Bone Fixation System

Abstract

To provide a configuration so that arrangement of a bone fixation tool or plate is changeable depending on a patient's situation, to optimize bone fracture fixation states depending on situations of various patients and improve bone fixation stability and holding strength.SOLUTION: A bone fixation system 100 comprises: a first bone fixation tool 130 and a second bone fixation tool 140 that each are introduced from an outside part toward a bone head part; a first holding body 110 for holding the first bone fixation tool; and a second holding body 120 for holding the second bone fixation tool, the second holding body configured so as to be capable of engaging with the first holding body. The first and second holding bodies are mutually movable in a movement direction XL in which an interval between first and second holding positions changes and are configured so as to be capable of being arranged in a plurality of mutual positional relations differing from each other along the movement direction. The plurality of mutual positional relations are configured so as to be capable of being maintained in a state of being fitted to a bone.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a bone fixing system. [Background technology]

[0002] Conventionally, various bone fixation systems have been used in which a plurality of bone fixation devices are introduced toward the femoral head to fix a fractured portion. For example, in the following Patent Document 1, a plurality of (three) sliding screws held by a plate fixed on the bone surface of the lateral part of the proximal femur are introduced toward the femoral head to fix the femoral head.

[0003] Meanwhile, as described in Patent Document 2, a known CHS (compression hip screw) system has a plate fixed onto the bone surface of the lateral part of the proximal femur, and includes a tube 13 in which a cylindrical body 17 is integrated with a plate 15, a tube plate 5 configured to be able to fit onto the plate 15, and a lag screw 25 inserted into the cylindrical body 17, and is provided with a structure for attaching and detaching the tube 13 and the tube plate 5. In this case, as shown in Figure 6 of Patent Document 2, an extension 51 with a hole 53 may be provided on the tube plate 5, and a cortical screw (fixation screw) 55 may be screwed through the hole 53 toward the femoral head. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 2018-015432 [Patent Document 2] Japanese Patent Application Laid-Open No. 2003-038508 Summary of the Invention [Problem to be solved by the invention]

[0005] As described above, in a bone fixation system in which a plurality of bone fixators held by a plate fixed on the bone surface of the lateral part of the proximal femur are introduced toward the femoral head, the bone shape and size of the proximal femur, the extent of the fracture, the bone strength, etc. vary from patient to patient, so it may be necessary to set various positions for the bone fixator to pass through in the cross section of the femoral neck and the position for the tip (screw portion) of the bone fixator to reach in the femoral head. For this reason, it is necessary to select a plate in advance according to the patient's condition or to change it for a plate with a different shape during surgery, thereby adjusting the position of the bone fixator to suit the patient's situation.

[0006] Furthermore, because the shape of the bone surface of the lateral portion of the proximal femur varies from patient to patient, the placement of the plate on the lateral portion during actual surgery may result in the plate shape not matching the shape of the bone surface, resulting in a loss of stability on the bone surface of the lateral portion. In particular, because the greater trochanter is located proximal to the lateral portion where the plate is to be placed, the bone surface curves more significantly toward the proximal side of the lateral portion. This results in a mismatch between the curvature of the bone surface and the plate shape, making it difficult to stably place the plate. This makes it difficult to ensure the support strength of the bone fixation device inserted into the femoral head, resulting in insufficient retention strength at the fracture site. Furthermore, the bone surface shape of the lateral portion may interfere with the plate shape, changing the installation angle of the plate and potentially preventing the bone fixation device from being properly oriented toward the femoral head.

[0007] Therefore, the present invention solves the above problems, and its objective is to optimize the fracture fixation method according to the various patient conditions by configuring the bone fixation device or plate so that its position can be changed depending on the patient's condition, thereby improving the stability and holding strength of bone fixation. [Means for solving the problem]

[0008] In order to solve the above problems, the bone fixing system according to the present invention is a bone fixing system comprising: a first bone fastener and a second bone fastener, each of which is introduced from the lateral side toward the femoral head; a first holder that holds the first bone fastener at a first holding position; and a second holder that is configured to be engageable with the first holder and holds the second bone fastener at a second holding position. In this bone fixing system, the first holder and the second holder are configured to be relatively movable in a movement direction in which the distance between the first holding position and the second holding position changes. The first holder and the second holder are configured to be movable in a plurality of different relative positional relationships along the movement direction. , i.e., at each of a plurality of positions corresponding to a plurality of mutually different intervals, In this case, the plurality of relative positional relationships , i.e., a plurality of positions corresponding to the plurality of intervals are configured to be able to maintain a state in which the first bone fixation device introduced from the outer portion is held by the first holder at the first holding position, and the second bone fixation device introduced from the outer portion is held by the second holder at the second holding position.

[0009] In the present invention, the first holder and the second holder are arranged in the plurality of relative positional relationships. , i.e., a plurality of positions corresponding to the plurality of intervals in the movement direction While holding it so that it does not move relative to It is preferable that the device further includes positioning means configured to enable positioning. This positioning means desirably has a first engagement portion provided on the first holding body, a second engagement portion provided on the second holding body, and an engagement member that is detachably engaged with the first engagement portion and the second engagement portion, respectively. This engagement member may be a screw that is threaded into at least one of the first engagement portion and the second engagement portion, and in particular may be a bone screw that is screwed into a bone, or a positioning engagement screw that is not screwed into a bone.

[0010] In these cases, it is desirable that the first engagement portion and the second engagement portion each be an engagement hole that can engage with the head of the engagement member, and that the other engagement hole include a plurality of hole portions arranged along the movement direction. Here, as will be described later, the plurality of hole portions are not limited to being integrally formed within a single opening, but may be configured as an array of separate holes. Furthermore, it is even more desirable that the head of the engagement member includes a male thread, and that the engagement hole of one of the first engagement portion and the second engagement portion be a female-threaded screw hole that screws into the male thread of the head.

[0011] It is also desirable that the first engagement portion and the second engagement portion are each engagement holes that can engage with the head of the engagement member, and that the other engagement hole is an elongated hole along the movement direction. In this case, it is even more desirable that the head of the engagement member includes a male thread, and that the engagement hole of one of the first engagement portion and the second engagement portion is an internally threaded screw hole that screws into the male thread of the head. In this case, it is even more desirable that the head of the engagement member includes a portion that can be fastened to the periphery of the elongated hole. In other words, it is desirable that the other engagement hole is an elongated hole along the movement direction that has a periphery that can be fastened by the head of the engagement member.

[0012] The engaging member may be a positioning engaging screw that is not inserted into the bone while engaged with both the first engaging portion and the second engaging portion, or a bone screw that is inserted into the bone while passing through both the first engaging portion and the second engaging portion, thereby fixing the first retaining body and the second retaining body to the bone in addition to the positioning function.

[0013] In the present invention, it is preferable that the first retainer includes a first structural part disposed on the bone surface at an outer side facing away from the femoral head, and that the second retainer includes a second structural part disposed on the bone surface and engaging with the first structural part on the bone surface in a manner that allows relative movement in the movement direction. Here, it is preferable that the first structural part and the second structural part engage with each other in a manner that overlaps with each other on the bone surface. In this case, it is preferable that the first structural part and the second structural part include a guide structure that guides the second retainer along the movement direction so that it can move relative to the first retainer. Here, it is more preferable that the guide structure includes a groove structure formed along the movement direction and a groove fitting part that fits into the groove structure and is configured to be slidable along the movement direction. It is preferable that both the first structural part and the second structural part are configured in a plate shape. It is also preferable that the first retainer (the first structural part) and the second retainer (the second structural part) are configured to be detachable.

