Tibial tray fixation structure and tibial tray assembly

Abstract

The application discloses a tibial tray fixing structure and a tibial tray assembly. The tibial tray fixing structure comprises a first fixing part and a second fixing part, the first fixing part and the second fixing part are arranged on a distal end surface of the tibial tray, and the first fixing part and the second fixing part extend from the distal end surface to a distal end direction; the distal end surface is in contact with cancellous bone of a tibia of a patient; the first fixing part is located in or near a most dense region of lateral bone in the cancellous bone, and the second fixing part is located in or near a most dense region of medial bone in the cancellous bone; the first fixing part and the second fixing part are in communication with each other to form an integral fixing part; or the first fixing part and the second fixing part are separated from each other to form two independent structures. The application can increase the fixing effect of the tibial tray assembly under the premise of a small amount of bone cutting.

Description

Technical Field

[0001] This invention relates to the field of knee joint prosthesis replacement technology, and in particular to a tibial support fixation structure and tibial support assembly. Background Technology

[0002] Artificial joint prostheses are typically used to repair or replace damaged bones and tissues in the human body. For the knee joint, tibial support components (hereinafter referred to as tibial support), tibial plate components (hereinafter referred to as tibial plate), and femoral condyle components (hereinafter referred to as tibial condyle) can be used to repair or replace damaged knee joints.

[0003] The tibial support is fixed to the proximal end of the patient's tibia (proximal is closer to the heart), and the femoral condyle is fixed to the distal end of the patient's femur (distal is farther from the heart). The tibial pad is installed on the tibial support and is located between the tibial support assembly and the femoral assembly.

[0004] The forces generated by the femoral condyle are transmitted through the tibial spacer to the tibial support, ultimately acting on the proximal tibia of the patient. To ensure the short-term and long-term performance of the knee prosthesis, it is crucial that the tibial support assembly is stably and securely fixed to the patient's tibia. Tibial supports can be classified into cement-fixed tibial supports and biologically fixed tibial supports based on their fixation method.

[0005] Currently, the two main fixation structures used in clinical practice are as follows:

[0006] The first type of fixation method: The tibial support assembly includes: a base plate, a long and thick fixation post in the center of the base plate, and four short and thin auxiliary fixation posts around the fixation post.

[0007] However, this fixation method has the following drawbacks: It features a relatively long and thick central fixation post. When this post is implanted in the proximal tibia, it sacrifices a significant amount of bone, leading to a reduction in bone tissue involved in bone ingrowth or extension. Furthermore, in the foreseeable future, minimally invasive surgery will be a trend in knee joint surgery, and a longer fixation post is not conducive to future minimally invasive surgical procedures.

[0008] The second type of fixation method uses a tibial support assembly consisting of a base plate with two shorter, thicker fixation posts. However, this method has the following disadvantages: due to the smaller spacing between the fixation posts, its early-stage torsional and posterior tilt resistance is slightly inferior to the first type of fixation method. Summary of the Invention

[0009] The purpose of this invention is to provide a tibial support fixation structure and tibial support assembly to achieve anti-torsion, anti-backward tilting and anti-pull-out properties after tibial support fixation, thereby extending the service life of the tibial support.

[0010] To achieve the above objectives, the present invention is implemented through the following technical solution:

[0011] A tibial support fixation structure includes: a first fixation part and a second fixation part, wherein the first fixation part and the second fixation part are disposed on the distal surface of the tibial support, and both the first fixation part and the second fixation part extend distally from the distal surface. The distal surface contacts the cancellous bone region of the patient's tibia; the first fixation part is located in or near the lateral densest bone region of the cancellous bone region, and the second fixation part is located in or near the medial densest bone region of the cancellous bone region. The first fixation part and the second fixation part are interconnected to form a single integral fixation part; or, the first fixation part and the second fixation part are separate and constitute two independent structures.

[0012] Optionally, the width W of the integral fixation part in the coronal plane is 40% to 80% of the total width ML of the distal surface of the tibial support, and the total width ML of the distal surface of the tibial support is the width of the distal surface of the tibial support in the coronal plane; the length L of the integral fixation part is 10% to 50% of the total width ML of the distal surface of the tibial support.

[0013] Optionally, the integral fixing part is provided with a notch, which is recessed toward the distal surface of the tibial support.

[0014] Optionally, the overall fixing part includes a secondary fixing part connecting the first and second fixing parts; the width of the secondary fixing part in the sagittal plane is smaller than the width of the two ends of the overall fixing part in the sagittal plane.

[0015] Optionally, the interior of the integral fixing part is hollow, or the interior of the independent first fixing part and / or the second fixing part is hollow.

[0016] Optionally, the integral fixing part is provided with an undercut structure, or the independent first fixing part and / or second fixing part are provided with an undercut structure;

[0017] The undercut structure protrudes outward from the side surface of the body of the fixing part where it is located; or, the undercut structure is recessed inward from the side surface of the body of the fixing part where it is located.

[0018] Optionally, the inverted structure has an included angle toward the distal surface, and the included angle is an acute angle.

[0019] Optionally, both the independent first fixing part and the second fixing part are cylindrical;

[0020] Projecting from the far end to the near end, the outer contour of the first fixing part and / or the second fixing part has a concave surface.

[0021] Optionally, it further includes: an insert; the first fixing part and / or the second fixing part are expandable structures; in the initial state, when the insert is located inside the expandable structure, its outer sidewall surface is in contact with at least a portion of the inner sidewall surface of the expandable structure; in the operating state, the insert is subjected to force and displaces relative to the expandable structure, squeezing at least a portion of the sidewall of the expandable structure to expand it radially.

