CN111544169B - Integrated woven covered stent edge folding process - Google Patents

Integrated woven covered stent edge folding process Download PDF

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Publication number
CN111544169B
CN111544169B CN202010404900.8A CN202010404900A CN111544169B CN 111544169 B CN111544169 B CN 111544169B CN 202010404900 A CN202010404900 A CN 202010404900A CN 111544169 B CN111544169 B CN 111544169B
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film
covered stent
weaving
polymer
woven
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CN111544169A (en
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关国平
李志荣
王璐
郭爱军
王富军
林婧
刘晓凤
李彦
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USHARE MEDICAL Inc
Donghua University
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USHARE MEDICAL Inc
Donghua University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention relates to an integrated edge folding process for a woven covered stent, belonging to the technical field of medical instruments; the method comprises a starting end edge closing process and an ending end edge closing process; the 'two-step finishing method' is adopted to perform edge folding on the integrated woven covered stent mixed and woven by metal and polymer fiber materials. Through the edge folding process of the two-step finishing method, the end part of the integrated woven covered stent can be smoothly folded, and the supporting performance of the covered stent is improved to a certain extent. The process is simple, the practicability is strong, and the creativity is outstanding; the application of the stent is beneficial to promoting the industrialization of the binary mixed-woven integrated covered stent.

