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 stem 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 present invention relates to the technical field of medical devices, and in particular to an orthopedic internal fixation implant medical device, including an iron matrix and a filling material including polylactic acid and an alkaline substance. The polylactic acid has a weight-average molecular weight of Mw kDa, the alkaline substance includes a metal element, the mass ratio of the metal element in the alkaline substance to the polylactic acid is p, and the p and the Mw satisfy a formula of 2Mw{circumflex over (?)}?0.8?p?30Mw{circumflex over (?)}?0.5. The orthopedic internal fixation implant medical device, with good mechanical properties, can control local pH values and induce bone healing.

Abstract: An iron-based alloy absorbable and implantable medical device for internal fixation. A substrate includes an iron-based alloy and degradable polymer. The mass ratio of the iron-based alloy to the degradable polymer is between 1:4 and 4:1. The weight-average molecular weight of the degradable polymer is between 150000 to 3000000, and the polydispersity index thereof is between 1 and 6. The device further includes antioxidants. The iron-based alloy is used as a load-bearing framework or reinforcement phase of the device. By adjusting the mass ratio of the iron-based alloy to the degradable polymer and the combination mode thereof, the corrosion rate of the iron-based alloy in the late period of the implantation is accelerated, and the quantity of corrosion products poorly soluble in the iron-based alloy is reduced. Adding antioxidants to the device further reduces the quantity of the corrosion products poorly soluble in the iron-based alloy.

Abstract: An absorbable metal stent includes an absorbable metal substrate; the absorbable metal substrate includes a plurality of wave-shaped annular structures and a plurality of axial connecting portions, two ends of each axial connecting portion being connected to two adjacent wave-shaped annular structures, respectively, so as to axially connect the plurality of wave-shaped annular structures; a corrosion-promoting coating is formed on each axial connecting portion, the corrosion-promoting coating containing a corrosion-promoting substance, and the corrosion-promoting substance being selected from at least one of a degradable polymer and a degradable polymer antioxidant; the corrosion-promoting coatings cause the corrosion of the axial connecting portions to occur earlier than the corrosion of the plurality of wave-shaped annular structures. The absorbable metal stent has good bending performance and may prevent the problems of secondary hyperplasia after implantation and stenosis caused thereby.

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: A stent and a preparation method therefor. The stent includes a stent substrate. The stent substrate is provided with at least one radiopaque structure thereon. Each radiopaque structure includes at least one radiopaque unit. A radiopaque material is inlaid in each radiopaque unit, and a ratio of the volume of the radiopaque material to the volume of the radiopaque unit ranges from 1.1 to 1.4. By the stent and the preparation method therefor, the interference fit between the radiopaque material and the radiopaque unit can be better implemented, so that the radiopaque material and the radiopaque unit have strong bonding force therebetween, and the problem of embolism caused by the drop of a radiopaque material is avoided.

Abstract: The present invention relates to a zinc-containing medical device, including a zinc-containing matrix and a polylactic acid coating arranged on the zinc-containing matrix. The polylactic acid coating has a thickness of x ?m; and when x and the weight-average molecular weight Mn (kDa) of polylactic acid satisfied the following formula: ( - b + b 2 - 4 ? a ? c ) / 2 ? a - 2 ? x ? ( - b + b 2 - 4 ? a ? c ) / 2 ? a + 2 , the corrosion rate of zinc in the matrix is relatively small, sufficient mechanical properties can be maintained within the repair period, and the biological risk is relatively low. When the polylactic acid is poly-racemic lactic acid, a=0.0336 ln(Mn)?0.1449, b=?0.472 ln(Mn)+2.1524, and c=1.1604 ln(Mn)?5.7128; and when the polylactic acid is poly-L-lactic acid, a=?0.006 ln(Mn)+0.03441, b=0.0648 ln(Mn)?0.3662, and c=?0.162 ln(Mn)+0.7847.

Abstract: An evaluation method and system for the corrosion degree of an absorbable stent.

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: 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 stem 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: 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 number 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 number 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: An absorbable stent includes an absorbable matrix. The matrix includes a number of wave-shaped rings connected by connection units and arranged in an axial direction. The wave-shaped ring includes a number of waves arranged in a circumferential direction. A peak, a valley and a support connecting the peak and the valley form the wave. Two adjacent wave-shaped rings and the connection unit form a closed side supporting unit. The matrix has a volume of 4 ?m to 40 ?m per unit blood vessel area. The absorbable stent has sufficient radial supporting strength of no less than 55 kPa for clinical applications. Moreover, the volume of the matrix per unit blood vessel area is less than volumes of existing stents. When the absorbable stent and existing stents are made of the same material, the absorbable stent has a shorter degradation and absorption cycle.

