Electroplated parts and manufacturing method thereof, as well as manufacturing jigs and equipment

Abstract

The present invention provides electroplated parts that contain almost no organic residues and have a uniform electroplated layer. It also provides an electroplating method for producing electroplated parts, which improves the uniformity of the thickness of the electroplated layer at each portion by controlling the ratio of the length of the electroplated part's movement path relative to the anode during the electroplating process to the anode's width and adding an auxiliary cathode to the electroplated part. It also provides a jig and electroplating apparatus for implementing the electroplating method. The electroplated parts produced by the electroplating method have a relatively uniform electroplated layer thickness, a high electroplated layer coverage, and almost no problems such as burns or breakage during the electroplating process. The electroplated parts have a high yield and low defect rate, and the plating layer weight accuracy between each electroplated part reaches 99% or more.

Description

[Technical Field]

[0001] The present invention relates to the technical field of electroplating, and more particularly to electroplated parts for medical devices, methods for manufacturing the same, and tools and equipment for manufacturing the same. [Background technology]

[0002] Medical devices are ultimately implanted in the human body and interact with human tissues for long periods of time, so they require high safety, excellent biocompatibility, and efficacy. Therefore, high requirements are placed on the composition and content of each component on the device. Not only must each component pass the corresponding safety verification, but the accumulation of degradation products released from each component during the degradation process in the body around the device must not adversely affect the human body. Related research has shown that even trace amounts of organic residues in the electroplated layer of a device can cause significant safety reactions, such as inflammation, pustules, and other adverse reactions. Therefore, to ensure good biocompatibility of electroplated parts in the human body and thereby improve the safety and efficacy of devices in the body, it is essential to control the type and content of each component in the electroplated layer on the device surface.

[0003] Electroplating is now widely used in industry. Industrial electroplating generally involves two main methods: rack plating and barrel plating. Rack plating involves fixing the workpiece in a custom-fitted fixture and then placing the workpiece in the electroplating solution. This method is suitable for large workpieces. Barrel plating involves placing multiple small workpieces in a barrel, applying a constant current from the electroplating power supply, and plating for a corresponding period of time to achieve the desired plating layer thickness. Currently, this method is primarily used for electroplating small workpieces. It is relatively simple to operate and facilitates mass production.

[0004] However, various organic additives are often added to the electroplating solutions currently used in industrial electroplating. While the presence of various organic additives allows for relatively high uniformity and electroplating precision in industrial electroplated parts, in the case of medical devices, these organic additives are deposited to a greater or lesser extent on the surface of the device substrate along with the electroplating layer, resulting in a certain amount of residue on the electroplating layer. Even trace amounts of organic residue can have serious adverse effects at the device implant site, causing safety and other issues. Therefore, there is an urgent need to develop an electroplating method suitable for medical devices. Summary of the Invention [Problem to be solved by the invention]

[0005] To overcome the above-mentioned shortcomings of the prior art, the present invention provides an electroplated part for a medical device suitable for application to the human body, in which the types and contents of components in the electroplated layer are strictly controlled to avoid causing toxicity to cells and tissues, severe inflammatory reactions, and other adverse reactions after implantation in the human body. The present invention provides an electroplated part with high biological safety. [Means for solving the problem]

[0006] The technical solution of the present invention provides an electroplated part comprising a substrate and an electroplated layer coated on the substrate, wherein the content of organic residues in the electroplated layer is less than 0.2%. During the manufacturing process of electroplated parts, various substances, particularly certain functional organic substances, are added to the electroplating solution. These substances can significantly improve the quality of the electroplated part, such as the efficiency, uniformity, and brightness of the electroplating. However, these functional organic substances have specific functional groups that carry specific charges or adsorb in the solution, making them prone to being deposited on the electroplated layer during the electroplating process. After an electroplated part or a finished medical device is implanted in the human body, trace amounts of organic residues deposited on the electroplated layer may gradually be released into the human blood as the electroplated layer decomposes, potentially causing a series of adverse reactions, such as biological toxicity. Therefore, to avoid serious safety issues caused by trace components, it is necessary to strictly control the various components in the electroplated layer of electroplated parts for medical devices.

[0007] Furthermore, the content of organic residues in the electroplated layer according to the present invention is less than 0.1%, furthermore, the content of organic residues in the electroplated layer is less than 0.05%, furthermore, the content of organic residues in the electroplated layer is less than 0.019%, furthermore, the content of organic residues in the electroplated layer is less than 0.01%, and furthermore, the electroplated layer according to the present invention contains almost no organic residues.

[0008] The uniformity of the thickness of the electroplated layer at various portions of a medical device not only significantly affects the corrosion rate, corrosion cycle, device failure time, and effective support time of the substrate, but also may lead to fibrin deposition and tissue proliferation near the device. Cell proliferation in the narrowed portion of the lumen can cause the lumen to narrow again. Therefore, it is extremely necessary to control the uniformity of the thickness of the electroplated layer on the surface of the device at various portions of the substrate to ensure that the device meets the corrosion rate, corrosion cycle, and effective support time while avoiding cell proliferation and restenosis of the lumen, thereby improving the safety and effectiveness of the device in vivo.

[0009] In the above technical solutions according to the present invention, the ratio of the thickness of the thickest portion of the electroplating layer on the substrate to the thickness of the thinnest portion is controlled to be (1-30):1; the ratio of the thickness of the thickest portion of the electroplating layer on the substrate to the thickness of the thinnest portion is (1-20):1; the ratio of the thickness of the thickest portion of the electroplating layer on the substrate to the thickness of the thinnest portion is (1-15):1; the ratio of the thickness of the thickest portion of the electroplating layer on the substrate to the thickness of the thinnest portion is (1-12):1; the ratio of the thickness of the thickest portion of the electroplating layer on the substrate to the thickness of the thinnest portion is (1-8):1; the ratio of the thickness of the thickest portion of the electroplating layer on the substrate to the thickness of the thinnest portion is (1-5):1; and the ratio of the thickness of the thickest portion of the electroplating layer on the substrate to the thickness of the thinnest portion is (2-5):1.

[0010] According to the electroplated part of the above technical solution, the thickness of the thickest part of the electroplated layer on the substrate is (1,7.5) times the average thickness, and further, the thickness of the thickest part of the electroplated layer on the substrate is (1,5) times the average thickness. Once the average thickness of the electroplated layer is determined, the closer the ratio of the thickness of the thickest part of the electroplated layer on the substrate to the average thickness is to 1, the more uniform the electroplated layer will be.

[0011] According to the electroplated part of the above technical solution, the thickness of the thinnest part of the electroplated layer on the substrate is [0.25, 1] ​​times the average thickness. Once the average thickness of the electroplated layer is determined, the closer the ratio of the thickness of the thinnest part of the electroplated layer on the substrate to the average thickness is to 1, the more uniform the electroplated layer will be.

[0012] The present invention controls the uniformity of the electroplated layer by controlling the ratio of the thickness of the thickest portion of the electroplated layer on the substrate to the thickness of the thinnest portion, the ratio of the thickness of the thickest portion of the electroplated layer to the average thickness of the electroplated layer, and the ratio of the thickness of the thinnest portion of the electroplated layer to the average thickness of the electroplated layer. It is important to avoid areas of the electroplated layer being too thick or too thin. If an area is too thin, the electroplated layer in that area will be completely decomposed prematurely, resulting in the electroplated layer being unable to properly perform its corresponding functions, such as controlling corrosion of the substrate or promoting endothelialization. On the other hand, if an area of ​​the electroplated layer is too thick, after the nearby thin electroplated layer is completely decomposed, the subsequent decomposition rate in the thicker area of ​​the electroplated layer will be accelerated due to potential or other reasons, resulting in the release of large amounts of decomposition products of the components of the electroplated layer in a short period of time. This may lead to excessive accumulation of the decomposition products in a short period of time, which may cause toxic reactions in certain cells or tissues. For example, when electroplating a zinc-containing layer on a ferrous device to control the initial corrosion rate and mechanical properties of the ferrous material, if the zinc plating layer is too thin in some areas, the zinc layer will decompose prematurely in those areas, exposing the ferrous material, leading to premature corrosion and rupture. Furthermore, in some application scenarios, if the zinc plating layer is too thin in some areas, it can have a significant negative impact on device endothelialization. On the other hand, if the zinc plating layer is too thick in some areas, a large amount of zinc will remain in those areas after the nearby zinc layer is completely corroded and decomposed. Under the influence of electrical potential, the release rate of the zinc layer in those areas will be significantly accelerated. As a result, a large amount of zinc ions will accumulate in those areas in a short period of time, causing cytotoxicity and ultimately problems such as fibrin deposition and cell proliferation. Therefore, the present invention controls the above ratio of the electroplating layer to control the uniformity of the plating layer and ensure that the plating layer can perform its function without causing other adverse effects.