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 standardize and automate. 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 instead of a cylindrical mold is adopted in the initial stage of weaving, and only high-molecular yarns are used for weaving in the initial stage of weaving to obtain a coating;
step 2: when the covering film is woven to the cylindrical part, the metal wires participate in weaving;
and step 3: when the covered stent is woven to the effective use length, the metal wires do not participate in the weaving any more, and the polymer yarns are woven forwards continuously to obtain the covered membrane;
and 4, step 4: when the forward weaving is continued, a circular truncated cone-shaped weaving mold is adopted instead of a cylindrical mold; continuously weaving forward for a certain length, then finishing weaving, and taking the covered stent out of the machine;
and 5: after the covered stent is taken off the machine, carrying out heat treatment or adhesion treatment on the covering film at the starting end;
step 6: the head end of the metal wire at the starting end is completely positioned outside the film, and the head end of the metal wire is subjected to spot welding, spot gluing or polymer film and polymer tube coating treatment;
and 7: continuously turning the film coated with the starting end outwards twice towards the main body of the film coated stent, so that the head end of the treated metal wire is positioned in a cavity formed by eversion of the film;
and step 9: fixing the everted film and the film-covered stent in a sewing or bonding mode, and finishing the edge folding at the starting end;
step 10: carrying out heat treatment or bonding treatment on the film end at the knot end;
step 11: the tail end metal wire head end is completely positioned outside the film, and the metal wire head end is subjected to spot welding, dispensing or polymer film and polymer tube coating treatment;
step 12: continuously turning the coated film with the tail end processed outwards twice towards the main body direction of the coated stent, so that the head end of the processed metal wire is positioned in a cavity formed by eversion of the coated film;
step 13: fixing the everted film and the film-covered stent by adopting a sewing or bonding mode, and finishing the edge folding at the tail end.
Preferably, the circular truncated cone-shaped knitting die adopted in the step 1 and 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-truncated-cone-shaped knitting die is set to be 4-10 mm.
Preferably, in the step 6, the length of the metal wire end is set to be 2-5mm, and the polymer film and the polymer tube are made of a heat-shrinkable and biocompatible polymer material.
Preferably, the material of the polymer membrane and the polymer tube is PE or PTFE.
Preferably, the width of the film folded outwards in the step 7 is set to be 2-5 mm.
Preferably, in the step 11, the length of the metal wire end is set to be 2-5mm, and the polymer film and the polymer tube are made of a heat-shrinkable and biocompatible polymer material.
Preferably, the material of the polymer membrane and the polymer tube is PE or PTFE.
Preferably, the width of the film folded outwards in the step 12 is set to be 2-5 mm.
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, the problem of edge scattering is solved, and the supporting performance of the covered stent is improved to a certain extent.
(5) The process greatly promotes the industrialization process of the binary mixed-woven integrated covered stent, and has strong process practicability, creativity and novelty. .
Drawings
FIG. 1 is a schematic view of a longitudinal cutting structure of an end of a binary hybrid integrated covered stent.
FIG. 2 is a schematic structural view of the binary hybrid-woven integrated covered stent after one-time outward flanging.
FIG. 3 is a schematic structural view of the binary hybrid-woven integral covered stent after two outward flanging.
Fig. 4 is a schematic view 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. 1-4, 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 instead of a cylindrical mold is adopted in the initial stage of weaving, and only high-molecular yarns are used for weaving in the initial stage of weaving to obtain a coating;
step 2: when the covering film is woven to the cylindrical part, the metal wires participate in weaving;
and step 3: when the covered stent is woven to the effective use length, the metal wires do not participate in the weaving any more, and the polymer yarns are woven forwards continuously to obtain the covered membrane;
and 4, step 4: when the forward weaving is continued, a circular truncated cone-shaped weaving mold is adopted instead of a cylindrical mold; continuously weaving forward for a certain length, then finishing weaving, and taking the covered stent out of the machine;
and 5: after the covered stent is taken off the machine, carrying out heat treatment or adhesion treatment on the covering film at the starting end;
step 6: the head end of the metal wire at the starting end is completely positioned outside the film, and the head end of the metal wire is subjected to spot welding, spot gluing or polymer film and polymer tube coating treatment;
and 7: continuously turning the film coated with the starting end outwards twice towards the main body of the film coated stent, so that the head end of the treated metal wire is positioned in a cavity formed by eversion of the film;
and step 9: fixing the everted film and the film-covered stent in a sewing or bonding mode, and finishing the edge folding at the starting end;
step 10: carrying out heat treatment or bonding treatment on the film end at the knot end;
step 11: the tail end metal wire head end is completely positioned outside the film, and the metal wire head end is subjected to spot welding, dispensing or polymer film and polymer tube coating treatment;
step 12: continuously turning the coated film with the tail end processed outwards twice towards the main body direction of the coated stent, so that the head end of the processed metal wire is positioned in a cavity formed by eversion of the coated film;
step 13: fixing the everted film and the film-covered stent by adopting a sewing or bonding mode, and finishing the edge folding at the tail end.
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 4-10 mm.
In the step 6 of the starting end edge closing process, the length of the metal wire end is set to be 2-5mm, and the materials of the polymer film and the polymer tube are heat-shrinkable and biocompatible polymer materials; the material of the polymer film or the polymer tube is, but not limited to, Polyethylene (PE) or Polytetrafluoroethylene (PTFE). The width of the film which is folded outwards once in the step 7 of the starting end edge closing process is set to be 2-5 mm.
In the step 11 of the tail end edge folding process, the length of the metal wire end is set to be 2-5mm, and the materials of the polymer film and the polymer tube are heat-shrinkable and biocompatible polymer materials; the material of the polymer film or the polymer tube is, but not limited to, PE or PTFE. The width of the film folded outwards once in the step 12 of the tail end edge folding process is set to be 2-5 mm.
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 (9)