[0014] In the present invention, the first holder preferably has a barrel portion that guides the first bone fastener so that it can be inserted and removed, and a flange portion that is integral with the barrel portion and can engage with the second holder. In this case, the flange portion corresponds to a first structural part that is disposed on the bone surface on the outer side facing away from the femoral head.

[0015] In the present invention, the second holder preferably includes a retaining hole for retaining the head of the second bone fastener. Here, it is preferable that the retaining hole is a screw hole with an internal thread that screws into the head of the second bone fastener, and the head of the second bone fastener includes an external thread that screws into the internal thread.

[0016] In the present invention, the second bone fixation device preferably includes a sleeve portion held by the second holder, and a bone fixation shaft that is inserted retractably into the sleeve portion and has a bone engagement portion at its tip that engages with a bone. Here, the sleeve portion preferably includes a head portion of the second bone fixation device that is held by a holding hole in the second holder. Also, it is desirable that the sleeve portion has a bone engagement structure on the outer circumferential surface that engages with a bone. Examples of this bone engagement structure include a screw structure and a group of multiple protrusions.

[0017] In the present invention, it is preferable that one each of the first bone fastener and the first holding portion is provided, and two each of the second bone fastener and the second holding portion is provided.

[0018] In the present invention, it is preferable that the femoral head is provided in the proximal femur, and that the first bone fixation device and the second bone fixation device pass through locations adjacent to the inside of each apex of the inverted triangular cross section of the femoral neck toward the femoral head. That is, it is desirable that the first bone fixation device and the second bone fixation device pass through a location adjacent to the inside of the distal apex of the three apexes of the inverted triangular cross section of the femoral neck and a location adjacent to the inside of at least one of the two proximal apexes toward the femoral head. In this case, it is further desirable that the second holder protrudes proximally from the first holder and has a proximal region including the second holding position and a distal region configured to be movable relative to the first holder along the movement direction, and that the proximal region have a back surface shape that is gradually curved outward from the distal region along the movement direction. [Effects of the Invention]

[0019] According to the present invention, by configuring the arrangement of plates and bone fixation devices to be changeable depending on the patient's condition, it is possible to optimize the fracture fixation mode and improve the stability and strength of bone fixation. [Brief explanation of the drawings]

[0020] [Figure 1]FIG. 1A is a front perspective view showing a first treatment mode for an affected area to which the first embodiment of the bone fixing system according to the present invention is applied, as seen from the front side, and FIG. 1B is a side assembly view showing a state of the implant assembly as seen from the side. [Figure 2] FIG. 1A is an axial assembly view showing the state of the implant assembly in a first treatment state of the first embodiment as seen along the axial direction, and FIG. 1B is a rear perspective view as seen from the diagonally inner side, and FIG. 1C is an explanatory view showing the relationship between the cross-sectional shape of the femoral neck and the introduction position of the bone fixation device. [Figure 3] FIG. 1A is a front view of a first holder equipped with a bone fixation device of the first embodiment; FIG. 1B is an axial view of the first holder; FIG. 1C is a cross-sectional view of a portion where a reference hole is provided; FIG. 1D is a plan view of a second holder; and FIG. 1E is an explanatory perspective view showing how a flange portion formed on the first holder is engaged with the second holder. [Figure 4] 1A is a front perspective view showing a second treatment mode of the first embodiment as seen from the front side, and FIG. 1B is a side assembly view showing the state of the implant assembly as seen from the side. [Figure 5] 1A is an axial assembly view showing a state of the implant assembly in a second surgical procedure state of the first embodiment as viewed along the axial direction, and FIG. 1B is a rear perspective view as viewed from the diagonally inner side. [Figure 6] 10A is a plan view showing a second holder of the second embodiment, and FIG. 10B is a cross-sectional view of a positioning hole corresponding to a reference hole and a fixing bone screw. [Figure 7] 1A to 1C are explanatory diagrams showing the procedure of a surgical procedure using each embodiment. [Figure 8] 1A and 1B are explanatory diagrams showing the procedure of the surgical procedure, and FIG. 1C is a perspective view of an angle guide used in the surgical procedure. DETAILED DESCRIPTION OF THE INVENTION

[0021] (First embodiment) Next, embodiments of the present invention will be described in detail with reference to the accompanying drawings. First, the overall configuration of a first embodiment of a bone fixing system according to the present invention will be described with reference to Figs. 1 to 5. As shown in Fig. 1, the bone fixing system 100 of the first embodiment includes a first holder 110, a second holder 120, a first bone fixing device 130, and a second bone fixing device 140. Here, the first bone fixing device 130 is held by the first holder 110. Furthermore, the second bone fixing device 140 is held by the second holder 120.

[0022] As shown in FIGS. 3( a)-(c), the first holder 110 has a barrel portion 111 that accommodates the first bone fastener 130 in a retractable manner, and a flange portion 112 that is integral with the barrel portion 111. The barrel portion 111 is the portion that is inserted into the bone and is preferably cylindrical. The flange portion 112 is formed in a plate shape that extends in a direction intersecting the axis of the barrel portion 111 and includes an opening 112a that communicates with the interior of the barrel portion 111 and a reference hole 113 for receiving a bone screw 150 or a positioning engagement screw. The angle φ between the axis of the barrel portion 111 and the plate surface of the flange portion 112 is set to match the patient's neck-shaft angle (usually 120 to 135 degrees). In addition, a side edge 112b of the flange portion 112 is configured to be able to fit into a side groove 122b of a fitting portion 122a, which will be described later. A female thread 113a is formed on the inner surface of the reference hole 113, and this female thread 113a is configured to be able to threadably engage with a male thread 152a formed on the outer peripheral surface of a head 152 of a bone screw 150, which is a locking screw.

[0023] In the illustrated example, the first bone fastener 130 is a bone screw having a bone engagement portion 131 with a screw thread at its tip, and having a shaft portion 132 that is inserted so as to be able to freely protrude into the barrel portion 111. However, the first bone fastener 130 is not limited to a bone screw, and may be any device that has a bone engagement portion, and may be configured, for example, by a locking pin having an expandable bone engagement portion at its tip, or a hook pin having a hook portion at its tip that can protrude in a hook shape as a bone engagement portion.

[0024] In the illustrated example, the first bone fastener 130 is introduced toward the femoral head T3 of the proximal femur. In this embodiment, both the first bone fastener 130 and the second bone fastener 140 are introduced toward the femoral head T3, but the first bone fastener 130 is introduced distally of the femoral head T3. The second bone fastener 140 is introduced proximally of the femoral head T3.

[0025] 1, the second bone fixation device 140 has a sleeve 140A held by the second holder 120, and a bone fixation shaft 140B that is retractably inserted into the sleeve 140A, has a bone engagement portion 141 at its tip that engages with a bone, and has a shaft portion 142 on its proximal end that can be inserted into the sleeve portion 140A. The sleeve 140A is provided with a head portion 143 that corresponds to the holding hole 124 of the second holder 120. The head portion 143 is formed with a male thread 143a that screws into the female thread 124a of the holding hole 124. A bone engagement structure 144 is formed on the outer peripheral surface of the sleeve 140A on the tip side of the head portion 143. In the illustrated example, the bone engagement structure 144 is a helical thread formed on the outer peripheral surface of the sleeve 140. When the second bone fastener 140 is introduced into the bone, this bone engagement structure 144 engages with the cortical bone of the outer part T1 during the process of locking the retaining hole 124 of the second retainer 120 and the head 143 of the second bone fastener 140, and firmly fixes the second retainer 120 to the outer part T1 via the sleeve 140A.

