CN113117160A

CN113117160A - Novel degradable blood vessel stent and manufacturing method thereof

Info

Publication number: CN113117160A
Application number: CN201911387110.7A
Authority: CN
Inventors: 金皓天
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2021-07-16

Abstract

The invention relates to a degradable stent used in blood vessels, in particular to a novel degradable blood vessel stent and a manufacturing method thereof, wherein the method comprises the following steps: the zinc alloy contains 4-10mg of zinc element, the diameter of crystal grains is 10-17nm, a coating of the natural degradable high polymer material is prepared on the surface of the zinc alloy, a layer of medicine coating is arranged on the coating of the natural degradable high polymer material, the degradable intravascular stent obtains higher strength and better ductility through improvement and optimized processing technology of the zinc alloy material, the supporting force of the novel intravascular stent is increased, the coverage rate of the stent is reduced, and the effects of promoting re-endothelialization, improving endothelial functions, reducing inflammatory reactions and inhibiting excessive hyperplasia of neointima by coating a proper coating are achieved.

Description

Novel degradable blood vessel stent and manufacturing method thereof

Technical Field

The invention relates to a degradable stent used in a blood vessel, and particularly provides a novel degradable blood vessel stent and a manufacturing method thereof.

Background

The angioplasty and stenting is an interventional operation in which a stent is implanted in a body to support a blood vessel and compress an intraluminal plaque of the blood vessel to prevent rebound of the blood vessel and protrusion of an intimal plaque into the blood vessel, and the stent is delivered to a lesion site through a delivery system and then plastically expanded to maintain smooth blood flow.

The main existing forms of the current vascular stent are: the bare metal stent is easy to induce adverse reactions such as thrombus, endothelial hyperplasia and the like after being implanted into a human body, thereby causing restenosis in blood vessels. The drug eluting stent is formed by coating a polymer coating capable of carrying drugs on the surface of a metal stent, so that the restenosis rate can be effectively reduced, but the metal stent is still permanently implanted into a patient body, and long-term potential safety hazards are unknown. The degradable stent can be dissolved while releasing the medicine to the disease blood vessel area in a directional way, and the stent completely disappears after the reconstruction process of the blood vessel cavity is completed.

The currently studied biodegradable materials mainly include polymer materials, iron alloys, magnesium alloys, and zinc alloys, wherein the polymer materials are limited in their applications due to non-developability under X-ray, insufficient radial support strength, and poor deformability. Magnesium alloy materials are common materials in the research of degradable stents at present, but the degradation speed of magnesium alloy in vivo is too high, so that the supporting performance of the magnesium alloy materials cannot meet the requirement of the reconstruction of the normal function of blood vessels. Although the mechanical property of the degradable iron alloy material is excellent, the degradation rate is too slow, and the biocompatibility is controversial, so that the application of the degradable iron alloy material to the vascular stent is difficult; the zinc alloy stent has good biocompatibility and moderate in-vivo degradation performance, and has good prospect in the material research of the degradable stent.

A woven stent and a pipe network structure stent cut by laser trace the preparation process of the vascular stent, and the preparation process mainly comprises the following forms: weaving, flat plate photoetching roll welding and laser cutting, wherein the weaving support is formed by weaving and winding metal wires on a die; the flat plate engraving and roll welding is to engrave support patterns on a metal sheet by utilizing a photoetching technology, and then to crimp and weld; the three-dimensional laser cutting technology is a processing mode of performing hollow cutting on a thin-wall circular tube by laser. However, in the current market, the problems of low elongation rate, high brittleness, poor plastic deformation, high corrosion degradation speed and the like exist in the material development process of the degradable stent, so that the development of an optimized degradable vascular stent made of a zinc alloy material is essential.

Disclosure of Invention

The invention aims to solve the problems and provides a novel degradable blood vessel stent and a manufacturing method thereof.

The technical scheme of the invention is as follows:

a novel degradable vascular stent comprising: the zinc alloy contains 4-10mg of zinc element, the diameter of crystal grains is 10-17nm, a coating of the natural degradable high polymer material is prepared on the surface of the zinc alloy, and a drug coating is arranged on the coating of the natural degradable high polymer material.

Preferably, the drug coating is poly-L-lactic acid or chitosan.

Preferably, the coating thickness of the natural degradable high polymer material is 150-260 nm.

Preferably, the drug coating thickness is no greater than 150 nm.

