A 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device and a preparation method thereof

Abstract

The present invention discloses a 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device, including a 3D printed PEEK intervertebral fusion device body, wherein the 3D printed PEEK intervertebral fusion device body includes a 3D printed solid part, a developing rod and a 3D printed hollow mesh part. The present invention uses 3D printing technology to print an intervertebral fusion device model using a high-performance polymer material polyetheretherketone, and prints the central part of the intervertebral fusion device into a porous structure that is conducive to bone growth, so that the intervertebral fusion device meets the requirements of spinal biomechanics, has good biomechanical matching, does not interfere with imaging examinations, is personalized and customized, meets biomechanical requirements, and is easy to be combined and fixed with a 3D printed titanium alloy zero-cut fixing component. By setting a finite element model to simulate biomechanical experiments, the size or position of the intervertebral fusion device is adjusted according to the stress distribution borne by the intervertebral fusion device, and the intervertebral fusion device model that best meets the biomechanics of the spine is obtained.

Description

Technical Field

[0001] The present invention relates to the technical field of spinal vertebral reconstruction, and in particular to a 3D printed bionic porous zero-cut anterior cervical interbody fusion device and a preparation method thereof. Background Art

[0002] Discectomy and intervertebral fusion internal fixation is an effective means to treat cervical degenerative diseases. The intervertebral fusion device has functions such as support and load distribution, and can better restore the intervertebral space height and physiological curvature of the cervical spine. During the operation, the diseased intervertebral disc is removed and the intervertebral fusion device is implanted between the upper and lower vertebrae. After the bony fusion between the upper and lower vertebrae is achieved, the sequence and stability of the spine can be restored. Since the intervertebral fusion device has been successfully used for intervertebral fusion, various types of intervertebral fusion devices have been introduced one after another and are widely used in clinical practice.

[0003] Currently, the most commonly used material for anterior cervical interbody fusion devices in clinical practice is PEEK. PEEK has the advantages of excellent biocompatibility, chemical stability and wear resistance, and its Young's modulus is close to that of human bone. It can effectively avoid stress shielding and loosening with adjacent vertebral bones after implantation in the human body. PEEK has good material tracing ability and can pass through X-rays, which is convenient for postoperative X-ray observation of fusion status. PEEK has small MRI artifacts, which is convenient for postoperative evaluation of spinal nerve function.

[0004] Although the existing PEEK intervertebral fusion devices have achieved good clinical therapeutic effects, the PEEK material itself is difficult to form bony bonds with new bones, which can easily cause loosening and displacement problems in the later stage of implantation; the traditional molding process cannot modify the material during the molding process to improve its biological properties; the surface of PEEK is sprayed with materials with bone induction activity, such as hydroxyapatite, which can easily cause problems such as surface coating shedding during the implantation process. In current clinical applications, the hollow part of the intervertebral fusion device is usually filled with autologous bone, allogeneic bone, artificial bone, etc. to promote good bony fusion of the upper and lower vertebrae to improve the bone ingrowth ability of the intervertebral fusion device. The operation is cumbersome, and the bone grafting materials increase the cost of the operation.

[0005] There are many products of anterior cervical zero-profile interbody fusion devices, such as PEEK, PREVAIL, Zero-P, etc., which have been widely used in Europe, America, Asia and other regions. However, there are few domestically authorized independently designed zero-profile anterior cervical fusion devices, and there are no reports on 3D printed bionic porous zero-profile interbody fusion devices. The present invention patent designs a 3D printed bionic porous zero-profile anterior cervical interbody fusion device, adopts a new zero-profile interbody fusion device to fix titanium alloy, and organically combines it with a 3D printed bionic porous zero-profile interbody fusion device. Summary of the invention

[0006] The purpose of the present invention is to provide a 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device and a preparation method thereof, so as to solve the problem of insufficient clinical application of traditional intervertebral fusion devices mentioned in the above background technology.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solutions: a 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device, comprising a 3D printed PEEK intervertebral fusion device body, the 3D printed PEEK intervertebral fusion device body comprising a 3D printed solid part, a developing rod and a 3D printed hollow mesh part, the left side of the 3D printed PEEK intervertebral fusion device body is movably connected with a 3D printed titanium alloy fixing device, the 3D printed titanium alloy fixing device comprises a fixing block, an upper push piece, a lower push piece and a fixing buckle, the surfaces of the upper push piece and the lower push piece are fixedly connected to the fixing buckle, the inner wall of the fixing block is movably connected to the upper push piece and the lower push piece respectively, and the surface of the fixing buckle is movably connected to the 3D printed solid part.

[0008] Preferably, threaded holes are provided inside the upper push member and the lower push member.

[0009] Preferably, the surfaces of the upper push member and the lower push member are both provided with screw holes, and the number of the screw holes is two.

[0010] Preferably, the top and bottom of the 3D printed PEEK intervertebral fusion device body are both inclined, and the total inclination angle of the top and bottom of the 3D printed PEEK intervertebral fusion device body is 4°.

