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High-safety nickel-free metal drug-eluting vascular stent and manufacturing method thereof

A technology for vascular stents and manufacturing methods, which is applied in the field of nickel-free metal drug-eluting vascular stents and its manufacture, can solve the problems of stent segment restenosis, thrombus, and stent failure, and reduce the risk of thrombus, improve fatigue strength, and ensure safety sex high effect

Active Publication Date: 2022-02-08
ZHONGKE YIAN MEDICAL TECH BEIJING CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after stent implantation, there will still be restenosis, thrombosis and late stent failure in some patients.

Method used

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  • High-safety nickel-free metal drug-eluting vascular stent and manufacturing method thereof
  • High-safety nickel-free metal drug-eluting vascular stent and manufacturing method thereof
  • High-safety nickel-free metal drug-eluting vascular stent and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Example 1 High-nitrogen nickel-free austenitic stainless steel seamless thin-walled pipe 1

[0065] Take a forged high-nitrogen nickel-free stainless steel bar with a nitrogen content of 0.62% by weight and a manganese content of 15.4% by weight, and process it with a deep hole drilling machine to obtain a tube blank with a size of Φ30×6mm. The designed finished pipe size is Φ3.0×0.11mm. The number of cold deformation passes is 17, and the deformation amount of each pass is 40-50%. Each pass is divided into three cold deformations, and the deformation amount of each pass is 45-50%, 30-35%, and 20-25% of the deformation amount of the pass. After each cold deformation, the surface of the pipe is ultrasonically cleaned to remove surface lubricants. After drying, put it into a heat treatment furnace that can be vacuumed and pressurized. The material of the furnace is 2520 superalloy, and there are three temperature-measuring thermocouples to monitor the temperature in rea...

Embodiment 2

[0067] Example 2 High-nitrogen nickel-free austenitic stainless steel seamless thin-walled pipe 2

[0068]Take a forged high-nitrogen nickel-free stainless steel bar with a nitrogen content of 0.62% by weight and a manganese content of 15.4% by weight, and process it with a deep hole drilling machine to obtain a tube blank with a size of Φ30×6mm. The designed finished pipe size is Φ1.8×0.09mm. The number of cold deformation passes is 21, and the deformation amount of each pass is 40-50%. When the outer diameter of the pipe is ≥3.0mm, each pass is divided into three cold deformations, and the deformation amount of each pass is 45-50%, 30-35% and 20-25% of the deformation amount of the pass; when the outer diameter of the pipe is -1 Continue pumping for more than 10 minutes after Pa, and close the valve of the vacuum system. Fill the furnace with a mixture of nitrogen and argon, the total pressure is 0.25MPa, the ratio of nitrogen to argon is 1:4, that is, the partial pressure ...

Embodiment 3

[0070] Example 3 High-nitrogen nickel-free austenitic stainless steel seamless thin-walled pipe 3

[0071] Take a forged high-nitrogen nickel-free stainless steel bar with a nitrogen content of 0.62% by weight and a manganese content of 15.4% by weight, and process it with a deep hole drilling machine to obtain a tube blank with a size of Φ30×6mm. The designed finished pipe size is Φ4.5×0.19mm. The number of cold deformation passes is 15, and the deformation amount of each pass is 40-50%. Each pass is divided into three cold deformations, and the deformation amount of each pass is 45-50%, 30-35%, and 20-25% of the deformation amount of the pass. After each cold deformation, the surface of the pipe is ultrasonically cleaned to remove surface lubricants. After drying, put it into a heat treatment furnace that can be vacuumed and pressurized. The material of the furnace is 2520 superalloy, and there are three temperature-measuring thermocouples to monitor the temperature in rea...

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Abstract

The invention relates to a high-safety nickel-free metal drug-eluting vascular stent and a manufacturing method thereof. The nitrogen content of the material is further increased when the bracket pipe is prepared by step-by-step nitriding, and a high-nitrogen nickel-free austenitic stainless steel with a nitrogen content of 0.8-1.2% is obtained as the metal platform material of the bracket. By adopting the rolling line contact type electrochemical polishing, the surface of the stent can form a micron-scale convex-concave structure through crystal grains with different orientations, thereby improving the bonding force between the metal material of the stent and the drug coating. The blood vessel stent has the characteristics of high fatigue life, high biological safety and high binding force between drug coating and matrix.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a nickel-free metal drug-eluting vascular stent with long service life and high safety and a manufacturing method thereof. Background technique [0002] Stent implantation is currently the most effective and safe method for treating vascular stenosis. After more than 30 years of development, stent implantation and stent manufacturing technology have basically matured. Coronary stents generally use the method of preparing a drug coating on the surface of the metal stent, and through balloon expansion, the stent is fixed on the target lesion of the vessel, which acts as a long-term physical support for the lesion vessel and participates in the blood supply of the vessel. However, after stent implantation, restenosis of the stent segment, thrombosis and late failure of the stent will still occur in some patients. The reason may be related to the following factors: (1) during the sten...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/02A61L31/14A61L31/16A61L31/08C22C38/58C22C38/44C22C38/02C22C38/42C23C8/26C25F3/24
CPCA61L31/028A61L31/14A61L31/16A61L31/08C22C38/58C22C38/44C22C38/02C22C38/001C22C38/42C23C8/26C25F3/24A61L2300/606A61L2300/406
Inventor 李文白树功
Owner ZHONGKE YIAN MEDICAL TECH BEIJING CO LTD
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