Artificial knee joint implant and cut guide

Abstract

This artificial knee joint implant comprises a tibial tray, a tibial component, a fixing member, and an insert. The insert has a plate-shaped first portion and a second portion, a through-hole that penetrates the first portion and the second portion and in which the fixing member is positioned, and a support portion positioned around the through-hole and supporting a portion of the fixing member. A side surface of the first portion includes a second surface having a longitudinal length greater than the diameter of the through-hole. The tibial tray has a fitting portion that fits with the fixing member.

Description

Knee implants and cutting guides

[0001] The present disclosure relates to an artificial knee joint implant used in surgery to replace a patient's knee joint with an artificial knee joint, and a cutting guide used when performing osteotomy.

[0002] An artificial knee joint implant used in knee joint replacement surgery, which replaces a knee joint with an artificial knee joint, is known. The artificial knee joint implant includes a femoral component fixed to the distal end of the femur and a tibial component fixed to the proximal end of the tibia.

[0003] Patent Document 1 describes a tibial prosthesis for use in knee joint replacement surgery, which includes a tibial bearing component, an insert disposed in a recess of the tibial bearing component, and a tibial baseplate fastened to the tibial bearing component via the insert by a fastener.

[0004] U.S. Patent Publication No. 2018 / 0256346

[0005] DePuy Synthes "The Attunement Revision Fixed Bearing Knee System" Simple Procedure Manual 2020 Zimmer Biomet "Persona Revision Knee System" Surgical Technique 2020 DePuy Synthes "Attunement Revision Knee System Fixed Bearing Surgical Technique"

[0006] An artificial knee joint implant according to one aspect of the present disclosure comprises a tibial tray fixed to the tibia, a tibial component that fits with the tibial tray and has a sliding surface along which a femoral component slides, a fixation member that fixes the tibial tray and the tibial component, and an insert that is inserted into a recess in the tibial component, wherein the insert has a plate-shaped first portion, a second portion that protrudes from a first surface of the first portion, a through hole that penetrates the first portion and the second portion and in which the fixation member is located, and a support portion that is located around the through hole and supports a portion of the fixation member, and the side of the first portion that is inserted into the tibial component includes a second surface whose longitudinal length is longer than the diameter of the through hole, and the tibial tray has a fitting portion that fits with the fixation member.

[0007] A cutting guide according to one aspect of the present disclosure comprises a main body portion having a first surface at least a portion of which abuts against a bone and a slot penetrating from the first surface to a surface opposite the first surface, and a spacer positioned between the first surface and the bone, wherein the first surface has a groove portion that is open only at a first end, and the spacer has a protrusion that is inserted into the groove portion while engaging with the groove portion, and further comprises a blocking portion that prevents the protrusion from moving from the first end of the groove portion out of the groove portion.

[0008] 6 is a diagram showing an example of use of the artificial knee joint implant according to embodiment 1 of the present disclosure. FIG. 7 is a diagram showing the structure of a tibial assembly of the artificial knee joint implant. FIG. 8 is a cross-sectional view of the tibial assembly cut along line II-II shown in FIG. 2. FIG. 9 is an external view showing details of the shape of an insert included in the tibial assembly. FIG. 10 is a diagram showing another embodiment of an insert. FIG. 11 is a schematic diagram showing a state in which a cut guide according to embodiment 2 of the present disclosure is attached to a femur. FIG. 12 is a perspective view and a front view showing an example of the main body shown in FIG. 13. FIG. 14 is a perspective view, a front view, a side view, and a plan view showing an example of the spacer shown in FIG. 13. FIG. 15 is a perspective view and a side view showing an example of the position adjustment member shown in FIG. 14. FIG. 16 is an exploded perspective view showing an example of the cut guide shown in FIG. 16. FIG. 17 is a perspective view showing an example of the cut guide shown in FIG. 16. FIG. 18 is a schematic diagram explaining reduction in spacer detachment.

[0009] First Embodiment Overview of the Artificial Knee Joint Implant 100 When the tibial bearing component and the tibial base plate are joined together in an artificial knee joint implant, there is a risk of misalignment or a gap occurring.

[0010] According to one aspect of the present disclosure, it is possible to reduce misalignment of the connection between the tibial component and the tibial tray, and also to reduce the possibility of the connection between the tibial component and the tibial tray becoming loose.

[0011] A first embodiment of the present disclosure will be described in detail below. A knee prosthesis implant 100 according to the first embodiment is an implant used in knee prosthesis replacement surgery. Fig. 1 shows an example of how the knee prosthesis implant 100 is used. As shown in Fig. 1, the knee prosthesis implant 100 includes a tibial assembly 1 that is attached to the tibia, and a femoral component 2 that is attached to the femur.

[0012] [Tibia Assembly 1] The tibia assembly 1 will be described in detail with reference to Figures 2 and 3. Figure 2 is a diagram showing the structure of the tibia assembly 1.

[0013] Reference numerals 201 and 203 in Fig. 2 are perspective views of the tibial assembly 1. Here, the longitudinal direction of the tibia when the tibial assembly 1 is attached to the tibia is defined as the Z direction, the direction corresponding to the anterior-posterior direction of the knee is defined as the X direction, and the direction perpendicular to the Z and X directions is defined as the Y direction. Reference numeral 201 in Fig. 2 is a perspective view of the tibial assembly 1 as viewed from the +Z direction. Reference numeral 203 in Fig. 2 is a perspective view of the tibial assembly 1 as viewed from the -Z direction.

[0014] As shown in FIG. 2 , the tibial assembly 1 includes a tibial tray 11 , a tibial component 12 , a fixation member 13 , and an insert 10 .

[0015] Reference numerals 202 and 204 in Fig. 2 show exploded views of the above-mentioned components constituting the tibial assembly 1. Reference numeral 202 in Fig. 2 shows the exploded view of the tibial assembly 1 as viewed from the same direction as reference numeral 201, i.e., the +Z direction. Reference numeral 204 in Fig. 2 shows the exploded view of the tibial assembly 1 as viewed from the same direction as reference numeral 203, i.e., the -Z direction.

[0016] The tibial tray 11 is located furthest in the -Z direction in the tibial assembly 1. The tibial tray 11 is fixed to the tibia. The tibial tray 11 has a surface on the -Z direction side that contacts the tibia. The tibial tray 11 has a surface on the +Z direction side. The tibial tray 11 has an engaging portion 119 on the +Z direction side that engages with the fixation member 13. The tibial tray 11 has an area on the +Z direction side that covers part of the periphery of the tibial component 12. For example, the tibial tray 11 has an area on the +Z direction side that engages with part of the periphery of the tibial component 12.

