CN111544168B - A kind of integrated braided stent-graft edge closing process - Google Patents

Abstract

Translated fromChinese

本发明涉及一种一体式编织覆膜支架收边工艺，属于医疗器械技术领域；包括起始端收边工艺和结尾端收边工艺；采用“二步结束法”对金属和高分子纤维材料混编的一体式编织覆膜支架进行了收边。通过“二步结束法”收边工艺，可对一体式编织覆膜支架的端部进行光滑收边，且在一定程度上提高了覆膜支架的支撑性能。工艺简约、实用性强、创造性突出；本发明的应用将有利于推动二元混编一体式覆膜支架的产业化。

The invention relates to an integrated braided film-covered stent edging process, which belongs to the technical field of medical devices; it includes a starting-end edging process and an end-end edging process; and a "two-step finishing method" is adopted to mix metal and polymer fiber materials. The one-piece braided stent-graft has been edged. Through the "two-step end method" edge closing process, the end of the one-piece braided stent graft can be smoothly closed, and the support performance of the stent graft can be improved to a certain extent. The process is simple, the practicability is strong, and the creativity is outstanding; the application of the present invention will help to promote the industrialization of the two-component mixed-integrated stent-graft.

Description

Integrated woven covered stent edge folding process

Technical Field

The invention relates to an edge folding process of an integrated woven covered stent, and belongs to the technical field of medical instruments.

Background

The traditional covered stent consists of three parts, namely a covered membrane, a stent and a suture line, and the manufacturing process flow is as follows: respectively manufacturing a tectorial membrane and a stent, and then connecting the tectorial membrane and the stent by adopting a manual suture mode. The manual suture is different in suture methods and individual differences, so that the quality control of a final product is very difficult, and the traditional manufacturing process for manually suturing the covered stent has the defects of low production efficiency and uneven product quality; the process flow is not easy to reach standardization and automation. However, the currently developed integrated woven covered stent is formed by directly weaving the stent and the covering membrane in one step through a weaving method. Obviously, this process well overcomes the deficiencies of conventional stent grafts. However, after the integral type woven and covered stent is woven, broken ends of yarns often exist at two ends of the stent; the problems of loose edges, unsmooth edges and poor determination of heat treatment temperature exist in the metal and high polymer fiber binary integrated woven covered stent. When the edge is processed, if the heat treatment temperature of the high polymer material is selected, the metal wire cannot be welded. And if the welding temperature of the metal wire is adopted, the high polymer material is damaged. Therefore, how to perform the edge folding treatment of the integrated woven covered stent is very important.

Disclosure of Invention

The invention aims to solve the technical problem of how to narrow the edge of an integrated woven covered stent.

In order to solve the problems, the technical scheme adopted by the invention is to provide an integrated woven covered stent edge folding process, which comprises a starting end edge folding process and an ending end edge folding process; the method comprises the following steps:

step 1: a circular truncated cone-shaped weaving mold is adopted at the initial stage of weaving instead of a cylindrical mold, and only metal fibers are used for weaving at the initial stage of weaving to obtain an initial end support;

step 2: when the support is woven to the cylindrical part, the polymer fibers or yarns participate in weaving;

and step 3: when the covered stent is woven to the effective use length, the polymer fibers or the yarns do not participate in the weaving any more, and the metal fibers are woven forwards;

and 4, step 4: when the forward weaving is continued, a circular truncated cone-shaped weaving mold is adopted instead of a cylindrical mold;

and 5: continuously weaving forward for a certain length to obtain a tail end stent, finishing weaving, and taking off the covered stent;

step 6: after the covered stent is taken off the machine, connecting the metal stent at the starting end;

and 7: carrying out heat treatment fixing on the end part of the polymer fiber or the yarn at the starting end to finish the edge folding of the starting end;

and 8: connecting the knot end metal fibers;

and step 9: and (4) carrying out heat treatment fixing on the end part of the knot tail end polymer fiber or yarn to finish the end edge folding.

Preferably, the circular truncated cone-shaped knitting die adopted in the step 1 or the step 4 is provided with two circular surfaces which are parallel up and down, and central axes of the two circular surfaces are overlapped; the two circular surfaces are provided with different diameters, and the diameter of the large circular surface is 1.1-1.5 times of that of the small circular surface.

Preferably, the length of the inclined edge of the trapezoidal section formed by the central axis of the circular surface between the large circular surface and the small circular surface of the circular-frustum-shaped weaving mold is set to be 6-45 mm.

Preferably, the connection processing of the metal bracket at the starting end in the step 6 adopts a welding, binding, riveting with a metal cap or a manual back-knitting method.

Preferably, in the step 8, the connection treatment of the metal fibers at the knot end is performed by welding, binding, riveting with a metal cap or by a manual back-knitting method.

The invention provides an edge folding process of an integrated woven covered stent, which is specially used for folding edges of a metal and high polymer fiber binary integrated woven covered stent and can be used for folding edges of the integrated binary woven covered stent by a two-step finishing method. The two ends of the covered stent after the edge is folded are not easy to be loosened, and the supporting performance of the covered stent is improved to a certain extent; the process can carry out ideal edge folding treatment on the two ends of the integrated woven covered stent, and the rough edges of the covered stent can be smoothly treated and are beneficial to improving the anti-slip performance of the covered stent.

Compared with the prior art, the invention has the following beneficial effects:

(1) the invention solves the problem that the prior art does not have an integrated film-coated bracket which can be mixed-woven by metal and high molecular binary fiber to better edge.

