CN114642528A - Method for preparing stent - Google Patents

Method for preparing stent Download PDF

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Publication number
CN114642528A
CN114642528A CN202011521806.7A CN202011521806A CN114642528A CN 114642528 A CN114642528 A CN 114642528A CN 202011521806 A CN202011521806 A CN 202011521806A CN 114642528 A CN114642528 A CN 114642528A
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CN
China
Prior art keywords
wire
wave ring
wave
stent
ring
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Pending
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CN202011521806.7A
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Chinese (zh)
Inventor
沈湘
方毅
肖本好
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Lifetech Scientific Shenzhen Co Ltd
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Shenzhen Xianjian Changtong Medical Co ltd
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Priority to CN202011521806.7A priority Critical patent/CN114642528A/en
Publication of CN114642528A publication Critical patent/CN114642528A/en
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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
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention provides a preparation method of a stent, which can avoid the situation that the free end of a braided wire is positioned at the near end or the far end of the stent, so that a blood vessel and an auxiliary instrument are easy to be punctured.

Description

Method for preparing stent
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a preparation method of a stent.
Background
With the development of aging society, the incidence of cardiovascular diseases is increasing, wherein diseases of the aortic system including aortic aneurysm and aortic dissection are in a high-incidence and critical state. The most common current method of treating aortic disease is by intraluminal intervention. The intracavity interventional therapy is to perform intracavity isolation on the aorta lesion position by using a covered stent by means of radiation equipment so as to achieve the effect of reconstructing blood flow of blood vessels.
The covered stent consists of two parts, namely a metal framework and a covered membrane, wherein the metal framework generally has two technical routes, namely cutting treatment is carried out by using a metal pipe, and weaving is carried out by using a metal wire.
The metal wire is knitted and then is subjected to heat treatment setting, the metal wire heads positioned at the head end and the tail end of the stent are inevitably formed, and if the metal wire heads are not treated, the stent covered with the membrane is implanted into a human body, and the risk of puncturing the membrane and then stabbing the blood vessel along with the pulsating metal wire heads of the blood vessel is generated.
Disclosure of Invention
The aim of the invention is at least to avoid that the free end of the braided wire is positioned at the near end or the far end of the stent and easily stabs the blood vessel. This object is achieved by:
a method of making a stent comprising a mid-wave ring and a proximal-wave ring, or a mid-wave ring and a distal-wave ring, comprising the steps of:
fixing a first end of a first wire, weaving a second end of the first wire around the axial direction of the stent, wherein the second end of the first wire is woven for at least one circle to form a first node middle wave ring, and winding and fixing the first end of the first wire on the first node middle wave ring by the second end of the first wire to form a first fixed knot;
extending the second end of the first wire to a far end or a near end, weaving the second end of the first wire around the axial direction of the stent at a position axially adjacent to the first nodal middle wave ring, and completing weaving for at least one circle to form a second nodal middle wave ring, wherein the second nodal middle wave ring is axially adjacent to the first nodal middle wave ring;
continuing to extend the second end of the first wire material to the far end or the near end, and sequentially weaving according to the weaving mode of the middle wave ring of the second node until the middle wave ring of the last node is formed;
after the middle wave ring of the last section is finished, winding the second end of the first wire material on any middle wave ring to form a second fixed knot;
the method comprises the steps of winding and fixing a first end of a second wire in any one middle wave ring to form a third fixed knot, extending a second end of the second wire to a near end or a far end, weaving around the axis direction of the stent, finishing weaving for at least one circle at the second end of the second wire to form the near end wave ring or the far end wave ring, wherein the near end wave ring or the far end wave ring is adjacent to and located at the near end or the far end of the first node middle wave ring, and winding and fixing the second end of the second wire on any one middle wave ring to form a fourth fixed knot.
In one embodiment, the preparation method further comprises:
winding and fixing a first end of a third wire in any one middle wave ring to form a fifth fixed knot, extending a second end of the third wire to a far end or a near end, weaving around the axial direction of the stent, completing weaving for at least one circle at the second end of the third wire to form the far end wave ring or the near end wave ring, wherein the far end wave ring or the near end wave ring is adjacent to the middle wave ring of the last node and is positioned at the far end or the near end of the middle part of the last node, and winding and fixing the second end of the third wire on any one middle wave ring to form a sixth fixed knot,
wherein the middle wave circle is located between the proximal wave circle and the distal wave circle, and the third wire forms the distal wave circle when the second wire forms the proximal wave circle; when the second wire forms the distal end wave turn, the third wire forms the proximal end wave turn.
