Abstract:
An improved method and apparatus for restraining a patient&#39;s leg during knee surgery or similar procedure features and improved restraining member that is attachable to an operating room table. The restraining member has a lower concave portion that engages the upper portion and sides of the patient&#39;s leg. The restraining member has an upper convex portion that is reinforced with a plurality of ridges. The concave portion can be fitted with an inflatable bladder. The concave portion in other embodiments is fitted with a belt arrangement that enables different degrees of constriction to be imparted to the leg.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a continuation of U.S. patent application Ser. No. 13/570,624, filed Aug. 9, 2012 (issuing as U.S. Pat. No. 8,689,793 on Apr. 8, 2014), which is a continuation in part of U.S. patent application Ser. No. 11/566,485, filed Dec. 4, 2006, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/845,833, filed Sep. 19, 2006, U.S. Provisional Patent Application Ser. No. 60/816,842, filed Jun. 27, 2006, U.S. Provisional Patent Application Ser. No. 60/794,164, filed Apr. 24, 2006, and U.S. Provisional Patent Application Ser. No. 60/761,402, filed Jan. 23, 2006, each of which is hereby incorporated herein by reference and priority of which is claimed. 
         [0002]    Priority of U.S. Provisional Patent Application Ser. No. 60/845,833, filed Sep. 19, 2006, incorporated herein by reference, is hereby claimed. 
         [0003]    Priority of U.S. Provisional Patent Application Ser. No. 60/794,164, filed Apr. 24, 2006, incorporated herein by reference, is hereby claimed. 
         [0004]    Priority of U.S. Provisional Patent Application Ser. No. 60/816,842, filed Jun. 27, 2006, incorporated herein by reference, is hereby claimed. 
         [0005]    Priority of U.S. Provisional Patent Application Ser. No. 60/761,402, filed Jan. 23, 2006, incorporated herein by reference, is hereby claimed. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0006]    Not applicable 
       REFERENCE TO A “MICROFICHE APPENDIX” 
       [0007]    Not applicable 
       BACKGROUND OF THE INVENTION 
       [0008]    1. Field of the Invention 
         [0009]    The present invention relates to devices for holding or securing the leg of a patient during knee arthroscopy surgery and any other medical procedures that require immobilizing of a patient&#39;s leg. More particularly, the present invention relates to a leg restraining apparatus that is connectable to an operating room table and that holds the patient&#39;s leg above the knee during knee surgery or like medical procedures. Even more particularly, the present invention relates to an improved method and apparatus for restraining the leg of a patient above the knee wherein a specially configured restraining member is equipped in one embodiment with an inflatable bladder that interfaces between the restraining member and the patient&#39;s leg and in other embodiments, cradles the leg both above and below and in other embodiments, provides an interlocking ratcheting mechanism that enables a surgeon to selectively tighten the device around the patient&#39;s leg. 
         [0010]    2. General Background of the Invention 
         [0011]    During numerous medical procedures, the leg of a patient must be restrained. For example, a patient&#39;s leg must be restrained during knee surgery. 
         [0012]    There is a prior U.S. Pat. No. 4,766,892 issued to Gary Krietman that discloses a leg restraint device adapted for orthopedic examinations and operating procedures that provides a firm support for a portion of a patient&#39;s limb while the limb or joint is manipulated or stressed. The restraint includes a rigid frame which defines a partially enclosed area within which the patient&#39;s limb is inserted. The enclosed area of the frame accommodates a blood pressure type air bag cuff which is secured to the frame by a fastener. Restraintive force is applied to the limb and monitored by pressurizing the air bag to a controlled level. In one embodiment, the partially enclosed area is shaped as an inverted “U” and with the operating table providing the bottom closure. In a further embodiment, the frame includes a horizontal weigh which extends along the operating table and terminates at an upward laterally curved jaw. An adjustable medially curved jaw is positioned along the weigh. After the adjustable jaw has been positioned, the air bag is pressurized to restrain the limb. 
         [0013]    The present invention is an improvement of the device shown in the Krietman U.S. Pat. No. 4,766,892. 
       BRIEF SUMMARY OF THE INVENTION 
       [0014]    The method and apparatus of the present invention incorporates the use of a polycarbonate materials combined with a air bladder to fixate the leg for the purposes of a medical procedure, such as knee arthroscopy and other procedures that include but are not limited to EP studies, vascular intervention via catheters, where the leg is required to remain immobile to facilitate the medical procedure. 
         [0015]    The apparatus of the present invention is unique in its concept and structural design, incorporating proprietary structural ridges and support biases, to provide the stiffness and strength characteristics to withstand a minimum of 50 lbs lateral force when flexing valgus and varus angle pressure on the knee joint for arthroscopic knee surgery exposure. 
         [0016]    The present invention utilizes an intricate design of Celstran ridges, supports, cross members, and diagonal supports. 
         [0017]    The apparatus of the present invention is designed to be both a “disposable leg restraint”, and/or a re-useable device in those markets that are not suited for a disposable device. The device weighs between 1 and 1.5 lbs, and is made of about 60% glass polycarbonate material(s). 
