WO2023165071A1 - Interbody fusion cage, manufacturing method and system therefor, intelligent manufacturing device, and medium - Google Patents

Abstract

Provided are an interbody fusion cage, a manufacturing method and system therefor, an intelligent manufacturing device, and a medium. The manufacturing method for the interbody fusion cage comprises: acquiring medical image data for a target patient, and acquiring, according to the medical image data, a reference bone mineral density value of a region of interest, the region of interest comprising a position at which implantation is to be performed and an adjacent region thereof; acquiring, according to the reference bone mineral density value, a reference Young's modulus, and acquiring a target porosity matched with the reference Young's modulus; and acquiring, according to the medical image data, interbody fusion cage size information, generating, according to the interbody fusion cage size information and the target porosity, a target interbody fusion cage structure, the target interbody fusion cage structure comprising a porous skeleton structure with the target porosity, and generating, according to the target interbody fusion cage structure, the target interbody fusion cage. The interbody fusion cage prepared by the manufacturing method has better biomechanical matching performance, and can accelerate fusion while reducing the risk of stress deformation of the vertebral body.

Description

Intervertebral fusion device and its manufacturing method, system, intelligent manufacturing equipment and medium technical field

The invention relates to the field of biomedicine, in particular to an intervertebral fusion device and its manufacturing method, system, intelligent manufacturing equipment and media.

Background technique

Since the intervertebral fusion device was used for spinal fusion and achieved success, the intervertebral fusion device has been widely used clinically and relieved pain for many patients. But present intervertebral fusion device is mass-produced by manufacturer according to fixed model and size, and its shape, size are fixed. However, the structure, size, and bone density of each patient's intervertebral disc and adjacent upper and lower endplates are different, and the surgically implanted intervertebral fusion device cannot perfectly meet the needs of the patient.

technical problem

The technical problem to be solved by the present invention is that the intervertebral fusion device cannot perfectly meet the needs of patients. Aiming at the above-mentioned defects in the prior art, an intervertebral fusion device and its manufacturing method, system, intelligent manufacturing equipment and medium are provided, which have more advantages Good biomechanical matching performance can speed up fusion while reducing the risk of vertebral body stress deformation.

technical solution

The technical solution adopted by the present invention to solve the technical problem is to provide a manufacturing method of an intervertebral fusion device, comprising:

Obtain medical image data of the target patient, and obtain reference bone density values of the region of interest according to the medical image data, where the region of interest includes the position to be implanted and its adjacent region.

Obtaining a reference Young's modulus according to the reference bone density value, obtaining a target porosity matching the reference Young's modulus, and generating a porous skeleton structure with the target porosity.

Acquire the size information of the intervertebral fusion device according to the medical image data, adjust the edge of the porous skeleton structure according to the size information of the intervertebral fusion device, and generate a target intervertebral fusion device structure, according to the target intervertebral fusion device structure Generate the target intervertebral fusion cage.

Wherein, the step of obtaining the target porosity matched with the reference Young's modulus includes.

The target porosity is obtained according to the following formula.

Wherein, E represents the reference Young's modulus, Esolid represents the Young's modulus of the structure itself when no hole exists, Porosity represents the target porosity, and a and b are constants.

Wherein, the step of generating the target intervertebral fusion cage structure according to the size information of the intervertebral fusion cage and the target porosity includes.

generating the porous framework structure according to the target porosity, and performing edge adjustment on the porous framework structure according to the fusion size information to generate the target intervertebral cage structure; or.

Using the size information of the intervertebral cage as the limit range generated by the porous skeleton structure, generating a porous skeleton structure satisfying the limit range, and using the porous skeleton structure satisfying the limit range as the target intervertebral fusion device structure.

Wherein, the step of generating the porous framework structure with the target porosity includes.

A three-dimensional polycrystalline structure with the target porosity is generated by a method for generating a polyhedral unit structure, and a boundary line of the three-dimensional polycrystalline structure is geometrically thickened to obtain the porous skeleton structure.

Wherein, the step of performing edge adjustment on the porous skeleton structure according to the size information of the intervertebral fusion cage to generate a target intervertebral fusion cage structure includes.

An intervertebral fusion frame that meets clinical needs is generated according to the size information of the intervertebral fusion.

The porous skeleton structure and the frame of the intervertebral cage are fused into the target intervertebral cage structure through Boolean operations.