[0011] Preferably, the 3D printed hollow mesh portion is compatible with the 3D printed solid portion.

[0012] Preferably, the number of the fixing buckles is two groups.

[0013] A method for preparing a 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device comprises the following steps:

[0014] S1: Obtain the patient's cervical spine CT data, use the finite element analysis method to construct a three-dimensional digital model of the cervical spine, mesh the generated three-dimensional digital model to obtain a meshed geometric model, and combine the meshed geometric model with the anatomical structure of the cervical spine to construct a finite element model of the cervical spine;

[0015] S2: Conduct a simulated biomechanical experiment on the constructed cervical spine finite element model, analyze the data of the cervical spine finite element model under normal compressive stress, rotational stress, flexion-extension stress and lateral bending stress, and analyze the stress of the intervertebral fusion cage;

[0016] S3: According to the intervertebral space height after discectomy, the intervertebral fusion device is designed, the predetermined surgical method is simulated, the cervical reconstruction surgery is completed, and the data of the anterior cervical surgery model under normal compressive stress, rotational stress, flexion-extension stress and lateral bending stress are analyzed again. The stress of the intervertebral fusion device is analyzed and compared with the preoperative data. According to the stress distribution of the intervertebral fusion device, the size or position of the intervertebral fusion device is adjusted to obtain the intervertebral fusion device model that best conforms to the biomechanics of the cervical spine;

[0017] S4: Using 3D printing technology, the intervertebral fusion cage model designed in S3 was printed using PEEK material, and the central part of the intervertebral fusion cage was printed into a porous structure that was conducive to bone ingrowth;

[0018] S5: Use 3D printing technology to print titanium alloy zero-cut fixing components using titanium alloy materials.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] 1. The present invention utilizes 3D printing technology and uses high-performance polymer material polyetheretherketone to print an intervertebral fusion cage model, and prints the central part of the intervertebral fusion cage into a porous structure that is conducive to bone ingrowth, so that the intervertebral fusion cage meets the biomechanical requirements of the spine, has good biomechanical matching, does not interfere with imaging examinations, is personalized and meets biomechanical requirements, and is easy to combine and fix with a 3D-printed titanium alloy zero-cut fixation component.

[0021] 2. The preparation method of the present invention performs a simulated biomechanical experiment by setting a finite element model, and adjusts the size or position of the intervertebral fusion cage according to the stress distribution borne by the intervertebral fusion cage to obtain an intervertebral fusion cage model that best conforms to spinal biomechanics. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a schematic diagram of the structure of the present invention;

[0023] Figure 2 It is a bottom-up cross-sectional view of the structure of the present invention;

[0024] Figure 3 It is a partial left view of the structure of the present invention.

[0025] In the figure: 1. 3D printed PEEK intervertebral fusion device body; 11. developing rod; 12. 3D printed hollow mesh part; 13. 3D printed solid part; 2. 3D printed titanium alloy fixing device; 21. fixing block; 22. push-up piece; 23. fixing buckle; 24. push-down piece; 25. threaded hole; 26. screw hole. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] See also Figure 1-3 A 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device, comprising a 3D printed PEEK intervertebral fusion device body 1, the 3D printed PEEK intervertebral fusion device body 1 comprising a 3D printed solid part 13, a developing rod 11 and a 3D printed hollow mesh part 12, the 3D printed hollow mesh part 12 is adapted to the 3D printed solid part 13, the left side of the 3D printed PEEK intervertebral fusion device body 1 is movably connected with a 3D printed titanium alloy fixing device 2, the 3D printed titanium alloy fixing device 2 comprises a fixing block 21, an upper push piece 22, a lower push piece 24 and a fixing buckle 23, the number of the fixing buckles 23 is two groups, the surfaces of the upper push piece 22 and the lower push piece 24 are fixedly connected to the fixing buckle 23, the inner wall of the fixing block 21 is movably connected to the upper push piece 22 and the lower push piece 24, the surface of the fixing buckle 23 is movably connected to the 3D printed solid part The core 13 is movably connected, and threaded holes 25 are provided inside the upper push piece 22 and the lower push piece 24. There are two screw holes 25. A threaded hole 26 is provided in the center of the front of the 3D printed titanium alloy fixing device 2. The top and bottom of the 3D printed PEEK intervertebral fusion device body 1 are inclined, and the total inclination angle of the top and bottom of the 3D printed PEEK intervertebral fusion device body 1 is 4°. By utilizing 3D printing technology, a high-performance polymer material polyetheretherketone is used to print an intervertebral fusion device model, and the central part of the intervertebral fusion device is printed into a porous structure that is conducive to bone ingrowth, so that the intervertebral fusion device meets the biomechanical requirements of the spine, has good biomechanical matching, does not interfere with imaging examinations, is personalized, meets biomechanical requirements, and is easy to combine and fix with a 3D printed titanium alloy zero-cut fixation component.

