FIG. 1 is an exploded perspective view of abalancer 1 according to an embodiment of the invention as seen from diagonally forward right, and FIG. 2 is an exploded perspective view of thebalancer 1 of the present embodiment as seen from diagonally backward left.
The arrow X in FIG. 1 indicates a width direction (left-right direction)of the balancer, the arrow Y the depth direction (front-back direction) of the balancer, and the arrow Z the height direction (thickness direction) of the balancer.
Thebalancer 1 according to the present embodiment is, for example, a measuring apparatus to be inserted between the femur and the tibia in a total knee replacement operation and essentially includes abase plate 3 that is to be located on the tibia side, atop plate 5 that is to be located on the femur side, aslider 7 coupled to thetop plate 5, and a pair of coil springs (resilient members) 9 disposed between thebase plate 3 and thetop plate 5 to bias them to move apart from each other.
Thebalancer 1 of the present embodiment is also accompanied by a handle 11 (FIG. 16) for reliably grasping thebalancer 1 for the above-mentioned insertion, a shim 13 (FIG. 19) for making it possible to deal with small and large sizes of the gap between the femur and the tibia, and a tilt plate 15 (FIG. 23) for making it possible to deal with the inclination in the anterior posterior direction of the above-mentioned gaps.
These components may be made of, for example, suitably heat-treated, precipitation hardened stainless steel (concretely, e.g., SUS 630) which has an excellent balance of hardness and corrosion resistance.
(1) Base Plate
Referring to FIGS. 3 to 7, thebase plate 3 has a substantially kidney shape or a substantially broad-bean shape when viewed from above and preferably has a size nearly the same as that of the proximal end surface of the tibia.
Substantially the center of each of the left and right sides of the top surface of thebase plate 3 is provided with a cylindrical raisedportion 21 for holding thecoil spring 9.
At the anterior side of the top surface of thebase plate 3, a pair of upstanding portions 23 (23a, 23b) is provided to stand symmetrically a predetermined distance spaced apart in the horizontal direction.
The opposing vertical surfaces of theupstanding portions 23a, 23b slidably engage with the corresponding surfaces of theslider 7, which will be described later, thereby guiding translational movement of theslider 7 in the vertical direction (Z direction back and forth).
The front surface of eachupstanding portion 23 is provided, along the vertically extending outer edge, with a gap scale 25 (25a, 25b) (in the drawings, scale marks or nicks at 1 mm intervals) and numerical characters for the scale (in the drawings, 8, 10, and 12).
On substantially the center of the top surface of thebase plate 3, a substantially rectangular parallelepiped guide post 29 for guiding the translational movement of thetop plate 5 in the Z direction is vertically provided.
The front surface of theguide post 29 is formed with a vertically elongatedopening 31 that penetrates theguide post 29 in the Y direction.
Ashaft 47 of the top plate 5 (which will be described later) fits into the vertically elongatedopening 31, and as thetop plate 5 translationally moves in the vertical direction (Z direction, back and forth), theshaft 47 hits the upper and lower inner ends of the vertically elongated opening 31 to limit the movement in the vertical direction (Z direction) to a certain distance. In other words, the length of the vertically elongatedopening 31 determines the maximum stroke length of the translational movement (Z direction) of thetop plate 5.
Further, in the front surface of theguide post 29, below the verticallyelongated hole 31, a horizontally elongatedopening 33, which penetrates theguide post 29 in the Y direction in the same manner, is formed. The horizontally elongatedopening 33 receives one of the two ends of thehandle 11, which will be described later, for grasping thebalancer 1.
Further, awall surface 26 of theguide post 29 and awall surface 44 of thetop plate 5 engage to guide the translational movement and, at the same time, awall surface 27 of theguide post 29 and awall surface 45 of thetop plate 5 engage to guide the translational movement, thereby restraining rotation of thetop plate 5 within the Y-Z plane. This allows more stable measurement.
The bottom surface (under surface) of thebase plate 3 is provided with a plurality of protrusions 35 (four in the illustrated configuration) for positioning and connecting theshim 13 and thetilt plate 15, which will be described later. These protrusions are stuck into the end surface of the tibia for fixation of the base plate.
(2) Top Plate
Referring to FIGS. 8 to 13, similarly to thebase plate 3, thetop plate 5 is of substantially kidney shape or broad-bean shape when viewed from above.
Substantially the center of each of the left and right sides of the under surface (bottom surface) of thetop plate 5 is provided with a raisedportion 41 having a circular cylindrical form with a diagonally cut top for holding thecoil spring 9.
Substantially the center of the top surface of thetop plate 5 is provided with arectangular opening 43 that penetrates thetop plate 5 in the Z direction (vertical direction). Thisrectangular opening 43 fittingly receives theguide post 29 of thebase plate 3.
The center of the rear inner face in the Y direction of therectangular opening 43 is provided with a holding hole that receives and holds the rear end of theshaft 47 extending in the Y direction, and the corresponding front inner face in the Y direction is provided with a through hole that holds the front of theshaft 47.
