Preparation method of biological tibial prosthesis

Abstract

The invention discloses a preparation method of a biological tibial prosthesis, and relates to the technical field of prosthesis preparation. The preparation method of the biological tibial prosthesis comprises the following steps: acquiring image data of a tibial plateau of a patient; establishing a platform model according to the image data; acquiring bone mineral density data of a plurality of unit areas on the platform model; based on the multiple pieces of bone mineral density data, bone nail parameters of the multiple unit areas are determined respectively, and the bone nail parameters comprise the number of bone nails; and preparing the tibial prosthesis according to the platform model and the plurality of bone nail parameters. According to the preparation method of the biological tibial prosthesis, the tibial prosthesis adapting to the bone density distribution condition of a tibial plateau of a patient can be prepared, and the stability of the tibial prosthesis in the early stage of implantation is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of prosthesis preparation, and in particular to a method for preparing a biological tibial prosthesis. Background Art

[0002] Currently, Kaschin-Beck disease (KBD) is often treated by surgically implanting a manufactured tibial tray into the patient's tibia. The tray consists of a main body and bone screws protruding from its underside. The screws are relatively simple in design, typically a single one or four evenly spaced. During implantation, the screws fit into holes in the tibial plateau.

[0003] Since the tibial plateau of patients with KBD is usually accompanied by osteoporosis and the bone density in different areas varies greatly, the tibial tray with a uniform structure has poor fastening effect of the bone screws after implantation, which makes the tibial tray easy to loosen in the early stage of implantation. Summary of the Invention

[0004] The purpose of the present invention is to provide a method for preparing a biological tibial prosthesis, which can prepare a tibial prosthesis that adapts to the patient's tibial plateau bone density distribution and improves the stability of the implant in the early stage.

[0005] The embodiment of the present invention provides a technical solution:

[0006] A method for preparing a biological tibial prosthesis, comprising:

[0007] Obtain imaging data of the patient's tibial plateau;

[0008] establishing a platform model according to the image data;

[0009] Acquiring bone density data of multiple unit areas on the platform model;

[0010] Determining bone screw parameters of each of the unit areas based on the plurality of bone density data, wherein the bone screw parameters include the number of bone screws;

[0011] A tibial prosthesis is prepared according to the platform model and a plurality of bone screw parameters.

[0012] In an optional embodiment, the bone screw parameters further include bone screw hole diameter and bone screw porosity, and the step of preparing a tibial prosthesis according to the platform model and the plurality of bone screw parameters includes:

[0013] A semi-finished prosthesis is prepared according to the platform model and the number of the plurality of bone screws; wherein the semi-finished prosthesis includes a main body and a plurality of bone screws, and the plurality of bone screws are distributed in a plurality of mapping areas on the main body corresponding one-to-one to the plurality of unit areas;

[0014] According to the multiple bone screw hole diameters and the multiple bone screw porosities, the bone screws within the multiple mapping areas on the prosthesis semi-finished product are respectively surface-drilled to obtain the tibial prosthesis.

[0015] In an optional embodiment, the step of preparing a semi-finished prosthesis according to the platform model and the number of the plurality of bone screws includes:

[0016] Establishing a prosthesis model of the tibial prosthesis according to the platform model and the number of the plurality of bone screws;

[0017] The prosthesis model is 3D printed to obtain the prosthesis semi-finished product.

[0018] In an optional embodiment, the step of performing surface drilling on the bone screws within the plurality of mapping areas on the prosthesis semi-finished product based on the plurality of bone screw hole diameters and the plurality of bone screw porosities to obtain the tibial prosthesis includes:

[0019] According to the multiple bone screw hole diameters and the multiple bone screw porosities, a laser beam is used to perform surface ablation on the bone screws in the multiple mapping areas on the prosthesis semi-finished product to obtain the tibial prosthesis.

[0020] In an optional embodiment, the step of determining the bone screw parameters of the plurality of unit areas based on the plurality of bone density data includes:

[0021] According to the formula N=4*(1-ρ / 800)+2, the number of bone screws in the unit area corresponding to the plurality of bone density data is calculated respectively;

[0022] Wherein, N represents the number of bone screws; ρ represents the bone density data.

