Porous bone grafting-free window type interbody fusion cage

Abstract

The utility model belongs to the technical field of orthopedic implants, and particularly relates to a porous bone grafting-free window type interbody fusion cage. The multi-hole type bone grafting window-free interbody fusion cage comprises a frame body which comprises four side faces and two end faces, and the four side faces are of hollow structures; the space defined by the frame body is filled with the porous structure body; the meshing teeth are arranged on the upper surface and the lower surface of the frame body; and the clamping structure is arranged at one end part of the frame body. According to the multi-hole type bone grafting-free window type interbody fusion cage, due to the design of the bone grafting-free window, the complexity of the using process is reduced, the operation is convenient, and the possibility that the fusion cage is polluted is reduced; the porous structure body with the bionic bone trabecula can be printed through 3D printing, and pore channels for bone tissue to grow in and a surface beneficial to cell adhesion can be effectively provided; the hydroxyapatite coating improves the biological activity of the surface of the base material and enhances the interface integration of the interbody fusion cage and the upper and lower end plates of the vertebral body.

Description

Technical Field

[0001] This utility model belongs to the field of orthopedic implant technology, specifically relating to a porous, non-grafted interbody fusion device. Background Technology

[0002] Although there are many types of intervertebral fusion cage systems on the market, using materials including titanium and its alloys, medical metals such as tantalum, medical polymers such as PEEK, and allogeneic bone, and the manufacturing process is mainly based on traditional precision machining, they generally have reserved intermediate bone graft windows in the design. They mainly rely on auxiliary filling with autologous bone or BMPs (bone growth factors) to ensure rapid fusion between the upper and lower vertebrae and achieve the treatment goal.

[0003] However, in clinical use, additional bone grafting or the addition of BMPS bone growth factor is required, making the surgery more difficult, the process more complex, and the price more expensive. Furthermore, improper selection and treatment of bone can easily lead to infection. Utility Model Content

[0004] The purpose of this invention is to provide a porous, bone-graft-free interbody fusion device to solve the above-mentioned technical problems.

[0005] To solve the above-mentioned technical problems, this utility model provides a porous, bone-graft-free window-type interbody fusion device, comprising:

[0006] The frame consists of four sides and two end faces, with all four sides being openwork structures.

[0007] A porous structure is filled within the space enclosed by the frame.

[0008] Engaging teeth are located on the upper and lower surfaces of the frame; and

[0009] The clamping structure is located at one end of the frame.

[0010] In one embodiment of this application, the unit types of the porous structure include: triangular pyramid structure, cube structure, rhombic dodecahedron structure, diamond structure, truncated octahedron structure, and three-dimensional Thiessen polygon structure.

[0011] In one embodiment of this application, the porous structure includes at least one of the following features:

[0012] The diameter of the porous structure is 100-800 μm;

[0013] The pore size of the porous structure is 200-1000μm;

[0014] The porosity of the porous structure is 20-90%.

[0015] In one embodiment of this application, the biting teeth are spike-shaped, wedge-shaped, or barbed.

[0016] In one embodiment of this application, the clamping structure includes a plurality of threaded holes and / or clamping notches.

[0017] In one embodiment of this application, the porous, bone-graft-free interbody fusion device is integrally manufactured by 3D printing.

[0018] In one embodiment of this application, the porous, bone-graft-free interbody fusion device is made of titanium, titanium alloy, tantalum, or polyetheretherketone.

[0019] In one embodiment of this application, at least a portion of the surface of the porous, bone-graft-free interbody fusion device is coated with a hydroxyapatite coating.

[0020] In one embodiment of this application, at least a portion of the surface of the porous, bone-graft-free interbody fusion device is coated with a nano-hydroxyapatite coating.

[0021] In one embodiment of this application, at least a portion of the surface of the porous, bone-graft-free window-type interbody fusion device is provided with a polydopamine layer and a nano-hydroxyapatite coating.

[0022] The beneficial effects of this utility model are:

[0023] 1. The bone graft-free window design reduces the complexity of the process, facilitates operation, and reduces the possibility of contamination of the fusion device;

[0024] 2. Porous structures with biomimetic bone trabeculae can be 3D printed, which can effectively provide channels for bone tissue ingrowth and surfaces conducive to cell adhesion. This allows new bone to grow into the fusion device through micropores and adhere to the surface of the metal bone trabeculae, forming a tight integration of bone and implant.

[0025] 3. Hydroxyapatite coating, nano-hydroxyapatite coating, or polydopamine layer and nano-hydroxyapatite coating improve the bioactivity of the matrix material surface and enhance the integration of the interbody fusion device with the upper and lower endplates of the vertebral body.

[0026] Other features and advantages of this invention will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practicing the invention. The objectives and other advantages of this invention are realized and obtained through the structures particularly pointed out in the description and the accompanying drawings.

