stack to
create high-rise
fucative points up to on the order of three inches talE, extending to
approximately six
inches tall when combined with bridge 56.. Similarly, m inclinable table may
be created.
hooks 68 can be used as feet either individually or stanked to create an
inclined surface.
Rooks also stack to create effective palm grips, which ;illows forgers to be
stabilized in a
rst configuration.
The same components may have retractors attached for static retraction, which
is
retraction that: is constant for a given retractor position. Dynamic
rebcaction is achieved
by applying elastic tubes to rctmctor tips and anchoring; the elastic tubes to
a static base.
Such dynamic retraction can maintain a nearly constant force over a retractive
tango. For
example, as r~ surgeati deepens an incision it is simultan~.e~usly further
retracted. In short,
unlike static retraction, it maintains a nearly constant force as an incision
opens. _ This is
ideal for incision retraction requiring repositioning ar minor manipulation.
xn both cases,
the retractor anchors can be moved as required.
The components may also be used as trapping mechanisms. Ivl~arrow waist 104
24 allows a series of rooks 68 or queens 66 to be used to snake "finger
grippcrs," shown in
Fig. 24, by placing one component oa either side of a finger, holding it in
place. In
addition, either cleat 106 of rook 68 allows elastic tube 160 to bind one or
two fingers, as
shown in dig. 25.
System i b components also combine to form various anchor elements. For
instance, among many other alternatives, solid anchor points may bE created by
combining edge-locked pawn 64 and queen 66. Two queens 66 may be combined to
provide an anchor, with each queen 66 locked to a siz~glE retraction
component.
Components with top basses 90, 98, 11 G, or 124 will ~xceommodate two
retractors 134,
13G, 150, 152, plus a dynamic retractor in each cleat, and retraction
components, such as
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lour-prong retractor 134, and extenders 150 may soak ttogether to increase
roach as shown
in rig. 1. 'two queens 66 may be placed on either side of a wrist or other
Iimb and used
to trap a tourniquet in place. one or two queens 66 or rooks 68 tray hold the
wrist in
place.
'this fixation and retraction system lU is hig~Iy compatible with conventional
components, which adapt easily to the system. For e~cample, hemostats may b$
attached
using elastic tubes by threading one end of an elastic tube through a finger
l~oIe opening
on a hemostat and binding the other end of the el3~tic tube to a cleat an a
fix~ion
cotxipoaent. The herttostat may lhe» be used to clamp a~n object while the
fixation
14 component provides the fixation and retraction required by holding the
hemostat in place.
iJtiiization of Fiim
Fig_ 26 shows another embodiment of the magnetic fCxation system attaching
latex
material such as latex glove 174 to plate SU. Elastic filc~a may be used to
enrobc anatomical
members to immobilize them and maintain sterility in the surgical field. For
instance, as
shown in Fig. 2G, a latex glove 174 covers the patient's hand after it has
been stetili~..ad and
prepared for surgery. Fig. 2fi shows glove 174 covering ono finger 176. Each
tip of each
Fnger of glove I74 may be elongated and fixed against plate 50 with a fixative
component
such as rook 68 or queen 6G. Stretching fingers of glove '174 causes theta to
grip the patient's
fingers. 'I~is process is repeated until all required sections of the glove
are secured to the
surf'acx. This embodiment of the fixation system provides medical personae!
additional
assurance that hard to sterilize finl;email beds or other anatomical areas arc
effectively
isolated from adjacent surgical fields on the hand, Surgery is perfntmed
simply by cutting
open a section of the secured glove and exposing the surgiical area.
Portions ox specifically designed Iatex or other types of film, gloves or may
be
reinforced to strengthen the glove and resist tearing by making portions of
the glove thicker.
This can be accomplished, For instance, by forming ar,~ annular depression it:
the finger-
fornung position of the glove mold, thereby creating a tlhickened sing at the
location of the
depression in the glove finger.
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Surgical l7rape Fixation
l~il;. 27 shows a perspective view of aciive fiycation of drape fixation
system 188.
Active fixation is the attraction between two magnets and provides for a
strong attraction that
is polarity dependent. Active fixation is used in minimal clearance
circumstances where the
surgical drape is to be held in close proximity to the operative site and a
low profle fixarion
system is required.