[0022] On the other hand, the present invention also provides a tibial support assembly, comprising: a tibial support body, a base plate, and a tibial support fixation structure as described above; the base plate comprises: a proximal surface; and a distal surface opposite to the proximal surface, wherein the proximal surface of the base plate is disposed on the distal surface of the tibial support body, and the tibial support fixation structure is disposed on the distal surface of the base plate.

[0023] The tibial support body is integrally formed with the base plate; or, the tibial support body and the base plate are interconnected.

[0024] Optionally, the tibial support body and the substrate are welded together using a resistance welding process.

[0025] This invention has at least one of the following advantages:

[0026] On one hand, the present invention provides a tibial support fixation structure, including a first fixation part and a second fixation part that are interconnected to form an integral fixation part. The interconnected first fixation part and the second fixation part can increase the contact area between the fixation structure and the cancellous bone of the patient's tibia. The first fixation part and the second fixation part can be located in the area of ​​the densest bone at the distal end of the tibia, where the bone quality is best, which is beneficial to the early and long-term fixation effect of the tibial support, that is, it increases the effect of bone ingrowth or bone extension, thereby increasing the fixation effect of the tibial support assembly, and thus improving the early fixation anti-torsion and anti-posterior tilt performance of the tibial support assembly.

[0027] The hollow interior of the first and / or second fixation parts provided by this invention further increases the contact area between the fixation structure and the patient's tibial cancellous bone, and reduces damage to the patient's cancellous bone caused by the fixation structure, which is beneficial for future minimally invasive surgical procedures. This further enhances the effect of bone ingrowth or extension, and further improves the early fixation, torsion resistance, and anti-hysteresis performance of the tibial support assembly.

[0028] The fixation structure (specifically, the overall fixation part) provided by the present invention has a width W in the coronal plane that is 40% to 80% of the total width ML of the substrate, thereby allowing the fixation structure to be located in the cancellous bone region of the patient.

[0029] The length L of the fixation structure (specifically, the overall fixation part) provided by the present invention is 10% to 50% of the total width ML of the substrate. It can be seen that the length of the fixation structure is relatively short, thereby reducing the damage to the patient's cancellous bone, which is conducive to bone preservation. More importantly, it prevents the fixation structure from being too long and penetrating the cortical bone, thus facilitating future minimally invasive surgical operations.

[0030] The integral fixation part provided by this invention has a notch in the middle portion, which is recessed towards the distal surface of the substrate. This indicates that the middle portion of the integral fixation part is relatively short, thereby reducing damage to the patient's cancellous bone and promoting bone preservation. More importantly, it prevents the fixation structure from being too long and penetrating the cortical bone, thus facilitating future minimally invasive surgical procedures. Additionally, it increases the contact area between the fixation structure and the cancellous bone of the patient's tibia.

[0031] The fixation structure provided by the present invention has an inverted structure. Since the backward tilting phenomenon is manifested as the pull-out phenomenon of one side of the fixation structure, the inverted structure increases its pull-out force, making it more difficult for the fixation structure to be pulled out from the patient's tibia, and further improving the anti-backward tilting performance of the tibial support assembly.

[0032] The fixing structure of the present invention is connected to the substrate by resistance welding, which has the advantages of reliable connection, stable process and controllable cost.

[0033] The present invention provides another tibial support fixation structure, comprising: a first fixation part and a second fixation part. At least one of these two fixation parts is a hollow structure. Therefore, the present invention increases the contact area between the fixation structure and the cancellous bone of the patient's tibia while reducing damage to the cancellous bone of the patient's tibia. The arrangement of the first and second fixation parts increases the effect of bone ingrowth or extension, thereby enhancing the fixation effect of the tibial support assembly and improving its early fixation, torsion resistance, and posterior tilt resistance.

[0034] The maximum length L of the first and second fixation parts provided by the present invention is 10% to 50% of ML. It can be seen that the length of the first and second fixation parts is limited, which is beneficial to bone preservation and, more importantly, prevents the fixation structure from being too long and penetrating the cortical bone.

[0035] At least one of the first and second fixing parts provided by the present invention has a concave outer contour. Therefore, it can be seen that fixing posts (fixing parts) of different shapes can adapt to the bone conditions at different positions of the distal tibia, which is beneficial to the early and long-term fixation effect of the tibial support, that is, to increase the service life of the tibial support assembly. Attached Figure Description

[0036] Figure 1 This is a schematic diagram illustrating the definition of a human body cross-section or orientation in the prior art;

[0037] Figure 2 A schematic diagram of bone mineral density distribution in the distal tibia as provided in the prior art;

[0038] Figure 3 A three-dimensional structural diagram of a tibial support assembly provided in the first embodiment of the present invention;

[0039] Figure 3a for Figure 3 A bottom view of the tibial support assembly shown;

[0040] Figure 3b for Figure 3 A front view of the tibial support assembly shown;

[0041] Figure 4 A three-dimensional structural diagram of a tibial support assembly provided in the second embodiment of the present invention;

[0042] Figure 4a for Figure 4 A bottom view of the tibial support assembly shown;

[0043] Figure 4b for Figure 4 A front view of the tibial support assembly shown;

[0044] Figure 5 A three-dimensional structural diagram of a tibial support assembly provided in the third embodiment of the present invention;

[0045] Figure 5a for Figure 5 A bottom view of the tibial support assembly shown;

[0046] Figure 5b for Figure 5 Left view of the tibial support assembly shown;

[0047] Figure 5c for Figure 5c A schematic diagram of the cross-sectional structure of the fixation structure in the tibial support assembly along the BB direction is shown.

[0048] Figure 5d for Figure 5 A front view of the tibial support assembly shown;

[0049] Figure 6 A three-dimensional structural diagram of a tibial support assembly provided in the fourth embodiment of the present invention;

[0050] Figure 6a for Figure 6 A bottom view of the tibial support assembly shown;

[0051] Figure 6b for Figure 6 Left view of the tibial support assembly shown;

[0052] Figure 6c for Figure 6b The diagram shows a cross-sectional view of the fixation structure of the tibial support assembly along the BB direction.