[0027] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0028] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0029] Figures 1 to 5 These are perspective views of some embodiments of the porous, bone-graft-free window-type interbody fusion device of this utility model;

[0030] Figure 6 This is a schematic diagram of a triangular pyramid structure;

[0031] Figure 7 This is a schematic diagram of a cube structure;

[0032] Figure 8 This is a schematic diagram of a rhombic dodecahedron structure;

[0033] Figure 9 This is a schematic diagram of the diamond structure;

[0034] Figure 10 This is a schematic diagram of a truncated octahedral structure;

[0035] Figure 11 This is a schematic diagram of a three-dimensional Thiessen polygon structure;

[0036] Figure 12 This is a schematic diagram of spiked occlusal teeth;

[0037] Figure 13 This is a schematic diagram of wedge-shaped bite teeth;

[0038] Figure 14 This is a schematic diagram of hook-shaped bite teeth;

[0039] Figure 15 Scanning electron microscope images of samples treated with polydopamine;

[0040] Figure 16 Scanning electron microscope (SEM) image of a sample after treatment with nano-hydroxyapatite slurry.

[0041] In the picture:

[0042] Frame body 1, porous structure 2, interlocking teeth 3, clamping structure 4, threaded hole 41, clamping notch 42. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0044] See Figures 1 to 5 In some embodiments of this application, the porous non-grafted interbody fusion device includes: a frame body 1, which includes four sides and two end faces, and the four sides are all hollow structures; a porous structure 2, which fills the space enclosed by the frame body 1; occlusal teeth 3, which are disposed on the upper and lower surfaces of the frame body 1; and a clamping structure 4, which is disposed at one end of the frame body 1.

[0045] In this embodiment, optionally, the frame body 1 can be a solid frame, which, as the main load-bearing structure, can provide sufficient strength for the interbody fusion device. See also Figures 1 to 5 In some embodiments, the four sides of the frame 1 are hollow structures; the two end faces can be both closed, or they can be designed as two hollow types as needed, or one closed type and one hollow type.

[0046] In this embodiment, optionally, the unit type of the porous structure 2 may be, but is not limited to, a triangular pyramid structure, a cube structure, a rhombic dodecahedron structure, a diamond structure, a truncated octahedron structure, or a three-dimensional Thiessen polygon structure.

[0047] Furthermore, the porous structure 2 is uniformly filled inside the frame 1 and can also fill the hollow structure of the frame 1 for bone tissue ingrowth; support beams may be provided inside or on the surface of the porous structure; see also Figures 6 to 11 The unit type of the porous structure 2 may be, but is not limited to, a triangular pyramid structure, a cubic structure, a rhombic dodecahedron structure, a diamond structure, a truncated octahedron structure, or a three-dimensional Thiessen polygon structure; the rod diameter of the porous structure 2 may be 100-800 μm; the pore diameter of the porous structure 2 may be 200-1000 μm; and the porosity of the porous structure 2 may be 20-90%.

[0048] In this embodiment, optionally, the occlusal teeth 3 located on the same side can be symmetrically distributed. The occlusal teeth 3 are used to occlude into the upper and lower endplates of the vertebral body to maintain the stability of the interbody fusion device.

[0049] Further, see Figures 12 to 14 The biting teeth 3 may be, but are not limited to, spike-shaped, wedge-shaped, or barbed.

[0050] In this embodiment, the clamping structure 4 located at the end of the frame 1 can facilitate the clamping of the intervertebral fusion device during operation.

[0051] In some embodiments, the clamping structure 4 can be a clamping notch 42, for example Figure 1 The clamping notch 42 facilitates clamping with pliers.

[0052] In some embodiments, the clamping structure 4 may include a threaded hole 41 and clamping notches 42 located on both sides of the threaded hole 41, for example... Figure 2 and Figure 4 .

[0053] In some embodiments, the clamping structure 4 may be a threaded hole 41, see [link / reference] Figure 3 Alternatively, it can have 3 threaded holes (41), see [link / reference]. Figure 5 .

[0054] In this embodiment, preferably, the porous, bone-graft-free interbody fusion device is manufactured in one piece by 3D printing; its raw materials may be, but are not limited to, titanium, titanium alloy, tantalum or polyetheretherketone.

[0055] In this embodiment, further, in order to improve the problem of insufficient activity and poor intervertebral fusion and interface healing ability caused by the inherent inertness of the interbody fusion device material, a hydroxyapatite coating, a nano-hydroxyapatite coating, or a polydopamine layer and a nano-hydroxyapatite coating can be provided on the surface of the porous bone graft-free window-type interbody fusion device.

[0056] It should be noted that the hydroxyapatite coating, nano-hydroxyapatite coating, or polydopamine layer and nano-hydroxyapatite coating on the surface of the porous, bone-graft-free interbody fusion cage can be achieved using existing processes, and can be implemented in the following ways:

[0057] As an optional method for forming the hydroxyapatite coating, the hydroxyapatite coating can be vacuum plasma sprayed and applied to the end face except for the clamping structure 4, with a thickness of 30-200 μm.

