Abstract: Absorbable iron-based alloy implanted medical device and manufacturing method thereof. The iron-based alloy implanted medical device comprises an iron-based alloy substrate (11), a degradable polymer layer (13) disposed on a surface of the iron-based alloy substrate (11), and a tannic acid chemical conversion film (12) disposed on a surface of the iron-based alloy substrate (11). After the medical device is implanted into a body, the tannic acid chemical conversion film (12) is configured to protect the iron-based alloy substrate (11) coated thereby from being in contact with a body fluid, thereby ensuring that the device meets a clinical mechanical property requirement in the early stage of implantation. Furthermore, the iron-based alloy implanted medical device has a decreased size, and produces a decreased amount of a corrosive product after being implanted, facilitating faster absorption or elimination of the corrosive product.

Abstract: An absorbable implantable medical device made of iron-based alloy, including a base made of iron-based alloy and a complex, wherein the complex includes a complexing agent. In a physiological solution, the base made of iron-based alloy can react with the complexing agent to generate a water-soluble iron complex having solubility in the physiological solution of no less than 10 mg/L. A corrosion product generated after the absorbable implantable medical device made of iron-based alloy is implanted in a human body can be quickly metabolized/absorbed by the body.

Abstract: An absorbable iron-based alloy implantable medical device includes an iron-based alloy matrix, a degradable polymer coating disposed on the surface of the iron-based alloy matrix, and a corrosion inhibition layer disposed on the surface of the iron-based alloy matrix. The corrosion inhibition layer can delay early-stage corrosion of the iron-based alloy matrix, ensure mechanical performance of a medical device in the early stage of the implantation, prevent degradation of a polymer in the early stage of the implantation of the medical device, and reduce the usage of the degradable polymer, thereby reducing risks of inflammatory reactions.

Abstract: The invention discloses an absorbable iron-based alloy stent, comprising an iron-based alloy substrate and a degradable polyester in contact with the surface of the substrate, in which the degradable polyester has a weight average molecular weight of between 20,000 and 1,000,000 and a polydispersity index of between 1.2 and 30. With the degradable polyester, the iron-based alloy is capable of corroding rapidly and controllably within a predetermined period. Following implantation into the human body, the degradable stent serves as a mechanical support at early stage, then gradually degrading and being metabolized and absorbed by the human body. During the process of degradation, minimal or no solid product is produced. Ultimately, the configuration of the lumen with an implanted stent as well as the systolic and diastolic functions thereof return to their natural states.

Abstract: An iron based and absorbable implanted prefabricated tube (1) for medical device and preparation method therefor, and a medical device prepared by the prefabricated tube and preparation method therefor. The average nitrogen content of nitrogen in the prefabricated tube is from 0.04-0.4 wt. % or 0.02-0.04 wt. %. The prefabricated tube can be cut along the length direction directly by laser or by machining to obtain multiple absorbable implanted medical devices.

Abstract: An intravascular stent (100, 200, 300) comprises a framework with openings and at least one radiopaque structure (103, 201, 301). Each radiopaque structure (103, 201, 301) comprises fixed bodies and radiopaque markers (105, 208, 307) filled in the fixed bodies. The fixed bodies are connected with the framework, and are at least partially disposed in the openings. The envelope enclosed area of all the radiopaque markers (105, 208, 307) in each radiopaque structure (103, 201, 301) is less than or equal to 2 mm2, and a sum of effective areas of all the radiopaque markers (105, 208, 307) in each radiopaque structure (103, 201, 301) is greater than or equal to 0.15 mm2, and a ratio of said sum of effective areas to said envelope enclosed area is greater than or equal to 1:5. The radiopaque structure (103, 201, 301) has a desirable visibility, and does not substantially affect the crimped diameter of the intravascular stent (100, 200, 300).

Abstract: A bioabsorbable medical device or a medical device component comprises an absorbable component prepared by subjecting a prefabricated component of an iron-based raw material to ion nitriding. Substance composition inside the absorbable component changes with the depth from the surface. The absorbable component comprises at least a first part and a second part. The first part surrounds the second part. Hardness of the first part is higher than hardness of the second part. An interface exists between the first part and the second part. A crack generated in the first part is impeded by the interface when extending to the second part. On the premise of ensuring radial stand strength, the bioabsorbable medical device or medical device component and a preparation method thereof reduce wall thickness of an iron-based stand, improve a stand corrosion rate and malleability, and achieve broader adaptability.

Abstract: A lumen stent preform is provided using a plasma nitriding technology, a preparation method thereof, a method for preparing a lumen stent by using the preform, and a lumen stent obtained according to the method. The preform is manufactured by using pure iron or an iron alloy containing no strong nitrogen compound, has a hardness of 160-250HV0.05/10, and has a microstructure that is a deformed structure having a grain size scale greater than or equal to 9 or a deformed structure after cold machining. Alternatively, the preform is an iron alloy containing a strong nitrogen compound, and has a microstructure that is a deformed structure having a grain size scale greater than or equal to 9 or a deformed structure after cold machining. The lumen stent preform meets the requirements of a conventional stent for radial strength and plasticity, so that plasma nitriding is applicable to commercial preparation of a lumen stent.

Abstract: The invention discloses an absorbable iron-based alloy stent, comprising an iron-based alloy substrate and a degradable polyester in contact with the surface of the substrate, in which the degradable polyester has a weight average molecular weight of between 20,000 and 1,000,000 and a polydispersity index of between 1.2 and 30. With the degradable polyester, the iron-based alloy is capable of corroding rapidly and controllably within a predetermined period. Following implantation into the human body, the degradable stent serves as a mechanical support at early stage, then gradually degrading and being metabolized and absorbed by the human body. During the process of degradation, minimal or no solid product is produced. Ultimately, the configuration of the lumen with an implanted stent as well as the systolic and diastolic functions thereof return to their natural states.

Abstract: A bioabsorbable medical device or a medical device component comprises an absorbable component prepared by subjecting a prefabricated component of an iron-based raw material to ion nitriding. Substance composition inside the absorbable component changes with the depth from the surface. The absorbable component comprises at least a first part and a second part. The first part surrounds the second part. Hardness of the first part is higher than hardness of the second part. An interface exists between the first part and the second part. A crack generated in the first part is impeded by the interface when extending to the second part. On the premise of ensuring radial stand strength, the bioabsorbable medical device or medical device component and a preparation method thereof reduce wall thickness of an iron-based stand, improve a stand corrosion rate and malleability, and achieve broader adaptability.