[0026] As shown in FIGS. 3(d) and 3(e), the second holding body 120 is configured in a plate shape overall and has a surface 121 facing away from the bone and a back surface 122 facing the bone. The surface 121 and the back surface 122 are provided with an opening 123, which is a through-hole, a holding hole 124, and a positioning hole 125. The back surface 122 is provided with a recess 122a into which the flange portion 112 of the first holding body 110 fits, and side grooves (groove structure portions) 122b into which side edges (groove fitting portions) 112b of the flange portion 112 fit are formed on both widthwise sides of the recess 122a. The second holding body 120 is assembled so that it overlaps with the flange portion 112 by fitting the recess 122a from the distal side and sliding it toward the proximal side. The second holding body 120 (front surface 121 and back surface 122) has a substantially flat plate shape along the longitudinal axis XL in a distal region including the range from the opening 123 to the positioning hole 125. On the other hand, in a proximal region proximal to the opening 123, the second holding body 120 gradually curves outward toward the proximal end, and at the proximal end, has a plate shape extending in a direction forming an angle δ with respect to the longitudinal axis XL. This angle δ is set so that the second bone fastener 140 held in the holding hole 124 formed in the proximal region is aligned with the neck-shaft angle.

[0027] The second holding body 120 has an opening 123 near the center in the direction along the longitudinal axis XL, through which the base of the shaft portion 132 of the first bone fastener 130 can pass. This opening 123 has an opening shape (elliptical or oval) that extends along the longitudinal direction of the second holding body 120 (the vertical direction in the figure, i.e., the movement direction XL) for the reason of not interfering with the relative movement between the first holding body 110 and the second holding body 120, which will be described later. Furthermore, two holding holes 124 are formed proximal to the opening 123. In the illustrated example, these holding holes 124 have female threads 124a on their inner surfaces, and these female threads 124a are configured to be able to threadably engage with male threads 143a formed on the outer periphery of a head 143 of the second bone fastener 140, which will be described later.

[0028] As shown in FIG. 3( e), the flange 112 of the first holding body 110 fits into a recess 122a provided in the back surface 122 of the second holding body 120. More specifically, the flange 112 is held in a fitted state with its side edges 112b on both sides in the width direction engaged with side grooves 122 provided on both sides in the width direction of the recess 122a. At this time, the flange 112 and the recess 122 can be moved between a separated state and a fitted state by sliding them along the longitudinal direction of the first holding body 110 and the second holding body 120. In the illustrated example, the flange 112 and the second holding body 120 are assembled such that the flange 112 and the second holding body 120 can move relative to each other in the longitudinal direction due to the side edges 112b and the side grooves 122b fitting together, but cannot move relative to each other in the thickness direction due to their engagement with each other. However, in the present invention, it is sufficient that the first holding body 110 (flange portion 112) and the second holding body 120 can be positioned in an overlapping state, and they may be configured to be movable relative to each other in the thickness direction and to be detachable.

[0029] The second holder 120 is provided with a positioning hole 125, which is a third opening. The positioning hole 125 has a first position A and a second position B, which correspond to the reference hole 113 of the flange 112 when the flange 112 is fitted into the recess 122a. That is, the positioning hole 125 has two hole portions, positions A and B, where the bone screw 150 or the positioning engagement screw 150′ to be attached to the reference hole 113 is positioned. Note that a plurality of these hole portions may be provided, and three or more hole portions may also be provided. Furthermore, the multiple hole portions may not be interconnected within a single opening as in the illustrated example, but may be formed as multiple holes provided separately. Here, the distance between the first position A and the second position B is a positioning range ΔS, which is the distance between the set positions along the longitudinal axis XL. Bone screws 150 or positioning engagement screws 150', which are engagement members, are inserted into the reference holes 113 and the positioning holes 125, and male threads 152a formed on the outer peripheral surfaces of their heads 152 are threadedly engaged with the female threads 113a and 125a, 125b, thereby positioning the flange portion 112 and the second holder 120 in the longitudinal direction and thickness direction. Here, although not shown, one example of the positioning engagement screw 150' is a structure in which the bone engagement portion 151 is removed from the bone screw 150, i.e., a structure having only the head 152. The male threads 152a that can be threadedly engaged with the female threads 113a, 125a, 125b are formed on the outer peripheral surface of the head 152.

[0030] At this time, by fitting slidably in the longitudinal direction into the guide structure (side edge 112b and side groove 122b) formed between flange portion 112 and second holder 120, bone screw 150 or positioning engagement screw 150', which is an engagement member that threadably engages with reference hole 113, can be positioned and fixed so that it is disposed at either first position A or second position B. Note that while both bone screw 150 and positioning engagement screw 150' are screw members having male threads 152a on head 152, the engagement member may be formed of something other than a screw member as long as it has the function of positioning and fixing relative to first position A and second position B. When the engagement member is bone screw 150, in addition to the function of positioning first holder 110 (flange portion 112) and second holder 120 relative to each other, it also has the function of fixing first holder 110 and second holder 120 to the bone surface. In addition, as in this embodiment, by threading the engaging member into both the first engaging portion and the second engaging portion, it is possible to improve the accuracy and strength of the positioning function.

[0031] 1 and 2 show a state in which the reference hole 113 of the flange portion 112 is arranged at a position corresponding to the first position A of the positioning hole 125 of the second holder 120 via an engaging member such as a bone screw 150 or a positioning engaging screw 150′. In this state, as shown in Fig. 2, the distance between the axis X1 of the first bone fastener 130, whose shaft portion 132 is held in the opening 123 of the second holder 120 via the barrel portion 111 of the first holder 110, and the axis X2, X3 of the second bone fastener 140, whose head portion 143 is held in the holding hole 124 of the second holder 120 that holds it, is the bone fastener spacing LS1. Here, there are two second bone fasteners 140, and their axes are X2 and X3. In the illustrated example, the interval LS1 is based on the intersection of the longitudinal axis XL passing through the axis X1 with the straight line connecting the axes X2 and X3, and indicates the distance between the intersection and the axis X1. However, the parameter indicating the distance between the axis X1 and the axes X2 and X3 need only be one that correlates with the above-mentioned relative positional relationship in the movement direction XL, and is not limited to the interval LS1. In this embodiment, the axes X1, X2, and X3 are parallel to each other.

[0032] As shown in Fig. 1(a), the first bone fixation device 130 and the second bone fixation device 140 are both introduced from the lateral part T1 through the neck part T2 toward the femoral head T3, so the relative positions of the axes X1, X2, and X3 are extremely important. Here, as shown in Fig. 2(a), when the distance between the distal axis X1 and the proximal front axis X3 is L1, the distance between the axis X1 and the proximal rear axis X2 is L2, and the longitudinal axis XL passing through the axis X1 is used as a reference, the angle of the line from the axis X1 to the axis X3 is θ1, and the angle of the line from the axis X1 to the axis X2 is θ2, the fracture stability of the proximal femur T is determined by these distances L1 and L2 and the angles θ1 and θ2. When one second bone fastener 140 is used, the fracture stability of the proximal femur T is determined by the distance L1 between the axes X1 and X2 and the angle θ1 between the longitudinal axis XL of the line extending from the axis X1 to X2. Whether one or two second bone fasteners 140 are used, the distances L1 and L2 determine the positions where the shanks 132 and 142 pass inside the neck T2 (the distance from the cortical bone on the side of the neck T2) and also determine the positions of the bone engaging portions 131 and 141 inside the femoral head T3 (the distance from the cortical bone at the tip of the femoral head T3). Therefore, the reduction holding force for the fracture of the proximal femur T is determined, and the rotational stability that prevents rotation of the femoral head T3 is also determined.