[0017] The tibial component 12 is located on the +Z direction side of the tibial tray 11. The tibial component 12 has a surface on the -Z direction side that contacts the tibial tray 11. The tibial component 12 fits into the tibial tray 11. The tibial component 12 has a sliding surface 121 on the +Z direction side, on which the femoral component 2 slides. The shape of the sliding surface 121 is not particularly limited, and may be, for example, a curved surface with a gradually changing radius of curvature. The tibial component 12 has a recess 122 located on the surface on the -X direction. The recess 122 is open in the -X direction. The recess 122 may be open in the +X direction, the +Y direction, or the -Y direction.

[0018] The fixing member 13 is a member that fixes the tibial tray 11 and the tibial component 12. The fixing member 13 is disposed through a through-hole 123 located on the tibial component 12 and an engaging portion 119 located on the tibial tray 11, thereby fixing the tibial tray 11 and the tibial component 12 together. The fixing member 13 may be, for example, a screw or a post. When the fixing member 13 is a screw, the engaging portion 119 may be a screw hole into which the screw threads. By using a screw as the fixing member 13 and a screw hole as the engaging portion 119, the tibial tray 11 and the tibial component 12 can be easily fixed together.

[0019] The insert 10 is inserted into a recess 122 of the tibial component 12. The recess 122 of the tibial component 12 is provided on the surface of the tibial component 12 facing the -X direction, and the insert 10 is inserted in the +X direction. Therefore, the +X direction can be said to be the insertion direction of the insert 10. Details of the insert 10 will be described later.

[0020] Furthermore, when the insert 10 is inserted into the tibial component 12, movement of the insert 10 in the Z direction within the tibial component 12 is restricted. In other words, when the insert 10 is inserted into the tibial component 12, the insert 10 and the tibial component 12 move together in the Z direction.

[0021] The Z direction can be said to be the longitudinal direction of the fixing member 13, and therefore, when the insert 10 is inserted into the tibial component 12, it can also be said that movement of the fixing member 13 in the longitudinal direction is restricted.

[0022] Figure 3 is a cross-sectional view of the tibial assembly 1 taken along line II-II indicated by 201 in Figure 2. Figure 3 shows a state in which the insert 10 is inserted into the tibial component 12, and the tibial tray 11 and the tibial component 12 are fixed together by a fixation member 13. As shown in Figure 3, in the tibial assembly 1, the fixation member 13 fits into the tibial tray 11 via the insert 10, thereby fixing the tibial component 12 and the tibial tray 11 together.

[0023] [Details of Insert 10] Next, the details of the shape of the insert 10 will be described with reference to Fig. 4. Fig. 4 is an external view showing the details of the shape of the insert 10.

[0024] 401 in Fig. 4 is a perspective view of the insert 10 as seen from the +Z direction. 402 in Fig. 4 is a view of the insert 10 as seen from the +Z direction. 403 in Fig. 4 is a view of the insert 10 as seen from the -Y direction. 404 in Fig. 4 is a view of the insert 10 as seen from the -X direction.

[0025] As shown in 401 of FIG. 4 , the insert 10 has a plate-shaped first portion 101 and a second portion 102 protruding from a first surface 111 of the first portion 101. The first portion 101 has the first surface 111, which is the surface on the −Z direction side. The insert 10 has a through hole 106 that penetrates the first portion 101 and the second portion 102. A fixing member 13 may be located inside the through hole 106. The insert 10 has a support portion 107 that supports a portion of the fixing member 13. The support portion 107 is located around the through hole 106. The support portion 107 may be located only in the first portion 101 of the insert 10. The support portion 107 may be located in both the first portion 101 and the second portion 102 of the insert 10.

[0026] If the fixation member 13 is a screw, the support portion 107 may support the head of the screw as part of the fixation member 13. Specifically, the support portion 107 may support only the bottom surface of the head of the screw, i.e., the surface on the −Z direction side. By supporting the head of the screw with the support portion 107, if the screw moves in the −Z direction, the insert 10 will also move in the −Z direction. When the insert 10 is inserted into the tibial component 12, movement in the Z direction is restricted, and therefore, if the insert 10 moves in the −Z direction, the tibial component 12 will also move in the −Z direction.

[0027] Therefore, by tightening the screw to move it in the direction in which the screw advances, i.e., in the −Z direction, the tibial component 12 can be moved toward the tibial tray 11, and the tibial component 12 and the tibial tray 11 can be coupled together. This reduces the possibility of the tibial tray 11 and the tibial component 12 becoming loose when coupled together. It also reduces the possibility of misalignment between the tibial tray 11 and the tibial component 12.

[0028] As indicated by 402 in FIG. 4 , the side surface of the first part 101 that is inserted into the tibial component 12, i.e., the side surface on the +X direction side, includes a second surface 112 whose longitudinal length Lxa is longer than the diameter Lxb of the through hole. Here, the second surface 112 refers to the surface of the side surface on the +X direction side of the first part 101 that faces in the Y direction. The side surface of the second part 102 is located more inward than the outer periphery of the first part 101. This allows a force in the −Z direction applied to the insert 10 to be transmitted to the tibial component 12, thereby enabling the tibial component 12 to be pressed toward the tibial tray 11.

[0029] The first portion 101 also has a sidewall 105 that is generally parallel to the insertion direction of the insert 10, i.e., the +X direction. The sidewall 105 extends further toward the insertion side, i.e., the +X direction, than the through-hole 106. This allows for a structure that makes it easy to transmit a force applied to the insert 10 in the -Z direction to the tibial component 12.

[0030] Furthermore, when viewed from a direction perpendicular to the first surface 111, the connection between the second surface 112 and the side wall 105 has an approximately arc-shaped configuration that is convex outward. Here, the term "approximately arc-shaped" includes, for example, a shape in which a portion of the arc is missing or a shape in which the curvature of the arc gradually changes. This reduces the possibility of the insert 10 being deformed by a force applied to it, compared to a configuration in which the insert 10 has an outwardly concave arc-shaped configuration in the prior art. Furthermore, the area around the through hole 106 in the first portion 101 can be increased, compared to the prior art. This increases the range over which the insert 10 presses the tibial component 12 toward the tibial tray 11. This allows the tibial component 12 and the tibial tray 11 to be firmly coupled together, reducing the possibility of the tibial component 12 and the tibial tray 11 becoming loose when coupled together.

