A tantalum-modified bone implant, method of manufacture and use thereof

By combining a tantalum-modified bone implant with a biodegradable zinc alloy cap and a titanium alloy substrate, and designing a drug storage structure and a magnetron sputtered tantalum layer, the problems of fracture fixation device failure under high-frequency load and long bone healing time were solved, resulting in shorter bone healing time and improved implant stability.

CN116636915BActive Publication Date: 2025-12-30HUNAN HUAXIANG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202310708182.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-06-15
Publication Date
2025-12-30
Estimated Expiration
2043-06-15

AI Technical Summary

Technical Problem

Existing fracture fixation devices are prone to failure when subjected to high-frequency loads. Traditional titanium alloy materials do not promote bone growth during the bone healing process and require a second surgery for removal. Uneven degradation of polyetheretherketone/polylactic acid materials leads to premature failure of fixation devices, affecting bone healing time.

Method used

The bone implant is modified with tantalum, combined with a biodegradable zinc alloy cover plate and a non-biodegradable titanium alloy substrate. The surface is magnetron sputtered with a tantalum layer, and a unique drug storage structure is designed. The drug is released by the degradation of the cover plate, and the connection mechanism is used to improve wear resistance and stability.

Benefits of technology

It shortens bone healing time, reduces the need for secondary surgeries, reduces the burden of implants on the affected area, promotes bone repair, prevents implants from adhering to the bone surface, and improves the wear resistance and stability of implants.

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Abstract

The application discloses a tantalum-modified bone implant, a preparation method and application thereof, and comprises a base plate, a cover plate and a connecting mechanism, the base plate and the cover plate are dissimilar metals, and the base plate and the cover plate are connected through the connecting mechanism; after the base plate and the cover plate are connected, a closed space for storing medicine exists between the base plate and the cover plate; the cover plate is a degradable metal, and the base plate is a non-degradable metal; after the cover plate is implanted into a body, the cover plate starts to slowly degrade; after a period of degradation, the medicine in the medicine storage space starts to be released, thus creating favorable conditions for bone repair, and further shortening a healing time; the preparation method comprises the following steps: forming of an implant product, cleaning of a product surface, tantalum coating forming and post-processing; the tantalum coating is formed through a combination of magnetron sputtering and electrolytic polishing, a passivation film is generated while roughness is reduced, the wear resistance of the product is enhanced, and meanwhile, product and bone surface adhesion is effectively avoided.
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Description

TECHNICAL FIELD

[0001] The present application belongs to the field of orthopedic instruments, and particularly relates to a tantalum-modified bone implant, a preparation method and application thereof. BACKGROUND

[0002] Fracture / bone fracture is a common disease in orthopedics, and the commonly used fixing method is an external fixing device such as plaster. However, it is very difficult to externally fix the skull, maxillofacial or other complex structures, and it will affect the physiological function. Therefore, the prior art uses the method of implanting an internal device for fixation, which not only has a simpler structure, but also can reduce the influence on the physiological function. For example, the mandibular fracture of the skull and maxillofacial is required to bear a larger and more frequent load because it needs to participate in daily chewing. In particular, for patients with insufficient support of the bone fracture end, the fixing device will bear almost all the load in the early stage. Therefore, the prior art often uses a fixing device mainly made of titanium alloy, as shown in the figure, which temporarily or permanently stabilizes the bone block and / or bridges the gap until the bone heals. Figure 1

[0003] However, although the traditional titanium alloy has biological inertia and is not easy to cause rejection reaction, it does not have the effect of promoting bone growth, so the healing time is relatively long and needs to be removed by secondary surgery. On the other hand, with the development of technology, the base material is no longer limited to titanium alloy, and degradable materials represented by polyether ether ketone / polylactic acid have appeared. However, the degradable material will begin to degrade after being implanted, and its strength will gradually decrease. Moreover, the degradation rate in different human bodies is not the same, so the problem of premature failure of the fixing device often occurs when the fracture has not healed. SUMMARY

[0004] The present application provides a tantalum-modified bone implant, a preparation method and application thereof. The implant is fixed to the fractured part by implantation and bears the load. The surface is modified by tantalum to improve wear resistance. At the same time, it has a unique drug storage structure, and the drug carried therein is released by cooperation and loosening with the degradation process, which provides favorable conditions for bone repair and shortens the healing time.

