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High-biosafety heart stent and manufacturing method thereof

A biosafety and heart stent technology, which is applied in pharmaceutical formulation, drug delivery, medical science, etc., can solve problems affecting the blood compatibility of the stent, insufficient biosafety, and insufficient strength of the stent, so as to improve blood compatibility , Improve the strength and hydrophilicity, and the effect of excellent degradation performance

Active Publication Date: 2020-05-08
SHENZHEN MEDOO MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the raw materials used in this method are all polylactic acid, the acidic substances produced during its metabolism are likely to cause inflammation in the body; and the strong hydrophobicity of polylactic acid will affect the blood compatibility of the stent, increasing the risk of thrombus In addition, the stent made by this method still has the problems of insufficient strength and low supporting force, and it is easy to retract during the process of vasoconstriction and expansion, and the overall biological safety is insufficient.
[0005] Based on the problem of insufficient biological safety brought about by polylactic acid scaffolds, it is currently mainly solved by compounding polylactic acid with other materials, and how to choose suitable materials to compound with polylactic acid to obtain suitable performance and high biosafety heart stent, key to current study

Method used

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  • High-biosafety heart stent and manufacturing method thereof
  • High-biosafety heart stent and manufacturing method thereof
  • High-biosafety heart stent and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] This embodiment provides a method for manufacturing a high biosafety heart stent, which includes the following steps:

[0055] S1. Polylactic acid is prepared by a lactide ring-opening polymerization method, and the polylactic acid is dissolved in 1,4-dioxane at a mass-volume ratio of 1g:10mL, and fully stirred before use;

[0056] The preparation of polylactic acid by the lactide ring-opening polymerization method includes the following steps:

[0057] S11. Put the L-lactic acid monomer in a round-bottom flask, heat and reduce pressure for dehydration at 170℃, 5kPa for 5h, then add 1wt% of stannous octoate as a catalyst, and carry out propylene at 200℃, 0.5kPa Distillation of lactide and condensation to obtain crude lactide;

[0058] S12. The crude lactide obtained in step S11 is washed and recrystallized in sequence to obtain purified L-lactide; the washing process includes placing the crude lactide in deionized water, rapidly stirring and then performing suction filtration ...

Embodiment 2~5 and comparative example 1

[0069] Examples 2 to 5 and Comparative Example 1 respectively provide a method for manufacturing a high biosafety heart stent. Compared with Example 1, the difference is that Examples 2 to 5 change the time of the ring-opening polymerization reaction in step S13. , Thereby obtaining polylactic acid with different molecular weights; Comparative Example 1 did not prepare polylactic acid through step S1, but directly purchased commercially available polymer L-polylactic acid with a molecular weight of 900,000. The ring-opening polymerization reaction time corresponding to each example and the molecular weight of polylactic acid in each example and comparative example are shown in Table 2.

[0070] Table 2 The ring-opening polymerization reaction time of Examples 2 to 5 and Comparative Example 1 and the molecular weight of polylactic acid

[0071] Example Ring-opening polymerization reaction time (h) Polylactic acid molecular weight Example 212 400000 Example 318 600000 Example...

Embodiment 6~9 and comparative example 2

[0079] Examples 6 to 9 and Comparative Example 2 respectively provide a method for manufacturing a high biosafety cardiac stent. Compared with Example 1, the difference is that Examples 6 to 9 change the nano-tricalcium phosphate and nano-tricalcium phosphate in step S3. The mass ratio of magnesium oxide or the sintering temperature and sintering time of the sintering process; in Comparative Example 2, nano-tricalcium phosphate was directly used as the inorganic filler, without the addition of magnesium oxide and the sintering process. The raw material mass ratio and sintering parameters corresponding to each embodiment and comparative example are shown in Table 4.

[0080] Table 4 The raw material mass ratio and sintering parameters of step S3 in Examples 6-9 and Comparative Example 2

[0081]

[0082] The radial strength, porosity and degradation performance of the high biosafety cardiac stents prepared in Examples 6-9 and Comparative Example 2 were tested, and the results are sh...

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Abstract

The invention discloses a high-biosafety heart stent and a manufacturing method thereof. The method comprises the following steps: preparing polylactic acid by a lactide ring-opening polymerization approach, mixing and sintering nano calcium phosphate and magnesium oxide to prepare an inorganic filler, blending polylactic acid, polyethylene glycol and the inorganic filler to prepare printing slurry, forming a heart stent structure through 3D printing, and carrying out freeze drying and dipping drug loading to obtain the heart stent with high biosafety. According to the method, the molecular weight of the polylactic acid can be adjusted, so that the polylactic acid has excellent mechanical property and degradation property at the same time; the strength of the prepared heart stent is effectively improved by utilizing the synergistic effect of polylactic acid, inorganic filler and polyethylene glycol, and the heart stent has a proper degradation rate and relatively high biological safety. In addition, the prepared high-biosafety heart stent has high radial strength, proper porosity and degradation time, and can meet the requirements of practical application.

Description

Technical field [0001] The invention relates to the technical field of heart stents, in particular to a heart stent with high biological safety and a manufacturing method thereof. Background technique [0002] Cardiac stents are commonly used medical devices in cardiac interventional operations, which have the function of dredging arteries and are often used in the treatment of coronary heart disease. At present, heart stents are mainly divided into three types: metal stents, drug-coated stents and bioabsorbable stents. Among them, traditional metal stents and drug-coated stents cannot be completely degraded and will permanently exist in the blood vessel, which is likely to cause chronic damage to the blood vessel and intimal hyperplasia, and the risk of intrastent thrombosis and restenosis in the stent increases. High; and the bioabsorbable stent can dissolve in the body after the stent function is completed and be absorbed by the body, thereby avoiding the adverse consequences...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/14A61L31/06A61L31/02A61L31/16A61L31/18C08G63/08C08G63/78
CPCA61L31/028A61L31/06A61L31/14A61L31/146A61L31/148A61L31/16A61L31/18A61L2300/102A61L2300/404A61L2300/602A61L2400/12C08G63/08C08G63/78C08G2230/00C08L67/04C08L71/02
Inventor 王雯雯
Owner SHENZHEN MEDOO MEDICAL TECH
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