Orthopedic implantation instrument

Abstract

The invention relates to an orthopedic implantation instrument which comprises a porous layer, the porous layer comprises a variable-diameter section, the variable-diameter section is made of a memory material, so that the variable-diameter section has an original state and a deformation state, and in the deformation state, the variable-diameter section can respond to deformation to the original state after receiving specific stimulation; in a deformation state, the surface of the porous layer is smooth, the thickness is matched with a receptor bone tissue part, and the thickness of the reducing section is smaller than that in an original state; the memory material is used as the reducing section, so that the orthopedic implantation instrument can be directly implanted into a corresponding receptor bone tissue part in a deformation state, tool striking and pressurizing implantation is not needed, and the possibility of potential complications and frequent postoperative pain caused by striking and pressurizing implantation is reduced; besides, after implantation is completed, the reducing section can respond to special stimulation to deform to an original state, and the thickness of the reducing section is increased to realize active pressurization, so that the orthopedic implantation instrument and a receptor bone tissue are fixed through interference fit, and better initial stability is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an orthopedic implant device. Background Art

[0002] In orthopedic surgery, the initial stability brought by the press-fit technology is an important prerequisite for good bone ingrowth of cementless artificial joint prostheses. Take cementless total hip arthroplasty (THA) as an example: the initial stability of the press-fit cup follows the anchoring principle that the rigid body is larger than the elastic body, so as to ensure that the porous structure or coating on the surface of the acetabular cup after implantation is in full contact with the acetabular bone tissue, and promote the growth of surrounding bone tissue into the porous structure or coating. Therefore, the acetabular cup is usually one size larger than the final acetabular rasp, and the donor implant is slightly larger than the recipient bone tissue site by 1-2mm.

[0003] The current press-fit implantation technology requires instrument-assisted impact press-fitting to deform the acetabular cup bone tissue and fully contact the acetabular cup. However, on the one hand, the technical requirements of traditional press-fit implantation are high, and impact press-fitting may lead to potential complications and frequent postoperative pain. On the other hand, the pressure-applied part of the acetabular cup is usually at the edge of the acetabular cup and cannot be adjusted during the operation. When the patient's acetabular edge bone density is insufficient or cannot withstand pressure, press-fitting at this site may lead to surgical failure. Summary of the invention

[0004] Based on this, it is necessary to provide an orthopedic implant device that has high initial stability without the need for instrument-assisted press-fitting in order to address the problem that traditional press-fitting implant technology requires instrument-assisted press-fitting.

[0005] The present application provides an orthopedic implant device, comprising a porous layer, wherein the porous layer comprises a variable diameter section, wherein the material of the variable diameter section is a memory material, so that the variable diameter section has an original state and a deformed state, and in the deformed state, the variable diameter section can respond to deformation to the original state after receiving a specific stimulus; in the deformed state, the surface of the porous layer is flush and the thickness matches the recipient bone tissue site, and the thickness of the variable diameter section is less than the original state.

[0006] In one embodiment, the wire diameter size, wire diameter shape and / or hole shape of the variable diameter section in the deformed state are different from those in the original state.

[0007] In one embodiment, the variable diameter section has at least one intermediate state between the deformed state and the original state. After receiving a specific stimulus in the deformed state, it can respond to deformation to the intermediate state, and after receiving a specific stimulus in the intermediate state, it can respond to deformation to other intermediate states or the original state; the thickness of the variable diameter section in the deformed state is smaller than that in the intermediate state, and the thickness and aperture of the variable diameter section in the intermediate state are both smaller than those in the original state.

[0008] In one of the embodiments, the pore size range of the variable diameter section in an intermediate state is 50 μm to 400 μm, the pore size range of the variable diameter section in the original state is 400 μm to 800 μm, and the interval time between the variable diameter section in the intermediate state and the original state is 2 days to 14 days.

[0009] In one embodiment, the memory material is a shape memory alloy, a shape memory polymer, a shape memory ceramic or a composite material containing a stimulus response factor; the stimulus response mode of the memory material is light waves, temperature, electric fields, sound waves, magnetic fields, forces or chemicals.

[0010] In one embodiment, the pores of the porous layer are loaded with BMP-2, collagen, antibiotics and / or antibacterial ions.

[0011] In one embodiment, the porous layer further includes a sizing section, the thickness and pore size of the sizing section are constant, and in an original state, the diameter-varying section protrudes from the surface of the porous layer.

[0012] In one embodiment, the variable diameter section has a sudden change portion, and in an original state, the sudden change portion protrudes from the surface of the porous layer.

