Intervertebral fusion cage and design method, system, intelligent device and storage medium thereof

Abstract

The application provides an intervertebral fusion cage and a design method, system, intelligent device and storage medium thereof. The design method of the intervertebral fusion cage comprises the following steps: setting a top frame and a bottom frame, setting at least one pair of arc-shaped rods along the edges of the top frame and the bottom frame, one end of each arc-shaped rod being connected with the top frame and the other end being connected with the bottom frame, connecting the two ends of each pair of arc-shaped rods with two long rods to generate a unit wire frame, setting the thickness of the unit wire frame to generate a unit structure, combining at least one unit structure so that the axis of the at least one unit structure is located on the same straight line to generate an intervertebral fusion cage structure, and adjusting the structural parameters of the intervertebral fusion cage structure so that the stiffness parameters of the intervertebral fusion cage generated according to the intervertebral fusion cage structure meet the preset stiffness requirements. The application can flexibly realize the stiffness adjustment of the local and the whole of the intervertebral fusion cage, thereby effectively reducing the workload of designing the intervertebral fusion cage and improving the work efficiency.

Description

Technical Field

[0001] This invention relates to the field of biomedicine, specifically to interbody fusion devices and their design methods, systems, intelligent devices, and storage media. Background Technology

[0002] Since the successful use of intervertebral fusion cages for spinal fusion, they have been widely applied in clinical practice, alleviating the suffering of many patients. The uneven distribution of bone in the intervertebral disc from the center to the outer ring results in localized variations in its stiffness. Therefore, it is necessary to adjust both the overall and local stiffness of the intervertebral fusion cage during its design to match the overall and local stiffness requirements of the disc at the desired implantation location. However, adjusting the overall and local stiffness of existing intervertebral fusion cages requires adjustments to the entire structure, which is labor-intensive and inefficient. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a simple and usable design method for adjusting the overall stiffness of the local area, which solves the technical defects of the prior art in designing the overall and local stiffness of the interbody fusion device, which involves a large workload and low work efficiency. The present invention also provides an interbody fusion device and its design method system, intelligent device and storage medium, which can effectively reduce the workload of designing the interbody fusion device and improve work efficiency.

[0004] The technical solution adopted by this invention to solve its technical problem is: to provide a design method for an interbody fusion device, comprising:

[0005] Set a top frame and a bottom frame, and set at least one pair of arc-shaped rods along the edges of the top frame and the bottom frame. One end of each arc-shaped rod is connected to the top frame and the other end is connected to the bottom frame. Connect the two ends of each pair of arc-shaped rods with two long rods to generate a unit line frame.

[0006] The thickness of the unit wireframe is obtained, a unit structure is generated, and at least one of the unit structures is combined such that the axes of the at least one unit structure are on the same straight line to generate an intervertebral fusion device structure.

[0007] The structural parameters of the intervertebral fusion device are adjusted so that the stiffness parameters of the intervertebral fusion device generated based on the intervertebral fusion device structure meet the preset stiffness requirements. The structural parameters include the member parameters of each of the arc-shaped rods, and the member parameters include at least one of the length, roundness, thickness, and number of the arc-shaped rods and / or the spacing between adjacent arc-shaped rods.

[0008] The step of combining at least one of the unit structures such that the axes of the at least one unit structure are on the same straight line includes:

[0009] The unit structure is scaled horizontally to generate multiple scaled unit structures with different horizontal dimensions but the same vertical height. The multiple scaled unit structures are then nested in ascending order, with their axes aligned on the same straight line, to generate a nested structure. This nested structure serves as the intervertebral fusion device structure.

[0010] The step of adjusting the structural parameters of the interbody fusion device includes:

[0011] Adjust the rotation angle of at least one of the scaling unit structures in the horizontal plane; and / or

[0012] Adjust the spacing between at least one group of adjacent scaling units.

[0013] The step of combining at least one of the unit structures such that the axes of the at least one unit structure are on the same straight line includes:

[0014] At least two of the scaling unit structures or the unit structures or the nesting structures are stacked, and the axes of the multiple scaling unit structures or the multiple unit structures are located on the same straight line to generate a stacked structure, which is used as the intervertebral fusion device structure.

[0015] Prior to the step of adjusting the structural parameters of each of the arc-shaped rods so that the stiffness parameters of the interbody fusion device generated based on the interbody fusion device structure meet the preset stiffness requirements, the procedure includes:

[0016] Acquire medical imaging data of the target patient, and obtain reference intervertebral parameters of the region of interest based on the medical imaging data. The region of interest includes the implantation site and its adjacent area.

[0017] The preset stiffness requirement is obtained based on the reference intervertebral parameters.

[0018] The step of acquiring the medical imaging data of the target patient includes:

[0019] The outer shell shape of the interbody fusion device structure is obtained based on the medical imaging data.