Wherein, the step of acquiring size information of the intervertebral cage according to the medical image data includes.

The height information and length information of the area to be implanted are obtained according to the medical image data, and the size information of the intervertebral cage is obtained according to the height information and the length information.

After the step of generating the frame of the intervertebral fusion device that satisfies the size information of the intervertebral fusion device, it includes.

Obtain angle information of upper and lower adjacent endplates of the area to be implanted according to the medical image data, and obtain the gap and relative angle between frames of the intervertebral cage according to the height information and the angle information.

Wherein, the step of generating the target intervertebral fusion device according to the structure of the target intervertebral fusion device includes.

The manufacturing file is generated according to the structure of the target intervertebral fusion device, and the manufacturing file is imported into additive manufacturing software to generate the target intervertebral fusion device through additive manufacturing.

The technical solution adopted by the present invention to solve the technical problem is to provide a manufacturing system of an intervertebral fusion device, comprising:

An acquisition module, configured to acquire medical image data of a target patient, and acquire a reference bone density value of the region of interest according to the medical image data, where the region of interest includes the position to be implanted and its adjacent region.

A structure module, configured to obtain a reference Young's modulus according to the reference bone density value, obtain a target porosity matching the reference Young's modulus, and generate a porous skeleton structure with the target porosity.

The generation module is used to obtain the size information of the intervertebral fusion device according to the medical image data, and adjust the edge of the porous skeleton structure according to the size information of the intervertebral fusion device to generate a target intervertebral fusion device structure. The interbody cage structure creates the target interbody cage.

The technical solution adopted by the present invention to solve the technical problem is to provide an intervertebral fusion device, which includes a porous skeleton structure, and the intervertebral fusion device is manufactured and obtained through the above-mentioned method.

The technical solution adopted by the present invention to solve the technical problem is: to provide a storage medium storing a computer program, and when the computer program is executed by a processor, the processor executes the steps of the above-mentioned method.

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

Beneficial effect

The beneficial effect of the present invention is that, compared with the prior art, the present invention acquires the reference bone density value including the target patient's region of interest (including the position to be implanted and its adjacent area), and obtains the reference bone density value according to the reference bone density value. Young's modulus, obtaining a target porosity matched with the reference Young's modulus, generating a porous skeleton structure with the target porosity, obtaining size information of the intervertebral cage according to the medical image data, and generating the Fusing the target intervertebral fusion device structure matched with the size information, generating the target intervertebral fusion device according to the target intervertebral fusion device structure, so that the target intervertebral fusion device matches the target patient and has better biomechanical matching performance. Referring to the microstructure of the target patient's human bone, it is beneficial to the osteogenesis process, which can speed up the fusion and reduce the risk of vertebral deformation under stress.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention. Those skilled in the art can also obtain other drawings based on these drawings without creative work.

in.

Fig. 1 is a schematic flowchart of the first embodiment of the manufacturing method of the intervertebral fusion device provided by the present invention.

FIG. 2 is a schematic diagram of an embodiment of medical image data of a viewing angle provided by the present invention.

Fig. 3 is a schematic diagram of an embodiment of medical image data of another perspective provided by the present invention.

Fig. 4 is a schematic diagram of an embodiment of medical image data from another perspective provided by the present invention.

Fig. 5 is a schematic structural view of an embodiment of the porous skeleton structure provided by the present invention.

Fig. 6a is a schematic structural view of the first embodiment of the target intervertebral fusion device provided by the present invention.

Fig. 6b is a schematic structural diagram of the second embodiment of the target intervertebral fusion device provided by the present invention.

Fig. 6c is a schematic structural diagram of a third embodiment of the target intervertebral fusion device provided by the present invention.

Fig. 6d is a schematic structural view of the fourth embodiment of the target intervertebral fusion device provided by the present invention.

Fig. 7 is a schematic flowchart of the second embodiment of the manufacturing method of the intervertebral fusion device provided by the present invention.

FIG. 8 is a schematic diagram of the first structure of the Voronoi three-dimensional polycrystal division method provided by the present invention.

FIG. 9 is a schematic diagram of the second structure of the Voronoi three-dimensional polycrystal division method and division method provided by the present invention.

FIG. 10 is a schematic diagram of the third structure of the Voronoi three-dimensional polycrystal division method provided by the present invention.