Theshaft 47 is fixedly supported by thetop plate 5 via these two holes and the shaft end located on the front side forwardly protrudes a certain length from the front end surface of thetop plate 5. Theslider 7 is mounted on the thus-protruding shaft portion.
Specifically, thecoil springs 9 are set on thebase plate 3, theguide post 29 is passed through therectangular opening 43, and thetop plate 5 is moved closer to thebase plate 3 against the biasing force of the coil springs 9, and when the front through hole and the rear holding hole of thetop plate 5 and the vertically elongated opening 31 of the guide post 29 (and acentral opening 57 of the slider 7) are aligned as seen from the front side, theshaft 47 is fitted to thetop plate 5.
The left and right sides of the front surface of thetop plate 5 are each provided with a single pointing mark or nick 51 (51a , 51b) (hereinafter referred to as an angular pointer) for pointing at an angular scale (which will be described later) on theslider 7.
(3) Slider
Referring to FIGS. 14 and 15, theslider 7 includes a rectangularthick plate portion 59, which has at its center thecentral opening 57 that penetrates in the anterior posterior direction (Y direction), andthin plate portions 61 at both left and right sides, which extend horizontally outwards from both sides of thethick plate portion 59 and have edges (outer boundary) formed by an arc whose center is thecentral opening 57.
Thecentral opening 57 of theslider 7 is, as described previously, fitted rotatably relative to theshaft 43 that projects from the front end surface of thetop plate 5.
Thethick plate portion 59 has opposing vertical surfaces on both sides in the horizontal direction, and each vertical surface slidably engages, as described above, with the corresponding vertical surface of theupstanding portions 23a and 23b of thebase plate 3.
The front surface of eachthin plate portion 61 is provided, along its outer edge, with an angular scale 65 (in the drawing, scale marks or nicks at 1 degree intervals) and numerical characters for the scale (in the drawing, +5 and -5).
The vertically center (horizontal position)scale mark 65n in each of the left and rightangular scales 65a and 65b is formed thicker and longer than others. Thisscale mark 65n forms a gap pointer (65n) for pointing at thegap scale 25 on theupstanding portion 23 of thebase plate 3.
(4) Coil Spring
In the present embodiment, thecoil springs 9 are used. However, springs, rubbers, or the like of other forms may be used provided that they can bias thebase plate 3 and thetop plate 5 to move apart (to be spaced apart) relative to each other.
(5) Handle
Referring to FIGS. 16 to 18, thehandle 11 is a tool for grasping thebalancer 1 to insert it between the femur and the tibia, and pinches thebase plate 3 and thetop plate 5 against the biasing force of the coil springs 9, reducing the overall thickness to achieve easy insertion.
Thehandle 11 has a construction such that two substantially S-likeshape bar members 71, 73 are crossed and connected at a crossed section by means of apin 75.
The front side of one of thebar members 71 is bifurcated so that the left and right can be pressed in a well-balanced manner when depressing the top surface of thetop plate 5 downwards, and thefront end portion 71a (pressing portion or contacting portion) is rounded to be able to make point or line contact for minimizing the generation of unnecessary component forces during the pressing.
For easy insertion and withdrawal from the horizontally elongated opening 33 formed in the front surface of theguide post 29 of thebase plate 3, the front end side of theother bar member 73 is provided with a straightflat plate portion 73a having a complementary and similar cross-section.
(6) Shim
Referring to FIGS. 19 to 22, when inserting thebalancer 1 between the femur and the tibia, if the gap is larger than usual, theshim 13 temporarily forms an overall balancer thickness that corresponds to the gap.
The illustratedshim 13 has a thickness of 2.5 mm. As a matter of course, alternatively or additionally, shim having other thickness, e.g. thickness of 5.0 mm and 7.5 mm, are provided.
The top surface of theshim 13 is provided, for attachment of theshim 13 to thebase plate 3, with fourfitting holes 81 that receive the fourprotrusions 35 provided on the under surface of thebase plate 3.
The under surface of theshim 13 is provided with threeprotrusions 85 for attachment of thetilt plate 15.
Further, the top surface of theshim 13 is provided with a C-likeshape protruding portion 89. This protrudingportion 89 is constructed to enter within the base plate, when theshim 13 is attached to the under surface of thebase plate 3, through an opening 37 (FIG. 7) formed in the base plate under surface so as to communicate with the horizontallyelongated hole 33 and substantially align with the horizontallyelongated hole 33.
In addition, it is constructed so that, when theflat plate portion 73a of the front end of thehandle 11 enters the horizontallyelongated hole 33 of thebase plate 3, the protrudingportion 89 is caught by theflat plate 73a, and the detachment (falling) of theshim 13 can be reliably prevented.
(7) Tilt plate
Referring to FIGS. 23 to 26, the illustratedtilt plate 15 has a top surface forming an attachment surface for thebase plate 3 or the shim 13 (the illustrated shim has a thickness of 5 mm), and has a thinner front side, a thicker rear side, and an inclination of 5 degrees. As a matter of course, alternatively or as needed, the tilt plate may have a different inclination angle (e.g., 10 degrees, 15 degrees or the like).
