Abstract:
An apparatus to facilitate a physician&#39;s examination and manipulation of a patient&#39;s joint which includes an elastic stretchable wrap for wrapping a limb of a patient and for restricting its size to avoid pooling of blood and liquid during manipulation and a surgical garment for the physician, said wrap and garment having cooperating surfaces for affixing the patient&#39;s limb to the garment for effecting manipulation of the patient&#39;s joint by the surgeon.

Description:
Cross Reference. This application claims the benefit of U.S. Provisional Application No. 60/072,288, filed Jan. 23, 1998. 
    
    
     Field of the Invention and Related Art. This invention is directed to the problems of arthroscopic surgery. More particularly, it facilitates the very difficult manipulation requirements of the patient&#39;s joints during the arthroscopic surgery. 
     Illustrative of these difficulties are the manipulations needed to position the arthroscope for examination of all of the compartments of the knee. Such an examination often starts with insertion of the arthroscope through an anterolaterial or anteromedial portal to first examine the lateral or medial gutters. This examination is usually made with the knee being fully extended. Thereafter, the knee must be bent to permit examination of the notch and groove of the femur. Subsequently, varus and valgus forces are applied to the knee to open the medial and lateral joint lines to permit examination of the meniscus. 
     After examination, remedial repair of the meniscus, the ligaments and tendons may be necessary. Such repair imposes further demands upon the surgeon. For these repairs a surgical instrument is inserted through another portal and both of the surgeon&#39;s hands are fully engaged. Similarly, his feet may be needed to actuate and control the speed of motorized instruments such as a shaver. These ambidextrous efforts often require the use of a nurse or surgical assistant to whom various requests for movement of the leg must be made. These requests are for various movements in terms of direction, degree and extent of movement of the extremity. One group of authors has described the problems: 
     Manipulation of the knee joint to open and close the various compartments of the knee is critical for adequate visualization of intra-articular structures and successful arthroscopic surgery. For the inexperienced arthroscopist, manipulating the arthroscope and instrument, as well as the knee to provide adequate exposure, can be overwhelming. Therefore, a surgical assistant is usually necessary during arthroscopy of the knee. The surgical assistant stands below the surgeon and manipulates the knee with either varus or valgus stresses in varying degrees of flexion and extension. The surgical assistant is also available to lend a hand when handheld instrumentation is being exchanged or more than two portals are being used. 
     Fu, Harner and Vince, Knee Surgery, V. 1, p. 550 (Williams and Wilkins, 1994). 
     The magnitude of these problems is emphasized by the fact that in excess of 400,000 arthroscopic knee surgeries are believed to take place annually within the U.S. Consequently, there are numerous surgeons facing the problem of manipulation daily and many are resorting to the cost and expense of a surgeon&#39;s assistant. 
     The present invention is intended to facilitate these manipulations. In addition, it is intended to minimize or obviate the need for the surgical assistant, to provide more precise positioning of the entire limb, to open the joint further with accuracy while providing excellent control over the extent of the movement so as to minimize the danger of accidental slips with delicate instruments in very delicate spaces. In addition, the invention enables the surgeon to control the pressures exerted on the limb and possibly decrease the incidence of nerve palsies and collateral ligament damage associated with manipulation of the extremity. 
     Description of the Prior Art. To this inventor&#39;s knowledge, the above quotation represents the today&#39;s state of the art solution to manipulating the knee during arthroscopic surgery. Such is the only prior method known to him or printed in medical books and journals. 
