Orthopedic implant device

Abstract

The present application relates to a kind of orthopedic implant instruments, including porous layer, porous layer includes variable diameter section, the material of variable diameter section is memory material, so that variable diameter section has original state and deformed state, and variable diameter section can respond to deformation to original state after receiving specific stimulation in deformed state;In deformed state, the surface of porous layer is smooth and the thickness is matched with recipient bone tissue part, and the thickness of variable diameter section is less than original state;By using memory material as variable diameter section, so that in deformed state, orthopedic implant instrument can be directly implanted in corresponding recipient bone tissue part, without the need of tool impact and pressurized implant, reduce the possibility of potential complications and frequent postoperative pain caused by impact and pressurized implant;In addition, after implantation is completed, variable diameter section can respond to special stimulation and deform to original state, and the thickness of variable diameter section increases to realize active pressurization, so that orthopedic implant instrument and recipient bone tissue are fixed by interference fit, so as to achieve better initial stability.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a bone implant device. BACKGROUND

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

[0003] Currently, press-fit implant technology requires instrument-assisted impact press-fit to deform the acetabular cup bone tissue and make it fully contact with the acetabular cup; however, on the one hand, the technical requirements of traditional press-fit implantation are high, and impact press-fit can cause potential complications and frequent postoperative pain; on the other hand, the press-fit site of the acetabular cup is usually at the edge of the acetabular cup, which cannot be adjusted during the operation, and when the patient's acetabular edge bone density is insufficient or cannot withstand the press-in pressure, press-fitting at this site can lead to surgical failure. SUMMARY

[0004] Therefore, it is necessary to provide a bone implant device with high initial stability without instrument-assisted impact press-fit for the problem of traditional press-fit implant technology requiring instrument-assisted impact press-fit.

[0005] The present application provides a bone implant device, which comprises a porous layer, the porous layer comprises a variable diameter section, 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 the variable diameter section can respond to deformation to the original state after receiving a specific stimulus in the deformed state; 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 smaller than that in 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 also has at least one intermediate state between the deformed state and the original state, the variable diameter section can respond to deformation to the intermediate state after receiving a specific stimulus in the deformed state, and the variable diameter section can respond to deformation to other intermediate states or the original state after receiving a specific stimulus in the intermediate state; the thickness of the variable diameter section in the deformed state is smaller than that in the intermediate state, and the thickness and hole diameter of the variable diameter section in the intermediate state are smaller than those in the original state.

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

[0009] In one of the 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; and the stimulus response mode of the memory material is light wave, temperature, electric field, sound wave, magnetic field, force, or chemical substance.

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

[0011] In one of the embodiments, the porous layer further comprises a constant diameter section, the thickness and the diameter of the constant diameter section are constant, and in the original state, the variable diameter section protrudes from the surface of the porous layer.

[0012] In one of the embodiments, the variable diameter section has a mutation, and in the original state, the mutation protrudes from the surface of the porous layer.

[0013] In one of the embodiments, the orthopedic implant further comprises a solid layer, and the porous layer is fixed to the solid layer; the solid layer is a memory material or a biomedical material.

[0014] In one of the embodiments, the solid layer has a protrusion corresponding to the variable diameter section, and in the original state, the corresponding part of the variable diameter section protrudes from the surface of the porous layer.

[0015] The orthopedic implant described above uses a memory material as the variable diameter section, 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 can be directly implanted into the corresponding recipient bone tissue site without the need for tooling and pressing implantation, reducing the possibility of potential complications and frequent postoperative pain caused by tooling and pressing implantation, and also reducing the difficulty of the operation. In addition, after the implantation is completed, by applying a specific stimulus to the variable diameter section, the variable diameter section can respond to deformation to the original state, the thickness of the variable diameter section increases to achieve active pressing, so that the orthopedic implant and the recipient bone tissue are fixed by interference fit, thereby achieving better initial stability. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 The above-mentioned orthopedic implant of the present application is an enlarged structural schematic diagram of the orthopedic implant in different states in one of the embodiments;

[0017] Figure 2Fig. 6 is a schematic view of the enlarged structure of the hole shape change of the orthopedic implant device in different states according to another embodiment;

[0018] Figure 3 Fig. 7 is a schematic view of the enlarged structure of the wire diameter shape change of the orthopedic implant device in different states according to another embodiment;