[0013] In the electroplated parts according to the above technical solutions, the average thickness of the electroplated layer is 0.5 to 5 μm, and even 0.5 to 4 μm. The electroplated layer typically plays a crucial role in the device, such as preventing substrate corrosion, ensuring the substrate's initial mechanical properties, and promoting endothelialization. If the plating layer is too thin, it cannot fulfill these roles. If the plating layer is too thick, other adverse effects, such as the device being too large and difficult to transport within the body, will occur, reducing the overall mechanical properties of the device. The plating layer is a foreign substance to the human body, and if its content is too high, it will increase the burden on the human body and inevitably cause a series of adverse reactions. If the zinc plating layer on an iron-based stent is too thin or its average thickness is too thin, it will be prone to early corrosion of the iron, making it difficult to ensure that the iron is not corroded or only slightly corroded within six months of implantation, resulting in early device failure. If the zinc-plated layer on the iron-based stent is too thick, the external shape of the pressed stent will be too large, making it difficult to transport after implantation in the human body. At the same time, a large amount of zinc ions will accumulate near the device, causing cytotoxicity and easily leading to cell proliferation and vascular restenosis.

[0014] The "average thickness D of the electroplated layer" in the present invention is the total mass M of the electroplated layer. 総 , density ρ, sum of the area of ​​all electroplatable surfaces of the electroplating layer S 総 Based on this, it is calculated by the following formula: JPEG2024022535000001.jpg12145

[0015] Furthermore, the present invention strictly controls the thickness of the thickest and thinnest parts of the electroplated layer, thereby further ensuring the uniformity of the electroplated layer and ensuring that the electroplated layer has as little adverse effects on the human body as possible and fully meets the corresponding functional requirements.

[0016] In the above technical solutions according to the present invention, the thickness of the thinnest portion of the electroplated layer on the substrate is 0.25 μm to 4.25 μm, the thickness of the thinnest portion of the electroplated layer on the substrate is 0.375 μm to 3.2 μm, the thickness of the thinnest portion of the electroplated layer is 0.6 μm to 3.2 μm, and the thickness of the thinnest portion of the electroplated layer is 0.6 μm to 2.5 μm.

[0017] In the above technical solutions according to the present invention, the thickness of the thickest portion of the electroplated layer on the substrate is 1.1 μm to 15 μm, further, the thickness of the thickest portion of the electroplated layer on the substrate is 1.1 to 9.75 μm, further, the thickness of the thickest portion of the electroplated layer on the substrate is 1.1 to 7.5 μm, and further, the thickness of the thickest portion of the electroplated layer on the substrate is 1.2 to 5 μm.

[0018] According to the electroplated part of the above technical solution, the electroplated layer covers more than 99% of the surface of the substrate, and further, the electroplated part covers more than 99.5% of the surface of the substrate, and further, the electroplated part covers more than 99.9% of the surface of the substrate.

[0019] According to the electroplated part of the above technical solution, the electroplated layer is a pure metal layer or an alloy layer. The electroplated layer may be degradable or non-degradable as needed. Furthermore, the electroplated layer is degradable. In some embodiments of the present invention, the electroplated layer is a pure zinc layer; in some embodiments of the present invention, the electroplated layer is a zinc-iron alloy layer; in some other embodiments of the present invention, the electroplated layer is a pure iron layer; in some further embodiments of the present invention, the electroplated layer is a pure magnesium layer; and in some further embodiments of the present invention, the electroplated layer is a magnesium alloy layer.

[0020] According to the electroplated part of the above technical solution, the electroplated layer is a pure zinc layer or a zinc alloy layer, and the zinc content in the electroplated layer is 50% or more, and the zinc content in the electroplated layer is 99% or more.

[0021] According to the technical solution of the above technical solution, the device is a vascular stent, a non-intravascular stent, an occluder, an orthopedic implant, a heart valve, a spacer, an artificial blood vessel, a dental implant device, a vascular clamp, a dental implant, a respiratory implant, a gynecological implant, a male medical implant, a suture and a bolt.

[0022] According to the technical solution of the above technical solution, the device is a degradable medical device that can be gradually degraded in the body and absorbed by the human body. Furthermore, the substrate of the present invention is a degradable metal or a degradable non-metallic material, and further, the substrate of the present invention is a degradable pure metal or metal alloy, and further, the substrate of the present invention includes at least one of pure iron, iron alloy, pure zinc, zinc alloy, pure magnesium, and magnesium alloy.

[0023] Furthermore, the electroplated part in the above technical solution of the present invention is a tubular hollowed-out medical device. Furthermore, the electroplated part according to the above technical solution of the present invention is a stent or other derivatives having a stent structure, such as a heart valve. The stent in the present invention includes a vascular stent and a non-vascular stent.

[0024] According to the above technical solution of the present invention, the mass-to-volume ratio of the electroplated part is 0.001-10 g / cm 3 and the mass-to-volume ratio of the electroplated part is 0.001 to 5 g / cm. 3 and the mass-to-volume ratio of the electroplated part is 0.001 to 0.4 g / cm. 3 and the mass-to-volume ratio of the electroplated part is 0.005 to 0.3 g / cm. 3and the mass-to-volume ratio of the electroplated part is 0.01 to 0.2 g / cm. 3 In the present invention, the smaller the mass-to-volume ratio of the electroplated part, the more complex the structure of the electroplated part and the more difficult it is to electroplate.

[0025] JPEG2024022535000002.jpg34170

[0026] According to the technical solution of the above technical solution, the substrate is a decomposable metal or a decomposable non-metallic material, and further, the substrate includes at least one of pure iron, iron alloy, pure zinc, zinc alloy, pure magnesium, and magnesium alloy, and further, the iron alloy includes at least one of low-alloy steel or an iron-based alloy with a carbon content of 2.5 wt.% or less.

[0027] To ensure the safety of the electroplated parts of the present invention, the composition of the electroplating solution is strictly controlled in the manufacturing process of the electroplated parts of the present invention to ensure that the components deposited on the plating layer have excellent biocompatibility and do not cause serious adverse reactions. Restrictions on the components added to the electroplating solution inevitably affect the uniformity of the electroplated layer and other indicators. Electroplated parts for medical devices are mainly used inside the human body, often have some kind of function, and have complex shapes and precise structures, so they have high requirements for the uniformity of the electroplated layer, the coverage rate of the plating layer, and the mass accuracy of the plating layer. Direct use of conventional electroplating methods for electroplating is likely to result in problems such as low coverage rate of the electroplated layer on electroplated parts, burning or fracture of some device parts, and low yield, resulting in substandard quality of electroplated parts that do not meet the corresponding quality and safety requirements.

[0028] Based on this, the present invention provides a method that can avoid introducing a large amount of organic residue into the electroplated layer of the electroplated part and ensure that the electroplated layer has good uniformity.

[0029] The present invention provides an electroplating method suitable for electroplating parts that require high uniformity and safety of the electroplated layer. Meanwhile, this method can significantly improve the in vivo safety of the electroplated part, without causing obvious inflammatory reactions or pustules on contacted tissues, and also ensure uniformity of the plating layer thickness at each part, optimizing various indicators of uniformity of the electroplated part, thereby significantly improving the uniformity of the electroplated part.

[0030] The technical solution of the present invention provides a method for electroplating a part, in which the part to be electroplated is immersed in an electroplating solution and moved together with a jig relative to an anode with a specific amplitude and frequency, wherein the length of the movement trajectory of the part to be electroplated relative to the anode during the electroplating process is 2 to 980 times the width of the anode, and / or an auxiliary cathode is connected to the part to be electroplated.

[0031] In the present invention, the ratio of the length of the path of movement of the electroplating part relative to the anode during the electroplating process to the width of the anode is increased to improve the uniformity of the electroplating at each portion of the electroplating part, while connecting an auxiliary cathode to the electroplating part also improves the uniformity of the electroplating at each portion of the electroplating part. The greater the ratio of the length of the path of movement of the electroplating part relative to the anode during the electroplating process to the width of the anode, the more uniform the thickness of the electroplating layer at each portion of the electroplating part. However, as the ratio of the length of the path of movement of the electroplating part relative to the anode during the electroplating process to the width of the anode increases, the requirements for the size of the electroplating bath, the amount of electrolyte used, and the amount of electricity consumed increase. The greater the ratio of the length of the path of movement of the electroplating part relative to the anode during the electroplating process to the width of the anode, the larger the size of the electroplating bath must be, which results in a corresponding decrease in the amount of electrolyte used and electricity consumed, resulting in resource waste and even increased emissions. If the ratio of the length of the path of movement of the electroplated part relative to the anode during the electroplating process to the width of the anode is small, for example, less than 2, the thickness uniformity across each portion of the electroplated part will be significantly reduced, resulting in the device's thinnest part being less than 0.2 μm, reducing the effectiveness of the manufactured device after implantation in the body. In another aspect, the present invention improves the uniformity of the electroplating across each portion of the electroplated part by connecting an auxiliary cathode to the electroplated part. During the electroplating process of the device, the thickness of the electroplated layer increases toward both ends, and also increases toward the outer layers and decreases toward the center, with the thickness of the electroplated layer decreasing toward the inner layers. Furthermore, electroplating has a tip advantage, where the thickness of the electroplated layer increases toward the tip and decreases away from the tip. Therefore, during the electroplating process, the thickness of the electroplated part increases at both ends and becomes relatively uniform in the center. Therefore, in the present application, by adding auxiliary cathodes at both ends of the electroplating part during the electroplating process, the uniformity of the electroplated layer on each portion of the electroplating part is improved.

