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Novel bioresorbable slide fastener scaffold and use thereof

A sliding button and a new type of technology, applied in the field of medical devices, can solve problems such as being unsuitable for paediatric vascular stents, hindering lumen reconstruction and expansion, and affecting surgical treatment, so as to reduce the difficulty of surgical operations, have good clinical application prospects, and achieve good degradation. Effects of Sex and Biocompatibility

Active Publication Date: 2011-02-16
XIN HUA HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIV SCHOOL OF MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the fixed size of the metal stent will not change with the growth of the blood vessel after implantation, and it is easy to cause artificial stenosis due to the mismatch with the size of the blood vessel in the later stage. It is especially not suitable for pediatric vascular stents for children with growth characteristics.
[0005] The metal stent also has the following defects: (1) it is prone to thrombosis and requires long-term antiplatelet therapy; (2) it stays in the human body for life, which affects subsequent possible surgical treatment; (4) It may change the geometric configuration of the blood vessel and block the branches; (5) It hinders the subsequent reconstruction and expansion of the lumen; (6) If the metal stent does not fit tightly with the vessel wall, there will often be small residual gaps after implantation
However, there is no report on the new type of sliding buckle bioabsorbable stent with strong support and easy manufacture and use, and its application as a cardiovascular system stent or luminal stent in cardiovascular or luminal stenosis diseases.

Method used

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  • Novel bioresorbable slide fastener scaffold and use thereof
  • Novel bioresorbable slide fastener scaffold and use thereof
  • Novel bioresorbable slide fastener scaffold and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1 Structural Design and Comparison of Bioabsorbable Scaffolds

[0051] According to the current clinical vascular stent structure and the performance of bioabsorbable materials, three structures of stents were designed using PDO materials.

[0052](1) Self-expanding network pipe support: a stainless steel cylindrical mold is used to obtain the network pipe support. The diameter of the mold is consistent with the diameter of the required bracket. A circle of holes is evenly punched on the circumference of both ends of the mold, and steel needles are inserted. The number of upper and lower steel needles is the same, and they are aligned with each other. PDO fibers are woven and wound back and forth on the mold. Pay attention to the weaving sequence, you can directly weave a cylinder in which the fibers are interlaced and mutually restricted, and then heat-set (90°C, 4 hours) to keep it in this shape , Weaving density and fiber angle can be adjusted at will.

[0...

Embodiment 2

[0080] Embodiment 2 The in vitro simulated release of four kinds of PDO sliding buckle stents

[0081] (1) Observe the simulated release of polydioxanone (PDO) snap-in stent in vitro

[0082] 1. Materials and methods:

[0083] Materials: Polydioxanone (PDO) buckle-type stents 20*8mm, 10 each, rubber hoses with a diameter of 6 cm, stent delivery systems and pressure pumps.

[0084] method:

[0085] 1. First use the pressure pump to suck the delivery system balloon into negative pressure, then withdraw the outer sheath tube, crimp and wrap the slider brackets on the delivery system balloon respectively, and then push the outer sheath tube forward to the cone to cover stand.

[0086] 2. Insert the stent delivery system into the target site of the artificial blood vessel along the guide wire, expand and release the stent at 12atm*30 seconds.

[0087] 3. Suction the balloon back into negative pressure and withdraw the balloon.

[0088] 2. Observation indicators:

[0089] 1. V...

Embodiment 3

[0130] Example 3 The in vitro simulated release of edge-sliding buckle-type stents of five kinds of materials

[0131] (1) Observing the simulated release of polydioxanone (PDO) edge-sliding buckle stents in vitro

[0132] 1. Materials and methods:

[0133] Materials: Polydioxanone (PDO) edge-slip buckle-type stents 20*8mm, 10 each, rubber hoses with a diameter of 6 cm, a stent delivery system, and a pressure pump.

[0134] Methods: (see Observation of Polydioxanone (PDO) snap-on stent simulated release in vitro).

[0135] 2. Observation indicators:

[0136] (See Observation of Polydioxanone (PDO) snap-on stent simulated release in vitro).

[0137] 3. Results:

[0138] PDO edge-sliding buckle stents can be released under conventional release pressure (10-14atm), all stents can be successfully buckled, and no stent is curled into the lumen; the stent basically maintains the preset lumen diameter and has a very low Acute elastic recoil (0.3%). It is proved that the stent d...

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Abstract

The invention discloses use of a novel bioresorbable slide fastener scaffold as a cardiovascular system scaffold or endoluminal stent for cardiovascular disease or luminal stenosis disease. The invention has the advantages that: the novel bioresorbable slide fastener scaffold has good degradability and biocompatibility, is more suitable for a blood vessel scaffold in paediatrics, and cannot causelate stent thrombosis after being implanted so as to ensure that the patient does not need taking an anti-platelet agent for a long time and the subsequently possible surgical operation cannot be influenced; the novel bioresorbable slide fastener scaffold has strong support force, and can serve as the cardiovascular system scaffold or endoluminal stent to be widely applied to the cardiovascular disease or luminal stenosis disease; the novel bioresorbable slide fastener scaffold is easy and convenient to manufacture, is convenient to load medicines and can be used as a carrier of medicines or a vector for gene therapy; the scaffold is equipped with a deliver system to reduce the surgical operating difficulty; and a large number of animal experiments prove that the novel bioresorbable slidefastener scaffold has higher success rate during use, obvious treatment effect and better clinical application prospect.

Description

【Technical field】 [0001] The invention relates to a medical device, in particular to a novel sliding buckle bioabsorbable bracket and its application. 【Background technique】 [0002] Congenital heart disease (hereinafter referred to as congenital heart disease) is the most common cardiovascular disease in childhood, with an incidence rate of 0.678% of live-born babies. Congenital heart disease in infants is accompanied by congenital pulmonary artery and pulmonary vein stenosis, systemic vein and main artery Stenosis of arteries and their branches accounts for 7%-15% of all congenital heart diseases, and right ventricle-pulmonary artery artificial conduit (RV-PA conduit) stenosis after acquired surgery, postoperative restenosis of pulmonary artery and pulmonary vein, systemic vein and aorta The number of patients with restenosis of its branches and stenosis of Fontan's channel will continue to rise with the increase in the surgical capacity of congenital heart disease. [00...

Claims

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Application Information

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IPC IPC(8): A61L31/06A61F2/90
Inventor 孙锟孙康冯其茂
Owner XIN HUA HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIV SCHOOL OF MEDICINE
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