FIG. 11 is a structural schematic diagram of an embodiment of a three-dimensional polycrystalline structure divided by a Voronoi three-dimensional polycrystal division method provided by the present invention.

Fig. 12 is a schematic structural diagram of an embodiment of the three-dimensional polycrystalline structure provided by the present invention.

FIG. 13 is a schematic structural diagram of an embodiment of a porous skeleton structure generated from the three-dimensional polycrystalline structure in FIG. 12 .

Fig. 14 is a schematic structural view of the lower frame of the intervertebral fusion device provided by the present invention.

Fig. 15 is a schematic structural view of an embodiment of the intervertebral cage frame provided by the present invention.

Fig. 16 is a structural schematic diagram of another embodiment of the target intervertebral cage structure provided by the present invention.

Fig. 17 is a structural schematic diagram of another embodiment of the target intervertebral cage structure provided by the present invention.

Fig. 18 is a structural schematic diagram of an embodiment of the manufacturing system of the intervertebral fusion provided by the present invention.

Fig. 19 is a schematic structural diagram of an embodiment of an intelligent manufacturing device provided by the present invention.

Fig. 20 is a schematic structural diagram of an embodiment of a storage medium provided by the present invention.

BEST MODE FOR CARRYING OUT THE INVENTION

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

Please refer to FIG. 1 in conjunction with FIG. 1 . FIG. 1 is a schematic flowchart of a first embodiment of a manufacturing method of an intervertebral fusion device provided by the present invention. The manufacturing method of the intervertebral fusion device provided by the present invention includes the following steps.

S101: Obtain medical image data of a target patient, and obtain a reference bone density value of a region of interest according to the medical image data, where the region of interest includes a location to be implanted and its adjacent regions.

In a specific implementation scenario, the region of interest of the target patient is obtained, and the region of interest includes the region where the target intervertebral fusion device is implanted, that is, the region adjacent to the position to be implanted, for example, including several nodes adjacent to the position to be implanted Vertebrae and/or muscle, adipose tissue, etc. Use medical imaging equipment to obtain the medical image data of the target patient. In this implementation scenario, computed tomography technology (computed tomography, CT) to obtain medical imaging data, and in other implementation scenarios, medical imaging data can also be obtained through other medical imaging methods. Please refer to FIG. 2-FIG. 4 in combination. FIG. 2 is a schematic diagram of an embodiment of medical image data of one viewing angle provided by the present invention, and FIG. 3 is a schematic diagram of an embodiment of medical image data of another viewing angle provided by the present invention. Fig. 4 is a schematic diagram of an embodiment of medical image data from another perspective provided by the present invention. As shown in FIGS. 2-4 , the circled area is the area of interest.

Obtain the endplate bone density value of at least one of the upper and lower adjacent endplates in the region of interest. The endplate bone density value can be obtained by CT. The upper and lower adjacent endplates are the target intervertebral fusion device after implantation The inferior endplate of the adjacent superior vertebra and the superior endplate of the inferior vertebra adjacent to the target intervertebral cage. Further, the bone density value of the end plate can be obtained in combination with the density of muscle and fat in the medical image data. In this implementation scenario, the average value of the bone density values of the upper and lower endplates (for example, either the arithmetic mean value or the weighted average value) is obtained as a reference bone density value. In other implementation scenarios, the upper The bone density value of the endplate or the lower endplate was used as the reference bone density value.

S102: Obtain a reference Young's modulus according to the reference bone density value, and obtain a target porosity matching the reference Young's modulus.

In a specific implementation scenario, the reference Young's modulus is obtained according to the reference bone density value, and the Young's modulus is a physical quantity describing the ability of a solid material to resist deformation, also called tensile modulus. In this implementation scenario, the reference Young's modulus-bone density relationship obtained by mechanical testing in the references is as follows.

Among them, E is the reference Young's modulus, and BMD is the reference bone density value.

The target porosity is exponentially related to the reference Young's modulus, and the target porosity matching the reference Young's modulus can be obtained according to the reference Young's modulus. For example, the target porosity is calculated according to the following formula.

Among them, E represents the reference Young's modulus, Esolid represents the Young's modulus of the structure itself when no pores exist, Porosity represents the target porosity, and a and b are constants.