     SUMMARY OF INVENTION 
     This invention is an attaching device for affixing a patient&#39;s limb to the surgeon&#39;s body for manipulation of the limb and its associated joint or intra-articular structure to facilitate arthroscopic examination or surgery. The invention includes an fastener on the limb and a cooperating fastener carried by the surgeon&#39;s body. The fasteners can take many forms. A preferred form is a pressure sensitive fastener such as an adhesive and a bonding surface, the Dual Lock(&amp; fabric fastening system of the 3M Company of St. Paul, Minnesota, etc. More particularly, the preferred pressure sensitive fasteners are those of the traditional hook and loop fasteners such as those sold under the trademark Smart Touch™ by YKK of America and under the Velcro® brand sold by Velcro, USA of Manchester, N.H. Either the hook or loop is formed on a flexible strip that can be wrapped around the limb of the patient with the fastener exposed while the other cooperating fastener is the surface of a surgeon&#39;s gown or apron. With the cooperating fasteners being-joined by pressure, the surgeon can easily affix the limb to his gown or apron. In addition, such can be quickly and easily unfastened and affixed to the other side of the apron or gown to facilitate joint manipulation for examination on the opposite side of the joint. In one preferred embodiment, the flexible strip is formed of an elastic fastening material that can be tightly wrapped around the patient&#39;s limb for two distinct benefits. The first benefit is a simplistic method of fastening or attaching the limb to the physician&#39;s gown or apron for purposes of manipulation, control and stability during the surgery. The second synergistic benefit is that of eliminating the requirement for Coban® or Ace® wrap and the utilization of the elastic fastening material to avoid pooling of blood and fluids within the patient&#39;s leg during the surgery. 
     Accordingly, the objectives of this invention are to provide, among other things, 
     1) a fastening system for affixing a patient&#39;s limb to a surgeon&#39;s body to enable the surgeon to accurately manipulate and position the limb&#39;s associated joint to facilitate arthroscopic examination and surgery; 
     2) a pressure sensitive fastening system for affixing a patient&#39;s limb to a surgeon&#39;s body and to facilitate release and refastening of the limb to a different portion of the surgeon&#39;s body for further manipulation; 
     3) a garment apparatus for arthroscopic examinations that will elimimate the need for a surgeon&#39;s assistant and simultaneously facilitate accurate position of the limb and the opening of an intra-articular structure for insertion and examination of the structure; 
     4) a garment wrap for arthroscopic examinations that will simultaneously serve to prevent the pooling of liquid and blood in a patient&#39;s limb and as a fastener device for attaching the garment apparatus and the patient&#39;s limb to the surgeon&#39;s body; 
     5) an elastic garment wrap for a patient&#39;s limb that will simultaneously serve to prevent or reduce the pooling of liquid and blood in the patient&#39;s limb and as a fastener device for affixing the limb to a fixture or a surgeon&#39;s body, thereby eliminating the need for Coban or Ace wrappings which performs the single function of preventing pooling of blood; 
     6) a low cost adhesive device for affixing a patient&#39;s limb to a surgeon&#39;s body for manipulation thereof; and 
     7) a simplified arthroscopic surgery method avoids confusion and miscommunications between the surgeon and the assistant as to the angle, height or magnitude of the necessary movement of the limb; 
     8) elimination or minimization of the need for surgeons assistant to manipulate a patient&#39;s limb during surgery; 
     9) an arthroscopic surgical method and system for decreasing the incidence of nerve palsies and collateral ligament damage as well as damage to other elements of the joint, 
     10) a low cost wrap for simultaneously preventing the pooling of blood and for fastening a patient&#39;s limb to a fixture, support of a surgeon&#39;s body; and 
     11) a low cost garment wrap combination for simultaneously preventing the pooling of blood in a patient&#39;s limb, for positioning and affixing said limb to a support, fixture or surgeon&#39;s garment and for facilitating arthroscopic surgical examinations. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     The manner in which these objectives and other desirable characteristics can be obtained from this invention is explained in the following specification and attached drawings in which: 
     FIG. 1 is a partial plan view of an operating room illustrating a surgeon performing arthroscopic surgery on a patient&#39;s knee using a preferred embodiment of this invention; 
     FIG. 2 is a plan view illustrating some of the movements and manipulations required of a leg during arthroscopic surgery. 