[0020] The outer shell structure is generated according to the shape of the outer shell and the structure of the intervertebral fusion device, and the outer shell structure is fitted around the outer periphery of the intervertebral fusion device structure.

[0021] The step of adjusting the structural parameters of each of the arc-shaped rods includes:

[0022] A manufacturing file is generated based on the structure of the intervertebral fusion device, and the manufacturing file is imported into additive manufacturing software to generate the intervertebral fusion device through additive manufacturing.

[0023] The technical solution adopted by the present invention to solve its technical problem is: to provide an interbody fusion device, characterized in that the interbody fusion device is manufactured and obtained by the method described above, comprising at least one unit structure, wherein the axes of the at least one unit structure are located on the same straight line, and the unit structure comprises:

[0024] Top frame and bottom frame;

[0025] At least one pair of arc-shaped rods are provided along the edges of the top frame and the bottom frame, with one end of each arc-shaped rod connected to the top frame and the other end connected to the bottom frame;

[0026] Each pair of arc-shaped rods is connected at both ends by two long rods.

[0027] The technical solution adopted by the present invention to solve its technical problem is: to provide a storage medium storing a computer program, wherein when the computer program is executed by a processor, the processor performs the steps of the method described above.

[0028] The technical solution adopted by the present invention to solve its technical problem is: to provide an intelligent manufacturing device, including a memory and a processor, wherein the memory stores a computer program, and when the computer program is executed by the processor, the processor performs the steps of the method described above.

[0029] The beneficial effects of this invention are that, compared with the prior art, in this invention, one end of each arc-shaped rod is connected to the top frame and the other end is connected to the bottom frame. When designing the interbody fusion cage structure, the stiffness parameters of the interbody fusion cage can be effectively and quickly adjusted by changing the rod parameters of the arc-shaped rod. When designing interbody fusion cages for different patients, only the structural parameters of the same interbody fusion cage structure can be modified. Through experiments or finite element verification, it can be ensured that the interbody fusion cage generated by the modified interbody fusion cage structure matches the patient's needs, effectively reducing the workload of modifying and adjusting the interbody fusion cage and improving the design efficiency of the interbody fusion cage. Attached Figure Description

[0030] The present invention will be further described below with reference to the accompanying drawings and embodiments. In the accompanying drawings:

[0031] Figure 1 This is a flowchart illustrating an embodiment of the design method for the interbody fusion device provided by the present invention;

[0032] Figure 2 This is a schematic diagram of the structure of an embodiment of the unit wireframe provided by the present invention;

[0033] Figure 3This is a schematic diagram of an embodiment of the unit structure provided by the present invention;

[0034] Figure 4 This is a top view of an embodiment of the scaling unit structure provided by the present invention;

[0035] Figure 5 This is a schematic diagram of the structure of the first embodiment of the interbody fusion device provided by the present invention;

[0036] Figure 6 This is a schematic diagram of the structure of the second embodiment of the interbody fusion device provided by the present invention;

[0037] Figure 7 This is a schematic diagram of the vertical stress-vertical strain curve of the titanium alloy itself.

[0038] Figure 8 This is a schematic diagram of the vertical stress-strain curve of a titanium alloy considering strain strengthening.

[0039] Figure 9 This is a schematic diagram of a scenario provided by the finite element analysis method of this invention;

[0040] Figure 10 This is a schematic diagram of the vertical stress-vertical strain curve when the intervertebral fusion cage is a unit structure.

[0041] Figure 11 This is a schematic diagram of a structure of an embodiment of the arc-shaped rod provided by the present invention;

[0042] Figure 12 A schematic diagram showing the vertical stiffness-roundness relationship with different values ​​of the roundness e of the arc-shaped rod, while keeping other structural parameters of the unit structure unchanged.

[0043] Figure 13 A schematic diagram of the vertical stress-vertical strain curves with different values ​​of the roundness e of the arc rod, while keeping other structural parameters of the unit structure unchanged.

[0044] Figure 14 yes Figure 5 The diagram shown illustrates the principle and structure of the interbody fusion device.

[0045] Figure 15 This is a schematic diagram of another scenario of finite element analysis provided by the present invention;

[0046] Figure 16 It is an intervertebral fusion device Figure 5 A schematic diagram of the vertical stress-vertical strain curve for the structure shown.

[0047] Figure 17 This is a top view schematic diagram of the third embodiment of the interbody fusion device structure provided by the present invention;

[0048] Figure 18 yes Figure 6 The diagram shown illustrates the principle and structure of the interbody fusion device.

[0049] Figure 19 It is an intervertebral fusion device Figure 6 A schematic diagram of the vertical stress-vertical strain curve for the structure shown.

[0050] Figure 20 This is a schematic diagram of an embodiment of medical imaging data for the entire endplate region provided by the present invention.

