Abstract:
A medical stirrup device includes a base adapted for fixed securement to an associated support member. The device further includes a gooseneck shaft member having a proximal end connected to the base and a distal end spaced from the base. The gooseneck shaft member is selectively manually bendable by an end-user into a curvilinear operative shape between an unbent linear position and a bendable limit of the gooseneck shaft member. A fastener is located at the distal end of the gooseneck shaft member. The fastener is adapted to engage a mating fastener of an associated limb support member to connect the associated limb support member to the shaft. In one version of the development, the shaft member includes first and second co-axial spiral-wound tubular members. In another version, the shaft has adjustable rigidity and is defined from a series of articulated links. A method of positioning a human limb for a medical procedure is also disclosed.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    The present development relates to a medical stirrup device and method for supporting patient limbs during surgery or other procedures. More particularly, the present development relates to a pediatric stirrup device for supporting the legs or arms of an infant or other small child during surgery or other procedures.  
           [0002]    Medical stirrup devices are well known and in widespread use. Heretofore, medical stirrup devices have been provided in one of two forms. One prior device is exemplified by that disclosed in U.S. Pat. No. 3,982,742 to Ford. The Ford &#39;742 patent discloses a medical stirrup device that utilizes an elongate curvilinear shaft to support foot/ankle straps. The shaft is said to be “flexible” but the shaft are preformed into the curvilinear shape and are not bendable or moldable into a different shape. To adjust the position of the foot/ankle strap and, consequently, the patient&#39;s limb supported thereby, the shaft is rotated. The shaft cannot be bent or otherwise shaped by an end-user during a procedure or otherwise.  
           [0003]    Other stirrup devices are disclosed, e.g., in U.S. Pat. No. 3,944,205 to Mueller and U.S. Pat. No. 6,289,537 to Hopper et al. Here, various linkages and the like are used to adjust the position of the foot/ankle support. The Mueller &#39;205 patent discloses a stirrup extension bar held in place during use by friction. The Hopper &#39;537 patent also discloses a device that relies upon friction to hold the stirrup support shaft in a desired operative position.  
           [0004]    These prior devices and others have been found to be unsuitable for use during pediatric procedures. In particular, these prior devices do not provide a convenient and effective means by which a physician, nurse or technician can infinitely adjust limb position prior to beginning or in the midst of a procedure. Also, these prior devices typically provide a completely rigid support that does not yield at all to increase comfort. Furthermore, with these prior devices, it is possible to set the stirrup in a position that results in over-extension of the patient&#39;s limb. In light of the foregoing, a need has been identified for a novel and unobvious medical stirrup device that overcomes the foregoing deficiencies and others while providing better overall results.  
         SUMMARY OF THE INVENTION  
         [0005]    In accordance with the present invention, a medical stirrup device comprises a base adapted for fixed securement to an associated support member. A gooseneck shaft member includes a proximal end connected to the base and a distal end spaced from the base. The gooseneck shaft member is selectively manually bendable into a curvilinear operative shape between an unbent linear position and a bendable limit of the gooseneck shaft member. A fastening element is located at the distal end of the gooseneck shaft member. The fastening element is adapted to engage an associated mating fastening element of an associated limb support member to connect the associated limb support member to the gooseneck shaft member. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]    The invention comprises various components and arrangements of components, preferred embodiments of which are illustrated in the accompanying drawings that form a part hereof and wherein:  
         [0007]    [0007]FIG. 1 is a perspective view of first and second stirrup devices formed in accordance with the present invention operatively secured to opposite lateral sides of a procedure table (with the table being only partially shown);  
         [0008]    [0008]FIG. 2 is a front elevational view of a medical stirrup device formed in accordance with the present invention in first and second positions, with the first position shown in phantom lines to illustrate the adjustability of the device;  
         [0009]    [0009]FIG. 3 is a partial side elevational view of the medical stirrup device of FIG. 2;  
         [0010]    [0010]FIG. 4 is similar to FIG. 2 but illustrates the shaft of the medical stirrup device in section; and,  
         [0011]    [0011]FIG. 5 is similar to FIG. 4 but illustrates a medical stirrup device formed in accordance with an alternative embodiment of the present invention.  
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0012]    Referring now to the drawings, which are for purposes of illustrating preferred embodiments only and are not intended to limit the invention in any way, FIG. 1 illustrates first and second identical medical stirrup devices  10  formed in accordance with the present invention. Each device  10  comprises a base  12  adapted for connection to a side-rail S of a procedure table T or another suitable support member. A handle  14  is connected to a set screw  16  that is used to releasably fixedly secure the base  12  to the side-rail S in a desired operative position. A gooseneck shaft  20  includes a proximal end  22  connected to the base and a distal end  24  spaced from the base  10 . A snap-hook, ring, split-ring, D-ring, clip, strap, hook-and-loop fastening element or other fastener or fastening element  32  is provided to mate releasably with a corresponding or mating fastener or fastening element  33  of a fabric loop or other limb support member  30  to the distal end  24  of the shaft  20 . The limb support member  30  is adapted to receive and retain a patient&#39;s limb/foot/ankle/leg/arm etc. as is generally known. The limb support member  30 , itself, is conventional in all respects and is omitted from FIGS.  2 - 5  for clarity.  