         [0018]    The present invention is light weight, can be disposable, and negates any cross contamination potential for infection and affords direct access to all points of the knee joint. The apparatus of the present invention provides ease of use and set-up, cost effectiveness by avoiding re-sterilization, cleaning, and administrative costs such as record keeping and liability costs. 
         [0019]    The apparatus of the present invention does not act as a tourniquet, and allows for continuation of procedure during long cases requiring release of tourniquet, permits limited blood flow-safety factor. The apparatus of the present invention provides enhanced patient comfort and safety via air bladder that insures equal distribution of stress forces. The apparatus of the present invention can be sterile draped and is readily removable during surgical procedure (w/o breaking sterility) extending operative field. 
         [0020]    The apparatus of the present invention can be manufactured as a single molded piece and/or a two section piece incorporating a metal stem (SS/titanium/etc) attached to a polycarbonate arc that supports the air bladder cushion system for immobilizing the leg. 
         [0021]    The materials can comprise 60% long strand glass and polycarbonate plastics (e.g. Celstran PA66-GF60-02-BK) and can be produced in a variety of colors (black, natural, yellow, red, blue). 
         [0022]    An optional bottom attachment can be used to connect the proximal portion of the arc and the distal end of the arc, in the event that it might be required to provide addition stiffness to the overall brace. The attachment would be passive, merely clipping into place, and supporting additional lateral force, should it be needed. 
         [0023]    The present invention incorporates a unique approach to fixating the leg via two methods. In a first method, a base (e.g. Celestran) with interlocking teeth on both sides of the base engage two semi circular pieces that complete the encirclement of the leg, around a circular foam padding (adjusts for size). The operator merely tightens the encircling pieces to the desired tension/fixation position by pressing inward and engaging the next set of teeth on the ends of the two encircling pieces. 
         [0024]    The tension of encirclement increases the engagement on the teeth since all the pressure is outward keeping the teeth well engaged into one another. To release, one merely pulls upward on the piece with the handle, and the system of encirclement releases pressure totally, allowing for the removal of the device after the procedure. The attached CAD drawings clearly depict the construction and design of the device, alluding to the unique structural supports required to withstand the lateral pressures of knee surgery requirements. 
         [0025]    In a second procedure and embodiment, a base that is somewhat larger and more encompassing than “a” provides a more stabilizing structure to attach a ridged belt that serves to encircle the leg, pass through a geared mechanism that has a locking pin to immobilize the gear and fix the belt at the desired point of tension/fixation. 
         [0026]    The tension on the belt is achieved by merely pulling downward/outward on the belt as it passes thru the gear and out of the base housing, and at the desired tension is fixed by engaging the locking pin to the gear. This locks the belt in place, and it can not be released without disengaging the locking pin. 
         [0027]    The ridged belt can be padded with a foam pad between the belt and the patients leg. Either of these devices can be manufactured as “disposable” devices, and re-useable devices for those markets that do not lend themselves to disposable products. The foam pads would be a disposable item helping to eliminate the potential for cross contamination and/or infection on both embodiments. These devices can be manufactured as a single base portion with the above described attachments/components, and are unique in design and concept for fixating a leg for the purposes of providing leg stability for medical procedures such as arthroscopic knee surgery and any other medical procedures that require the use of keeping the leg immobile (such as EP studies, vascular catheter intervention-angioplasty and/or stent placement). The first embodiment involves the use of an air bladder and does not totally encircle the leg tension. The second embodiment does in fact encircle the leg and does perform a limited tourniquet effect, while not employing the air bladder. Both embodiments are for practical purposes, aside of design and mechanical function, provide the same features, benefits and advantages. Both can be disposable in nature or re-useable as well. The re-useable model in both embodiments would incorporate a disposable feature. The “air bladder” could be a disposable item. The foam pad would be a disposable item. When designated as a single use device, the entire device would be disposed of after each use. 
         [0028]    The present invention includes a limb restraining apparatus for use in combination with a table upon which a patient is resting, comprising: a restraining member removably attached to the table, the restraining member being an integrally molded plastic member having a curved underside concave portion that is positioned to cradle the patient&#39;s leg from a position above the patient&#39;s leg; the restraining member preventing substantial movement of the patient&#39;s limb while allowing movement and manipulation of a distal limb section; a flexible support attached to the concave portion of the restraining member; and the upper surface of the restraining member being a convex surface that is reinforced with a plurality of webs that intersect to form acute angles. 
