A tibial support with a reinforced structure

Abstract

This invention discloses a tibial support with a reinforced structure, wherein the distal end of the tibial support has one or more reinforcing ribs. Preferably, the reinforcing ribs are located in the center of the tibial support, and the distal surface of the tibial support has a structure extending onto or into the bone. This invention provides a tibial support with a reinforced structure that effectively improves upon the shortcomings of existing tibial supports, particularly by simultaneously minimizing osteotomy and maximizing structural strength.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, and in particular relates to a tibial support with a reinforced structure. Background Technology

[0002] In knee replacement surgery, tibial supports for knee joint products are generally classified into two categories based on the structure used to fix the tibial prosthesis. The first category includes... Figure 1 As shown, at the distal center of the tibial support, there is a relatively long and thick keel bone that is driven into the bone tissue to fix the prosthesis. This keel bone is integrally formed or assembled with the main body; the second type is as follows... Figure 2 As shown, there is no keel at the distal central position of the tibial support. The prosthesis is fixed by inserting multiple fixation posts into the bone tissue at non-central positions.

[0003] The first type of tibial support involves a large amount of osteotomy, which significantly weakens the postoperative strength of the tibia. The second type of tibial support significantly improves the disadvantages caused by the central keel, but its structural strength is relatively low, and may even be lower than the structural strength required by relevant standards, such as "People's Republic of China Medical Industry Standard YY / T 0810.1-2010 / ISO 14879-1:2000 Surgical Implants Total Knee Prostheses Part 1: Determination of Fatigue Performance of Tibial Supports".

[0004] Existing tibial supports can be divided into biological tibial supports and bone cement tibial supports based on their materials. The main difference between the two is that the biological tibial support has a structure on the distal surface of the main body of the tibial support that is extended or ingrained into the bone. After the structure is in contact with the tibial cross-section, the tibia can gradually grow into the pores of the structure, thereby increasing the stability of the tibial support and the tibial cross-section. On the other hand, the bone cement tibial support has a layer of bone cement applied to the distal surface of the main body of the tibial support. The tibial support is firmly adhered and fixed to the tibial cross-section through the bonding effect of the bone cement. Summary of the Invention

[0005] The purpose of this invention is to provide a tibial support with a reinforced structure that is superior to the two types of tibial supports mentioned above: it inherits the advantages of the second type of tibial support while providing sufficient structural strength.

[0006] To achieve the above objectives, the technical solution of the present invention is to design a tibial support with a reinforced structure, wherein the distal end of the tibial support has one or more reinforcing ribs, which do not have fixation properties or only have auxiliary fixation properties (different from the keel of the first type of tibial support).

[0007] Preferably, at least one of the reinforcing ribs is located at the center of the distal face of the tibial support. For example... Figure 8 The structure consists of structures I through IV, as well as "human" shaped reinforcing ribs.

[0008] Preferably, there is one reinforcing rib, and the cross-section of the reinforcing rib is in a "human" shape.

[0009] Preferably, there are multiple reinforcing ribs, which are dispersed on the distal surface of the tibial tray. Such as Figure 8 Structures V and VI in

[0010] Furthermore, the tibial tray includes a tibial tray main body and a connecting layer structure located on the distal surface of the tibial tray main body for closely contacting the tibial cross-section; the connecting layer structure includes a structure for bone growth or bone ingrowth on the distal surface of the biocompatible tibial tray or bone cement of the bone cement type tibial tray; the reinforcing rib is located on the distal surface of the tibial tray main body, and a groove for avoiding the reinforcing rib is provided in the center of the connecting layer structure.

[0011] Furthermore, the thickness of the reinforcing rib is less than or equal to 50% of the total thickness of the tibial tray.

[0012] Furthermore, fixing columns are respectively provided on both sides of the distal surface of the tibial tray main body.

[0013] Furthermore, the axis of the reinforcing rib is adjacent to the center of the tibial tray main body; the lower part of the reinforcing rib is similar to the contour of the proximal surface of the corresponding tibial tray main body, and the contour of the lower part of the reinforcing rib is smaller than the contour of the proximal surface of the tibial tray main body, and they do not overlap with each other.

[0014] Furthermore, on the proximal surface of the tibial tray main body, the two shoulder positions of the clamping retaining wall for installing the tibial tray and the tibial spacer are the maximum stress points ( Figure 5 、 6 、Point A in 7); the lower bifurcations of the reinforcing rib located on the distal surface of the tibial tray main body respectively extend to both sides of the center of the tibial tray ( Figure 7 Point B), corresponding to the distal position adjacent to the maximum stress point (i.e., Point A) of the clamping retaining wall on the proximal surface of the tibial tray main body.