[0005] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0006] A tantalum-modified bone implant, comprising: a base plate, a cover plate and a connecting mechanism, the base plate and the cover plate are combined into a whole through the connecting mechanism, and a space for storing drugs is formed between the two; the cover plate is made of degradable material, and the base plate is made of non-degradable material. The cover plate will begin to degrade slowly after being implanted in the body. After a period of degradation, the cover plate and the base plate are loose, and the drug in the space for storing drugs between the cover plate and the base plate will begin to be released.

[0007] ​The connecting mechanism comprises a bone nail, the base plate and the cover plate are provided with nail holes corresponding in position, i.e. base plate nail hole and cover plate nail hole, the bone nail passes through the holes to fix the two on the bone surface.

[0008] Further, the connecting mechanism further comprises a connecting nail, the base plate and the cover plate are also provided with connecting holes corresponding in position, i.e. base plate connecting hole and cover plate connecting hole, the connecting nail passes through the holes to connect the two.

[0009] Further, the surfaces of the base plate and the cover plate in contact are provided with protruding shapes, after the base plate and the cover plate are connected, the protruding shapes provided on the surfaces in contact of the two are interlaced with each other to divide the space between the base plate and the cover plate into multiple independent spaces.

[0010] Further, the protruding shape on the base plate is a curved partition strip, the protruding shape on the cover plate is a curved partition strip, and a gap is left at the interlaced position of the partition strips; after the base plate and the cover plate are connected, the partition strip is inserted into the partition strip.

[0011] Further, the partition strip and the partition strip are coiled between the base plate nail hole and the base plate connecting hole.

[0012] Further, the base plate nail hole is provided with internal threads, the bone nail is screwed into the base plate nail hole to be threadedly connected with the base plate nail hole, and the base plate is fixed to the bone surface of the affected area; the screw head of the connecting nail is a conical surface that converges towards the screw column portion, the base plate connecting hole is provided with internal threads, and the cover plate connecting hole is a funnel-shaped slope surface with the same shape as the screw head of the connecting nail.

[0013] Further, the surface of the cover plate in contact with the base plate is further provided with a baffle, the baffle is a convex strip curved into a closed figure, the baffle is in contact with the base plate after the cover plate and the base plate are connected, and an independent space is separated between the cover plate and the base plate.

[0014] Further, the cover plate connecting hole is provided with hemispherical protrusions in the length direction of the cover plate and close to one side of the end portion.

[0015] Further, the cover plate is a zinc alloy, and the base plate is a titanium alloy, wherein the surface of the titanium alloy is modified by tantalum.

[0016] A preparation method of a tantalum-modified bone implant, comprising: S1. forming of an implant product; S2. cleaning of the surface of the product; S3. forming of a tantalum coating; and S4. post-processing, characterized in that: the tantalum coating is formed on the surface of the product by magnetron sputtering to form a tantalum layer with a thickness of 20-40 μm.

[0017] This invention utilizes tantalum modification of the implant surface combined with magnetron sputtering technology to form a dense and stable tantalum modification layer, thereby improving its surface wear resistance and preventing direct contact between the matrix material and the body fluid environment. Tantalum itself has good ductility and will not fall off due to frequent micro-deformation, making the modification layer more stable. At the same time, the polishing process after the tantalum modification layer is formed can reduce the roughness on the side of tantalum that contacts the bone surface, preventing bone tissue from growing into and adhering to the tantalum side, which would be detrimental to later removal.