[0028] A method for preparing a 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device, comprising the following steps S1: obtaining cervical CT data of a patient, constructing a three-dimensional digital model of the cervical spine using a finite element analysis method, meshing the generated three-dimensional digital model to obtain a meshed geometric model, combining the meshed geometric model with the anatomical structure of the cervical spine to construct a cervical finite element model; S2: conducting a simulated biomechanical experiment on the constructed cervical finite element model, analyzing the data of the cervical finite element model under normal compressive stress, rotational stress, flexion-extension stress and lateral bending stress, and analyzing the stress condition of the intervertebral fusion device; S3: designing an intervertebral fusion device according to the intervertebral space height after discectomy, simulating a predetermined surgical method, completing cervical reconstruction surgery, and again analyzing the anterior cervical surgical model under normal conditions. The data under normal compressive stress, rotational stress, flexion-extension stress and lateral bending stress were used to analyze the stress conditions of the intervertebral fusion device, which were compared with the preoperative data. According to the stress distribution of the intervertebral fusion device, the size or position of the intervertebral fusion device was adjusted to obtain the intervertebral fusion device model that best conforms to the biomechanics of the cervical spine; S4: Using 3D printing technology, the intervertebral fusion device model designed in S3 was printed using PEEK material, and the central part of the intervertebral fusion device was printed into a porous structure that is conducive to bone ingrowth; S5: Using 3D printing technology, titanium alloy zero-cut fixation components were printed using titanium alloy materials, and a finite element model was set to simulate biomechanical experiments. According to the stress distribution of the intervertebral fusion device, the size or position of the intervertebral fusion device was adjusted to obtain the intervertebral fusion device model that best conforms to the biomechanics of the spine.

[0029] The one-piece bionic porous anterior cervical interbody fusion device prepared by 3D printing can simplify the intraoperative operation steps. There is no need to fill the interbody fusion device with bone material during the operation. Its bionic porosity is conducive to vertebral bone ingrowth, which can achieve better clinical therapeutic effects.

[0030] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device, comprising a 3D printed PEEK intervertebral fusion device body (1), characterized in that: The 3D printed PEEK intervertebral fusion device body (1) comprises a 3D printed solid part (13), a developing rod (11) and a 3D printed hollow mesh part (12); the left side of the 3D printed PEEK intervertebral fusion device body (1) is movably connected to a 3D printed titanium alloy fixing device (2); the 3D printed titanium alloy fixing device (2) comprises a fixing block (21), an upper push piece (22), a lower push piece (24) and a fixing buckle (23); the surfaces of the upper push piece (22) and the lower push piece (24) are both fixedly connected to the fixing buckle (23); the inner wall of the fixing block (21) is movably connected to the upper push piece (22) and the lower push piece (24) respectively; and the surface of the fixing buckle (23) is movably connected to the 3D printed solid part (13); The upper push piece (22) and the lower push piece (24) are both provided with threaded holes (25); The surfaces of the upper push piece (22) and the lower push piece (24) are both provided with screw holes (26), and the number of the screw holes (26) is two; The top and bottom of the 3D printed PEEK intervertebral fusion device body (1) are both inclined, and the total inclination angle of the top and bottom of the 3D printed PEEK intervertebral fusion device body (1) is 4°; The 3D printed hollow mesh portion (12) is compatible with the 3D printed solid portion (13); The number of the fixing buckles (23) is two groups.

2. A method for preparing a 3D printed bionic porous zero-cut anterior cervical intervertebral fusion device, characterized in that: The following steps are included S1: Obtain the patient's cervical spine CT data, use the finite element analysis method to construct a three-dimensional digital model of the cervical spine, mesh the generated three-dimensional digital model to obtain a meshed geometric model, and combine the meshed geometric model with the anatomical structure of the cervical spine to construct a finite element model of the cervical spine; S2: Conduct a simulated biomechanical experiment on the constructed cervical spine finite element model, analyze the data of the cervical spine finite element model under normal compressive stress, rotational stress, flexion-extension stress and lateral bending stress, and analyze the stress of the intervertebral fusion cage; S3: According to the intervertebral space height after discectomy, the intervertebral fusion device is designed, the predetermined surgical method is simulated, the cervical reconstruction surgery is completed, and the data of the anterior cervical surgery model under normal compressive stress, rotational stress, flexion-extension stress and lateral bending stress are analyzed again. The stress of the intervertebral fusion device is analyzed and compared with the preoperative data. According to the stress distribution of the intervertebral fusion device, the size or position of the intervertebral fusion device is adjusted to obtain the intervertebral fusion device model that best conforms to the biomechanics of the cervical spine; S4: Using 3D printing technology, the intervertebral fusion cage model designed in S3 was printed using PEEK material, and the central part of the intervertebral fusion cage was printed into a porous structure that was conducive to bone ingrowth; S5: Use 3D printing technology to print titanium alloy zero-cut fixing components using titanium alloy materials.

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