[0023] In an optional embodiment, the step of determining the bone screw parameters of the plurality of unit areas based on the plurality of bone density data further includes:

[0024] Calculating the bone screw hole diameters of the unit areas corresponding to the plurality of bone density data according to the formula d=800-1.25ρ;

[0025] Wherein, d represents the hole diameter of the bone screw, in micrometers; ρ represents the bone density data.

[0026] In an optional embodiment, the step of determining the bone screw parameters of the plurality of unit areas based on the plurality of bone density data further includes:

[0027] Calculating the porosity of the bone screw in the unit area corresponding to the plurality of bone density data according to the formula P=(80-0.2ρ) / 100;

[0028] Wherein, P represents the porosity of the bone screw; ρ represents the bone density data.

[0029] In an optional embodiment, the step of acquiring image data of the patient's tibial plateau includes:

[0030] Perform a CT scan on the tibial plateau to obtain the image data.

[0031] In an optional embodiment, the step of establishing a platform model based on the image data includes:

[0032] The platform model is obtained by performing three-dimensional reconstruction based on the image data using three-dimensional reconstruction software.

[0033] In an optional embodiment, the step of obtaining bone density data of multiple unit areas on the platform model includes:

[0034] Based on the three-dimensional reconstruction software, the platform model is divided into a plurality of unit areas, and the bone density data of the plurality of unit areas are read.

[0035] Compared with the prior art, the method for preparing a biological tibial prosthesis provided by the present invention establishes a platform model based on the imaging data of the patient's tibial plateau, and obtains the bone density data of multiple unit areas on the platform model to obtain the bone density conditions of the corresponding multiple unit areas on the patient's tibial plateau. The bone screw parameters of the multiple unit areas are determined based on the multiple bone density data, and then the tibial prosthesis is prepared in combination with the platform model. The bone screw parameters in different areas of the prepared tibial prosthesis correspond to the bone density conditions of the corresponding unit areas on the tibial plateau, including matching different numbers of bone screws with unit areas of different bone densities, thereby ensuring that the tibial prosthesis can obtain higher stability in the early stage of implantation and reducing the risk of loosening. Therefore, the beneficial effects of the method for preparing a biological tibial prosthesis provided by the present invention include: being able to prepare a tibial prosthesis that adapts to the bone density distribution of the patient's tibial plateau, and improving the stability of the tibial prosthesis in the early stage of implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] To more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly describes the drawings required for use in the embodiments. It should be understood that the following drawings illustrate only certain embodiments of the present invention and should not be construed as limiting the scope of the present invention. Those skilled in the art can, without inventive effort, derive other relevant drawings from these drawings.

[0037] Figure 1 A schematic structural diagram of a tibial prosthesis prepared by the method for preparing a biological tibial prosthesis provided in an embodiment of the present invention;

[0038] Figure 2 A flowchart of a method for preparing a biotype tibial prosthesis according to an embodiment of the present invention;

[0039] Figure 3 for Figure 2 A flow chart of sub-steps of step S104;

[0040] Figure 4 for Figure 2 A flow chart of sub-steps of step S105;

[0041] Figure 5 for Figure 4 A flow chart of a sub-step of neutron step S1051.

[0042] Icons: 100-tibial prosthesis; 110-main body; 120-bone screw; 121-porous structure. DETAILED DESCRIPTION

[0043] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings of the embodiments of the present invention. It should be understood that the described embodiments are only a portion of the embodiments of the present invention, not all of them. Generally, the components of the embodiments of the present invention described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations.

[0044] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort shall fall within the scope of protection of the present invention.

[0045] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0046] In the description of the present invention, it should be understood that the terms "upper", "lower", "inside", "outside", "left", "right", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, or are the orientations or positional relationships in which the inventive product is conventionally placed when in use, or are the orientations or positional relationships conventionally understood by those skilled in the art. These are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or component referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0047] Furthermore, the terms “first”, “second”, etc. are merely used for distinguishing descriptions and should not be understood as indicating or implying relative importance.

[0048] In the description of the present invention, it should also be noted that, unless otherwise expressly specified or limited, terms such as "disposed" and "connected" should be understood in a broad sense. For example, "connected" can mean a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can also mean internal communication between two components. Those skilled in the art will be able to understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0049] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0050] Example

[0051] This embodiment provides a method for preparing a bio-type tibial prosthesis, which can prepare a tibial prosthesis 100 that adapts to the bone density distribution of the patient's tibial plateau.

