CN112137757A

CN112137757A - Novel coated blood vessel covered stent

Info

Publication number: CN112137757A
Application number: CN201910845302.1A
Authority: CN
Inventors: 李虎; 黄兴龙; 丁峰; 顾浩栋; 徐硕
Original assignee: Shanghai Hongpai Medical Technology Co Ltd
Current assignee: Shanghai Hongpai Medical Technology Co Ltd
Priority date: 2019-09-08
Filing date: 2019-09-08
Publication date: 2020-12-29

Abstract

The invention relates to a novel coated blood vessel covered stent in the field of peripheral blood vessels, which consists of an inner surface covered stent, a metal stent, an outer surface covered stent and a developing structure, wherein the surface of the metal stent is coated with a parylene coating, the head end of a product is processed into a petal-shaped structure, and the surfaces of the inner surface covered stent and the outer surface covered stent are coated with a heparin coating. The petal-shaped structure of the head end of the product can reduce the stimulation of the head end of the product to the inner wall of the blood vessel of the contact part, thereby preventing the occurrence of the marginal stenosis of the head end of the bracket. The metal stent forms a protective layer after passing through the parylene coating, so that the metal stent can be prevented from being corroded by blood, metal ions of the stent are prevented from entering human bodies to harm the health of patients, the smoothness of the parylene coating can improve the pushing performance of products when the products are conveyed, and the heparin coating on the surface of the coating can prevent thrombosis of the contact position of the products and further prevent restenosis of blood vessels.

Description

Novel coated blood vessel covered stent

Technical Field

The invention relates to a medical apparatus, in particular to a coated blood vessel covered stent in the field of peripheral blood vessels.

Background

At present, when treating vascular diseases such as hemangioma and vascular perforation clinically, endovascular repair provides a great deal of clinical benefit for patients, and has proven to be a safe and effective method-the minimally invasive method becomes a substitute treatment of standard open surgical repair by placing an endovascular stent, shortens the time of hospitalization in a ward and recovers normal activities more quickly, and has the advantages of low morbidity, quick recovery of patients and the like. With the use of endovascular stent-grafts, clinical adverse events such as thrombosis, blockage, marginal stenosis, etc. have been reported, resulting in patients being hospitalized again.

Metal stents are commonly used in the prior art as the framework structure. However, in the process of contacting the metal with human blood for a long time, metal ions are easy to precipitate and permeate into the human body, and the health of the human body is affected in severe cases. Especially nickel ions, the element nickel is toxic. In addition, due to different body systems of patients, part of patients have the phenomenon of allergy to nickel alloy, so that the nickel alloy material stent cannot be used at all. .

Disclosure of Invention

In order to overcome the defects of blood vessel restenosis and metal ion precipitation of the blood vessel covered stent, the invention provides the blood vessel covered stent with the Parylene coating, the blood vessel covered stent consists of an inner surface covering film, a metal stent, an outer surface covering film and a developing structure, the head end of the stent is in a petal-shaped structure, the surfaces of the metal stent are coated with Parylene or derivatives (Parylene) of Parylene) coatings, and the surfaces of the inner surface covering film and the outer surface covering film are coated with heparin coatings.

The outer surface coating film is composed of ePTFE and FEP or one of the materials, and the inner surface coating film is composed of an ePTFE material.

The outer surface coating can be a structure which completely covers the metal stent, and the length of the outer surface coating is equal to that of the inner surface coating.

The external surface film covering structure can also be processed into a strip shape to cover part of the surface of the metal stent.

One end or two ends of the covered stent are processed into petal-shaped structures.

The surface of the metal bracket can be coated with Parylene or derivatives thereof (Parylene) coating, or not coated with Parylene or derivatives thereof (Parylene) coating; the surface of the inner surface coating or the outer surface coating can be coated with a heparin coating or not.

The metal bracket can be made into a cylindrical structure by heat treatment of metal wires such as nickel titanium wires, stainless steel wires or alloy wires thereof. The cylindrical structure is formed by weaving a single metal wire which is processed into an S-shaped structure clockwise or anticlockwise, and no additional connecting structure exists between every two adjacent rows of woven wires.

The cylindrical structure of the metal stent can also be formed by laser cutting and expanding a nickel-titanium tube, a cobalt-chromium alloy tube, a stainless steel tube or a modified alloy thereof and the like. The cylindrical structure is formed by clockwise or anticlockwise surrounding metal rods processed into an S-shaped structure, and additional connecting structures or no additional connecting structures are arranged between every two adjacent rows of metal wires.

One end of the metal stent is processed with a radiopaque developing structure or both ends of the metal stent are processed with radiopaque developing structures, and developing materials are composed of one or more alloy materials of gold, platinum, osmium, rhenium, tungsten, iridium, rhodium and tantalum.

The outer surface film structure and the inner surface film structure are compounded with the metal stent into a whole through a heat treatment process or a bonding process. The surface of the metal bracket is also coated with Parylene or Parylene derivative coating, and the coating thickness is 0.1-100 microns.

The parylene coating is prepared by placing a metal support in a room temperature deposition chamber by adopting a vacuum vapor deposition method, cracking paraxylene dimer to obtain monomer steam, and forming a compact polymer layer on the surface of the metal support by the steam.

