Method for preparing stent with coating in blood vessel

A technology of inner coating and blood vessels, which is applied in the field of preparation of endovascular coated stents, to achieve good compatibility, prevent complications, and good biocompatibility

Inactive Publication Date: 2009-04-22
RENJI HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIV SCHOOL OF MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, in the prior art, there is no report on using the layer-by-layer electrostatic self-assembly method to use silk fibroin peptide and chitosan as coating materials for scaffold modification

Method used

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  • Method for preparing stent with coating in blood vessel
  • Method for preparing stent with coating in blood vessel
  • Method for preparing stent with coating in blood vessel

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Experimental program
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Effect test

preparation example Construction

[0036] 本发明血管内涂层支架的制备方法,包括以下步骤:

[0037] (1)在支架体表面上涂覆形成聚合物底层;

[0038] (2)在上述聚合物底层表面上交替涂覆形成多层丝素肽层和几丁糖层。

[0039] 所述涂层包括聚合物底层、多层丝素肽层和几丁糖层。

[0040] 上述的制备方法中,在支架体表面涂覆聚合物底层时,所使用的溶液为含聚乙烯亚胺的NaCl水溶液,其中聚乙烯亚胺的浓度为5-10mg / ml,浸泡时间为10- 60 minutes.

[0041] 上述的制备方法中,在涂覆丝素肽层时,所使用的溶液为含丝素肽的NaCl水溶液,pH5.0-7.0(利用pH调节剂0.1mol / LNaOH溶液或0.1mol / LHCl溶液),其中丝素肽的浓度为2-5mg / ml,浸泡时间为5-20分钟。

[0042] 上述的制备方法中,在涂覆几丁糖层时,所使用的溶液为含几丁糖的NaCl水溶液,乙酸调节pH3.0-4.0,其中几丁糖的浓度为2-5mg / ml,浸泡时间为5-20分钟。

[0043] 上述的制备方法中,所使用的各NaCl水溶液中NaCl的浓度为0.14mol / L。

[0044] 上述的制备方法中,在每次浸泡后用生理盐水冲洗表面,并用真空干燥 / 氮气干燥方法进行干燥。

[0045] refer to figure 1 ,对本发明的制备方法进行具体的说明:

[0046] (1)在支架体表面上涂覆聚合物底层:将预处理过的支架体浸入聚乙烯亚胺的水溶液(聚乙烯亚胺的浓度为5-10mg / ml,含0.14mol / LNaCl)中浸泡10-60分钟左右,会在支架体的表面形成聚合物底层。形成的聚合物底层带有正电荷。将涂覆有聚合物底层的支架体用少量的生理盐水冲洗,并干燥。

[0047] (2)在聚合物底层表面上涂覆丝素肽层:将上述涂覆有聚合物底层的支架体浸入丝素肽的水溶液(丝素肽的浓度为2-5mg / ml,含0.14mol / LNaCl,利用pH调节剂0.1mol / LNaOH溶液或0.1mol / LHCl溶液调节pH5.0-7.0)中浸泡5-20分钟,会在聚合物底层的表面形成丝素肽层。丝素肽的等电点为4.23,在pH5.0-7.0的溶液中带负电荷。所以形成的丝素肽层带有负电荷。将涂覆有丝素肽层的支架体用少量的生理盐水冲洗,...

Embodiment 1

[0085] Example 1 Hydrophilic test of the endovascular coated stent of the present invention

[0086] Experimental apparatus: The contact angle of the coating surface was measured by an OCA20 video optical contact angle measuring instrument (manufactured by Dataphysics, Germany). Measurement accuracy: ±0.1°.

[0087] Experimental material: 316L stainless steel was used as the stent body, and 12 coated stents were prepared by the above-mentioned electrostatic self-assembly method of the present invention. The coating of the first piece is composed of polyethyleneimine layer and 1 layer of silk fibroin peptide layer; the coating of the second piece is composed of polyethyleneimine layer, 1 layer of silk fibroin peptide layer and 1 layer of chitosan from the inside to the outside Layer composition; the coating of the third layer is polyethyleneimine layer from inside to outside, (silk fibroin peptide layer + chitosan layer) 1 +Silk fibroin peptide layer; the fourth layer of coat...

Embodiment 2

[0090] Example 2 Experiment of anticoagulant effect of endovascular coated stent of the present invention

[0091] Experimental materials: 6 pieces of 316L stainless steel endovascular coated stents (1 layer of polyethyleneimine layer, 21 layers of multi-layer silk fibroin peptide layer and chitosan layer in total) prepared according to the above electrostatic self-assembly method of the present invention, and only the surface Clean 6 pieces of uncoated 316L stainless steel brackets.

[0092] Experimental method: 0.1ml of anticoagulated human blood was dropped on the surface of the stent, and 0.01ml of CaCl was added with a micropipette 2 The solution (0.2mol / l) was gently stirred with a micro-syringe needle, and the time was recorded immediately. At 10, 20, 30, 40, 50, and 60 min, rinse with 50 ml of distilled water respectively. The absorbance OD-time curve was measured by ultraviolet photometer at 540nm wavelength and compared with the uncoated 316L stainless steel stent. ...

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Abstract

The invention relates to a preparation method for a medical product for interventional therapy, in particular to a preparation method for a novel intravascular coated stent. The preparation method comprises the following steps: coating on the surface of a stent body through a method of electrostatic self-assembly layer upon layer to form a polymer bottom layer, and alternately coating on the surface of the polymer bottom layer to form multilayer silk peptide layers and chitosan layers. A stent coat obtained by the preparation method has better compatibility with blood, and can reduce late restenosis rate of post-operative heart.

Description

technical field [0001] The invention relates to a preparation method of a medical product for interventional treatment, in particular to a preparation method of a novel intravascular coating stent. In particular, the use of silk fibroin and chitosan to modify the metal surface through a layer-by-layer electrostatic self-assembly method makes it more compatible with blood, which can reduce the late restenosis rate of cardiovascular vessels after stenting. Background technique [0002] In 1987, Sigwart et al. used intravascular metal stents for the first time in coronary arteries, and received unexpected results, providing a good way for the treatment of vascular occlusive diseases. Coronary stent is an intravascular supporter made of metal stainless steel. It has good plasticity and geometric stability. It can be sent to the lesion through the catheter in a closed state, and then expanded by balloon dilation and other methods. function to support blood vessels. Coronary ste...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L33/12A61L33/08A61F2/82
Inventor 刘建平蒋容静李晓燕曹梅讯
Owner RENJI HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIV SCHOOL OF MEDICINE
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