Iron-base alloy implanted medical device and manufacturing method thereof

A technology for implanting medical devices and iron-based alloys, which is applied in medical formulas, medical preparations containing active ingredients, medical science, etc., and can solve problems such as limited therapeutic effects and side effects of drugs

Active Publication Date: 2016-05-25
BIOTYX MEDICAL (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the total drug dosage range of the device is constant, if the drug release rate is too slow, the therapeutic effect of the drug will be limited; if the drug release rate is too fast, the local drug concentration will be too high to produce toxic and side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Using ethyl acetate as the solvent, the polylactic acid-glycolic acid with a weight average molecular weight of 100,000 and paclitaxel were mixed and dissolved in ethyl acetate at a mass ratio of 3:1, and the solution was coated on the surface of the pure iron stent to form a drug carrier Coating, the thickness of the drug-loaded coating is 15μm, the pore size is 0.2μm, and the amount of paclitaxel on the stent substrate area is 200μg / cm 2 . The prepared drug-loaded stents were implanted into the abdominal aorta of rabbits, and samples were taken at 1 day, 7 days, 14 days, and 28 days. The test showed that the drug release percentages on the stent were 20%, 40%, 50%, and 65%, respectively. The experimental results show that the stent drug-loaded coating prepared in this example has a controllable drug release performance.

Embodiment 2

[0032] Dissolve polysuccinate and rapamycin with a weight average molecular weight of 200,000 in a chloroform solution in a ratio of 4:1, and spray on the surface of the stent to form a polysuccinate-rapamycin drug carrier Coating, the thickness of the coating is about 5μm, the pore diameter is less than 0.1μm, and the amount of rapamycin on the stent substrate area is 50μg / cm 2 ; Then the chloroform solution with a molecular weight of 60,000 polysuccinate is coated on the surface of the drug-carrying coating of the iron-zinc alloy stent substrate, as the top layer, with a thickness of 10 μm and a pore diameter of less than 0.1 μm. The prepared drug-loaded stent was implanted into the abdominal aorta of rabbits, and samples were taken at 1, 7, 14, and 28 days. The test results showed that the drug release percentages were 15%, 35%, 50%, and 65%, respectively. The experimental results showed The stent drug-loaded coating prepared in this embodiment has a controllable drug release...

Embodiment 3

[0034] Using acetone as the solvent, dissolve polyracemic lactic acid with a weight average molecular weight of 300,000, polyglycolic acid and dexamethasone in a mass ratio of 1:1:1, and coat the solution on the nitriding iron with a cavity A drug-loaded coating is formed in the cavity of the base alloy stent. The thickness of the drug-loaded coating is 25μm, the pore diameter is 2μm, and the amount of active drug on the stent substrate area is 300μg / cm 2 . The prepared drug-loaded stent was implanted into the rabbit's abdominal aorta, and samples were taken at 1, 7, 14, and 28 days. The test results showed that the drug release percentages were 40%, 50%, 60%, and 80%. The experimental results showed The stent drug-loaded coating prepared in this embodiment has a controllable drug release performance.

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PUM

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Abstract

The invention provides an iron-base alloy implanted medical device. The iron-base alloy implanted medical device comprises an iron-base alloy matrix and a medicine-loaded coating, wherein the drug-loaded coating comprises a polymer and an active medicine; the weight-average molecular weight of the polymer is from 50000 to 1000000; micropores are formed in the medicine-loaded coating, and the aperture of each micropore is less than or equal to 10 micrometers. The release percentage of the active medicine on the iron-base alloy implanted medical device ranges from 4t<1 / 2>-1 to 6.9t<1 / 2>+63, wherein t belongs to (0, 28], t is a sampling time / day, and the medical device has a proper medicine release speed.

Description

Technical field [0001] The invention belongs to the field of degradable implanted medical devices, and relates to an iron-based alloy drug-carrying implanted medical device with controllable drug release and a preparation method thereof. Background technique [0002] Currently, implanted medical devices are usually made of metals and their alloys, ceramics, polymers and related composite materials. Among them, metal material-based implanted medical devices are particularly popular due to their superior mechanical properties, such as high strength and high toughness. [0003] As an important element of the human body, iron participates in many biochemical processes, such as the transport of oxygen. PeusterM et al. used a laser engraving method to make a corrosive pure iron stent similar in shape to the metal stent used in clinical practice and implanted it into the descending aorta of 16 New Zealand rabbits. The results of this animal experiment showed that there were no thromboti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/16A61L31/02A61L31/10
CPCA61L31/022A61L31/10A61L31/16A61L2300/216A61L2300/222A61L2300/41A61L2300/416C08L67/04C08L67/02C08L51/08C08L87/00A61L27/047A61L27/34A61L2300/42A61L2300/43A61L2300/602A61K31/337A61K31/436A61K31/498A61K31/5415A61K31/575A61L2300/204A61L2300/426A61L2420/02
Inventor 孙宏涛陈丽萍胡军张德元
Owner BIOTYX MEDICAL (SHENZHEN) CO LTD
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