[0013] In one embodiment, the orthopedic implant device further includes a physical layer, and the porous layer is fixed on the physical layer; the physical layer is a memory material or a biomedical material.

[0014] In one embodiment, the solid layer has a protrusion corresponding to the diameter-changing section, and in an original state, the diameter-changing section at a portion corresponding to the protrusion protrudes from the surface of the porous layer.

[0015] The above-mentioned orthopedic implant device uses the memory material as a variable diameter segment so that in the deformed state, the surface of the porous layer is flush and the thickness matches the recipient bone tissue site. The orthopedic implant device can be directly implanted into the corresponding recipient bone tissue site without the need for tools to impact and pressurize the implant, thereby reducing the possibility of potential complications and frequent postoperative pain caused by impact and pressurization of the implant, and also reducing the difficulty of the operation. In addition, after the implantation is completed, by applying specific stimulation to the variable diameter segment, the variable diameter segment can respond to the deformation to the original state, and the thickness of the variable diameter segment increases to achieve active pressurization, so that the orthopedic implant device and the recipient bone tissue are fixed by interference fit, thereby achieving better initial stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic diagram of the enlarged structure of the orthopedic implant device of the present application in different states in one embodiment;

[0017] Figure 2It is an enlarged structural schematic diagram of the changes in the hole shape of an orthopedic implant device in different states in another embodiment;

[0018] Figure 3 It is an enlarged structural schematic diagram of the change of the wire diameter shape of the orthopedic implant device in different states in another embodiment;

[0019] Figure 4 It is an enlarged structural schematic diagram of the change of the wire diameter size of the orthopedic implant device in different states in another embodiment;

[0020] Figure 5 It is a schematic diagram of the enlarged structure of the variable diameter section and the fixed diameter section of the orthopedic implant device in different states in another embodiment;

[0021] Figure 6 is a schematic diagram of the enlarged structure of the mutation part of the orthopedic implant device in different states in another embodiment;

[0022] Figure 7 It is a schematic diagram of the enlarged structure of the protrusion and the diameter-changing section of the orthopedic implant instrument in different states in another embodiment.

[0023] Figure numerals: 10, porous layer; 11, diameter-changing section; 11a, sudden change section; 12, diameter-fixed section; 20, solid layer; 21, protrusion. DETAILED DESCRIPTION

[0024] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific embodiments disclosed below.

[0025] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0026] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0027] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0028] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0029] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are for illustrative purposes only and are not intended to be the only implementation method.

[0030] Please refer to Figure 1 As shown, the present application provides an orthopedic implant device, including a porous layer 10, the porous layer 10 includes a variable diameter section 11, the material of the variable diameter section 11 is a memory material, so that the variable diameter section 11 has an original state and a deformed state, and in the deformed state, the variable diameter section 11 can respond to deformation to the original state after receiving a specific stimulus; in the deformed state, the surface of the porous layer 10 is flush and the thickness matches the recipient bone tissue site, and the thickness of the variable diameter section 11 is less than the original state.

[0031] The porous layer 10 in this article refers to the layer with a porous structure to facilitate the growth of bone tissue; the surface of the porous layer 10 is flat in the deformed state here, which means that there are no protrusions or depressions on the surface of the porous layer 10, and it is not a limitation on the shape of the porous layer 10. The porous layer 10 can be flat or curved.

[0032] In the present application, the memory material is used as the variable diameter section 11, so that in the deformed state, the surface of the porous layer 10 is smooth and the thickness matches the recipient bone tissue site, and the orthopedic implant device can be directly implanted into the corresponding recipient bone tissue site without the need for tools to impact and pressurize the implant, thereby reducing the possibility of potential complications and frequent postoperative pain caused by impact and pressurization implantation, and also reducing the difficulty of the operation;

[0033] In addition, after the implantation is completed, by applying specific stimulation to the reducing section 11, the reducing section 11 can respond and deform to its original state, and the thickness of the reducing section 11 increases to achieve active pressurization, so that the orthopedic implant device and the recipient bone tissue are fixed by interference fit, thereby achieving better initial stability.

[0034] It should be noted that non-bone cement joint implants can achieve good ingrowth of bone tissue through porous structures, thereby achieving long-term stability of the implant. The pore size range of the porous structure of the joint implant products currently on the market is generally 600-800μm, and the pore size of the porous structure after implantation cannot be adjusted. This type of porous structure size is not conducive to the early adhesion of osteoblasts; there are also some irregular porous structures. Although they are equipped with different pore sizes, the smaller pores in the irregular porous structure are not easy to prepare by additive manufacturing, and the cleaning of small pores is difficult, which increases the product risk; in addition, the uncontrollable pore size makes the bone ingrowth performance of the irregular porous structure still have room for optimization.

