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Simulation liquid and method for in-vitro detection of zinc-containing medical instrument

A medical device and in vitro detection technology, applied in the field of medical devices, can solve the problems of long cycle, large individual differences, and high cost of animal experiments

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

AI Technical Summary

Problems solved by technology

[0004] For the monitoring method of the zinc corrosion rate of zinc-containing implantable medical devices, animal experiments can be used to obtain results close to those of humans, but due to the high cost and long cycle of in vivo animal experiments, it takes a long time to obtain test results , individual differences are large, and in the research and development process of medical devices, the quality monitoring in the production of devices should require the ability to quickly collect test results, be able to simulate the corrosion of zinc in the body, and have a good correlation between in vivo and in vitro

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0036] In this embodiment, the preparation method of the simulated liquid includes: first weighing the DMEM powder and the antibacterial agent, making up the volume with water, then using serum, whole blood or plasma to make up the volume, and adjusting the pH value to obtain the simulated liquid.

[0037] This embodiment also provides a method for in vitro detection of zinc-containing medical devices, including the following steps: placing the zinc-containing medical devices in the above-mentioned simulated liquid, reacting at 20-60°C, and detecting the zinc content in the simulated liquid , to obtain the zinc release amount of zinc-containing medical devices.

[0038] The amount of zinc released from zinc-containing medical devices in the above-mentioned simulated solution is used to characterize the quality of zinc corrosion in the body and released into surrounding tissues, and can initially analyze the biological safety of zinc-containing implanted devices. The quality of ...

Embodiment 1

[0068] Simulation solution: 10g / L low-sugar DMEM medium, 20mmol / L 4-hydroxyethylpiperazineethanesulfonic acid (HEPES), 10% volume ratio serum, 1g / L sodium azide.

[0069] Put A and B stents in 10mL simulated solution respectively, and the solutions completely submerge the stents respectively, and take out the stents after 2 days of corrosion in a water bath at 37°C. The surface coating of A stents needs to be removed with ethyl acetate first, and then A and B stents Ultrasonic cleaning was performed with saturated glycine solution for 1 min, and the cleaning solutions of brackets A and B were collected, tested and calculated by the above method, and the zinc release amount, zinc corrosion amount and the percentage of zinc corrosion amount were obtained.

[0070] The release amount of zinc in stent A and stent B in the simulated solution was 40 μg and 150 μg respectively, that is, the content of zinc released into the simulated solution after B stent was corroded was higher than...

Embodiment 2

[0073] Simulation solution: 10g / L high-glucose DMEM medium without phenol red, 20mmol / L 4-hydroxyethylpiperazineethanesulfonic acid (HEPES), 10% volume ratio of serum.

[0074] Place C and D stents in 10mL of simulated solution respectively, and the solutions completely submerge the stents, and take out the stents after 2 days of corrosion in a water bath at 37°C. Firstly, the surface coating of C stents needs to be removed with ethyl acetate, and then C and D stents Ultrasonic cleaning was performed with saturated glycine solution for 1 min, and the cleaning solutions of C and D brackets were collected, respectively detected and calculated by the above method, and the zinc release amount, zinc corrosion amount and the percentage of zinc corrosion amount were obtained.

[0075] The amount of zinc released in the simulated solution of C and D supports was 60 μg and 200 μg respectively, that is, the content of zinc released into the simulated solution after D support was corroded...

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Abstract

The invention relates to a simulation liquid for in-vitro detection of a zinc-containing medical instrument. The simulation liquid comprises 1-50g / L of a DMEM culture medium, 0-80% of serum or whole blood or plasma and a pH buffer substance in volume ratio. In vitro, the zinc-containing medical instrument is placed in the simulation liquid, the zinc content in the simulation liquid and the zinc content in the cleaning liquid are tested, the biological risk can be evaluated, the zinc corrosion speed can be obtained, and the result can correspond in vivo and in vitro. The testing method can be used for detecting whether the zinc corrosion speed of a product in production is stable or not, and can also be used for preliminarily judging whether the support design meets the requirements or notin the research and development process.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a simulated liquid for in vitro detection of zinc-containing medical devices and a method for in vitro detection of zinc-containing medical devices. Background technique [0002] Zinc is a metal that has suitable strength and hardness by itself, and its strength and hardness will be greatly improved after being mixed with alloying elements such as aluminum and copper. Zinc is also one of the essential trace elements for the human body. Zinc exists in the human body itself. In the field of implantable degradable medical devices, zinc / zinc alloys are used as device materials, which can provide suitable mechanical support to ensure that the device can effectively support tissues / vessels for a certain period of time, and can also be safely placed in the body. Realize full degradation and full absorption. At the same time, as a relatively active and safe metal element, zinc is coated ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50
CPCG01N33/50
Inventor 齐海萍陆妍媚杨涵
Owner BIOTYX MEDICAL (SHENZHEN) CO LTD
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