[0019] Figure 4 Fig. 8 is a schematic view of the enlarged structure of the wire diameter size change of the orthopedic implant device in different states according to another embodiment;

[0020] Figure 5 Fig. 9 is a schematic view of the enlarged structure of the variable diameter section and the constant diameter section of the orthopedic implant device in different states according to another embodiment;

[0021] Figure 6 Fig. 10 is a schematic view of the enlarged structure of the sudden change section of the orthopedic implant device in different states according to another embodiment;

[0022] Figure 7 Fig. 11 is a schematic view of the enlarged structure of the protrusion and the variable diameter section of the orthopedic implant device in different states according to another embodiment.

[0023] Fig. 12 is a schematic view of the enlarged structure of the orthopedic implant device according to another embodiment. DETAILED DESCRIPTION

[0024] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. It will be apparent, however, to one skilled in the art that the present application can be practiced without some or all of these specific details. In other instances, well known process operations have not been described in detail in order to not unnecessarily obscure the present application.

[0025] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0026] In addition, the terms "first", "second", etc. are used only for descriptive purposes and do not connote or imply relative importance or an ordering between the indicated technical features. Thus, a feature defined with "first", "second" can include at least one of the features explicitly or implicitly. In the description of the present application, the meaning of "a plurality" is at least two, for example, two, three, etc., unless otherwise explicitly and specifically limited.

[0027] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting", "fixing" and the like should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0028] In the present application, unless otherwise explicitly specified and limited, the first feature is "on" or "under" the second feature, which can be direct contact between the first and second features, or indirect contact between the first and second features through an intermediate medium. Moreover, the first feature "above", "above" and "above" the second feature can be directly above or obliquely above the first feature, or only indicate that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "below" and "below" the second feature can be directly below or obliquely below the first feature, or only indicate that the horizontal height of the first feature is less than that of the second feature.

[0029] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there can be a mediating element. When an element is referred to as "connected" to another element, it can be directly connected to the other element or there can be a mediating element. The terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used herein are for illustrative purposes only and are not the only implementation.

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

[0031] The porous layer 10 herein refers to a layer having a porous structure to facilitate bone tissue ingrowth; the phrase "the surface of the porous layer 10 is flush in the deformed state" herein refers to the surface of the porous layer 10 being free of protrusions or recesses, and is not a limitation on the shape of the porous layer 10, which can be planar 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, the orthopedic implant device can be directly implanted into the corresponding recipient bone tissue site without the need for tooling and pressurized implantation, reducing the possibility of potential complications and frequent postoperative pain caused by pressurized implantation, and also reducing the difficulty of the surgery;

[0033] In addition, after the implantation is completed, the variable-diameter section 11 can be deformed to the original state in response to a specific stimulus applied thereto, and the thickness of the variable-diameter section 11 is increased to achieve active pressurization, so that the orthopedic implant device is fixed to the recipient bone tissue through an interference fit, thereby achieving better initial stability.

[0034] It should be noted that the non-cemented joint implant can achieve good bone tissue ingrowth through the porous structure, thereby achieving long-term stability of the implant. Currently, the pore size range of the porous structure of the marketed joint implant product is generally 600-800 pm, and the pore size of the porous structure after implantation cannot be adjusted. Such a porous structure size is not conducive to the early adhesion of osteoblasts; there are also some irregular porous structures, which although are matched with different size pores, the smaller size pores in the irregular porous structure are not easy to be prepared by additive manufacturing, and the cleaning of small size pores is difficult, which increases the product risk; in addition, the uncontrolled pore size makes the bone ingrowth performance of the irregular porous structure still have optimization space.

[0035] Please refer to Figure 1 In some embodiments, the variable-diameter section 11 also has at least one intermediate state between the deformed state and the original state, and the variable-diameter section 11 can be deformed to the intermediate state in response to a specific stimulus applied thereto in the deformed state, and can be deformed to another intermediate state or the original state in response to a specific stimulus applied thereto in the intermediate 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 pore size of the variable-diameter section 11 in the intermediate state are smaller than those in the original state.

[0036] so that the pore size of the variable-diameter 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 bone in the later stage of bone repair. The size-adjustable pore size of the variable-diameter section 11 optimizes and accelerates the bone repair process, achieving the effect of actively regulating bone ingrowth.