[0032] The electroplating part in the present invention is connected to the electroplating apparatus via a jig and can move relative to the anode driven by the jig, or can be fixed and not moved by the jig, with the anode moving under the drive of a driver. That is, in the present invention, "the electroplating part moves relative to the anode during the electroplating process" can mean that the electroplating part moves relative to the anode without moving the anode, or the electroplating part can be stationary and the anode can move relative to the electroplating part.

[0033] In the present invention, the movement trajectory of the electroplated part relative to the anode during the electroplating process may be linear, curved, circular, conical, regular polygonal, or irregular polygonal. In some embodiments of the present invention, the electroplated part is driven by a fixture to perform a curved movement relative to the anode. In some embodiments of the present invention, the electroplated part is driven by a fixture to perform a linear movement relative to the anode. In some other embodiments of the present invention, the electroplated part is driven by a fixture to perform a regular polygonal movement relative to the anode. In some further embodiments of the present invention, the electroplated part is driven by a fixture to perform an irregular polygonal movement relative to the anode. In still some embodiments of the present invention, the electroplated part is driven by a fixture to perform a circular movement relative to the anode.

[0034] Furthermore, the length of the path of movement of the electroplated part relative to the anode during the electroplating process is 2 to 540 times the width of the anode, the length of the path of movement of the electroplated part relative to the anode during the electroplating process is 2 to 400 times the width of the anode, the length of the path of movement of the electroplated part relative to the anode during the electroplating process is 2 to 240 times the width of the anode, and the length of the path of movement of the electroplated part relative to the anode during the electroplating process is 2 to 150 times the width of the anode. In the present invention, by reducing the ratio of the length of the path of movement of the electroplated part relative to the anode during the electroplating process to the width of the anode, the uniformity of the plating film on the surface of the electroplated part is ensured, while eliminating waste of resources, suppressing costs, and minimizing waste liquid discharge as much as possible.

[0035] In some embodiments of the invention, the length of the path of movement of the electroplated part relative to the anode during the electroplating process is 3, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 150, 180, 190, 200, 220 times the width of the anode. In some embodiments of the invention, the length of the path of movement of the electroplated part relative to the anode during the electroplating process is 65, 75, 85, 25, 35, 45, 55, 95, 105, 125, 160, 170, 195 times the width of the anode.

[0036] In this invention, the term "length of the movement trajectory of the electroplated part relative to the anode during the electroplating process" refers to the length of the trajectory of the electroplated part moving once relative to the anode during the electroplating process, and the term "width of the anode" refers to the width of one anode.

[0037] In the present invention, the uniformity of the electroplated layer on each part of the electroplated part can be significantly improved by controlling the relationship between the length of the path of movement of the electroplated part relative to the anode and the width of the anode. By controlling the length of the path of movement of the electroplated part relative to the anode during the electroplating process within the range of 2 to 240 times the width of the anode, the uniformity of the electroplated layer can be significantly improved, thereby ensuring that the device meets the corrosion rate, corrosion cycle, and effective support time while reliably avoiding cell proliferation and restenosis of the lumen.

[0038] Furthermore, the present invention increases the ratio of the movement path of the electroplating part relative to the anode to the width of the anode during the electroplating process by decreasing the width of the anode and / or increasing the length of the cathode or increasing the swing range of the jig, and controlling the effective swing length of the jig. By adjusting each parameter simultaneously or individually, the corresponding objective, i.e., improving the uniformity of the plating layer on the electroplated part, can be achieved.

[0039] Furthermore, the width of the anode is 0.1 cm or more. In some embodiments of the present invention, the width of the anode may be 0.1 cm, in some other embodiments of the present invention, the width of the anode may be 5 cm, in some other embodiments of the present invention, the width of the anode may be 10 cm, and in some embodiments, the width of the anode may be 20 cm or more. In the present invention, there is no further limitation on the width of the anode, but when the length of the movement path of the electroplating part relative to the anode during the electroplating process is constant, the smaller the width of the anode, the higher the thickness uniformity at each portion of the electroplating part.

[0040] According to the above technical solution of the present invention, the present invention further controls the uniformity of the electroplated layer by adjusting the swing range of the electroplated part relative to the anode, and controls the swing range of the electroplated part relative to the anode in the range of 0° to 180°. Furthermore, the present invention further controls the uniformity of the electroplated layer by adjusting the swing range of the electroplated part relative to the anode, and controls the swing range of the electroplated part relative to the anode in the range of 0° to 160°. When the electroplated part moves in a curved, linear, or conical motion relative to the anode, the swing range of the electroplated part relative to the anode is (0°, 160°). When the electroplated part moves in a circular, regular, or irregular polygonal motion relative to the anode, the swing range of the electroplated part relative to the anode is 0°. When the electroplated part moves in a curved, linear, or conical motion relative to the anode, the swing range of the electroplated part relative to the anode can also be (0°, 150°) or (0°, 145°). In some embodiments of the present invention, the swing range of the electroplated part relative to the anode can be (0°, 150°) or (0°, 145°). The swing range of the electroplated part relative to the anode is 0.5°, 0.8°, 1°, 2°, 5°, 8°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, or 60°; in some other embodiments of the invention, the swing range of the electroplated part relative to the anode is 70°, 80°, 90°, 100°, 110°, 120°, 130°, or 135°; in some other embodiments of the invention, the swing range of the electroplated part relative to the anode is 138°, 140°, 145°, 148°, 150°, 155°, or 158°.

[0041] In this invention, the "swing amplitude of the electroplated part relative to the anode" refers to the magnitude of the angle between the two connecting lines formed by the highest point at two relative positions of the movement locus of the electroplated part relative to the anode and the fixed point / rotation point or each of the intersections thereof that move the electroplated part. For example, if the movement locus of the electroplated part relative to the anode is curved or straight, it is the angle formed by the connecting lines between the highest point at both ends of the curved or straight locus and each of the fixed points / rotation points that move the electroplated part. If there are two fixed points or rotation points, it is the angle formed by the connecting lines between the highest point at both ends of the curved or straight locus and each of the intersections of the two fixed points / rotation points that move the electroplated part.

[0042] Furthermore, in the present invention, auxiliary cathodes are connected to both ends of the electroplated part in the longitudinal direction or in the direction parallel to the anode surface. By connecting the auxiliary cathodes to both ends of the electroplated part in the longitudinal direction or in the direction parallel to the anode surface and removing the auxiliary cathodes after electroplating is completed, the thickness uniformity at each part of the device can be significantly improved.

[0043] Furthermore, the area of ​​the auxiliary cathode accounts for 30% to 70% of the cathode area. Furthermore, the length of the auxiliary cathode is 0.5 mm to 20 mm. Preferably, the length of the auxiliary cathode is 0.5 mm to 10 mm, more preferably 1 mm to 10 mm. By rationally adjusting the area ratio of the auxiliary cathode to the entire cathode and / or the length of the auxiliary cathode, it is possible to improve the thickness uniformity of the electroplated layer on the device while maintaining high reproducibility or precision, thereby increasing the pass rate of the device electroplating process.

[0044] In the present invention, the cathode area in the phrase "the area of ​​the auxiliary cathode occupies 30% to 70% of the cathode area" includes the surface area of ​​the stent, the exposed area of ​​the jig, and the area of ​​the auxiliary cathode.

[0045] Furthermore, the auxiliary cathode may have any shape. Furthermore, the auxiliary cathode may have at least one of a linear shape, an annular shape, a circular shape, a prismatic shape, a conical shape, a spiral shape, a ring shape, a cylindrical shape, and a wave shape. In some embodiments, the auxiliary cathode has one of the above shapes. In some other embodiments, the auxiliary cathode is a combination / connection of at least two of the above shapes. In some other embodiments, the auxiliary cathode is composed of any one of the above shapes. In some other embodiments, the auxiliary cathode is composed of a plurality of the above shapes. In some embodiments, the various shapes described above can be combined / connected along the short axis of the device to form the auxiliary cathode. In some other embodiments, auxiliary cathodes of the various shapes described above can be combined / connected along the long axis of the device.

[0046] In the present invention, the "prismatic, conical, spiral, ring, and cylindrical" shapes may be solid, hollow, or hollow.

[0047] Furthermore, the cross-sectional area of ​​the auxiliary cathode perpendicular to the anode surface or along the long axis of the electroplated part is larger than the cross-sectional area of ​​the electroplated part along the short axis, i.e., the auxiliary cathode completely covers the interface of the device at its distal end, i.e., the projection of the auxiliary cathode on an interface perpendicular to the long axis of the device is larger than the projection of the device on that interface.

[0048] Additionally, the auxiliary cathodes and the electroplating components are connected via connecting rods or points. In some embodiments of the present invention, multiple auxiliary cathodes in a linear configuration are connected at specific points at the distal end of the device to form an outwardly radiating umbrella-like structure. In some other embodiments of the present invention, multiple auxiliary cathodes in a ring-shaped configuration are connected together layer by layer along the longitudinal axis of the device via connecting rods.

[0049] Furthermore, the connecting rod is fixedly or detachably connected to the electroplating part, the jig, and the auxiliary cathode. In some embodiments of the present invention, the auxiliary cathode having the above shape may be detachably connected to all of the electroplating part, the jig, and the auxiliary cathode, or may be detachably connected to only a part of them, and in the latter case, the remaining parts are fixedly connected.