S103: Obtain the size information of the intervertebral fusion device according to the medical image data, and generate the target intervertebral fusion device structure according to the size information of the intervertebral fusion device and the target porosity, the target intervertebral fusion device structure includes a porous skeleton structure with the target porosity, according to The target interbody cage structure generates the target interbody cage.

In a specific implementation scenario, the target intervertebral fusion needs to be implanted at the position to be implanted, so its outline needs to match and fit with the position to be implanted and the upper and lower adjacent endplates before it can be implanted. Finally, it has a very good stability and support effect. The size information of the intervertebral cage is obtained according to the medical image data (for example, any one or more of Fig. 2-Fig. 4). The size information of the intervertebral fusion cage includes the shape, structure, radian, etc. of each surface of the target intervertebral fusion cage, and the included angle between the various surfaces of the target intervertebral fusion cage, and the like.

Generate the target intervertebral fusion cage structure according to the size information of the intervertebral fusion cage and the target porosity. It can use the size information of the intervertebral fusion cage as the limit range generated by the porous skeleton structure, and generate a porous skeleton structure that meets the limit range, which will meet the limit range The porous skeleton structure is used as the target intervertebral fusion cage structure. It is also possible to first generate a porous skeleton structure according to the target porosity, and then adjust the edge of the porous skeleton structure according to the fusion size information to generate the target intervertebral cage structure.

Please refer to FIG. 5 in conjunction with FIG. 5 , which is a structural schematic diagram of an embodiment of the porous skeleton structure provided by the present invention. As shown in FIG. 5 are porous framework structures with different target porosity, the porous framework structure on the left has a higher target porosity, and the porous framework structure on the right has a lower target porosity.

In this implementation scenario, the porous skeleton structure is a cube structure as shown in FIG. 5 , and the edges of the porous skeleton structure are adjusted according to the size information of the intervertebral cage, for example, the porous skeleton structure is cut to generate the target intervertebral cage structure. A target intervertebral cage is generated according to the target intervertebral cage structure. For example, the manufacturing file is generated according to the structure of the target intervertebral fusion device, and the manufacturing file is imported into the additive manufacturing software to generate the target intervertebral fusion device through additive manufacturing. Please refer to Fig. 6a-Fig. 6d together, Fig. 6a-Fig. 6d are structural schematic diagrams of different embodiments of the target intervertebral cage structure provided by the present invention.

In other implementation scenarios, the size information of the intervertebral cage can be used as the limit range for generating the porous skeleton structure, and the target intervertebral cage structure shown in Figs. 6a-6d can be directly generated.

Specifically, the target intervertebral cage structure can be saved as CAD (Computer Aided Design, computer-aided design) files (such as STP, STL, etc.), import CAD files into additive manufacturing software for pre-manufacturing processing; in the pre-processing stage before printing, perform layered division processing, and adjust according to the actual manufacturing materials used For layer thickness, the CAD file with layered processing will be submitted to the manufacturing equipment.

In this implementation scenario, the material for manufacturing the target intervertebral fusion cage is titanium alloy (such as Ti6Al4V) or tantalum metal (Ta) powder, and its preparation method is Selective Laser Melting (Selective Laser Melting, SLM) or Electron Beam Melting (Electron Beam Melting). Melting, EBM). In other implementation scenarios, it is also possible to use non-metallic materials such as silicon nitride (silicon nitride) or polyetheretherketone (PEEK) to manufacture the target intervertebral fusion cage, and Fused Deposition Molding (Fused Deposition Molding) can be used. Filament Modeling) to manufacture.

In an implementation scenario, the target intervertebral fusion cage is manufactured using Ti6Al4V powder of the SLM process. The reference range of the process parameters is: laser power 200~400kw, scanning speed 800~1500mm/s, and powder particles 15~55 micrometers.

In other implementation scenarios, after the target intervertebral fusion is acquired, post-processing, such as surface treatment, is performed on the target intervertebral fusion. Taking the polyether ether ketone intervertebral fusion cage as an example, the surface treatment process used is hydroxyapatite coating (hydroxyapatite coating, HA coating).

It can be seen from the above description that in this embodiment, the reference bone density value including the region of interest of the target patient is obtained, the reference Young's modulus is obtained according to the reference bone density value, and the target porosity matching the reference Young's modulus is obtained. The size information of the intervertebral cage and the target porosity generate the target intervertebral cage structure, and the target intervertebral cage is generated according to the target intervertebral cage structure, so that the target intervertebral cage matches the target patient and has better biomechanical matching performance , whose structure refers to the microstructure of human bone in the target patient, which is conducive to the osteogenesis process, can speed up fusion and reduce the risk of vertebral deformation under stress.