The invention has the following effective benefits: the product metal support is formed by weaving a single metal wire or cutting a metal pipe, an additional connecting structure can be arranged between every two adjacent rows of metal wires or not, and the structure can ensure that the two ends of the metal support have large moving space, strong tensile property and good flexibility. The metal stent forms a protective layer after passing through the parylene coating, so that the stent processed by metal materials can be prevented from being corroded by blood, metal ions of the stent are prevented from entering human bodies to harm the health of patients, the parylene coating can also prevent thrombosis, and the vasculitis of the implanted part of the stent is reduced; the parylene coating has good surface smoothness, and can improve the pushing performance of the product. The petal-shaped structure of the head end of the bracket can reduce the stimulation of the inner wall of the blood vessel at the contact part of the head end of the product, thereby preventing the occurrence of the marginal stenosis of the head end of the bracket. The heparin coating coated on the surface of the inner surface coating and the outer surface coating can prevent thrombosis at the contact part of the product and prevent the stenosis of the blood vessel.

Drawings

FIG. 1 is a partial sectional structural schematic view of the present invention.

Fig. 2 is a schematic cross-sectional structure of fig. 1.

Fig. 3 is a schematic structural diagram of another embodiment of the present invention.

Detailed Description

The invention is further illustrated in the following description with reference to the drawings in which:

as shown in figure 1, the invention consists of an inner surface coating film 1, a metal stent 2, an outer surface coating film 3 and a developing structure 4, and the two ends of the developing structure are processed into petal-shaped structures 7. The metal support 2 is woven into a cylindrical structure from a plurality of rows of S-shaped structural wires 5. The metal stent 2 is positioned between the inner surface coating film 1 and the outer surface coating film 3, and the developing structure 4 is processed at the head end of the metal stent 2.

The outer surface coating film 3 is composed of ePTFE and FEP, and the inner surface coating film is composed of an ePTFE material.

As shown in fig. 1, the outer surface coating 3 completely covers the metal stent 2, and the length of the outer surface coating 3 is equal to the length of the inner surface coating 1.

The metal support 2 is formed by weaving a single metal wire processed into an S-shaped structure clockwise, and no additional connecting structure is arranged between every two adjacent rows of the weaving wires 5.

Radiopaque developing structures 4 are processed at two ends of the metal stent 2, and developing materials are composed of one or more alloy materials of gold, platinum, osmium, rhenium, tungsten, iridium, rhodium and tantalum.

The outer surface coating film 3 and the inner surface coating film 1 are compounded with the metal stent 2 into a whole through a heat treatment process.

The surface of the metal support 2 is also coated with Parylene or derivatives thereof, and the thickness of the coating is 0.1-100 microns.

As shown in fig. 2, the outer surface coating 3 is composed of two materials, ePTFE 8 and FEP 9, and the metal stent 2 is positioned between the inner surface coating 1 and the outer surface coating 3.

As shown in fig. 3, another embodiment of the present invention comprises an inner surface coating 1, a metal stent 2, an outer surface coating 6, and a developing structure 4, wherein petal-shaped structures 7 are formed at both ends. The metal stent 2 is arranged between the inner surface coating 1 and the outer surface coating 6, and the developing structure 4 is processed at the head end of the metal stent 2.

As shown in fig. 3, the outer surface coating film 6 is processed into a strip shape and covers each row of the woven wires of the metal stent 2. The other structure is identical to that of fig. 1.

The above description is only a typical example of the present invention, and is not intended to limit the present invention, and all examples modified and extended based on the present invention are within the scope of the present invention.

Claims

1. A novel coated blood vessel covered stent consists of an inner surface covered stent, a metal stent, an outer surface covered stent and a developing structure, and is characterized in that the head end of the novel coated blood vessel covered stent is processed into a petal-shaped structure, the surface of the metal stent is coated with a parylene or derivative coating, and the surfaces of the inner surface covered stent and the outer surface covered stent are coated with a heparin coating.

2. The novel coated stent graft of claim 1, wherein the outer surface coating is configured to completely cover the metallic stent structure in a sheet-like configuration, and the length of the outer surface coating is equal to the length of the inner surface coating.

3. The novel coated stent graft of claim 1, wherein the outer surface coating comprises ePTFE and FEP and the inner surface coating comprises ePTFE material.

4. The novel coated stent graft as claimed in claim 1, wherein the metal stent structure is formed by processing metal wires such as ni-ti wires, co-cr alloy wires, stainless steel wires, etc. into a cylindrical structure, and the cylindrical structure is formed by weaving a single metal wire processed into an S-shaped structure clockwise or counterclockwise, and there is no additional connection structure between every two adjacent rows of woven wires.

5. The novel coated stent graft according to claim 1, wherein the metal stent has a cylindrical structure formed by laser cutting and expanding a nickel-titanium tube, a cobalt-chromium alloy tube, a stainless steel tube or a modified alloy thereof, and the like, the cylindrical structure is formed by clockwise or counterclockwise encircling of a metal rod processed into an S-shaped structure, and an additional connecting structure is or is not arranged between every two adjacent rows of metal wires.

6. The novel coated stent graft as claimed in claim 2, wherein the outer surface of the stent graft is formed into a strip-like structure covering each row of the woven filaments of the metal stent.

7. The novel coated stent graft of claim 1, wherein the metallic stent is provided with radiopaque imaging structures at one or both ends.

8. The novel coated stent graft as claimed in claim 7, wherein the developing material is composed of one or more alloy materials selected from gold, platinum, osmium, rhenium, tungsten, iridium, rhodium and tantalum.

9. The novel coated stent graft of claim 1, wherein the thickness of the parylene or derivative thereof is 0.1-100 μm.

10. The novel coated stent graft of claim 1, wherein the surface of the metal stent is optionally coated with parylene or a derivative thereof, and the surface of the inner surface coating or the outer surface coating is optionally coated with heparin.