[0031] As shown by 403 and 404 in FIG. 4 , the outer periphery of the third surface 113 of the first portion 101, which is opposite to the first surface 111, is chamfered to form a chamfered portion 116. If the third surface 113 does not have the chamfered portion 116, the first portion 101 of the insert 10 will have a corner on the +Z direction side. If the first portion 101 has a corner on the +Z direction side, the corner on the +Z direction side is likely to collide with the upper surface or side surface of the recess 122 when the insert 10 is inserted into the tibial component 12. The chamfered portion 116 allows the insert 10 to be easily inserted into the tibial component 12.

[0032] 4 , the first part 101 has a recess 109 that is open to the first surface 111 on the insertion side of the first part 101, i.e., on the side opposite to the +X direction side. The recess 109 allows the surgeon to apply a predetermined instrument to the recess 109 and remove the insert 10 from the tibial component 12, thereby making it possible to easily remove the insert 10 from the tibial component 12.

[0033] [Other Embodiments of the Insert 10] Next, other embodiments of the insert 10 will be described with reference to Fig. 5. Fig. 5 is a diagram showing inserts 10A to 10E which are other embodiments of the insert 10.

[0034] 5 differ from one another in the relationship between the distance between the through hole 106 in the first portion 101 and the side surface 114 on the −X direction side. More specifically, in the order of the inserts 10A to 10E, the distance between the center of the through hole 106 and the side surface 114 becomes longer relative to the distance between the center of the through hole 106 and the second surface 112.

[0035] That is, the relationship is (DB1 / DA1)>(DB2 / DA2)>(DB3 / DA3)>(DB4 / DA4)>(DB5 / DA5).

[0036] Here, DA1 is the distance between the center of the through hole 106 and the second surface 112. DB1 is the distance between the center of the through hole 106 and the side surface 114 in the insert 10A. DA1 and DB1 may be approximately the same length. DB2 is the distance between the center of the through hole 106 and the side surface 114 in the insert 10B. DA2 is the distance between the center of the through hole 106 and the second surface 112. DB3 is the distance between the center of the through hole 106 and the side surface 114 in the insert 10C. DA3 is the distance between the center of the through hole 106 and the second surface 112. DB4 is the distance between the center of the through hole 106 and the side surface 114 in the insert 10D. DA4 is the distance between the center of the through hole 106 and the second surface 112. DB5 is the distance between the center of the through hole 106 and the side surface 114 in the insert 10E. DA5 is the distance between the center of the through-hole 106 and the second surface 112.

[0037] The configuration of the inserts 10B to 10E can be described as follows: When the third surface 113 is divided by a line that passes through the center of the through hole 106 in the third surface 113 opposite the first surface 111 of the first portion 101 and is perpendicular to the insertion direction of the insert 10, the area of ​​the surface on the insertion side is smaller than the area of ​​the surface on the opposite side.

[0038] In this way, by making the area of ​​the through hole 106 on the -X direction side on the first surface 111 or the third surface 113 of the first part 101 smaller than the area on the +X direction side, the force applied to the Z direction side of the insert 10 can be transmitted to the tibial component 12.

[0039] Furthermore, instead of having different areas as described above, the weight of the first portion 101 may be different between the −X direction side and the +X direction side of the through hole 106. That is, when the first portion 101 is divided by a line that passes through the center of the through hole 106 in the third surface 113 opposite the first surface 111 of the first portion 101 and is perpendicular to the insertion direction, the weight of the first portion 101 on the insertion side may be lighter than the weight of the first portion 101 on the opposite side. Even with this configuration, a force applied in the Z direction of the insert 10 can be transmitted to the tibial component 12.

[0040] <Embodiment 2> In total knee joint replacement surgery, a cutting guide is used when performing osteotomy on the distal portion of the femur, which is the end of the femur B on the knee side. When attaching a cutting guide to the distal portion of the femur during osteotomy, it is known to attach a spacer to the cutting guide to adjust the distance between the cutting guide and the femur. In this case, there is a possibility that the spacer will fall off the cutting guide due to vibrations during osteotomy, etc. According to one aspect of the present disclosure, it is possible to reduce the risk of the spacer falling off the main body of the cutting guide.

[0041] A cutting guide 1000 according to a second embodiment of the present disclosure will be described below with reference to the drawings. An example will be described below in which the cutting guide 1000 is used as a guide instrument for indicating a cutting position in the distal portion B1 of the femur B in total knee joint replacement surgery. However, the present disclosure is not limited to this, and the cutting guide 1000 can also be applied to total hip joint replacement surgery, total ankle joint replacement surgery, etc. Furthermore, when the cutting guide 1000 is applied to total knee joint replacement surgery, it may also be applied to, for example, revision surgery of an artificial knee joint, total knee joint replacement surgery for a patient with a lower limb tumor, etc.

[0042] <Overview> First, a brief overview of total knee joint replacement surgery will be provided to facilitate understanding of the cutting guide 1000. Total knee joint replacement surgery is a procedure in which a patient's knee joint is replaced with an artificial knee joint.

[0043] The artificial knee joint includes a femoral implant that is placed in the distal portion of the patient's femur on the knee side, and a tibial implant that engages with the femoral implant and is placed in the proximal portion of the tibia.

[0044] A portion of the distal portion of the patient's femur and a portion of the proximal portion of the tibia are resected with a bone resection tool such as a bone saw to form mounting surfaces for the implants. A femoral implant is attached to the mounting surface of the femur, and a tibial implant is attached to the mounting surface of the tibia, and the femoral implant and the tibial implant are engaged with each other to function as the patient's knee joint. The cutting guide 1000 according to an embodiment of the present disclosure is used in the above process of resecting the distal portion of the femur to form the mounting surfaces.

[0045] Fig. 6 is a schematic diagram showing the state in which the cutting guide 1000 is attached to the distal portion B1 of the femur B. As shown in Fig. 6, the cutting guide 1000 includes a main body portion 2000, a spacer 3000, and a position adjustment member 4000 that adjusts the attachment position of the main body portion 2000.

[0046] When performing bone resection on the distal portion B1 of the femur B, first, a surgical reamer 9, which is an instrument separate from the cutting guide 1000, is inserted into the bone marrow of the femur B.