         [0029]    Preferably, flexible support is an inflatable cuff. 
         [0030]    Preferably, the present invention further comprises a cradle that removably fits the restraining member, the cradle having an upwardly facing concavity that cradles the patient&#39;s leg from below. 
         [0031]    Optionally, the restraining member is of a polycarbonate material. 
         [0032]    Optionally, the restraining member is of a glass polycarbonate blend. 
         [0033]    Optionally, the restraining member is of in excess of 50% long strand glass and polycarbonate plastic material. 
         [0034]    Preferably, the cuff includes an inflation stem, the restraining member including an aperture, the stem extending through the aperture to facilitate inflation. 
         [0035]    The present invention includes a method of accessing areas of a limb joint for insertion and manipulation of arthroscopic instruments during anthroscopic examination or surgery, the method comprising the steps of: confining a first zone of a limb with a restraining member that has a downwardly facing concavity that covers the top and at least part of the sides of the limb, said restraining member including on the inside an air bag cuff, the first zone being positioned between the patient&#39;s body and the joint, said restraining member including on the outside a plurality of structural ridges that form multiple acute angles; immobilizing the air bag cuff; inflating the cuff to a minimum predetermined pressure to restrain the first zone from movement; monitoring and maintaining the inflating pressure while stressing the limb joint, the stressing of the joint being attained by applying forces to a second zone of the limb, the second zone being spaced from the joint in a direction away from the patient&#39;s body. 
         [0036]    Preferably, the limb is a leg, the joint comprising a knee joint, the first zone comprising a portion of a thigh, the step of immobilizing the air bag cuff comprising immobilizing the cuff adjacent the top and opposite sides of the thigh. 
         [0037]    Preferably, the confining step includes positioning the cuff only around the top and sides of the thigh, the underside of the thigh being free of contact with the inflated cuff. 
         [0038]    Preferably, the joint is stressed by applying rotational stress to the second zone relative to the first zone. 
         [0039]    Preferably, the step of immobilizing the cuff comprises fixing the cuff with respect to a rigid frame, the frame being operatively positioned to overlie the air bag cuff, the fixing step comprising peripherally securing the cuff to the frame, the frame being spaced from the first zone. 
         [0040]    The present invention includes a method of restraining a portion of a limb of a patent resting upon a surgical table for orthopedic examination and operating procedures upon a joint of the limb, the method comprising the steps of: providing a restraining member having a rigid support that surrounds the top and sides of the limb to be restrained, said restraining member having an upper convex surface reinforced with a plurality of intersecting ridges and a lower concave surface that engages a patient&#39;s leg, and an inflatable cuff on the lower curved surface; registering the restraining member with a first zone of the limb, the first zone being spaced from the joint in a direction towards the patient&#39;s torso by adjustably anchoring the rigid support means to the table at a selected position along the length of the table, the support means being out of direct contact with the limb; peripherally confining the first zone of the limb except for an underside portion of the first zone resting upon the surgical table with the inflatable cuff; applying restraintive force to the first zone by inflating the cuff to a pressure while immobilizing portions of the cuff spaced from the first zone of the limb with the rigid support means; monitoring and maintaining the inflated pressure of the cuff for the duration of the operating procedure; and separating portions of the joint to permit the insertion and manipulation of arthroscopic instruments by applying controlled forces to a second zone of the limb, the second zone being spaced from the joint in a direction away from the first zone. 
         [0041]    Preferably, the cuff includes an outer periphery, the step of inflating and immobilizing the cuff includes the step of anchoring the cuff to the restraining member. 
         [0042]    Preferably, the restraining member includes a plastic frame having a depending leg, the step of anchoring including anchoring the restraining member to the table by inserting the flange into a slot which provided on the table. 
         [0043]    The present invention includes a method of stabilizing and rendering immobile the thigh area of a patient for cardiovascular intervention procedures involving the placement of catheters and/or instruments in the patient&#39;s cardiovascular system via the femoral arterial vessel, whereby catheter placement and maintenance of position is vital to successful angioplasty intervention and/or placement of arterial stents. 
         [0044]    The present invention includes a limb restraining apparatus for use in combination with a table upon which a patient is resting, comprising: a restraining member removably attached to the table, the restraining member being an integrally molded plastic member having a curved underside concave portion that is positioned to cradle the patient&#39;s leg from a position above the patient&#39;s leg; the restraining member preventing substantial movement of the patient&#39;s limb while allowing movement and manipulation of a distal limb section; a flexible belt attached to the restraining member, the belt extending about 360 degrees for encircling and holding a patient&#39;s leg; and interlocking portions of the belt enabling the belt to adjust to legs of differing sizes. 