[0050] Furthermore, the shape of the connecting rod may be one of straight and non-straight, and the connecting rod is at least one of straight, S-shaped, ω-shaped, and Ω-shaped.As in some embodiments of the present invention, the auxiliary cathode is a hollow cylindrical shape.

[0051] Furthermore, the connecting rod is detachably or fixedly connected to at least one of an electroplating part, a jig, and an auxiliary cathode. In some embodiments, the connecting rod is ω-shaped or Ω-shaped, the auxiliary cathode is a hollow cylindrical shape, and the auxiliary cathode is fixedly connected to the device via the connecting rod.

[0052] According to the above technical solution of the present invention, the present invention further controls the quality, such as the uniformity of the plating layer, by adjusting the frequency of movement of the electroplated part relative to the anode, and the frequency of movement of the electroplated part relative to the anode is controlled to 0.1 to 20 seconds per revolution, further controlled to 0.2 to 18 seconds per revolution, and further controlled to 0.2 to 15 seconds per revolution. In some embodiments of the present invention, the frequency of movement of the electroplating part relative to the anode is 0.3 s / cycle, 0.8 s / cycle, 1 s / cycle, 2 s / cycle, 3 s / cycle, 4 s / cycle, 5 s / cycle, 7 s / cycle, 8 s / cycle, 9 s / cycle, 10 s / cycle, or 11 s / cycle, and in some other embodiments of the present invention, the frequency of movement of the electroplating part relative to the anode is 12 s / cycle, 13 s / cycle, 14 s / cycle, 15 s / cycle, 16 s / cycle, 17 s / cycle, 18 s / cycle, or 19 s / cycle. By adjusting the frequency of movement of the electroplating part relative to the anode, the present invention can avoid problems such as sparks and deformation of the stent due to a frequency that is too low, while avoiding problems such as a deterioration in the quality of the plating layer due to a frequency that is too high.

[0053] For electroplated parts with a lightweight hollowed-out shape, such as the stent described in the present invention, the interaction force between the stent and the jig is small due to the effect of buoyancy in the electroplating solution and the small mass of the electroplated part. Furthermore, electroplated parts require a high plating coverage, meaning that the contact area between the jig and the electroplated part must be very small, so that almost the entire surface of the stent is exposed to the electroplating solution. In this case, if the current density is relatively high, the stent rod is prone to breakage due to "ignition," even resulting in partial burning or fracture of the stent rod. Therefore, the present invention controls the interaction force and contact area between the jig and the stent by improving the shape of the jig and the interaction relationship between the jig and the stent. Controlling the magnitude of this interaction force can avoid "ignition," stent burning, or fracture due to insufficient interaction between the jig and the stent, and can prevent stent rod deformation due to excessive interaction force between the jig and the stent, further improving stent yield and reducing the reject rate in the electroplating process. Therefore, the technical solution of the present invention overcomes the burning and breaking of the stent rod by controlling the force applied to the electroplating part by the jig during the electroplating process. This force is less than 1×10 -3 -0.5N, and the force exerted by the jig on the electroplating part during the electroplating process is 1×10 -3 -0.35N, and the force exerted by the jig on the electroplating part during the electroplating process is 1×10 -3 It is -0.28N.

[0054] In the embodiment of the present invention, the jig Electroplated parts The acting force is simply called the clamping force.

[0055] In the present invention, the force applied to the electroplated part by the jig during the electroplating process is closely related to the electroplated part itself, and if the mass, shape, etc. of the electroplated part changes, the range of force applied to the electroplated part by the jig will also change. For example, for the 30018 stent, if the force applied by the jig is within the range of 0.005 to 0.05 N, the stent will not be deformed or burned. For stents larger than the 30018 stent, the optimal force range exceeds 0.05 N and even reaches 0.5 N. For orthopedic devices, which weigh significantly more than the stent, the appropriate maximum force will be larger. On the other hand, for stents or medical devices smaller than the 30018 stent, the appropriate minimum and maximum force applied by the jig will be smaller than those of the 30018 stent.

[0056] According to the above technical solution of the present invention, in the present invention, the acting force applied to the electroplating part by the jig during the electroplating process is a pressing acting force.

[0057] According to the above technical solution of the present invention, the contact area between the electroplated part and the jig is 0.1 mm 2 In the present invention, by controlling the shape of the jig, the contact between the jig and the electroplated part is not surface-to-surface contact but point-to-point contact or point-to-surface contact. Therefore, the contact area between the jig and the electroplated part is 0.1 mm 2 The contact area is very small, at less than 0.1%, with the total contact area accounting for less than 0.1% of the total surface area of ​​the stent. In the present invention, by controlling the contact area between the electroplating part and the jig, the exposed area of ​​the electroplating part in the electroplating solution is sufficiently increased, allowing 99%, or even 99.9%, or more of the stent surface to be in direct contact with the electroplating solution, i.e., 99%, or even 99.9% or more of the stent surface is covered with the electroplating layer. Therefore, the coverage of the electroplating layer is very high, effectively preventing corrosion and safety problems caused by insufficient coverage of the bracket surface with the plating layer.

[0058] In the present invention, the contact area between the electroplated part and the jig is 0.1 mm 2 , the total contact area accounts for less than 0.1% of the total surface area of ​​the stent. Therefore, the exposed area of ​​the electroplated part in the electroplating solution corresponds to the area of ​​the electroplated part, and refers to the area of ​​all electroplated parts that can directly contact the electroplating solution. If the electroplated part is a stent, the area of ​​the electroplated part includes the area of ​​each surface of the stent rod, that is, the total area of ​​all surfaces of the stent that can directly contact the solution.

[0059] According to the above technical solution of the present invention, the temperature of the electroplating solution during the electroplating process of the electroplated parts is 10-50°C, and the current density of the electroplating is 1-20 A dm 2 In the present invention, the current density of the electroplating must be consistent with the electroplating speed, but at the same time, it must be comprehensively adjusted in combination with the contact area and applied force between the electroplating part and the jig.

[0060] According to the above technical solution of the present invention, the electroplating time of the electroplating part during the electroplating process is 10 to 300 seconds, and further, the electroplating time of the electroplating part during the electroplating process is 10 to 95 seconds. In the present invention, the average thickness of the electroplating layer is controlled by a combination of current, current density and electroplating time.

[0061] The electroplating method of the present invention is suitable for plating various alloys such as zinc, nickel, copper, silver, gold, and zinc-copper alloys. The electroplating components of the present invention are made of degradable materials and are suitable for electroplating pure iron or iron alloys, as well as zinc, zinc alloys, and other metals. It is also suitable for electroplating stents and other non-stent devices.

[0062] In the present invention, the anode material is controlled according to the composition of the plating layer, and if the plating layer contains zinc, the anode is zinc, if the plating layer is silver, the anode is silver, etc. The anode in the present invention may be at least one of zinc, nickel, copper, nickel-copper alloy, nickel-zinc alloy, gold, and copper-gold alloy.

[0063] The electroplating method of the present invention also relates to the components of the electroplating solution. When the electroplated part in the present invention is a medical device, the requirements for the components of the electroplating solution are very high. Components harmful to the human body must not be introduced into the electroplating solution. Therefore, the present invention provides a safe electroplating solution formulation. Because it does not contain any organic functionalizing agents, organic residues with poor biocompatibility will not be mixed into the electroplated layer of the final electroplated part, and will not cause serious adverse reactions in human tissues at the implantation site. Therefore, the safety of the medical device and the effectiveness of the implant are greatly improved.

[0064] Furthermore, each component of the electrolyte solution according to the present invention is an inorganic component, and no organic additives are present in the electrolyte solution.

[0065] Furthermore, when the plating layer contains zinc, the electroplating solution contains 3.4 to 4.5 wt.% of a zinc-containing component and 2.1 to 3.1 wt.% of a pH adjuster, or the electroplating solution contains 1.5 to 3.0 wt.% of a zinc-containing component and 6.5 to 8.8 wt.% of a pH adjuster; the zinc-containing component is at least one of zinc chloride, zinc sulfate, and zinc oxide; The pH adjuster is at least one of boric acid, sodium borate, potassium borate, calcium borate, sodium hydroxide, and potassium hydroxide.

[0066] The jig further includes a connecting portion and a clamping portion connected perpendicularly to the connecting portion, the clamping portion being parallel to the longitudinal axis of the electroplated component, and the connecting portion having at least two connecting rods at an end closer to the electroplated component. In the present invention, the two or more clamping portions and the connecting rods cooperate to "clamp" the electroplated component, allowing the electroplated component to remain relatively stable during the electroplating process and preventing burns or breakage. In some embodiments of the present invention, the number of connecting rods and clamping portions is two, in some other embodiments, the number of connecting rods and clamping portions is three, and in some embodiments, the number of connecting rods and clamping portions is four, five, six, eight, or more.