[0018] The implant also has a unique drug storage structure, which combines the drug-carrying space by inserting the spacers on the base plate and the cover plate, while increasing the stability of the connection. The baffle outside the spacers will create another layer of drug-carrying space outside the spacers, which increases the drug loading capacity and allows for adjustment of the assembly gap to achieve continuous release.

[0019] Meanwhile, because the cover plate can degrade in the body fluid environment, as the degradation process proceeds, the drug-carrying space enclosed by the septum loosens and slowly releases the drug. The implant gradually transitions to being supported by a single metal, making the fixation device lighter and reducing the burden on the affected area in the later stages. Attached Figure Description

[0020] To more clearly illustrate the specific embodiments of the present invention 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 the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0021] Figure 1 This diagram illustrates the usage of the technology.

[0022] Figure 2 A schematic diagram of the structure of the present invention is shown.

[0023] Figure 3 A schematic diagram of the cross-sectional structure cut along line AA is shown.

[0024] Figure 4 Schematic illustration Figure 3 Enlarged view of the end;

[0025] Figure 5 Schematic illustration Figure 4 A magnified view of part B in the middle section;

[0026] Figure 6 A schematic diagram of the substrate structure is shown.

[0027] Figure 7 A schematic diagram of the cover plate is shown.

[0028] Fig.:

[0029] Substrate, 11 - mounting groove, 12 - spacer strip;

[0030] Pin hole, 21a - substrate pin hole, 21b - cover plate pin hole, 22 - connection hole, 22a - substrate connection hole, 22b - cover plate connection hole, 23 - bone pin, 24 - connecting pin;

[0031] 3 - cover plate, 31 - spacer strip, 32 - stopper. DETAILED DESCRIPTION

[0032] In order to have a clearer understanding of the technical features, objectives and effects of the present application, the specific embodiments of the present application will be described in detail with reference to the accompanying drawings. In the following description, it should be understood that the "front", "back", "upper", "lower", "left", "right", "vertical", "horizontal", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail" and other directions or positional relationships indicated are based on the directions or positional relationships shown in the drawings, constructed and operated in a particular direction, and are only for the convenience of describing the technical solutions, and are not intended to indicate that the devices or elements referred to must have a particular direction. Therefore, it cannot be understood as a limitation on the present application. It should also be noted that, unless otherwise specified and limited, the terms "mounting", "connection", "connection", "fixing", "setting" and the like should be broadly understood, 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, or it can be the internal communication of two elements or the interaction relationship between two elements. When an element is referred to as "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there can be one or more intervening elements. 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.

[0033] In the following description, specific details such as specific system structures, techniques, etc. are presented for the purpose of explanation, not for limitation, so that the embodiments of the present application can be thoroughly understood; however, those skilled in the art should understand that the present application can also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices and methods are omitted to avoid unnecessary details that hinder the description of the present application. EMBODIMENTS

[0034] As Figure 1The image shows a tantalum-modified bone implant, comprising: a substrate 1, a cover plate 3, and a connecting mechanism. The substrate 1 and the cover plate 3 are dissimilar metals and are connected by the connecting mechanism. After the substrate 1 and the cover plate 3 are connected, the protrusions on their contact surfaces are staggered to divide the space between the substrate and the cover plate into multiple independent spaces that can be used for drug storage. The cover plate 3 is a biodegradable metal, while the substrate 1 is a non-biodegradable metal. After the cover plate 3 is implanted in the body, it will begin to slowly degrade. After a period of degradation, the drug in the storage space will begin to be released, creating favorable conditions for bone repair and thus shortening the healing time.