Magnets 190, 192, shown in Fig. 27, arc prete~rably rare earth magnets, as
described
above. Skin fixation tape is made by several manufacturers. For example, 3M
makes a skin
securiztg tape usable for the fixatiota tape 194 sold undex the product name
Tegaderm. Smith
t 0 & Nephew also sells skin fixation tape un~dcr the product name Hypaiix.
Preferably, the skin
securing tape has pz~operties similar to skin scxuring tape used to attach
electrodes to a body.
In an alternative embodiment, magnets either covered, with an inactive finish
or ones with
non reactive properties may be attached to the skin »sing adhesive or double
Sided foam
adhesive.
As shown in Fig. 27, drape fixation system 188 of this invention holds a
material such
as surgical drape 182 in place without puncturing the membrane of drape I82.
Magnets 190,
192 secure surgical drape 182 to a patient pmvidiag foul safe fluid
protection. Fixation tape
194 has first side 196 and second side 198. First side 1!~C> of fixation tape
194 adheres to skin
surf~~~ 200.
Second magnet 192 mounts within metal cup 202 in comity 204, which is sued to
receive it. Attraction of magnet 192 for cup 202 holdls magnet 192 in place,
but it xnay be
further secured with an appropriate adhesive_ Cup 202 may attach to fixation
tape 194 with a
snap connector. In ~ alternative embodiment, magneaic attraction between metal
cup 202
and fixation tape 194 provide the locking mechanism for securing drape
fixation system 188
in position.
Surgical drape 182 is positioned between magnets 190, 192 and is secured when
magnet 192 locks into position on fixation tape 194. Medical personnel may
place a
sufficient number of drape taxation systems t 88 around. a patient to proteci
the patient during
a medical procedure_
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As shown in Fig. 28, fixation tape system T88 can be manui'a~ctured in a
manner such
that a plurality of fixation tape units 201i are removably connected in a roll-
up configuration.
In this conf~guratian, each individual fixation tape unit 20fi can be torn
away from the roil
and used as needed. Each fixation tape unit 206 includes magnet 207, fixation
tape i Q4, and
cover 208. Magnet 207 is disposed between fixation tape 194 and cover 208.
Preferably,
magnet 207 is formed in a flat disc shape.
rig. 29 shows passive fixation system 210, an alternative embodiment of the
drape
fixation system. Passive fixation is the attraction betWrecn a magnet and
magnetic material.
This attraction is independent of magnetic pole orientation. Passive fixation
is used where
14 adequate clearance is available to allow the use of metal cups which
provide far greater force
and the additional advantage of a closed magnetic loop minimizing magnetic
Iields.
Passive fixation system 2I0 includes a fixative component, such as queen 66,
surgical
drape 182 and fixation tape emit 206. An alternative einbodimnc~t of passive
fixation system
210 utili-res disposable elements packaged in a sterile condition and used
only once. Tape
unit 206 includes a metal plate or other ferrcuaagaetic material that may be
temporally ai'fixed
to the patient with adhesive and that is strongly attra~ctcd to queen 66.
Fixation may be
provided by fixation tape unit 206 or by adhesive. Surl~cal drape 182 is
removably disposed
between queen 66 and fixation tape unit 206. Attraction occurs from queen 66
and the metal
plate of fixation tape unit 210.
Any number of accessories may be included wiith drape fixation system I88 or
210.
Accessories may include, for example, tubes, canncdas, intravenous shunts,
airways or
electroiuc mnniloring systems. In addition, strain from other apparatus can be
relieved using
an accessory with fixation system 188 or 210. An accessory such as a htbe is
connected to
the magnet. Any number of connection methods may be used including adhesiv~
tape or
another magnet combination.
The fixation system of this invention is not confined to the embodiments
described
herein but inciudes variations and modifications within the scope and spirit
of the foregoing
description, the accompanying drawings, and the following claims. ThE
components mxy be
si-rxd io accommodate a particular surgical procedure. For e~cample, larger
versions of the
a0 components described herein may be used far variaua types of surgery,
including human
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craniofacial aad orthopedic surgery. Additionally, nuimerous modifications in
the shape and
size of the described fixation cornponeats can he aiad,. in order to adapt the
principals of this
invention to the anatomical and other requirements of surgical procedures on
humans in
addition to hand surgery and veterinary surgical procedures of all kinds,
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