[0051] Figure 21 This is a schematic diagram of an embodiment of medical imaging data in the central region of the endplate provided by the present invention.

[0052] Figure 22 This is a schematic diagram of an embodiment of the interbody fusion device provided by the present invention;

[0053] Figure 23 This is a schematic diagram of the structure of an embodiment of the intelligent manufacturing equipment provided by the present invention;

[0054] Figure 24 This is a schematic diagram of an embodiment of the storage medium provided by the present invention. Detailed Implementation

[0055] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0056] Please refer to the following: Figure 1 , Figure 1 This is a flowchart illustrating an embodiment of the interbody fusion device design method provided by the present invention. The interbody fusion device design method provided by the present invention includes the following steps:

[0057] S101: Set up a top frame and a bottom frame. Set at least one pair of arc-shaped rods along the edges of the top frame and the bottom frame. One end of each arc-shaped rod is connected to the top frame and the other end is connected to the bottom frame. Connect the two ends of each pair of arc-shaped rods with two long rods to generate a unit wireframe.

[0058] In a specific implementation scenario, the interbody fusion device (IVM) needs to be configured, which comprises multiple unit structures. When designing the IVM, the unit structures are first defined, and then transformed and / or combined to form the IVM required by the user. In this implementation scenario, the unit wireframes are designed first, and then the thickness of the wireframes is adjusted to generate the unit structures.

[0059] Please refer to the following: Figure 2 , Figure 2 This is a structural schematic diagram of an embodiment of the unit wireframe provided by the present invention. The unit wireframe 10 includes a top frame 11 and a bottom frame 12. The top frame 11 and the bottom frame 12 can have the same or different shapes. The top frame 11 and the bottom frame 12 can be arranged in parallel or non-parallel arrangements. The top frame 11 and the bottom frame 12 can be regular shapes (e.g., circles, ellipses, squares, rectangles, regular hexagons, etc.) or irregular shapes. The setting parameters of the top frame 11 and the bottom frame 12 can be set by the user according to actual usage requirements (e.g., the size and shape of the implantable space, the size and shape of the upper and lower end plates, etc.).

[0060] At least one pair of arc-shaped rods 13 are arranged along the edges of the top frame 11 and the bottom frame 12. One end of each arc-shaped rod 13 is connected to the top frame 11, and the other end is connected to the bottom frame 12. Each pair of arc-shaped rods 13 is arranged opposite to each other. The ends of each pair of arc-shaped rods 13 on the top frame 11 are connected by a long rod 14, and the other ends on the bottom frame 12 are connected by another long rod 14, forming a unit wireframe 10. Each pair of arc-shaped rods 13 and the two long rods 14 connecting the pair of arc-shaped rods 13 will form a loop unit wireframe. When there are multiple pairs of arc-shaped rods 13, there are multiple loop unit wireframes. These loop unit wireframes intersect at the center of the top frame 11 and the bottom frame 12, generating the intersection point of the top frame 11 and the intersection point of the bottom frame 12. The line connecting the intersection point of the top frame 11 and the intersection point of the bottom frame 12 can be used as the axis of the unit wireframe 10, which is the axis of the subsequently generated unit structure. Alternatively, the vertical line where the intersection of the top frame 11 or the bottom frame 12 is located can be used as the axis of the unit frame 10, which is the axis of the subsequently generated unit structure.

[0061] S102: Obtain the thickness of the unit wireframe, generate the unit structure, combine at least one unit structure so that the axes of at least one unit structure are on the same straight line, and generate the intervertebral fusion device structure.

[0062] In a specific implementation scenario, the thickness of the unit wireframe is obtained. For example, the diameter, thickness, cross-sectional shape, and area of ​​the top frame, bottom frame, curved rod, and long rod are set to generate a hollow unit structure. The thicknesses of the top frame, bottom frame, curved rod, and long rod can be the same or different. The thickness of the top frame, bottom frame, and connecting long rod of the unit wireframe itself can be a fixed value or the same as the thickness of the curved rod, which can be flexibly selected or set by the user according to actual usage requirements. Please refer to the following: Figure 3 , Figure 3 This is a schematic diagram of an embodiment of the unit structure provided by the present invention.

[0063] In one implementation scenario, a single Figure 3 The illustrated unit structure serves as an interbody fusion cage structure. In other implementation scenarios, the unit structure can be scaled, deformed, or combined in at least one of the following ways to generate an interbody fusion cage structure. For example, the unit structure can be scaled along the horizontal direction (the plane containing the top frame or the plane containing the bottom frame) to generate multiple scaled unit structures with different horizontal dimensions but the same vertical height. Please refer to [reference needed]. Figure 4 , Figure 4 This is a top view of an embodiment of the scaling unit structure provided by the present invention. Figure 3 The unit structures in the diagram are scaled down and enlarged according to predetermined ratios, respectively. Figure 4 The diagram shows three scaling units. The scaling ratio is set by the user according to their actual usage needs.