[0053] Figure 6d for Figure 6 A front view of the tibial support assembly shown;

[0054] Figure 7 A three-dimensional structural schematic diagram of a tibial support assembly provided in the fifth embodiment of the present invention;

[0055] Figure 7a for Figure 7 A bottom view of the tibial support assembly shown;

[0056] Figure 7b for Figure 7a A schematic diagram of the cross-sectional structure of the main fixation part of the tibial support assembly along the AA direction.

[0057] Figure 7c for Figure 7 Left view of the tibial support assembly shown;

[0058] Figure 7d for Figure 7 A front view of the tibial support assembly shown;

[0059] Figure 7e for Figure 7d The diagram shows an enlarged view of region G in the tibial support assembly.

[0060] Figure 8 A three-dimensional structural diagram of a tibial support assembly provided in the sixth embodiment of the present invention;

[0061] Figure 8a for Figure 8 A bottom view of the tibial support assembly shown;

[0062] Figure 8b for Figure 8a A schematic diagram of the cross-sectional structure of the main fixation part of the tibial support assembly along the AA direction.

[0063] Figure 8c for Figure 8 Left view of the tibial support assembly shown;

[0064] Figure 8d for Figure 8 A front view of the tibial support assembly shown;

[0065] Figure 8e for Figure 8dThe diagram shows an enlarged view of region G in the tibial support assembly.

[0066] Figure 9 A three-dimensional structural diagram of a tibial support assembly provided in the seventh embodiment of the present invention;

[0067] Figure 9a for Figure 9 A bottom view of the tibial support assembly shown;

[0068] Figure 9b for Figure 9 Left view of the tibial support assembly shown;

[0069] Figure 9c for Figure 9 A front view of the tibial support assembly shown;

[0070] Figure 9d for Figure 9c The diagram shows an enlarged view of region G in the tibial support assembly.

[0071] Figure 10 A three-dimensional structural diagram of a tibial support assembly provided in the eighth embodiment of the present invention;

[0072] Figure 10a for Figure 10 A bottom view of the tibial support assembly shown;

[0073] Figure 10b for Figure 10 Left view of the tibial support assembly shown;

[0074] Figure 10c for Figure 10b The diagram shows a cross-sectional view of the fixation structure of the tibial support assembly along the BB direction.

[0075] Figure 10d for Figure 10 A front view of the tibial support assembly shown;

[0076] Figure 11 A three-dimensional structural diagram of a tibial support assembly with multiple independent fixation parts is provided for one embodiment;

[0077] Figure 12 A three-dimensional structural diagram of a tibial support assembly provided in the ninth embodiment of the present invention;

[0078] Figure 12a for Figure 12 A bottom view of the tibial support assembly shown;

[0079] Figure 12b for Figure 12a A schematic diagram of the cross-sectional structure of the second main fixation part in the tibial support assembly along the AA direction;

[0080] Figure 12c for Figure 12 Left view of the tibial support assembly shown;

[0081] Figure 12d for Figure 12c The diagram shows a cross-sectional view of the fixation structure of the tibial support assembly along the BB direction.

[0082] Figure 12e for Figure 12 A front view of the tibial support assembly shown;

[0083] Figure 12f for Figure 12e An enlarged structural diagram of region I in the tibial support assembly is shown below;

[0084] Figure 13 This is a three-dimensional structural diagram of a tibial support assembly provided in the thirteenth embodiment of the present invention;

[0085] Figure 13a for Figure 13 A bottom view of the tibial support assembly shown;

[0086] Figure 13b for Figure 13 The diagram shows a cross-sectional view of the main fixation part of the tibial support assembly along the AA direction. Detailed Implementation

[0087] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a further detailed explanation of the tibial support fixation structure and tibial support assembly proposed in this invention. The advantages and features of this invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, intended only to facilitate and clearly illustrate the embodiments of this invention. Please refer to the drawings to make the objectives, features, and advantages of this invention more apparent and understandable. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only for illustrative purposes and to enable those skilled in the art to understand and read them, and are not intended to limit the implementation conditions of this invention. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to the size, without affecting the effects and objectives achieved by this invention, should still fall within the scope of the technical content disclosed in this invention.

[0088] like Figure 1 As shown, it provides a schematic diagram for defining the human body cross-section or direction. As can be seen from the figure, the top to bottom is the transverse section, the left to right is the sagittal plane, and the front to back is the coronal plane. For the knee joint, the side closer to the midline sagittal plane is the medial side, and the side further away is the lateral side. The direction of the tibial support can also be distinguished according to the installation position of the artificial tibial support in the body.

[0089] like Figure 2 As shown, it presents a schematic diagram of bone mineral density distribution in the distal tibia of a typical patient. The diagram shows that bone mineral density was measured in multiple regions along the coronal plane of the tibia. Figure 2 The sampling areas are shown in small circles 1 to 15. The area included in the large circle near the inner side, including small circles 3, 4 and 7, is the densest area of ​​the inner bone, while the area included in the large circle near the outer side, including small circles 10 to 12, 14 and 15, is the densest area of ​​the outer bone.

[0090] Example 1

[0091] like Figure 3 As shown, this embodiment provides a tibial support fixation structure, including: a base plate 21 and a fixation structure 30. The base plate 21 includes: a proximal surface; and a distal surface 200 opposite to the proximal surface, the size and shape of which are configured to substantially cover the proximal post-cut surface of the tibia, the distal surface 200 being contactable with the proximal post-cut surface of the tibia; the fixation structure 30 is connected to the distal surface 200, and the fixation structure 30 extends distally from the distal surface (e.g., ...). Figure 3b As shown, the length direction of the fixing structure 30 corresponds to the direction extending from the distal surface 200 to the distal end.

