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Absorbable iron-based instrument

An iron-based and device technology, applied in the field of absorbable iron-based devices, can solve problems such as corrosion of iron-based devices and affect the structural integrity and mechanical properties of iron-based devices, to accelerate corrosion, reduce the possibility of adverse reactions, and avoid cell damage. toxic effect

Active Publication Date: 2018-07-10
BIOTYX MEDICAL (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the acidic environment will also accelerate the degradation of the degradable polyester itself. The rapid degradation of the degradable polyester will cause the iron-based device to corrode too quickly in the early stage of implantation, and affect the structure of the iron-based device within 1 to 6 months after implantation. integrity and mechanical properties

Method used

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  • Absorbable iron-based instrument
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  • Absorbable iron-based instrument

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] The absorbable iron-based stent provided in Example 1 is composed of a plurality of stent rods. See figure 1 , each stent rod includes an iron-based substrate 11 , a zinc-containing protective body 12 completely covering the iron-based substrate 11 , and a degradable polyester coating 13 completely covering the zinc-containing protective body 12 . The iron-based substrate 11 is made of an iron-based alloy with a carbon content of 1.19%. The zinc-containing protective body 12 is a single zinc coating. The degradable polyester coating 13 is poly-racemic lactic acid with a mass fraction of low molecular weight fractions below 10,000 of 2% and a mass fraction of residual monomers of 1.6%.

[0075] The manufacturing process of the absorbable iron-based stent provided in Example 1 is as follows:

[0076] On the surface of the iron-based stent with an original radial support force of 145kPa and a mass of 4.5mg, the vacuum evaporation method is used to uniformly plate zinc a...

Embodiment 2

[0081] On the surface of the iron-based stent with an original radial support force of 145kPa and a mass of 4.5mg, the vacuum evaporation method is used to uniformly plate zinc as a zinc-containing protective body, so that the zinc element completely covers the surface of the iron-based stent, and the mass of the zinc element The mass ratio to the iron-based support is 1:200 to obtain a galvanized iron-based support. The polyracemic lactic acid is separated and purified by GPC method, and the mass fraction of the low molecular weight part with a molecular weight of less than 10,000 is 2%, and the mass fraction of the residual monomer is 1.6%. The obtained polyracemic lactic acid was dissolved in ethyl acetate to obtain a coating solution. Spray the coating solution onto the surface of the galvanized iron-based stent, and make the ratio of the mass of polyracemic lactic acid to the mass of the iron-based stent be 1:10, dry to remove ethyl acetate, crimp on the crimping device a...

Embodiment 3

[0084] On the surface of the iron-based stent with an original radial support force of 145kPa and a mass of 4.5mg, the vacuum evaporation method is used to uniformly plate zinc as a zinc-containing protective body, so that the zinc element completely covers the surface of the iron-based stent, and the mass of the zinc element The mass ratio to the iron-based support is 1:20 to obtain a galvanized iron-based support. The polyracemic lactic acid is separated and purified by GPC method, and the mass fraction of the low molecular weight part with a molecular weight of less than 10,000 is 2%, and the mass fraction of the residual monomer is 1.6%. The obtained polyracemic lactic acid was dissolved in ethyl acetate to obtain a coating solution. Spray the coating solution onto the surface of the galvanized iron-based bracket, and make the ratio of the mass of polylactic acid to the mass of the iron-based bracket 1:10, dry to remove ethyl acetate, press on the crimping equipment and us...

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Abstract

The invention discloses an absorbable iron-based instrument. The absorbable iron-based instrument comprises an iron-based matrix, a zinc-containing protecting body and degradable polyester, wherein the zinc-containing protecting body is in contact with the iron-based matrix; and the degradable polyester is in contact with the iron-based matrix body and / or the zinc-containing protecting body. The range of the ratio of the mass of the zinc-containing protecting body to the mass of the iron-based matrix is 1: 200 to 1: 2. In the degradable polyester, the mass fraction of a portion of which the molecular weight is smaller than 10 thousand is smaller than or equal to 5%; or in the degradable polyester, the mass fraction of residual monomers is smaller than or equal to 2%. By control over a degrading process of the degradable polyester, the structural completeness of the instrument can be maintained for 1-6 months under protection of the zinc-containing protecting body; the circumstance thatthe zinc-containing protecting body corrodes to generate a large number of zinc ions and produce cytotoxicity; and moreover, after being implanted for 1-6 months, the instrument still has sufficientdegradable polyester to accelerate corrosion of the iron-based instrument, and thus, side effects caused by the reason that the iron-based instrument stays in a human body for a long time are avoided.

Description

technical field [0001] The invention belongs to the field of implantable medical devices, in particular to absorbable iron-based devices. Background technique [0002] Absorbable implantable devices support or connect the diseased part after being implanted in the human body, until the diseased part heals or returns to normal shape and function, the device gradually corrodes or degrades and is completely absorbed by the body. Depending on the application site of the implantable device, it is generally believed that the healing period of the lesion is 1 to 6 months. That is, absorbable implantable devices need to maintain structural integrity within 1 to 6 months after implantation, and have sufficient mechanical properties to support or connect the lesion site. However, after 1 to 6 months of implantation, the lesion will heal, and the device should corrode or degrade as soon as possible within a relatively short period of time. [0003] Absorbable implantable devices made...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L17/10A61L17/12A61L27/04A61L27/18A61L27/58A61L27/54A61L31/02A61L31/06A61L31/14A61L31/16
CPCA61L17/005A61L17/105A61L17/12A61L27/04A61L27/18A61L27/54A61L27/58A61L31/022A61L31/06A61L31/148A61L31/16A61L2300/42A61L2300/41A61L2300/416C08L67/00A61L27/042A61L27/34A61L31/10A61L27/306A61L31/088C08L67/04A61K45/06
Inventor 孙宏涛张德元胡军陈丽萍
Owner BIOTYX MEDICAL (SHENZHEN) CO LTD
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