[0033] The shapes and sizes of the lateral portion T1, neck T2, and femoral head T3 vary not only among individuals but also among races and genders. Furthermore, differences also occur in the type of fracture and bone quality, such as osteoporosis. To maintain appropriate fracture reduction according to these shapes, sizes, and bone quality, the following conditions must be met for the introduction positions of the first bone anchor 130 and the second bone anchor 140, which both pass through the neck T2 and into the femoral head T3. Typically, the introduction position of the first bone anchor 130 is set to a position inside the cancellous bone CA that is in contact with or adjacent to the inside of the calcar CL, which is part of the cortical bone CR located distal to the neck T2 and has an inverted triangular cross-sectional structure perpendicular to the neck axis, as shown in FIG. 2(c). In this case, the first bone anchor 130 primarily serves to support the patient's weight. This is because the cortical bone CR of the calcar CL is generally thick, which is expected to provide stable support. Furthermore, when a pair of second bone fasteners 140 are used, they are preferably placed in positions in the cancellous bone CA that are in contact with or adjacent to the inside of the cortical bone CR that correspond to two vertices, anterior (left side in the figure) and posterior (right side in the figure), on the proximal side of the inverted triangular cross section of the neck T2. In this case, since the cortical bone CR that corresponds to the posterior vertex is thicker, more stable support can be expected from the second bone fastener 140 that passes near this area.

[0034] The reason for using the second bone fastener 140 in addition to the first bone fastener 130 is to prevent the femoral head T3 from rotating around the first bone fastener 130. For this reason, the insertion position of the second bone fastener 140 into the femoral head T3 is preferably a position that can prevent rotation of the femoral head T3 around the first bone fastener 130. That is, it is most desirable that the second bone fastener 140 having the axes X2 and X3 be configured to abut against the cortical bone of the femoral head T3 and prevent the rotation when the rotation is about to occur. In a preferred embodiment, L1 ≧ L2, particularly L1 > L2, and θ1 ≧ θ2, particularly θ1 > θ2. Here, the insertion angles of the first bone fastener 130 and the second bone fastener 140 are firmly held by the barrel 111 of the first holder 110 and by the locking of the holding hole 124 of the second holder 120. This makes it possible to avoid the occurrence of the so-called "chop-stick phenomenon," in which multiple bone fixation devices overlap in an X-shape and break, and to prevent rotation of the femoral head T3.

[0035] When only one second bone anchor 140 is used, the second bone anchor 140 is introduced into the cancellous bone CA that is in contact with or adjacent to the inside of the cortical bone CR on the proximal side of the neck T2, and it is particularly preferable that the second bone anchor 140 passes through a position in the cancellous bone CA that is in contact with or adjacent to the inside of the cortical bone CR at either the anterior or posterior corner (preferably posterior in terms of the thickness of the cortical bone CR) on the proximal side of the inverted triangular cross section.

[0036] In this embodiment, as shown in Fig. 4, the first holder 110 (flange portion 112) and the second holder 120 are configured to be relatively movable along the longitudinal axis XL (movement direction) while fitted together, so that the bone screw 150 or the positioning engagement screw 150' can be positioned and fixed at the second position B (see Fig. 3(c)). As a result, as shown in Fig. 5, the distance between the axes X1 and X3 can be set to LS2, which is smaller than LS1. In this way, the distances L3 and L4 between the axis X1 and the axes X2 and X3 can be made smaller than L1 and L2, respectively.

[0037] In this embodiment, by placing the bone screw 150 or the positioning engagement screw 150′ at the first position A, for example, the distance LS1 between the axes X1 and X3 is set large. In this case, since the distance between the first bone fastener 130 and the second bone fastener 140 is large, if the neck T2 is thin, the second bone fastener 140 may interfere with the cortical bone proximal to the neck T2, making it impossible to introduce the second bone fastener 140. As shown in FIG. 2( c), the anterior corner is generally placed more proximally and the posterior corner is placed more distally. However, since the difference in the vertical positions of the anterior corner and the posterior corner varies depending on the patient, it is not possible to determine the position of the bone fastener to be introduced adjacent to the cortical bone CR of the posterior corner unless the distal position of the posterior corner is recognized. However, in the frontal image of the X-ray image, the bone fixation device that passes near the inside of the anterior corner on the proximal side of the inverted triangle shape and the bone fixation device that passes near the inside of the posterior corner overlap front to back, making it difficult to visually confirm the passing position of the posterior bone fixation device, and also because the posterior corner itself overlaps with the image of the anterior bone tissue and is therefore difficult to identify, it is difficult to recognize the position of the posterior corner before surgery.

[0038] For this reason, in the past, multiple types of plates corresponding to the second holder 120 were prepared during surgery to correspond to different neck widths, and if the first plate did not fit, it was removed and a plate of a different size was reinstalled. This resulted in problems such as increased costs due to the need to prepare multiple plates and longer surgery times due to the need for unnecessary work.

[0039] In this embodiment, after actually starting the surgery and placing the guide pin, the first holding body 110, and the second holding body 120 on the outer part T1, the position of the holding hole 124 of the second holding body 120 relative to the first holding body 110 (flange part 112) is configured to be movable relative to the movement direction along the longitudinal axis XL, so that the position of the second bone fixation device 140 can be appropriately adjusted relative to the neck T2, and in particular, it becomes possible to easily set the position of the second bone fixation device 140 which is placed corresponding to the posterior corner part whose position is difficult to recognize.

[0040] Furthermore, if the bone surface on the proximal side of the lateral part T1 protrudes significantly due to the protrusion of the greater trochanter, the proximal end of the second holder 120 may interfere with the bone surface of the lateral part T1, making it impossible to stably fix the second holder 120 to the bone surface of the lateral part T1. Furthermore, because the protrusion of the greater trochanter varies greatly from patient to patient, it is difficult to perfectly match the back surface 122 (plate shape) of the second holder 120 to the bone surface of the lateral part T1. However, generally, the closer to the proximal greater trochanter, the greater the curvature of the bone surface, while the bone surface of the distal lateral part T1 is configured to be approximately parallel and flat along the diaphyseal axis. Therefore, even if a problem occurs in which the second holder 120 does not match the bone surface of the lateral part T1, this can often be resolved by moving the second holder 120 distally. In particular, when the shape of the back surface 122 in the proximal region of the second holder 120 is curved outward, as is clear from a comparison of FIGS. 1(a) and 4(a), interference between the back surface 122 and the bone surface on the proximal side of the lateral portion T1 can be avoided by simply moving the second holder 120 slightly distally. In the example of FIG. 4, a "gap" exists between the proximal region of the second holder 120 and the proximal surface of the lateral portion T1. In this way, the back surface 122 of the second holder 120, together with the flange portion 112, can be firmly fixed onto the surface of the lateral portion T1, and the first bone fixation device 130 and the second bone fixation device 140 can be firmly fixed. This increases the holding strength of the fractured portion, making it possible to reliably withstand loads such as body weight, and preventing serious defects such as rotation of the femoral head T3 after surgery. In a second embodiment described later, it is also possible to eliminate this "gap" and bring the entire back surface 122 of the second holding body 120 into close contact with the outer portion T1.