(2) The edge folding process of the two-step finishing method solves the problem that the heat treatment temperature difference between the high polymer material and the metal material is huge and difficult to process, and realizes the smooth edge folding of the end part of the integrated covered stent.

(3) The process is simple and needs no special instrument and equipment.

(4) The effect is excellent, not only solves the problem of edge scattering, but also improves the supporting performance and the anti-slip performance of the covered stent to a certain extent.

(5) The application of the process is favorable for promoting the industrialization process of the binary mixed-woven integrated covered stent, and the process is strong in practicability, and outstanding in creativity and novelty.

Drawings

FIG. 1 is a schematic view of a longitudinal cutting structure of one end of a binary hybrid integrated covered stent.

Fig. 2 is a schematic diagram of a longitudinal cutting structure of a truncated cone-shaped die.

Detailed Description

In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:

as shown in fig. 1-2, the present invention provides an integrated woven covered stent edge folding process, which comprises a starting end edge folding process and an ending end edge folding process; the method comprises the following steps:

step 1: a circular truncated cone-shaped weaving mold is adopted at the initial stage of weaving instead of a cylindrical mold, and only metal fibers are used for weaving at the initial stage of weaving to obtain an initial end support;

step 2: when the support is woven to the cylindrical part, the polymer fibers or yarns participate in weaving;

and step 3: when the covered stent is woven to the effective use length, the polymer fibers or the yarns do not participate in the weaving any more, and the metal fibers are woven forwards;

and 4, step 4: when the forward weaving is continued, a circular truncated cone-shaped weaving mold is adopted instead of a cylindrical mold;

and 5: continuously weaving forward for a certain length to obtain a tail end stent, finishing weaving, and taking off the covered stent;

step 6: after the covered stent is taken off the machine, connecting the metal stent at the starting end;

and 7: carrying out heat treatment fixing on the end part of the polymer fiber or the yarn at the starting end to finish the edge folding of the starting end;

and 8: connecting the knot end metal fibers;

and step 9: and (4) carrying out heat treatment fixing on the end part of the knot tail end polymer fiber or yarn to finish the end edge folding.

The circular truncated cone-shaped weaving mold adopted in the step 1 and the step 4 is provided with two circular surfaces which are parallel up and down, and the central axes of the two circular surfaces are superposed; the two circular surfaces are provided with different diameters, and the diameter of the large circular surface is 1.1-1.5 times of that of the small circular surface. The length of the inclined edge of a trapezoidal section formed between the large circular surface and the small circular surface of the circular platform-shaped weaving mold through the central axis of the circular surface is set to be 6-45 mm.

In the step 6, the metal bracket at the starting end is connected by welding, binding, riveting a metal cap or manually back-knitting.

In the step 8, the metal fibers at the knot tail end are connected by welding, binding, riveting a metal cap or manually back-knitting.

The invention provides an edge folding process of an integrated woven covered stent, which is used for perfectly folding the edge of the integrated binary woven covered stent by a two-step method aiming at the edge folding of a metal and high polymer fiber binary integrated woven covered stent. The two ends of the covered stent after edge folding are not easy to fall apart, and the supporting performance of the covered stent is improved to a certain extent.

While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims (5)

1. The utility model provides an edge folding technology of integral woven covered stent, which is characterized in that: the method comprises a starting end edge closing process and an ending end edge closing process; the method comprises the following steps:

step 1: a circular truncated cone-shaped weaving mold is adopted at the initial stage of weaving instead of a cylindrical mold, and only metal fibers are used for weaving at the initial stage of weaving to obtain an initial end support;

step 2: when the support is woven to the cylindrical part, the polymer fibers or yarns participate in weaving;

and step 3: when the covered stent is woven to the effective use length, the polymer fibers or the yarns do not participate in the weaving any more, and the metal fibers are woven forwards;

and 4, step 4: when the forward weaving is continued, a circular truncated cone-shaped weaving mold is adopted instead of a cylindrical mold;

and 5: continuously weaving forward for a certain length to obtain a tail end stent, finishing weaving, and taking off the covered stent;

step 6: after the covered stent is taken off the machine, connecting the metal stent at the starting end;

and 7: carrying out heat treatment fixing on the end part of the polymer fiber or the yarn at the starting end to finish the edge folding of the starting end;

and 8: connecting the knot end metal fibers;

and step 9: and (4) carrying out heat treatment fixing on the end part of the knot tail end polymer fiber or yarn to finish the end edge folding.

2. The integrated woven covered stent edging process according to claim 1, characterized in that: the circular truncated cone-shaped weaving mold adopted in the steps 1 and 4 is provided with two circular surfaces which are parallel up and down, and the central axes of the two circular surfaces are superposed; the two circular surfaces are provided with different diameters, and the diameter of the large circular surface is 1.1-1.5 times of that of the small circular surface.

3. The integrated woven covered stent edging process according to claim 2, characterized in that: the length of the inclined edge of a trapezoidal section formed between the large circular surface and the small circular surface of the circular platform-shaped weaving mold through the central axis of the circular surface is set to be 6-45 mm.

4. The integrated woven covered stent edging process according to claim 1, characterized in that: in the step 6, the metal bracket at the starting end is connected by welding, binding, riveting a metal cap or manually back-knitting.

5. The integrated woven covered stent edging process according to claim 1, characterized in that: in the step 8, the metal fibers at the knot tail end are connected by welding, binding, riveting with a metal cap or manually back-knitting.

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