[0067] above According to the jig of the above technical solution, the distance between each pair of the connecting rods is smaller than the distance between the electroplated parts and the corresponding contact points of the connecting rods. Furthermore, the distance between each pair of the connecting rods is smaller than the distance between the electroplated parts and the corresponding contact points of the connecting rods [0 .The distance between each pair of connecting rods is [0.6, 0.98] times the distance between the electroplated part and the corresponding contact points of the connecting rods, [0.6, 0.95] times the distance between the electroplated part and the corresponding contact points of the connecting rods, [0.7, 0.95] times the distance between the electroplated part and the corresponding contact points of the connecting rods, and [0.8, 0.95] times the distance between the electroplated part and the corresponding contact points of the connecting rods. When there are two connecting rods and two clamping parts, the two connecting rods and two clamping parts of the jig clamp both ends of the electroplated part in the longitudinal direction. In this case, the distance between each pair of connecting rods is the width of the jig, and the distance between the electroplated part and the corresponding contact points of the connecting rods is the length of the electroplated part. However, the connecting rods and clamping parts of the jig in the present invention can clamp the electroplated part not only in the longitudinal direction but also in the thickness and width directions of the electroplated part. In particular, if the electroplated part has another special structure, it can be clamped from the center or from another part. For example, if the electroplated part is a stent, the connecting rods and clamping parts of the jig can clamp any two stent rods of the stent. The jig of the present invention controls the force applied to the electroplated part by controlling the distance between each pair of connecting rods to be the ratio of the distance between the electroplated part and the corresponding contact point of the connecting rod.

[0068] According to the jig of the above technical solution, the jig contacts the electroplating part at points or points, and the clamping portion may be cylindrical or cubic, and may be regular or irregular.

[0069] According to the jig of the technical solution described above, the ratio of the distance between the line connecting any two points on a cross section of the electroplated part perpendicular to the longitudinal direction of the clamping part to the inner diameter of the electroplated part is 1:1 to 1:20. The smaller the distance between the line connecting any two points on a cross section of the electroplated part perpendicular to the longitudinal direction of the clamping part relative to the inner diameter of the electroplated part, the smaller the contact area with the device, which contributes to the full electroplating of the device surface. The contact area between the electroplated part and the jig described in the present invention is 0.1 mm 2 The following is the result.

[0070] According to the jig of the above technical solution, the length of the clamping portion of the jig is 0.16 to 7 mm. The length of the jig side not only affects the weight of the final plating layer on the electroplated part, but also the interaction force between the jig and the electroplated part. If the jig side length is too long, more plating will be deposited on the jig side during the electroplating process, significantly reducing the quality of the actual plating layer on the electroplated part. If the jig side length is too short, the electroplated part will not be clamped properly, making the electroplated part more likely to slip during the electroplating process.

[0071] According to the jig of the above technical solution, the surface of the jig ofAt least 95% of the jig surface is covered with an insulating layer, or at least 25% of the jig surface is covered with an insulating layer. In some technical solutions of the present invention, the surface of the jig exposed to the electroplating solution is covered with an insulating layer as much as possible, thereby reducing the plating solution on the jig, thereby enabling control of the weight of the plating layer covering the electroplated parts and increasing the accuracy of control. The number of electroplated parts is small, allowing weight control and high accuracy. In some embodiments of the present invention, the insulating layer covers the entire surface of the connecting part. In some embodiments of the present invention, the insulating layer covers most of the surface of the connecting part. In some other embodiments of the present invention, the insulating layer covers the surfaces of the connecting part and the fixing part. In still some embodiments of the present invention, the insulating layer covers partial surfaces of the connecting part, the fixing part, and the clamping part. In some other forms of the present invention, the auxiliary cathode is fixedly connected to the jig, in which case at least 25% of the jig surface is covered with an insulating layer.

[0072] According to the fixture of the above technical solution, the insulating layer is a polymer material, which may be one of PVC, PET, polyolefin, and polyresin, and the material of the fixture body may be a conductive metal such as stainless steel, iron, copper, titanium, etc.

[0073] According to the jig of the above technical solution, the connecting part is also connected to a fixing part at the end remote from the electroplating part, and the jig is connected / fixed to the electroplating apparatus via the fixing part.

[0074] The technical solution of the present invention also provides an electroplating apparatus including the above jig, wherein the electroplating apparatus further includes a power supply, an electrolytic cell, and an anode, and the jig is connected to the electroplating apparatus via a support rod.

[0075] In the electroplating apparatus according to the above technical solutions, the number of the anodes is equal to or greater than 2. In some embodiments of the present invention, the number of the anodes is 2, in some other embodiments of the present invention, the number of the anodes is 3, 4, 6 or 8, and in some other embodiments of the present invention, the number of the anodes is 10 or greater.

[0076] In the electroplating apparatus according to the above technical solution, the center positions of the multiple anodes are aligned with the center position of the moving trajectory of the electroplating part. In this invention, the arrangement of the anodes ensures that the current density experienced by each part of the electroplating part in the electroplating solution is as consistent as possible, thereby making the thickness of the plating layer at each part of the electroplating part more uniform.

[0077] According to the electroplating apparatus of the above technical solution, the width of the anode is more than 0.1 cm.

[0078] According to the electroplating apparatus of the above technical solution, the electroplating apparatus further includes a component for controlling and driving the jig and the anode to move them relatively. In some embodiments of the present invention, the component controls and drives the jig to move them relatively. In some other embodiments, the component controls and drives the anode to move them relatively. In some further embodiments, the controller simultaneously controls and drives the electroplating component and the anode to move them relatively. The component described in the present invention can control the length of the jig's movement path relative to the anode to be 2 to 980 times, or even 2 to 240 times, the width of the anode.

[0079] According to the electroplating apparatus of the above technical solution, the electroplating apparatus further includes a display screen.

[0080] According to the electroplating apparatus of the above technical solution, the power supply is a DC power supply or a DC pulse power supply.

[0081] In the electroplating apparatus according to the above technical solution, the shape of the anode is regular or irregular, and the shape or projected shape of the anode may be a regular shape such as a square, a rectangle, a triangle, an oval, a circle, a heart, or the like, or may be an irregular shape.

[0082] According to the electroplating device of the above technical solution, the shape of the electrolytic cell is not limited and can be circular, square, or rectangular. The size of the electrolytic cell is not limited and can be adjusted to fit the width of the anode by controlling the size of the movement trajectory of the electroplating part relative to the anode.

[0083] The method of the present invention, on the one hand, can significantly improve the uniformity of the thickness of the zinc plating layer, reducing the ratio between the thickest and thinnest parts of the electroplated part by several times, even several tens of times, and bringing it as close to 1 as possible. On the other hand, the method of the present invention can minimize the reject rate of electroplated parts during the electroplating process, improving product yield and safety performance. Furthermore, the method of the present invention increases the precision between each electroplated part, and multiple electroplated parts electroplated in succession exhibit a high degree of consistency and stability in terms of plating layer thickness and plating layer quality, with the RSD being controlled within 1%.

[0084] The jig according to the present invention has good elasticity and durability, can be used repeatedly without wear, can make the contact area with the electroplated part very small, and can apply a moderate force to the electroplated part, thereby avoiding burning of the electroplated part or deformation of the stent during the electroplating process.

[0085] Although the present invention is described using zinc plating as an example, this does not mean that the technical solutions disclosed in the present invention are only applicable to zinc plating. The electroplating method, electroplating tool, and electroplating apparatus of the present invention are suitable for plating any coating on any metal substrate. The metal substrate may be a pure metal or metal alloy, such as pure iron, iron alloy, pure zinc, zinc alloy, pure magnesium, or magnesium alloy. The coating may be a pure zinc layer, a zinc alloy layer, a pure nickel layer, a nickel alloy layer, a pure copper layer, a copper alloy layer, a pure silver layer, a silver alloy layer, a pure gold layer, a gold alloy layer, a pure platinum layer, or a platinum alloy layer, or any other metal coating. The method and tool of the present invention are suitable for electroplating small and lightweight electroplated parts, such as stents or other small and lightweight electroplated parts with high requirements for the electroplated layer, and may be other than devices, especially devices. Although the present invention uses stents as an example, this does not mean that the method and apparatus of the present invention is suitable only for electroplating of stents, and although the present invention uses zinc plating as an example, this does not mean that the method and apparatus of the present invention is suitable only for zinc plating.

[0086] It should be noted that the diagram of the electroplating apparatus in the present invention is merely an example, and as long as it can achieve the same function and has the same parts and structure, the relative positional relationship between each part can be changed randomly.

[0087] The range of values ​​according to the present invention is not limited to a specified range, but may be a value in a new range consisting of any two values ​​within the range, or any one specific value within the range. For example, in the present invention, "the current density of electroplating is 1 to 20 A dm 2 However, the current density Value of is 1~20A·dm 2 The value range is not limited to 1 to 20 A·dm 2 It can also be a new interval consisting of any two values ​​from the infinite values ​​between 1.5 and 18 A dm 2, 2~15A·dm 2 , 1~10A·dm 2 , or 1 to 8 A·dm 2 Furthermore, when there are multiple combinations of numerical values, each parameter can take any value within the range of values, and multiple parameter values ​​can be combined in any way.