[0035] like Figures 2-3 As shown, the base plate 1 and the cover plate 3 are assembled into a whole by a connecting mechanism, which includes: bone screws 23 and connecting screws 24. The base plate 1 and the cover plate 3 are provided with corresponding screw holes 21, namely: base plate screw hole 21a and cover plate screw hole 21b. Only the base plate screw hole 21a has an internal thread. After screwing in, the bone screw 23 is threadedly connected to the base plate screw hole 21a, fixing the base plate 1 to the bone surface of the affected area. The screw head of the connecting screw 24 is a conical surface that converges towards the stud portion, similar to a funnel shape. Of course, the base plate 1 and the cover plate 3 are also provided with corresponding connecting holes 22, namely: base plate connecting hole 22a and cover plate connecting hole 22b, as shown... Figures 6-7 As shown, all are connected to each other by threads. The cover plate connection hole 22b is also provided with a funnel-shaped slope with the same shape as the screw head of the connecting nail 34. After the connecting nail 24 is screwed in, its screw head contacts the cover plate connection hole 22b, which prevents the screw head of the connecting nail from protruding above the plate surface and also increases the contact area with the cover plate 3, pressing the cover plate 3 onto the base plate 1. The connecting nail 24 is shorter than the bone nail 23. After the connecting nail 24 is fully screwed in, it does not contact the bone surface, which strengthens the tightness of the connection between the base plate 1 and the cover plate 3.

[0036] The substrate 1 and the cover plate 3 are made of different materials. The cover plate 3 is a biodegradable material, while the substrate 1 is a non-biodegradable material. In this embodiment, the cover plate 3 is made of titanium alloy, while the substrate 1 is made of zinc-based alloy. Zinc-based alloy can degrade in the body fluid environment, with a moderate degradation rate and degradation products that are harmless to the human body. Compared with titanium alloy, the elastic modulus of zinc-based alloy is closer to that of human cortical bone. In this application, the substrate 1 is used as the main load-bearing part, and the cover plate 3 is used for reinforcement. The substrate 1 and the cover plate 3 are connected into a whole by a connecting structure. Therefore, different thicknesses of cover plate 3 and substrate 1 can be selected according to the patient's condition. For example, a thicker cover plate 3 and substrate 1 can be used for parts with greater load, making the use more flexible. On the other hand, due to the use of biodegradable metal, as the degradation process proceeds, the volume of cover plate 3 begins to shrink, the original tight fit between cover plate 3 and substrate 1 begins to loosen, and the drug between substrate 1 and cover plate 3 begins to be released. Thus, the effect of delayed release is achieved by utilizing the biodegradable properties.

[0037] It is worth noting that the degradable characteristics of the cover plate 3 determine that the fixing system will gradually transition to a structure supported by a single metal, which is lighter and less burdensome to the affected area in the later stages after implantation.

[0038] Specifically, the substrate 1 is a strip-shaped plate, and one surface of the substrate 1 is provided with a mounting groove 11 which has the same shape as the cover plate 3 and is used to accommodate the cover plate 3. In use, the bone screw 23 passes through the substrate hole 21a to fix the substrate 1 to the bone surface. Of course, the profile shape, length or hole 21 position of the substrate 1 can be adjusted according to the different positions used to meet the needs of use, so the product in this embodiment is only illustrative and is not a limitation on the profile shape, length or hole 21 position of the substrate 1.

[0039] The drug loading in this application is achieved by the insertion and combination of the substrate 1 and the cover plate 3, as shown in Figure 6 The substrate 1 is provided with a curved partition strip 12 which is coiled between the substrate hole 21a and the substrate connecting hole 22a; as shown in Figure 7 The cover plate 3 is also provided with a curved partition strip 31 which is coiled between the cover plate hole 21b and the cover plate connecting hole 22b; after the cover plate 3 is inserted into the mounting groove 11 of the substrate 1, the partition strip 31 and the partition strip 12 will be interlaced, as shown in Figure 6 Figure 6 The dashed part in

[0040] The partition strip 31 and the partition strip 12 in this embodiment adopt a shape similar to a sine wave, and a gap is left at the interlaced part of the partition strip 31 and the partition strip 12, so that the partition strip 31 and the partition strip 12 can be inserted and enclosed to form a closed space during cooperation; secondly, the cooperation mode of the partition strip 31 and the partition strip 12 has a limiting effect, which can limit the movement of the cover plate 3 in the mounting groove 11; in addition, after being subjected to tension, the tension received by the substrate 1 will be transmitted to the cover plate 3 through the part where the partition strip 31 and the partition strip 12 are connected and the connecting nail 24, avoiding the concentration of force on the connecting nail 24 part.