[0092] The fixation structure 30 is used to be implanted into the bone of the proximal end of the patient's tibia. The material of the fixation structure is metal, and hydroxyapatite, stem cells, or growth factors can be attached to the metal surface to promote bone ingrowth.

[0093] The fixing structure 30 includes two main fixing parts 301 and a secondary fixing part 302. The two main fixing parts 301 are located at both ends of the fixing structure 30 along the coronal plane direction, that is, one of the two main fixing parts 301 is disposed on the substrate 21 near the inner side, and the other is disposed on the substrate 21 near the outer side. The secondary fixing part 302 is located between the two main fixing parts 301 and is connected to both of the main fixing parts 301.

[0094] In this embodiment, the distal surface 200 contacts the cancellous bone region of the patient's tibia (the cancellous bone region here refers to the area on the distal surface 200 of the base plate 21 that is directly opposite to the cancellous bone region on the proximal cut surface of the tibia), the fixation structure 30 is located within the cancellous bone region, one of the two main fixation parts 301 is located in or near the lateral densest bone region of the cancellous bone region, and the other is located in or near the medial densest bone region of the cancellous bone region.

[0095] Please continue to refer to this. Figure 3and Figure 3a As shown, the fixing structure 30 is generally shaped like the handset of a landline telephone. The two main fixing parts 301 have the same shape and are generally columnar. The secondary fixing part 302 is generally arc-shaped. Please continue to refer to... Figure 3a As shown, the projection of the fixing structure 30 from the distal direction onto the distal surface of the substrate 21 is given. The width of the secondary fixing portion 302 in the sagittal plane is smaller than the width of the main fixing portion 301 in the sagittal plane; that is, the fixing structure 30 is approximately concave in the middle and protruding at both ends.

[0096] Please refer to Figure 3a As shown, the two main fixing parts 301 are arranged asymmetrically with respect to the in-situ axis H. The distances from the centers of the two main fixing parts 301 to the in-situ axis H are not equal.

[0097] In this embodiment, the width W of the fixing structure 30 in the coronal plane direction is 40% to 80% of the total width ML of the substrate 21, and the total width ML of the substrate 21 is the width of the substrate 21 in the coronal plane direction.

[0098] The length L of the fixing structure 30 is 10% to 50% of the total width ML of the substrate 21.

[0099] The fixation structure provided in this embodiment has a width W in the coronal plane that is 40% to 80% of the total width ML of the substrate, thereby allowing the fixation structure to be located within the patient's cancellous bone region.

[0100] The length L of the fixation structure provided in this embodiment is 10% to 50% of the total width ML of the substrate. It can be seen that the length of the fixation structure is relatively short, thereby reducing the damage to the patient's cancellous bone and facilitating bone preservation. More importantly, it prevents the fixation structure from being too long and penetrating the cortical bone, which is conducive to future minimally invasive surgical operations.

[0101] In this embodiment, the fixation structure 30 is an integral structure. The secondary fixation part 302 increases the contact area between the fixation structure and the cancellous bone of the patient's tibia. The main fixation part is located in the area with the densest bone at the distal end of the tibia, where the bone quality is best, which is beneficial to the early and long-term fixation effect of the tibial support, that is, it increases the effect of bone ingrowth or bone extension, thereby increasing the fixation effect of the tibial support assembly, and thus improving the early fixation anti-torsion and anti-posterior tilt performance of the tibial support assembly.

[0102] Example 2

[0103] Combination Figure 4 , Figures 4a-4bAs shown, the difference between this embodiment and the first embodiment described above is that, in this embodiment, the secondary fixing part 302 is provided with a notch 3021, and the notch 3021 is recessed toward the distal surface 200 of the substrate 21. That is, as Figure 4 As shown, the distance between the distal surface of the secondary fixing part 302 and the distal surface 200 of the substrate 21 is a first length, and the distance between the distal surface of the main fixing part 301 and the distal surface 200 of the substrate 21 is a second length, wherein the first length is less than the second length.

[0104] In this embodiment, the notch 3021 is recessed towards the distal surface 200 of the substrate 21, indicating that the secondary fixation portion 302 is shorter. This reduces damage to the patient's cancellous bone caused by the fixation structure 30, which is beneficial for bone preservation. More importantly, it prevents the fixation structure 30 from being too long and penetrating the cortical bone, thus facilitating future minimally invasive surgical procedures. Additionally, it increases the contact area between the fixation structure 30 and the cancellous bone of the patient's tibia.

[0105] Example 3

[0106] Combination Figure 5 , Figures 5a-5d As shown, the difference between this embodiment and Embodiment 1 is that in this embodiment, the fixing structure 30 has an opening located at the distal end of the fixing structure 30, and the interior of the fixing structure 30 is hollow; that is, the main fixing part 301 has a first hollow structure 3010, and the secondary fixing part has a second hollow structure 3020. Please continue to refer to... Figure 5d As shown, the first hollow structure 3010 and the second hollow structure 3020 are interconnected. The tibial support fixation structure 30 is shown in a cross-sectional view along the BB direction. The overall external contour of the interconnected first hollow structure 3010 and second hollow structure 3020 and the transverse cross-sectional contour of the fixation structure 30 are shown (refer to...). Figure 5a The bottom views shown are similar to each other.

[0107] It is understood that, in this embodiment, the first hollow structure 3010 and the second hollow structure 3020 may not be interconnected.

[0108] The hollow internal structure of the fixation structure provided in this embodiment further increases the contact area between the fixation structure and the patient's tibial cancellous bone, and reduces damage to the patient's cancellous bone, which is beneficial for future minimally invasive surgical procedures. This further enhances bone ingrowth or extension, and further improves the early fixation, torsional resistance, and anti-posterior tilting performance of the tibial support assembly.