         [0045]    Preferably, the belt has multiple sections. 
         [0046]    Preferably, the belt has interlocking toothed portions. 
         [0047]    Preferably, the belt has a handle at one end portion for enabling tension to be applied to the belt. 
         [0048]    Preferably, the belt has belt teeth on a surface of the belt and further comprising a toothed wheel on the restraining member that engages the belt teeth. 
         [0049]    Preferably, the toothed wheel can be rotated to tighten or loosen the belt about a patient&#39;s leg. 
         [0050]    Preferably, the belt has teeth on a belt outer surface, the belt having an inner surface that engages the patient&#39;s leg. 
         [0051]    Preferably, there is a locking device that locks movement of the belt and wheel in a selected position. 
         [0052]    Preferably, the locking device comprises aperatures on the wheel and a locking pin that can interlock with a selected one of the aperatures. 
         [0053]    The present invention includes a tourniquet in order to lower the position of the tourniquet from the high thigh to proximal to the knee joint, thus reducing potential tissue and vascular damage caused by the tourniquet on the upper thigh area. 
         [0054]    The present invention can be used for procedures including ACL repairs, arthroscopy meniscus repair, and vascular intervention. 
         [0055]    The present invention includes a single device with no moving parts and/or attachments. The present invention does not require added bottom support. The present invention can be used on various patients, including small school soccer players, older athletes, adults and elderly (both slim and obese). 
         [0056]    In the present invention, a surgeon can use the device for quick case repairs. Using the device of the present invention, a surgeon can perform a surgery in a seated position. The present invention saves time and costs. Patients benefit from the comfort and stability of the present invention. There is less operative time and lower costs associated with use of the present invention. One other advantage is that the apparatus of the present invention standardizes the arthroscopic procedure approach for every patient. The device is easy to set up and avoids MCL tears during surgery that would occur using another apparatus. 
         [0057]    The present invention includes a method of accessing areas of a leg joint of a patient who is supported upon an operating room table, for insertion and manipulation of arthroscopic instruments during surgical arthroscopic examination of the patient&#39;s leg joint. The method provides a restraining member that removably attaches to the operating room table, the restraining member having a connecting portion that includes a flange and that attaches to the table, a curved section having a free end, and a thickened transition section that joins the connecting flange to the curved section, the transition section having a first tapered portion connecting to the flange and a second tapered portion connected to the curved section, said first and second tapered sections joined together. A first zone of the patient&#39;s leg can be confined with the restraining member, wherein the restraining member covers the top and part of the sides of the patient&#39;s leg, but does not engage the underside of the patient&#39;s leg that rests upon the operating room table. The curved section can extend over but does not encircle the patient&#39;s leg. 
         [0058]    In one embodiment, the joint can comprise the patient&#39;s knee joint, the first zone can comprise a portion of the patient&#39;s thigh, and further comprises the step of selectively immobilizing the leg with an inflatable cuff adjacent the top and sides of the patient&#39;s thigh by inflation of said cuff. 
         [0059]    In one embodiment, the cuff can be placed only around the top and sides of the patient&#39;s thigh, the underside of the thigh being free of contact with the inflatable cuff. 
         [0060]    In one embodiment, the patient&#39;s leg joint can be stressed by applying rotational stress to a second zone of the patient&#39;s leg relative to the said first zone. 
         [0061]    In one embodiment, the inflatable cuff can be not connected to the patient&#39;s thigh at a position spaced proximally of the restraining member. 
         [0062]    The present invention includes a method of restraining a portion of a leg of a patient resting upon a surgical table for orthopedic examination upon a knee joint of the patient&#39;s leg. The method can provide a restraining member having a rigid curved support that surrounds the top and sides of the leg to be restrained, said restraining member having a lower concave curved surface that engages the patient&#39;s leg, and an inflatable cuff on the lower concave curved surface. The restraining member can be registered with a first zone of the patient&#39;s leg above the knee, the first zone being spaced from the knee joint in a direction towards the patient&#39;s torso by adjustably anchoring the rigid support member to the table at a selected position along the length of the table. The first zone of the leg can be peripherally confined with the curved support. The underside of the patient&#39;s leg can be rested upon the surgical table. Portions of the joint can be separated to permit the insertion and manipulation of arthroscopic instruments by applying controlled forces to a second zone of the leg below the knee, the second zone being spaced from the knee joint in a direction away from the first zone. The restraining member does not encircle the patient&#39;s leg in any of the steps. 
