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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 the biological abnormalities of human tissue, affect the mechanical properties of iron-based devices, and cause biological safety risks, etc. Effect

Pending 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

Slight uneven corrosion of iron-based devices usually does not lead to serious consequences such as partial fracture and support structure collapse within 1 month after implantation, but the degradable polyester applied on the surface of iron-based devices will aggravate the corrosion of iron-based devices. The degree of uneven corrosion is likely to cause local fracture of iron-based devices in the early stage of implantation, affecting the mechanical properties of iron-based devices in the early stage of implantation
In addition, uneven corrosion will lead to local accumulation of corrosion products in iron-based instruments, and human tissues in contact with this part may produce biological abnormalities and biological safety risks

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055]Polylactic acid was separated and purified by GPC to obtain polylactic acid with a residual monomer mass fraction of 0.1%. Polylactic acid with a residual monomer mass fraction of 0.1% was dissolved in ethyl acetate, and then sprayed on the surface of an iron-based alloy stent with a carbon content of 2.11 wt%, to obtain the degradable polyester-coated iron-based alloy of Example 1 Stent. In the degradable polyester-coated iron-based alloy vascular stent of this embodiment, the average thickness of the degradable polyester coating is 5 microns. The mass ratio of the degradable polyester to the iron-based matrix is ​​1:80.

[0056] Using the same material and method, make three identical stents, and randomly put one of the stents into a sample bottle, and add physiological saline to make it just completely submerge the stent. Place the sample bottle in a constant temperature water bath environment at 36.5°C to 37.5°C, and shake at a speed of 40-80 rpm. Then at day 3, t...

Embodiment 2

[0060] The polylactic acid is separated and purified by GPC method to obtain the preferred polylactic acid with a mass fraction of low molecular weight fractions of less than 100,000 and a mass fraction of residual monomers of 1.0%. The obtained preferred polylactic acid was dissolved in ethyl acetate, and sprayed on the surface of the pure iron stent to obtain the degradable polyester-coated pure iron stent of Example 2. In this embodiment, the average thickness of the degradable polyester coating is 5 microns. The mass ratio of the degradable polyester to the iron-based matrix is ​​1:100.

[0061] The degradable polyester-coated pure iron stent provided in Example 2 was implanted into the abdominal aorta of New Zealand rabbits. The stent and its surrounding vascular tissue were taken out 7 days after implantation. Cut and flatten the stent with vascular tissue in the axial direction, use a microscope to observe the appearance integrity of the stent, and observe whether the...

Embodiment 3

[0064] The polylactic acid is separated and purified by an ultrafiltration membrane filtration method to obtain the preferred polylactic acid with a residual monomer mass fraction of 0.05%. The obtained preferred polylactic acid was dissolved in ethyl acetate, and then sprayed on the surface of the iron-based alloy stent to obtain the degradable polyester-coated iron-based alloy stent of Example 3. In this embodiment, the average thickness of the degradable polyester coating is 2 microns. The mass ratio of the degradable polyester to the iron-based matrix is ​​1:200.

[0065] The degradable polyester-coated iron-based alloy stent provided in Example 3 was implanted into the abdominal aorta of New Zealand rabbits. The stent and its surrounding vascular tissue were taken out 7 days after implantation. Cut and flatten the stent with vascular tissue in the axial direction, use a microscope to observe the appearance integrity of the stent, and observe whether there is serious loc...

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Abstract

The invention discloses an absorbable iron-based instrument. The absorbable iron-based instrument comprises an iron-based matrix and degradable polyester which is in contact with the surface of the iron-based matrix. The mass fraction of a low-molecular-weight portion of the degradable polyester is smaller than or equal to 5%, and the molecular weight of the low-molecular-weight portion is smallerthan 10 thousand, and the mass fraction of residual monomers in the degradable polyester is smaller than or equal to 2%. By control over the mass fraction of the low-molecular-weight portion in the degradable polyester applied to the iron-based instrument or the mass fraction of the residual monomers in the degradable polyester, the absorbable iron-based instrument is corroded more uniformly in early period of implantation. Meanwhile, in a corrosion process of the absorbable iron-based instrument in the early period of implantation, a large number of degradation products cannot be generated within a short time. Therefore, effectiveness reduction or biology safety risk caused by rapid and non-uniform corrosion of the iron-based instrument in the early period of implantation can be prevented effectively.

Description

technical field [0001] The present invention relates to implanted medical devices, in particular to absorbable iron-based devices. Background technique [0002] As an important element in the human body, iron is involved in many biochemical processes. Implantable devices made of pure iron or iron-based alloys can gradually corrode and be absorbed by the human body after being implanted into the human body, which is safer and more reliable, and can effectively avoid long-term adverse effects caused by permanent implants remaining in the human body for a long time Reactions, such as long-term vascular restenosis, inflammatory reactions, and the site of the implant cannot be re-intervened. [0003] The corrosion rate of iron-based devices is slow in the environment of living organisms, and the application of degradable polyester on the surface can accelerate the corrosion of iron-based devices. The principle of degradable polyester to accelerate the corrosion of iron-based de...

Claims

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Application Information

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IPC IPC(8): A61L31/14A61L31/06A61L31/02A61L31/16A61L17/12A61L17/10A61L17/00
CPCA61L17/005A61L17/105A61L17/12A61L31/022A61L31/06A61L31/148A61L31/16A61L2300/42A61L2300/416A61L2300/41C08L67/00C08L67/04C08L67/02A61L27/042A61L27/58A61L27/54A61L27/34A61L31/10A61L2300/418A61L2400/18
Inventor 胡军张德元孙宏涛陈丽萍
Owner BIOTYX MEDICAL SHENZHEN CO LTD
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