In one embodiment, the middle wave ring has a plurality of first wires having different wire diameters, and a first end and a second end of each of the first wires are fixed to any one of the middle wave rings.
In an embodiment, at least one of the first fixing knot, the second fixing knot, the third fixing knot, the fourth fixing knot, the fifth fixing knot and the sixth fixing knot is at least partially wrapped with a thread or a film or partially wrapped with a connecting member.
In one embodiment, the thread or film is developable.
In an embodiment, the connector comprises a first part and a second part, the first part and the second part being fixedly connected, the first end of the first wire, the second end of the first wire, the first end of the second wire, the second end of the second wire, the first end of the third wire or the second end of the third wire being disposed between the first part and the second part.
In an embodiment, the connector has a maximum width in the axial direction of the connector of 1.5 to 3 times the diameter of the first, second or third wire.
In one embodiment, the first component comprises a first projection and a first groove, the second component further comprises a second projection and a second groove, the first projection and the second groove are mutually matched and connected, and the second projection and the first groove are mutually matched and connected; alternatively, the first member and the second member are connected by welding.
In one embodiment, the material of the connector comprises a developable metal material.
In one embodiment, the connector has a rounded outer surface.
According to the preparation method of the stent, the first fixed knot, the second fixed knot, the third fixed knot and the fourth fixed knot are all positioned on the middle wave ring, and the near-end wave ring or the far-end wave ring is adjacent to the middle wave ring of the first node and positioned at the near end or the far end of the middle wave ring of the first node, so that the fixed knots are not arranged on the near-end wave ring or the far-end wave ring, namely the first end and the second end of the corresponding wire are not arranged on the near-end wave ring or the far-end wave ring, and the near end or the far end of the stent is prevented from exposing the free end of the wire, and the blood vessel is prevented from being punctured.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like parts are designated by like reference numerals throughout the drawings. Wherein:
fig. 1 is a partial schematic view of a completed stent according to an embodiment.
Fig. 2 is a partial schematic view of a completed stent knit according to another embodiment.
Fig. 3 is a schematic diagram of a connector attached to a wave ring according to an embodiment.
Fig. 4 is a schematic diagram of a connector and a schematic diagram of a cross section B of a connector 30 with the largest axial dimension according to an embodiment.
FIG. 5 is a schematic view of different angles of a first component of a connector according to one embodiment.
Fig. 6 is a schematic view of a connector according to another embodiment.
FIG. 7 is a schematic view of a different angle of a second member of a connector according to another embodiment.
Detailed Description
Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.
Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
It should be noted that "distal end" and "proximal end" are used as orientation terms, which are conventional terms in the field of interventional medical devices, wherein "proximal end" means the proximal end and the end closer to the heart; "distal" means distal, the end further from the heart. Blood flows from the heart, first through the proximal end and then to the distal end.
The embodiment provides a method for preparing a stent 100, which comprises the following steps:
s101: fixing the first end of a first wire, weaving the second end of the first wire around the axis direction of the support, completing weaving for at least one circle at the second end of the first wire to form a first middle wave ring, winding the second end of the first wire on the first middle wave ring, and fixing the first end of the first wire to form a first fixed knot.
Referring to fig. 1, in the embodiment, the mold 1 is a fixed structure processed in advance, the mold 1 is cylindrical as a whole, a plurality of protruding structures 80 are arranged on the mold 1, and the protruding structures 80 are arranged at the peaks and valleys of the stent to facilitate hooking and weaving of the filaments, so as to form the structure of the stent 100. It should be noted that a wave rod is arranged between adjacent wave crests and wave troughs.