[0037] Specifically, after the implantation is completed, the variable diameter section 11 can be deformed to an intermediate state by applying a specific stimulus to the variable diameter section 11, in which the thickness of the variable diameter section 11 is increased to achieve active pressurization, so that the orthopedic implant device has better initial stability with the recipient bone tissue, and meanwhile the pore diameter of the variable diameter section 11 is smaller than that in the original state, thereby facilitating the adhesion and growth of osteoblasts in the early stage of bone repair.

[0038] When the orthopedic implant device is implanted for a period of time, the variable diameter section 11 is deformed from the intermediate state to the original state by applying a specific stimulus again, on the one hand, the thickness is further increased, and the orthopedic implant device is further pressed against the bone tissue, and on the other hand, the pore diameter of the variable diameter section 11 is increased, which is conducive to the osteogenic differentiation of cells and the formation of bone tissue.

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

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

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

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

[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 wave, temperature, electric field, sound wave, magnetic field, force or chemical substance, or a combination of multiple modes of the above modes.

[0044] For example, in the case of a temperature-responsive memory material, before the orthopedic implant device is implanted, the implant is exposed to a specific temperature (corresponding to a low temperature martensite temperature for a shape memory material) to compress the variable diameter section 11 from the original state to the deformed state; when the variable diameter section 11 needs to be deformed, the local temperature of the variable diameter section 11 is raised to above the critical temperature by a heating medium or device to achieve the 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 combinations of materials, the finished product is already in the deformed state, and there is no need for a pre-implantation size and shape adjustment step.

[0046] In some embodiments, the memory material can be prepared preoperatively by selecting a target area for compression according to the patient's bone condition, selecting one or more smart materials, and designing a digital model containing smart response factors through simulation analysis and programming. The implant containing a porous structure is prepared by 3D printing, and some of the porous structure regions contain smart response factors.

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

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

[0049] For patients who have insufficient or unpressurizable acetabular rim bone density, the orthopedic implant device of the present application can adjust the area or position of the compression region as needed to tailor the compression region to the patient, so that the implant strength and the patient's bearing strength are compatible.

[0050] In some embodiments, in the original state, the porous layer 10 has a self- protruding active compression part; and in the deformed state, the active compression part is flush with the surface of the porous layer 10.

[0051] Therefore, by selecting a target area that can be compressed according to the patient's bone condition, and designing the active compression part of the orthopedic implant device to correspond to the target area, the orthopedic implant device can be customized, thereby achieving local compression of the target area, achieving fixation and good initial stability without damaging the patient's bone.

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

[0053] According to the bone condition of the patient, the target region capable of being pressurized is selected, and the orthopedic implant device is customized according to the target region, so that the variable-diameter section 11 corresponds to the target region, and the specific implantation process is as follows:

[0054] In the deformed state, the constant-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 part of the recipient bone tissue, and the orthopedic implant device can be directly implanted into the corresponding part of the recipient bone tissue;

[0055] 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 the original state, and the thickness of the constant-diameter section 12 does not change, so that the variable-diameter section 11 protrudes from the surface of the porous layer 10, thereby realizing local pressurization of the target region, completing fixation and achieving good initial stability without damaging the bone of the patient.

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

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

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

[0059] Before implantation, the implant is exposed to a specific temperature (corresponding to a low temperature martensite temperature below for shape memory materials) to compress the porous layer 10 from the original state to the deformed state, at which time the thickness of the porous layer 10 matches the recipient bone tissue, so that the implant does not need to be pressurized for implantation by tool impact.

[0060] In some embodiments, the original state porous layer 10 obtained by 3D printing has a thickness corresponding to the target region protruding from the part corresponding to the non-target region, so as to directly form the active pressurizing part by 3D printing.

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

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

[0063] Please refer to Figure 1 In some embodiments, the orthopedic implant device further comprises a solid layer 20, and the porous layer 10 is fixedly arranged on the solid layer 20. The solid layer 20 is made of a memory material or a biomedical material.