     FIG. 3 is a perspective view of a surgical gown having a fastener surface of this invention bonded or otherwise affixed to the surgical gown; 
     FIG. 4 is a view in perspective of a fastener wrapping for a patient&#39;s limb; 
     FIG. 5 is perspective view of a preferred embodiment of the surgical apron having a surface of this invention; 
     FIG. 6 is a perspective view of another preferred embodiment of an elastic fastening wrap for wrapping a patient&#39;s limb to prevent the pooling of blood and the affixation of the limb to a support or a surgeon&#39;s garment; and 
     FIG. 7 is a perspective view of a low cost surgeon&#39;s gown for facilitating arthroscopic surgeries. 
    
    
     DETAILED DESCRIPTION 
     A preferred embodiment of the present invention is depicted in one intended environment in FIG. 1 of the drawings. This environment is the operating room  10  in which a patient P is undergoing arthroscopic surgery on his right knee  14  by a surgeon S. The patient&#39;s leg  18  extends off the operating table. Through a wrapping  22 , the patient&#39;s foot  20  is affixed to the surgeon&#39;s gown  70  having the pressure sensitive fastener system  72  of this invention. When the foot is so affixed, this fastener system permits the supporting plate  24  of the operating table to be pivoted about its hinge  26  to a vertical, non-supporting position and simultaneously gives the surgeon complete control over the positioning of the foot  20 , leg  18  and the knee  14 . To further assist manipulation of the knee, the patient&#39;s thigh  16  is encapsulated in a relatively rigid plastic or foam holder  30  that is affixed to the operating table  12  through a mounting holder or post  28 . This holder  28  is conventional and may be used by the surgeon as a fulcrum to manipulate the knee joint. 
     Before considering the detail construction of the fastening system, its benefits and the problem it solves can best be described in reference to FIGS. 1 and 2. A surgeon often begins arthroscopic examination of the knee  14  in the position generally depicted in FIG. 1, ie., the leg  18  generally straight. In this position, the arthroscope  34  is inserted through a portal into the knee  14  and passed along the medial and lateral gutters (not shown). The camera of the scope is connected to the TV camera  36  to provide the surgeon with a picture of the gutters. Next, the leg  18  is flexed downward approximately 70 degrees to permit the scope to view and examine the grove on the femur (not shown). This flexing of the knee  14  can be effected by the surgeon&#39;s body movement in squatting down or, alternatively, he can remove the scope  34 , grasp the leg  18  and merely reposition it downward on the fastening system  72  of his gown. With the leg  18  extending downward as shown in the dotted line position of FIG. 2, the notch of the femur can be examined. 
     Finally with the leg  18  generally straight, as shown in FIG. 2, the surgeon can easily apply a varus stress to the knee  15  by leaning into the leg  18  to fulcrum the knee  14  about the post  28  and its holding member  30 . Such will open the lateral side of the knee to facilitate insertion of the scope  34  into the joint line and examination of the meniscus. Alternatively, the surgeon can move the leg  18  to his opposite hip to apply a valgus force to open the medial joint line. Significantly, this body movement and control of the leg  18  and knee  14  eliminates the confusing communications between a surgeon and an assistant. No longer does the assistant have to guess at the desired angle or magnitude of movement of the leg  18 , its height or the extent of the desired manipulation. The surgeon, observing the TV and using his body motion, can precisely move the knee  14  and leg  18  until he observes the desired compartment of the joint. 
     As will be appreciated by those skilled in the art, the fastening system for affixing the patient&#39;s limb to the surgeon&#39;s body may take many forms. In some instances, a sterile adhesive or a tape applied to the patient&#39;s skin will provide a sufficient bonding to a surgeon&#39;s gown upon the application of pressure. However, the preferred embodiment of the fastening system is a hook and loop system which may be sold under a brand name such as Velcro® fastener. This preferred fastener system is depicted in FIGS. 4 through 7. 
