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A high biosafety heart stent and its manufacturing method

A biosafety, cardiac stent technology, used in drug delivery, pharmaceutical formulations, surgery, etc., can solve the problems of affecting stent blood compatibility, insufficient biosafety, and increase the risk of thrombosis, and achieve high support and biosafety. The effect of improving blood compatibility, improving strength and hydrophilicity

Active Publication Date: 2020-12-22
SHENZHEN MEDOO MEDICAL TECH
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  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • A high biosafety heart stent and its manufacturing method
  • A high biosafety heart stent and its manufacturing method
  • A high biosafety heart stent and its manufacturing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] This embodiment provides a method for manufacturing a high biosafety heart stent, comprising the steps of:

[0055] S1. Polylactic acid was prepared by ring-opening polymerization of lactide, and the polylactic acid was dissolved in 1,4-dioxane according to the mass volume ratio of 1g:10mL, and it was fully stirred for later use;

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

[0057] S11. Put the L-lactic acid monomer in a round-bottomed flask, heat and dehydrate under reduced pressure at 170°C and 5kPa for 5h, then add 1wt% of stannous octoate as a catalyst, and carry out the third step at 200°C and 0.5kPa. Distillation of lactide, after condensation, crude lactide is obtained;

[0058] S12. Washing and recrystallizing the crude lactide obtained in step S11 in sequence to obtain purified L-lactide; the washing process is to place the crude lactide in deionized water, and perform suction fil...

Embodiment 2~5 and comparative example 1

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

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

[0071] Example Ring-opening polymerization reaction time (h) Molecular weight of polylactic acid Example 2 12 400000 Exam...

Embodiment 6~9 and comparative example 2

[0079]Embodiments 6-9 and Comparative Example 2 respectively provide a method for manufacturing a high-biosafety heart stent, compared with Example 1, the difference is that Embodiments 6-9 have changed the step S3 of nano tricalcium phosphate and The mass ratio of magnesia or the sintering temperature and sintering time of the sintering process; in comparative example 2, nanometer tricalcium phosphate was directly used as the inorganic filler without adding magnesia and sintering process. The mass ratio of raw materials 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 shown in Table 5.

[0083] Table 5 T...

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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 high biosafety heart stent and a manufacturing method thereof. Background technique [0002] Cardiac stent is a commonly used medical device in cardiac interventional surgery. It has the effect of dredging arteries and blood vessels, and is often used for the treatment of coronary heart disease. At present, cardiac stents are mainly divided into three categories: metal stents, drug-coated stents and bioabsorbable stents. Among them, traditional metal stents and drug-coated stents will permanently exist in blood vessels because they cannot be completely degraded, which is likely to cause chronic damage to blood vessels and intimal hyperplasia, and lead to increased risks of in-stent thrombosis and in-stent restenosis. High; and the bioabsorbable stent can dissolve in the body after the stent function is completed and be absorbed by the body, thus avoiding the adverse conse...

Claims

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Application Information

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Patent Type & Authority Patents(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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