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Metal-polymer composite scaffold with multi-layer design to adjust degradation rate and its preparation method and application

A composite stent and polymer technology, applied in coatings, pharmaceutical formulations, surgery, etc., can solve the problems of insufficient mechanical properties, too fast degradation time of degradable metal material stents, etc., achieve constant radial strength and reduce stent defects The effect of the event

Active Publication Date: 2020-11-06
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Patent CN105412996A discloses a biodegradable stent and its preparation method. The main body of the biodegradable stent is composed of a degradable metal material layer, a development control layer and a degradable polymer material protective layer. The main body of the biodegradable stent is formed from a single The material becomes a composite material, so that the obtained biodegradable scaffold not only has the ideal degradation cycle of the degradable polymer material scaffold, but also has the mechanical properties of the degradable metal material scaffold, which can overcome the lack of mechanical properties of the degradable polymer material scaffold And the shortcoming of degradable metal material stent degradation time is too fast

Method used

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  • Metal-polymer composite scaffold with multi-layer design to adjust degradation rate and its preparation method and application
  • Metal-polymer composite scaffold with multi-layer design to adjust degradation rate and its preparation method and application
  • Metal-polymer composite scaffold with multi-layer design to adjust degradation rate and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042]Cut a pure iron sheet with a thickness of 200 μm (purity >99.9%) into 22mm×26mm, polish it with 800, 1500, 2000, and 3000 mesh sandpaper in sequence, and put the polished iron sheet in acetone and absolute ethanol for ultrasonic cleaning in sequence 10min, then dry the surface of the iron sheet with nitrogen, and place the iron sheet in an oven at 60°C to fully dry.

[0043] Polylactic acid (PLA) with a molecular weight of 60,000 was dissolved in ethyl acetate to prepare a PLA solution with a concentration of 1 mg / mL. The PLA solution was sprayed on the surface of the treated iron sheet by an ultrasonic spraying method to prepare an iron sheet with a PLA coating with a thickness of 4 μm on the surface. During the spraying process, the flow rate of the pump liquid is 0.1mL / min, and the ultrasonic power is 5.0W. Place the PLA-coated iron sheet in a fume hood to fully evaporate the ethyl acetate solvent.

[0044] Polydimethylsiloxane (PDMS) terminated with dialkyl 76 -OH...

Embodiment 2

[0049] Iron sheets of the same specifications were processed in the same manner as in Example 1 and PLA coatings of the same thickness were prepared on the surface of the iron sheets.

[0050] Polydimethylsiloxane (PDMS) terminated with dialkyl 76 -OH) as the initiator to synthesize the block copolymer of polytrimethylene carbonate-polydimethylsiloxane-polytrimethylene carbonate, namely PTMC 15 -PDMS 76 -PTMC 15 .

[0051] PTMC 15 -PDMS 76 -PTMC 15 and the precursor of Dow Corning 184 silicone rubber (the mass ratio of the basic component to the crosslinking agent is 10:1) was dissolved in ethyl acetate to prepare a solution with a concentration of 10 mg / mL, and the two solutions were combined at a volume ratio of 1:10. Mix to get a mixture. The above mixed solution was sprayed onto the PLA-coated surface of the PLA-coated iron sheet by the ultrasonic spraying method. During the spraying process, the pump flow rate was 0.05mL / min, and the ultrasonic power was 5.0W. For...

Embodiment 3

[0055] Iron sheets of the same specifications were processed in the same manner as in Example 1 and PLA coatings of the same thickness were prepared on the surface of the iron sheets.

[0056] Synthesize polylactic acid-polydimethylsiloxane-polylactic acid that is terminated by two hydroxyl groups in the same manner as in Example 1, i.e. PLA 15 -PDMS 76 -PLA 15 . PLA 15 -PDMS 76 -PLA 15 The structural formula is as Figure 6 shown.

[0057] Prepare PLA at a concentration of 2mg / mL 15 -PDMS 76 -PLA 15 The ethyl acetate solution of Dow Corning 184 silicone rubber precursor (wherein the mass ratio of the basic component and the crosslinking agent is 10:1) with a concentration of 2mg / mL, the two solutions were mixed in a volume ratio of 1:10 Blend to obtain a mixed solution. The above-mentioned mixed solution was sprayed on the PLA-coated surface of the above-mentioned PLA-coated iron sheet by an ultrasonic spraying method. During the spraying process, the flow rate of ...

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Abstract

The invention relates to a metal-macromolecule compound stent and a preparation method and application thereof. The compound stent comprises an iron-based stent and a degradable polyester coating anda water-proof coating which cover the outer portion of the iron-based stent in sequence, wherein the water-proof coating is a coating formed by cross-linking block polymer and a nondegradable component, the nondegradable component is silicone rubber or organic polysilazane, and the block polymer comprises a water-proof block and a degradable block. According to the metal-macromolecule compound stent and the preparation method and application thereof, a strategy of adjusting degradation behavior of the iron stent by applying multi-layer design is proposed, wherein the degradable polyester coating on the inner layer can accelerate iron corrosion, the water-proof coating on the outer layer can maintain radial strength of the stent in an initial stage of implantation, and by means of the multi-layer design, a time-varying degradation contour of the overall mechanical performance of the stent meets the clinical requirements more, so that by means of a thin stent beam, the requirements of stent radial strength and degradation characteristics in application are met.

Description

technical field [0001] The invention belongs to the field of degradable biomedical materials and medical devices, and in particular relates to a metal-polymer composite bracket and its preparation method and application. Background technique [0002] When used in the treatment of coronary artery stenosis, the degradable stent can be degraded and absorbed by the human body after providing mechanical support to the blood vessel for a certain period of time, avoiding the long-term clamping effect of the traditional metal drug-eluting stent on the blood vessel and causing late stents The occurrence of adverse events such as thrombosis. [0003] An ideal degradable stent should use the thinnest possible stent beam to provide radial support to the blood vessel for 3 to 6 months at the initial stage of implantation, and the degradation products will be gradually absorbed by the body. Iron has excellent mechanical properties and good biocompatibility, and can be degraded by the bod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/10A61L31/02A61L31/08A61L31/14A61L31/16
CPCA61L31/022A61L31/08A61L31/10A61L31/14A61L31/148A61L31/16A61L2300/416A61L2300/602A61L2400/18A61L2420/02A61L2420/06A61L2420/08C08L67/04C08L83/04
Inventor 丁建东齐永丽何垚
Owner FUDAN UNIV