[0052] See also Figure 1 , Figure 1 FIG2 is a schematic structural diagram of a tibial prosthesis 100 prepared by the method for preparing a biological tibial prosthesis provided in this embodiment. The tibial prosthesis 100 includes a main body 110 and a plurality of bone screws 120 . The surface of the bone screws 120 has a porous structure 121 .

[0053] See also Figure 2 , Figure 2 The figure shows a flow chart of a method for preparing a biological tibial prosthesis provided in this embodiment. The method for preparing a biological tibial prosthesis may include:

[0054] Step S101: acquiring image data of the patient's tibial plateau.

[0055] Preferably, in this embodiment, the imaging data of the tibial plateau of the patient's knee joint is obtained by CT scanning.

[0056] Step S102: establishing a platform model based on the image data.

[0057] In this embodiment, three-dimensional reconstruction software is used to perform three-dimensional reconstruction based on the image data to obtain a platform model.

[0058] Specifically, the image data obtained in step S101 is imported into the three-dimensional reconstruction software. The three-dimensional reconstruction software can use the gray value distribution of the image data to accurately identify the bone tissue area through the image segmentation algorithm, and distinguish the boundary between the bone tissue and the soft tissue to generate a three-dimensional platform model of the tibial plateau.

[0059] In practical applications, the three-dimensional reconstruction software may be Mimics or Simpleware, and the established platform model can accurately reflect the bone density distribution of the patient's tibial plateau.

[0060] Step S103: Obtain bone density data of multiple unit areas on the platform model.

[0061] Specifically, based on three-dimensional reconstruction software, multiple unit areas can be divided on the platform model, and bone density data of the multiple unit areas can be read.

[0062] The size of the unit area can be set in the 3D reconstruction software according to actual needs. In this embodiment, the unit area is 1 square centimeter. The bone density data in each unit area is directly read through the 3D reconstruction software to obtain multiple bone density data corresponding to the multiple unit areas.

[0063] Step S104: determining bone screw parameters of the plurality of unit areas based on the plurality of bone density data.

[0064] In this embodiment, the bone screw parameters include the number of bone screws, the diameter of the bone screw holes, and the porosity of the bone screws. Different unit areas of bone density data correspond to different bone screw parameters. For each bone screw parameter, it includes the number of bone screws 120 required for the corresponding unit area, the pore size and porosity of the pore structure on the surface of the bone screw 120.

[0065] Since the lower the bone density data, the more severe the osteoporosis in the unit area, the poorer the mechanical support provided to the tibial prosthesis 100, and therefore more bone screws 120 are required to compensate for the mechanical defects of the unit area. In other words, the lower the bone density data, the more bone screws are required in the unit area.

[0066] By configuring different numbers of bone screws for unit areas with different bone density data, it is possible to ensure that the tibial prosthesis 100 can obtain uniform and reliable support in different unit areas of the tibial plateau after implantation, thereby improving the stability of the tibial prosthesis 100 in the early stage of implantation.

[0067] The bone screw 120 of the tibial prosthesis 100 prepared by the biotype tibial prosthesis preparation method provided in this embodiment also has a porous structure 121 on the surface, so that bone tissue in different unit areas can better grow into the tibial prosthesis 100 in the later stage of implantation, achieving stable biological fixation with the tibial prosthesis 100.

[0068] That is, the bone screw parameters in this embodiment also include the bone screw hole diameter and the bone screw porosity. The bone screw hole diameter refers to the hole size of the surface opening of each bone screw 120 in the corresponding unit area, and the bone screw porosity refers to the porosity of the surface opening of each bone screw 120 in the corresponding unit area.

[0069] Because lower bone density indicates more severe osteoporosis in a unit area, bone tissue ingrowth in the later stages of implantation is poorer. Therefore, to compensate for the poor bone tissue ingrowth in unit areas with lower bone density and to balance the ingrowth across different unit areas, the bone screw aperture and porosity are increased for unit areas with lower bone density.

