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Medicine eluting instrument and manufacturing method thereof

A drug and device technology, applied in the field of drug-eluting devices and its manufacturing, can solve the problems of inability to play a therapeutic role, increase the risk of thrombus, and match the repair process of drug lesions, etc.

Inactive Publication Date: 2020-07-03
BIOTYX MEDICAL (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the inner and outer surfaces of most drug-eluting stents are coated with drugs. When the drug-eluting stent is implanted in a blood vessel, only the outer surface and the side surface of the stent are in contact with the vessel wall, and the outer surface of the stent The active drug released from the side surface of the stent will enter the blood vessel wall to play a curative effect, while the active drug on the inner surface of the stent will not only fail to play a therapeutic role, but will be released into the blood and circulate to the whole body, which may play a role in other organs. toxic side effect
In addition, active drugs on the inner surface of the stent can also inhibit stent endothelialization, thereby increasing the risk of thrombosis
[0003] Moreover, the drug release period of the existing drug-eluting stent is too short, which makes it difficult for the drug release to match the repair process of the diseased tissue, thus making it difficult to effectively play a therapeutic role

Method used

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  • Medicine eluting instrument and manufacturing method thereof
  • Medicine eluting instrument and manufacturing method thereof
  • Medicine eluting instrument and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] First prepare the ethyl acetate solution of rapamycin with a concentration of 5 mg / mL and the ethyl acetate solution of poly(racemic lactic acid) with a concentration of 3 mg / mL; prepare a matrix formed of pure iron with a specification of 30008, and wrap the matrix with On the inner struts, the base is slightly compressed so that the inner surface of the base is pressed against the inner struts. Then spray the ethyl acetate solution of rapamycin on the substrate by ultrasonic spraying, remove the inner strut after drying to obtain a stent containing a pure drug layer, wherein the pure drug layer completely covers the outer surface and side surface of the substrate; Spray the ethyl acetate solution of polyracemic lactic acid onto the inner surface, outer surface and side surface of the stent, the coating speed of this step is 0.03mL / min, the ethyl acetate in the ethyl acetate solution of polyracemic lactic acid Dissolve all the rapamycin in the pure drug layer into the ...

Embodiment 2

[0088] First prepare the ethyl acetate solution of rapamycin with a concentration of 5 mg / mL and the ethyl acetate solution of poly(racemic lactic acid) with a concentration of 10 mg / mL; prepare a matrix formed of pure iron with a specification of 30008, and cover the matrix with On the inner struts, the base is slightly compressed so that the inner surface of the base is pressed against the inner struts. Then spray the ethyl acetate solution of rapamycin on the substrate by ultrasonic spraying, remove the inner strut after drying to obtain a stent containing a pure drug layer, wherein the pure drug layer completely covers the outer surface and side surface of the substrate; Spray the ethyl acetate solution of polyracemic lactic acid onto the inner surface, outer surface and side surface of the stent, the coating speed of this step is 0.10mL / min, the ethyl acetate in the ethyl acetate solution of polyracemic lactic acid The rapamycin in the pure drug layer is partially dissolv...

Embodiment 3

[0091]First prepare the ethyl acetate solution of rapamycin with a concentration of 5 mg / mL and the ethyl acetate solution of poly(racemic lactic acid) with a concentration of 10 mg / mL; prepare a matrix formed of pure iron with a specification of 30008, and the surface of the matrix is ​​treated with For roughening treatment, grooves are formed on the substrate, and the plane where the opening end of the groove is located is coplanar with the outer surface of the substrate. The substrate is placed on the inner strut, and the substrate is slightly compressed so that the inner surface of the substrate is close to the inner strut. Then spray the ethyl acetate solution of rapamycin on the substrate by ultrasonic spraying, remove the inner strut after drying to obtain a stent containing a pure drug layer, and the groove of the substrate is filled with rapamycin, the pure drug layer Completely cover the outer surface and side surface of the matrix; then spray the ethyl acetate soluti...

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Abstract

The invention relates to a medicine eluting instrument and a manufacturing method thereof. The medicine eluting instrument comprises a basal body and a medicine carrying layer, wherein the basal bodycomprises an outer surface, side surfaces and an inner surface; the medicine carrying layer contains a medicine carrier and an active medicine; the outer surface, the side surfaces and the inner surface of the basal body are covered by the medicine carrying layer; and the active medicine is only distributed on at least a part of regions covering the outer surface and the side surfaces, of the medicine carrying layer, in the thickness direction of the at least a part of the regions, the concentration of the active medicine on one side adjacent to the basal body is greater than that of the active medicine on one side away from the basal body, and the region in the inner surface of the basal body, of the medicine carrying layer does not contain the active medicine. Through the adoption of themedicine eluting instrument disclosed by the invention, the release period of the active medicine is long, and the risk of generating thrombosis is low.

Description

technical field [0001] The invention relates to the field of implantable medical devices, in particular to a drug-eluting device and a manufacturing method thereof. Background technique [0002] Drug-eluting stents are increasingly used in the treatment of cardiovascular diseases. At present, the inner and outer surfaces of most drug-eluting stents are coated with drugs. When the drug-eluting stent is implanted in a blood vessel, only the outer surface and the side surface of the stent are in contact with the vessel wall, and the outer surface of the stent The active drug released from the side surface of the stent will enter the blood vessel wall to play a curative effect, while the active drug on the inner surface of the stent will not only fail to play a therapeutic role, but will be released into the blood and circulate to the whole body, which may play a role in other organs. toxic side effect. In addition, the active drug on the inner surface of the stent can also in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/82
CPCA61F2/82A61F2240/001
Inventor 林文娇胡军
Owner BIOTYX MEDICAL (SHENZHEN) CO LTD
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