     FIG. 4 depicts a wrapping formed of Velcro, USA&#39;s ONE WRAP™ tape in a width of two inches and having an HTH  22  hook. This fastening tape has a back-to-back fastening system that permits the tape to be wrapped around the leg  18  with some overlap so as to fasten to itself about the leg. Preferably, the loop side  22   a  is positioned adjacent the patients skin and hook side  22   b  is exposed for further fastening or affixation to the apron of FIG. 5 which is formed of a loop material such as L 3610 of Velcro, USA. Many surgeons will find that this ONE WRAP™ tape can be applied rather tightly so as to eliminate the elastic Coban® tape that is normally used to constrict the leg&#39;s volume and preclude the pooling of liquid and blood in the leg during surgery. Alternatively, Velcro, USA, as well as others are believed to make an elastic loop tape which can be used as a substitute for the Coban® and thereby further reduce costs. After the leg is wrapped, it is affixed, by the application of pressure, to the surface of gown  72  having a hook structure for manipulation by the surgeon as discussed above. 
     One alternative for the gown  72  is the apron  80  of FIG. 5 which takes the general shape of apron with shoulder straps  82  which can be interconnected by a cross straps  84  of hook and loop material to hold the shoulder straps in place. Just below the waist of the surgeon are two apron strings  86  formed of a hook material for passing around the surgeon and locking to the hoop material of the apron skirt. Preferably a cardboard holder  88  is placed on the strings for shipping and for wrapping about the physician by a scrub nurse without affecting the sterility of the strings. 
     In the event that the apron  80  of FIG. 5 is utilized, it will be worn over the traditional surgical gown (not shown). Alternatively, the embodiment of FIG. 3 depicts a gown  70  in which the skirt  72  is formed of the loop material which is attached to the gown  70 . For example, the fastening skirt  72  may be sewn or ultrasonically welded to the gown, affixed. thereto by pressure sensitive adhesives, etc. Since loop material is not normally impervious to liquids, the material of the surgeon&#39;s gown may be used as a backing. 
     Those skilled in the art will appreciate that this invention may take many forms and that the preferred embodiment is subject to various modifications. For example, the hook and loop material may be reversed with the hook material being used as the apron  80  or the skirt  72  of gown  70 . One such alternative is depicted in FIGS. 6 and 7. This embodiment may be preferred where the primary consideration is one of costs. 
     As shown in FIG. 6, the wrap  122  is formed of a stretchable, elastic loop material for wrapping the patient&#39;s leg. A preferred material is that sold by Velcro, USA of Manchester, N.H. under the designation “MED FLEX.” With the smooth side  122   b  being placed against the patient&#39;s skin, this material is stretched and wrapped around the leg  22  to eliminate the need for the Coban® or Ace® wraps that are normally used to prevent swelling and pooling of blood and fluids in the leg. In addition to prevention of pooling of fluid, the wrapping has a loop structure  122   a  which is remains exposed after the wrapping. This loop structure permits a pressure sensitive affixation of the leg to the surgeon&#39;s gown depicted in FIG.  7 . 
     The gown of FIG. 7 is a standard surgical gown such as that manufactured and sold by Allegiance Healthcare Corporation of McGaw Park, Ill. 60085 under the catalog designation  9575 . Affixed to this gown are preferably three generally rectangular segments of hook material  130 ( a ),  130 ( b ) and  130 ( c ). Preferably this material is one such as that sold as HTH  805  having a  0115  adhesive affixed thereto. Such permits the individual segments to be cut into the desired shape. The adhesive backing can then be removed from the adhesive for bonding to the gown  132  in the position shown. It is believed that such a gown with the three hook segments bonded thereto provide adequate control to the surgeon. 
     In the wrapping depicted in FIG. 6, a hook tab  124  can be can be stitched thereto for locking to the loop structure after the wrapping of the leg. In addition, another hook piece,  126  can be affixed to the wrap  122  to avoid unravelling. 
     Those skilled in the art will also appreciate alternative pressure sensitive fastening systems. For example, some may prefer the Dual Lock® fabric fastening system of the 3M Company of St. Paul, Minn. Others will find that certain sterile adhesives may be used, particularly for short duration arthroscopic examinations. Moreover, depending upon the expected weight of the patient&#39;s leg, a stronger hook and loop systems may be substituted. Numnerous such alternatives will provide acceptable control and manipulation the patient&#39;s limbs and joints so as to achieve the benefits of my invention. As known to those skilled in the art, the garment may be sterilized by conventional methods, including the use of ethylene oxide or gamma irradiation.