[0041] It should be noted that the curved shape of the partition sleeve and the partition strip 12 is not only a sine wave, but also other shapes that can be interlaced, and the sine wave shape in this application is only illustrative.

[0042] In addition, the cover plate 3 is also provided with a partition strip 32 on the surface in contact with the substrate 1, as shown in Figure 7 ​As shown, the stopper 32 is a convex curved isohypse closed figure, which is similar to the shape of the extension of the cover plate, and the cover plate nail hole 21b, the cover plate connecting hole 22b and the block 31 are enclosed therein. After the cover plate 3 is connected with the base plate 1, the stopper 32 is in contact with the bottom surface of the mounting groove 11, and another medicine storage space is formed between the cover plate 3 and the base plate 1, that is, after the cover plate 3 is connected with the base plate 1, two levels of medicine storage spaces are formed at the same time, one is the part enclosed by the partition 31 and the partition 12, and the other is the part enclosed by the stopper 32 and the mounting groove 11, so that the medicine storage capacity is larger.

[0043] On the other hand, the stopper 32 also plays a role of reinforcing the cover plate 3, which is similar to a reinforcing rib.

[0044] As shown in Figure 5 , 7 , after the connecting nail 24 is screwed into the cover plate 3, an outward pulling force is applied to the cover plate 3, and the direction of the pulling force is the length direction of the cover plate 3, that is Figure 1 , the outward extension direction of the A-A line, and this pulling force makes the cover plate 3 in a stressed state, which plays a role of preventing loosening. Specifically, a semispherical protrusion is arranged in the cover plate connecting hole 22b, and the protrusion is not surrounded in the cover plate connecting hole 22b, as shown in Figure 5 , Figure 5 , the dashed part is the shape of the head of the connecting nail 24, so that after being screwed, the connecting nail 24 will apply an outward force to the protrusion, and the connecting hole 22 is located on both sides of the cover plate 3, and the protrusions of the cover plate connecting hole 22b are located on the A-A line and are respectively close to the side of the end portion, so that the tensile force is applied to the direction of the two end portions.

[0045] It is worth noting that after the connecting nail 24 is screwed into the cover plate 3, the cover plate 3 is in a tensile state, which can accumulate stress, facilitate the extension and development of the pitting pit generated in the initial degradation, and further accelerate the degradation of the zinc-based alloy.

[0046] It should be noted that: in order to ensure better use effect, the fracture fixation device of the application does not need to be preassembled, the base plate 1, the cover plate 3, the connecting mechanism, and the like are respectively processed and sterilized and stored in the warehouse; the assembly process is carried out in a sterile environment of the operation; specifically, the installation slot 11 is filled with the medicine first, then the cover plate 3 is placed into the installation slot 11, part of the medicine will overflow from the assembly gap and the nail hole 21 or the connecting hole, then the connecting nail 24 is screwed in to fix the cover plate 3, and the medicine overflowing on the surface and in the nail hole 21 is scraped off, and the surface is coated with anti-inflammatory medicine, then the implantation is carried out according to the predetermined operation process, and the bone nail 23 is screwed in after implantation; the anti-inflammatory medicine coated on the surface can cooperate with the medicine to reduce the inflammatory response in the early stage of implantation, and after the cover plate 3 degrades for a period of time, its volume will be reduced or even a pitted hole will appear, the medicine between the cover plate 3 and the base plate 1 will be released at the beginning, and this time-release process can avoid the inflammatory stage of bone repair and play a role in the bone growth stage, thereby creating favorable conditions for bone growth.