[0047] Next, the surgical reamer 9 is inserted through the through-hole 2500 (see FIG. 7 ) of the main body 2000 of the cutting guide 1000, and the first surface 2100 of the main body 2000 facing the end surface B2 of the femur B is brought into contact with the end surface B2. Then, the position adjustment member 4000 is fitted into the main body 2000, and the main body 2000 is fixed to the femur B with a fixing pin (not shown).

[0048] In this case, if the total knee joint replacement surgery is not a primary surgery but a revision surgery in which the existing total knee joint is removed and replaced with a new total knee joint, there may be a bone defect or the like, and the shape of the end surface B2 may differ between the medial and lateral sides. In such a case, a gap G may occur between the first surface 2100 of the main body 2000 and the end surface B2 of the femur B.

[0049] By inserting a spacer into this gap G and fixing it to the main body, the cutting guide can be stably attached to the femur B. However, there is a possibility that the spacer may come loose from the spacer insertion port and fall off due to vibrations generated when cutting bone with a bone saw or the like.

[0050] The cutting guide 1000 according to the embodiment of the present disclosure can easily reduce the risk of the spacer 3000 falling off from the main body 2000 without increasing the number of parts. This allows the practitioner to attach the cutting guide 1000 to the distal portion B1 of the femur B, insert a bone resection tool into the slot 2400 (described later), and perform bone resection on the femur B in a stable state.

[0051] Furthermore, the cutting guide 1000 can be used not only in reoperations but also in initial total knee replacement surgeries.

[0052] <Configuration of Cut Guide 1000> Next, the configuration of the cut guide 1000 will be described with reference to the drawings. As described above, the cut guide 1000 includes the main body 2000, the spacer 3000, and the position adjustment member 4000.

[0053] [Main Body 2000] Figure 7 shows a perspective view and a front view of an example of the main body 2000, with the views indicated by reference numerals 700A and 700B being perspective views and the view indicated by reference numeral 700C being a front view. Here, the installation direction of the cutting guide 1000 is referred to as the Za1 direction, and the direction opposite to the Za1 direction is referred to as the Za2 direction. Furthermore, the direction perpendicular to Za1 and Za2 and parallel to the first surface 2100, toward the inside, is referred to as the Xa1 direction, and the direction opposite to the Xa1 direction, toward the outside, is referred to as the Xa2 direction. The upward direction in Figure 7, perpendicular to Xa1 and Xa2 and perpendicular to Za1 and Za2, is referred to as the Ya1 direction, and the downward direction opposite to the Ya1 direction is referred to as the Ya2 direction. When Xa1 and Xa2, Ya1 and Ya2, and Za1 and Za2 are referred to collectively without distinction, they are referred to as the Xa direction, Ya direction, and Za direction.

[0054] As shown in FIG. 7 , the main body 2000 is formed in a generally plate-like shape when viewed overall. The shape of the main body 2000 is not limited to this and may be other shapes, and is not particularly limited. The main body 2000 includes a first surface 2100, a second surface 2200 opposite the first surface 2100, a slot 2400, a guide plate 2800, a dovetail groove (groove) 2300, a through hole 2500, a plunger receiving portion 26, and a pin insertion hole 2700. At least a portion of the first surface 2100 abuts against the end surface B2 of the femur B.

[0055] The shape of the dovetail groove 2300 is not particularly limited as long as it can secure the spacer 3000 (described later). For example, it may be formed as a T-shaped groove, or may have any other shape. In this case, the dovetail 3300 (described later) is formed as a convex portion that fits into the T-shaped groove, or a convex portion of any other shape that fits into the groove.

[0056] (Slot 2400) The slot 2400 is a member for guiding a cutting blade that cuts bone. One or more slots 2400 are provided in the main body 2000. The slot 2400 penetrates the main body 2000 from the first surface 2100 to the second surface 2200. The practitioner inserts a bone resection tool into the slot 2400 and slides the bone resection tool along the upper surface of the guide plate 2800 to resect the femur B. The slot 2400 is formed so that its width is greater than the thickness of the cutting blade so that the cutting blade can be inserted.

[0057] The slot 2400 also indicates the cutting position of the femur B. By including multiple slots 2400 in the main body 2000, multiple cutting positions can be indicated with a single attachment. For example, the slots 2400 include a first slot 2410, a second slot 2420, a third slot 2430, and a fourth slot 2440. The second slot 2420 includes three slots that are slightly different in position in the Ya direction so that bone can be resected at a desired position. The third slot 2430 and the fourth slot 2440 penetrate the first surface 2100 at a different angle than the first slot 2410.

[0058] The femur B is resected on five sides to fit the shape of the implant to be attached. More specifically, the distal portion B1 of the femur B is first resected perpendicular to the bone axis to form an end surface B2. The end surface B2 is one of the five installation surfaces of the implant.

[0059] Next, the cutting guide 1000 is attached to the end face B2, and the spacer 3000 is inserted into the gap G to secure the spacer 3000 to the main body 2000. To prevent the spacer 3000 from falling off, a position adjustment member 4000 is attached to the main body 2000 (see FIG. 10 ). Details of the position adjustment member 4000 will be described later, but in addition to its function of adjusting the position of the main body 2000, the position adjustment member 4000 also serves to reduce the possibility of the spacer 3000 falling off.

[0060] The distal portion B1 of the femur B is resected along the first slot 2410, the second slot 2420, the third slot 2430, and the fourth slot 2440, respectively, to form four installation surfaces. This allows the cutting guide 1000 to indicate four cutting positions that follow the shape of the implant with just one installation.

[0061] (Dovetail Groove 2300) The dovetail groove 2300 is a groove for fixing the spacer 3000 to the main body 2000. A dovetail tenon 3300 (protrusion) of the spacer 3000 (described later) is inserted into the dovetail groove 2300 in a state where it fits into the dovetail groove 2300.

[0062] A plurality of dovetail grooves 2300 are provided on the first surface 2100 side of the main body 2000, extending in the Xa direction. The dovetail grooves 2300 include a dovetail groove 2300a disposed on the inner side (Xa1 side) and a dovetail groove 2300b disposed on the outer side (Xa2 side). Hereinafter, when there is no need to distinguish between the dovetail grooves 2300a and 2300b, they may be referred to as dovetail grooves 2300.