[0015] Furthermore, the tibial tray is a biocompatible tibial tray; the structure for bone growth or bone ingrowth and the tibial tray main body are formed in one step or by different processes.

[0016] Furthermore, the distal surface of the reinforcing rib is recessed relative to the distal surface of the connecting layer structure or is on the same plane (that is, the thickness of the reinforcing rib is equal to or less than the thickness of the structure for bone growth or bone ingrowth / bone cement).

[0017] Furthermore, the tibial tray is a bone cement type tibial tray. The distal surface of the tibial tray is in close contact with the tibial osteotomy surface by coating bone cement, and fixing column and other structures are provided at non-central positions on the distal end of the tibial tray and inserted into the tibial bone tissue to achieve a stable combination of the prosthesis and the bone.

[0018] Furthermore, the tibial support is a biological tibial support, with a bone extension or bone ingrowth structure on the distal surface of the tibial support where reinforcing ribs are provided. This structure is formed in one step or in separate processes with the main structure of the tibial support, and fixing posts are provided on both sides of the distal surface of the bone extension or bone ingrowth structure.

[0019] The advantages and beneficial effects of the present invention are as follows: The present invention provides a tibial support with a reinforced structure, which effectively improves the shortcomings of existing tibial supports, especially by simultaneously minimizing osteotomy and maximizing structural strength. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the structure of the first type of prior art.

[0021] Figure 2 This is a schematic diagram of the structure of the second type of prior art.

[0022] Figure 3 This is a schematic diagram of the structure of the present invention (far end face).

[0023] Figure 4 This is an exploded view (far end face) of the present invention.

[0024] Figure 5 A schematic diagram (proximal end) of the tibial pad mounting surface of the tibial support body.

[0025] Figure 6 This is a cloud diagram of CAE simulation under the fatigue test conditions of the present invention.

[0026] Figure 7 This is a planar perspective view of the main body of the tibial support.

[0027] Figure 8 Schematic diagram of other derivative structures that provide reinforcement ribs to the main body of the tibial support.

[0028] Among them, the tibial support body 1, reinforcing rib 1-1, structure 2 on the bone length or into the bone length, groove 2-1, fixation column 2-2, and maximum stress point A. Detailed Implementation

[0029] The specific embodiments of the present invention will be further described below with reference to the accompanying drawings and examples. The following examples are only used to more clearly illustrate the technical solutions of the present invention and should not be construed as limiting the scope of protection of the present invention.

[0030] Example:

[0031] like Figure 1 and Figure 2 The images shown represent the first and second types of tibial support bodies in the prior art, respectively.

[0032] like Figure 3 and Figure 4 As shown, a tibial tray with a reinforcement structure includes a tibial tray body (1) and a structure (2) for bone growth on or bone ingrowth into. The distal end surface of the tibial tray body (1) and the proximal end surface of the structure (2) for bone growth on or bone ingrowth into are joined together in a fixed connection or integrally formed, and the surface of the structure (2) for bone growth on or bone ingrowth into is a bioactive structure that can induce bone growth and attachment. The edge of the tibial gasket mounting surface of the tibial tray body (1) is a clamping retaining wall (the function of the clamping retaining wall is to fix the tibial gasket). Fixed columns (2-2) are provided on both sides of the groove (2-1) of the structure (2) for bone growth on or bone ingrowth into. A reinforcing rib (1-1) is provided at the center of the distal end surface of the tibial tray body (1).<00000�8>

[0033] The cross-section of the reinforcing rib (1-1) is in the shape of a "person".

[0034] The thickness of the reinforcing rib (1-1) is equal to or less than the thickness of the structure (2) for bone growth on or bone ingrowth into (the thickness of the reinforcing rib (1-1) is about 50% - 100% of the thickness of the structure (2) for bone growth on or bone ingrowth into). The purpose is to ensure that the surface of the structure (2) for bone growth on or bone ingrowth into better fits the osteotomy surface and induces bone growth and attachment.

[0035] According to the "YY / T 0810.1-2010 / ISO 14879-1:2000 Surgical implants - Total knee joint prostheses - Part 1: Determination of fatigue properties of tibial trays" of the Pharmaceutical Industry Standard of the People's Republic of China, a fatigue test was carried out on the above bioactive tibial tray reinforcement structure, and a CAE simulation was carried out on the bioactive tibial tray reinforcement structure in this test to obtain Figure 6 the nephogram of the CAE simulation under fatigue test conditions.