[0047] In the embodiment, the medicine carried in the medicine storage space is a non-liquid medicament such as a freeze-dried powder, and of course, those skilled in the art can also select different combinations of medicines through limited experiments, and the application does not limit the type of medicine carried.

[0048] For the above-mentioned bone implant, it mainly plays a role in fixation and connection, but in use, it is found that after the implant is fixed with the bone surface, there must be a gap between them, and when the bone moves relatively, the implant and the bone surface will inevitably produce friction, which will cause part of the implant to peel off after long-term use, or even the connection to be loose, and further, it may induce adverse reactions such as inflammation; the application adopts the method of preparing a more wear-resistant metal as the outer layer to improve the wear resistance, and tantalum is used as the plating metal in the application; tantalum itself has extremely strong corrosion resistance and good biocompatibility, and bone cells are more likely to proliferate on the surface of tantalum, so as a medical metal, tantalum is mostly in the form of porous tantalum, which promotes bone ingrowth by utilizing its porous structure, and finally forms a bone-metal combination, which is an ideal material for permanent implants; on the contrary, for non-permanent implants, this characteristic will directly cause the implant to adhere to the bone surface, affecting subsequent removal, in order to solve this problem, the application adopts the following scheme.

[0049] S1. Forming of implant product;

[0050] The forming of each part of the implant is completed by machining, and the product machined has relatively high structural strength, and the process is mature, and the cost is greatly reduced.

[0051] S2. Cleaning of product surface;

[0052] After the orthopedic implant is sandblasted, it is cleaned, the surface oil stain is removed with acetone, and then ultrasonic cleaning is performed with ethanol as the cleaning agent.

[0053] S3. Forming of the tantalum coating;

[0054] S31. Magnetron sputtering forming of the tantalum coating: the cleaned implant and the tantalum metal target are installed into the instrument cavity, the position of the orthopedic implant is adjusted, the orthopedic implant is clamped by the clamp, and the parameters of the magnetron sputtering spraying instrument are adjusted: the target power supply voltage is 600 V, the target is a 400*200*4 mm metal tantalum, the protective gas is 99.99% high-purity argon, the sputtering cavity is vacuumed to less than 2*10 - 3 Pa, the argon gas is filled to 2-5 Pa; the target-to-base distance is 20 mm; the cathode is negatively charged at 260-320 V, the Ar ions accelerate to the cathode target under the action of the electric field, and hit the target surface with high energy, causing the target to sputter and deposit on the surface of the orthopedic implant; the magnetron sputtering orthopedic implant is performed for 30-120 min, and the tantalum coating on the surface of the orthopedic implant is between 20-40 μm;

[0055] The coating formed by the magnetron sputtering technology is more compact, which can protect the substrate from contacting with the body fluid environment, and even if medical stainless steel is used, it will not affect the use performance, so the selection range of the substrate is larger, and the cost can be flexibly selected in combination, and the tantalum coating also has excellent ductility, and for the implant which needs to be loaded after implantation, the slight deformation caused by loading will not cause the coating to fall off, and the coating is more stable;

[0056] S32. Polishing: a direct current power supply with a 10 A / 100 V range is used as the polishing power supply, the electrolyte is 90% H2SO4+10% HF, the current density is 0.12 A / cm 2 -0.16 A / cm 2 , two pieces of stainless steel with an area greater than 6 times that of the product are used as cathodes and placed in a plastic electrolytic tank, and the product is used as an anode and placed between the two cathodes, and the roughness of the product is reduced to below 0.1 μm through polishing;

[0057] Of course, the electrolytic polishing is used after fine grinding, and if the surface roughness after magnetron sputtering is high, mechanical polishing needs to be performed first and then electrolytic polishing; and the electrolytic polishing and magnetron sputtering combination of the present application also has the additional technical effect that after the compact tantalum coating is formed, a high-resistance non-metallic compound composed of a semi-conductive passivation film is generated on the surface of the anode during the electrolytic polishing process, the passivation film not only improves the corrosion resistance, but also reduces the bone induction of tantalum, the smooth surface also reduces the adhesion of bone cells, and effectively avoids the adhesion of the bone surface to the product;