In step S101, the first wire 700 has a first end 701 and a second end 702, the protruding structure 80A is used as a starting point, the first end 701 is fixed at the starting point, the second end 702 is hooked on the protruding structure 80 in sequence around the axial direction of the stent along the horizontal direction, the first wire 700 completes at least one circle of weaving to form a first node middle wave ring 70A, in the embodiment, just one circle of weaving is completed, the second end 702 returns to the starting point protruding structure 80A, and then continues to wind around the first node middle wave ring 70A on the formed first node middle wave ring 70A in the weaving direction to form a first fixed knot 703, and the first fixed knot 703 is wound to fix the first end 701 of the first wire 700. In fig. 1, for the convenience of weaving, the first end 701 of the first wire 700 has a longer extending wire, and the first end 701 of the new first wire 700 can be just fixed in the first fixing knot 703 only by cutting the portion of the first wire 700 close to the first end 701 at the protruding structure 80 a.
In this embodiment, the first fixing knot 703 is shaped like a V, both ends of which are respectively located on the protruding structures 80a and 80b at two adjacent valleys, and the tip of which is located at the peak between the two adjacent valleys. In other embodiments, two ends of the V-shape are located at two adjacent peaks respectively, a tip of the V-shape is located at a valley between the two adjacent peaks, or the V-shape has an asymmetric structure. The shape of the first fixing knot 703 may be linear, dotted, W-shaped, or the like.
S102: and extending the second end of the first wire to a far end or a near end, weaving the second end of the first wire around the axial direction of the stent at a position axially adjacent to the first node middle wave ring, and finishing weaving for at least one circle at the second end of the first wire to form a second node middle wave ring, wherein the second node middle wave ring is axially adjacent to the first node middle wave ring.
In step S102, in this embodiment, the second end 702 of the first wire 700 extends down the wave bar 81 at the projection structure 80b, wherein the downward direction may be a distal direction or a proximal direction. At the axially adjacent position of the first mid-nodal wave ring 70A (i.e., the position of the second mid-nodal wave ring 70B), the second end 702 of the first wire 700 hooks the protruding structures 80 in sequence around the axial direction of the stent along the horizontal direction, completing the weaving for at least one turn to form the second mid-nodal wave ring 70B, which in this embodiment, just completes the weaving for one turn. It will be appreciated that the beginning of the second internodal undulating ring 70B is the projection 80B, and the second end 702 of the first wire 700 returns to the beginning after one complete revolution of braiding.
In order to allow the first and second mid-nodal wave rings 70A and 70B to be connected to each other, when the second mid-nodal wave ring 70B is woven, the first wire 700 hooks the projecting structure 80, and the second mid-nodal wave ring 70B and the first mid-nodal wave ring 70A cross each other at the overlapping point of the first mid-nodal wave ring 70A and the second mid-nodal wave ring 70B (i.e., the corresponding projecting structure 80).
S103: and continuously extending the second end of the first wire to the far end or the near end, and sequentially weaving according to the weaving mode of the middle wave ring of the second node until the middle wave ring of the last node is formed.
In step S103, the second end 702 of the first wire 700 continues to extend downward, and a third middle wave loop 70C is sequentially woven in the weaving manner of the second middle wave loop 70B until a last middle wave loop is formed. The number (node number) of the middle wave ring can be set according to requirements.
S104: and after the middle wave ring of the last section is completed, winding the second end of the first wire material on any middle wave ring to form a second fixed knot.
In step S104, the second fixed knot is not shown, and the second fixed knot has the same shape as the first fixed knot 703. Steps S101 to S104 are mainly used for knitting to form the middle wave ring.
S105: the method comprises the steps of winding and fixing a first end of a second wire in any one middle wave ring to form a third fixed knot, extending a second end of the second wire to a near end or a far end, weaving around the axis direction of the stent, finishing weaving for at least one circle at the second end of the second wire to form a near end wave ring or a far end wave ring, wherein the near end wave ring or the far end wave ring is adjacent to and located at the near end or the far end of the first node middle wave ring, and winding and fixing the second end of the second wire on any one middle wave ring to form a fourth fixed knot.
In step S105, in fig. 1, a second wire 600 includes a first end 601 and a second end 602. The first end 601 of the second wire 600 is wound and fixed on any middle wave, and in this embodiment, the first end 601 of the second wire is wound and fixed on the first middle wave 70A to form a third fixed knot 603.