Preferably, in the manufacturing method of the novel degradable vascular stent, the material of the vascular stent is cut, melted, vaporized and ablated or reaches a burning point by a three-dimensional laser, the material of the vascular stent is cut and positioned by a positioning control system, then the material is cut by blowing off the molten substance by the high-speed airflow coaxial with the light beam, the surface of the cut material is uniformly coated with the natural degradable high polymer material, and finally the coating of the natural degradable high polymer material is coated with a drug coating to manufacture the degradable vascular stent.

Preferably, the three-dimensional laser comprises a long pulse width laser and an ultra-short pulse laser, wherein the pulse width of the long pulse width laser is greater than 10ps, and the pulse width of the ultra-short pulse laser is less than 10 ps.

Preferably, the high-speed gas flow is mixed with auxiliary gas, and the auxiliary gas comprises oxygen, argon and nitrogen.

The invention has the technical effects that: by improving and optimizing the processing technology of the zinc alloy material, the degradable intravascular stent can obtain higher strength and better ductility, the supporting force of the novel intravascular stent is increased, the coverage rate of the stent is reduced, and the effects of re-endothelialization, endothelial function improvement, inflammatory reaction reduction and neointimal hyperplasia inhibition can be realized by coating a proper coating.

Detailed Description

Example 1

A novel degradable vascular stent comprising: the zinc alloy contains 4mg of zinc element, the diameter of crystal grains is 10nm, a coating of the natural degradable high polymer material is prepared on the surface of the zinc alloy, and a drug coating is arranged on the coating of the natural degradable high polymer material.

A degradable blood vessel support is made up through such technological steps as cutting the material by three-dimensional laser, fusing, vaporizing, ablating or burning, cutting by locating control system, blowing off the fused substance by high-speed airflow, cutting, uniformly coating natural degradable high-molecular material on the surface of the material, and coating medicine layer on the coating of natural degradable high-molecular material.

Example 2

Contain 7 mg's zinc element in the zinc alloy among the novel degradable vascular support, the diameter size of its crystalline grain is 15nm, prepare natural degradable macromolecular material's coating on zinc alloy's surface, set up one deck drug coating on natural degradable macromolecular material's coating, drug coating is poly levolactic acid or chitosan, natural degradable macromolecular material's coating thickness is 150nm, drug coating thickness is not more than 150nm, vascular support's material cuts the material through long pulse width laser, make degradable vascular support.

Example 3

Contain 10 mg's zinc element in the zinc alloy among the novel degradable vascular support, the diameter size of its crystalline grain is 17nm, prepare natural degradable macromolecular material's coating on zinc alloy's surface, set up one deck drug coating on natural degradable macromolecular material's coating, drug coating is poly levolactic acid or chitosan, natural degradable macromolecular material's coating thickness is 260nm, drug coating thickness is not more than 150nm, vascular support's material cuts the material through section pulse width laser, make degradable vascular support.

Claims

1. A novel degradable vascular stent comprising: zinc alloy and natural degradable high molecular material, its characterized in that: the zinc alloy contains 4-10mg of zinc element, the diameter of crystal grains is 10-17nm, a coating of a natural degradable high polymer material is prepared on the surface of the zinc alloy, and a drug coating is arranged on the coating of the natural degradable high polymer material.

2. The novel degradable vascular stent of claim 1, wherein: the drug coating is poly-L-lactic acid or chitosan.

3. The novel degradable vascular stent of claim 2, wherein: the coating thickness of the natural degradable high polymer material is 150-260 nm.

4. The novel degradable vascular stent of claim 3, wherein: the thickness of the drug coating is not more than 150 nm.

5. The method for manufacturing the novel degradable vascular stent of claim 4, wherein: the material of the vascular stent is cut, melted, vaporized and ablated or reaches a burning point through a three-dimensional laser, the material of the vascular stent is cut and positioned through a positioning control system, then the melted substances are blown off through high-speed airflow coaxial with light beams to cut the material, the surface of the cut and formed material is evenly coated with a natural degradable high polymer material, and finally a medicine coating is coated on the coating of the natural degradable high polymer material to prepare the degradable vascular stent.

6. The method for manufacturing the novel degradable vascular stent of claim 5, wherein: the three-dimensional laser comprises a long pulse width laser and an ultra-short pulse laser, wherein the pulse width of the long pulse width laser is more than 10ps, and the pulse width of the ultra-short pulse laser is less than 10 ps.

7. The method for manufacturing the novel degradable vascular stent of claim 6, wherein: the high-speed gas flow is mixed with auxiliary gas, and the auxiliary gas comprises oxygen, argon and nitrogen.