         [0063]    In one embodiment, the inflatable cuff can be connected to the curved support and further comprise selectively inflating the cuff. 
         [0064]    In one embodiment, the restraining member can include a plastic frame having a flange and anchoring the flange to the table by inserting the flange into a slot on the table. 
         [0065]    The present invention includes a leg restraining apparatus for use in knee surgery wherein a patient is resting on an operating room table. The invention can comprise a restraining member removably attached to the said table, the restraining member being an integrally molded, generally semicircular plastic member having a curved underside concave portion that can be sized and shaped to conform the patient&#39;s leg from a position above the patient&#39;s leg. The restraining member can prevent substantial movement of the patient&#39;s leg while allowing movement and manipulation of the patient&#39;s distal leg section. An inflatable cuff can be attached to the restraining member, the cuff extending only a partial distance around the patient&#39;s leg including engaging the upper surface of the patient&#39;s leg but not the underside of the patient&#39;s leg. 
         [0066]    The present invention includes a leg restraining apparatus for use in knee surgery and in combination with a surgical table upon which a patient is resting. The invention includes a restraining member that can be removably attached to the table, the restraining member being an integrally molded plastic member having a curved section with an underside concave surface that is positioned to cradle part of the patient&#39;s leg from a position above the patient&#39;s leg. The restraining member can prevent substantial movement of the patient&#39;s leg while allowing movement and manipulation of that patient&#39;s distal leg section below the patient&#39;s knee. The restraining member can have a connector that enables connection to the table. The restraining member can have a thickened section in between the connector and the curved section, the thickened section including first and second tapered sections that are joined at a location of maximum cross sectional area of the thickened section. 
         [0067]    In one embodiment, the present invention can further comprise an inflatable cuff attached to said curved section. 
         [0068]    In one embodiment, the inflatable cuff does not encircle the patient&#39;s leg. 
         [0069]    In one embodiment, the present invention can further comprise a cradle that can be removably connectable to the restraining member, the cradle having an upwardly facing concavity that cradles the patient&#39;s leg from below. 
         [0070]    In one embodiment, the restraining member can be of a polycarbonate material. 
         [0071]    In one embodiment, the restraining member can be of a glass polycarbonate blend. 
         [0072]    In one embodiment, the restraining member can be of in excess of 50% long strand glass and polycarbonate plastic material. 
         [0073]    In one embodiment, the cuff can include an aperture, the connector extending through the aperture to facilitate inflation. 
         [0074]    In one embodiment, the restraining member extends about half way around the patient&#39;s leg. 
         [0075]    In one embodiment, the first tapered section can be attached to the connector and a second tapered section can be attached to the curved section, wherein the first tapered section has a smallest cross sectional area next to the connector. 
         [0076]    In one embodiment, the first tapered section can be attached to the connector and the second tapered section can be attached to the curved section, wherein the second tapered section has a smallest cross sectional area next to the curved section. 
         [0077]    In one embodiment, the first tapered section can have two surfaces that form an acute angle. 
         [0078]    In one embodiment, the second tapered section can have two surfaces that form an acute angle. 
         [0079]    In one embodiment, an obtuse angle can be formed by one surface of the first tapered section and one surface of the second tapered section. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0080]    For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein: 
           [0081]      FIG. 1  is a fragmentary perspective view of a preferred embodiment of the apparatus of the present invention; 
           [0082]      FIG. 2  is a sectional view taken along lines  2 - 2  of  FIG. 1 ; 
           [0083]      FIG. 3  is a sectional view taken along lines  3 - 3  of  FIG. 1 ; 
           [0084]      FIG. 4  is a top view taken along lines  4 - 4  of  FIG. 1 ; 
           [0085]      FIG. 5  is a partial perspective view of a preferred embodiment of the apparatus of the present invention; 
           [0086]      FIG. 6  is a partial perspective view of a preferred embodiment of the apparatus of the present invention; 
           [0087]      FIG. 7  is a partial perspective view of a preferred embodiment of the apparatus of the present invention; 
           [0088]      FIG. 8  is a perspective view of a preferred embodiment of the apparatus of the present invention; 
           [0089]      FIG. 9  is a fragmentary perspective exploded view of a preferred embodiment of the apparatus of the present invention; 
           [0090]      FIG. 10  is a close-up perspective view of a preferred embodiment of the apparatus of the present invention; 
           [0091]      FIG. 11  is a fragmentary perspective view of a preferred embodiment of the apparatus of the present invention illustrating a different construction for the restraining member; 