Please refer to FIG. 7 in conjunction with FIG. 7 . FIG. 7 is a schematic flowchart of a second embodiment of the manufacturing method of the intervertebral fusion device provided by the present invention. The manufacturing method of the intervertebral fusion device provided by the present invention includes the following steps.

S201: Obtain medical image data of a target patient, and obtain reference bone density values of a region of interest according to the medical image data, where the region of interest includes a location to be implanted and its adjacent regions.

S202: Obtain a reference Young's modulus according to the reference bone density value, and obtain a target porosity matching the reference Young's modulus.

In a specific implementation scenario, steps S201-S202 are basically the same as the corresponding content in steps S101-S102 in the first embodiment of the method for manufacturing an intervertebral cage provided by the present invention, and will not be repeated here.

S203: Generate a three-dimensional polycrystalline structure with a target porosity by using a polyhedron unit structure generation method, and perform geometric thickening processing on boundary lines of the three-dimensional polycrystalline structure to obtain a porous skeleton structure.

In a specific implementation scenario, the polyhedral unit structure generation technique provides a control theory for the number of units and the unit size of the target polyhedral unit structure in a specific space. In an implementation scenario, the polyhedral unit structure generation technology generates a three-dimensional polycrystalline structure with a target porosity by means of Voronoi (controllable Vorowian) three-dimensional polycrystalline division.

In a specific implementation scenario, the polyhedral unit structure generation technique provides a control theory for the number of units and the unit size of the target polyhedral unit structure in a specific space. In an implementation scenario, the polyhedral unit structure generation technology generates a three-dimensional polycrystalline structure with a target porosity by means of Voronoi (controllable Vorowian) three-dimensional polycrystalline division.

Please refer to Fig. 8-Fig. 11 in combination, Fig. 8 is the first schematic structural diagram of the Voronoi three-dimensional polycrystal division mode division mode provided by the present invention, and Fig. 9 is the second of the Voronoi three-dimensional polycrystal division mode division mode provided by the present invention Schematic diagram of the structure, Fig. 10 is a third structural schematic diagram of the Voronoi three-dimensional polycrystal division method provided by the present invention, and Fig. 11 is a three-dimensional polycrystal structure of the division method of the Voronoi three-dimensional polycrystal division method provided by the present invention Schematic diagram of the structure of the embodiment.

According to Figures 8-11, in this implementation scenario, a cube is used as an example for illustration. First, obtain the boundary range of the three-dimensional polycrystal structure and the number of polycrystals. The boundary range of the structure can be obtained based on experience, or the volume of the target patient's region of interest. It can also be obtained according to the size information of the intervertebral fusion cage. The number of polycrystals can be obtained according to the target porosity. The first structure shown in FIG. 8 can be generated by uniformly dividing the boundary range of the structure according to the number of polycrystals, and obtaining the core origin of each divided crystal. All core origins divide the core random point search range to generate the second structure shown in FIG. 9 . Afterwards, a unique core random point is found within the search range for each random point, and the third structure shown in FIG. 10 can be generated. The 3D polycrystalline structure shown in Fig. 11 can be obtained by taking the core random point as the core point of the polycrystal partition to carry out the Volovii partition.

Please refer to Figure 12 and Figure 13 in combination, Figure 12 is a schematic structural diagram of an embodiment of a three-dimensional polycrystalline structure provided by the present invention, and Figure 13 is a structural schematic diagram of an embodiment of a porous skeleton structure generated by the three-dimensional polycrystalline structure of Figure 12 . In this embodiment, the boundary line of the three-dimensional polycrystalline structure is geometrically thickened, so that the three-dimensional polycrystalline structure is transformed into a porous skeleton structure in a porous shape. In an implementation scenario, the target porosity is achieved by changing the thickness of the pore skeleton by using geometric parameters without changing the number of pores in the three-dimensional polycrystalline structure, or by changing the size of the pores itself to adjust the porosity to achieve the target porosity. In this implementation scenario, after obtaining the porous skeleton structure, the code representation of the porous skeleton structure is obtained through a software programming algorithm.