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 instead of a cylindrical mold is adopted in the initial stage of weaving, and only high-molecular yarns are used for weaving in the initial stage of weaving to obtain a coating;
step 2: when the covering film is woven to the cylindrical part, the metal wires participate in weaving;
and step 3: when the covered stent is woven to the effective use length, the metal wires do not participate in the weaving any more, and the polymer yarns are woven forwards continuously to obtain the covered membrane;
and 4, step 4: when the forward weaving is continued, a circular truncated cone-shaped weaving mold is adopted instead of a cylindrical mold; continuously weaving forward for a certain length, then finishing weaving, and taking the covered stent out of the machine;
and 5: after the covered stent is taken off the machine, carrying out heat treatment or adhesion treatment on the covering film at the starting end;
step 6: the head end of the metal wire at the starting end is completely positioned outside the film, and the head end of the metal wire is subjected to spot welding, spot gluing or polymer film and polymer tube coating treatment;
and 7: continuously turning the film coated with the starting end outwards twice towards the main body of the film coated stent, so that the head end of the treated metal wire is positioned in a cavity formed by eversion of the film;
and step 9: fixing the everted film and the film-covered stent in a sewing or bonding mode, and finishing the edge folding at the starting end;
step 10: carrying out heat treatment or bonding treatment on the film end at the knot end;
step 11: the tail end metal wire head end is completely positioned outside the film, and the metal wire head end is subjected to spot welding, dispensing or polymer film and polymer tube coating treatment;
step 12: continuously turning the coated film with the tail end processed outwards twice towards the main body direction of the coated stent, so that the head end of the processed metal wire is positioned in a cavity formed by eversion of the coated film;
step 13: fixing the everted film and the film-covered stent by adopting a sewing or bonding mode, and finishing the edge folding at the tail end.
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 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.
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 4-10 mm.
4. The integrated woven covered stent edging process according to claim 1, characterized in that: in the step 6, the length of the metal wire head end is set to be 2-5mm, and the polymer film and the polymer tube are made of heat-shrinkable and biocompatible polymer materials.
5. The integrated woven covered stent edging process according to claim 4, characterized in that: the material of the polymer film and the polymer pipe is PE or PTFE.
6. The integrated woven covered stent edging process according to claim 1, characterized in that: the width of the film folded outwards once in the step 7 is set to be 2-5 mm.
7. The integrated woven covered stent edging process according to claim 1, characterized in that: in the step 11, the length of the metal wire head end is set to be 2-5mm, and the polymer film and the polymer tube are made of heat-shrinkable and biocompatible polymer materials.
8. The integrated woven covered stent edging process according to claim 7, characterized in that: the material of the polymer film and the polymer pipe is PE or PTFE.
9. The integrated woven covered stent edging process according to claim 1, characterized in that: the width of the film folded outwards once in the step 12 is set to be 2-5 mm.
CN202010404900.8A 2020-05-13 2020-05-13 Integrated woven covered stent edge folding process Active CN111544169B (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113523159B (en) * 2021-07-08 2023-06-23 东华大学 Edge folding process for mechanical braiding type metal wire and polymer wire mixed braiding pipeline

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2312044Y (en) * 1997-05-13 1999-03-31 黄勇玲 Dilator for prostate
US20040172970A1 (en) * 2003-03-06 2004-09-09 Hiromasa Namiki Accessory and method of making the same
CN1675422A (en) * 2002-06-20 2005-09-28 费德罗-莫格尔动力系公司 Multiple layer insulating sleeve
CN1736346A (en) * 2004-08-19 2006-02-22 龚善石 Stopper for congenital heart structural defect, its manufacturing method and delivery arrangement
CN104689379A (en) * 2015-02-15 2015-06-10 东华大学 Woven integrally formed blood vessel covered stent and preparation method thereof
CN105105867A (en) * 2015-07-16 2015-12-02 东华大学 Integrally-molded woven blood vessel covered stent and preparation method thereof
CN207400830U (en) * 2017-01-04 2018-05-25 微创神通医疗科技(上海)有限公司 A kind of stent

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2312044Y (en) * 1997-05-13 1999-03-31 黄勇玲 Dilator for prostate
CN1675422A (en) * 2002-06-20 2005-09-28 费德罗-莫格尔动力系公司 Multiple layer insulating sleeve
US20040172970A1 (en) * 2003-03-06 2004-09-09 Hiromasa Namiki Accessory and method of making the same
CN1736346A (en) * 2004-08-19 2006-02-22 龚善石 Stopper for congenital heart structural defect, its manufacturing method and delivery arrangement
CN104689379A (en) * 2015-02-15 2015-06-10 东华大学 Woven integrally formed blood vessel covered stent and preparation method thereof
CN105105867A (en) * 2015-07-16 2015-12-02 东华大学 Integrally-molded woven blood vessel covered stent and preparation method thereof
CN207400830U (en) * 2017-01-04 2018-05-25 微创神通医疗科技(上海)有限公司 A kind of stent

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