[0063] Dovetail grooves 2300a and 2300b are arranged, for example, symmetrically about center C1 (see the drawing indicated by reference numeral 700C) of main body 2000. Dovetail grooves 2300a and 2300b do not have to be strictly symmetrical, and do not have to be symmetrical.

[0064] The dovetail groove 2300a has an opening 2310a only at the first longitudinal end (first end). The dovetail 3300 of the spacer 3000 is inserted into the dovetail groove 2300a through the opening 2310a, and with the dovetail 3300 and the dovetail groove 2300a engaged, the spacer 3000 is slid in the Xa2 direction to fix the spacer 3000 to the main body 2000.

[0065] On the other hand, the dovetail groove 2300b has an opening 2310b only at the first longitudinal end (first end). To secure the spacer 3000 to the dovetail groove 2300b, the dovetail tenon 3300 is inserted into the dovetail groove 2300b through the opening 2310b, and with the dovetail tenon 3300 and the dovetail groove 2300b engaged, the spacer 3000 is slid in the Xa1 direction to secure the spacer 3000 to the main body 2000. In this way, whether the spacer 3000 is inserted into the dovetail groove 2300a or the dovetail groove 2300b, it is attached from the center of the main body 2000 outward.

[0066] In the following description, when the openings 2310a and 2310b are not distinguished from each other and are referred to collectively, they will be referred to as openings 2310.

[0067] By providing multiple dovetail grooves 2300, such as dovetail groove 2300a and dovetail groove 2300b, the positional relationship between main body portion 2000 and end face B2 can be adjusted according to the position of dovetail groove 2300. In other words, if there is gap G on the medial side of femur B, spacer 3000 can be attached to dovetail groove 2300a, and if there is gap G on the lateral side, spacer 3000 can be attached to dovetail groove 2300b. This allows main body portion 2000 to be appropriately attached to end face B2 with a variety of shapes having different steps.

[0068] The shape of the dovetail groove 2300 is not particularly limited as long as it can secure the spacer 3000. For example, it may be formed as a T-shaped groove or any other shape. In this case, the dovetail 3300 of the spacer 3000 is formed as a convex portion that fits into the T-shaped groove, or a convex portion of any other shape that fits into the groove.

[0069] The through-hole 2500 is a hole that penetrates the center part of the main body 2000 in the Za direction, and a pair of legs 4200 (blocking portions) of the position adjustment member 4000 (described later) is inserted through the through-hole 2500 (see FIG. 10 ). The pair of legs 4200 includes a first leg (blocking portion) 4200 a and a second leg 4200 b.

[0070] The through-hole 2500 has a leg insertion portion 2510a at the end in the Ya2 direction through which the first leg 4200a is inserted, and a leg insertion portion 2510b at the end in the Ya1 direction through which the second leg 4200b is inserted.

[0071] Openings 2310a and 231b of dovetail groove 2300 are located at opening 2520 (end) on the first surface 2100 side of through hole 2500. Opening 2520 of through hole 2500 opens in the Za1 direction, and openings 2310a and 231b of dovetail groove 2300 open in the Xa1 direction or the Xa2 direction.

[0072] When inserting dovetail 3300 of spacer 3000 into dovetail groove 2300a, dovetail 3300 is inserted in the Xa1 direction from opening 2310a on the opening 2520 side of through-hole 2500. End 232a of dovetail groove 2300a on the Xa1 direction side is not open, so spacer 3000 will not fall off from end 232a, but the end on the Xa2 direction has opening 2310a, so there is a possibility that spacer 3000 may fall off from here.

[0073] On the other hand, when inserting dovetail 3300 of spacer 3000 into dovetail groove 2300b, dovetail 3300 is inserted in the Xa2 direction from opening 2310b on the opening 2520 side of through-hole 2500. Since end 232b of dovetail groove 2300b on the Xa2 direction side is not open, spacer 3000 will not fall off from end 232b, but since there is opening 2310b at the end on the Xa1 direction, there is a possibility that spacer 3000 will fall off from here.

[0074] Therefore, leg portions (blocking portions) 42a of the position adjustment member 4000 (described later) are inserted into the through-holes 2500 so as to block at least a portion of the openings 2310a and 2310b. This makes it possible to easily reduce the risk of the spacer 3000 falling off the main body 2000 without increasing the number of parts.

[0075] Plunger fitting portion 2600 fits into ball plunger 3400 provided on spacer 3000 to align spacer 3000 with main body portion 2000. If spacer 3000 is not inserted sufficiently and dovetail 3300 is not inserted all the way into dovetail groove 2300, the end of spacer 3000 will protrude from opening 2310a of dovetail groove 2300a and block part of through-hole 2500. This will prevent leg portion 4200 of position adjustment member 4000 from being inserted into through-hole 2500, making it impossible to reduce the risk of spacer 3000 falling off.

[0076] The plunger fitting portion 2600 is provided on the first surface 2100 side of the main body portion 2000, and when the dovetail 3300 of the spacer 3000 is inserted into the dovetail groove 2300, it fits with the ball plunger 3400 at a predetermined position.

[0077] When the user slides the spacer 3000 along the dovetail groove 2300, the ball at the tip of the ball plunger 3400 fits into the plunger fitting portion 2600 due to the biasing force of a spring or the like. This gives the user a clicking sensation, allowing the user to recognize that the spacer 3000 has been inserted to the correct position.

[0078] A fixing pin is inserted into the pin insertion hole 2700 to fix the main body portion 2000 and the spacer 3000 to the femur B. At least one pin insertion hole 2700 is provided penetrating the main body portion 2000 and the spacer 3000.

[0079] [Spacer 3000] As described above, the spacer 3000 is inserted into the gap G between the first surface 2100 of the main body 2000 and the end surface B2 of the femur B to eliminate rattling and enable the cutting guide 1000 to be stably attached to the femur B. The spacer 3000 is disposed between the first surface 2100 and the femur B, and defines the distance between the main body 2000 and the femur B.

[0080] 8A and 8B are perspective, front, side, and plan views showing an example of a spacer 3000. The view indicated by reference numeral 800A is a perspective view, the view indicated by reference numeral 800B is a front view, the view indicated by reference numeral 800C is a side view, and the view indicated by reference numeral 800D is a plan view.

[0081] 8, spacer 3000 is generally block-shaped. When spacer 3000 is attached to main body 2000, dovetail 3300 and ball plunger 3400 are provided on first surface 3100, which is the surface opposite first surface 2100 of main body 2000. Also provided is pin insertion hole 3500 that connects to pin insertion hole 2700 of main body 2000.