[0109] Example 4

[0110] Combination Figure 6 , Figures 6a to 6d As shown, the difference between this embodiment and Embodiment Two is that in this embodiment, the fixing structure 30 is hollow inside; that is, the main fixing part 301 has a first hollow structure 3010, and the secondary fixing part has a second hollow structure 3020. Please continue to refer to... Figure 6d As shown, the first hollow structure 3010 and the second hollow structure 3020 are interconnected. The tibial support fixation structure 30 is shown in a cross-sectional view along the BB direction. The overall external contour of the interconnected first hollow structure 3010 and second hollow structure 3020 and the transverse cross-sectional contour of the fixation structure 30 are shown (refer to...). Figure 6a The bottom view shown is a similar graphic, which can maximize the contact area with the patient's cancellous bone, increase the effect of bone ingrowth or bone extension, and increase the service life of the tibial support assembly, but the present invention is not limited thereto.

[0111] It is understood that, in this embodiment, the first hollow structure 3010 and the second hollow structure 3020 may not be interconnected.

[0112] The fixation structure provided in this embodiment is hollow inside and has an inwardly recessed notch 3021, which further increases the contact area between the fixation structure and the patient's tibial cancellous bone and reduces damage to the patient's cancellous bone, which is beneficial for future minimally invasive surgical procedures. This further increases the effect of bone ingrowth or extension, and further improves the early fixation, torsional resistance, and anti-hysteresis performance of the tibial support assembly.

[0113] Example 5

[0114] Combination Figure 7 , Figures 7a-7e As shown, the difference between this embodiment and Embodiment 4 is that this embodiment further includes: a first inverted buckle structure 3011. For details, please refer to... Figure 7aAs shown, the fixing structure 30 is projected from the distal end to the proximal end. The envelope contour of the body of the fixing structure 30 on all or part of its side surfaces is obscured by the maximum envelope contour corresponding to the first undercut structure 3011. A plurality of first undercut structures 3011 are provided, spaced apart on the side surfaces of the fixing structure 30 from the distal surface 200 near the substrate 21 towards the distal end, and surrounding the fixing structure 30. The first undercut structures 3011 avoid the notch 3021 of the secondary fixing portion 302. It is understood that in some other embodiments, the first undercut structure 3011 may not complete a full circle; it may be one or more segments, discontinuous. When the first undercut structure 3011 is segmented, it may be disposed on the side surfaces on both sides of the notch 3021. In this embodiment, the first undercut structure 3011 protrudes outward. Please continue to refer to... Figure 7e As shown, the generatrix of the first inverted structure 3011 forms an angle with the side surface of the fixing structure 30, and the angle is acute. Specifically, the first inverted structure 3011 extends from the side surface of the fixing structure 30 toward the distal surface 200 of the base plate 21. It can also be understood that the generatrix of the first inverted structure 3011 intersects with the side surface of the fixing structure 30, and the generatrix of the first inverted structure 3011 extends proximally from the intersection point. In this embodiment, the first inverted structure 3011 makes the fixing structure 30 less likely to be pulled out of the patient's tibia, further improving the anti-tilting performance of the tibial support assembly.

[0115] Example 6

[0116] Combination Figure 8 , Figures 8a-8e As shown, the difference between this embodiment and embodiment four is that this embodiment further includes: a second inverted structure 3012, which is disposed on the side surface of the fixing structure 30 and surrounds the fixing structure 30.

[0117] A plurality of second inverted fastening structures 3012 are provided, and the plurality of second inverted fastening structures 3012 are spaced apart from the distal end surface 200 near the substrate 21 toward the distal end on the side surface of the fixing structure 30, and are arranged around the fixing structure 30. The second inverted fastening structures 3012 avoid the notch 3021 of the secondary fixing part 302. It is understood that in some other embodiments, the second inverted fastening structure 3012 may not be a complete circle, and may be one or more segments, and is discontinuous. When the second inverted fastening structure 3012 is segmented, it may be provided on the side surfaces on both sides of the notch 3021.

[0118] In this embodiment, please continue to refer to Figure 8e As shown, the second inverted structure 3012 is recessed inward.

[0119] Please continue to refer to this. Figure 8b As shown, the cross-sectional shape of the second inverted structure 3012 along the coronal plane is approximately an acute angle formed in the side of the fixing structure 30, and this acute angle extends away from the distal surface 200 of the substrate 21.

[0120] In this embodiment, the second inverted structure 3012 makes it more difficult for the fixation structure 30 to be pulled out from the patient's tibia, which can further improve the anti-tilting performance of the tibial support assembly.

[0121] The main fixing structure 301 and the secondary fixing structure 302 described in Embodiments 1 to 6 above can also be integrated into one unit.

[0122] Example 7

[0123] Combination Figure 9 , Figures 9a to 9d As shown, the difference between this embodiment and embodiment two is that this embodiment further includes: a second inverted structure 3012, which is disposed on the side surface of the fixing structure 30 and surrounds the fixing structure 30.

[0124] A plurality of second inverted fastening structures 3012 are provided, and the plurality of second inverted fastening structures 3012 are spaced apart from the distal end surface 200 near the substrate 21 toward the distal end on the side surface of the fixing structure 30, and are arranged around the fixing structure 30. The second inverted fastening structures 3012 avoid the notch 3021 of the secondary fixing part 302. It is understood that in some other embodiments, the second inverted fastening structure 3012 may not be a complete circle, and may be one or more segments, and is discontinuous. When the second inverted fastening structure 3012 is segmented, it may be provided on the side surfaces on both sides of the notch 3021.