[0058] As an optional method for forming the nano-hydroxyapatite coating, it can be formed by dip coating, covering the surface of the porous structure 2 and the upper and lower surfaces of the framework 1, with a thickness of 20-100μm.

[0059] The specific steps are as follows:

[0060] The 3D-printed intervertebral fusion device undergoes alkaline heat treatment, specifically by immersing it in a 5M NaOH solution at 60℃ for 6-8 hours. After removal, it is rinsed with deionized water until the pH reaches 7 and dried in an oven at 60-80℃ for 24 hours, yielding the alkaline-treated intervertebral fusion device. This device is then immersed in nano-hydroxyapatite slurry and ultrasonically treated for 10-30 minutes. Once the nano-hydroxyapatite slurry fills the porous structure of the alkaline-treated intervertebral fusion device, it is removed and centrifuged at 100-500 rpm / min for 1-2 minutes. It is then dried in an oven at 60-80℃. This coating process can be repeated 2-3 times. Finally, the dried intervertebral fusion device is heat-treated in a muffle furnace at 600℃ for 1-2 hours.

[0061] The polydopamine layer and nano-hydroxyapatite coating can also be applied by dip coating to cover the surface of the porous structure 2 and the upper surface of the frame 1, with a thickness of 20-100 μm.

[0062] The specific steps are as follows:

[0063] The 3D-printed intervertebral fusion device was subjected to alkaline heat treatment, which involved placing the device in a 5M NaOH solution at 60℃ for 6-8 hours, rinsing it with deionized water until the pH reached 7, and then drying it in an oven at 60-80℃ for 24 hours to obtain the alkaline heat-treated intervertebral fusion device.

[0064] The alkaline heat-treated intervertebral fusion device is immersed in a dopamine solution and continuously stirred at a rate of 200-400 rpm for 12-16 hours to form a polydopamine coating on the surface of the intervertebral fusion device. Then it is washed with deionized water 3-5 times and dried in an oven at 40-60℃. Figure 15 This is a scanning electron microscope image of a sample treated with polydopamine.

[0065] Immerse it in nano-hydroxyapatite slurry, sonicate for 10-30 minutes, and after the nano-hydroxyapatite slurry fills the porous structure of the intervertebral fusion device after alkali heat treatment, take it out, centrifuge at 100-500 rpm / min for 1-2 minutes, and dry it in an oven at 60-80℃. Figure 16 Scanning electron microscope (SEM) image of a sample after treatment with nano-hydroxyapatite slurry.

[0066] The process of applying the polydopamine layer and the nano-hydroxyapatite coating can be repeated 2-3 times. The dried intervertebral fusion device is then placed in a muffle furnace and heat-treated at 600℃ for 1-2 hours.

[0067] Preparation method of dopamine solution: Prepare a 10-15 mmol / L tris(hydroxymethyl)aminomethane hydrochloride solution with deionized water or pure water; add dopamine powder to the tris(hydroxymethyl)aminomethane hydrochloride solution at a concentration of 1-4 mg / ml, and adjust the pH of the solution to 8-9 to obtain the dopamine solution.

[0068] Based on the above-described preferred embodiments of this utility model, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the technical concept of this utility model. The technical scope of this utility model is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A porous, bone-graft-free window-type interbody fusion device, characterized in that, include: The frame consists of four sides and two end faces, with all four sides being openwork structures. A porous structure is filled within the space enclosed by the frame. Engaging teeth are located on the upper and lower surfaces of the frame; and The clamping structure is located at one end of the frame.

2. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, The unit types of the porous structure include: triangular pyramid structure, cubic structure, rhombic dodecahedral structure, diamond structure, truncated octahedral structure, and three-dimensional Thiessen polygon structure.

3. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, The porous structure includes at least one of the following features: The diameter of the porous structure is 100-800 μm; The pore size of the porous structure is 200-1000μm; The porosity of the porous structure is 20-90%.

4. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, The biting teeth are spike-shaped, wedge-shaped, or barbed.

5. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, The clamping structure includes several threaded holes and / or clamping notches.

6. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, The porous, bone-graft-free window-type interbody fusion device is manufactured in one piece using 3D printing.

7. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, The porous, bone-graft-free window-type interbody fusion device is made of titanium, titanium alloy, tantalum, or polyetheretherketone.

8. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, At least a portion of the surface of the porous, bone-graft-free window-type interbody fusion device is coated with a hydroxyapatite coating.

9. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, At least a portion of the surface of the porous, bone-graft-free window-type interbody fusion device is coated with a nano-hydroxyapatite coating.

10. The porous, bone-graft-free window-type interbody fusion device according to claim 1, characterized in that, At least a portion of the surface of the porous, bone-graft-free window-type interbody fusion device is provided with a polydopamine layer and a nano-hydroxyapatite coating.

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