[0082] As described above, dovetail tenon 3300 is inserted into dovetail groove 2300 of main body 2000 while fitted therein, thereby fixing spacer 3000 to main body 2000. Dovetail tenon 3300 is inserted into dovetail groove 2300 from the tip end 3310 side of dovetail tenon 3300, with first surface 3100 facing first surface 2100 of main body 2000.

[0083] As described above, ball plunger 3400 is provided on first surface 3100 of spacer 3000 to align spacer 3000. When dovetail 3300 of spacer 3000 is inserted into dovetail groove 2300, ball plunger 3400 engages with plunger engaging portion 2600 of main body 2000 at a predetermined position, producing a clicking sensation for the user. This allows the user to easily recognize that spacer 3000 has been inserted to the correct position.

[0084] The ball plunger 3400 also has the function of fixing the spacer 3000 and the main body 2000 together.

[0085] The spacers 3000 include a spacer 3000 for the medial side of the femur B and a spacer 3000 for the lateral side. The spacers 3000 may also include a plurality of types with different thicknesses in the Za direction. For example, there may be spacers 3000 with thicknesses that differ in increments of about 5 mm, such as about 5 mm, about 10 mm, about 15 mm, or about 20 mm.

[0086] This makes it possible to adjust the positional relationship between the main body 2000 and the end face B2 depending on the type of spacer 3000. Specifically, when the gap G is large, a thicker spacer 3000 can be attached, and when the gap G is small, a thinner spacer 3000 can be attached. This makes it possible to appropriately attach the main body 2000 to end faces B2 of various shapes.

[0087] [Position Adjustment Member 4000] The position adjustment member 4000 is attached to the main body 2000 and adjusts the position of the main body 2000 with respect to the femur B. When resecting the distal portion B1 of the femur B, as described above, first, the surgical reamer 9 is inserted into the center of the bone marrow of the femur B. Because the center of the bone marrow of the femur B is slightly offset from the center of the end surface B2 of the femur B, the position of the main body 2000 is adjusted using the position of the surgical reamer 9 as a reference via the position adjustment member 4000. The position of the entire cutting guide 1000 may also be adjusted using the position of the surgical reamer 9 as a reference via the position adjustment member 4000.

[0088] 9A and 9B are perspective and side views showing an example of the position adjustment member 4000. The views indicated by reference numerals 900A and 900B are perspective views, and the view indicated by reference numeral 900C is a side view.

[0089] 9 , the position adjustment member 4000 includes a generally cylindrical body 4100 and a pair of legs 4200. As described above, the pair of legs 4200 is composed of a first leg 4200a and a second leg 4200b. The pair of legs 4200 are inserted into the through-hole 2500 of the main body 2000. The through-hole 2500 includes a leg insertion portion 2510a at the end in the Ya2 direction and a leg insertion portion 2510b at the end in the Ya1 direction. The first leg 4200a is inserted into the leg insertion portion 2510a, and the second leg 4200b is inserted into the leg insertion portion 2510b.

[0090] As will be described in detail later, when first leg 4200a is inserted into leg insertion portion 2510a, tip portion 4210 of first leg 4200a protrudes from opening 2520 of through-hole 2500. As a result, tip portion 4210 protruding from opening 2520 at least partially blocks opening 2310 of dovetail groove 2300.

[0091] By blocking opening 2310 of dovetail groove 2300, dovetail tenon 3300 of spacer 3000 inserted into dovetail groove 2300 is prevented from moving from opening 2310 of dovetail groove 2300 to the outside of dovetail groove 2300. This prevents spacer 3000 from falling off from opening 2310, reducing the risk of spacer 3000 falling off main body 2000.

[0092] Fig. 10 is an exploded perspective view showing an example of the cutting guide 1000, and Fig. 11 is a perspective view. As shown in Figs. 10 and 11 , when assembling the main body 2000, spacer 3000, and position adjustment member 4000 of the cutting guide 1000, the dovetail 3300 of the spacer 3000 is inserted into the dovetail groove 2300a through the opening 2310 of the dovetail groove 2300. With the dovetail 3300 engaged with the dovetail groove 2300, it is slid in the Xa direction to fix the spacer 3000 to the main body 2000.

[0093] Next, the first leg 4200a of the position adjustment member 4000 is inserted into the leg insertion portion 2510a of the main body 2000, and the second leg 4200b is inserted into the leg insertion portion 2510b, thereby holding the position adjustment member 4000 to the main body 2000. With the first leg 4200a inserted into the leg insertion portion 2510a, the tip 4210 of the first leg 4200a protrudes from the opening 2520 of the through-hole 2500. As a result, the tip 4210 protruding from the opening 2520 at least partially blocks the opening 2310 of the dovetail groove 2300.

[0094] When opening 2310 of dovetail groove 2300 is closed, spacer 3000 fixed to main body 2000 cannot fall off from opening 2310 even if it moves within dovetail groove 2300 due to vibrations during bone resection. This makes it possible to easily reduce the risk of spacer 3000 falling off from main body 2000 without increasing the number of parts.

[0095] 12 is a schematic diagram illustrating the reduction of falling off of the spacer 3000. As shown in Fig. 12, the first leg 4200a of the position adjustment member 4000 is inserted into the leg insertion portion 2510a so that the tip 4210 protrudes from the opening 2520 of the through-hole 2500. This blocks at least a portion of the opening 2310 of the dovetail groove 2300.

[0096] 12 is a line indicating the position of opening 2310 of dovetail groove 2300, and L2 is a line indicating the position of tip 4210 of first leg 4200a. Position L2 of tip 4210 protrudes by a length W from position L1 of opening 2310 of dovetail groove 2300.

[0097] As a result, the dovetail 3300 of the spacer 3000 cannot move in the Xa2 direction from the opening 2310 of the dovetail groove 2300 , and therefore the spacer 3000 cannot fall off from the opening 2310 .

[0098] [Summary] An artificial knee joint implant according to aspect 1 of the present disclosure comprises a tibial tray fixed to the tibia, a tibial component that fits with the tibial tray and has a sliding surface along which a femoral component slides, a fixation member that fixes the tibial tray to the tibial component, and an insert that is inserted into a recess of the tibial component, wherein the insert has a plate-shaped first portion, a second portion that protrudes from a first surface of the first portion, a through hole that passes through the first portion and the second portion and in which the fixation member is located, and a support portion that is located around the through hole and supports a part of the fixation member, wherein the side of the first portion that is inserted into the tibial component includes a second surface whose longitudinal length is longer than the diameter of the through hole, and the tibial tray has a fitting portion that fits with the fixation member.