[0041] However, if multiple plates for matching the bone shape and size as described above are not prepared, after a flange member corresponding to the first holder 110 is introduced and a plate is attached, if the shape of the protruding portion of the greater trochanter on the bone surface of the lateral portion T1 does not match the plate, for example, if the flange member corresponds to a cervical angle of 125 degrees, it is replaced with a new flange member corresponding to a cervical angle of 135 degrees, shifted slightly distally, and then attached with a plate corresponding to this flange member. However, this not only requires a great deal of time and effort during surgery, but also requires multiple perforations to be formed in the lateral portion T1 to attach flange members of different shapes, which reduces the strength of the bone and makes it more susceptible to problems such as secondary fractures.

[0042] Furthermore, in this embodiment, a guide structure that allows the second holding body 120 to slide in the movement direction XL relative to the first holding body 110 is formed by the side edge 112b of the flange portion 112 and the side groove 122b of the recess 122a. This makes it easy to slide the second holding body 120 without moving the position of the axis X1 of the first bone fastener 130, even during surgery, thereby simplifying the movement work during positioning. In particular, the above-mentioned guide structure allows movement only in the movement direction XL and guides so as to prevent movement in the thickness direction, so that the relative positional relationship after positioning is maintained more reliably and with high rigidity.

[0043] In this embodiment, the relative positional relationship between the first holder 110 (flange portion 112) and the second holder 120 along the movement direction XL is configured to be changeable. Different relative positional relationships can be set at two locations, corresponding to a first position A and a second position B, and the relationship can be maintained. Therefore, the distances L1 and L2 between the axis X1 and the axes X2 and X3 can be increased or decreased to distances L3 and L4 corresponding to the large and small intervals LS1 and LS2, respectively. In the illustrated example, the distance between the axes X2 and X3 is constant, so that the angles θ1 and θ2 also change (increase to θ3 and θ4) as the distances L1 and L2 decrease (to L3 and L4). The number of mutually different positionable positions A and B is not limited to two, as in the illustrated example, but may be three or more. In this way, configuring the first holder 110 and the second holder 120 to be positionable at multiple, discontinuous positions facilitates adjustment and avoids hesitation during surgery.

[0044] The positioning range ΔS = LS1 - LS2, which is the amount of change in the intervals LS1 and LS2, is not particularly limited, but is preferably set taking into consideration the distance distribution function F(L1) corresponding to the distance L1 between the corners of the inverted triangle of the patient's neck T2, the distance distribution function F(L2) corresponding to the distance L2, the angle distribution function F(θ1) corresponding to the angle θ1, and the angle distribution function F(θ2) corresponding to the angle θ2. Here, it is preferable to set each distribution function for a specific patient group for each case. Specifically, it is preferable to set the positioning range ΔS so that it can accommodate all patients between the value (M - σ) obtained by adding the standard deviation σ to the mean value M of each distribution function and the value (M + σ) obtained by subtracting the standard deviation σ. It is particularly preferable to set the positioning range ΔS so that it can accommodate all patients between (M - 2σ) and (M + 2σ).

[0045] For example, in the illustrated example, LS1 corresponding to the first position A is 14.4 mm, and LS2 corresponding to the second position B is 11.5 mm. In this case, L1 is 16.3 mm, L2 is 14.5 mm, θ1 is 23 degrees, θ2 is 19 degrees, L3 is 13.8 mm, L4 is 11.9 mm, θ3 is 27 degrees, θ4 is 23 degrees, and ΔS is 2.9 mm. The ranges of L1 and L3 are preferably within the range of 12.0-18.0 mm, and more preferably within the range of 13.0-17.0 mm. The ranges of L2 and L4 are preferably within the range of 11.0-16.0 mm, and more preferably within the range of 12.0-15.0 mm. Furthermore, the ranges of θ1 and θ3 are preferably within the range of 21.0-29.0 degrees, and more preferably within the range of 22.0-28.0 degrees. The ranges of θ2 and θ4 are preferably within the range of 17.0-25.0 mm, and more preferably within the range of 18.0-24.0 mm. The range of ΔS is preferably within the range of 1.0 mm-5.0 mm, and more preferably within the range of 2.0-4.0 mm. These points also apply to the second embodiment described below.

[0046] (Second embodiment) Next, a bone fixing system 100' according to a second embodiment will be described with reference to Fig. 6. In this second embodiment, only the structures of the second holder 120' and the bone screw 160 or the positioning engagement screw 160' are different from those of the first embodiment, so only the different parts will be described and a description of the same parts as in the first embodiment will be omitted.

[0047] In this embodiment, as shown in Fig. 6(a), a second holding body 120' is used instead of the second holding body 120 of the first embodiment. This second holding body 120' has a positioning hole 125' with a different structure instead of the positioning hole 125 of the first embodiment, but the structure other than the positioning hole 125' can be configured in the same way as the second holding body 120 of the first embodiment.

[0048] As shown in the figure, the positioning hole 125' has an elongated hole shape extending in the direction of the longitudinal axis XL. Here, no internal thread is formed on the inner surface 125a' of the positioning hole 125'. Here, the positioning hole 125' and the reference hole 113 overlapping with the positioning hole 125' are used with the bone screw 160 shown in FIG. 6(b) or a positioning engagement screw 160' (not shown) having a structure in which the bone engagement portion 161 is removed from the bone screw 160. The internal thread 113a formed on the inner surface of the reference hole 113 is configured to be threadably engaged with the external thread 162b of the head 162 of the bone screw 160 or the positioning engagement screw 160'. The head 162 has an upper head region H1 that engages with the inner surface 125a' of the positioning hole 125' of the second holder 120' and a lower head region H2 in which the internal thread 162b is formed. As a result, the bone screw 160 or positioning engagement screw 160' is locked to the first retaining body 110 (flange portion 112) by the engagement of the male thread 162b and the female thread 113a, and also functions to tighten and fix the second retaining body 120' to the first retaining body 110 (flange portion 112) by the engagement of the fastening surface 162a of the upper head region H1 with the inner surface 125a'.

[0049] In this embodiment, the positioning structure consisting of the positioning hole 125', the reference hole 113, and the bone screw 160 or the positioning engagement screw 160' is relatively movable along the longitudinal axis XL of the first holder 110 (flange portion 112) and the second holder 120', and is therefore capable of positioning and fixing the bone screw 160 or the positioning engagement screw 160' at any position within the positioning range ΔS from the first position A to the second position B. Furthermore, even if the bone screw 160 or the positioning engagement screw 160' remains positioned inside the positioning hole 125' and the reference hole 113, as long as the upper temporal region H1 is in a screwed-in state in which it does not tighten against the second holder 120', it can be moved to any position within the positioning range ΔS, which has the advantage of further facilitating position changes during surgery. In other words, the engaging member screws into one of the engaging holes and tightens around the periphery of the other engaging hole, which is an elongated hole, so that the positioning function can be performed at any location within the structural range of the elongated hole, thereby increasing the freedom of the positioning position.

[0050] (Usage - Surgical procedure) Finally, an example of how to use the bone fixing systems 100, 100' of the respective embodiments will be described with reference to Figures 7 and 8. First, as shown in Figure 7(a), the base 10B of the plate-type angle guide 10 inserted through an incision is abutted against the outer part T1, and the guide pins 13, 14 are inserted through the guide sleeves 11, 12 of the angle guide 10 and inserted into the femoral head T3 through the neck T2. Here, the angle guide 10 is shown enlarged in Figure 8(c).

