Lifetech Scientific (shenzhen) Co., Ltd

Biotyx Medical (shenzhen) Co. Ltd.

Lifetech Scientific Co., Ltd.

Haiping Qi

Wenjiao Lin

Deyuan Zhang

Li Qin

Ziqiang Liu

Liping Chen

Hongtao Sun

Jun Hu

Gui Zhang

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 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

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

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.

Absorbable iron-based alloy implantable medical device

Disclosed is an implanted device, comprising a device base body and an active drug, wherein the device base body is pure zinc and/or a zinc alloy, the zinc content in the device base body is 0.1-100%, and the active drug comprises anti-allergic drugs. After the implantation of the implanted device into the human body, the surrounding tissues of the implant would not have a clear hypersensitive reaction due to the presence of the anti-allergic drugs, and the implanted device can be used to be implanted into the body for supporting organ chambers, to fill the hollow chambers of the organs and tissues or as orthopaedic implants etc.

Implanted device

Provided are an iron-based absorbable and implantable medical device and manufacturing method thereof. The iron-based absorbable and implantable medical device () comprises a substrate (), a degradable polymer layer (), and an anionic surfactant layer () located between the substrate () and the degradable polymer layer (). The anionic surfactant, by using the hydrophobicity thereof, can form a hydrophobic barrier layer in a solution to isolate a surface of the iron-based substrate () from a body fluid environment, thereby avoiding direct contact with an acidic environment resulting from degradation of the degradable polymer layer () at the initial and early stages of implantation, thus preventing severe local corrosion of the iron-based substrate ().

Iron-based absorbable and implantable medical device and manufacturing method thereof

Absorbable iron-based alloy implanted medical device and manufacturing method thereof. The iron-based alloy implanted medical device comprises an iron-based alloy substrate (), a degradable polymer layer () disposed on a surface of the iron-based alloy substrate (), and a tannic acid chemical conversion film () disposed on a surface of the iron-based alloy substrate (). After the medical device is implanted into a body, the tannic acid chemical conversion film () is configured to protect the iron-based alloy substrate () 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.

Absorbable iron-based alloy medical instrument implant and manufacturing method

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.

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Shenzhen, China

Haiping Qi