[0070] Please refer to Figure 3 , Figure 3 The figure shows a flow chart of a sub-step of step S104. Step S104 may include the following sub-steps:

[0071] Sub-step S1041 , according to the formula N=4*(1-ρ / 800)+2, respectively calculate the number of bone screws per unit area corresponding to the plurality of bone density data.

[0072] It should be noted that when the calculation result is not an integer, it is rounded off.

[0073] Sub-step S1042 , according to the formula d=800-1.25ρ, respectively calculate the bone screw hole diameters of the unit areas corresponding to the plurality of bone density data.

[0074] In sub-step S1043 , the porosity of the bone screw per unit area corresponding to the plurality of bone density data is calculated according to the formula P=(80-0.2ρ) / 100.

[0075] It is understandable that there is no order in which sub-steps S1041, S1042, and S1043 are executed. In the above three formulas, N represents the number of bone screws; ρ represents the bone density data; d represents the diameter of the bone screw hole, in microns; and P represents the porosity of the bone screw.

[0076] Please continue reading Figure 2 The method for preparing the biological tibial prosthesis may further include:

[0077] Step S105 : preparing the tibial prosthesis 100 according to the platform model and the multiple bone screw parameters.

[0078] Please refer to Figure 4 , Figure 4 The figure shows a flow chart of a sub-step of step S105. Step S105 may include the following sub-steps:

[0079] Sub-step S1051 : preparing a semi-finished prosthesis according to the platform model and the number of bone screws.

[0080] The semi-finished prosthesis includes a main body 110 and a plurality of bone screws 120 . The plurality of bone screws 120 are distributed in a plurality of mapping areas on the main body 110 corresponding one-to-one to the plurality of unit areas.

[0081] In other words, for a unit area with lower bone density data, the number of bone screws 120 distributed in the mapping area on the prosthesis semi-finished product is greater; for a unit area with higher bone density data, the number of bone screws 120 distributed in the mapping area on the prosthesis semi-finished product is less.

[0082] Furthermore, the number of bone screws 120 distributed within the mapping area corresponding to any unit area is calculated by the aforementioned sub-step S1041.

[0083] In sub-step S1052 , according to the multiple bone screw hole diameters and the multiple bone screw porosities, the bone screws 120 in the multiple mapping areas on the prosthesis semi-finished product are respectively drilled to obtain the tibial prosthesis 100 .

[0084] In this embodiment, laser ablation is used to create holes on the surface of bone screw 120, forming a porous surface structure 121. Specifically, laser ablation is performed on the surface of bone screw 120 within multiple mapping areas on the semi-finished prosthesis, based on multiple bone screw hole diameters and multiple bone screw porosities, to produce tibial prosthesis 100.

[0085] Please refer to Figure 5 , Figure 5 The figure shows a sub-step flow chart of sub-step S1051. Sub-step S1051 may include the following sub-steps:

[0086] Sub-step S1051 a: establishing a prosthesis model of the tibial prosthesis 100 according to the platform model and the number of bone screws.

[0087] Sub-step S1051 b: 3D printing the prosthesis model to obtain a semi-finished prosthesis.

[0088] As can be seen, in this embodiment, tibial prosthesis 100 is produced by combining 3D printing with laser beam ablation. 3D printing can better match the size and topography of the patient's tibial plateau, achieving a better implant effect. Laser beam ablation can precisely control the parameters of the porous structure 121 on the surface of the bone screw 120, forming a uniform porous structure 121. The aperture of the openings on the surface of the bone screw 120 can be precisely controlled within a range of 50 μm to 200 μm, thereby increasing the contact area with bone tissue and facilitating bone tissue ingrowth.

[0089] In another embodiment, the diameter and length of the bone screw 120 can also be designed according to a set bone density threshold.

[0090] For example, if the bone density data of a certain unit area is higher than the set bone density threshold, the bottom diameter of the bone screw 120 corresponding to the unit area is designed to be 3 mm and the tip diameter is 2 mm; if the bone density data of a certain unit area is lower than or equal to the set bone density threshold, the bottom diameter of the bone screw 120 corresponding to the unit area is designed to be 5 mm and the tip diameter is 2 mm to increase the contact area.