[0051] The angle guide 10 includes a plate-shaped base 10B that abuts against the outer portion T1 and a handle 10H that the surgeon grips. The guide sleeves 11, 12 are attached to the base 10B, and are attached to the base 10B so that they are in a predetermined position and orientation that correspond to the axes of the openings 123 and the holding holes 124 of the second holders 120, 120′. Here, it is preferable that the base 10B has the same outer shape as the second holders 120, 120′, and in particular, it is desirable that the base 10B has a back surface shape that is the same as the shape of the back surface 122 of the assembly of the flange portion 112 of the first holder 110 and the second holders 120, 120′. In this way, before actually using the bone fixation systems 100, 100′, a trial operation can be performed in parallel to confirm the attachment position relative to the fractured part using X-ray images or the like. The mounting positions of the guide sleeves 11 and 12 are set to predetermined positions (i.e., pre-change positions, for example, standard positions) within the positioning range ΔS. In the illustrated example of the first embodiment, they are set to the standard positions corresponding to the first position A.

[0052] However, the guide sleeves 11 and 12 of the angle guide 10 may be configured to be adjustable so that they can be set to a plurality of positions within at least the positioning range ΔS. For example, in each of the above-described embodiments, the guide sleeve 12 may be configured to be movable by at least ΔS in the direction along the longitudinal axis XL. In this way, even in a procedure using the angle guide 10, the guide pin 14 can be inserted so that it aligns with the changed position that is previously adapted to the affected area of ​​the patient. This eliminates the need to reinsert the guide pin 14, as described below.

[0053] Next, as shown in Fig. 7(b), using the guide pin 13 as a reference, a drilling operation for the first holding body 110 and the first bone fastener 130 is performed using a drilling instrument 30 (step reamer) via a sleeve instrument 20 (reamer sleeve). Thereafter, as shown in Fig. 7(c), using the guide pin 13 as a reference, the first holding body 110 and the first bone fastener 130 are assembled, and further the flange portion 112 is attached to the second holding bodies 120, 120' and introduced into the body. Then, using a rotary tool 40 (screwdriver), the first bone fastener 130 is screwed into the femoral head T3.

[0054] Next, as shown in Figure 8(a), using the guide pin 14 as a reference, a drilling tool 50 (screw-type reamer sleeve) is used to drill a hole through the retaining hole 124 of the second retainer 120, and then, as shown in Figure 8(b), the second bone fixation tool 140 is inserted and introduced to a predetermined position within the femoral head T3 using a rotary tool 60 (barrel T wrench).

[0055] The above-described surgical procedure is an example of application (surgical procedure) of the bone fixation system 100, 100′ in a standard position initially set by the guide pins 13, 14. However, in practice, as described above, it is conceivable that the position between the first holder 110 (flange 112) and the second holders 120, 120′ may be changed within the positioning range ΔS. In this case, for example, in the above-described embodiments, after the first bone fixation device 130 shown in FIG. 7( c) is introduced, the guide pin 14 needs to be changed from its introduced position (e.g., the standard position), preferably with the second holder 120, 120′ positioned on the lateral portion T1. Therefore, after the position of the second holder 120, 120′ is changed, the second holder 120, 120′ is fixed using the bone screws 150, 160 or the positioning engagement screws 150′, 160′, and the guide pin 14 is reinserted through an individual guide sleeve (not shown) attached to the holder hole 124. In addition, when two retaining holes 124 or two second bone fixation devices 140 are used, it is desirable to use a method in which one of the two guide pins 14 remains inserted, the other is removed and reinserted, and then one is reinserted in order to maintain the reduction state of the fractured part.

[0056] At this time, it is preferable to set the opening diameter of the retaining hole 124 large so that the guide pin 14 inserted at the original standard position can pass through the retaining hole 124 of the second retainer 120, 120'. That is, when the guide pin 14 is corrected from the pre-change position (standard position) to the post-change position as described above, it is preferable that the opening radius of the retaining hole 124 be larger than the above-mentioned positioning range ΔS. In this way, when the insertion position of the guide pin 14 is changed from the pre-change position to the post-change position by the positioning range ΔS, after the second retainer 120, 120' is introduced in the step of FIG. 7(c) in such a manner that the guide pin 14 at the pre-change position (e.g., the standard position) passes through the opening range of the retaining hole 124, it is possible to confirm that the second retainer 120, 120' can be set to the post-change position, and then the guide pin 14 can be reinserted into the appropriate post-change position. In practice, by setting the second holding body 120, 120' to the changed position, it is possible to confirm that the guide pin 14, which is set to pass through the center of the holding hole 124, can be inserted into the correct position, and then the guide pin 14 can be reinserted.

[0057] The positioning engaging screws 150', 160' can be attached to the positioning holes 125, 125' and the reference hole 113 in advance, and after the first holder 110, the first bone fastener 130, and the second holder 120 are introduced as shown in FIG. 7(c), the second holder 120 can be moved and the positioning engaging screws 150', 160' can be tightened to fix the second holder 120 while checking the fitting status on the lateral portion T1. In this case, if it is ultimately necessary to use the bone screws 150, 160, the positioning engaging screws 150', 160' can be removed after the second bone fastener 140 is introduced, and the bone screws 150, 160 can be attached. Note that the above-described usage is merely an example, and each embodiment can be used in various usage modes. For example, the first retaining body 110 and the second retaining body 120, 120' may be positioned or fixed in advance using positioning engagement screws 150', 160' or the like according to the patient's condition, and then introduced into the body. When bone screws 150, 160 are not used, such as when positioning engagement screws 150', 160' are ultimately used, it is preferable that the flange portion 112 engages with the second retaining body 120 in the direction of axis X1 (thickness), and that the second retaining body 120 engages with the outer portion T1 in the directions of axes X2, X3 by other means, such as bone engagement structure 144.

[0058] An advantage of the positioning engaging screws 150', 160' is that, unlike the bone screws 150, 160, they can perform the positioning function of the first holder 110 and the second holder 120 without accessing the bone. In particular, as shown in FIG. 2(c), the axis of the femoral neck T2 is offset anteriorly by ΔX from the diaphyseal axis XT, and therefore the axis X1 of the first bone fastener 130 by the first holder 110 is similarly offset. Therefore, when the bone screws 150, 160 are used, these bone screws 150, 160 are also inserted at a position offset from the diaphyseal axis XT. This can lead to problems such as the bone being easily cracked due to eccentric insertion of the bone screws, or the bone screws 150, 160 themselves being unusable depending on the bone quality. This problem can be avoided by using the positioning engaging screws 150', 160'. The eccentric insertion of the bone screws 150, 160 due to the forward offset ΔX of the radial portion T2 can be avoided by orienting the reference hole 113 and the positioning holes 125, 125′ obliquely backward, thereby introducing the bone screws 150, 160 toward the diaphyseal axis XT. However, this method requires separate implants for the left and right sides, which increases costs, such as increasing inventory.

[0059] (Action and effect) According to the bone fixing systems 100, 100′ of the above-described embodiments, the first holding body 110 and the second holding body 120 are configured to be relatively movable in the movement direction XL in which the distance between the first holding position X1 and the second holding positions X2, X3 changes, and are configured to be respectively positionable in a plurality of mutually different relative positional relationships (within a range of A, B, or AB) along the movement direction XL, and these plurality of relative positional relationships are configured to be maintainable in a state in which the first bone fixation device 130 introduced from the lateral part T1 is held by the first holding body 110 at the first holding position X1, and the second bone fixation device 140 introduced from the lateral part T1 is held by the second holding body 120 at the second holding positions X2, X3. Thus, by configuring the arrangement of plates and bone fixation devices to be changeable according to the patient's condition, it is possible to optimize fracture fixation and improve the stability and strength of bone fixation.