S204: Obtain the size information of the intervertebral fusion device according to the medical image data, and generate the frame of the intervertebral fusion device that meets the clinical needs according to the size information of the intervertebral fusion device; fuse the porous skeleton structure and the frame of the intervertebral fusion device into the target vertebral body through Boolean operations fuser structure.

In a specific implementation scenario, the size information of the intervertebral fusion cage is obtained according to the medical image data. Fusion Dimensions Information. Combined with the actual clinical needs to generate the frame of the intervertebral fusion cage. Please refer to FIG. 14 in conjunction with FIG. 14 , which is a schematic structural view of one side frame of the intervertebral fusion device provided by the present invention. Obtain the angle information of the upper and lower adjacent endplates of the region of interest according to the medical image data, and obtain the gap and relative angle between the frames of the intervertebral fusion cage according to the height information and angle information. According to the actual clinical needs, further adjust the gap and relative angle between the frames of the intervertebral fusion device. Please refer to FIG. 15 in conjunction with FIG. 15 , which is a schematic structural view of an embodiment of the frame of the intervertebral cage provided by the present invention. The porous skeleton structure obtained in the above steps and the frame of the intervertebral cage with adjusted gaps and relative angles are fused through Boolean operations. The porous skeleton structure only retains the gap range between the frames of the intervertebral cage, and the obtained results can be further analyzed. Processing is performed so that the multi-porous skeleton structure fills the frame body of the intervertebral fusion cage, so as to obtain the target intervertebral fusion cage structure. Please refer to FIG. 16 in conjunction with FIG. 16 , which is a structural schematic view of another embodiment of the target intervertebral cage structure provided by the present invention.

In this implementation scenario, the frame of the intervertebral fusion device is the frame on both sides of the upper and lower sides. In other implementation scenarios, the frame of the intervertebral fusion device includes the frames of each surface (for example, the upper, lower, inner and outer sides) of the target intervertebral fusion device. Please refer to FIG. 17 in conjunction with FIG. 17 . FIG. 17 is a structural schematic diagram of another embodiment of the target intervertebral cage structure provided by the present invention. The target intervertebral cage structure shown in Fig. 17 has upper and lower frames and outer side frames.

S205: Generate the target intervertebral fusion device according to the structure of the target intervertebral fusion device.

In a specific implementation scenario, step S205 is basically the same as the corresponding part in step S03 in the first embodiment of the method for manufacturing an intervertebral cage provided by the present invention, and will not be repeated here.

It can be seen from the above description that in this embodiment, the size information of the intervertebral cage is obtained according to the height information and length information of the position to be implanted according to the medical image data, and the upper and lower adjacent endplate angles of the region of interest obtained according to the medical image data The information acquires the gap and relative angle between the frames of the intervertebral fusion, and fuses the porous skeleton structure and the frame of the intervertebral fusion into the target intervertebral fusion structure through Boolean operations, which can make the structure of the target intervertebral fusion more suitable for the target patient It has better biomechanical matching performance, and its structure refers to the microstructure of human bone in the target patient, which is conducive to the osteogenesis process, can speed up fusion and reduce the risk of vertebral body stress deformation.

Please refer to FIG. 18 . FIG. 18 is a schematic structural diagram of an embodiment of a manufacturing system for an intervertebral fusion device provided by the present invention. The manufacturing system 10 of the intervertebral fusion includes: an acquisition module 11 , a structure module 12 and a generation module.

The acquiring module 11 is used to acquire medical image data of a target patient, and acquire reference bone density values of a region of interest according to the medical image data, and the region of interest includes the position to be implanted and its adjacent regions. The structure module 12 is used to obtain the reference Young's modulus according to the reference bone density value. The generation module 13 is used to obtain the size information of the intervertebral fusion device according to the medical image data, and generate the target intervertebral fusion device structure according to the size information of the intervertebral fusion device and the target porosity, and the target intervertebral fusion device structure includes a porous skeleton with a target porosity structure, generate the target intervertebral fusion cage according to the target intervertebral fusion cage structure.

The acquiring module 11 is further configured to acquire the endplate bone density value of at least one of the upper and lower adjacent endplates of the region of interest, and calculate a reference bone density value according to the endplate bone density value.

The structure module 12 is also used to obtain the target porosity according to the following formula.