Wherein the starting point of the third fixed knot 603 is a protruding structure 80c, and the ending point of the third fixed knot 603 is a protruding structure 80 d. Extending a second end 602 of the second wire 600 upward from the projecting structure 80d, wherein the upward direction may be in a proximal direction or in a distal direction.
Then, the second end 602 of the second wire 600 is hooked on the protruding structure 80 along the horizontal direction around the axial direction of the stent in sequence, at least one round of weaving is completed, a proximal end wave ring or a distal end wave ring is formed, in this embodiment, just one round of weaving is completed, a proximal end wave ring 60A is formed, and the second end 602 of the second wire 600 just returns to the protruding structure 80 d. With the proximal coil 60A being adjacent to the first mid-nodal coil 70A and being proximal to the first mid-nodal coil 70A. It is understood that 60A in fig. 1 may also be a distal wave ring.
After forming the proximal wave 60A, the second end 602 of the second wire 600 may be wound and secured over any of the medial waves to form a fourth fixed knot. In this embodiment, the second end 602 of the second wire 600 extends downward from the projecting structure 80d and is wound and fixed onto the first mid-nodal wave ring 70A, forming a fourth fixed knot 604. Wherein the fourth fixed knot 604 starts with the protruding structure 80d and ends with the protruding structure 80 e.
It should be noted that various shape changes of the third fixed knot 603 and the fourth fixed knot 604 can be referred to the first fixed knot 703. In fig. 1, in order to facilitate weaving, two ends of the second wire 600 have longer extended wires, and the first end 601 of the new second wire 600 can be just fixed in the third fixed knot 603 only by cutting the portion of the second wire 600 close to the first end 601 at the protruding structure 80c, and similarly, the second end 602 of the new second wire 600 can be just fixed in the fourth fixed knot 604 only by cutting the portion of the second wire 600 close to the second end 602 at the protruding structure 80 e.
A stent 100 having a mid-wave ring 70 and a proximal-wave ring 60A, or a stent 100 having a mid-wave ring 70 and a distal-wave ring (not shown) may be prepared according to steps S101-S105. In the stent 100 having the middle wave 70 and the proximal wave 60A, the free ends (first and second ends) of the wire on the proximal side are not provided at the proximal end of the stent 100, thereby preventing the free ends of the wire from sticking out of the proximal end of the stent 100, and thus from sticking into the blood vessel. Also, in the stent 100 having the middle wave and the distal wave, the free ends (the first end and the second end) of the wire on the distal side are not provided at the distal end of the stent 100, thereby preventing the free ends of the wire from sticking out of the distal end of the stent 100, and thus preventing the blood vessel from being punctured. Because the freedom degree of the head and the tail of the stent is highest, if the free ends of the wires are arranged on the stent, the risk of puncturing blood vessels or matching instruments (chimney technology) is high, and the risk of transferring the free ends of the wires to the position of the middle wave ring is greatly reduced.
In one embodiment, the method for preparing the stent further includes step S106: and winding and fixing a first end of a third wire on any one middle wave ring to form a fifth fixed knot, extending a second end of the third wire to a far end or a near end, weaving around the axial direction of the stent, finishing weaving for at least one circle at the second end of the third wire to form the far end wave ring or the near end wave ring, wherein the far end wave ring or the near end wave ring is adjacent to the middle wave ring of the last node and is positioned at the far end or the near end of the middle part of the last node, and winding and fixing the second end of the third wire on any one middle wave ring to form a sixth fixed knot. Wherein the middle wave ring is located between the proximal wave ring and the distal wave ring, and when the second wire forms the proximal wave ring, the third wire forms the distal wave ring; when the second wire forms the distal end wave circle, the third wire forms the proximal end wave circle.
In step S106, a distal end wave ring or a proximal end wave ring is further knitted in addition to steps S101 to S105. Referring to FIG. 2, stent 100 now includes proximal wave ring 60A, middle wave ring 70, and distal wave ring 60B. When the near-end wave ring is prepared in step S105, the far-end wave ring is prepared in step S106; when the distal end wave ring is prepared in step S105, the proximal end wave ring is prepared in step S106.
