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Absorbable peripheral stent and preparation method thereof

A prefabricated, end-region technology, applied in the field of medical devices, which can solve the problems of perforation of the blood vessel wall, high patient risk, and fast corrosion rate of local stent rods.

Active Publication Date: 2021-07-16
BIOTYX MEDICAL (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Then it is easy to cause the corrosion rate of local support rods to be too fast, and some support rods have not yet started to corrode
In extreme cases, if the stent rod collapses significantly in the middle or breaks into two halves, the stent rod that has not started to corrode may cause perforation of the vessel wall, which is extremely risky to the patient

Method used

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  • Absorbable peripheral stent and preparation method thereof
  • Absorbable peripheral stent and preparation method thereof

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preparation example Construction

[0048] The present application also provides a method for preparing an absorbable peripheral stent, including providing an absorbable stent preform, and performing nitriding, carburizing, or carbonitriding treatment on the two end regions of the absorbable stent preform, so that The material composition of the end region and the middle region of the treated absorbable stent preform is different, and the material strength of the end region is greater than that of the middle region, and the corrosion rate of the end region is greater than that of the middle region .

[0049] In an embodiment of the present application, the absorbable preform is laser cut from a pure iron (iron content > 99.96wt%) circular tube, and the bracket pattern in the end region is basically consistent with the bracket pattern in the middle region (circumferential The number of upward support rods is the same, and the width and wall thickness of the support rods are basically the same).

[0050] Since th...

Embodiment 1

[0062] A pure iron (iron content>99.96wt%) round tube with a wall thickness of about 100 μm is laser cut to form a stent with a symmetrical pattern. After the bracket is initially polished, the outer surface is smooth to form a prefabricated part. The prefabricated part is ion nitriding, the outer surface of the middle area is blocked by a metal ring, and the two end areas are exposed for ion nitriding. The time of ion nitriding is 120 minutes. After the nitriding stent was polished, it was expanded to a nominal diameter with a balloon catheter, and then its properties were measured.

[0063] Using an oxygen, nitrogen and hydrogen analyzer, it is measured that the nitrogen content of the stent rod at the end area is 2000ppm, the Vickers hardness is 357HV, and the in vitro immersion corrosion rate is about 2.0mm / y. The nitrogen content of the stent rod in the middle area is 500ppm, the hardness is 252HV, and the in vitro immersion corrosion rate is about 0.7mm / y.

Embodiment 2

[0065] A pure iron (iron content>99.96wt%) round tube with a wall thickness of about 100 μm is laser cut to form a stent with a symmetrical pattern. After the bracket is initially polished, the outer surface is smooth to form a prefabricated part. The prefabricated part is ion carburized, and the outer surface of the middle area is blocked by a metal ring, and the two end areas are exposed for ion carburizing. The time of ion carburizing is 80 minutes. After the carburized stent was polished, it was expanded to a nominal diameter with a balloon catheter, and then its properties were measured.

[0066] Using scanning electron microscope energy spectrum analysis, it is measured that the carbon content of the support rod in the end region is 1100ppm, the Vickers hardness is 305HV, and the in vitro immersion corrosion rate is about 0.9mm / y. The carbon content of the support rod in the middle area is 500ppm, the Vickers hardness is 219HV, and the in vitro immersion corrosion rate ...

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Abstract

The invention relates to an absorbable peripheral stent. The absorbable peripheral stent comprises two end regions and a middle region arranged between the two end regions, wherein the material components of the end regions are different from the material components of the middle region, so that the material strength of the end regions is higher than that of the middle region, and the corrosion speed of the end regions is higher than that of the middle region. According to the absorbable peripheral stent, on the premise that other problems are not introduced, the deformation probability of the absorbable peripheral stent can be reduced, the corrosion speed of the end regions is increased, the absorbable peripheral stent starts to be corroded from the end regions, and the vascular perforation risk caused by a stent rod generated by the reason that the middle region is corroded firstly and then broken is reduced. The invention further relates to a preparation method of the absorbable peripheral stent.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to an absorbable peripheral stent and a preparation method thereof. Background technique [0002] This section provides background information related to the present disclosure only and is not necessarily prior art. [0003] With the aging population and changes in diet structure, the incidence of arteriosclerosis of the lower extremities is increasing year by year, and severe patients even have arteriosclerosis of the lower extremities. The prevalence rate of this disease in patients over 60 years old in our country can reach 20%, which seriously affects the quality of life of the elderly and even threatens their lives. The lower extremity artery stent implantation is one of the powerful weapons for the treatment of lower extremity arteriosclerosis, which can effectively open up blood vessels, relieve lower extremity pain, difficulty walking and other ischemic symptoms. The basic m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/915A61L31/02A61L31/14
CPCA61F2/915A61L31/022A61L31/148A61L31/14A61F2240/001A61L31/02
Inventor 温焘源
Owner BIOTYX MEDICAL (SHENZHEN) CO LTD
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