[0125] In this embodiment, please continue to refer to Figure 8e As shown, the second inverted structure 3012 is recessed inward.

[0126] Please continue to refer to this. Figure 8b As shown, the cross-sectional shape of the second inverted structure 3012 along the coronal plane is approximately an acute angle formed inside the side of the fixing structure 30, and this acute angle extends away from the distal surface 200 of the substrate 21 inside the fixing structure 30.

[0127] In this embodiment, the second inverted structure 3012 makes it more difficult for the fixation structure 30 to be pulled out from the patient's tibia, which can further improve the anti-tilting performance of the tibial support assembly.

[0128] In this embodiment, the second inverted structure 3012 can also be replaced with the first inverted structure 3011 (e.g., Figure 7e The structure shown can also be a combination of inverted fasteners, each having a first inverted fastener structure 3011 and a second inverted fastener structure 3012. For example, there are several inverted fasteners, and these inverted fasteners are spaced apart on the side surface of the fixing structure 30 from the far end surface 200 near the substrate 21 toward the far end.

[0129] Among the plurality of said inverted structures, there are a first inverted structure 3011 and a second inverted structure 3012. The present invention is not limited thereto.

[0130] The fixing structure 30 described in Embodiments 1 to 7 is connected to the substrate 21 using resistance welding. Resistance welding offers advantages such as reliable connection, stable process, and controllable cost.

[0131] In some other embodiments, the fixing structure 30 described in Embodiments 1 to 7 above is integrated with the substrate 21.

[0132] Example 8

[0133] Please continue to refer to this. Figures 3-8 As shown, this embodiment also provides a tibial support assembly 1, including: a tibial support body 20, as described in Embodiments 1 to 7 above; the proximal surface of the base plate 21 is fixedly connected to the distal surface 200 of the tibial support body 20.

[0134] In this embodiment, the tibial support body 20 and the base plate 21 are integrally formed.

[0135] In some other embodiments, the tibial support body 20 and the base plate 21 are welded together using resistance welding. Using resistance welding offers advantages such as reliable connection, stable process, and controllable cost.

[0136] Example 9

[0137] This embodiment provides a tibial support fixation structure, including: a fixation structure disposed on the distal surface of the tibial support, which is cut in the sagittal or coronal plane, and at least one of the fixation structures is hollow. The hollow interior of the fixation structure allows for more bone preservation and significantly increases the contact area with bone, thus improving the early and long-term fixation effect of the tibial support.

[0138] To facilitate understanding of Embodiment Nine above, please refer to Embodiments Ten and Eleven below.

[0139] Example 10

[0140] Combination Figure 10 , Figures 10a to 10d As shown, this embodiment provides a tibial support fixation structure, including: a base plate 21, a first fixation part 303, and a second fixation part 304. The base plate 21 includes: a proximal surface; and a distal surface 200 opposite to the proximal surface, the size and shape of which are configured to substantially cover the proximal post-cut surface of the tibia so that the distal surface 200 contacts the proximal post-cut surface of the tibia; the first fixation part 303 and the second fixation part 304 are connected to the distal surface 200, and both the first fixation part 303 and the second fixation part 304 extend distally from the distal surface 200, i.e., the first fixation part 303 and the second fixation part 304... The length direction of 304 corresponds to the direction extending distally from the distal surface 200; the distal surface 200 contacts the cancellous bone region of the patient's tibia, that is, the region of the cancellous bone region on the proximal cut surface of the tibia; the first fixation part 303 is located in or near the lateral densest bone region of the cancellous bone region of the distal surface 200, and the second fixation part 304 is located in or near the medial densest bone region of the cancellous bone region of the distal surface 200; the first fixation part 303 and / or the second fixation part 304 are hollow inside. That is, when the first fixation part and the second fixation part have a hollow structure, the distal ends of the first fixation part and the second fixation part have openings.

[0141] Therefore, in this embodiment, at least one of the two fixing parts, the first fixing part 303 and the second fixing part 304, is a hollow structure. Thus, this embodiment increases the contact area between the first fixing part 303 and the second fixing part 304 and the cancellous bone of the patient's tibia, while reducing damage to the cancellous bone of the patient's tibia. The arrangement of the first fixing part 303 and the second fixing part 304 increases the effect of bone ingrowth or bone extension, thereby increasing the fixation effect of the tibial support assembly and improving the early fixation anti-torsion and anti-posterior tilt performance of the tibial support assembly.

[0142] The length of the first fixation part 303 is the same as the length of the second fixation part 303. The distance between the distal end face of the first fixation part 303 and the distal surface 200 of the substrate 21 is the length L of the first fixation part 303. The length L of the first fixation part 303 is 10% to 50% of the total width ML of the substrate 21. The maximum width of the substrate 21 along the coronal plane is the total width ML of the substrate 21. Therefore, the lengths of the first fixation part 303 and the second fixation part 304 are limited, which is beneficial for bone preservation and, more importantly, prevents the fixation structures (first fixation part 303 and second fixation part 304) from being too long and perforating the cortical bone.

[0143] In this embodiment, please continue to refer to Figure 10 As shown, the first fixing part 303 and the second fixing part 304 are generally cylindrical. In this embodiment, the first fixing part 303 and the second fixing part 304 are cylindrical.

[0144] In this embodiment, the first fixing part 303 or the second fixing part 304 is projected from the distal end to the proximal end. The outer contour of the first fixing part 303 or the second fixing part 304 has a concave surface, and the first fixing part 303 is provided with a notch opened along its length direction. In this embodiment, the notch faces the second fixing part 304.

[0145] That is, Figure 10d As shown, the cross-sectional shape of the first fixing part 303 is semi-circular or C-shaped, and the cross-sectional shape of the second fixing part 304 is circular.