Among them, E represents the reference Young's modulus, Esolid represents the Young's modulus of the structure itself when no pores exist, Porosity represents the target porosity, and a and b are constants.

The generation module 13 is also used to generate the porous skeleton structure according to the target porosity, and adjusts the edge of the porous skeleton structure according to the fusion size information to generate the target intervertebral cage structure; the generation module 13 is also used to use the intervertebral fusion cage size information as a porous The limit range of skeleton structure generation, generate a porous skeleton structure that meets the limit range, and use the porous skeleton structure that meets the limit range as the target intervertebral cage structure.

The structure module 12 is also used to generate a three-dimensional polycrystalline structure with a target porosity through a polyhedron unit structure generation method, and perform geometric thickening on the boundary lines of the three-dimensional polycrystalline structure to obtain a porous skeleton structure.

The generating module 13 is also used to generate an intervertebral cage frame meeting clinical requirements according to the size information of the intervertebral cage; fuse the porous skeleton structure and the intervertebral cage frame into a target intervertebral cage structure through Boolean operations.

The generation module 13 is also used to obtain the height information and length information of the region of interest according to the medical image data, obtain the size information of the intervertebral cage according to the height information and the length information; obtain the upper and lower adjacent endplate angles of the region of interest according to the medical image data Information, according to the height information and angle information to obtain the gap and relative angle between the frame of the intervertebral cage.

The generating module 13 is also used to generate a manufacturing file according to the structure of the target intervertebral fusion device, import the manufacturing file into the additive manufacturing software, and generate the target intervertebral fusion device through additive manufacturing.

It can be seen from the above description that in this embodiment, the manufacturing system of the intervertebral fusion device obtains the reference bone density value including the region of interest of the target patient, obtains the reference Young's modulus according to the reference bone density value, and obtains the reference Young's modulus matching The target porosity of the intervertebral fusion device is obtained according to the medical imaging data, and the intervertebral fusion device structure is generated according to the intervertebral fusion device size information and the target porosity. The target intervertebral fusion device structure includes a porous skeleton with a target porosity structure, the target intervertebral fusion device is generated according to the structure of the target intervertebral fusion device, so that the target intervertebral fusion device matches the target patient, and has better biomechanical matching performance. Its structure refers to the microstructure of the human bone of the target patient, which is beneficial The osteogenesis process can speed up fusion while reducing the risk of vertebral body stress and deformation.

Please refer to FIG. 19 . FIG. 19 is a schematic structural diagram of an embodiment of an intelligent manufacturing device provided by the present invention. The intelligent manufacturing device 20 includes a processor 21 and a memory 22 . The processor 21 is coupled to the memory 22 . A computer program is stored in the memory 22, and the processor 21 executes the computer program to implement the methods shown in Fig. 1 and Fig. 7 when working. For the detailed method, reference may be made to the above, which will not be repeated here.

Please refer to FIG. 20 . FIG. 20 is a schematic structural diagram of an embodiment of a storage medium provided by the present invention. At least one computer program 31 is stored in the storage medium 30, and the computer program 31 is used to be executed by a processor to implement the methods shown in FIG. 1 and FIG. In one embodiment, the computer-readable storage medium 30 may be a storage chip in the terminal, a hard disk, or a mobile hard disk, USB flash drive, optical disk, or other readable and writable storage tools, or a server and the like.

Those of ordinary skill in the art can understand that all or part of the processes in the methods of the above embodiments can be implemented through computer programs to instruct related hardware, and the programs can be stored in a non-volatile computer-readable storage medium. When the program is executed, it may include the procedures of the embodiments of the above-mentioned methods. Wherein, any references to memory, storage, database or other media used in the various embodiments provided in the present application may include non-volatile and/or volatile memory. Nonvolatile 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 many forms such as Static RAM (SRAM), Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDRSDRAM), Enhanced SDRAM (ESDRAM), Synchronous Chain Synchlink DRAM (SLDRAM), memory bus (Rambus) direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM), etc.

The technical features of the above embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be It is considered to be within the range described in this specification.

The above examples only express several implementation modes of the present application, and the description thereof is relatively specific and detailed, but should not be construed as limiting the patent scope of the present application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of protection of the patent application should be based on the appended claims.