[0035] Please refer to Figure 1 As shown, in some embodiments, the variable diameter section 11 also has at least one intermediate state between the deformed state and the original state. After receiving a specific stimulus in the deformed state, it can respond to deformation to the intermediate state, and after receiving a specific stimulus in the intermediate state, it can respond to deformation to other intermediate states or the original state; the thickness of the variable diameter section 11 in the deformed state is smaller than that in the intermediate state, and the thickness and aperture of the variable diameter section 11 in the intermediate state are both smaller than those in the original state.

[0036] The pore size of the variable section 11 can be adjusted as needed. The smaller pore size in the intermediate state is suitable for the adhesion and growth of cells in the early stage of bone repair, and the larger pore size in the original state is suitable for the formation of bones in the late stage of bone repair. The adjustable pore size of the variable section 11 optimizes and accelerates the bone repair process, thereby achieving the effect of actively regulating bone ingrowth.

[0037] Specifically, after implantation is completed, by applying a specific stimulus to the variable diameter section 11, the variable diameter section 11 can respond to deformation to an intermediate state. In the intermediate state, the thickness of the variable diameter section 11 increases to achieve active pressure application, so that the orthopedic implant device and the recipient bone tissue have good initial stability. At the same time, the pore size of the variable diameter section 11 is smaller than the original state, which is conducive to the adhesion and growth of osteoblasts in the early stage of bone repair.

[0038] After the orthopedic implant device has been implanted for a period of time, a specific stimulus is applied to the variable diameter section 11 again, causing it to respond and deform from the intermediate state to the original state. On the one hand, the thickness is further increased, and the orthopedic implant device and the bone tissue are further compressed. On the other hand, the aperture of the variable diameter section 11 is enlarged, which is beneficial to cell osteogenic differentiation and the formation of bone tissue.

[0039] In some embodiments, the pore size range of the variable diameter segment 11 in an intermediate state is 50μm to 400μm, the pore size range of the variable diameter segment 11 in the original state is 400μm to 800μm, and the interval time between the intermediate state and the original state of the variable diameter segment 11 is 2 days to 14 days.

[0040] When the pore size ranges from 50μm to 400μm, it is beneficial to the adhesion and growth of osteoblasts in the early stage of bone repair. According to actual conditions, the pore size range of the variable diameter section 11 can also be 50μm to 200μm or 200μm to 400μm; when the pore size ranges from 400μm to 800μm, it is beneficial to cell osteogenic differentiation and the formation of bone tissue.

[0041] According to actual needs, the number of intermediate stages can be increased or decreased to slow down or speed up the deformation speed of the diameter-changing section 11 .

[0042] Please refer to Figures 2 to 4 As shown, in some embodiments, the wire diameter size, wire diameter shape and / or hole shape of the variable diameter segment 11 in the deformed state are different from those in the original state; that is, the changes in thickness and hole diameter of the variable diameter segment 11 between different states can be achieved by changing one or more of its own wire diameter size, wire diameter shape and hole shape.

[0043] In some embodiments, the memory material is a shape memory alloy, a shape memory polymer, a shape memory ceramic, or a composite material containing a stimulus response factor; the stimulus response mode of the memory material is one of light waves, temperature, electric fields, sound waves, magnetic fields, forces, or chemical substances, or a combination of multiple of the above modes.

[0044] Taking the stimulus response mode of the memory material as temperature as an example, before the orthopedic implant device is implanted, the implant is exposed to a specific temperature (corresponding to below the low-temperature martensite temperature for shape memory materials) to compress the variable diameter section 11 from the original state to the deformed state; when it is necessary to apply stimulation to the variable diameter section 11, the local temperature that needs to be deformed is raised to above the critical temperature through a heating medium or device to achieve deformation from the deformed state to the intermediate state, or from the intermediate state to the original state, and then the heating medium or device is removed.

[0045] Of course, for some material combinations, the finished product is already in a deformed state, and there is no need for size and shape adjustment steps before implantation.

[0046] In some embodiments, the preparation of memory materials can select the target area for pressure according to the patient's bone condition before surgery, select one or more smart materials and design a digital model containing smart response factors through simulation analysis "programming", and prepare implants containing porous structures through 3D printing, in which some porous structure areas contain smart response factors.

[0047] In some embodiments, the pores of the porous layer 10 are loaded with BMP (bone morphogenetic protein)-2, collagen, antibiotics and / or antibacterial ions.