[0064] The biomedical material herein includes common medical materials such as biomedical metal materials, bioactive / inert ceramic materials, and biodegradable / non-degradable medical polymer materials. The biomedical metal materials include titanium alloy, cobalt-chromium alloy, stainless steel, iron alloy, zinc alloy, and magnesium alloy. The bioactive / inert ceramic materials include hydroxyapatite, bioactive glass, calcium phosphate, calcium silicate, zirconium oxide, aluminum oxide, and silicon nitride. The biodegradable / non-degradable medical polymer materials include polylactic acid, polyurethane, and polyether ether ketone.

[0065] The thickness of the porous layer 10 can be determined according to whether it is covered on the surface of the solid layer 20 or the bone tissue site of the recipient to which the orthopedic implant device is applied. If the porous layer 10 is covered on the surface of the solid layer 20, for example, the acetabular cup, the thickness of the porous layer 10 in the deformed state is 0.3mm-3mm. If the porous layer 10 is not covered on the surface of the solid layer 20, for example, the spinal fusion cage, the thickness of the porous layer 10 in the deformed state is greater than or equal to 0.3mm.

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

[0067] Please refer to Figure 7 In some embodiments, the solid layer 20 has a protrusion 21 corresponding to the variable diameter section 11. In the original state, the variable diameter section 11 corresponding to the protrusion 21 is protruded from the surface of the porous layer 10.

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

[0069] Any combination of the technical features in the above embodiments can be made, and for the sake of brevity, not all possible combinations are described above, however, as long as the combination of the technical features does not exist in contradiction, it shall be considered within the scope of the present disclosure.

[0070] The above embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it shall not be understood as a limitation on the patent scope of the present application. It shall be pointed out that, for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, and these shall be within the protection scope of the present application. Therefore, the protection scope of the present application patent shall be subject to the appended claims.

Claims

1. An orthopedic implant device, comprising: The porous layer (10) comprises a variable diameter section (11), the material of the variable diameter section (11) is a memory material, the variable diameter section (11) has an original state and a deformed state, and the variable diameter section (11) can respond and deform to the original state after receiving a specific stimulus in the deformed state. In the deformed state, the thickness of the porous layer (10) matches the bone tissue site of the recipient, and the thickness of the variable diameter section (11) is smaller than that in the original state. The variable diameter section (11) also has at least one intermediate state between the deformed state and the original state, the variable diameter section (11) can respond and deform to the intermediate state after receiving a specific stimulus in the deformed state, and the variable diameter section (11) can respond and deform to other intermediate states or the original state after receiving a specific stimulus in the intermediate 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 pore size of the variable diameter section (11) in the intermediate state are smaller than those in the original state. In the original state, the porous layer (10) has a positive pressure part protruding from its surface. The variable diameter section (11) has a mutation part (11a), the deformation amplitude of the mutation part (11a) after receiving a specific stimulus is greater than that of other parts of the variable diameter section (11), and the positive pressure part is the mutation part (11a). In the original state, the mutation part (11a) protrudes from the surface of the porous layer (10); or The porous layer (10) further comprises a constant diameter section (12), the thickness and pore size of the constant diameter section (12) are constant, the positive pressure part is the variable diameter section (11), and in the original state, the variable diameter section (11) protrudes from the surface of the porous layer (10).

2. The orthopedic implant instrument of claim 1, wherein, The wire diameter size, wire diameter shape and / or hole shape of the variable diameter section (11) in the deformed state are different from those in the original state.

3. The orthopedic implant instrument of claim 1, wherein, The pore size of the variable diameter section (11) in one of the intermediate states ranges from 50 μm to 400 μm, and the pore size of the variable diameter section (11) in the original state ranges from 400 μm to 800 μm.

4. The orthopedic implant instrument of claim 1, wherein, The porous layer (10) is prepared by 3D printing of one or more materials.

5. The orthopedic implant instrument of claim 4, wherein, The positive pressure part is obtained by coating the surface of the porous layer (10) with a memory material having a porous structure.

6. The orthopedic implant device of any of claims 1-5, wherein, The orthopedic implant device further comprises a solid layer (20), and the porous layer (10) is arranged on the solid layer (20).

7. The orthopedic implant instrument of claim 6, wherein, The solid layer (20) has a protrusion (21) corresponding to the variable diameter section (11), and in the original state, the variable diameter section (11) corresponding to the protrusion (21) protrudes from the surface of the porous layer (10).

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