           [0092]      FIG. 12  is a fragmentary perspective view of a preferred embodiment of the apparatus of the present invention illustrating a different construction for the restraining member; 
           [0093]      FIG. 13  is a fragmentary perspective view of a preferred embodiment of the apparatus of the present invention illustrating a different construction for the restraining member; 
           [0094]      FIG. 14  is a perspective view of an alternate embodiment of the apparatus of the present invention; 
           [0095]      FIG. 15  is a perspective view of an alternate embodiment of the apparatus of the present invention; 
           [0096]      FIG. 16  is a sectional elevation view of the second embodiment of the apparatus of the present invention; 
           [0097]      FIG. 17  is a fragmentary sectional view of the second embodiment of the apparatus of the present invention; 
           [0098]      FIG. 18  is an exploded perspective view of the second embodiment of the apparatus of the present invention; 
           [0099]      FIG. 19  is a perspective view of a third embodiment of the apparatus of the present invention; 
           [0100]      FIG. 20  is a perspective view of a third embodiment of the apparatus of the present invention; and 
           [0101]      FIG. 21  is a sectional view taken along lines  21 - 21  of  FIG. 19 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0102]      FIGS. 1-10  show a preferred embodiment of the apparatus of the present invention designated generally by the numeral  10  in  FIG. 8 . 
         [0103]    Leg restraint apparatus  10  is shown in use in  FIG. 8  with a standard operating room table  11  having an upper surface  12  that is receptive of a patient  13 . During certain types of orthopedic examination procedures or surgeries, it is necessary to restrain or immobilize a patient&#39;s leg  14 . A locking mechanism  15  is used in combination with table  11  to hold the leg  14  of a patient  13 . The locking mechanism  15  includes a body  16  that is mounted to the table  11 . The body  16  provides a vertical slot  17  intersected laterally with an internally threaded opening  18  that is receptive of threaded set screw  19 . In this fashion, restraining member  20  or  20 A or  20 B can be inserted into slot  17  and then clamped and rigidly held to body  16  when set screw  19  is tightened relative to body  16 . Operating room tables  11  typically have instrumentation holders for varied apparatus that slide along table rails for positioning, then clamped down in accordance with the patient&#39;s height/size. 
         [0104]    The restraining member  20 ,  20 A,  20 B can include a vertical or mounting flange  22  to which is integrally attached a thickened section  23  and a curved section  21 . The restraining member  20 ,  20 A,  20 B is of a disposable plastic material, such as of injection molded plastic. 
         [0105]    Curved section  21  provides an upper surface  24  that is reinforced with a plurality of longitudinal webs  25  and a plurality of diagonally positioned webs  26 . Lower surface  27  of curved section  21  is preferably smooth, as shown in  FIGS. 1 and 2 . As seen in  FIG. 2 , flange  22  has inner surface  22   a  and outer surface  22   b . Thickened section  23  has surfaces  23   a ,  23   b ,  23   c . Surfaces  22   a ,  23   b  form a first obtuse angle. Surfaces  22   b ,  23   c  form a second obtuse angle that is larger than the first obtuse angle. 
         [0106]    The first obtuse angle created by surfaces  22   a  and  23   b  can be preferably 121°-125°, and most preferably 123°. The second obtuse angle created by surfaces  22   b  and  23   c  can be preferably 141°-145°, and most preferably 143°. This is preferably the angle range at which the thickened section  23  can be molded and therefore maintain the required rigidity and strength of the brace arc. A different angle could be used based on the different size of the overall arc/brace required, for example, to accommodate smaller or larger leg mass based on the size of a person. Adjusting the angle to a greater or a smaller angle would result in a reduced or increased arc facilitating the overall size of the brace and its use with different leg sizes. This variation of angle ranges would allow for extreme sizes and possibly rigidity and strength issues when made with hybrid materials. 
         [0107]    The angles as specified herein fit approximately 95% of the population due to the design and use of the air bladder/tourniquet technique. The design is further unique in that this angle arc interface allows for a singular device to address such a large population of patients requiring no further adjustment in order to perform the surgical procedures of meniscectomy and/or ACL repair. Furthermore, it allows for the implementation of a technique that does no require a tourniquet by applying partial restrictive pressure to blood vessels via the air bladder, combined with cold saline, to perform meniscus repairs (the air bladder does not circumvent the patient limb/leg). The aspect that the air bladder does not circumvent the limb is also unique, as other devices with air bladders and/or foam padding circumvent the limb. 
         [0108]    Opening  28  extends between the upper surface  24  and lower surface  27 . The leg restraining member  20  provides sides  29 ,  30  that are preferably flat and generally parallel. In  FIGS. 3-10 , restraining member  20  is provided with an inflatable bladder  31 . 
         [0109]    The bladder  31  can be supplied with air through a valve  32 . As indicated by arrow  33  in  FIG. 5 , valve  32  can extend through opening  28 . Inflatable bladder  31  can be attached to restraining member  20  using adhesive  34  as indicated by arrow  35  in  FIG. 5 . 
