CA2353723C - Surgical fixation and retraction system - Google Patents

Abstract

A fixation and retraction system utilizing table-like ferromagnetic base components to which shielded magnet components attach in order to locate movable fixation and retraction components or other operating theater devices, such as surgical drapes. Use of rare earth magnets permits system components to be attached quickly, easily and securely in almost an infinite number of configurations.

Description

WO 00/32111 1'CTI1B99/01927 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 CONFIRMATION COIPY

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 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 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 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 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 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.

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.

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.

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 or WO 00!3211 I PCTIIB99/01927 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 REC1'IF>ED SHEET (RUILE 91) 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 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.

RECTIFIED SHEET (RUDE 91) WO 00/321 I 1 PCTlIB99/01927 (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 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, 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 WO bb/32111 PCT/IB99/01927 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 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.

3, fhe elastic tube 160 can be made from any suitable elastic material, including, without RECTIFIED SHEET (RU1:E 91) 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 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.

RECTg'IED SHEET (RULE 91) 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 RECTIFIED SHEET (RUILE 91) 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.
RECTIFIED SHEET (RIfJLE 9I) 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_ RECTIFIED SHEET (IItULE 91) 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 RECTIFIED SHEET (RULE 91) 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, RECTIFIED SHEET (RULE 91)

Claims (56)

Claims:

1. A system for use in surgical fixation comprising a metal base plate, a fixation component including a magnet for positioning the fixation component on the base plate magnetically and a coupling component for linking the fixation component to a member to be immobilized.

2. The system for use in fixation as claimed in claim 1, wherein the fixation component comprises a non-magnetic housing and a ferromagnetic cup.

3. The system of claim 2, further comprising a base cap and wherein the housing and the base cap are formed of stainless steel.

4. The system of claim 3, wherein the housing and the base cap form a hermetic seal around the magnet.

5. The system of claim 2, wherein the magnet is contained in the ferromagnetic cup and the ferromagnetic cup is contained in the housing.

6. The system of claim 2, wherein the ferromagnetic cup is formed of stainless steel.

7. The system of claim 1, wherein the fixation component has a first face, and magnetic flux associated with the magnet is focused on the first face.

8. The system of claim 1, wherein the fixation component further comprises at least one cleat.

9. The system for use in fixation as claimed in claim 1, wherein the fixation component further comprises a body having narrow waist.

10. The system of claim 1, further comprising a boss on the fixation component.

11. The system of claim 1, further comprising a stainless steel plate.

12. The system for use in fixation as claimed in claim 11, wherein instructions for use of the system are indelibly affixed to the plate.

13. The system for use in fixation as claimed in claim 11, further comprising a fabric covering at least a portion of the plate.

14. The system of claim 13, wherein the fabric is a microfiber.

15. The system for use in fixation as claimed in claim 11, wherein the plate is treated to reduce friction between the plate and the magnet.

16. The system of claim 1, wherein the coupling component comprises at least one prong.

17. The system of claim 16, wherein the at least one prong is blunt.

18. The system of claim 16, wherein the at least one prong is sharp.

19. The system of claim 1, wherein the coupling component comprises an elongated member having at least one aperture.

20. The system as claimed in claim 19 for use in fixation for mechanically linking the member to be immobilized, wherein the at least one aperture has at least two widths.

21. The system of claim 1, further comprising elastic tubing.

22. The system of claim 21, wherein the elastic tubing comprises at least one silicone rubber tube.

23. The system of claim 1, wherein the magnet comprises a rare earth magnet.

24. The system of claim 23, wherein the magnet comprises somarium cobalt.

25. The system of claim 23, wherein the magnet comprises neodymium.

26. The system of claim 23, wherein the magnet is disk shaped.

27. The system of claim 1, further comprising a sterilization tray.

28. The system of claim 27, wherein the tray comprises a metal plate perforated with a plurality of holes.

29. The system of claim 27, wherein the tray comprises a metal plate having a plurality of protrusions.

30. The device of claim 10, wherein the boss is adapted to receive an end of the silicone rubber tube.

31. The device of claim 8, wherein the coupling component includes the cleat adapted to receive an end of the silicone rubber tube.

32. The device of claim 20, wherein the second width is adapted to receive a boss on the fixation component to couple the elongated member to the fixation component.

33. Use of the system of claim 1 for stabilizing or retracting a member comprising:
(a) coupling a magnet to the anatomical member; and (b) attaching the magnet to a ferromagnetic base plate in an indeterminate location.

34. Use of the system for stabilizing or retracting an anatomical member as claimed in claims 1 and 33, comprising:

(a) coupling a magnet to the anatomical member by coupling to the magnet an elongated member having two ends, key-hole shaped apertures and at least one prong on one end; and (b) attaching the magnet to a ferromagnetic base plate.

35. Use of the system of claim 34, wherein the at least one prong engages a portion of the member to be immobilized.

36. Use of the system of claim 34, wherein the at least one prong is blunt.

37. Use of the system of claim 34, wherein the at least one prong is sharp.

38. Use of the system of claim 34, wherein the at least one prong comprises a plurality of blunt prongs.

39. Use of the system of claim 34, wherein the coupling the magnet to the elongated member is accomplished using elastic tubing.

40. Use of the system of claim 39, wherein the elastic tubing comprises silicone rubber tubing.

41. The use of the system of claim 34, wherein coupling the magnet to the elongated member is accomplished using a second member having key-hole shaped apertures.

42. The use of the system of claim 33, wherein the magnet is housed in a fixation component.

43 The use of the system as claimed in claim 42 for stabilizing or retracting an anatomical member comprising:
(a) coupling a magnet to the anatomical member; and (b) attaching the magnet to a ferromagnetic base plate, wherein the magnet is housed in a fixation component comprising at least one cleat.

44. The use of the system of claim 42, wherein the fixation component further comprises a boss.

45. The use of the system of claim 44, wherein the boss is adapted to receive an end of an elastic tube.

46. The use of the system of claim 45, wherein the elastic tube comprises silicone rubber.

47. The surgical fixation system of claim 1, further comprising a body attached to the magnet having a post.

48. The surgical fixation system of claim 47, further comprising a body attached to the magnet having a post and a boss on the top of the post.

49. The surgical fixation system of claim 1, further comprising a locking base attached to the magnet.

50. The surgical fixation system of claim 1, further comprising a boss attached to the housing and to which another component can be attached.

51. The surgical fixation system of claim 8, further comprising a second cleat and a boss attached to the body and to which another component can be attached.

52. The surgical fixation system of claim 1, further comprising a flat surface to which a second magnet can be attached.

53. The surgical fixation system of claim 1, further comprising a socket within which a post can be positioned.

54. The surgical fixation system of claim 1, further comprising a body attached to the housing, the body having a narrow waist between two flared regions.

55. The surgical fixation system of claim 1, the boss comprising a shank having two ends, one of which is attached to the body and the other of which attaches to a conical cap.

56. The surgical fixation system of claim 1, further comprising a stainless steel plate, wherein the plate is generally crescent-shaped.