[0048] By loading different components in the pores of the porous layer 10, different functions can be given to orthopedic implants. For example, loading bioactive components such as BMP (bone morphogenetic protein)-2 and collagen can enhance the bone ingrowth performance of orthopedic implants; and loading components such as antibiotics and antibacterial ions can give orthopedic implants antibacterial functions.

[0049] For some patients who have insufficient bone density at the acetabulum edge or cannot withstand pressure, the orthopedic implant device of the present application can adjust the area or position of the pressure zone according to actual needs, and tailor the pressure zone for the patient so that the implant strength is adapted to the patient's tolerance.

[0050] In some embodiments, in the original state, the porous layer 10 has an active pressurizing portion protruding from its own surface; and in the deformed state, the active pressurizing portion is flush with the surface of the porous layer 10 .

[0051] Therefore, the customization of the orthopedic implant device can be completed by simply selecting the target area that can be pressurized according to the patient's bone condition and designing the active pressurization part of the orthopedic implant device to correspond to the target area, thereby achieving local pressurization of the target area, completing fixation and achieving better initial stability without damaging the patient's bone.

[0052] Please refer to Figure 5As shown, in some embodiments, the porous layer 10 further includes a sizing section 12 , the thickness and pore size of the sizing section 12 are constant, and the active pressurizing portion is a diameter-changing section 11 , which protrudes from the surface of the porous layer 10 in the original state.

[0053] The target area that can be pressurized is selected according to the patient's bone condition, and the orthopedic implant device is customized according to the target area so that the variable diameter section 11 corresponds to the target area. The specific implantation process is as follows:

[0054] In the deformed state, the fixed diameter section 12 is flush with the variable diameter section 11, the surface of the porous layer 10 is smooth and the thickness matches the recipient bone tissue site, and the orthopedic implant device can be directly implanted into the corresponding recipient bone tissue site;

[0055] After the implantation is completed, by applying specific stimulation to the variable diameter section 11, the variable diameter section 11 can respond and deform to the original state, and the thickness of the fixed diameter section 12 does not change. Therefore, the variable diameter section 11 protrudes from the surface of the porous layer 10, thereby achieving local pressure on the target area, completing fixation and achieving better initial stability without damaging the patient's bone.

[0056] Please refer to Figure 6 As shown, in some embodiments, the variable diameter section 11 has a mutation portion 11a, and the deformation amplitude of the mutation portion 11a after receiving a specific stimulus is greater than that of other parts of the variable diameter section 11, and the active pressurizing portion is the mutation portion 11a. In the original state, the mutation portion 11a protrudes from the surface of the porous layer 10.

[0057] Since the mutation portion 11a protrudes from the surface of the porous layer 10 in the original state, the mutation portion 11a can further pressurize the target area relative to the other parts of the variable diameter section 11, thereby achieving local pressurization of the target area, completing fixation and achieving better initial stability without damaging the patient's bone.

[0058] In some embodiments, the porous layer 10 is prepared by 3D printing of one or more materials, and the prepared porous layer 10 is in an original state, in which the thickness of the porous layer 10 is larger than that of the recipient bone tissue;

[0059] Before implantation, the porous layer 10 is compressed from its original state to a deformed state by exposing the implant to a specific temperature (corresponding to below the low-temperature martensite temperature for shape memory materials). At this time, the thickness of the porous layer 10 completely matches the recipient bone tissue, so that the implant can be implanted without the need for tool impact and pressure.

[0060] In some embodiments, the original porous layer 10 obtained by 3D printing has a portion corresponding to the target area that is thicker than a portion corresponding to the non-target area, so that an active pressurizing portion is directly formed by 3D printing.

[0061] In some embodiments, the active pressurizing portion is obtained by coating a memory material having a porous structure on the surface of the porous layer 10 .

[0062] For example, the porous layer 10 is prepared by 3D printing, and at this time there is a certain gap between the thickness of the porous layer 10 and the recipient bone tissue site; the target area for pressurization is selected according to the patient's bone condition, and a memory material with a porous structure is coated on the target area of ​​the porous layer 10, so that the target area protrudes from the non-target area, and the thickness of the porous layer 10 in the non-target area is completely matched with the recipient bone tissue site.

[0063] Please refer to Figure 1 As shown, in some embodiments, the orthopedic implant device further includes a solid layer 20, and the porous layer 10 is fixed on the solid layer 20; the solid layer 20 is a memory material or a biomedical material.