         [0110]    Inflatable bladder  31  can be attached to restraining member  20  using a hook and loop or Velcro® type connection, the hook fasteners  36  being attached for example to inflatable bladder  31  while the loop fasteners  37  are provided on the curved surface  27  of restraining member  20 . Arrow  38  in  FIG. 7  illustrates an attachment of bladder  31  to restraining member  20  using a hook fastener  36  and loop fastener  37  connection. 
         [0111]    In  FIGS. 11-13 , other arrangements of a restraining member are shown. In  FIG. 11 , restraining member  20 A provides an ell shaped flanged member  40  that is separate from curved section  21 , the parts  21 ,  40  being joined with a connection  39  that is formed by a plurality of openings  41  in flanged member  40  that align with openings  43  through flanges  45 ,  46  of curved section  21 . The parts  21  and  40  being secured with one or more bolted connections that can include a plurality of bolts  42  and nuts  44  as shown in  FIG. 11 . Slot  47  provides a space in between the flanges  45 ,  46  that is receptive of flange member  40 . 
         [0112]    In  FIGS. 12 and 13 , the restraining member  20 B is first threaded through a leg cradle  48  having a projection  49  that cooperates with and connects to a socket  50  provided on the restraining member  20 B. In  FIG. 13 , the connection has been complete, the vertical flange  22  of restraining member  20 B extending through opening  73  of cradle  48  and then being connectable to the body  16  as with the embodiment of  FIGS. 1-10 . 
         [0113]      FIGS. 14-18  show another embodiment of the apparatus of the present invention, designated generally by the numeral  51 . 
         [0114]    Leg restraining apparatus  51  provides a vertical flange  52  that is connectable to the vertical slot  17  of body  16  using threaded set screw  19  and internally threaded opening  18  as with the embodiment of  FIGS. 1-13 . In  FIG. 14 , a cradle  53  has a flat underside that can be rested upon upper surface  12  of operating room table  11 . Cradle  53  provides a concavity  55  defined by curved surface  56  of cradle  53 . Cradle  53  provides a curved slot  57  that is receptive of belt  58 . The belt  58  can include multiple belt sections  69 ,  70 . 
         [0115]    A belt free end portion  59  forms a connection with another belt free end portion  60 . Outer surface  61  of each belt section  69 ,  70  can be provided with transverse grooves  62  for increasing belt  58  flexibility. Each belt section  69 ,  70  has an inner surface  63  that is generally smooth and curved as shown. However, the inner surface  63  of each belt  58  or belt section  69 ,  70  can also be provided with transverse grooves  64  as shown. 
         [0116]    The belt free end portion  60  provides a handle  65  that enables a user to tighten the free end portion  60  relative to the free end portion  59 . In that regard, the free end portion  59  provides upwardly facing teeth  66 , while the free end portion  60  provides downwardly facing teeth  67  as shown in  FIGS. 14-18 . If the belt  58  is formed of multiple belt sections  69 ,  70 , the curved slot  57  can provide teeth at  74  that form a connection with the teeth  71 ,  72  of the belt sections  69 ,  70 . 
         [0117]    In  FIGS. 15-16 , the patient&#39;s leg  14  is shown secured within the belt sections  69 ,  70 . A donut shaped pad  68  can be placed as an interface between the belt sections  69 ,  70  and cradle  53  and the patient&#39;s leg  14 . 
         [0118]      FIGS. 19-21  show another embodiment of the apparatus of the present invention. In  FIGS. 19-20 , leg restraining apparatus  75  provides a vertical flange  76  that is integrally attached to cradle  77 . Cradle  77  provides a flat surface or underside  78  that can rest upon the operating room table  11  upper surface  12 . Cradle  77  provides a concavity  79  defined by curved surface  80 . The curved surface  80  can extend a full 180 degrees as shown in  FIG. 20  or can be less than 180 degrees as shown in  FIG. 19 . An ell shaped channel  81  extends through cradle  77  as shown in  FIG. 19 . Channel  81  extends to pinion gear  82  and then exits via outlet  96 . The free end portion of belt  84  can be gripped at d-ring  89  by a user as shown in  FIG. 19 , illustrated schematically by the arrow  97 . Belt  84  is a toothed belt, having a toothed surface  87  that engages teeth  83  of pinion gear  82 . Belt anchor pin  85  anchors belt  84  to cradle  77  as shown in  FIGS. 19 and 20 . Belt anchor pin  85  is secured to pin opening  86 , also extending through an opening at an end portion of the belt  84 . 
         [0119]    Pinion gear  82  has a gear shaft  90  that is mounted to opposing sides of cradle  77  as shown in  FIG. 21 . Locking pin  91  can be used to form an interlocking connection with an opening  95  in gear plate  94  that is attached to and rotates with pinion gear  82 . Locking pin  91  can provide a knob  92  and spring  93 . The spring  93  normally holds the locking pin  91  in a locking position as is shown in  FIG. 21 . Knob  92  enables a user to pull the pin away from pinion gear  82  for unlocking the pinion gear and enabling a user to tighten the belt  84 . When a user releases the knob  92 , spring action provided by spring  93  thrusts the locking pin  91  back into engagement with one of the openings  95  in plate  94  of gear  82 . 
         [0120]    The embodiment of  FIGS. 19-21  can also be used with a donut shaped pad  68 , as is shown in  FIGS. 15-16 . 
         [0121]    The following is a list of parts and materials suitable for use in the present invention. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                   
               