[0036] From Figure 5 、 Figure 6 、 Figure 7 it can be seen that on the proximal end surface (i.e., the tibial gasket mounting surface) of the tibial tray body (1), the two shoulder positions of the clamping retaining wall at the central position of the tibial tray body (1) are the maximum stress points A( Figure 6 in, the maximum stress point A has the darkest color). In order to enhance the strength of the maximum stress point A, the lower bifurcations of the "person"-shaped reinforcing rib (1-1) can be extended to the two side positions B at the center of the tibial tray body (1), corresponding to the distal positions of the maximum stress point A of the clamping retaining wall adjacent to the tibial gasket mounting surface of the tibial tray body (1).

[0037] Comparison Figure 8Of the six derivative structures I to VI, I and II cannot enhance the strength of the maximum stress point A of the retaining wall. Although IV can enhance the strength of the maximum stress point A of the retaining wall, this structure will cause the structure 2 on the bone length or in the bone to be divided into two parts, and the strength of each of the two parts of the structure 2 on the bone length or in the bone will decrease. Moreover, this structure will significantly reduce the area of ​​the structure 2 on the bone length or in the bone that covers the cortical bone. Similarly, III, V, and VI also significantly reduce the area of ​​the structure 2 on the bone length or in the bone that covers the cortical bone.

[0038] The design of stiffener 1-1 must balance enhancing structural strength with maximizing the contact area between structure 2 (grooving into or extending into the bone) and the osteotomy surface. In contrast, the "V"-shaped design balances the requirements of enhancing structural strength and maximizing contact area, making it the optimal design for the cross-section of stiffener 1-1.

[0039] like Figure 7 The axis of the "human"-shaped reinforcing rib 1-1 is close to the center of the tibial support body 1, thereby achieving optimal strength.

[0040] To ensure uniform strength at the lower bifurcation of reinforcing rib 1-1 (i.e. Figure 7 The portion within the dashed box (the part where the reinforcing rib is located) has a lower bifurcation that is similar to the proximal end face contour of the corresponding tibial support body, but the lower bifurcation contour of the reinforcing rib is smaller than the proximal end face contour of the tibial support body, and they do not overlap, thus ensuring that the lower bifurcation of the reinforcing rib 1-1 (i.e., Figure 7 The part within the dashed square (the part within the square) presents a uniform arc shape, which is evenly stressed and not easily broken.

[0041] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the technical principles of the present invention. For example, cement fixation of the tibial support (when attempting to reduce the amount of osteotomy, thinner inner and outer sides may lead to insufficient structural strength and breakage) can also benefit from the technology of the present invention. These improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A tibial support with a reinforced structure, characterized in that: The distal end of the tibial tray has one or more reinforcing ribs that do not have fixing performance or only have auxiliary fixing performance; at least one of the reinforcing ribs is located at the central position of the distal end face of the tibial tray; The cross-section of the reinforcing rib is in a "human" shape; The tibial tray includes a tibial tray main body and a connection layer structure located on the distal end face of the tibial tray main body for tightly contacting the tibial cross-section; the connection layer structure includes a structure for bone growth or bone ingrowth on the distal end face of the biological tibial tray or the bone cement of the bone cement type tibial tray; the reinforcing rib is located on the distal end face of the tibial tray main body, and a groove for avoiding the reinforcing rib is provided in the center of the connection layer structure; The thickness of the reinforcing rib is less than or equal to 50% of the total thickness of the tibial tray; On the proximal end face of the tibial tray main body, the two shoulder positions of the clamping retaining wall for installing the tibial tray and the tibial spacer are the maximum stress points; the lower bifurcations of the reinforcing ribs located on the distal end face of the tibial tray main body extend to both sides of the center of the tibial tray respectively, corresponding to the distal positions of the maximum stress points of the clamping retaining wall adjacent to the proximal end face of the tibial tray main body.

2. A tibial support with a reinforced structure according to claim 1, characterized in that: Fixing columns are respectively provided on both sides of the distal end face of the tibial tray main body.

3. A tibial support with a reinforced structure according to claim 1, characterized in that: The axis of the reinforcing rib is adjacent to the center of the tibial tray main body; the lower part of the reinforcing rib is similar to the contour of the proximal end face of the corresponding tibial tray main body, and the contour of the lower part of the reinforcing rib is smaller than the contour of the proximal end face of the tibial tray main body and they do not overlap each other.

4. A tibial support with a reinforced structure according to claim 1, characterized in that: The tibial tray is a biological tibial tray; the structure for bone growth or bone ingrowth and the tibial tray main body are formed in one process or in divided processes.

5. A tibial support with a reinforced structure according to claim 1, characterized in that: The distal end face of the reinforcing rib is recessed relative to the distal end face of the connection layer structure or is in the same plane.

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