         [0013]    The medical stirrup device  10  is also shown in FIG. 2 and is partially shown in FIG. 3. There, it can be seen that the shaft  20  is made from gooseneck or other suitable material that is selectively flexible and/or bendable in any desired direction and into any desired position as indicated by the arrows A 1 ,A 2 . The bendable limit that determines the range of motion for the shaft  20  is defined herein as the a point where further bending of the shaft  20  will damage the shaft and/or permanently deform the shaft). The bendable limit of the shaft  20  will vary depending upon the particular gooseneck material used to manufacture the shaft  20 . The shaft  20  is bendable from a straight or unflexed position as shown in phantom to any desired curvilinear operative position such as that shown in solid lines up to the bendable limit of the shaft.  
         [0014]    [0014]FIG. 4 illustrates a preferred embodiment of the medical stirrup device  10  wherein the shaft  20  comprises first and second gooseneck members  40 , 50 . The first gooseneck member  40  comprises a proximal end  42  and a distal end  44 . The second gooseneck member  50  comprises a proximal end  52  and a distal end  54 . The first gooseneck member  40  defines a through-bore  46  in which the second gooseneck member  50  is positioned, in at least roughly a coaxial manner as shown. The second gooseneck member  50  also defines a through-bore  56 .  
         [0015]    The first and second gooseneck members  40 , 50  are fixedly secured to the base  12  by means of a first mounting stud  60 . In the illustrated embodiment, the first mounting stud  60  comprises a bosses  62 , 64  defined at its opposite ends. The boss  62  is slidably received in a bore  66  defined by the base  12 . A set-screw  68  is used to secure the boss  62  in the bore  66 . Alternatively, the first mounting stud  60  can be threadably secured to the base  12  or be secured by fasteners or be integral to the base as a one-piece construction or by a weld.  
         [0016]    The first and second gooseneck members  40 , 50  are both fixedly secured to the first mounting stud  60 . The boss  64  is closely slidably received in the bore  56  at the proximal end  52  of the second gooseneck member  50 . A set-screw  58  or other fastener or another suitable means is used to fixedly secure the boss  64  in the bore  56 . Similarly, at least a portion of the first mounting stud  60  is closely slidably received in the bore  46  of the first gooseneck member  40 . A set-screw  48  or other fastener or another suitable means is used to fixedly secure the first mounting stud  60  in the bore  46 . For aesthetics and to provide a good surface against which the set-screws  48 , 58  seat, the proximal end  42  of the first gooseneck member  40  is preferably surrounded by an inflexible sleeve member  34  as shown which is defined, e.g., from stainless steel. The set-screws  48 , 58  preferably pass through the sleeve member  34  and fixedly secure the sleeve member in position.  
         [0017]    A second mounting stud  70  is secured to the distal end  24  of the shaft  20 . More particularly, the second mounting stud  70  is fixedly secured to both the respective distal ends  44 , 54  of the first and second gooseneck members  40 , 50 . In the illustrated embodiment, the second mounting stud  70  comprises a boss  72  that is closely slidably received in the bore  56  at the distal end  54  of the second gooseneck member  50 . At least a portion of the second mounting stud  70  is closely and slidably received in the bore  46  at the distal end  44  of the first gooseneck member  40 . A set-screw  74  or other fastener or another suitable means is used to fixedly secure the second mounting stud to the first and second gooseneck members  40 , 50 . Here, again, it is desirable for aesthetic and functional purposes that an inflexible sleeve member  36  be provided and surround the distal end  44  of the first gooseneck member. As noted above, in addition to improving the appearance of the device  10 , the sleeve member  36  provides a good surface against which the set screw  74  seats. The set-screw  74  passes through the sleeve member  36  and secures the sleeve member  36  in its operative position.  
         [0018]    The snap-hook  32  is preferably secured to the second mounting stud  70  via fastener  80 . More particularly, the fastener  80  is threadably or otherwise engaged with the second mounting stud  70 . A stand-off bushing  84  spaces the snap-hook  32  from the stud  70  and two washers  86   a , 86   b  or the like are located on opposite sides of the snap hook to trap the snap-hook  32  therebetween.  