The third wire 800 includes a first end 801 and a second end 802. The first end 801 of the third wire 800 is wound and fixed on any one of the middle wave rings 70. In this embodiment, the first end 801 of the third wire 800 is wound and fixed on the last and last middle wave coils 70N and 70M to form a fifth fixed knot 803, wherein the fifth fixed knot 803 is a linear structure wound around two wave bars. The starting point of the fifth fixed knot 803 is a protruding structure 80f, and the ending point of the fifth fixed knot 803 is a protruding structure 80 g. A second end 802 of the third wire 800 is extended downward from the projecting structure 80g, wherein the downward direction may be in a proximal direction or in a distal direction.
Then, the second end 802 of the third wire 800 is hooked on the protruding structure 80 along the horizontal direction around the axial direction of the stent in sequence, at least one round of weaving is completed, a proximal end wave ring or a distal end wave ring is formed, in this embodiment, just one round of weaving is completed, a distal end wave ring 60B is formed, and the second end 802 of the third wire 800 just returns to the protruding structure 80 g. Wherein the distal end wave coil 60B is adjacent to the last mid-wave coil 70N and is distal to the last mid-wave coil 70N. It is understood that 70N in fig. 1 may also be a proximal wave ring.
After forming the distal end wave 60B, the second end 802 of the third wire 800 may be wound and secured over any of the middle wave to form a sixth fixed knot. In this embodiment, the second end 802 of the third wire 800 extends upward from the projecting structure 80g and is wound and fixed on the last and last mid-nodal wave turns 70N and 70M, forming a sixth fixed knot 804. Wherein, the starting point of the sixth fixed knot 804 is a protruded structure 80g, and the ending point is a protruded structure 80 h.
It should be noted that various shape changes of the fifth fixing knot 803 and the sixth fixing knot 804 can be referred to the first fixing knot 703. In fig. 1, in order to facilitate weaving, two ends of the third wire 800 have longer extended wires, and only the portion of the third wire 800 close to the first end 801 needs to be cut short at the protruding structure 80f, so that the first end 801 of the new third wire 800 can be just fixed in the fifth fixed knot 803, and similarly, only the portion of the third wire 800 close to the second end 802 needs to be cut short at the protruding structure 80h, so that the second end 802 of the new third wire 800 can be just fixed in the sixth fixed knot 804.
In this embodiment, the first wire 600, the second wire 700, and the third wire 800 may have the same or different wire diameters. To further satisfy the different radial forces in the axial direction of the stent, the middle wave 70 has a plurality of first wires 600, the plurality of first wires 600 having different wire diameters. Referring to fig. 2, where the stent 100 has a varying diameter in the middle, it can be seen that two first wires 600 are used in fig. 2, and the first end and the second end of each first wire are fixed to any one middle wave ring 700 in a manner similar to the above-described fixing manner of the respective wires.
In one embodiment, the method of making the stent further comprises heat setting. The free ends (first and second ends) of each wire may be shaped to the inner surface facing the stent body during this heat setting process to avoid pricking the vessel wall.
In one embodiment, the preparation method of the stent further comprises coating the surface of the woven stent with a film.
In one embodiment, to further reduce the risk of the tip of the filament stabbing the vessel wall, at least one of the first, second, third, fourth, fifth, and sixth fixation knots is at least partially wrapped with a thread or film or partially wrapped with a connector 30 (see fig. 3). Specifically, the thread may be selected from PTFE thread, polyester suture, polypropylene suture, nylon suture, or the like. The membrane may be selected from a PTFE membrane or a PET membrane. Wherein the wire or film has developability, specifically, barium sulfate is added to the material of the wire or film.
Further, in an embodiment, when one or more of the first fixed knot, the second fixed knot, the third fixed knot, the fourth fixed knot, the fifth fixed knot and the sixth fixed knot is/are arranged on the middle wave ring of the first section or the middle wave ring of the last section, a developing thread or film can be used for winding and wrapping to form a V-shaped knot, so that the V-shaped knot has developing property, and the V-shaped knot can also be used for indicating the near end and the far end of the stent. In other embodiments, one or more of the first fixed knot, the second fixed knot, the third fixed knot, the fourth fixed knot, the fifth fixed knot and the sixth fixed knot, whether arranged on any middle wave ring, can be wrapped by using a developing thread or a developing film to form a V-shaped knot.