[0064] Will Figure 4 The scaling unit structures shown are nested sequentially in ascending order of size, ensuring that the axes of multiple scaling unit structures are aligned on the same straight line. That is, the smallest scaling unit structure is located at the center, and the second smallest scaling unit structure is nested around it, with its own axis as the axis of the smallest scaling unit structure. This process continues until the largest scaling unit structure is nested around the second smallest scaling unit structure, creating a nested structure that serves as the intervertebral fusion cage structure. Please refer to the relevant documentation. Figure 5 , Figure 5 This is a schematic diagram of the structure of the first embodiment of the intervertebral fusion device provided by the present invention.

[0065] In another implementation scenario, at least two scaling unit structures or stacked unit structures can be arranged, with the axes of multiple scaling unit structures or multiple unit structures located on the same straight line. For example, it can be... Figure 5 The stacked structure shown is configured to create a fusion cage structure. Please refer to the following references. Figure 6 , Figure 6 This is a schematic diagram of the second embodiment of the intervertebral fusion device provided by the present invention.

[0066] S103: Adjust the structural parameters of the interbody fusion cage structure so that the stiffness parameters of the interbody fusion cage generated based on the interbody fusion cage structure meet the preset stiffness requirements. The structural parameters include the member parameters of each arc-shaped bar, and the member parameters include at least one of the length, roundness, and thickness of the arc-shaped bar and / or the spacing between adjacent arc-shaped bars.

[0067] In a specific implementation scenario, the generated interbody fusion cage structure is experimentally or analytically tested. For example, finite element analysis (FEM) can be performed, placing the mesh entity of the interbody fusion cage structure between at least one pair of rigid plates. In each pair, one rigid plate is fixed, and the other is subjected to a vertical or horizontal load. Based on the reaction force and overall vertical displacement recorded in the FEM results, a force-displacement curve for the interbody fusion cage structure is obtained. The stiffness parameters of the interbody fusion cage, including its overall stiffness and local stiffness, are then obtained from the force-displacement curve. In other implementation scenarios, other experimental methods can also be used to analyze and obtain the overall and local stiffness of the interbody fusion cage.

[0068] The process involves determining whether the stiffness parameters of the interbody fusion cage meet the preset stiffness requirements. If they do, the cage structure is selected as the target structure. If not, the structural parameters are adjusted. Finite element analysis is used to obtain the adjusted stiffness parameters. If these parameters meet the preset requirements, the cage structure is selected as the target structure. If not, the stiffness parameters are adjusted until they do meet the requirements. The structural parameters of the interbody fusion cage include the parameters of each arc-shaped member, which include at least one of the following: length, roundness, thickness, and number of arc-shaped members, and / or the spacing between adjacent arc-shaped members. Individual or multiple member parameters can be adjusted.

[0069] For example, users can change the vertical stiffness of a unit structure by altering its roundness, thereby changing the vertical stiffness of the interbody fusion cage, which comprises at least one unit structure. Specifically, the stiffness parameters of the interbody fusion cage can be altered by changing at least one of the roundness, length, thickness, number, and spacing of the curved rods in the unit structure. For example, the roundness and thickness of the interbody fusion cage can be changed simultaneously, or the number and thickness of the curved rods in each unit structure can be changed simultaneously, and so on. One structural parameter can be changed first, then another, or both simultaneously; there are no restrictions on this.

[0070] In this embodiment, the material properties of the interbody fusion cage are assumed to be Ti6Al4V, with an elastic modulus of 110 GPa and a Poisson's ratio of 0.3. The elastoplastic behavior of Ti6Al4V is obtained using the von Mises criterion. Without considering strain hardening, the vertical stress-vertical strain curve of the titanium alloy itself is as follows... Figure 7 As shown. Considering an initial yield stress of 300 MPa, the plastic strain hardening characteristics of titanium are obtained, while the elastic part is calculated using Hooke's law. The stress-strain curve of the titanium alloy considering strain hardening is shown below. Figure 8 As shown. In this embodiment, according to Figure 8 Finite element analysis was performed on the stress-strain relationship shown.