[0146] In some other embodiments, the cross-sectional shape of the first fixing part 303 or the second fixing part 304 may be other shapes, such as triangles, quadrilaterals, hexagons, octagons, other regular or irregular rings or open rings, etc. The present invention is not limited thereto, as long as it can increase the contact area with the patient's cancellous bone without increasing the length of the fixing part.

[0147] In this embodiment, at least one of the first fixing part 303 and the second fixing part 304 has a concave outer contour (in this embodiment, the outer contour of the first fixing part 303 has a concave surface). It can be seen that fixing posts (fixing parts) of different shapes can adapt to the bone conditions at different positions of the distal tibia, which is beneficial to the early and long-term fixation effect of the tibial support, that is, to increase the service life of the tibial support assembly.

[0148] In some other embodiments, the fixing structure 30 includes multiple fixing parts, each fixing part having at least one shape different from the others, for example, by having a notch in the length direction of the fixing part. The third or more fixing parts are not on the same straight line as the first and second fixing parts, forming a more stable three-point support, four-point support, etc.

[0149] Specifically, such as Figure 11As shown, the tibial support assembly has three independent fixing parts: a first fixing part 303, a second fixing part 304, and a third fixing part 305. The first fixing part 303 and the second fixing part 304 are located on the same straight line, and the third fixing part 305 is located between the first fixing part 303 and the second fixing part 304, but not on the same straight line as the first fixing part 303 and the second fixing part 304. This forms a three-point support or three-point positioning point for the tibial support assembly, thereby enhancing the stability and torsional resistance of the tibial support assembly.

[0150] In this embodiment, multiple fixing parts are provided, thereby offering more positioning points, such as changing from two-point positioning to three-point positioning or four-point positioning, which enhances the stability and torsional resistance of the tibial support assembly.

[0151] Example 11

[0152] Combination Figure 12 , Figures 12a to 12f As shown, the difference between this embodiment and Embodiment 10 is that it further includes a third inverted fastening structure 3040. The first fixing portion 303 and / or the second fixing portion 304 are projected from the distal end to the proximal end, and the body of the fixing structure has a complete or partial lateral envelope contour that is obscured by the maximum envelope contour corresponding to the third inverted fastening structure 3040. The third inverted fastening structure 3040 is disposed around the first fixing portion 303 and / or the second fixing portion 304. It is understood that in some other embodiments, the third inverted fastening structure 3040 may not complete a full circle; it may be one or more segments, and is discontinuous.

[0153] The third inverted structure 3040 is provided in a plurality of such structures, and the plurality of the third inverted structures 3040 are provided at intervals on the side surfaces of the first fixing part 303 and / or the second fixing part 304 from the distal surface 200 near the substrate 21 toward the distal end.

[0154] Please continue to refer to this. Figure 12b As shown, the third inverted structure 3040 has an angle between itself and the side surface of the first fixing part 303 and / or the second fixing part 304, the angle being acute, and the third inverted structure 3040 extends from the side surface of the fixing structure 30 toward the distal surface 200 of the substrate 21.

[0155] In this embodiment, the third inverted structure 3040 is disposed on the second fixing part 304. For example... Figure 12fAs shown, the third inverted structure 3040 protrudes outward. In this embodiment, the third inverted structure 3040 makes it more difficult for the first fixing part 303 and the second fixing part 304 to be pulled out of the patient's tibia, further improving the anti-tilting performance of the tibial support assembly.

[0156] In this embodiment, the third undercut structure 3040 can be replaced with an inwardly recessed undercut structure, or it can be a combination of the third undercut structure 3040 and the inwardly recessed undercut structure. For example, there are several undercut structures, and the several undercut structures are spaced apart on the side surfaces of the first fixing part 303 and the second fixing part 304 from the far end surface 200 near the substrate 21 toward the far end.

[0157] Among the plurality of said undercut structures, there is a third undercut structure 3040 and an inwardly recessed undercut structure (e.g., in the above embodiment). Figure 8e The second inverted structure 3012 shown is not intended to limit the invention.

[0158] In this embodiment, the first fixing part 303 and the substrate 21, as well as the second fixing part 304 and the substrate 21, can be connected by resistance welding.

[0159] In this embodiment, the first fixing part 303 and the substrate 21 are integrally disposed, and the second fixing part 304 is integrally disposed with the substrate 21.

[0160] Example 12

[0161] Please continue to refer to this. Figure 10 and Figure 12 As shown, this embodiment provides a tibial support assembly 1, including: a tibial support body 20, and the tibial support fixation structure described in Embodiments 9, 10 and 11 above; the proximal surface of the base plate 21 is fixedly connected to the distal surface 200 of the tibial support body 20.

[0162] In this embodiment, the tibial support body 20 and the base plate 21 are integrally formed.

[0163] In some other embodiments, the tibial support body 20 and the substrate 21 are welded together using a resistance welding process.

[0164] Example 13

[0165] like Figure 13 , Figure 13a and Figure 13bAs shown, this embodiment provides a tibial support assembly 1. The difference between this embodiment and the first embodiment described above is that in this embodiment, the main fixation part 301 is an expandable structure, and at least a portion of the sidewalls 3013 of the expandable structure can be radially expanded. Specifically, the main fixation 301 includes a plurality of pieces 3013 that are spaced apart from each other and separable at the gaps. Figure 13b As shown, this embodiment also includes an insert 3014, which includes a force-receiving portion 310 and a driving portion 311 connected to the force-receiving portion 310. The driving portion 311 has a variable diameter structure; in this embodiment, the diameter of the driving portion 311 gradually increases from the direction away from the force-receiving portion 310 to the direction closer to the force-receiving portion 310. When the force-receiving portion 310 of the insert 3014 moves away from the substrate 21 after being subjected to force, the driving portion 311 can compress at least a portion of the sidewall of the main fixing portion 301 to cause it to expand radially.

