Biotyx Medical (shenzhen) Co. Ltd.

Lifetech Scientific (shenzhen) Co., Ltd

Lifetech Scientific (shenzhen) Inc

Lifetech Scientific Co., Ltd.

Wenjiao Lin

Deyuan Zhang

Li Qin

Haiping Qi

Xiangdong Liu

Wenchao Fu

Xianmiao Chen

Hongtao Sun

Ziqiang Liu

Liping Chen

Gui Zhang

Kai Zhang

Hao Wu

Haifeng Li

Jun Hu

Shaochun Zhuang

Ge Chen

Wenbin Wang

Dong Bian

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.

Absorbable implantable device

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 μm to 40 μm 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.

Absorbable stent

Disclosed are an absorbable iron-based alloy implanted medical device () and preparation method thereof. The device () comprises an iron-based alloy base (), a degradable polymer () arranged on the surface of the iron-based alloy base, and an alkaline protector () arranged on the surface of the iron-based alloy base. The alkaline protector () contains at least one alkaline substance capable of neutralizing the acidic substance produced by the polymer at the early stage after the device is implanted to delay the corrosion of the iron-based alloy base () in the early stage of implantation, hence the iron-based alloy base () would not substantially corrode or would corrode slowly, clinically satisfying the mechanical properties and requirements of the device () in the early stage of implantation; and in the meantime, after the neutralization and consumption of the alkaline protector () exposes the base (), the base () can still accelerate the corrosion speed thereof in the acidic environment formed by the polymer (), so as to clinically satisfy the requirement of the corrosion cycle of the device () at the same time.

Absorbable iron-based alloy implanted medical device and manufacturing method thereof

An evaluation method and system for the corrosion degree of an absorbable stent. The method includes the following steps: obtaining the total number Sof stent bars of the absorbable stent at the time zero of implantation (S); separately obtaining n frames of optical coherence tomography (OCT) images of the absorbable stent at the time x of implantation, wherein x is greater than 0, and n is a natural number greater than 1 (S); determining, according to the n frames of OCT images, the total number Ni of the stent bars corresponding to each frame of OCT image, wherein i is a natural number greater than or equal to 1 and less than or equal to n; and calculating the total number Sof the stent bars corresponding to the n frames of OCT images at the time x of implantation (I) (S); determining a corrosion degree Cij of a jth stent bar in an ith frame of OCT image at the time x of implantation, wherein j is a natural number greater than or equal to 1 and less than or equal to Ni (S); and calculating an overall corrosion degree Cx of the absorbable stent at the time x of implantation according to the following formula: (II) (S). The evaluation method can be applied to clinical treatment.

Evaluation method and system for corrosion degree of absorbable stent

An implantable device including a metal substrate; that contains particles having a size of 1 μm 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 μm 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 μm 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.

Implantable device

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.

Lumen stent and preform thereof, and methods for preparing the lumen stent and preform thereof

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.

Iron-based alloy absorbable and implantable medical device for internal fixation

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.

Absorbable metal stent

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.

Stent and preparation method therefor

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.

Absorbable iron-based alloy implanted medical device

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.

Lumen stent and preform thereof, and methods for preparing lumen stent and preform thereof

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] &#x3bc;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.

An absorbable iron-based alloy medical device implant, comprising an iron-based alloy substrate () and a degradable polymer () provided on a surface of an iron-based alloy substrate (), and a zinc-containing protective member () provided on the surface of the iron-based alloy substrate (). The zinc-containing protective member () 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 &#x2265;20% and &#x3c;100%. The zinc-containing protective member () can delay corrosion of the iron-based alloy substrate () during an early stage of medical device implantation. The iron-based alloy substrate () 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.

Absorbable iron-based alloy medical device implant

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&#x2212;0.0136(dm)a&#x2265;0, wherein &#x2212;0.95&#x2264;a&#x2264;&#x2212;0.85 and 1&#x2264;m&#x2264;n. The radiopaque structure has good or excellent visibility.

Radiopaque structure and implanted medical device having radiopaque structure

An absorbable iron-based alloy implantable medical device, including an iron-based alloy substrate and a degradable polymer coating and a zinc-containing protector which are arranged on the surface of the iron-based alloy substrate. The zinc-containing protector is selected from zinc and/or a zinc alloy, or a mixture of zinc and/or a zinc alloy and a degradable binder. The weight percentage of the zinc and/or zinc alloy in the mixture is greater than or equal to 20% and less than 100%. The zinc-containing protector is capable of delaying the corrosion of the iron-based alloy substrate during the early stage of implantation, such that the iron-based alloy substrate essentially avoids corrosion during the early stage of implantation and the clinical mechanical property requirements for the device in the early stage of implantation can be satisfied.

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Shenzhen, China

Wenjiao Lin