[0071] In one implementation scenario, the interbody fusion device structure is as follows: Figure 3 The unit structure is shown. After the interbody fusion cage structure design is completed, finite element analysis is performed on the corresponding interbody fusion cage to obtain its stiffness parameters. Please refer to [reference needed]. Figure 9 , Figure 9 This is a schematic diagram of a scenario analyzed using the finite element method provided by this invention. For example... Figure 9 As shown, two rigid plates are respectively placed on the upper and lower surfaces of the interbody fusion cage, with the lower rigid plate fixed and the vertical load applied to the upper rigid plate. According to... Figure 9 The boundary conditions shown are used for finite element compression simulation of the unit structure. The vertical stress is obtained by dividing the vertical reaction force obtained from the finite element analysis by the bottom area of ​​the initial unit structure. The vertical strain is obtained by dividing the vertical deformation obtained from the finite element analysis by the initial length of the curved rod. The initial length of the curved rod is the length of the curved rod when no vertical load is applied, that is, the length of the curved rod before deformation. Please refer to [reference needed]. Figure 10 , Figure 10 This is a schematic diagram of the vertical stress-strain curve when the intervertebral fusion cage is a unit structure. The stiffness parameters of the unit structure are obtained from the vertical stress-strain curve. For example, the vertical stiffness of the first structure, consisting of 8 members with a thickness of 2 mm, a roundness of 1.5 mm, and a length of 10.9 mm, is 300 MPa.

[0072] If based on Figure 10 If the stiffness parameters of the interbody fusion cage obtained from the vertical stress-vertical strain curve do not meet the preset stiffness requirements, the structural parameters of the unit structure will be adjusted. The structural parameters include the member parameters of each arc-shaped member, which include at least one of the following: length L, roundness e, thickness t, and / or the spacing between adjacent arc-shaped members. Please refer to [reference needed]. Figure 11 , Figure 11 This is a schematic diagram of an embodiment of the arc-shaped rod provided by the present invention.

[0073] In one implementation scenario, adjusting the roundness 'e' of the curved rod changes the stiffness parameters of the unit structure. Please refer to [reference needed]. Figure 12 and Figure 13 , Figure 12 This diagram illustrates the vertical stiffness-roundness relationship with different values ​​of the roundness e of the curved rod, while keeping other structural parameters of the unit structure constant. Figure 13 This is a schematic diagram of the vertical stress-strain curves for different values ​​of the roundness e of the curved rod, with other structural parameters of the unit structure remaining constant. Based on... Figure 12 and Figure 13 It is known that when the roundness 'e' of the curved rod increases while keeping other structural parameters (including the number, spacing, length, and thickness of the curved rods) constant, the overall vertical stiffness of the unit structure decreases. Therefore, users can change the vertical stiffness of the unit structure by altering the roundness, and thus change the vertical stiffness of the interbody fusion device, which includes at least one unit structure.

[0074] When users modify the length, roundness, and thickness of the curved rods, they can uniformly modify these rod parameters to change the overall stiffness of the interbody fusion cage with a unit structure. They can also modify the parameters of one or more curved rods individually to change the local stiffness of the interbody fusion cage with a unit structure. Modifying the structural parameters within the unit structure is relatively simple and easy to implement; users can adjust different structural parameters multiple times to ensure the stiffness parameters of the interbody fusion cage meet the requirements.

[0075] In another implementation scenario, the interbody fusion device structure is as follows: Figure 5 The structure shown has the same length, roundness, thickness, and number of arc-shaped rods in the three scaling units of the combined interbody fusion device. Therefore... Figure 5 The principle of the interbody fusion device shown can be simplified as follows: Figure 14 As shown. Figure 14 Each spring structure corresponds to Figure 5 Each layer of the scaling unit structure. The vertical forces transmitted from the upper and lower rigid plates to the interbody fusion cage structure will be distributed across these spring structures. After the interbody fusion cage structure is installed, finite element analysis is used to obtain... Figure 5 The stiffness parameters of the interbody fusion device corresponding to the structure shown are as follows.

[0076] Please refer to the following: Figure 15 , Figure 15 This is a schematic diagram of another scenario of finite element analysis provided by the present invention. (And...) Figure 9Similarly, two rigid plates are respectively placed on the upper and lower surfaces of the interbody fusion cage, with the lower rigid plate fixed and the vertical load applied to the upper rigid plate. According to... Figure 14 The boundary conditions shown are used in the finite element compression simulation of the element structure. Please refer to the following: Figure 16 , Figure 16 It is an intervertebral fusion device Figure 5 A schematic diagram of the vertical stress-vertical strain curve for the structure shown. The vertical stress-vertical strain curve yields... Figure 5 The stiffness parameters of the interbody fusion device shown are as follows: in this implementation scenario, the overall stiffness of the interbody fusion device in the vertical direction is 5.28 GPa.

[0077] If based on Figure 16 If the stiffness parameters of the interbody fusion cage obtained from the vertical stress-vertical strain curve do not meet the preset stiffness requirements, the structural parameters of the interbody fusion cage structure are adjusted. This can involve adjusting the structural parameters of one or more scaling unit structures that make up the interbody fusion cage structure, or it can involve adjusting the structural parameters of the entire interbody fusion cage structure. For example, the roundness and length of all the curved rods in the interbody fusion cage structure can be adjusted simultaneously to achieve overall stiffness adjustment of the entire interbody fusion cage. The thickness of the curved rods in a specific scaling unit structure can also be adjusted to achieve local stiffness adjustment in the corresponding area of ​​that scaling unit structure. Alternatively, the rod parameters of one or more curved rods can be modified individually to achieve local stiffness adjustment in the corresponding area of ​​that curved rod.