The specific operation is as follows: the first fixed knot is wrapped by a wire or a film to form a V-shaped knot; or/and when the second fixed knot is positioned on the middle wave ring of the last section, the second fixed knot is wound and wrapped by adopting a wire or a film to form a V-shaped knot; or/and when the third fixed knot is positioned on the wave ring in the middle of the first section, the third fixed knot is wound and wrapped by adopting a wire or a film to form a V-shaped knot; or/and when the fourth fixed knot is positioned on the wave ring in the middle of the first section, the fourth fixed knot is wound and wrapped by adopting a wire or a film to form a V-shaped knot; or/and when the fifth fixed knot is positioned on the middle wave ring of the last section, the fifth fixed knot is wound and wrapped by adopting a wire or a film to form a V-shaped knot; or/and when the sixth fixed knot is positioned on the middle wave ring of the last section, the sixth fixed knot is wound and wrapped by adopting a wire or a film to form a V-shaped knot.
In this embodiment, in fig. 3, the connecting member 30 has a rounded outer surface, which may be an ellipsoid or a sphere or other rounded surface, and can avoid damaging the membrane and the blood vessel.
In the embodiment, the maximum width of the connecting piece 30 in the axial direction of the connecting piece 30 is 1.5-3 times of the diameter of the wire, so that the connecting piece 30 can be prevented from being too large, and the overall compression diameter of the stent can be increased; the connectors are too small to hold the free end of the wire well. For example, when the connecting member 30 is an ellipsoid, the axial direction of the connecting member is the major axis direction of the ellipsoid, and the maximum width in the axial direction is the maximum width in the major axis direction of the ellipsoid; when the connecting member 30 is spherical, the maximum width in the axial direction of the connecting member is the diameter.
Referring to FIG. 4, the connector 30 comprises a first member 301 and a second member 302, the first member 301 and the second member 302 being fixedly connected, a first end 601 of the first wire 600, a second end 602 of the first wire 600, a first end 701 of the second wire 700, a second end 702 of the second wire 700, a first end 801 of the third wire 800, or a second end 802 of the third wire 800 being disposed between the first member 301 and the second member 302.
Referring to FIG. 5, the first member 301 includes a first groove 301A and a second groove 301B, and it will be understood that the second member 302 includes a third groove and a fourth groove, and in connection with FIG. 4, when the first member 301 and the second member 302 are coupled adjacent to each other, the first groove 301A and the third groove form a first channel 4, and the second groove 301B and the fourth groove form a second channel 5, and in this embodiment, the free ends (first end and second end) of the wire are wound around corresponding coils for fixation. The first channel 4 can clamp the free end of the wire, and the second channel 5 can clamp the corresponding wave ring, so that the free end of the wire is coated and fixed in the connecting piece 30.
In this embodiment, the first groove 301A, the second groove 301B, the third groove and the fourth groove are all arranged along the axial direction of the connector. In other embodiments, the first, second, third and fourth slots 301A, 301B may be oriented in any direction so long as the free end of the filament can be secured. The first channel 4 or/and the second channel 5 extend through the connection element 30, in other embodiments as long as one end of the first channel 4 extends through the connection element 30 and the other end is located within the connection element 30.
In this embodiment, the first member 301 and the second member 302 are connected by welding.
In other embodiments, referring to fig. 6 and 7, the first member 301 further comprises a first protrusion 301C and a first recess 301D, the second member 302 further comprises a second protrusion 302C and a second recess 302D, the first protrusion 301C and the second recess 302D are cooperatively connected with each other, and the second protrusion 302C and the first recess 301D are cooperatively connected with each other. In this embodiment, a welding manner may not be adopted, the first protrusion 301C and the second groove 302D are in interference fit, and the second protrusion 302C and the first groove 301D are also in interference fit, so that the specifically adopted manner is a press riveting manner. Compared with a welding mode, the pressing riveting mode can reduce the size of the whole connecting piece.