[0099] According to the above configuration, the area around the through hole in the plate portion can be increased compared to the conventional technology. This increases the range over which the insert presses the tibial component toward the tibial tray, reducing misalignment of the tibial component and the tibial tray. Also, the possibility of the tibial component and the tibial tray becoming loose when connected can be reduced.

[0100] In the artificial knee joint implant according to Aspect 2 of the present disclosure, in the above-mentioned Aspect 1, the first portion has a side wall that is substantially parallel to the insertion direction, and the side wall extends toward the insertion side beyond the through hole, thereby enabling a force applied to the insert to be transmitted to the tibial component.

[0101] In the artificial knee joint implant according to Aspect 3 of the present disclosure, in the case of Aspects 1 or 2, the connection between the second surface and the side wall has a generally arcuate shape that is convex outward when viewed perpendicularly to the first surface, thereby reducing the possibility of the insert being deformed by a force applied to the insert by a fixing member compared to conventional configurations.

[0102] In the artificial knee joint implant according to Aspect 4 of the present disclosure, in any one of Aspects 1 to 3, the side surface of the second portion is located inside the outer periphery of the first portion, thereby allowing the first surface of the plate portion of the insert to press the tibial component toward the tibial plate.

[0103] In the artificial knee joint implant according to Aspect 5 of the present disclosure, in any one of Aspects 1 to 4, when the third surface of the first portion is divided by a line that passes through the center of the through hole in the third surface opposite the first surface and is perpendicular to the insertion direction, the area of ​​the insertion side surface is smaller than the area of ​​the opposite surface, thereby allowing the force applied to the insert to be applied to the tibial plate.

[0104] In the artificial knee joint implant according to Aspect 6 of the present disclosure, in any one of Aspects 1 to 5, when the first portion is divided by a line that passes through the center of the through hole in a third surface opposite the first surface of the first portion and is perpendicular to the insertion direction, the weight of the first portion on the insertion side is lighter than the weight of the first portion on the opposite side, thereby allowing the force applied to the insert to be applied to the tibial plate.

[0105] In a knee joint prosthesis according to a seventh aspect of the present disclosure, in any one of the first to sixth aspects, an outer periphery of a third surface of the first portion opposite the first surface is chamfered, thereby facilitating insertion of an insert into the tibial component.

[0106] The artificial knee joint implant according to Aspect 8 of the present disclosure is any one of Aspects 1 to 7, wherein the first portion has a recess on a side opposite to the insertion side, the recess being open toward the first surface, thereby allowing the surgeon to easily remove the insert from the tibial component.

[0107] A ninth aspect of the present disclosure provides an artificial knee joint implant according to any one of the first to eighth aspects, wherein the fixing member is a screw, and the fitting portion is a screw hole into which the screw threads. This allows the tibial tray and the tibial component to be easily fixed together.

[0108] Aspect 10 of the present disclosure provides an artificial knee joint implant according to any one of Aspects 1 to 9, wherein the insert restricts longitudinal movement of the fixation member when inserted into the tibial component, thereby allowing the fixation member to fix the tibial tray and the tibial component via the insert.

[0109] The artificial knee joint implant according to Aspect 11 of the present disclosure is any one of Aspects 1 to 10, further comprising the femoral component. This allows the implant to include the femoral component.

[0110] A cutting guide according to a twelfth aspect of the present disclosure includes a main body having a first surface at least partially in contact with a bone and a slot extending from the first surface to a surface opposite the first surface, and a spacer positioned between the first surface and the bone, wherein the first surface has a groove having an open first end only, the spacer having a protrusion positioned within the groove when engaged with the groove, and further including a blocking portion that prevents the protrusion from moving out of the groove from the first end of the groove. With this configuration, the blocking portion prevents the protrusion from coming out of the groove, thereby reducing the risk of the spacer having the protrusion falling off the main body having the groove during use of the cutting guide.

[0111] In a cutting guide according to Aspect 13 of the present disclosure, in the above-described Aspect 12, the spacer may define a distance between the main body portion and the bone. With this configuration, the distance between the main body portion and the bone can be defined without the need for a separate member.

[0112] In a cutting guide according to Aspect 14 of the present disclosure, in Aspects 12 or 13, the blocking portion may block at least a portion of the opening of the groove portion. This configuration can reduce the risk of the spacer falling off the main body portion in a simple and space-saving manner.

[0113] According to a fifteenth aspect of the present disclosure, in any one of the twelve to fourteenth aspects, the cutting guide further includes an adjustment unit attached to the main body portion and configured to adjust the position of the main body portion relative to the bone, and the blocking unit may be a part of the adjustment unit. With this configuration, a part of the adjustment unit functions as the blocking unit, thereby reducing the risk of the spacer falling off the main body portion without the need for a separate blocking unit.

[0114] In a cut guide according to Aspect 16 of the present disclosure, in Aspect 15, the main body may have a through hole through which a portion of the adjustment portion passes, and the first end may be located at an end of the through hole on the first surface. With this configuration, the first end of the groove is located at the end of the through hole through which a portion of the adjustment portion passes, so that the first end of the groove can be easily blocked by a portion of the adjustment portion.

[0115] In a cutting guide according to Aspect 17 of the present disclosure, in any one of Aspects 12 to 16, the first surface may have a plurality of the grooves. With this configuration, the positional relationship between the main body and the bone can be adjusted depending on the position of the groove to which the spacer is attached, so that the main body can be appropriately attached to a variety of bones with different levels of unevenness.

[0116] In a cutting guide according to Aspect 18 of the present disclosure, in Aspect 17, the plurality of grooves may be arranged symmetrically on the inner and outer sides when attached to the bone. With this configuration, the positional relationship between the main body and the bone can be adjusted depending on the position of the groove where the spacer is attached, so that the main body can be appropriately attached to a variety of bones with different levels of unevenness.

[0117] In a cutting guide according to Aspect 19 of the present disclosure, in any one of Aspects 12 to 18, the groove portion may be a dovetail groove, and the protrusion portion may be a dovetail. This configuration reduces the possibility of the spacer coming off in a direction away from the main body.