[0166] It can be understood that in some other embodiments, the diameter of the driving part 311 gradually decreases from the direction away from the force-receiving part 310 to the direction closer to the force-receiving part 310. At this time, when the force-receiving part 310 of the insert 3014 is subjected to force and moves to the side closer to the substrate 21, the driving part 311 presses at least a portion of the sidewall of the main fixing part 301 to make it expand radially.

[0167] The main fixation part 301 has a hollow structure inside, and the tibial support body 20 has pin holes corresponding to the hollow structure of the main fixation part 301. Figure 13 (Not shown in the image), the insert 3014 is inserted into the hollow structure of the main fixing part 301 through the pin hole, so that the outer surface of its side wall is in contact with at least a part of the inner surface of the side wall of the main fixing part 301. In the operating state, the force-bearing part of the insert 3014 is subjected to force and is displaced relative to the expandable structure. The driving part of the insert 3014 presses at least a part of the side wall of the main fixing part 301 to make it expand radially.

[0168] When implanting the tibial support assembly 1, the main fixation part 301 is driven into the pre-placed hole in the tibia, and the insert 3014 is inserted into the hollow structure of the main fixation part 301. Then, a force is applied to the insert 3014 to move it. The expandable structure can be pre-expanded with a tool to reduce the resistance when the insert 3014 enters.

[0169] This embodiment can adapt to the differences in the patient's bone condition. In bones with relatively loose bone, the radial expansion range of the sidewall of the expandable structure by the driving part 311 of the insert 3014 is larger, while in bones with relatively strong bone, the radial expansion range of the sidewall of the expandable structure by the driving part 311 is smaller. Therefore, the expandable structure can achieve different depths of expansion and embedding according to the patient's bone condition, which helps to reduce installation resistance and rationalize the pressure distribution. At the same time, this structure also allows the installation force to be adjusted according to the individual during the implantation of the bone prosthesis, so as to achieve the most ideal installation and fixation effect.

[0170] That is, the radial dimension of the main fixation part 301 provided in this embodiment is variable, and the pressure fitting amount can be adjusted according to the patient's bone condition to reduce the installation resistance of the main fixation part 301 and increase the installation force between the main fixation part 301 and the bone after installation, rationalize the pressure fitting amount and make its pressure fitting stress distribution uniform. This structure can adjust the installation state according to the individual bone condition until the most ideal fixation effect is achieved, which improves the stability of the main fixation part 301 and the tibial support assembly 1 it supports.

[0171] It is understood that embodiments two or seven described above can also be configured with a similar expandable structure and equipped with inserts.

[0172] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0173] In the description of this invention, it should be understood that the terms "center," "height," "thickness," "upper," "lower," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0174] In the description of this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0175] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0176] Although the present invention has been described in detail through the preferred embodiments above, it should be understood that the above description should not be considered as a limitation of the present invention. Various modifications and substitutions to the present invention will be apparent to those skilled in the art after reading the above description. Therefore, the scope of protection of the present invention should be defined by the appended claims.

Claims

1. A tibial support fixation structure, characterized in that, include: substrate; A first fixing part and a second fixing part are disposed on the distal surface of the substrate, and both the first fixing part and the second fixing part extend from the distal surface toward the distal end. The distal surface contacts the cancellous bone region of the patient's tibia; the first fixation part is located in or near the lateral densest bone region of the cancellous bone region, and the second fixation part is located in or near the medial densest bone region of the cancellous bone region; The first fixing part and the second fixing part are interconnected to form an integral fixing part; the integral fixing part includes a secondary fixing part that connects the first fixing part and the second fixing part; the width of the secondary fixing part in the sagittal plane is smaller than the width of the two ends of the integral fixing part in the sagittal plane. The width W of the integral fixing part in the coronal plane direction is 40% to 80% of the total width ML of the substrate, and the total width ML of the substrate is the width of the substrate in the coronal plane direction; the length L of the integral fixing part is 10% to 50% of the total width ML of the substrate. The first fixing part and the second fixing part each have a first hollow structure, and the secondary fixing part has a second hollow structure. The first hollow structure and the second hollow structure are interconnected. Alternatively, the first fixing part and the second fixing part each have a first hollow structure, the secondary fixing part has a second hollow structure, the first hollow structure and the second hollow structure are interconnected, and the secondary fixing part is provided with a notch, the notch being recessed toward the distal surface of the substrate.

2. The tibial support fixation structure as described in claim 1, characterized in that, The overall fixing part is provided with an inverted buckle structure; The undercut structure protrudes outward from the side surface of the body of the fixing part where it is located; or, the undercut structure is recessed inward from the side surface of the body of the fixing part where it is located.

3. The tibial support fixation structure as described in claim 2, characterized in that, The inverted structure has an angle facing the distal surface, and the angle is acute.

4. The tibial support fixation structure as described in claim 1, characterized in that, Also includes: An insert; the first fixing part and / or the second fixing part are expandable structures; in the initial state, when the insert is located inside the expandable structure, its outer sidewall surface is in contact with at least a portion of the inner sidewall surface of the expandable structure; in the operating state, the insert is subjected to force and displaces relative to the expandable structure, squeezing at least a portion of the sidewall of the expandable structure to expand it radially.

5. A tibial support assembly, characterized in that, include: The tibial support body, the tibial support fixation structure as described in any one of claims 1 to 4; the base plate includes: a proximal surface; and a distal surface opposite to the proximal surface, wherein the proximal surface of the base plate is disposed on the distal surface of the tibial support body; The tibial support body is integrally formed with the base plate; or, the tibial support body and the base plate are interconnected.

6. The tibial support assembly as described in claim 5, characterized in that, The tibial support body and the substrate are welded together using resistance welding.

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