[0064] The biomedical materials here include common medical materials such as biomedical metal materials, bioactive / inert ceramic materials, and biodegradable / non-degradable medical polymer materials. Among them, medical metal materials include titanium alloys, cobalt-chromium alloys, stainless steel, iron alloys, zinc alloys, and magnesium alloys, etc., bioactive / inert ceramic materials include hydroxyapatite, bioactive glass, calcium phosphate, calcium silicate, zirconium oxide, aluminum oxide, and silicon nitride, etc., and biodegradable / non-degradable medical polymer materials include polylactic acid, polyurethane, polyetheretherketone, etc.

[0065] The thickness of the porous layer 10 can be determined according to factors such as whether it covers the surface of the solid layer 20 or the site of the recipient bone tissue to which the orthopedic implant device is applicable; if the porous layer 10 covers the surface of the solid layer 20, such as an acetabular cup, the thickness of the porous layer 10 in the deformed state is 0.3 mm to 3 mm; if the porous layer 10 does not cover the surface of the solid layer 20, such as a spinal fusion device, the thickness of the porous layer 10 in the deformed state is greater than or equal to 0.3 mm.

[0066] In some embodiments, the solid layer 20 can be 3D printed together with the porous layer 10 .

[0067] Please refer to Figure 7 As shown, in some embodiments, the solid layer 20 has a protrusion 21 corresponding to the diameter-changing section 11 , and in an original state, a portion of the diameter-changing section 11 corresponding to the protrusion 21 protrudes from the surface of the porous layer 10 .

[0068] Since the reduced diameter section 11 corresponding to the protrusion 21 in the original state protrudes from the surface of the porous layer 10, it is only necessary to select the target area that can be pressurized according to the patient's bone condition and design the protrusion 21 to correspond to the target area, so as to achieve local pressurization of the target area, thereby completing fixation and achieving better initial stability without damaging the patient's bone.

[0069] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, 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.

[0070] The above embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for those of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An orthopedic implant device, characterized in that: The porous layer (10) comprises a diameter-changing section (11), the diameter-changing section (11) is made of a memory material, the diameter-changing section (11) has an original state and a deformed state, and in the deformed state, the diameter-changing section (11) can respond to a specific stimulus and deform to the original state; In the deformed state, the thickness of the porous layer (10) matches the recipient bone tissue site and the thickness of the reduced diameter section (11) is smaller than that in the original state.

2. The orthopedic implant device according to claim 1, characterized in that: The wire diameter size, wire diameter shape and / or hole shape of the diameter-changing section (11) in the deformed state are different from those in the original state.

3. The orthopedic implant device according to claim 1, characterized in that: The variable diameter section (11) also has at least one intermediate state between the deformed state and the original state; in the deformed state, the variable diameter section (11) can respond and deform to the intermediate state after receiving a specific stimulus; in the intermediate state, the variable diameter section (11) can respond and deform to other intermediate states or the original state after receiving a specific stimulus; in the deformed state, the thickness of the variable diameter section (11) is smaller than that in the intermediate state; in the intermediate state, the thickness and pore size of the variable diameter section (11) are both smaller than that in the original state.

4. The orthopedic implant device according to claim 3, characterized in that: In one of the intermediate states, the pore size range of the diameter-changing section (11) is 50 μm to 400 μm, and in the original state, the pore size range of the diameter-changing section (11) is 400 μm to 800 μm.

5. The orthopedic implant device according to claim 1, characterized in that: In an original state, the porous layer (10) has an active pressurizing portion protruding from its surface.

6. The orthopedic implant device according to claim 5, characterized in that: The diameter-changing section (11) has a mutation portion (11a), the deformation amplitude of the mutation portion (11a) after receiving a specific stimulus is greater than that of other parts of the diameter-changing section (11), the active pressurizing portion is the mutation portion (11a), and in an original state, the mutation portion (11a) protrudes from the surface of the porous layer (10); or The porous layer (10) further comprises a sizing section (12), the thickness and pore size of the sizing section (12) being constant, the active pressurizing portion being the diameter-changing section (11), and in an original state, the diameter-changing section (11) protruding from the surface of the porous layer (10).

7. The orthopedic implant device according to claim 5, characterized in that: The porous layer (10) is prepared by 3D printing of one or more materials.

8. The orthopedic implant device according to claim 7, characterized in that: The active pressurizing portion is obtained by coating a memory material having a porous structure on the surface of the porous layer (10).

9. The orthopedic implant device according to any one of claims 1 to 8, characterized in that: The orthopedic implant device further comprises a solid layer (20), and the porous layer (10) is covered on the solid layer (20).

10. The orthopedic implant device according to claim 9, characterized in that: The solid layer (20) has a protrusion (21) corresponding to the diameter-changing section (11); in an original state, the diameter-changing section (11) at a portion corresponding to the protrusion (21) protrudes from the surface of the porous layer (10).

Images