[0088] It is to be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "said" are intended to include the plural forms unless the context clearly dictates otherwise. The terms "comprise," "include," "contain," and "have" are inclusive and indicate the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. Method steps, processes, and operations described herein should not be construed as requiring performance in the particular order described or illustrated, unless an order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be employed. [Brief explanation of the drawings]

[0089] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for the purpose of illustrating the preferred embodiments and are not to be construed as limiting the invention. The same reference numerals are used throughout the drawings to refer to the same parts. [Figure 1] 1 is a diagram showing an example of an electroplating apparatus used in the examples and comparative examples of the present invention, including: 1—positive electrode, 2—negative electrode, 3—DC power supply, 4—anode, 5—electroplating tank, 6—jig (cathode), 7—electroplating parts, and 8—transmission mechanism. [Figure 2-8] FIG. 2 is a diagram showing an example of a jig used in examples and comparative examples of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0090] The following description is merely a preferred embodiment of the present invention, and the protection of the present invention is not limited to the following preferred embodiment. Although a stent or a specific model of stent is described in the examples as an example, it does not mean that the technical solution of the present invention is only applicable to a stent or a specific model of stent. For those skilled in the art, any modifications and improvements made based on the concept of the present invention are all included in the protection scope of the present invention. If the manufacturers of the reagents and instruments used are not listed, commercially available conventional products will be used.

[0091] Test Method 1. Measurement of electroplated layer thickness In this invention, the thickness of the electroplated layer is measured using an X-ray fluorescence coating thickness meter. First, the device must be calibrated using a standard block of the corresponding element. After calibration is complete, the stent sample to be tested for electroplated layer thickness is fixed to the sample stage and placed in the X-ray fluorescence coating thickness meter. Parameters include the type of coating and base metal, a measurement time of 10-15 seconds, and thickness units in μm. Click "OK" to test the thickness of each part of the electroplated part and measure the thickness of the thickest and thinnest parts.

[0092] 2. Measurement of organic residues in plating layers The carbon contents C1 and C2 of the substrate and electroplated part are determined according to the method described in the national standard "GB / T 2013-2006 / ISO 15350:2000 Iron and steel - Determination of total carbon and sulfur content - infrared absorption method after combustion in a high-frequency induction furnace," thereby determining the carbon content C = C1 - C2 of the electroplated layer. Statistics on the carbon atom content of various types of organic matter show that formic acid has the lowest carbon content, at 26.1%, while benzene and acetylene have the highest carbon content, at 92.3%. The carbon content of organic matter is generally considered to be between 26.1% and 92.3%. Therefore, the content of organic residues is between 1.083 and 3.831 times the carbon content. Therefore, in this application, the carbon content measured according to the above national standard is multiplied by 3.831 to determine the content of organic residues.

[0093] The carbon content of electroplated parts is measured according to the method described in the national standard "GB / T 2013-2006 / ISO 15350:2000 Iron and steel - Determination of total carbon and sulfur content - Infrared absorption method after combustion in a high-frequency induction furnace" used in this invention. However, paragraph 2 of the standard, "1. Range," clearly states that "This method is suitable for measuring carbon content with a mass fraction of 0.005% to 4.3%." Therefore, the lower limit of the mass fraction of organic residues in the electroplated layer is 0.019% to 16.47%. % Therefore, in the present invention, when the carbon content in a certain detection target cannot be measured using this method, the carbon content in this detection target can be considered to be less than 0.005%, and furthermore, the mass content of organic residues in this detection target can be considered to be less than 0.019%, or even less than 0.0125% (as calculated from the carbon content in glucose).

[0094] Example 1 As shown in Figure 1, the width of the anode was 20 mm, the stent's rotation path was 50 mm, the movement period was 1 s, and the swing angle was 60°. The 30018 stent was electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 10°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 2. DThe ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.09 A and the current density was 10 A / dm 2 The electroplating time was 19 s, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 3.5 μm, and the minimum thickness at the center of the inner wall was 0.75 μm, with a ratio of maximum to minimum thickness of 4.67. Five stents were electroplated consecutively, with an RSD of 0.35% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 74 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months, and no cell proliferation or stent rod fractures were observed.

[0095] <Example 2> As shown in Figure 1, the width of the anode was 20 mm, the stent's rotation path was 80 mm, the movement period was 2 s, and the swing angle was 90°. The 30018 stent was electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 20°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 2. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.09 A and the current density was 10 A / dm 2The electroplating time was 19 s, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 3.0 μm, and the minimum thickness at the center of the inner wall was 0.76 μm, with a maximum / minimum thickness ratio of 3.94. Five stents were electroplated consecutively, with an RSD of 0.34% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 76 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months, and no cell proliferation or stent rod fractures were observed.

[0096] Example 3 As shown in Figure 1, the width of the anode is 20 mm, the moving path of the stent is 120 mm, and the moving period is 3 s. Swing The opening angle was 120°. 30018 stents were electroplated in a zinc plating solution containing 15 g / L zinc oxide and 120 g / L sodium hydroxide. The solution temperature was 30°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the jig is as shown in Figure 5. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.09 A and the current density was 10 A / dm 2The electroplating time was 19 s, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 2.8 μm, and the minimum thickness at the center of the inner wall was 0.77 μm, with a ratio of maximum to minimum thickness of 3.63. Five stents were electroplated consecutively, with an RSD of 0.33% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 78 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months, and no cell proliferation or stent rod fractures were observed.

[0097] Example 4 As shown in Figure 1, the width of the anode is 20 mm, the moving path of the stent is 160 mm, and the moving period is 4 s. Swing The opening angle was 135°. 30018 stents were electroplated in a zinc plating solution containing 15 g / L zinc oxide and 120 g / L sodium hydroxide. The solution temperature was 40°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the jig is as shown in Figure 4. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.09 A and the current density was 10 A / dm 2The electroplating time was 19 s, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 2.6 μm, and the minimum thickness at the center of the inner wall was 0.78 μm, with a ratio of maximum to minimum thickness of 3.33. Five stents were electroplated consecutively, with an RSD of 0.32% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 81 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months, and no cell proliferation or stent rod fractures were observed.

[0098] <Example 5> As shown in Figure 1, the width of the anode was 20 mm, the stent's rotation path was 800 mm, the movement period was 5 s, and the swing angle was 150°. Electroplating was performed on the 80023 stent in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 50°C, and the stent area was 0.025 dm 2 , mass-to-lumen volume ratio is 0.033 g / cm 3 The stent length is 23 mm, and the width of the fixture is as shown in Figure 2. D The ratio of the jig width to the electroplated part length was 0.8, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.05 N. The current was 0.25 A and the current density was 10 A / dm 2The electroplating time was 19 s, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 2.2 μm, and the minimum thickness at the center of the inner wall was 0.79 μm, with a ratio of maximum to minimum thickness of 3.09. Five stents were electroplated consecutively, with an RSD of 0.31% for the weight of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 83 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months, and no cell proliferation or stent rod fractures were observed.

[0099] Example 6 As shown in Figure 1, the width of the anode was 200 mm, the stent's rotation path was 200 mm, the movement period was 1 s, and the swing angle was 60°. The 30018 stent was electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 25°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 3. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.06 A and the current density was 5 A / dm 2The electroplating time was 19 s, resulting in a zinc layer with an average thickness of 0.5 μm. The maximum thickness at the tip of the outer wall of the stent was 2.5 μm, and the minimum thickness at the center of the inner wall was 0.375 μm, with a ratio of maximum to minimum thickness of 4.67. Five stents were electroplated consecutively, with an RSD of 0.25% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 50 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months. No cell growth was observed, but some of the stent rods were fractured.

[0100] Example 7 As shown in Figure 1, the width of the anode was 200 mm, the stent's rotation path was 400 mm, the movement period was 1 s, and the swing angle was 60°. The 30018 stent was electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 25°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the jig is as shown in Figure 7. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.15 A and the current density was 10 A / dm 2The electroplating time was 57 s, resulting in a zinc layer with an average thickness of 3 μm. The maximum thickness at the tip of the outer wall of the stent was 9.75 μm, and the minimum thickness at the center of the inner wall was 2.34 μm, with a ratio of maximum to minimum thickness of 4.17. Five stents were electroplated consecutively, and the RSD of the mass of the electroplated layer was 0.30%. No burns or breaks were observed in the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. cormorant Two stents were implanted into the abdominal aorta of a patient with Sagi. Stent No. 1 was removed three months later and found to be structurally intact, with a measured radial support strength of 90 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed six months later and found to have slight cell proliferation, a vascular stenosis rate of 27%, and no fractures of the stent rods.

[0101] Example 8 As shown in Figure 1, the width of the anode was 200 mm, the stent's rotation path was 400 mm, the movement period was 1 s, and the swing angle was 60°. The 30018 stent was electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 25°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 8. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.27 A and the current density was 15 A / dm 2The electroplating time was 50.7 s, resulting in a zinc layer with an average thickness of 4 μm. The maximum thickness at the tip of the outer wall of the stent was 12.8 μm, and the minimum thickness at the center of the inner wall was 3.2 μm, with a ratio of maximum to minimum thickness of 4. Five stents were electroplated consecutively, with an RSD of 0.35% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 94 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months. There was slight cell proliferation in some locations, and the vascular stenosis rate was high at 30%, but the stent rod was not fractured.

[0102] Example 9 As shown in Figure 1, the width of the anode was 20 mm, the stent's rotation path was 400 mm, the movement period was 1 s, and the swing angle was 60°. The 30018 stent was electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 25°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the jig is as shown in Figure 6. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.010 N. The current was 0.36 A and the current density was 20 A / dm 2The electroplating time was 47.5 seconds, resulting in a zinc layer with an average thickness of 5 μm. The maximum thickness at the tip of the outer wall of the stent was 15 μm, and the minimum thickness at the center of the inner wall was 4.25 μm, with a maximum / minimum thickness ratio of 3.53. Five stents were electroplated consecutively, with an RSD of 0.35% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted in rabbit abdominal aortas, and stent No. 1 was removed after three months. The stent's structure was intact, and the measured radial support strength was 98 kPa, meeting the mechanical property requirements within three months of implantation. When stent No. 2 was removed 6 months later, some cell proliferation was observed in some locations, the vascular stenosis rate was high at 35%, and the stent rod was not fractured.