[0118] The cutting guide according to Aspect 20 of the present disclosure is in any one of Aspects 12 to 19, and may further include a ball plunger that aligns the spacer. This configuration allows smooth movement of the spacer relative to the main body.

[0119] A cutting guide according to a twenty-first aspect of the present disclosure is any one of aspects twelve to twenty, further comprising at least one pin insertion hole penetrating the body portion and the spacer, wherein the body portion and the spacer can be fixed to the bone by inserting a pin into the pin insertion hole. With this configuration, the body portion and the spacer can be fixed together.

[0120] In a cutting guide according to Aspect 22 of the present disclosure, in any one of Aspects 12 to 21, the slot may guide a cutting blade that cuts the bone. According to the above configuration, the cutting blade can be guided in the slot.

[0121] In a cut guide according to Aspect 23 of the present disclosure, in Aspect 22, one or more slots may be provided in the main body portion. With this configuration, the cutting blade can be guided in multiple directions.

[0122] In a cutting guide according to Aspect 24 of the present disclosure, in any one of Aspects 12 to 23, the bone may be a femur, and the main body may be attached to a distal end of the femur, which is the end of the femur on the knee side. According to this configuration, the cutting guide can be used for osteotomy of the distal end of the femur in knee joint replacement surgery.

[0123] The invention according to the present disclosure has been described above based on the drawings and examples. However, the invention according to the present disclosure is not limited to the above-described embodiments. In other words, the invention according to the present disclosure can be modified in various ways within the scope of the present disclosure, and embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the invention according to the present disclosure. In other words, it should be noted that a person skilled in the art can easily make various modifications or corrections based on the present disclosure. It should also be noted that these modifications or corrections are included in the scope of the present disclosure.

[0124] 100 artificial knee joint implant 1 tibial assembly 2 femoral component 10 insert 101 first part 102 second part 105 side wall 106 through hole 107 support portion 108 convex portion 109 concave portion 111 first surface 112 second surface 113 third surface 11 tibial tray 116 chamfered portion 119 mating portion 12 tibial component 121 sliding surface 122 concave portion 13 fixing member 1000 cutting guide 2000 main body portion 2100 first surface 2200 second surface (opposite surface) 2300 dovetail groove (groove portion) 2310 opening (first end) 2400 slot 2500 through hole 2520 opening (end) 2700 pin insertion hole 3000 Spacer 3300 Dovetail (protruding portion) 3400 Ball plunger 3500 Pin insertion hole 4000 Position adjustment member (adjustment portion) 4200a First leg portion (blocking portion)

Claims

1. An artificial knee joint implant comprising: a tibial tray fixed to the tibia; a tibial component that fits with the tibial tray and has a sliding surface along which a femoral component slides; a fixation member that fixes the tibial tray and the tibial component together; and an insert that is inserted into a recess formed in the tibial component, wherein the insert has a plate-shaped first portion, a second portion protruding from a first surface of the first portion, a through hole that passes through the first and second portions and within which the fixation member is located, and a support portion that is located around the through hole and supports a part of the fixation member, wherein the side of the first portion that is inserted into the recess includes a second surface whose longitudinal length is longer than the diameter of the through hole, and the tibial tray has a fitting portion that fits with the fixation member.

2. The artificial knee joint implant according to claim 1, wherein the first portion has a side wall that is substantially parallel to the insertion direction, and the side wall extends toward the insertion side beyond the through hole.

3. An artificial knee joint implant according to claim 2, wherein the connection between the second surface and the side wall is in the shape of a generally arcuate convex outward when viewed from a direction perpendicular to the first surface.

4. The artificial knee joint implant according to claim 1, wherein the side surface of the second portion is located inside the outer periphery of the first portion.

5. An artificial knee joint implant as described in claim 1, wherein when the third surface is divided by a line that passes through the center of the through hole in a third surface opposite the first surface of the first part and is perpendicular to the insertion direction, the area of ​​the insertion side surface is smaller than the area of ​​the opposite surface.

6. An artificial knee joint implant as described in claim 1, wherein when the first portion is divided by a line that passes through the center of the through hole in a third surface opposite the first surface of the first portion and is perpendicular to the insertion direction, the weight of the first portion on the insertion side is lighter than the weight of the first portion on the opposite side.

7. The knee joint prosthesis according to claim 1, wherein the outer periphery of a third surface of the first portion opposite the first surface is chamfered.

8. The artificial knee joint implant according to claim 1, wherein the first portion has a recess on a side opposite to the insertion side, the recess being open to the first surface.

9. The artificial knee joint implant according to claim 1, wherein the fixing member is a screw, and the fitting portion is a screw hole into which the screw threads.

10. The knee prosthesis implant of claim 1, wherein the insert, when inserted into the tibial component, limits longitudinal movement of the fixation member.

11. The knee prosthesis implant of claim 1, further comprising the femoral component.

12. A cutting guide comprising: a main body having a first surface at least a portion of which abuts against a bone and a slot penetrating from the first surface to a surface opposite the first surface; and a spacer positioned between the first surface and the bone, wherein the first surface has a groove portion which is open only at a first end, the spacer has a protrusion portion which is positioned within the groove portion while engaging with the groove portion, and further comprising a blocking portion which prevents the protrusion portion from moving from the first end of the groove portion to outside the groove portion.

13. The cutting guide of claim 12, wherein the spacer defines the distance between the body portion and the bone.

14. The cutting guide of claim 13, wherein the blocking portion blocks at least a portion of the opening of the groove.

15. The cutting guide according to claim 14, further comprising an adjustment portion attached to said main body portion for adjusting the position of said main body portion relative to said bone, said blocking portion being a part of said adjustment portion.

16. A cutting guide as described in claim 15, wherein the main body portion has a through hole through which a portion of the adjustment portion passes, and the first end is located at an end of the through hole on the first surface.

17. The cutting guide of claim 13, wherein said first surface has a plurality of said grooves.

18. The cutting guide of claim 13, further comprising a ball plunger for aligning said spacer.

19. The cutting guide of claim 13, further comprising at least one pin insertion hole penetrating the main body portion and the spacer, the pin insertion hole allowing a pin to be inserted to fix the main body portion and the spacer to the bone.

20. The cutting guide according to claim 13, wherein the bone is a femur, and the main body portion is attached to the distal end of the femur, which is the end of the femur on the knee side.

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