Absorbable iron-based implantable device

An implantable, iron-based technology, applied in coatings, medical science, prostheses, etc., can solve problems such as difficulty in absorbing iron corrosion products, easy changes in chemical properties, and slow removal of solid corrosion products

Pending Publication Date: 2019-07-02
BIOTYX MEDICAL SHENZHEN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, if Fe(OH) 3 Solid corrosion products are aggregated together, and phagocytes can only contact the outermost layer of corrosion products, and the efficiency of swallowing and transporting solid corrosion products will become lower
Therefore, Fe(OH) 3 Solid corrosion products will be removed more slowly, resulting in longer absorption cycles
[0005] Aiming at the problems that the iron corrosion products are difficult to absorb in the body and the absorption cycle is long, the prior art adopts the method of adding antioxidants to promote the formation of soluble iron corrosion products, such as water-soluble polyphenols, tocopherols, sodium tripolyphosphate, etc., However, the above-mentioned antioxidants have the following problems: 1. Poor stability, the chemical properties are easy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0058] For the preparation of the above-mentioned absorbable iron-based implantable device, the iron-based substrate is first prepared according to the method mastered by those skilled in the art, and then the iron-based substrate is formed on the iron-based substrate by the method mastered by those skilled in the art. Degradable polymer layers for drugs, etc. For example, laser cutting is used to form the lumen iron-based matrix, and then plasma spraying, ultrasonic atomization spraying and other methods are used to form iron-absorbing agent and / or drug-containing degradable polymer layer on the iron-based matrix.

[0059]The above-mentioned iron absorption-promoting agent is purchased or polymerized using a polymerization method mastered by those skilled in the art. For example, the iron absorption promoting agent is formed by copolymerizing antioxidants and polymer monomers by melt polymerization, for example, polylactic acid vitamin E copolymer is formed by polymerization ...

Embodiment 1

[0069] Dissolve proanthocyanidin polymers with a weight-average molecular weight of 1000 in ethyl acetate to prepare a solution with a concentration of proanthocyanidin polymers of 10 mg / mL, and spray the solution evenly on iron bars with a nominal diameter of 4.0 mm and a wall thickness of 60 microns. An iron-absorbing agent layer with a thickness of 5 microns is formed on the inner and outer surfaces of the base body of the alloy-based coronary stent to obtain the iron-based alloy coronary stent. Wherein, the mass ratio of the iron absorption promoting agent to the iron in the iron-based alloy coronary stent matrix is ​​0.05:1. Continue to spray a 3 micron thick polylactic acid (weight average molecular weight: 20,000) loaded rapamycin layer on the surface of the iron-absorbing agent coating to obtain an iron-based alloy coronary stent. The prepared iron-based alloy coronary stents were implanted into the coronary arteries of minipigs, and the overexpansion ratio was kept in...

Embodiment 2

[0071] Dissolve tocopheryl polyethylene glycol maleate with a weight average molecular weight of 5000 in ethyl acetate to prepare a solution with a concentration of tocopheryl polyethylene glycol maleate of 10 mg / mL, and spray the solution evenly On the inner and outer surfaces of the base body of the iron-based alloy coronary stent with a nominal diameter of 3.0 mm and a wall thickness of 50 microns, a 10-micron-thick iron-absorbing agent layer is formed to obtain the iron-based alloy coronary stent. Wherein, the mass ratio of the iron absorption promoting agent to the iron in the iron-based alloy coronary stent matrix is ​​0.15:1. The prepared iron-based alloy coronary stents were implanted into the coronary arteries of minipigs, and the overexpansion ratio was kept in the range of 1.1:1 to 1.2:1 during the implantation process. After 36 months of follow-up, the residual iron-based alloy coronary stent and the surrounding vascular tissue were taken out, and the percentage of...

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Abstract

The invention relates to an absorbable iron-based implantable device. The absorbable iron-based implantable device comprises an iron-based matrix and an iron-promoting absorbent attached to the iron-based matrix. The iron-promoting absorbent is a polymer, and an iron-promoting absorbent molecular chain contains an antioxidant structural unit. An antioxidant is released gradually with gradual degradation or chain breaking of the iron-promoting absorbent and can play a role in promoting iron absorption.

Description

technical field [0001] The invention relates to the field of implantable medical devices, in particular to an absorbable iron-based implantable device. Background technique [0002] At present, absorbable implantable medical device materials mainly include degradable polymers and absorbable metal materials. Absorbable metal materials include magnesium-based alloys, iron-based alloys, zinc-based alloys and pure iron. Among them, iron-based alloys and pure iron have excellent mechanical properties comparable to those of permanent implanted medical metal materials such as stainless steel, cobalt-chromium alloy, and platinum-chromium alloy. Compared with other absorbable materials, smaller but Implanted medical devices with better mechanical properties can ensure better clinical operability and effectiveness. The ideal absorbable medical device design concept is to provide effective support during the recovery period of the lesion. After the lesion is cured, the absorbable imp...

Claims

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Application Information

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IPC IPC(8): A61L31/02A61L31/10A61L31/14A61L31/16
CPCA61L31/022A61L31/10A61L31/16A61L31/148A61L2300/416A61L2300/43A61L2400/18A61L2420/08C08L67/04A61L27/042A61L27/505A61L27/54A61L27/58A61L31/143A61L27/34A61L31/06
Inventor 林文娇陈丽萍秦莉
Owner BIOTYX MEDICAL SHENZHEN CO LTD
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