         [0019]    It is most preferred that the first and second gooseneck members  40 , 50  both be defined from spiral-wound stainless steel flexible tubing. Preferably, at least the first gooseneck member  40  is coated with a polymeric skin or film  38  (FIG. 1) that inhibits contamination and facilitates cleaning of the shaft  20  and that also improves the overall aesthetics of the device  10 .  
         [0020]    With continuing reference to the first and second coaxial gooseneck members  40 , 50 , this dual gooseneck arrangement has been found highly preferably to use of a single gooseneck member for various reasons. First, the use of at least two coaxial gooseneck members  40 , 50  increases the resistance of the shaft  20  to bending, while still allowing a physician or other person to bend the shaft  20  selectively into any desired shape. Thus, the illustrated dual gooseneck arrangement for the shaft  20  increases the rigidity of the shaft  20  without rendering same unusable for infinite adjustment in accordance with the present invention. Secondly, the use of more than one gooseneck member  40 , 50  provides a redundancy that increases safety. If one of the gooseneck members  40 , 50  fails, the presence of the other gooseneck member  40 , 50  will prevent sudden and uncontrolled patient limb movement as could lead to complications with respect to the medical procedure being performed. Furthermore, it has also been found highly desirable to fixedly secure both the first and second gooseneck members  40 , 40  to both mounting studs  60 , 70  as shown and described. This reduces “play” or “slop” in the shaft  20  and provides added rigidity and added safety. Depending upon the exact conformation into which the shaft  20  is bent by an end-user, the shaft  20  will support up to about seven (7) pounds without undesired bending of the shaft under the weight of the patient&#39;s limb, i.e., it is preferred that the shaft  20  be formable into a shape that will support the weight of at least about seven (7) pounds.  
         [0021]    With the foregoing in mind, those of ordinary skill in the art to which the invention pertains will appreciate that the shaft  20  can be bent manually in a selective manner so that the snap-hook  32  and limb support member  30  held thereby can be positioned as desired. In this manner, the shaft  20  is infinitely adjustable during use simply by direct manual manipulation. Also, owing to the bendable nature of the shaft  20 , the shaft  20  will resiliently yield somewhat without moving out of its intended position so that the device  10  increases patient comfort.  
         [0022]    [0022]FIG. 5 illustrates a medical stirrup device  110  formed in accordance with an alternative embodiment of the present invention. Except as otherwise shown and described, the device  110  is identical to the device  10  and, thus, like reference numerals that are “100” greater than those used in FIGS.  1 - 4  are used to identify corresponding components.  
         [0023]    The device  110  includes a gooseneck shaft  120  having a proximal end  122  and a distal end  124 . The proximal end  122  of the shaft  120  is secured to the base  112  and a snap-hook  132  is secured to the distal end  124  of the shaft  120 . The shaft  120 , itself, comprises a series of interconnected links  120   a - 120   f  that articulate relative to each other. The links  120   a - 120   f  are preferably defined from stainless steel.  
         [0024]    A cable  190  extends axially through the links  120   a - 120   f . A proximal end  192  of the cable is coupled to a tensioning member  194  that is, in turn, secured to the shaft  120  or to the base  112  as shown. In the illustrated example, the tensioning member  194  is threaded into the first mounting stud  160 . Rotation of the tensioning member  194  in a first direction increases the tension in the cable  190  while rotation of the tensioning member  194  in a second direction reduces tension in the cable  190 .  
         [0025]    When tension in the cable  190  increases, the links  120   a - 120   f  are drawn together so that friction between the links increases and the shaft  120  increases in rigidity. In contrast, when tension in the cable  190  is reduced, friction between the links  120   a - 120   f  decreases and the flexibility of the shaft  120  increases. The tensioning member  194  is used to control tension in the cable  190  and, consequently, the rigidity of the shaft  120 . At one extreme, tension in the cable  190  is minimized and the shaft is freely bendable but is also too flexible to function as a medical stirrup device. At the other extreme, when tension in the cable  190  is maximized, the shaft  120  becomes rigid and inflexible and is not manually bendable or adjustable as required for an adjustable stirrup device.  
         [0026]    Between these two extremes, the tension on the cable  190  can be set to provide a shaft  120  that is selectively bendable as desired but that is sufficiently rigid to support the weight of a pediatric patient&#39;s limb. Of course, using the device  110 , it is possible for a physician or other person to selectively bend to the shaft  120  to the desired position and then to operate the tensioning member  194  to increase tension in the cable thereby causing the shaft  120  to become rigid and immovably fixed in the desired position.  
         [0027]    A suitable material from which to define at least part of the shaft  120  is available commercially from Mediflex division of Flexbar Machine. Islandia, N.Y. and is sold under the trademark MEDIFLEX™.  
         [0028]    The invention has been described with reference to preferred embodiments. Modifications and alterations will occur to those of ordinary skill in the art to which the invention pertains. It is intended that the appended claims be construed as encompassing all such modifications and alterations.