In an embodiment of the present invention, the material of the connection member 30 includes a metal material having developability, such as tantalum, gold, platinum-iridium alloy, and the like. The connecting piece is made of developing materials, other developing points do not need to be arranged, and the positioning can be realized by the connecting piece.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (10)

1. A method of making a stent comprising a mid-wave ring and a proximal-wave ring, or a mid-wave ring and a distal-wave ring, comprising the steps of:
fixing a first end of a first wire, weaving a second end of the first wire around the axial direction of the stent, completing weaving for at least one circle to form a first middle wave ring, winding the second end of the first wire on the first middle wave ring, and fixing the first end of the first wire to form a first fixed knot;
extending the second end of the first wire to a far end or a near end, weaving the second end of the first wire around the axial direction of the stent at a position axially adjacent to the first nodal middle wave ring, and completing weaving for at least one circle to form a second nodal middle wave ring, wherein the second nodal middle wave ring is axially adjacent to the first nodal middle wave ring;
continuing to extend the second end of the first wire material to the far end or the near end, and sequentially weaving according to the weaving mode of the middle wave ring of the second node until the middle wave ring of the last node is formed;
after the middle wave ring of the last section is finished, winding the second end of the first wire material on any middle wave ring to form a second fixed knot;
and winding and fixing a first end of a second wire on any one of the middle wave rings to form a third fixed knot, extending a second end of the second wire to a near end or a far end, then weaving the second end of the second wire around the axial direction of the stent, completing weaving of the second end of the second wire for at least one circle to form the near end wave ring or the far end wave ring, wherein the near end wave ring or the far end wave ring is adjacent to the first node middle wave ring and is positioned at the near end or the far end of the first node middle wave ring, and then winding and fixing the second end of the second wire on any one of the middle wave rings to form a fourth fixed knot.
2. The method of making a stent of claim 1, further comprising:
winding and fixing a first end of a third wire on any one of the middle wave rings to form a fifth fixed knot, extending a second end of the third wire to a far end or a near end, then weaving the third wire around the axial direction of the stent, completing weaving of the second end of the third wire for at least one circle to form the far end wave ring or the near end wave ring, wherein the far end wave ring or the near end wave ring is adjacent to the middle wave ring of the last node and is positioned at the far end or the near end of the middle wave ring of the last node, and then winding and fixing the second end of the third wire on any one of the middle wave rings to form a sixth fixed knot,
wherein the middle wave circle is located between the proximal wave circle and the distal wave circle, and the third wire forms the distal wave circle when the second wire forms the proximal wave circle; when the second wire forms the distal end wave turn, the third wire forms the proximal end wave turn.
3. The method of making a stent of claim 1, wherein said mid-wave has a plurality of said first wires having different wire diameters, each of said first wires having a first end and a second end secured to any of said mid-wave.
4. The method of claim 1 or 2, wherein at least one of the first, second, third, fourth, fifth and sixth fixation nodes is at least partially wrapped with a thread or a film or partially wrapped with a connector.
5. The method of preparing a stent of claim 4, wherein the thread or film is developable.
6. The method of preparing a stent of claim 4, wherein the connector comprises a first component and a second component, the first component and the second component being fixedly connected, the first end of the first wire, the second end of the first wire, the first end of the second wire, the second end of the second wire, the first end of the third wire, or the second end of the third wire being disposed between the first component and the second component.
7. The method of preparing a stent of claim 4, wherein the connector has a maximum width in an axial direction of the connector of 1.5 to 3 times a diameter of the first, second or third wire.
8. The method of preparing a stent of claim 6, wherein the first member comprises a first protrusion and a first recess, the second member further comprises a second protrusion and a second recess, the first protrusion and the second recess are cooperatively connected with each other, and the second protrusion and the first recess are cooperatively connected with each other; alternatively, the first member and the second member are connected by welding.
9. The method of manufacturing a stent of claim 4, wherein the material of the connecting member comprises a metallic material having developability.
10. The method of preparing a stent of claim 4, wherein the connecting member has a rounded outer surface.
CN202011521806.7A 2020-12-21 2020-12-21 Method for preparing stent Pending CN114642528A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202011521806.7A CN114642528A (en) 2020-12-21 2020-12-21 Method for preparing stent

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202011521806.7A CN114642528A (en) 2020-12-21 2020-12-21 Method for preparing stent

Publications (1)

Publication Number Publication Date
CN114642528A true CN114642528A (en) 2022-06-21

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN202011521806.7A Pending CN114642528A (en) 2020-12-21 2020-12-21 Method for preparing stent

Country Status (1)

Country Link
CN (1) CN114642528A (en)

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