Abstract: A drug eluting device and a preparation method thereof are disclosed. The drug eluting device includes a substrate and a drug coating arranged on the substrate. The substrate has an outer wall, side walls, and an inner wall, the drug coating contains active drug and a drug carrier, the active drug is dispersed in the drug carrier, the drug coating covers the outer wall, the side walls, and the inner wall of the substrate, and the content of the active drug on both the outer wall and the side walls are greater than the content of the active drug on the inner wall; or, the active drug is only distributed on the outer wall and the side walls, and the inner wall does not contain the active drug. The drug eluting device is less prone to coating peeling off from the substrate.

Abstract: An absorbable stent includes an absorbable matrix. The matrix includes a number of wave-shaped rings connected by connection units and arranged in an axial direction. The wave-shaped ring includes a number of waves arranged in a circumferential direction. A peak, a valley and a support connecting the peak and the valley form the wave. Two adjacent wave-shaped rings and the connection unit form a closed side supporting unit. The matrix has a volume of [4, 40] ?m per unit blood vessel area. The absorbable stent has sufficient radial supporting strength for clinical applications. Moreover, the volume of the matrix per unit blood vessel area is less than volumes of existing stents. When the absorbable stent and existing stents are made of the same material, the absorbable stent has a shorter degradation and absorption cycle.

Abstract: An absorbable implantable device, including an iron-based substrate, and a zinc-containing protective layer and a corrosion promoting layer provided on the iron-based substrate. The iron-based substrate has an outer wall and an inner wall. The zinc-containing protective layer covers the outer wall and the inner wall of the iron-based substrate. The corrosion promoting layer covers the zinc-containing protective layer. The thickness ratio of the zinc-containing protective layer located on the outer wall to the corrosion promoting layer located on the outer wall is less than the thickness ratio of the zinc-containing protective layer located on the inner wall to the corrosion promoting layer located on the inner wall. The absorbable implantable device has a low risk of thrombosis and can meet the requirements of early support and later rapid corrosion.

Abstract: An implantable device including a metal substrate; that contains particles having a size of 1 ?m or more; if the wall thickness of the metal substrate is greater than or equal to 0.04 mm and less than or equal to 0.12 mm, the largest particle size is less than or equal to 15 ?m and the average content of the particles is less than or equal to 40 ppm; if the wall thickness of the metal substrate is greater than 0.12 mm and less than or equal to 0.2 mm, the largest particle size is less than or equal to 20 ?m and the average content of the particles is less than or equal to 100 ppm; The size of the particles and the average content of the particles are reasonably controlled according to the wall thickness of the metal substrate, improving the plastic deformation capability of the implantable device.

Abstract: An absorbable iron-based implantable device, including an iron-based substrate and a hydrophobically-modified high polysaccharide attached to the iron-based substrate. The solubility of the modified high polysaccharide in an organic solvent is increased when hydrophobically modified, this allows great film formation on the iron-based substrate when a coating method such as spraying or dip coating is employed for the preparation of a coating, thus allowing an increased amount of the modified high polysaccharide to be attached to the iron-based substrate. When the absorbable iron-based implantable device is implanted into the body, the degradation of the modified high polysaccharide produces an increased amount of degradation product that reacts with a corrosion product of the iron-based substrate to produce a water-soluble polysaccharide-iron complex, thus reducing the production of an insoluble solid corrosion product.

Abstract: An absorbable iron-based alloy medical device implant, comprising an iron-based alloy substrate (11) and a degradable polymer (13) provided on a surface of an iron-based alloy substrate (11), and a zinc-containing protective member (12) provided on the surface of the iron-based alloy substrate (11). The zinc-containing protective member (12) is either a zinc compound or a mixture comprising the zinc compound and at least one of a phosphate-containing compound, a degradable binder, or a water-soluble binder. The weight ratio of the zinc compound in the mixture is ?20% and <100%. The zinc-containing protective member (12) can delay corrosion of the iron-based alloy substrate (11) during an early stage of medical device implantation. The iron-based alloy substrate (11) is essentially corrosion-free during the early stage of medical device implantation, and is therefore able to satisfy clinical requirements of mechanical performance during the early stage of medical device implantation.

Abstract: A radiopaque structure and an implanted medical instrument having the radiopaque structure. The radiopaque structure includes at least one radiopaque unit, and each radiopaque unit includes at least one radiopaque object. In at least one incidence direction of a light source, all the radiopaque objects in the radiopaque structure are divided into n regions according to the thickness in the incidence direction, and a projection area Sm of m regions of the n regions and an effective thickness dm of the m regions meet Sm?0.0136(dm)a?0, wherein ?0.95?a??0.85 and 1?m?n. The radiopaque structure has good or excellent visibility.

Abstract: An absorbable iron-based device includes an iron-based matrix and degradable polyester in contact with the surface of the iron-based matrix. The mass fraction of a low-molecular-weight part of the degradable polyester is less than or equal to 5%, and the molecular weight of the low-molecular-weight part is less than 10,000; or the mass fraction of a residual monomer in the degradable polyester is less than or equal to 2%.