[0078] In one implementation scenario, the structural parameters of the interbody fusion cage also include the relative rotation angles between the various scaling unit structures and the spacing between adjacent scaling unit structures. Users can adjust the stiffness parameters of the interbody fusion cage by adjusting the rotation angle of at least one scaling unit structure in the horizontal plane. Please refer to [reference needed]. Figure 17 , Figure 17 This is a top view schematic diagram of the third embodiment of the interbody fusion device structure provided by the present invention. Figure 17 As shown, will Figure 5 The scaling unit structure in the middle layer of the interbody fusion cage structure shown can be rotated horizontally while keeping the axis unchanged. This rotation can simultaneously alter the overall stiffness of the interbody fusion cage and its horizontal stiffness, specifically the stiffness from the center to the edge. When the interbody fusion cage structure includes multiple scaling unit structures, the user can rotate one or more scaling units to ensure that the stiffness parameters of the resulting interbody fusion cage meet preset stiffness requirements. In other words... Figure 5The interbody fusion cage structure shown can adjust both vertical and horizontal stiffness, better meeting the actual needs of patients and reducing the difficulty and complexity of adjusting overall and local stiffness when designing an interbody fusion cage, thus improving design efficiency.

[0079] Users can also adjust the spacing between adjacent scaling unit structures, which changes the scaling ratio of at least one scaling unit. For example, enlarging the scaling unit structure located in the middle layer can simultaneously change the overall stiffness of the interbody fusion device and also change the horizontal stiffness of the interbody fusion device.

[0080] In yet another implementation scenario, the interbody fusion device is... Figure 6 The structure shown is identical in all three sleeved structures of the combined interbody fusion cage. Therefore... Figure 6 The principle of the interbody fusion device shown can be simplified as follows: Figure 18 As shown. Figure 18 Each spring structure corresponds to Figure 6 Each layer of the interbody fusion cage structure is nested within the spring system. The vertical forces transmitted from the upper and lower rigid plates to the interbody fusion cage structure are distributed across these spring structures. Once the interbody fusion cage structure is installed, finite element analysis is used to obtain... Figure 6 The stiffness parameters of the interbody fusion device corresponding to the structure shown are as follows.

[0081] Please refer to the following: Figure 19 , Figure 19 It is an intervertebral fusion device Figure 6 A schematic diagram of the vertical stress-vertical strain curve for the structure shown. The vertical stress-vertical strain curve yields... Figure 6 The stiffness parameters of the interbody fusion device shown are as follows: in this implementation scenario, the overall stiffness of the interbody fusion device in the vertical direction is 2.2 GPa.

[0082] If based on Figure 19 If the stiffness parameters of the interbody fusion cage obtained from the vertical stress-vertical strain curve do not meet the preset stiffness requirements, the structural parameters of the interbody fusion cage structure are adjusted. This can involve adjusting the structural parameters of one or more nested structures that make up the interbody fusion cage structure, adjusting the structural parameters of one or more scaling unit structures within a nested structure, or adjusting the structural parameters of the entire interbody fusion cage structure. For example, the roundness and length of all curved rods in the interbody fusion cage structure can be adjusted simultaneously to achieve overall stiffness adjustment of the entire interbody fusion cage. The thickness of a curved rod in a particular nested structure can also be adjusted to achieve local stiffness adjustment in the corresponding area of ​​the nested structure. Alternatively, the rod parameters of one or more curved rods can be modified individually to achieve local stiffness adjustment in the area corresponding to that curved rod.

[0083] In one implementation scenario, when adjusting the structural parameters of one or more scaling unit structures within a nested structure, the horizontal and vertical stiffness of the interbody fusion cage can be adjusted by adjusting the rotation angle of one or more scaling unit structures in the horizontal plane and / or adjusting the spacing between at least one set of adjacent scaling units. In other words... Figure 6 The interbody fusion cage structure shown can simultaneously adjust the stiffness in both the vertical and horizontal directions, which can better meet the actual needs of patients and reduce the difficulty and complexity of adjusting the overall and local stiffness when designing an interbody fusion cage, thereby improving design efficiency.

[0084] In this embodiment, preset stiffness requirements are customized according to the individual needs of the target patient. Medical imaging data of the target patient is acquired, and reference intervertebral parameters for the region of interest (ROI) are obtained based on the medical imaging data. The ROI includes the implantation site and its adjacent area. Reference intervertebral parameters include reference bone mineral density, reference intervertebral space, reference height, and reference width. Preset stiffness requirements are then obtained based on these reference intervertebral parameters. Please refer to the relevant documentation. Figure 20 and Figure 21 , Figure 20 This is a schematic diagram of an embodiment of medical imaging data for the entire endplate area provided by the present invention. Figure 21 This is a schematic diagram of an embodiment of medical imaging data in the central region of the endplate provided by the present invention.