[0060] In each of the above embodiments, the first retainer 110 is fixed to the lateral portion T1, and the second retainer 120 is fixed to the lateral portion T1. As a result, the above-described multiple relative positional relationships are maintained via the lateral portion T1 (cortical bone). In particular, the barrel portion 111 is integrally formed with the flange portion 112 disposed on the lateral portion T1, and is transversely secured by bone screws 150, 160 inserted into the bone through 125, 125′ of the flange portion 112, thereby fixing the first retainer 110 to the lateral portion T1. Furthermore, the sleeve portion 140A is locked into the retaining hole 124, and the bone engagement structure 144 engages with the cortical bone of the lateral portion T1, thereby fixing the second retainer 120 to the lateral portion T1. Therefore, the first retainer 110 and the second retainer 120 are fixed via the cortical bone of the lateral portion T1, thereby maintaining the multiple relative positional relationships.

[0061] In addition, as long as either the fixing action of the bone screws 150, 160 to the lateral part T1 in the direction of the axis X1 or the fixing action of the bone engagement structure 144 and the locking structures 124, 143 to the lateral part T1 in the directions of the axes X2, X3 is present, the fixed state of the first retaining body 110 and the second retaining body 120 on the lateral part T1 is maintained even if shortening of the fractured part occurs, and as a result, there is no indirect effect on the relative positional relationship in the movement direction XL. Furthermore, the axial locking action of the first bone fixation device 130 by the barrel portion 111 and the axial locking action of the second bone fixation device 140 by the threaded engagement between the retaining hole 124 and the head 143 of the sleeve portion 140A and the engagement of the bone engagement structure 144 with the cortical bone suppress tilting of the axes X1, X2, X3, thereby providing an effect equivalent to maintaining the relative positional relationship in the movement direction XL that intersects with these axes, in terms of maintaining the reduced state of the femoral head T3.

[0062] Furthermore, in each embodiment, by further providing positioning means 125, 125', 113 that are configured to be able to position the first holding body 110 and the second holding body 120 in the movement direction XL in the above-mentioned multiple relative positional relationships, it becomes possible to (structurally) maintain the position of the second holding body 120 in the movement direction XL relative to the first holding body 110 within the bone fixing system 100, 100', so that the relative positional relationships between the first holding body 110 and the second holding body 120 can be set reliably and accurately and surgery is facilitated.

[0063] Furthermore, in each embodiment, the positioning means includes a first engaging portion 113 provided on the first holding body 110, second engaging portions 125, 125' provided on the second holding body 120, and engaging members 150, 160, 150', 160' that are detachably engaged with the first engaging portion and the second engaging portion, respectively. This enables reliable positioning with a simple structure. Since the engaging members 150, 160, 150', 160' are screws that thread into at least one of the first engaging portion 113 and the second engaging portions 125, 125', reliable positioning can be achieved with a simple operation. In particular, since the engaging members are bone screws 150, 160 that are screwed into the bone, the first holding body 110 and the second holding body 120 can be reliably and stably fixed to the bone.

[0064] Specifically, the first engaging portion 113 and the second engaging portion 125, 125' are engaging holes that can engage with the head 152 of the engaging member 150, 150', respectively, and the other engaging hole 125 includes a plurality of hole portions 125a, 125b arranged along the movement direction. This allows the engaging member 150, 150' to be used simply by selecting one of the engaging holes 113 and the plurality of hole portions 125a, 125b, thereby facilitating positioning after movement in the movement direction. In this case, the head 152 of the engaging member has an external thread 152a, and one of the engaging holes 113 of the first engaging portion and the second engaging portion is a female-threaded screw hole that screws into the male thread 152a of the head, thereby enabling more reliable and accurate positioning based on the engagement action caused by the screw engagement.

[0065] Furthermore, the first engagement portion 113 and the second engagement portion 125' are engagement holes into which the heads 162 of the engagement members 160, 160' can be engaged, and the other engagement hole 125' is an elongated hole aligned with the movement direction XL. This allows the engagement members 160, 160' inserted through the engagement holes 113 to be positioned at any position within the range of the extension of the movement direction XL of the engagement hole 125', thereby increasing the degree of freedom in positioning. In this case, the heads 162 of the engagement members have male threads 162b, and the engagement hole 113 of one of the first and second engagement portions is an internally threaded hole that screws into the male threads 162b of the heads, thereby enabling more reliable and accurate positioning based on the engagement action achieved by the screw engagement.

[0066] Next, the first holder 110 comprises a first structural part 112 that is placed on the bone surface of the lateral part T1 facing away from the femoral head T3, and the second holder 120 comprises a second structural part 122a that is placed on the bone surface and engages with the first structural part on the bone surface in a manner that allows it to move relatively in the movement direction XL, and the first structural part 112 and the second structural part 122a engage with each other in an overlapping manner on the bone surface. Thus, the first structural part 112 and the second structural part 122a overlap with each other on the bone surface, and the first holder 110 and the second holder 120 are fixed on the bone surface and thus firmly fixed to each other, thereby making it possible to firmly hold the fractured part.

[0067] Here, the first structural portion 112 and the second structural portion 122a are provided with a guide structure that guides the second holding body 120 along the movement direction XL relative to the first holding body 110, and the guide structure stabilizes the manner of relative movement between the first holding body 110 and the second holding body 120, thereby facilitating the movement operation and increasing the positioning accuracy. In particular, the guide structure includes a groove structure 122b formed along the movement direction XL and a groove fitting portion 112b that fits into the groove structure 122b and is configured to be slidable along the movement direction XL, so that the first holding body 110 and the second holding body 120 fit together on the bone surface and are firmly fixed.

[0068] In each embodiment, the femoral head T3 is provided in the proximal femur, and the first bone fixation device 130 and the second bone fixation device 140 pass through a point adjacent to the inside of the distal apex of the three vertices of the inverted triangular cross section of the neck T2, and a point adjacent to the inside of at least one of the two proximal apexes, toward the femoral head T3, thereby enabling stable and strong support of the fractured portion of the proximal femur.

[0069] In this case, the second holder 120 has a proximal region that extends proximally beyond the first holder 110 and includes the second holding positions X2 and X3, and a distal region that is configured to be movable relative to the first holder 110 along the movement direction XL, and the proximal region has a back surface shape that gradually curves outward from the distal region along the movement direction XL, thereby allowing the second holder 110 to be stably and firmly positioned on the bone surface from the lateral portion T1 toward the greater trochanter. In particular, it is easy to position the proximal region of the second holder 120 in accordance with the curved shape of the bone surface toward the greater trochanter, and a wide positioning range ΔS can be ensured for moving the second holder 120 relative to the first holder 110 along the movement direction XL while ensuring stability of the second holder 120 on the bone surface.

[0070] Regarding the use modes and surgical procedures of each embodiment, the above-mentioned distances LS1 and LS2 can be advantageously adjusted during surgery, as described above. However, they can also be positioned before surgery based on the patient's condition, which is known in advance. In this case, the surgical time can be shortened, and the need to prepare multiple parts with different dimensions can be reduced, thereby reducing product costs. For example, in the past, many parts were required to be prepared to match the patient's bone shape and bone size, such as the neck-shaft angle and anteversion angle. However, by enabling the second holder 120 to move relative to the first holder 110 along the movement direction XL, differences in bone shape and size can be absorbed to a certain extent, and it is expected that the number of parts required to match the bone shape and size will be reduced.