[0103] Example 10 As shown in Figure 1, the anode width was 200 mm, the stent's rotation path was 400 mm, the rotation period was 1 s, and the swing angle was 60°. Two sections were electroplated on each end of the 30018 stent in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 25°C, and the stent area was 0.012 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 22 mm, and the width of the fixture is as shown in Figure 2. D The ratio of the jig width to the length of the electroplated part was 0.91, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.06 A and the current density was 5 A / dm 2The electroplating time was 38 s, resulting in a zinc layer with an average thickness of 1 μm. After removing 2 mm from each of the two stent ends, the maximum thickness at the tip of the outer wall of the stent was 2.48 μm, and the minimum thickness at the center of the inner wall was 0.6 μm, with a maximum / minimum thickness ratio of 4.13. Five stents were electroplated consecutively, with an RSD of 0.35% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted in rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 76 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months, and no cell proliferation or stent rod fractures were observed.

[0104] Example 11 As shown in Figure 1, the width of the anode was 200 mm, the moving path of the magnesium bone nail was 400 mm, the moving period was 1 s, and the swing angle was 60°. The magnesium bone nail was electroplated in an electroplating solution containing 90 g / L zinc chloride, 10 g / L ferrous sulfate, and 200 g / L potassium chloride. The solution temperature was 25°C, and the surface area of ​​the bone nail was 0.009 dm 2 The length of the bone nail is 18 mm, and the width of the jig is as shown in Figure 3. D The ratio of the jig width to the bone nail length was 0.89, and the contact area between the jig and the bone nail was 0.1 mm 2 The clamping force was 0.28 N. The current was 0.018 A and the current density was 2 A / dm 2The electroplating time was 95 seconds, resulting in a zinc-iron alloy layer containing 99.5% zinc and 0.5% iron with an average thickness of 1 μm. The maximum thickness of the bone nail was 2.4 μm at the tip, and the minimum thickness at the center was 0.8 μm, with a ratio of maximum to minimum thickness of 3.0. Five bone nails were electroplated consecutively, and the RSD of the mass of the electroplated layer was 0.25%. No burns or fractures were observed in the bone nails. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two bone nails were implanted into the ankle joint of a rabbit. After three months, bone nail No. 1 was removed, revealing that the bone nail structure was intact. After six months, bone nail No. 2 was removed. Bone nails Upon removal, there was no cell growth and the substrate of the bone nail was largely uncorroded.

[0105] Example 12 As shown in Figure 1, the width of the anode was 200 mm, the movement path of the iron-manganese occluder was 100 mm, the movement period was 1 s, and the swing angle was 60°. Electroplating was performed in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 25°C, and the surface area of ​​the occluder was 0.09 dm 2 , the diameter is 18 mm, the width of the jig as shown in Figure 2 D The ratio of the jig width to the occluder diameter was 0.89, and the contact area between the jig and the occluder was 0.1 mm 2 The clamping force was 0.35 N. The current was 0.72 A and the current density was 8 A / dm 2 The electroplating time was 23.8 s, and a zinc layer with an average thickness of 1 μm was obtained. The maximum thickness at the circumference of the occluder was 7.5 μm, and the minimum thickness inside the center was 0.25 μm, with a ratio of maximum to minimum thickness of 30. OccluderThe RSD of the mass of the electroplated layer was 0.25%. No burns or fractures were observed in the occluders. Two occluders were implanted into the atrial septum of rabbits. When removed after one month, the central portion of No. 1 occluder was not endothelialized. When removed after two months, the central portion was not endothelialized, but the outer wall edge was completely endothelialized. When removed after six months, No. 2 occluder showed severe cell proliferation at the edge.

[0106] Example 13 As shown in Figure 1, the width of the anode is 120 mm, the moving path of the stent is 120 mm, and the moving period is 3 s. Swing The opening angle was 120°. 30018 stents were electroplated in a zinc plating solution containing 15 g / L zinc oxide and 120 g / L sodium hydroxide. The solution temperature was 30°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 2. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.09 A and the current density was 10 A / dm 2The electroplating time was 19 s, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 5.0 μm, and the minimum thickness at the center of the inner wall was 0.6 μm, with a ratio of maximum to minimum thickness of 8.33. Five stents were electroplated consecutively, with an RSD of 0.3% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months. The stent structure was intact, and the measured radial support strength was 65 kPa, meeting the mechanical property requirements within three months of implantation. Stent No. 2 was removed after six months, and no cell proliferation or stent rod fractures were observed.

[0107] <Comparative Example 1> As shown in Figure 1, the width of the anode is 20 mm, the moving path of the stent is 50 mm, and the moving period is 1 s. Swing The opening angle was 60°. The 30018 stents were electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 10°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 2. D The ratio of the jig width to the electroplated part length was 0.97, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.0005 N. The current was 0.09 A and the current density was 10 A / dm 2The electroplating time was 19 seconds, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 3.6 μm, and the minimum thickness at the center of the inner wall was 0.76 μm, with a ratio of maximum to minimum thickness of 4.73. The stent failed because both ends were ablated and fused to the clamps. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%.

[0108] <Comparative Example 2> As shown in Figure 1, the width of the anode is 20 mm, the moving path of the stent is 80 mm, and the moving period is 2 s. Swing The opening angle was 90°. 30018 stents were electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, and 200 g / L potassium chloride. The solution temperature was 20°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 2. D The ratio of the jig width to the electroplated part length was 0.67, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.8 N. The current was 0.09 A and the current density was 10 A / dm 2 The electroplating time was 19 seconds, resulting in a zinc layer with an average thickness of 1 μm. The stent was twisted and deformed throughout and was rejected. Five stents were electroplated consecutively, and the RSD of the electroplated layer mass was 0.4%. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%.

[0109] <Comparative Example 3> As shown in Figure 1, the anode width was 200 mm, the stent's rotation path was 200 mm, the movement period was 1 s, and the swing angle was 60°. The 30018 stent was electroplated in a zinc plating solution containing 50 g / L zinc chloride, 25 g / L boric acid, 200 g / L potassium chloride, 0.1 g / L benzylidene acetone, 0.6 g / L fatty alcohol polyoxyethylene ether O-20, and 0.2 g / L sodium benzenesulfonate. The solution temperature was 25°C, and the stent area was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 The stent length is 18 mm, and the width of the fixture is as shown in Figure 2. D The ratio of the jig width to the electroplated part length was 0.89, and the contact area between the jig and the stent was 0.1 mm. 2 The clamping force was 0.005 N. The current was 0.09 A and the current density was 10 A / dm 2 The electroplating time was 19 seconds, resulting in a zinc layer with an average thickness of 1 μm. The maximum thickness at the tip of the outer wall of the stent was 2.4 μm, and the minimum thickness at the center of the inner wall was 0.8 μm, with a ratio of maximum to minimum thickness of 3. Five stents were electroplated consecutively, and the RSD of the mass of the electroplated layer was 0.25%. No burns or fractures were observed on the stents. The mass percentage of organic residues in the electroplated layer was 0.8%. Stents were implanted into the abdominal aorta of rabbits and removed after two weeks, revealing extensive inflammation and pus cells within the blood vessels.

[0110] <Comparative Example 4> As shown in Figure 1, the width of the anode is 600 mm, the moving path of the stent is 50 mm, and the moving period is 4 s. Swing The opening angle was 35°. The 30018 stent was electroplated in a zinc plating solution containing 15 g / L zinc oxide and 120 g / L sodium hydroxide. The solution temperature was 40°C, and the total area of ​​the stent was 0.009 dm 2 , mass-to-lumen volume ratio is 0.012 g / cm 3 , stent length is 18mm, single jig width D The ratio of the jig width to the electroplated part length was 0.87, and the total contact area between the jig and the stent was 1 mm2 The clamping force of a single jig was 0.005 N. The current was 0.09 A and the current density was 10 A / dm 2 The electroplating time was 95 seconds, the average thickness of the zinc layer on a single stent was 5 μm, the maximum thickness at the tip of the outer wall of the stent was 18 μm, and the minimum thickness at the center of the inner wall was 0.34 μm, with a ratio of maximum to minimum thickness of 52.9. Five stents were electroplated consecutively, with a RSD of 0.5% for the mass of the electroplated layer. No burns or fractures were observed on the stents. No carbon content was detected, and the content of organic residues in the electroplated layer was below the detection limit. Therefore, the mass content of organic residues in the electroplated layer was less than 0.019%. Two stents were implanted into rabbit abdominal aortas. Stent No. 1 was removed after three months, and the stent structure was intact. Stent No. 2 was removed after six months, and cell proliferation was observed, with significant cell proliferation in most areas. The vascular restenosis rate was high at 70%, and some stent rods fractured.