[0085] The target patient's region of interest (ROI) is identified. This ROI includes the area where the target interbody fusion device will be implanted, i.e., the region adjacent to the implantation site, such as several vertebral bodies and / or muscle and adipose tissue adjacent to the implantation site. Medical imaging data of the target patient is acquired using medical imaging equipment. In this implementation scenario, computed tomography (CT) is used to acquire the medical imaging data. In other implementation scenarios, other medical imaging methods can also be used to acquire the medical imaging data. The endplate bone mineral density (BMD) value of at least one of the adjacent endplates above and below the ROI is obtained. The BMD value can be obtained via CT. The adjacent endplates are the inferior endplate of the vertebral body above the target interbody fusion device and the superior endplate of the vertebral body below the target interbody fusion device after implantation. Furthermore, the BMD value of the endplates can be obtained by combining the density of muscle and fat in the medical imaging data. A preset stiffness requirement is determined based on the BMD value of at least one of the adjacent endplates above and below the ROI.

[0086] In other implementation scenarios, the outer shell shape of the interbody fusion cage is obtained based on medical imaging data. An outer shell structure is then generated based on this shape and the overall structure of the interbody fusion cage, and finally, this outer shell structure is fitted over the interbody fusion cage. Alternatively, a separate outer shell structure can be generated based on the outer shell shape, and then this shell is used to create the outer shell before being fitted over the interbody fusion cage. Using an outer shell structure provides better protection for the interbody fusion cage and better meets the actual needs of the patient.

[0087] In this embodiment, after determining that the stiffness parameters of the interbody fusion cage generated from the interbody fusion cage structure meet the preset stiffness requirements, a manufacturing file is generated based on the interbody fusion cage structure. This manufacturing file is then imported into additive manufacturing software, and the interbody fusion cage is generated through additive manufacturing. Specifically, the target interbody fusion cage structure can be saved as a CAD (Computer-Aided Design) file (e.g., STP, STL, etc.). The CAD file is imported into the additive manufacturing software for pre-manufacturing processing. During the pre-printing pre-processing stage, layer division is performed, and the layer thickness is adjusted according to the actual manufacturing material used. The CAD file with completed layer processing is then submitted to the manufacturing equipment.

[0088] In this implementation scenario, the target interbody fusion cage is manufactured using titanium alloy (such as Ti6Al4V) or tantalum (Ta) powder, prepared by selective laser sintering (SLM) or electron beam melting (EBM). In other implementation scenarios, non-metallic materials such as silicon nitride or polyetheretherketone (PEEK) can also be used to manufacture the target interbody fusion cage, employing fused deposition modeling (FDM). Please refer to [reference needed]. Figure 22 , Figure 22 This is a schematic diagram of an embodiment of the interbody fusion device provided by the present invention.

[0089] As described above, in this embodiment, one end of each arc-shaped rod is connected to the top frame, and the other end is connected to the bottom frame. When designing the interbody fusion cage structure, the stiffness parameters of the interbody fusion cage can be effectively and quickly adjusted by changing the rod parameters of the arc-shaped rod. When designing interbody fusion cages for different patients, only the structural parameters of the same interbody fusion cage structure can be modified. Finite element analysis can be used to ensure that the interbody fusion cage generated by the modified interbody fusion cage structure matches the patient's needs, effectively reducing the workload of modifying and adjusting the interbody fusion cage and improving the design efficiency of the interbody fusion cage.

[0090] Please see Figure 23 , Figure 23 This is a schematic diagram of an embodiment of the intelligent manufacturing equipment provided by the present invention. The intelligent manufacturing equipment 10 includes a processor 11 and a memory 12. The processor 11 is coupled to the memory 12. The memory 12 stores a computer program, which the processor 11 executes during operation to achieve the following: Figure 1 The method is shown above. For detailed instructions, please refer to the above; they will not be repeated here.

[0091] The specific technical details of the design method of the intervertebral fusion device implemented by the aforementioned intelligent manufacturing equipment 10 when executing the computer program have been discussed in detail in the aforementioned method steps, and therefore will not be repeated here.

[0092] Please see Figure 24 , Figure 24 This is a schematic diagram of an embodiment of the storage medium provided by the present invention. The storage medium 20 stores at least one computer program 21, which is executed by a processor to achieve, for example... Figure 1 The method shown is detailed above and will not be repeated here. In one embodiment, the computer-readable storage medium 20 can be a storage chip in a terminal, a hard disk, or other readable and writable storage tools such as a portable hard disk, USB flash drive, or optical disc, or it can be a server, etc.