[0071] It should be noted that the bone fixing system of the present invention is not limited to the above-described illustrated examples, and various modifications can be made without departing from the spirit and scope of the present invention. For example, the above-described embodiments have been described with reference to the case where one first bone fixing device 130 and two second bone fixing devices 140 are introduced from the lateral part T1, through the neck part T2, and toward the femoral head T3. However, even when only one second bone fixing device 140 is used in addition to the first bone fixing device 130, the same effects as those described above can be basically achieved. [Explanation of symbols]

[0072] 100...bone fixation system, 110...first retainer, 111...barrel portion, 112...flange portion, 112a...opening, 112b...side edge, 113...reference hole, 113a...female thread, 120...second retainer, 121...surface, 122...back surface, 122a...fitting portion, 122b...side groove, 123...opening, 124...retaining hole, 124a...female thread, 125...positioning hole, 125a...female thread formed at first position, 125b...female thread formed at second position, A...first position, B...second position, 130...first bone fixation device, 131...bone engagement portion, 132...shank portion, 140...second Bone fixation device, 141...bone engagement portion, 142...shank portion, 143...head portion, 143a...male thread, 144...bone engagement structure, 150...bone screw, 151...bone engagement portion, 152...head portion, 152a...male thread, 160...bone screw, 161...bone engagement portion, H1...upper head region, H2...lower head region, 162...head portion, 162a...fastening surface, 162b...male thread, 150', 160'...positioning engagement screws, L1-L4...distance, LS1, LS2...spacing, ΔS...positioning range, θ1-θ4...angle, 10...angle guide, 10B...base, 11, 12...guide sleeve, 10H...handle

Claims

1. A bone fixing system comprising: a first bone fastener and a second bone fastener, each of which is introduced from an outer side toward a femoral head; a first holder that holds the first bone fastener at a first holding position; and a second holder that is configured to be engageable with the first holder and holds the second bone fastener at a second holding position, the first holding body and the second holding body are configured to be relatively movable in a movement direction in which an interval between the first holding position and the second holding position changes, and are configured to be respectively positionable at a plurality of positions corresponding to a plurality of mutually different intervals, a plurality of positions corresponding to the plurality of intervals are configured to be able to be maintained in a state in which the first bone fastener introduced from the outer portion is held by the first holder at the first holding position, and the second bone fastener introduced from the outer portion is held by the second holder at the second holding position, a positioning means configured to be able to position the first holder and the second holder in a state in which the first holder and the second holder are held so as not to move relative to each other in the movement direction at each of a plurality of positions corresponding to the plurality of intervals, the positioning means has a first engaging portion provided on the first holding body, a second engaging portion provided on the second holding body, and engaging members that are respectively detachably engaged with the first engaging portion and the second engaging portion; the engaging member is a screw that is screwed into at least one of the first engaging portion and the second engaging portion, the engaging member is a bone screw that is screwed into the bone; Bone fixation system.

2. A bone fixing system comprising: a first bone fastener and a second bone fastener, each of which is introduced from an outer side toward a femoral head; a first holder that holds the first bone fastener at a first holding position; and a second holder that is configured to be engageable with the first holder and holds the second bone fastener at a second holding position, the first holding body and the second holding body are configured to be relatively movable in a movement direction in which an interval between the first holding position and the second holding position changes, and are configured to be respectively positionable at a plurality of positions corresponding to a plurality of mutually different intervals, a plurality of positions corresponding to the plurality of intervals are configured to be able to be maintained in a state in which the first bone fastener introduced from the outer portion is held by the first holder at the first holding position, and the second bone fastener introduced from the outer portion is held by the second holder at the second holding position, a positioning means configured to be able to position the first holder and the second holder in a state in which the first holder and the second holder are held so as not to move relative to each other in the movement direction at each of a plurality of positions corresponding to the plurality of intervals, the positioning means has a first engaging portion provided on the first holding body, a second engaging portion provided on the second holding body, and engaging members that are respectively detachably engaged with the first engaging portion and the second engaging portion; the first engaging portion and the second engaging portion are engaging holes into which the heads of the engaging members can engage, One of the engagement holes includes a plurality of hole portions arranged along the movement direction. Bone fixation system.

3. A bone fixing system comprising: a first bone fastener and a second bone fastener, each of which is introduced from an outer side toward a femoral head; a first holder that holds the first bone fastener at a first holding position; and a second holder that is configured to be engageable with the first holder and holds the second bone fastener at a second holding position, the first holding body and the second holding body are configured to be relatively movable in a movement direction in which an interval between the first holding position and the second holding position changes, and are configured to be respectively positionable at a plurality of positions corresponding to a plurality of intervals different from each other, a plurality of positions corresponding to the plurality of intervals are configured to be able to be maintained in a state in which the first bone fastener introduced from the outer portion is held by the first holder at the first holding position, and the second bone fastener introduced from the outer portion is held by the second holder at the second holding position, a positioning means configured to be able to position the first holder and the second holder in a state in which the first holder and the second holder are held so as not to move relative to each other in the movement direction at each of a plurality of positions corresponding to the plurality of intervals, the positioning means has a first engaging portion provided on the first holding body, a second engaging portion provided on the second holding body, and engaging members that are respectively detachably engaged with the first engaging portion and the second engaging portion; the first engaging portion and the second engaging portion are engaging holes into which the heads of the engaging members can engage, One of the engagement holes is an elongated hole along the movement direction and has a periphery that can be fastened by the head of the engagement member. Bone fixation system.

4. the engaging member is a screw that is screwed into at least one of the first engaging portion and the second engaging portion; The bone fixing system according to claim 2 or 3.

5. the engaging member is a bone screw that is screwed into the bone; The bone fixing system of claim 4.

6. A bone fixing system comprising: a first bone fastener and a second bone fastener, each of which is introduced from an outer side toward a femoral head; a first holder that holds the first bone fastener at a first holding position; and a second holder that is configured to be engageable with the first holder and holds the second bone fastener at a second holding position, the first holding body and the second holding body are configured to be relatively movable in a movement direction in which an interval between the first holding position and the second holding position changes, and are configured to be respectively positionable at a plurality of positions corresponding to a plurality of mutually different intervals, a plurality of positions corresponding to the plurality of intervals are configured to be able to be maintained in a state in which the first bone fastener introduced from the outer portion is held by the first holder at the first holding position, and the second bone fastener introduced from the outer portion is held by the second holder at the second holding position, The femoral head is provided in the proximal femur, the first bone fastener and the second bone fastener pass through a point adjacent to the inside of the distal apex of the three apexes of the inverted triangular cross section of the femoral neck and a point adjacent to the inside of at least one of the two apexes of the proximal side toward the femoral head; the second holding body has a proximal region that protrudes proximally from the first holding body and includes the second holding position, and a distal region that is configured to be relatively movable with respect to the first holding body along the movement direction, The proximal region has a back surface shape that is gradually curved outward from the distal region along the movement direction. Bone fixation system.

7. The device further comprises a positioning means configured to be able to position the first holder and the second holder in a state where they are held so as not to move relative to each other in the movement direction at each of a plurality of positions corresponding to the plurality of intervals. The bone fixing system of claim 6.

8. The positioning means has a first engaging portion provided on the first holder, a second engaging portion provided on the second holder, and an engaging member that is detachably engaged with the first engaging portion and the second engaging portion, respectively. The bone fixing system of claim 7.

9. The engaging member is a screw that screws into at least one of the first engaging portion and the second engaging portion. The bone fixing system of claim 8.

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