[0091] In summary, the method for preparing a biocompatible tibial prosthesis provided in this embodiment can prepare a tibial prosthesis 100 that adapts to the patient's tibial plateau bone density distribution, thereby improving the stability of the tibial prosthesis 100 in the early implantation stage and the ingrowth of bone tissue in different locations in the later implantation stage.

[0092] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A method for preparing a biological tibial prosthesis, characterized in that: include: Obtain imaging data of the patient's tibial plateau; establishing a platform model according to the image data; Acquiring bone density data of multiple unit areas on the platform model; Determining bone screw parameters of each of the unit areas based on the plurality of bone density data, wherein the bone screw parameters include the number of bone screws; A tibial prosthesis (100) is prepared according to the platform model and a plurality of bone screw parameters.

2. The method for preparing a biological tibial prosthesis according to claim 1, characterized in that: The bone screw parameters also include bone screw hole diameter and bone screw porosity. The steps of preparing the tibial prosthesis (100) according to the platform model and the plurality of bone screw parameters include: A prosthesis semi-finished product is prepared according to the platform model and the number of the plurality of bone screws; wherein the prosthesis semi-finished product includes a main body (110) and a plurality of bone screws (120), and the plurality of bone screws (120) are distributed in a plurality of mapping areas on the main body (110) corresponding one-to-one to the plurality of unit areas; According to the plurality of bone screw hole diameters and the plurality of bone screw porosities, the surface of the bone screws (120) within the plurality of mapping areas on the prosthesis semi-finished product is respectively opened to obtain the tibial prosthesis (100).

3. The method for preparing a biological tibial prosthesis according to claim 2, characterized in that: The step of preparing a semi-finished prosthesis according to the platform model and the number of the plurality of bone screws comprises: Establishing a prosthesis model of the tibial prosthesis (100) according to the platform model and the number of the plurality of bone screws; The prosthesis model is 3D printed to obtain the prosthesis semi-finished product.

4. The method for preparing a biological tibial prosthesis according to claim 2, wherein: The step of performing surface drilling on the bone screws (120) within the plurality of mapping areas on the prosthesis semi-finished product according to the plurality of bone screw hole diameters and the plurality of bone screw porosities to obtain the tibial prosthesis (100) comprises: According to the multiple bone screw hole diameters and the multiple bone screw porosities, a laser beam is used to perform surface ablation on the bone screws (120) in the multiple mapping areas on the prosthesis semi-finished product to obtain the tibial prosthesis (100).

5. The method for preparing a biological tibial prosthesis according to claim 2, characterized in that: The step of respectively determining the bone screw parameters of the plurality of unit areas based on the plurality of bone density data comprises: According to the formula N=4*(1-ρ / 800)+2, the number of bone screws in the unit area corresponding to the plurality of bone density data is calculated respectively; Wherein, N represents the number of bone screws; ρ represents the bone density data.

6. The method for preparing a biological tibial prosthesis according to claim 2, characterized in that: The step of respectively determining the bone screw parameters of the plurality of unit areas based on the plurality of bone density data further includes: Calculating the bone screw hole diameters of the unit areas corresponding to the plurality of bone density data according to the formula d=800-1.25ρ; Wherein, d represents the hole diameter of the bone screw, in micrometers; ρ represents the bone density data.

7. The method for preparing a biological tibial prosthesis according to claim 2, characterized in that: The step of respectively determining the bone screw parameters of the plurality of unit areas based on the plurality of bone density data further includes: Calculating the porosity of the bone screw in the unit area corresponding to the plurality of bone density data according to the formula P=(80-0.2ρ) / 100; Wherein, P represents the porosity of the bone screw; ρ represents the bone density data.

8. The method for preparing a biological tibial prosthesis according to claim 1, characterized in that: The step of obtaining image data of the patient's tibial plateau comprises: Perform a CT scan on the tibial plateau to obtain the image data.

9. The method for preparing a biological tibial prosthesis according to claim 1, characterized in that: The step of establishing a platform model according to the image data comprises: The platform model is obtained by performing three-dimensional reconstruction based on the image data using three-dimensional reconstruction software.

10. The method for preparing a biological tibial prosthesis according to claim 9, characterized in that: The step of obtaining bone density data of multiple unit areas on the platform model includes: Based on the three-dimensional reconstruction software, the platform model is divided into a plurality of unit areas, and the bone density data of the plurality of unit areas are read.

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