[0093] The specific technical details of the design method of the interbody fusion device implemented when the above-mentioned computer program 21 is executed have been discussed in detail in the aforementioned method steps, and therefore will not be repeated here.

[0094] Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. The program can be stored in a non-volatile computer-readable storage medium, and when executed, it can include the processes of the embodiments of the above methods. Any references to memory, storage, databases, or other media used in the embodiments provided in this application can include non-volatile and / or volatile memory. Non-volatile memory can include read-only memory (ROM), programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or flash memory. Volatile memory can include random access memory (RAM) or external cache memory. By way of illustration and not limitation, RAM is available in various forms, such as static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), dual data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous link DRAM (SLDRAM), RAMbus direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and RAMbus dynamic RAM (RDRAM), etc.

[0095] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0096] The above embodiments merely illustrate several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of this patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A design method for an interbody fusion device, characterized in that, include: Set a top frame and a bottom frame, and set at least one pair of arc-shaped rods along the edges of the top frame and the bottom frame. One end of each arc-shaped rod is connected to the top frame and the other end is connected to the bottom frame. Connect the two ends of each pair of arc-shaped rods with two long rods to generate a unit line frame. The thickness of the unit wireframe is obtained, a unit structure is generated, and at least one of the unit structures is combined such that the axes of the at least one unit structure are on the same straight line to generate an intervertebral fusion device structure. The structural parameters of the intervertebral fusion device are adjusted so that the stiffness parameters of the intervertebral fusion device generated based on the intervertebral fusion device structure meet the preset stiffness requirements. The structural parameters include the member parameters of each of the arc-shaped rods, and the member parameters include at least one of the length, roundness, thickness, and number of the arc-shaped rods and / or the spacing between adjacent arc-shaped rods.

2. The design method of the interbody fusion device according to claim 1, characterized in that, The step of combining at least one of the unit structures such that the axes of the at least one unit structure are on the same straight line includes: The unit structure is scaled horizontally to generate multiple scaled unit structures with different horizontal dimensions but the same vertical height. The multiple scaled unit structures are then nested in ascending order, with their axes aligned on the same straight line, to generate a nested structure. This nested structure serves as the intervertebral fusion device structure.

3. The design method of the interbody fusion device according to claim 2, characterized in that, The step of adjusting the structural parameters of the interbody fusion device includes: Adjust the rotation angle of at least one of the scaling unit structures in the horizontal plane; and / or Adjust the spacing between at least one group of adjacent scaling units.

4. The design method of the interbody fusion device according to claim 2, characterized in that, The step of combining at least one of the unit structures such that the axes of the at least one unit structure are on the same straight line includes: At least two of the scaling unit structures or the unit structures or the nesting structures are stacked, and the axes of the multiple scaling unit structures or the multiple unit structures are located on the same straight line to generate a stacked structure, which is used as the intervertebral fusion device structure.

5. The design method of the interbody fusion device according to claim 1, characterized in that, Before the step of adjusting the structural parameters of each of the arc-shaped rods so that the stiffness parameters of the interbody fusion cage generated according to the structure of the interbody fusion cage meet the preset stiffness requirements, the following steps are included: Acquire medical imaging data of the target patient, and obtain reference intervertebral parameters of the region of interest based on the medical imaging data. The region of interest includes the implantation site and its adjacent area. The preset stiffness requirement is obtained based on the reference intervertebral parameters.

6. The design method of the interbody fusion device according to claim 5, characterized in that, Following the step of acquiring the target patient's medical imaging data, the following steps are included: The outer shell shape of the interbody fusion device structure is obtained based on the medical imaging data. The outer shell structure is generated according to the shape of the outer shell and the structure of the intervertebral fusion device, and the outer shell structure is fitted around the outer periphery of the intervertebral fusion device structure.

7. The design method of the interbody fusion device according to claim 1, characterized in that, After the step of adjusting the structural parameters of each of the arc-shaped bars, the following steps are included: A manufacturing file is generated based on the structure of the intervertebral fusion device, and the manufacturing file is imported into additive manufacturing software to generate the intervertebral fusion device through additive manufacturing.

8. An interbody fusion device, characterized in that, The interbody fusion device is manufactured by the method of any one of claims 1-7, and includes at least one unit structure, wherein the axes of the at least one unit structure are located on the same straight line, and the unit structure includes: Top frame and bottom frame; At least one pair of arc-shaped rods are provided along the edges of the top frame and the bottom frame, with one end of each arc-shaped rod connected to the top frame and the other end connected to the bottom frame; Each pair of arc-shaped rods is connected at both ends by two long rods.

9. A storage medium storing a computer program, which, when executed by a processor, causes the processor to perform the steps of the method as claimed in any one of claims 1 to 7.

10. A smart manufacturing device, comprising a memory and a processor, the memory storing a computer program that, when executed by the processor, causes the processor to perform the steps of the method as described in any one of claims 1 to 7.

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