               
                 PARTS LIST 
               
             
          
           
               
                   
                 Part Number 
                 Description 
               
               
                   
                   
               
               
                   
                 10 
                 leg restraint apparatus 
               
               
                   
                 11 
                 operating room table 
               
               
                   
                 12 
                 upper surface 
               
               
                   
                 13 
                 patient 
               
               
                   
                 14 
                 leg 
               
               
                   
                 15 
                 locking mechanism 
               
               
                   
                 16 
                 body 
               
               
                   
                 17 
                 vertical slot 
               
               
                   
                 18 
                 internally threaded opening 
               
               
                   
                 19 
                 threaded set screw 
               
               
                   
                 20 
                 restraining member 
               
               
                   
                 20A 
                 restraining member 
               
               
                   
                 20B 
                 restraining member 
               
               
                   
                 21 
                 curved section 
               
               
                   
                 22 
                 vertical flange/mounting flange 
               
               
                   
                 22a 
                 inner surface 
               
               
                   
                 22b 
                 outer surface 
               
               
                   
                 23 
                 thickened section 
               
               
                   
                 23a 
                 surface 
               
               
                   
                 23b 
                 surface 
               
               
                   
                 23c 
                 surface 
               
               
                   
                 24 
                 upper surface 
               
               
                   
                 25 
                 longitudinal web 
               
               
                   
                 26 
                 diagonal web 
               
               
                   
                 27 
                 lower surface 
               
               
                   
                 28 
                 opening 
               
               
                   
                 29 
                 side 
               
               
                   
                 30 
                 side 
               
               
                   
                 31 
                 inflatable bladder 
               
               
                   
                 32 
                 valve 
               
               
                   
                 33 
                 arrow 
               
               
                   
                 34 
                 adhesive 
               
               
                   
                 35 
                 arrow 
               
               
                   
                 36 
                 hook fastener 
               
               
                   
                 37 
                 loop fastener 
               
               
                   
                 38 
                 arrow 
               
               
                   
                 39 
                 connection 
               
               
                   
                 40 
                 flanged member 
               
               
                   
                 41 
                 opening 
               
               
                   
                 42 
                 bolt 
               
               
                   
                 43 
                 opening 
               
               
                   
                 44 
                 nut 
               
               
                   
                 45 
                 flange 
               
               
                   
                 46 
                 flange 
               
               
                   
                 47 
                 slot 
               
               
                   
                 48 
                 leg cradle 
               
               
                   
                 49 
                 projection 
               
               
                   
                 50 
                 socket 
               
               
                   
                 51 
                 leg restraining apparatus 
               
               
                   
                 52 
                 vertical flange 
               
               
                   
                 53 
                 cradle 
               
               
                   
                 54 
                 flat underside 
               
               
                   
                 55 
                 concavity 
               
               
                   
                 56 
                 curved surface 
               
               
                   
                 57 
                 curved slot 
               
               
                   
                 58 
                 belt 
               
               
                   
                 59 
                 free end portion 
               
               
                   
                 60 
                 free end portion 
               
               
                   
                 61 
                 outer surface 
               
               
                   
                 62 
                 transverse groove 
               
               
                   
                 63 
                 inner surface 
               
               
                   
                 64 
                 transverse groove 
               
               
                   
                 65 
                 handle 
               
               
                   
                 66 
                 teeth 
               
               
                   
                 67 
                 teeth 
               
               
                   
                 68 
                 pad 
               
               
                   
                 69 
                 belt section 
               
               
                   
                 70 
                 belt section 
               
               
                   
                 71 
                 teeth 
               
               
                   
                 72 
                 teeth 
               
               
                   
                 73 
                 opening 
               
               
                   
                 74 
                 teeth 
               
               
                   
                 75 
                 leg restraining apparatus 
               
               
                   
                 76 
                 vertical flange 
               
               
                   
                 77 
                 cradle 
               
               
                   
                 78 
                 flat underside 
               
               
                   
                 79 
                 concavity 
               
               
                   
                 80 
                 curved surface 
               
               
                   
                 81 
                 ell shaped channel 
               
               
                   
                 82 
                 pinion gear 
               
               
                   
                 83 
                 tooth 
               
               
                   
                 84 
                 belt 
               
               
                   
                 85 
                 belt anchor pin 
               
               
                   
                 86 
                 pin opening 
               
               
                   
                 87 
                 toothed surface 
               
               
                   
                 88 
                 smooth surface 
               
               
                   
                 89 
                 d-ring 
               
               
                   
                 90 
                 gear shaft 
               
               
                   
                 91 
                 locking pin 
               
               
                   
                 92 
                 knob 
               
               
                   
                 93 
                 spring 
               
               
                   
                 94 
                 gear plate 
               
               
                   
                 95 
                 opening 
               
               
                   
                 96 
                 outlet 
               
               
                   
                 97 
                 arrow 
               
               
                   
                   
               
             
          
         
       
     
         [0122]    All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise. 
         [0123]    The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.