[0111] The present invention may also have various other embodiments, and those skilled in the art may make various appropriate changes and modifications according to the present invention without departing from the spirit and essence of the present invention, and all such appropriate changes and modifications should fall within the scope of the claims attached to the present invention. [Explanation of symbols]

[0112] 1-Fixed parts 2-Connection 3-Holding part D - Distance between connecting rods, i.e. width of connection 9-Auxiliary cathode

Claims

1. 1. An electroplated component comprising a substrate and an electroplated layer disposed on the substrate, wherein the electroplated layer has an organic residue content of less than 0.2%.

2. 2. The electroplated part of claim 1, wherein the content of organic residue in the electroplating layer is less than 0.1%, the content of organic residue in the electroplating layer is less than 0.05%, and the content of organic residue in the electroplating layer is less than 0.019%.

3. 2. The electroplated part of claim 1, wherein the ratio of the thickness of the thickest portion of the electroplated layer on the substrate to the thickness of the thinnest portion is (1-30):1, the ratio of the thickness of the thickest portion of the electroplated layer on the substrate to the thickness of the thinnest portion is (1-20):1, the ratio of the thickness of the thickest portion of the electroplated layer on the substrate to the thickness of the thinnest portion is (1-15):1, and the ratio of the thickness of the thickest portion of the electroplated layer on the substrate to the thickness of the thinnest portion is (1-12):

1.

4. 2. The electroplated part of claim 1, wherein the average thickness of the electroplated layer is 0.5 to 5 μm, the thickness of the thickest portion of the electroplated layer on the substrate is (1, 7.5) times the average thickness, and the thickness of the thinnest portion of the electroplated layer on the substrate is [0.25, 1] ​​times the average thickness.

5. 2. The electroplated component of claim 1, wherein the thickness of the thinnest portion of the electroplated layer on the substrate is 0.25 μm to 4.25 μm, the thickness of the thinnest portion of the electroplated layer on the substrate is 0.375 μm to 3.2 μm, the thickness of the thinnest portion of the electroplated layer on the substrate is 0.6 μm to 3.2 μm, and the thickness of the thinnest portion of the electroplated layer is 0.6 μm to 2.5 μm.

6. 10. The electroplated component of claim 1, wherein the thickness of the thickest portion of the electroplated layer on the substrate is 1.1 μm to 15 μm, the thickness of the thickest portion of the electroplated layer on the base is 1.1 to 9.75 μm, the thickness of the thickest portion of the electroplated layer on the substrate is 1.1 to 7.5 μm, and the thickness of the thickest portion of the electroplated layer on the base is 1.2 to 5 μm.

7. 2. The electroplated component of claim 1, wherein the electroplating layer covers 99% or more of the surface of the substrate, the electroplating layer is a pure metal layer or an alloy layer, the zinc content in the electroplating layer is 50% or more, and the zinc content in the electroplating layer is 99% or more.

8. The electroplated part described in claim 1, characterized in that the substrate is a degradable metal or a degradable non-metallic material, and the substrate includes at least one of pure iron, iron alloy, pure zinc, zinc alloy, pure magnesium, and magnesium alloy.

9. The mass-to-volume ratio of the electroplated part is 0.001 to 10 g / cm ３ and the mass-to-volume ratio of the electroplated part is 0.001 to 5 g / cm ３ and the mass-to-volume ratio of the electroplated part is 0.001 to 0.4 g / cm ３ 2. The electroplated part of claim 1, wherein the iron alloy comprises at least one of a low alloy steel or an iron-based alloy having a carbon content of 2.5 wt. % or less.

10. The method for producing an electroplated part according to any one of claims 1 to 9, wherein the electroplated part is immersed in an electroplating solution and moved together with a jig relative to an anode at a specific amplitude and frequency, wherein the length of the movement path of the electroplated part relative to the anode during the electroplating process is 2 to 980 times the width of the anode, and / or an auxiliary cathode is connected to the electroplated part.

11. 11. The manufacturing method of claim 10, wherein the length of the movement path of the electroplated part relative to the anode during the electroplating process is 2 to 540 times the width of the anode; the length of the movement path of the electroplated part relative to the anode during the electroplating process is 2 to 400 times the width of the anode; the length of the movement path of the electroplated part relative to the anode during the electroplating process is 2 to 240 times the width of the anode; and the length of the movement path of the electroplated part relative to the anode during the electroplating process is 2 to 150 times the width of the anode.

12. The manufacturing method described in claim 10, characterized in that the width of the anode is 0.1 cm or more, the swing range of the electroplated part relative to the anode is 0° to 180°, and the auxiliary cathodes are connected to both ends of the electroplated part in the longitudinal direction or in the direction parallel to the anode surface.

13. The manufacturing method according to claim 10, characterized in that the swing range of the electroplated part relative to the anode is 0° to 160°, and the movement frequency of the electroplated part relative to the anode is 0.1 s to 20 s per revolution.

14. 11. The method of claim 10, wherein the area of ​​the auxiliary cathode occupies 30% to 70% of the cathode area, the length of the auxiliary cathode is 0.5 mm to 20 mm, the length of the auxiliary cathode is 0.5 mm to 10 mm, and the shape of the auxiliary cathode is any shape, including at least one of a linear shape, an annular shape, a circular shape, a prismatic shape, a conical shape, a spiral shape, a ring shape, a cylindrical shape, and a wavy shape.

15. 11. The manufacturing method according to claim 10, wherein the cross-sectional area of ​​the auxiliary cathode in a direction perpendicular to the anode surface or in the direction of the major axis of the electroplated part is larger than the cross-sectional area of ​​the minor axis of the electroplated part, and the auxiliary cathode is connected to the electroplated part via a connecting rod or a connection point.

16. 16. The manufacturing method according to claim 15, wherein the shape of the connecting rod is one of straight and non-straight, the connecting rod is at least one of straight, S-shaped, ω-shaped, and Ω-shaped, and the connecting rod is fixedly or detachably connected to the electroplating part, the jig, and the auxiliary cathode.

17. The electroplated part is subjected to a force exerted by a jig during the electroplating process, and the force exerted by the jig on the electroplated part during the electroplating process is greater than or equal to 1×10 －３ 11. The method according to claim 10, wherein the tensile strength is 0.5N to 0.5N.

18. The contact area between the electroplated part and the jig is 0.1 mm ２ 11. The method of claim 10, wherein:

19. The temperature of the electroplating solution during the electroplating process of the electroplated part is 10°C to 50°C, and the current density during the electroplating process of the electroplated part is 1 A dm ２ ~20A・dm ２ and the electroplating time during the electroplating process of the electroplated part is 10 to 300 seconds.

20. 11. The manufacturing method according to claim 10, wherein each component of the electroplating solution is inorganic.

21. When the plating layer contains zinc, the electroplating solution contains 3.4 to 4.5 wt. % of a zinc-containing component and 2.1 to 3.1 wt. % of a pH adjuster, or the electroplating solution contains 1.5 to 3.0 wt. % of a zinc-containing component and 6.5 to 8.8 wt. % of a pH adjuster, and the zinc-containing component is at least one of zinc chloride, zinc sulfate, and zinc oxide; 11. The method of claim 10, wherein the pH adjuster is at least one of boric acid, sodium borate, potassium borate, calcium borate, sodium hydroxide, and potassium hydroxide.

22. 22. The control method of claim 21, wherein the electroplating solution further comprises 15.5 to 19.5 wt. % of a chloride salt, the chloride salt being at least one of sodium chloride, potassium chloride, and ammonium chloride.

23. A jig, A fixture for securing an electroplating part in an electroplating tank and for driving the electroplating part to move relative to an anode.

24. 24. The jig of claim 23, wherein the jig includes a connecting portion and a clamping portion connected perpendicularly to the connecting portion, the clamping portion being parallel to the longitudinal axis of the electroplated part, and the connecting portion has at least two connecting rods at an end near the electroplated part, each of the connecting rods having at least one clamping portion connected thereto.

25. 25. The jig of claim 24, wherein the distance between each pair of connecting rods is [0.6, 0.98] times the distance between the electroplated parts and corresponding contact points on the connecting rods.

26. A jig as described in claim 24, characterized in that the ratio of the distance of a straight line connecting any two points on a cross section of the electroplated part perpendicular to the longitudinal direction of the clamping portion to the inner diameter of the electroplated part is 1:1 to 1:20, and the length of the clamping portion is 0.16 mm to 7 mm.

27. 25. The jig of claim 24, wherein at least 95% of the surface of the jig is covered with an insulating layer, or at least 25% of the surface of the jig is covered with an insulating layer.

28. 25. The jig of claim 24, further comprising a fixing component connected to the end of the connection portion remote from the electroplated component.

29. 29. An electroplating apparatus comprising the jig according to any one of claims 23 to 28, and further comprising a power source, an electrolytic cell, and an anode, wherein the jig is connected to the electroplating apparatus via a support rod.

30. 30. The electroplating apparatus according to claim 29, wherein the number of the anodes is two or more, and the central positions of the two or more anodes overlap with the central position of the movement trajectory of the electroplating part.

31. 30. The electroplating apparatus of claim 29, wherein the width of the anode is 0.1 cm or more, and the electroplating apparatus further includes a component for controlling and driving the jig and the anode to move relative to each other.

32. 30. The electroplating apparatus of claim 29, wherein the electroplating apparatus further comprises a display screen.

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