[0058] S33. Prepare 1 mg / mL gentamicin solution in water, dissolve the water-soluble gene recombinant bone morphogenetic protein into 8 mg / mL bone growth factor solution or suspension with distilled water, mix the gentamicin solution and the bone growth factor solution or suspension in a ratio of 1:1, and spray the mixed solution onto the surface of the bone implant using an ultrasonic spray device, and dry at room temperature.

[0059] It should be noted that the antibiotic or bone growth promoting component is located on the outermost side, and can have an effect during the pre-implantation period, thereby greatly reducing the occurrence of infection during the pre-implantation period.

[0060] S4. Post-processing, including drying, sterilization, packaging and storage.

Claims

1. A tantalum-modified bone implant, characterized by: It comprises: a substrate, a cover plate, a connecting mechanism, the substrate and the cover plate are combined into a whole through the connecting mechanism, and a space for storing medicine is formed between the two; the cover plate is made of degradable material, the substrate is made of non-degradable material, the cover plate will start to degrade slowly after being implanted in the body, and after a period of degradation, the cover plate and the substrate will be loose, and the medicine in the space between the cover plate and the substrate will start to release; The connecting mechanism comprises a bone screw, the substrate and the cover plate are provided with corresponding screw holes, i.e. substrate screw holes and cover plate screw holes, and the bone screw passes through the screw holes to fix the substrate and the cover plate on the bone surface.

2. A tantalum-modified bone implant as defined in claim 1, wherein: The connecting mechanism further comprises a connecting screw; the substrate and the cover plate are also provided with corresponding connecting holes, i.e. substrate connecting holes and cover plate connecting holes, and the connecting screw passes through the connecting holes to connect the substrate and the cover plate.

3. A tantalum-modified bone implant as defined in claim 2, wherein: The surfaces of the substrate and the cover plate in contact with each other are provided with protruding shapes, and after the substrate and the cover plate are connected, the protruding shapes provided on the surfaces in contact with each other are interlaced and inserted, thereby dividing the space between the substrate and the cover plate into multiple independent spaces.

4. A tantalum-modified bone implant according to claim 3, wherein: The protruding shape on the substrate is a curved partition strip, and the protruding shape on the cover plate is a curved partition strip, and the partition strip is provided with a gap at the position interlaced with the partition strip; after the cover plate and the substrate are connected, the partition strip is inserted into the gap of the partition strip.

5. A tantalum-modified bone implant according to claim 4, wherein: The partition strip and the partition strip are coiled between the substrate screw hole and the substrate connecting hole.

6. The tantalum-modified bone implant of claim 1, wherein: The surface of the cover plate in contact with the substrate is also provided with a curved partition strip, the partition strip is at the same height and curved into a closed figure, and after the cover plate and the substrate are connected, the partition strip is in contact with the substrate, thereby separating an independent space between the cover plate and the substrate.

7. A tantalum-modified bone implant as defined in claim 2, wherein: The head of the connecting screw is a conical surface that converges towards the end of the stud portion, and the cover plate connecting hole is provided with a funnel-shaped slope surface with the same shape as the connecting screw head.

8. A tantalum-modified bone implant as defined in claim 7, wherein: The funnel-shaped slope surface of the cover plate connecting hole is provided with a hemispherical protrusion, and the protrusion is close to the end on one side.

9. The tantalum-modified bone implant of claim 1, wherein: The cover plate is made of one or more of zinc-based alloy, magnesium-based alloy and iron-based alloy, the surface of the substrate has a tantalum modification layer, and the roughness of the side of the substrate in contact with the bone surface is smaller than that of other parts.

10. The tantalum-modified bone implant according to any one of claims 1-9 for non-permanent implantation in the body.

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