Claims (7)

A method for manufacturing an intervertebral fusion device, comprising: Obtaining medical image data of the target patient, and obtaining a reference bone density value of a region of interest according to the medical image data, and the region of interest includes the position to be implanted and its adjacent region; Obtaining a reference Young's modulus according to the reference bone density value, and obtaining a target porosity matched with the reference Young's modulus; The size information of the intervertebral fusion device is obtained according to the medical image data, and the target intervertebral fusion device structure is generated according to the size information of the intervertebral fusion device and the target porosity, and the target intervertebral fusion device structure includes the target intervertebral fusion device structure. A porous skeleton structure with porosity, and a target intervertebral fusion cage is generated according to the target intervertebral fusion cage structure. The manufacturing method of the intervertebral fusion device according to claim 1, wherein the step of obtaining the target porosity matched with the reference Young's modulus comprises: Obtain the target porosity according to the following formula: Wherein, E represents the reference Young's modulus, Esolid represents the Young's modulus of the structure itself when no hole exists, porosity represents the target porosity, and a and b are constants. The manufacturing method of an intervertebral fusion device according to claim 1, wherein the step of generating a target intervertebral fusion device structure according to the size information of the intervertebral fusion device and the target porosity comprises: generating the porous framework structure according to the target porosity, and performing edge adjustment on the porous framework structure according to the fusion size information to generate the target intervertebral cage structure; or Using the size information of the intervertebral cage as the limit range generated by the porous skeleton structure, generating a porous skeleton structure satisfying the limit range, and using the porous skeleton structure satisfying the limit range as the target intervertebral fusion device structure. 4. The manufacturing method of the intervertebral cage according to claim 3, wherein the step of generating the porous skeleton structure with the target porosity comprises: A three-dimensional polycrystalline structure with the target porosity is generated by a method for generating a polyhedral unit structure, and a boundary line of the three-dimensional polycrystalline structure is geometrically thickened to obtain the porous skeleton structure. 5. The manufacturing method of intervertebral fusion device according to claim 3, characterized in that, the step of edge adjustment is carried out to the porous skeleton structure according to the fusion size information to generate the target intervertebral fusion device structure ,include: Generating an intervertebral fusion frame that meets clinical needs according to the size information of the intervertebral fusion; The porous skeleton structure and the frame of the intervertebral cage are fused into the target intervertebral cage structure through Boolean operations. The manufacturing method of the intervertebral fusion device according to claim 5, wherein the step of obtaining the size information of the intervertebral fusion device according to the medical image data includes: Obtaining height information and length information of the region of interest according to the medical image data, and obtaining size information of the intervertebral cage according to the height information and the length information; After the step of generating the frame of the intervertebral fusion device that satisfies the size information of the intervertebral fusion device, it includes: Obtaining angle information of upper and lower adjacent endplates of the region of interest according to the medical image data, and obtaining a gap and a relative angle between frames of the intervertebral fusion cage according to the height information and the angle information. The manufacturing method of the intervertebral fusion device according to claim 1, wherein the step of generating the target intervertebral fusion device according to the target intervertebral fusion device structure includes: The manufacturing file is generated according to the structure of the target intervertebral fusion device, and the manufacturing file is imported into additive manufacturing software to generate the target intervertebral fusion device through additive manufacturing. 8. A manufacturing system for an intervertebral fusion device, comprising: An acquisition module, configured to acquire medical image data of a target patient, and acquire a reference bone density value of the region of interest according to the medical image data, the region of interest including the position to be implanted and its adjacent region; A structure module, configured to obtain a reference Young's modulus according to the reference bone density value, and obtain a target porosity matched with the reference Young's modulus; A generating module, configured to acquire size information of the intervertebral fusion device according to the medical image data, and generate a target intervertebral fusion device structure according to the size information of the intervertebral fusion device and the target porosity, and the target intervertebral fusion device structure A porous skeleton structure having the target porosity is included, and a target intervertebral cage is generated according to the target intervertebral cage structure. 9. An intervertebral fusion device, characterized in that it comprises a porous skeleton structure, and the intervertebral fusion device is manufactured and obtained by the method according to any one of claims 1-7. A storage medium storing a computer program, which when executed by a processor causes the processor to execute the steps of the method according to any one of claims 1 to 7. An intelligent manufacturing device, comprising a memory and a processor, the memory stores a computer program, and when the computer program is executed by the processor, the processor performs the process described in any one of claims 1 to 7. method steps.