The top surface (attachment surface) of the tilt plate is provided with fourfitting holes 91, into which the fourprotrusions 35 protruding from the base plate under surface can fit for the connection with thebase plate 3, and also provided with threefitting holes 93 into which the threeprotrusions 85 projecting from the shim under surface can fit for the connection with theshim 13. For standardization, these sevenprotrusions 35, 85 may have the same outer diameter, and similarly, the sevenfitting holes 91, 93 may have the same inner diameter.
Hereinafter, the use of the balancer 1 (and/or the shim and the tilt plate) of the present embodiment having the construction as above will be briefly described.
Prior to insertion of thebalancer 1 between the femur and the tibia, theflat plate portion 73a of thehandle 11 is first inserted into the horizontally elongated opening 33 of theguide post 29 of thebase plate 3 and the top surface of thetop plate 5 is depressed by the otherfront end portions 71a of thehandle 11 to minimize the overall thickness of the balancer. In other words, thebase plate 3 and thetop plate 5 are located to be closest to each other.
The construction, which enables thebalancer 1 to be grasped in such a reduced thickness, allows for very easy insertion of thebalancer 1 into the gap between the femur and the tibia.
It should be noted that in cases that the above-mentioned gap is larger and/or more inclined than supposed, it is preferable to attach theshim 13 and/or thetilt plate 15 in advance.
As discussed above, when theshim 13 is attached, the novel interconnecting structure of the protrudingportion 89 of theshim 13, the horizontally elongated opening 33 of thebase plate 3, and theflat plate portion 73a of thehandle 11 can reliably prevent the falling of theshim 13.
Further, regardless of the existence of theshim 13, thehandle 11 can grasp thebalancer 1 with the usual opening angle, which may considerably improve work efficiency and performance.
Gradual release of the grasping force of thehandle 11 against thebalancer 1 inserted into the gap between the femur and the tibia causes the distance between thebase plate 3 and thetop plate 5 to increase due to the biasing force of thecoil spring 9, leading to thebase plate 3 abutting and engaging with the tibia side andtop plate 5 abutting and engaging with the femur side.
During the above, as discussed previously, theslider 7 and theshaft 47 move translationally upwards with respect to thebase plate 3 while thetop plate 5 moves upwards together with theslider 7 and the shaft, but swingably around theshaft 47.
The gap (dimension or distance) between the tibia and the femur can be visually confirmed (measured) with ease from the gap scale 25 (25a, 25b) of the base plate 3 (the upstanding portion 23) and thegap pointer 65n of theslider 7 pointing at the gap scale.
On the other hand, the inclination or balance of the femur against the tibia can be visually confirmed (measured) with ease from the angular scale 65 (65a, 65b) of theslider 7 and the angular pointer (pointing mark) 51 (51a, 51b) of thetop plate 5 pointing at the angular pointer.
As above, on setting thebalancer 1 into the gap between the femur and the tibia, the two visual confirmation (measuring) operations become possible.
As described hereinabove, according to the balancer of the present embodiment, an apparatus configuration corresponding to the opening and inclining conditions between the tibia and the femur can be achieved instantly, and the balancer can be set very simply and easily between the tibia and the femur and, in addition, real time measurement of the dimension and inclination (balance) between the two bones can be performed at the moment the balancer is set.
Further, the whole balancer can be constructed very compact and lightweight, allowing considerably improved operability and keeping damage to the subject to a minimum.
It should be noted that, in the present embodiment, the balancer is made up of a left-right symmetrical structure, and hence, when it is set between the femur and the tibia, measurements can be made from the combination of the scale and pointer on one side even if the combination of the scale and pointer on the other side cannot be visually confirmed due to an obstacle on that side. That is, suitable measuring operation can be realized. This allows measurements with the patella returned to its original position, resulting in reproduction of a situation closer to that of an actual knee joint.
Now, FIG. 27 shows thebalancer 1 of the present embodiment actually set between the femur F and the tibia T. In this figure, the femur F and the tibia T are in an extended condition, and the (unillustrated) patella is in its original location (non-everted position).
As can be clearly seen from FIG. 27, according to thebalancer 1 of the present embodiment, proper and quick measurement is possible for the knee (the femur and the tibia) that has no patella eversion and is functionally and physiologically in its natural conditions. As a matter of course, a similar measurement is possible for a knee (the femur and the tibia) in a flexed condition.
The present invention itself, however, is not limited to constructing balancers in a left-right symmetrical structure. For example, the balancer may be constructed in a left-right asymmetrical structure. In conclusion, the required measurements are possible provided that the scale and pointer combination is provided on either of left and right sides of the balancer.
The embodiment described above is a representative one of the present invention, provided for illustrative purposes, and not intended to limit the scope of the present invention. The elements, materials, and various means illustrated and described in the present specification are not limiting, but may be changed or modified within the scope of the present invention and are limited solely by the following appended claims.